Role of Intravascular Imaging in Optimising PCI Outcomes Infographic
Srihari S. Naidu, Arnold Seto, and Salvatore Brugaletta discuss the latest advancements in the field Interviews
10 Review of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2025 Congress Features
23 EuroPCR 2025: Making Quantum Leaps in Interventional Cardiology
Josip A. Borovac
28 Cardiac Imaging Innovations at EuroPCR 2025
Diaa Hakim
31 Improving Pacemaker Prediction After Transcatheter Aortic Valve Implantation with Machine Learning
de Albuquerque F et al.
33 Large Language Models in Real-World Interventional Cardiology: The ILLUMINATE Study
Lauretti A et al.
36 Endovascular Treatment of Vascular Complications in Mine-explosive Injuries
Furkalo S et al.
37 Improving Large Language Models via Heart Team Simulation
Garin D et al.
39 BCIS CHIP-PCI Score in Non-ST-Elevation Acute Coronary Syndrome
Kalogera V et al.
41 Impact on Re-Intervention and Amputation Rates Using Dual-Wire Re-Entry Balloon
Del Giudice and Gandini
43 AI-Guided Risk Stratification in Aortic Stenosis
Garin D et al.
45 Age Matters: Comparing Outcomes of Patient Foramen Ovale Closure
Beneki E et al.
47 Mitral Annular Remodelling Following HighLife Transcatheter Mitral Valve Replacement
Schneider L et al.
49 HEART Score and Coronary Artery Disease in Patients with Non-ST Acute Coronary Syndrome
Al Mamun A et al.
51 Invasive Biventricular Physiology and Response after Transcatheter Mitral Repair
Chehab O et al.
54 Outcomes of Functionally Guided Drug-Coated Balloon versus Drug-Eluting Stent Percutaneous Coronary Intervention
Leone AM et al. Congress Interview
58 Salvatore Brugaletta
60 Srihari S. Naidu
72 Role of Intravascular Imaging in Optimising PCI Outcomes
74 Editor's Pick: Transcatheter Aortic Valve Implantation and Pure Non-Calcified Aortic Regurgitation
Marrone and Ielasi 86 Drug-Coated Balloons in Percutaneous Coronary Interventions
Tanaka T et al. 101 Transverse Stent Fracture Diagnosis and Management
Elkhayat and Elhoseiny
Editorial Board
Editor-in-Chief
Dr Pablo Sepúlveda
Catholic University of Chile, Santiago, Chile
Pablo Sepúlved specialised in interventional cardiology at Clinique Saint Jean in Belgium. With over 20 years’ experience in the field, Sepúlveda's research focuses on pulmonary arterial hypertension, heart failure, and acute coronary syndromes.
European Prevention Center joint with Medical Center Düsseldorf (Grand Arc), Germany
Dr Sanjog Kalra
University of Toronto, Canada
Dr Aaron Kugelmass Baystate Health System, Springfield, Massachusetts, USA
Prof Eduard Margetic Clinical Hospital Center Zagreb, Croatia
Dr Gregory Pavlides University of Nebraska Medical Center, USA
Prof Dr Rainer Wessely Center for Cardiovascular Medicine, Germany
Aims and Scope
EMJ Interventional Cardiology is an open access, peerreviewed ejournal committed to helping elevate the quality of practices in interventional cardiology globally by informing healthcare professionals on the latest research in the field.
The journal is published annually, six weeks after the European Association for Percutaneous Cardiovascular Interventions (EuroPCR) Annual Meeting, and features highlights from this event, alongside interviews with experts in the field, reviews of abstracts presented at EuroPCR, as well as in-depth features on sessions from this event. The journal also covers advances within the clinical and pharmaceutical arenas by publishing sponsored content from congress symposia, which is of high educational value for healthcare professionals. This undergoes rigorous quality control checks by independent experts and the in-house editorial team.
EMJ Interventional Cardiology also publishes peer-reviewed research papers, review articles, and case reports in the field. In addition, the journal welcomes the submission of features and opinion pieces intended to create a discussion around key topics in the field and broaden readers’ professional interests. The journal is managed by a dedicated editorial team that adheres to a rigorous double-blind peer-review process, maintains high standards of copy editing, and ensures timely publication.
EMJ Interventional Cardiology endeavours to increase knowledge, stimulate discussion, and contribute to a better understanding of practices in the field. Our focus is on research that is relevant to all healthcare professionals in this area. We do not publish veterinary science papers or laboratory studies not linked to patient outcomes. We have a particular interest in topical studies that advance knowledge and inform of coming trends affecting clinical practice in interventional cardiology.
Further details on coverage can be found here: www.emjreviews.com
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EMJ is supported by various levels of expertise:
• Guidance from an Editorial Board consisting of leading authorities from a wide variety of disciplines.
• Invited contributors who are recognised authorities in their respective fields.
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On submission, all articles are assessed by the editorial team to determine their suitability for the journal and appropriateness for peer review.
Editorial staff, following consultation with either a member of the Editorial Board or the author(s) if necessary, identify three appropriate reviewers, who are selected based on their specialist knowledge in the relevant area.
All peer review is double blind.
Following review, papers are either accepted without modification, returned to the author(s) to incorporate required changes, or rejected.
Editorial staff have final discretion over any proposed amendments.
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Staff members attend medical congresses as reporters when required.
This Publication
Launch Date: 2013 Frequency: Yearly
Online ISSN: ISSN 2053-423X
All information obtained by EMJ and each of the contributions from various sources is as current and accurate as possible. However, due to human or mechanical errors, EMJ and the contributors cannot guarantee the accuracy, adequacy, or completeness of any information, and cannot be held responsible for any errors or omissions. EMJ is completely independent of the review event (EuroPCR 2025) and the use of the organisations does not constitute endorsement or media partnership in any form whatsoever. The cover photo is of Paris, France, the location of EuroPCR 2025.
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Welcome
Dear Readers,
Welcome to the 2025 issue of EMJ Interventional Cardiology, which presents a curated selection of key updates from the 2025 European Association of Percutaneous Cardiovascular Interventions (EuroPCR) Annual Meeting. This year’s programme spotlighted new approaches for managing patients with complex cases, emphasising novel strategies for the treatment of calcified lesions, in particular. The application of imaging techniques in intervention management was another key highlight of the event.
This issue also features exclusive interviews with distinguished experts, who discuss opportunities for improvement and the future of the field. They address topics such as managing hypertrophic cardiomyopathy and the efficient use of closed-loop communication in catheterisation labs.
You will also find a standout abstract review that summarises a propensity-matched analysis comparing drug-coated balloon and drug-eluting stent percutaneous coronary interventions. This study provides important insights into the viability and safety of a balloon as an alternative to stent implantation in appropriately selected patients.
It comes as no surprise that AI technology is becoming increasingly prominent in the field. This is exemplified by a compelling study comparing a machine learning classification for predicting pacemaker implantation after transcatheter aortic valve implantation with a more traditional regression-based model.
In closing, we would like to extend our gratitude to the Editorial Board, our contributors, expert interviewees, and insightful peer reviewers for their invaluable contributions to the production of this high-quality issue. Until the next issue, we trust that you will draw knowledge and inspiration from this content.
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Foreword
Dear Colleagues,
It is my pleasure to welcome you to the latest issue of EMJ Interventional Cardiology.
We present our coverage of this event, along with selected abstract reviews and interviews with experts from the congress
Following the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2025 Annual Global Course, held in Paris, France, from the 20th–23rd May 2025, we present our coverage of this event, along with selected abstract reviews and interviews with experts from the congress, who provide exclusive insights.
This issue also features a range of peerreviewed articles that highlight the latest advancements in the field, such as the use of drug-coated balloons in percutaneous coronary interventions. EMJ also had the delight of interviewing Srihari S. Naidu and Arnold Seto, who share their expertise across diverse areas of the field, with focus on alcohol septal ablation, hypertrophic cardiomyopathy, and procedural safety in the "cath lab".
Plus, learn more about the use of intravascular imaging with an infographic that highlights how advanced imaging tools are reshaping the precision and outcomes of percutaneous coronary interventions.
I would like to thank all the authors, Editorial Board, peer reviewers, and interviewees for their invaluable contributions to this edition of EMJ Interventional Cardiology.
Pablo Sepúlveda Catholic University of Chile, Santiago, Chile
EuroPCR 2025
This year, the quality of scientific content presented was higher than ever, with over 3,100 submissions received
Congress Review
Review of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2025
Location: Paris, France
Date: 20th–23rd May 2025
Citation: EMJ Int Cardiol. 2025;13[1]:11-22. https://doi.org/10.33590/emjintcardiol/YDBM9908
THE ANNUAL world-leading course in interventional cardiology, the European Association of Percutaneous Cardiovascular Interventions (EuroPCR), brought over 12,000 participants to Paris, France, for a dazzling 4-day event.
EuroPCR is world-renowned for bringing together interventional cardiologists, cardiac surgeons, imaging specialists, radiologists, nurses, allied professionals, researchers, innovators, and industry representatives. Together, they share their knowledge, skills, and experience regarding interventions for coronary and peripheral vessels, valvular disease, heart failure, hypertension, and stroke.
With over 800 hours of content scheduled in the programme, attendees were spoilt for choice when exploring the sessions on offer. This year, the quality of scientific content presented was higher than ever, with over 3,100 submissions received. Of these, three major, late-breaking trials were selected for their notable contributions to the field: ‘Meta-Analysis of individual patient data from the PROTECTED TAVR and BHF PROTECT-TAVI studies’, ‘Angiography versus physiologyguided PCI in patients undergoing TAVI: the functional assessment in TAVI (FAITAVI) trial’, and ‘One-month DAPT followed by dose reduction of prasugrel after drug-coated stent insertion in Acute Coronary Syndrome’.
Behind the tailored course are the six EuroPCR Course Directors: Thomas Cuisset, Nicolas Dumonteil, PCR CoChairman Jean Fajadet, Nieves Gonzalo, PCR Co-Chairman Bernard Prendergast, and PCR Chairman William Wijns. During the Welcome session, the course directors introduced the overarching theme of the event: complexity. They explained that there are three levels of complexity in interventional cardiology. Firstly, the complexity of the lesions themselves; secondly, increased patient complexity due to the presence of comorbidities and other factors; and thirdly, complexity linked to issues within the healthcare system. It was emphasised that the aim of EuroPCR 2025 was to share solutions for complexity and improve patient outcomes.
Fajadet took a moment during the Welcome Ceremony to pay tribute to Jean Marco, founder of the first annual meeting in 1989, originally called the "Course on Complex Coronary Angioplasty and New Techniques in Interventional Cardiology." He highlighted that it is thanks to Jean Marco’s pioneering ideas, vision, and tremendous work in the field that the event
is possible and 12,000 participants have the opportunity to attend. With a personal touch, he thanked Marco for sharing his remarkable career so closely with him.
The course directors also expressed their gratitude for the many people involved in making the event possible: the 33 track coordinators, 85 programme producers, 410 graders, 1,000 faculty, 1,500
presenters, and over 700 evaluators. The collective effort ensured that everyone at the four-day event was able to successfully share their knowledge.
Read on for key insights into this year’s congress, and don’t miss our coverage of EuroPCR 2026, which will be held again in Paris, France, from the 19th–22nd May.
People involved in making the event possible include the 33 track coordinators, 85 programme producers, 410 graders, 1,000 faculty, 1,500 presenters, and over 700 evaluators
Reducing Bleeding with Shorter Dual Antiplatelet Therapy and Reduced-Dose Prasugrel
ONE-MONTH dual antiplatelet therapy (DAPT), followed by reduced-dose prasugrel monotherapy, significantly reduced bleeding events without increasing ischaemic risk in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), according to a major late-breaking trial presented for the first time during EuroPCR 2025.1
DAPT has long been the cornerstone of secondary prevention following PCI in patients with ACS, aiming to minimise the risk of stent thrombosis and other ischaemic complications. However, prolonged DAPT is associated with an increased risk of bleeding, which can adversely affect long-term outcomes. Recent research has focused on optimising the balance between ischaemic protection and bleeding risk, particularly by tailoring DAPT duration and intensity to individual patient profiles. The 4D-ACS randomised trial was designed to assess whether a de-escalation strategy of 1 month of DAPT with aspirin and prasugrel, followed by prasugrel 5 mg monotherapy, could maintain ischaemic protection while reducing bleeding events, compared to the conventional 12-month DAPT protocol.
In this multicentre, double-blind study, 656 patients were randomised immediately after PCI with a biolimus-coated drugeluting stent to either the 1M-DAPT group (one month of DAPT then prasugrel 5 mg monotherapy) or the 12M-DAPT group (12 months of DAPT with aspirin and prasugrel 5 mg). The primary endpoint was net adverse clinical events at 12 months, defined as a composite of death, non-fatal myocardial infarction, stroke, ischaemiadriven target vessel revascularisation, and Bleeding Academic Research Consortium (BARC) Type 2–5 bleeding.
At 12 months, net adverse clinical events occurred in 4.9% of the 1M-DAPT group versus 8.8% in the 12M-DAPT group, meeting criteria for both non-inferiority (p=0.014) and superiority (p=0.034). Major bleeding was significantly reduced in the 1M-DAPT group (0.6% versus 4.6%; hazard ratio: 0.13; p=0.007), while ischaemic outcomes were similar between groups, indicating that the reduction in adverse events was primarily driven by decreased bleeding.
The reduction in adverse events was primarily driven by decreased bleeding
The findings of the 4D-ACS trial support a shift towards more individualised antiplatelet strategies in patients with ACS post-PCI, especially for those with an increased bleeding risk. However, further studies in more diverse populations and with different stent platforms are warranted. For clinical practice, this approach provides a viable alternative to prolonged DAPT, supporting a transition towards risk-adapted, patientcentred care in ACS management.
Physiology-Guided PCI Reduces Risks in Patients Undergoing TAVI
A NEW trial presented at EuroPCR 2025 shows that physiology-guided coronary intervention significantly lowers complication rates in patients undergoing transcatheter aortic valve implantation (TAVI) with coexisting intermediate coronary artery disease.2
Managing patients with both severe aortic stenosis and intermediate coronary artery disease remains a clinical dilemma, especially as over half of TAVI candidates present with coronary lesions. The FAITAVI trial was the first randomised study comparing fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with angiographyguided PCI in this population.
A total of 320 stable patients undergoing TAVI were randomised 1:1 to receive either FFR- or angiography-guided revascularisation. In the angiography arm, all lesions with ≥50% stenosis in vessels >2.5 mm were treated. In the physiologyguided arm, only lesions with FFR ≤0.80 were treated, while those with FFR >0.85 were deferred. For borderline FFR values (0.81–0.85), remeasurement post-TAVI was advised, as coronary flow may improve after valve replacement.
At 12-month follow-up, major adverse cardiac and cerebrovascular events occurred in 8.5% of patients in the FFR-guided group versus 16.0% in the angiography-guided group. The benefit was mainly driven by reductions in allcause mortality and ischaemia-driven target vessel revascularisation. Median SYNTAX scores were low, at 7, and patient age averaged 86 years in both groups, suggesting that the cohort represented a lower-complexity, elderly population. Notably, the trial excluded severe lesions (diameter stenosis >90%) and focused on intermediate stenoses, setting it apart from
A total of 320 stable patients undergoing TAVI were randomised 1:1 to receive either FFR- or angiographyguided revascularisation
prior studies like NOTION-3, which included a broader range of coronary diseases and compared PCI with conservative therapies rather than guidance strategies.
These results support the clinical value of functional lesion assessment in guiding revascularisation strategy for TAVI candidates with stable coronary disease. With evidence that physiology-guided PCI reduces adverse outcomes, clinicians may consider FFR assessment as a valuable decision-making tool when managing this growing patient group.
At 12-month follow-up, major adverse cardiac and cerebrovascular events occurred in 8.5% of patients in the FFR-guided group versus 16.0% in the angiography-guided group
Meta-Analysis Confirms No Routine Benefit of CEP During TAVI Procedures
STROKE remains a serious complication following transcatheter aortic valve implantation (TAVI), prompting the use of cerebral embolic protection (CEP) devices to capture dislodged debris during the procedure. Although several clinical trials have evaluated the efficacy of CEP devices in reducing periprocedural stroke risk, results have been inconclusive.
A new meta-analysis, presented for the first time during EuroPCR 2025, now provides the most comprehensive assessment to date by combining individual patient data from the two largest randomised trials in the field. Crucially, the findings show no reduction in stroke incidence with the routine use of CEP during TAVI.3
The study incorporated data from the PROTECTED TAVR (3,000 patients) and BHF PROTECT-TAVI (7,635 patients) trials, totalling 10,635 participants, which is the largest dataset yet studied in this context. The meta-analysis focused on the modified intention-to-treat population, including all patients whose TAVI procedures were initiated. Of these, 5,287 underwent TAVI with CEP using the SENTINEL™ device (Boston Scientific, Marlborough, Massachusetts, USA), and 5,293 underwent TAVI without CEP. Both patient groups were closely matched in age (mean: 80.6 years), gender distribution (less than 40% women), surgical risk score, Society of Thoracic Surgeons (STS) risk score, European System for Cardiac Operative Risk Evaluation (EuroSCORE II), and medical history, ensuring robust comparability.
The primary endpoint was stroke incidence within 72 hours of the procedure or by the time of hospital discharge.
Results demonstrated no statistically significant difference in stroke rates between the CEP and non-CEP arms. Secondary analysis using the Complier Average Causal Effect method, which adjusts for non-adherence in per-protocol populations, confirmed the absence of benefit.
Findings show no reduction in stroke incidence with the routine use of CEP during TAVI
These findings have important implications for clinical practice. Routine use of the SENTINEL CEP device during TAVI cannot be recommended based on current evidence. While the biological rationale for embolic protection remains valid, this study highlights the need for further research to refine patient selection. Limitations of the study include device-specificity, as the findings apply solely to the SENTINEL system, and a lack of data on long-term stroke outcomes or neurocognitive impact. Future directions should focus on identifying high-risk subgroups who might benefit from targeted CEP, understanding the impact of incomplete device deployment, and developing risk prediction models to inform decision-making in TAVI candidates.
10-Year Outcomes from the DANAMI-3-DEFER Trial
LONG-TERM data from the DANAMI-3-DEFER trial, presented at EuroPCR 2025, show that, while deferred stenting in patients with ST-elevation myocardial infarction didn’t significantly reduce all-cause mortality over 10 years, it was associated with a lower rate of hospitalisation for heart failure.4
All-cause mortality alone was similar across both groups, but hospitalisation for heart failure was significantly reduced in the deferred arm
The trial followed 1,215 patients randomised across four percutaneous coronary intervention centres in Denmark to either immediate stenting or a deferred strategy, where blood flow was first stabilised and stenting postponed. After a decade of follow-up, the composite primary outcome of hospitalisation for heart failure or allcause mortality occurred in 24% of patients in the deferred group compared to 25% in the conventional percutaneous coronary intervention group (hazard ratio: 0.82; 95% CI: 0.67–1.02; p=0.08).
All-cause mortality alone was similar across both groups, but hospitalisation for heart failure was significantly reduced in the deferred arm (odds ratio: 0.58; 95% CI: 0.39–0.88). Rates of target vessel revascularisation remained comparable.
While the headline result might not be a game changer for overall mortality, the heart failure data hint at a potential role for deferring stent placement in carefully selected patients with ST-elevation myocardial infarction, especially when longer-term cardiac function is a concern.
Heart failure or all-cause mortality occurred in 24% of patients in the deferred group compared to 25% in the conventional percutaneous coronary intervention group
Immediate Multivessel PCI Linked to Lower Mortality in Patients with STEMI Shock
THIS YEAR, Rasmus Paulin Beske, from Rigshospitalet, Copenhagen, Denmark, presented the findings of his team’s research at EuroPCR.5
This secondary analysis of the DanGer Shock trial found that immediate multivessel percutaneous coronary intervention (PCI) may reduce mortality in non-comatose patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock and multivessel coronary artery disease.
The international, multicentre trial, conducted from 2013–2023 across Denmark, Germany, and the UK, enrolled adult patients with STEMI-related cardiogenic shock. This sub-study focused on the 221 patients with multivessel disease, defined as at least one non-culprit artery with ≥70% stenosis, who were stratified by treatment strategy: immediate multivessel PCI (103 patients) or culprit-only PCI (118 patients).
After adjusting for confounders, immediate multivessel PCI was associated with significantly lower all-cause mortality at 180 days (adjusted odds ratio: 0.40; 95% CI: 0.19–0.83). Importantly, this
comprehensive approach was not linked to an increased risk of secondary complications such as acute kidney injury, bleeding, or stroke.
The post-procedural, median pre-PCI Synergy between PCI with TAXUS and Cardiac Surgery (SYNTAX) score, which measures coronary disease complexity, was 28 in the culprit-only group and 29 in the immediate multivessel PCI group, whereas the SYNTAX score after PCI was significantly lower in the immediate vessel group (9 versus 6; p=0.011).
These findings suggest that immediate multivessel PCI may be both safe and beneficial in this high-risk population. However, the authors caution that a dedicated randomised trial is needed to confirm these results and better define the role of multivessel PCI in patients with STEMI-related cardiogenic shock and multivessel disease.
stent delivery and expansion, and increasing the risk of adverse outcomes. Several plaque modification techniques, including rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL), have been developed to address severe calcification, but direct comparative data on their long-term clinical performance have been lacking. The ROLLER COASTR-EPIC22 trial is the first randomised study to directly compare these three modalities in patients with moderate-tosevere de novo calcified coronary stenosis, with a focus on 1-year clinical outcomes.
In this multicentre trial, 171 patients with angiographically moderate-to-severe calcified coronary lesions (mean age: 70.9 years; 77.2% male) were randomised equally to undergo percutaneous coronary intervention with RA, IVL, or ELCA. Acute coronary syndrome was the presenting diagnosis in 35.7% of cases, and severe angiographic calcification was confirmed in over 80% of lesions. Optical coherence tomography confirmed a mean calcium arc of 300.8 degrees, a maximum calcium thickness of 1.17 mm, and a calcification length of 30.9 mm, with nearly one-third of patients exhibiting calcium nodules. It was revealed that baseline characteristics were well balanced across groups.
target vessel revascularisation, and stent thrombosis, was low and did not differ significantly between groups (RA: 5.3%; IVL: 5.3%; ELCA: 3.5%; p=0.88). All-cause mortality was also similar between groups (RA: 5.3%; IVL: 0%; ELCA: 5.3%; p=0.22), and there were no significant differences in the rates of target vessel myocardial infarction, target vessel revascularisation, target lesion revascularisation, or stent thrombosis between the three treatment arms.
The ROLLER COASTR-EPIC22 trial provides important evidence that all three contemporary plaque modification techniques offer similar safety and efficacy profiles at 1 year in patients with calcified coronary stenosis. For clinical practice, this suggests that the choice between these modalities can be guided by operator experience, lesion characteristics, and device availability without compromising patient outcomes.
Optical coherence tomography confirmed a mean calcium arc of 300.8 degrees, a maximum calcium thickness of 1.17 mm, and a calcification length of 30.9 mm
TRI-SCORE Overpredicts Risk Following Transcatheter Tricuspid Repair
PRESENTED at EuroPCR 2025, new data from the EuroTR registry challenged the predictive accuracy of the TRI-SCORE for patients undergoing tricuspid valve transcatheter edge-to-edge repair (T-TEER). While the TRI-SCORE offered qualitative risk stratification, researchers found that it consistently overestimated both short- and long-term mortality across all risk categories.7
The study analysed outcomes for 1,062 patients with tricuspid regurgitation who were stratified into low (0–3), intermediate (4–5), and high (6+) TRI-SCORE groups. High scoring patients had more comorbidities, more advanced right ventricular dysfunction, and lower procedural success rates. Despite these clinical differences, 30-day mortality remained low overall: 0% in the low-risk group, 1.9% in the intermediate, and 2.9% in the high-risk patients, suggesting that the score may not reflect real-world post-T-TEER outcomes.
At 2 years, observed mortality rates were also significantly lower than predicted, with TRISCORE estimates of 4.6%, 13.9%, and 27.8% across increasing risk categories. Although the score maintained relative stratification accuracy, its absolute predictions did not match observed event rates.
These findings suggest that, while TRISCORE can help identify relative risk, its clinical utility in T-TEER populations may be limited without recalibration. The authors call for further refinement of risk prediction tools to better reflect outcomes in the evolving transcatheter landscape.
30-day mortality remained low overall:
in the low-risk group in the intermediate group in the high-risk patients % 0 % 1.9 % 2.9
High scoring patients had more comorbidities, more advanced right ventricular dysfunction, and lower procedural success rates
Transcatheter Repair Benefits Elderly with Atrial Mitral Regurgitation
A RECENT study, presented at the EuroPCR 2025 annual meeting, reveals that transcatheter edge-to-edge repair (TEER) significantly improves outcomes in elderly patients suffering from atrial functional mitral regurgitation (AFMR), a common heart valve disorder predominantly affecting individuals who are older or frail.8
Researchers analysed data from 1,081 patients with moderate-to-severe AFMR, drawn from two registries: OCENA-Mitral for those who underwent TEER and those who are medically managed from REVEAL-AFMR. The average patient age was over 80, with a majority being women (60.5%). Patients treated with TEER were generally older, had more severe disease, and had additional health conditions compared to those receiving standard medical therapy.
Researchers analysed data from 1,081 patients with moderate-to-severe AFMR, drawn from two registries
After balancing these differences using statistical techniques, results showed that TEER was associated with a 35% reduction in the combined risk of heart failure hospitalisation and death. Additionally, all-cause mortality was 42% lower in the TEER group compared to medical management alone.
Importantly, the benefits of TEER were strongest in patients who had minimal residual mitral regurgitation after the procedure. Patients with more significant residual leakage had similar outcomes to those who did not undergo the intervention.
These findings suggest that TEER offers a meaningful survival and heart failure risk benefit for elderly patients with AFMR, potentially changing the treatment landscape for this vulnerable population. Further studies are warranted to confirm these results and optimise patient selection for TEER therapy.
OCT-Guided Percutaneous Coronary Intervention Improves Outcomes in Acute Coronary Syndrome
NEW data from the OCCUPI trial, presented at EuroPCR 2025, demonstrate that using optical coherence tomography (OCT) to guide percutaneous coronary intervention (PCI) significantly reduces major adverse cardiac events in patients with acute coronary syndrome (ACS) and complex coronary lesions.9
While OCT is widely used to improve precision during PCI, its clinical benefit in ACS remains uncertain. The OCCUPI trial was a randomised study designed to assess the impact of OCT-guided versus angiography-guided PCI in patients requiring drug-eluting stents for complex coronary lesions. Researchers conducted a prespecified analysis focusing on the subgroup of patients presenting with ACS. The primary endpoint was the rate of major adverse cardiac events (MACE) at 1 year, defined as a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation.
Out of 1,604 total participants, 790 (49.3%) had ACS at presentation. Among these patients, those receiving OCT-guided PCI had a significantly lower incidence of MACE at 1 year compared to those treated with angiography guidance (4.9% versus 9.5%; hazard ratio: 0.50; 95% CI: 0.29–0.87; p=0.011). Further analysis showed that, within the OCT-guided group, patients who achieved stent optimisation as per OCT criteria experienced even greater
benefit, with a MACE rate of 2.9% versus 9.7% among those with suboptimal stent deployment (hazard ratio: 0.29; 95% CI: 0.12–0.72; p=0.004).
The primary endpoint was the rate of major adverse cardiac events (MACE) at 1 year
These findings support the use of OCT guidance in patients who have ACS with complex lesions, reinforcing guideline recommendations and offering a clear path to improved outcomes.
Those receiving OCT-guided PCI had a significantly lower incidence of MACE at 1 year compared to those treated with angiography guidance (4.9% versus 9.5%; hazard ratio: 0.50; 95% CI: 0.29–0.87; p=0.011)
References
1. Kang WC et al. One-month dual antiplatelet therapy followed by prasugrel monotherapy at a reduced dose: the 4D-ACS randomised trial. EuroPCR, 20-23 May, 2025.
2. Ribichini F. The FAITAVI trial: angiography versus physiology-guided PCI in patients undergoing TAVI –12-month follow-up data. EuroPCR, 20-23 May, 2025.
3. Kharbanda RK et al. Meta-analysis of individual patient data from the PROTECTED TAVR and BHF PROTECTTAVI studies. Abstract A68810MC. EuroPCR, 20-23 May, 2025
4. Lønborg J et al. Deferred or conventional stenting in patients with STEMI: 10-year outcome of DANAMI3-DEFER. Abstract A61911JM. EuroPCR, 20-23 May, 2025.
5. Paulin BR et al. PCI in multivessel disease and STEMI-related cardiogenic shock: a DanGer Shock substudy. Abstract A62091JM. EuroPCR, 20-23 May, 2025.
6. Jurado-Román A et al. Rotational atherectomy, lithotripsy or laser for calcified coronary stenosis. Oneyear outcomes. Abstract A63071AJ. EuroPCR, 20-23 May, 2025.
7. Gröger M et al. TRI-SCORE for mortality risk prediction after tricuspid valve TEER – the EuroTR registry. Abstract A65957MG. EuroPCR, 20-23 May, 2025.
8. Kaneko T et al. Impact of transcatheter edge-to-edge repair on prognosis in atrial functional mitral regurgitation. Abstract A64257TK. EuroPCR, 20-23 May 2025.
9. Kim BK et al. Optical coherence tomography-guided PCI in acute coronary syndrome patients with complex lesions. Abstract A61110YL. EuroPCR, 20-23 May, 2025.
EuroPCR 2025: Making Quantum Leaps in Interventional Cardiology
Author: *Josip A. Borovac1
1. Division of Interventional Cardiology, Cardiovascular Diseases Department, University Hospital of Split (KBC Split), Croatia
*Correspondence to josip.borovac@me.com
Disclosure: The author has declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:23-27. https://doi.org/10.33590/emjintcardiol/WSHQ8501
THIS YEAR'S EuroPCR 2025 reached a record-breaking attendance of more than 12,000 participants and introduced a new ‘Complexity Track’, that encompassed catheter-lab reality TV, immersive imaging workshops, and AI, thus sending a ‘complex’ message that a modern interventionalist now needs as many software and technology skills as wire managing skills.
NEWS IN INTRAVASCULAR IMAGING
The headline coronary session was opened with the OCCUPI acute coronary syndrome (ACS) substudy. This study focused on 790 patients with ACS with complex anatomy. It showed that optical coherence tomography (OCT)-guided percutaneous coronary intervention cut the 12-month composite of cardiac death, myocardial infarction, stent thrombosis, or target-vessel revascularisation from 9.5% to 4.9% (hazard ratio: 0.50), compared with plain angiography alone, which was largely driven by fewer periprocedural infarcts.1 Discussants noted that the benefit emerged within 30 days and persisted, echoing earlier bifurcation data, but this time in the emergent ACS setting. This study highlighted the point that was firmly maintained in numerous sessions throughout the congress; intravascular imaging nowadays is a must for the modern interventionalist to improve patient outcomes, and we all need to put in the hard work to increase penetration of these technologies in our everyday cath lab practice.
UPDATES IN INTRAVASCULAR LITHOTRIPSY
Moving forward, two late-breaking trials cemented intravascular lithotripsy (IVL) as the go-to strategy for persistent and refractory calcium deposits. The randomised BALI trial enrolled 200 OCT-defined severely calcified lesions.2 The study showed that IVL lowered the combined endpoint of procedural failure or target-vessel failure to 35.4% versus 51.5% with conventional balloons or atherectomy (relative risk: 0.69; p=0.02) without increasing perforation risk. An all-female EMPOWER-CAD registry then showed 389 women treated with an IVL-first algorithm achieved 90% procedural success and single-digit 30-day adverse events.3 These results were well received in the underserved patient population that typically fares worse with atherectomy. This brings us to the verdict: IVL’s up-front price tag is now outweighed by its predictable safety envelope. Thus far, we have termed the coin ‘rota regret’ in situations where we did not use rotational atherectomy, where in reality, we should now, and we could also add ‘IVL regret’ or ‘not doing IVL when we should have’ to the list.
NOVEL ANTIPLATELET STRATEGIES FOLLOWING ACUTE CORONARY SYNDROME
Korea’s 656-patient 4D-ACS trial took the stage with the focus on the pharmacotherapy arena.4 This important study showed that 1 month of aspirin + prasugrel 10 mg, followed by prasugrel 5 mg monotherapy, significantly cut net adverse clinical events to 4.9% versus 8.8% compared to the standard 12-month regimen. It is important to note that a 49% relative risk reduction was predominantly driven by a 77% drop in major bleeding, with no uptick in death, myocardial infarction, stroke, stent thrombosis, or repeat revascularisation. The data triggered standing-ovation calls to rewrite discharge checklists for any patient whose bleeding risk even vaguely outweighs their ischaemic/thrombotic risk.
UPDATES IN TRANSCATHETER AORTIC VALVE INTERVENTIONS
In the domain of structural cardiac interventions, the cardiac-damage substudy of EARLY-TAVR enrolled 538 asymptomatic patients with severe aortic stenosis, and showed that pre-emptive valve replacement significantly reduced death, stroke, or unplanned cardiovascular hospitalisation across all four stages of baseline myocardial injury, with 86% of patients already exhibiting biomarker evidence of cardiac damage before overt symptom onset.5 Yet, this enthusiasm was tempered 24 hours later by a TriNetX propensitymatched registry of 1,195 patients with a bicuspid aortic valve.6 This study provided sobering data by showing that two-year all-cause mortality was twice as high after transcatheter aortic valve implantation procedure compared to surgical aortic valve replacement, with a hazard ratio of 2.09.
This was also accompanied by a doubling of heart failure-related admissions associated with transcatheter aortic valve implantation, thus underscoring that bicuspid aortic valve anatomy still demands surgical respect.
REVIVING THE OLD CONCEPT: ‘UNCAGING’ THE VESSEL
While there seems to be a general sense that, lately, there are no field-advancing studies in the coronary as opposed to structural field, the BIOADAPTOR RCT begs to differ.7 Of note, 3-year data from the 445 patients enrolled in this trial showed the DynamX bioadaptor (Elixir Medical Corporation, Milpitas, California, USA), decreased target-lesion failure to 2.7% versus 7.2% with a contemporary drugeluting stent (p=0.030). This also reflected on cardiovascular death, which was 0.5% in the bioadaptor arm versus 3.2% in the contemporary drug-eluting stent arm. Benefits were even more pronounced in left anterior descending lesions, hinting that a scaffold which unlocks at 6 months and restores vessel pulsatility might finally deliver on the ‘leave nothing behind’ promise without the late catch-up that doomed bioresorbable vascular scaffolds.
Moving from imaging to physiology, a standing-room‐only symposium previewed the PROVISION study.8 Here, 401 patients were randomised to wire-based fractional flow reserve (FFR) versus non-wire-based CathWorks FFRangio® (CathWorks, Newport Beach, California, USA). At 1 year, major adverse cardiac events were numerically lower with FFR-angio (9.9% versus 12.6%), while saving wires, adenosine, radiation, and about 400 USD per case. Sceptics hammered on the external validity of the study, which has not been proven thus far, but when live demonstrations produced full‐tree colour pressure maps 30 seconds after the final cine run, even the most sceptical were filming with their phones.
APPROACH TOWARDS LEFT MAIN DISEASE ENDORSED
Beyond the headline trials, a joint session by the Latin American Society of Interventional Cardiology (SOLACI)/ Interamerican Society of Cardiology (SIAC), chaired by Latin American cardiovascular societies, unveiled harmonised guidelines for left-main revascularisation that hinge decision-making on intravascular ultrasound-measured minimal luminal area thresholds and an instantaneous wave-free ratio cut-off of ≤0.85, with equal emphasis on surgical risk and heart team consensus. The cross-continental authorship was hailed as a template for global collaboration and evidence appraisal in interventional cardiology.9
VIRTUAL VISIT TO CORONARY BIFURCATION LESION FACILITATED BY VISIBLE HEART TEAM
Personally, the most important teaching moment of EuroPCR 2025 came late Thursday in the Main Arena, where the Visible Heart® team (University of Minnesota Twin Cities, Minnesota, USA) resuscitated a porcine heart inside a transparent perfusion chamber, and streamed real-time 4K angioscopic images.10 Meanwhile, Emmanouil Brilakis and Ryan E. Davies walked the audience through a textbook double kissing-crush procedure for a distal left-main bifurcation. Under the steady narration of anchor Goran Stankovic and analyst Francesco Burzotta, every critical step, namely, side-branch stent deployment, first crush, re-cross with a wire, kissing-balloon inflation, and final proximal optimisation technique, was shown simultaneously via OCT and intracoronary videos. This allowed the packed theatre to see strut deformation and carina shift like never before. The operators used dual Ultimaster Nagomi™ (Terumo Europe, Leuven, Belgium) platforms and deliberately undersized the initial left circumflex artery balloon to provoke discussion on malapposition rescue. Imaging experts Nieves Gonzalo and Thomas Johnson paused the feed twice to measure stent expansion and demonstrate how real-time
OCT can avert both elliptical distortion and geographic miss. Maciej Lesiak fielded a torrent of questions on wire re-cross angles, while Paul Iaizzo, guardian of the beating heart, reminded everyone that the model reproduces physiologic shear and flow, making the visual lessons translatable to human cath labs. When the final angiogram showed <5% residual stenosis in both branches, the hall erupted. A standing-room crowd had just watched bifurcation theory turn into living, pulsating reality.
CONCLUDING REMARKS
Taken together, my own ‘to-do list’ on the flight home ran long: I should use OCT and intravascular ultrasound much more, gather more IVL catheters before the next calcified lesion, shorten default dual antiplatelet therapy prescriptions, tighten bicuspid screening protocols, trial FFRangio in our lab, and schedule a journal club on the BIOADAPTOR RCT. I also learned that the steps of double kissing crush look much uglier and more sobering in real-time
angioscopy than on our plain angiography films. I feel that EuroPCR’s unofficial mantra was ‘complex doesn’t mean complicated’ but it certainly means agile. If the week spent at EuroPCR proved anything, it’s that staying current now requires equal parts of mechanical dexterity, digital literacy, and a willingness to ditch dogma at the speed of new data. I’m landing back home in Croatia fully inspired, slightly exhausted, and more convinced than ever that the cath lab of 2026 will look nothing like the cath lab of 2020, and that is exactly what progress should feel like.
EuroPCR’s unofficial mantra was ‘complex doesn’t mean complicated’
References
1. Kim B-K. Optical coherence tomography-guided PCI in acute coronary syndrome patients with complex lesions: a subgroup analysis of the randomized OCCUPI trial. Abstract. EuroPCR 2025, 20-23 May, 2025.
2. Kristensen AT. Randomised comparison of lithotripsy vs. conventional preparation in severely calcified coronary lesions (BALI). Abstract. EuroPCR 2025, 20-23 May, 2025.
3. McEntegart M. The EMPOWER CAD study: women with calcified coronary arteries treated with intravascular lithotripsy. Abstract. EuroPCR 2025, 20-23 May, 2025.
4. Jang Y et al. One-month dual antiplatelet therapy followed by prasugrel monotherapy at
a reduced dose: the 4D-ACS randomised trial. EuroIntervention. 2025:EIJ-D-25-00331.
5. Généreux P. Incidence, evolution, and impact of cardiac damage in asymptomatic severe aortic stenosis: results from the EARLY TAVR trial. Abstract. EuroPCR 2025, 20-23 May, 2025.
6. Deharo P et al. Surgical versus percutaneous treatment of bicuspid aortic stenosis: a pro-pensity-score analysis. Abstract. EuroPCR 2025, 2023 May, 2025.
7. Saito S et al. First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery le-sions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT EClinicalMedicine. 2023;65:102304.
8. Tanigaki T et al. Prospective randomized trial evaluating clinical outcomes of FFRangio guid-ance versus wire-based fractional flow reserve guidance (PROVISION): 1-year results. Abstract. EuroPCR 2025, 2023 May, 2025.
9. Lamelas P et al. Percutaneous or surgical revascularization in patients with severe left main coronary artery disease in Latin America: a GRADE clinical practice guideline. Int J Cardiol. 2025;436:133401.
10. Stankovic G et al. Learning live DK crush stenting -in-vitro PCI in a beating heart: LIVE Edu-cational Case from Visible Heart® LaboratoriesMinneapolis, United States of America. Abstract. EuroPCR 2025, 20-23 May, 2025.
Author:
Cardiac Imaging Innovations at EuroPCR 2025
Diaa Hakim1
1. Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
*Correspondence to dhakim1@bwh.harvard.edu
Disclosure: The author has declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:28-29. https://doi.org/10.33590/emjintcardiol/RKZJ4021
THE EUROPEAN Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2025 Annual Meeting, held from the 20th–23rd May at the Palais des Congrès in Paris, France, was a landmark event in interventional cardiology, attracting over 12,000 professionals from more than 120 countries. The conference featured cutting-edge insights through late-breaking trials, live cases, interactive workshops, and sessions that spanned the entire spectrum of interventional cardiology. Among the standout themes this year were the transformative role of cardiac imaging, driven by the integration of AI; advanced imaging modalities; and improved procedural guidance. The author as an interventional cardiologist and cardiac imager was impressed by the innovations in cardiac imaging, including both non-invasive and intravascular imaging.
ADVANCEMENTS IN CARDIAC IMAGING
This year’s meeting spotlighted significant innovations in cardiac imaging aimed at enhancing diagnostic precision and procedural efficiency. Leaders in this space introduced next-generation AIpowered technologies. The SOMATOM Pro. Pulse CT scanner (Siemens Healthineers, Erlangen, Germany), equipped with Dual Source technology for improved temporal resolution, was showcased, and the NAEOTOM Alpha® photon-counting CT scanner (Siemens Healthineers), which delivers high-resolution images at a reduced radiation dose, was also exhibited. The Alphenix/Evolve Edition (Canon Medical Systems Europe, Amstelveen, the Netherlands), designed to optimise percutaneous coronary intervention (PCI) procedures through AI-enhanced imaging, was also unveiled. Additionally,
the world’s first intraprocedural Angio-CT system, tailored for left atrial appendage occlusion procedures, made its debut.
INNOVATIONS IN INTRAVASCULAR IMAGING
Intravascular imaging saw a surge of innovation, particularly in optical coherence tomography and intravascular ultrasound. EuroPCR 2025 featured advancements such as AI-assisted image interpretation, ultra-high-resolution systems, and real-time 3D reconstructions. These developments are revolutionising lesion assessment, stent optimisation, and overall procedural outcomes. Industry leaders are at the forefront of this race to deliver cuttingedge tools that enhance both clinical outcomes and operator performance.
Hands-on sessions and live cases within the Imaging Learning Centre gave attendees direct experience with next-generation platforms and their application in complex PCI, left main interventions, and plaque characterisation. A key focus was the growing integration of imaging with physiology and robotics, signalling a shift towards more intelligent, image-guided interventions.
ADVANCED ULTRASOUND AND INTRACARDIAC ECHOCARDIOGRAPHY TECHNOLOGIES
The latest intracardiac echocardiography innovation, the ACUSON AcuNav Volume ICE Catheter (Siemens Healthineers), was also presented. This offers real-time four-dimensional imaging with multiplanar reconstruction to support structural heart and electrophysiology procedures. Complementing this was the launch of the ACUSON Origin Ultrasound System (Siemens Healthineers), which uses AI to enhance diagnostic accuracy and provide actionable real-time insights for physicians.
INNOVATIONS IN PROCEDURAL GUIDANCE
The Dynamic Coronary Roadmap (DCR) system (Philips, Amsterdam, the Netherlands), which leverages AI to reduce the use of iodinated contrast media during PCI, was introduced. The EchoNavigator system (Philips), which fuses live echocardiography with fluoroscopy, providing intuitive guidance for structural heart interventions, was also highlighted.
FUTURE DIRECTIONS
EuroPCR 2025 underscored the growing synergy between AI and cardiac imaging. It is an evolution poised to revolutionise procedural planning and execution. The continued development of advanced imaging systems and smart algorithms will drive greater precision, personalisation, and improved outcomes in interventional cardiology.
Ultimately, the annual meeting highlighted the critical role of innovation in shaping the future of cardiac care, and signalled a new era of smarter, image-guided, and patient-centered interventions.
EuroPCR 2025
Abstract Reviews
Drawing on key findings presented at EuroPCR 2025, the following abstract reviews spotlight the latest advancements in interventional cardiology. Authored by the presenters themselves, topics include AI, advancements in trancatheter aortic valve implantation, and the evaluation of clinical risk scores in acute coronary syndromes and structural heart disease.
Improving Pacemaker Prediction After Transcatheter Aortic Valve Implantation: Development and Validation of a Machine Learning Model
Citation: EMJ Int Cardiol. 2025;13[1]:31-32. https://doi.org/10.33590/emjintcardiol/DEVN4289
BACKGROUND AND AIM
Transcatheter aortic valve implantation (TAVI) has increased in the latest years.1 Post-TAVI conduction disturbances remain frequent and variable among sites, despite continuous improvement in technology and procedural techniques, that often require pacemaker implantation (PMI).2 AI- and machine learning (ML)-based technologies may contribute to developing better prediction models in this clinical context.3-5
The authors’ aim was to develop a ML-based binary classification model for predicting PMI after TAVR, compare it with a regression-based model, and validate it in a prospective cohort.6
METHODS
This was a single-centre retrospective study on patients that underwent TAVI between 2018 and 2024. A comprehensive review of demographic, clinical, ECG, echocardiographic, cardiac CT scan, and intra-procedural data was performed. Both pre- and intra-procedural variables were included in the dataset to train the model.
A Python (Python Software Foundation, Wilmington, Delaware, USA) script was developed to build a binary classification model. Due to the dataset imbalance, a Synthetic Minority Oversampling TEchnique (SMOTE)-based upsampling technique was performed on the minority class. The eXtreme gradient boosting (XGBoost) open-source software library and algorithm was used to train the ML-based prediction model. To achieve better performance, the authors implemented an ensemble model approach consisting of 21 binary classifiers. For each patient, the final prediction was determined by aggregating the predictions from all classifiers and selecting the most frequently predicted value.
Both testing and validation model performance metrics were computed using the confusion matrix of predictions and include weighted precision (WP), weighted recall (WR), and weighted F1-score (WF1). In addition, logistic regression was executed for performance comparison between models. Receiver operating characteristic curves area under the curve (AUC) values were developed for both models.
RESULTS
From a total of 672 TAVI procedures during the study period, 611 patients entered the analysis. The mean age was 82 years and 44% were male. PMI occurred in 170 (27.8%) patients and the median time until implantation was 3 days.
Using the XGBoost ensemble ML algorithm, a scoring model was generated. Among the 21 variables, the highest weighted variables were the presence of right bundle branch block, QRS duration, peripheral artery disease, male gender, and left bundle branch block.
The ML-based model performance metrics were as follows: WP of 58.47%, WR of 59.07% and WF1 of 58.69%. The logistic regression
model had the following metrics: WP of 48.45%, WR of 54.80% and WF1 of 51.43%. The AUC for XGBoost was 0.73, compared to 0.63 for the logistic regression (Figure 1).
Seventy-eight patients entered the prospective validation cohort. PMI occurred in 23 (32%) patients. The metrics from the authors’ ML-based model in the validation cohort were as follows: WP of 66.17%, WR of 64.48%, and WF1 of 65.42%. The metrics from logistic regression-based model were: WP of 58.22%, WR of 52.28%, and WF1 of 55.09%.
CONCLUSION
The authors created and validated a ML-based prediction model for PMI after TAVI. This model outperformed the traditional used regression-based model. This underscores the move towards a more personalised medicine, where AI and ML-based models may enhance clinical decision-making for better patient outcomes.
Figure 1: Receiver operating characteristic curve comparing the eXtreme gradient boosting ensemble machine learning algorithm with logistic regression.
ROC Curve - XGBoost Emsemble Method versus Logistic Regression
XGBoost AUC = 0.73
Logistic Regression AUC = 0.63
False Positive Rate
AUC: area under the curve; ML: machine learning; ROC: receiver operating characteristic; XGBoost: eXtreme gradient boosting.
References
1. Gupta T et al. Temporal trends in transcatheter aortic valve replacement for isolated severe aortic stenosis. J Soc Cardiovasc Angiogr Interv. 2024;3(7):101861.
2. Vora AN et al. National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry. J Am Coll Cardiol Intv. 2024;17(3):391-401.
3. Agasthi P et al. Prediction of permanent pacemaker implantation after transcatheter aortic valve replacement: The role of machine learning. World J Cardiol. 2023;15(3):95-105.
4. El Ouahidi A et al. Machine learning for pacemaker implantation prediction after TAVI using multimodal imaging data. Sci Rep. 2024;14:25008.
5. Tsushima T et al. Machine Learning Algorithms for Prediction of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement. Circ Arrhythm Electrophysiol. 2021;14(4):e008941.
6. Barbas de Albuquerque F et al. Improving pacemaker prediction after TAVI - development and validation of a machine learning model. EuroPCR, 20-23 May, 2025.
Performance of Large Language Models in RealWorld Interventional Cardiology Scenarios: The ILLUMINATE Randomised, Blinded Evaluation Study
Authors: *Attilio Lauretti,1,9 Iginio Colaiori,1 Simone Calcagno,2 Enrico Romagnoli,3 Fabrizio D’Ascenzo,4,5 Antonio Di Matteo,1 Francesco Gemelli,1 Gaetano Pero,1 Marco Bernardi,1,6 Luigi Spadafora,1,6 Antonio Esposito,8 Marco Borgi,1 Giuseppe Biondi-Zoccai,6,7 Francesco Versaci1
1. Division of Cardiology, Santa Maria Goretti Hospital, Latina, Italy
2. Cardiology Unit, Department of Emergency and Admission, San Paolo Hospital, Civitavecchia, Italy
3. Department of Cardiovascular Sciences, Fondazione Policlinico Agostino Gemelli IRCCS, Rome, Italy
4. Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy
5. Division of Cardiology, Department of Medical Sciences, University of Turin, Italy
6. Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy
7. Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy
8. ICOT Marco Pasquali Institute, Cardiovascular Department, Latina, Italy
9. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Italy
*Correspondence to attilio.lauretti@uniroma1.it
Disclosure: The authors have declared no conflicts of interest.
Keywords: AI, interventional cardiology, large language models (LLM).
Citation: EMJ Int Cardiol. 2025;13[1]:33-35. https://doi.org/10.33590/emjintcardiol/WUXT8325
BACKGROUND
The integration of AI in cardiology has advanced considerably with the emergence of large language models (LLM), which offer new perspectives for clinical and interventional decision support.1,2 However, few studies to date have assessed their reliability in complex, real-world interventional cardiology cases.3-5 The ILLUMINATE6 study is a randomised, blinded evaluation that compares multiple LLMs in high-complexity clinical scenarios reflective of contemporary interventional practice.
METHODS
This study involved 20 anonymised cases (10 coronary artery disease and 10 structural heart disease), each presenting significant diagnostic or therapeutic complexity. Six LLMs were tested: default ChatGPT (ChatGPTd; OpenAI, San Francisco, California, USA), ChatGPT with embedded European Society of Cardiology guidelines (ChatGP-gl), ChatGPT with internetenabled search (ChatGPTi), Perplexity AI (San Francisco, California, USA), Mistral AI (Paris, France), and Gemini (Google, San Francisco, California, USA). For each case, models were prompted to offer a conclusive clinical recommendation. Their outputs were then randomised, anonymised, and blindly scored by five independent interventional cardiologists based on five predefined criteria: appropriateness, accuracy, relevance, clarity, and clinical utility. Each criterion was rated on a 0–10 scale, with composite scores calculated for comparative analysis using a mixed linear model.
RESULTS
A total of 120 evaluations were conducted. The mean composite score was 7.1 (95% CI: 7.0–7.2), though performance varied significantly across different models (p<0.001). ChatGPTi and ChatGPT-gl demonstrated superior performance with scores of 7.8 (95% CI: 7.5–8.0) and 7.7 (95% CI: 7.4–7.9), respectively. Intermediate performance was seen with Mistral AI (7.0), Perplexity AI (7.0), and ChatGPTd (6.9), while Gemini scored the lowest (6.3). No performance differences were found between coronary artery disease and structural heart disease cases (p=0.900), suggesting robustness across clinical domains. (Figure 1)
Models equipped with web search or guideline integration consistently outperformed those without, underscoring the value of external data access
for accurate, actionable responses. Nonetheless, no model reached optimal scores, and additional prompting was often required to elicit a definitive recommendation, underlining current limitations in LLM autonomy and clinical reasoning. Inter-rater reliability scoring variability was also observed.
CONCLUSION
The implications of these findings are twofold. First, LLMs may represent a useful adjunct in the management of interventional cardiology cases, particularly when enhanced with guideline-based or real-time data access. Second, these tools remain currently immature for autonomous decisionmaking and require further development to ensure consistency, contextual awareness, and safety in patient care.
Importantly, the ILLUMINATE study highlights the need for a regulatory oversight and physician involvement in AI deployment. While LLMs show promise as decision-support tools, their integration into clinical workflows must proceed cautiously. Future research should focus on improving interpretability, minimising hallucinations, and enabling dynamic updating with the latest evidence.
In conclusion, the ILLUMINATE study demonstrates that while LLMs can assist in complex interventional cardiology scenarios, their performance is highly variable and contingent on model configuration. The best-performing systems were those equipped with structured access to medical guidelines and web data. These results support the potential of LLMs as a valuable complement, and not as a replacement, to human expertise in high-stakes cardiovascular care.
ChatGPTd: default ChatGPT; ChatGPT-gl: ChatGPT with embedded European Society of Cardiology guidelines; ChatGPTi: ChatGPT with internet-enabled search; LLM: large language model.
Figure 1: Graphical summary about the mean performances of large language models with confidence intervals.
References
1. Alexandrou M et al. Performance of ChatGPT on ACC/SCAI interventional cardiology certification simulation exam. JACC Cardiovasc Interv. 2024;17(10):1292-3.
2. Geneş M et al. Assessment of ChatGPT's compliance with ESC-acute coronary syndrome management guidelines at 30-day intervals. Life (Basel). 2024;14(10):1235.
3. Itelman E et al. AI-assisted clinical decision making in interventional cardiology: the potential of commercially available large language models. JACC Cardiovasc Interv. 2024 Aug 12;17(15):1858-60.
4. Masanneck L et al. Triage performance across large language models, ChatGPT, and untrained doctors in emergency medicine: comparative study. J Med Internet Res. 2024;26:e53297.
5. Salihu A et al. Towards AI-assisted cardiology: a reflection on the performance and limitations of using large language models in clinical decisionmaking. EuroIntervention. 2023;19(10):e798-801.
6. Lauretti et al. Illuminate study: comparing large language models in complex interventional cardiology cases. Abstract A66015AL. EuroPCR 2025, 20-23 May, 2025.
Endovascular Treatment of Vascular Complications in Mine-explosive Injuries
Authors: Sergey Furkalo,1 Vadim Kondratiuk,1 Ivan Mazanovych,1 *Yurii Vahis1
1. Department of Endovascular Surgery and Interventional Radiology, National Scientific Center of Surgery and Transplantation named after O.O. Shalimov, National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine *Correspondence to vagisura@gmail.com
Disclosure: The authors have declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:36-36. https://doi.org/10.33590/emjintcardiol/JGZR4936
BACKGROUND AND AIMS
The characteristics of combat trauma to blood vessels include deep and widespread damage to the vascular wall, often extending beyond the visible boundaries of the damage, which differs significantly from domestic trauma or defects due to disease.
The aim of this study was to analyse and evaluate approaches to endovascular treatment of post-traumatic pseudoaneurysms and arteriovenous fistulas in patients with mine-explosive injuries.1
MATERIALS AND METHODS
The study consisted of 12 male patients with a mean age of 38.3±5.3 years. Seven participants (58.3%) were found to have pseudoaneurysms, while the other five (41.6%) had arteriovenous fistulas of various localisations. Of the patients, two (16.6%) had an aortic injury (pseudoaneurysm in the first and aortocaval fistula in the second), three (25%) had an hepatic artery pseudoaneurysm, one (8.3%) had a common carotid artery pseudoaneurysm, one (8.3%) had a radial artery pseudoaneurysm, two (16.6%) had deep femoral artery arteriovenous fistulas,
two (16.6%) had superficial femoral artery arteriovenous fistulas, and one (8.3%) had a peroneal artery arteriovenous fistula. Other comorbidities included septic conditions, rib fractures, tissue defects, and nerve damage.
Clinical manifestations were characterised by unstable haemodynamics, malperfusion syndrome, compression of surrounding tissues, and symptoms of blood flow stealing.
RESULTS
Seven patients (58.3%) had implanted stent-grafts; in two cases, stent-grafts were implanted in the abdominal aorta. In five cases, stent-grafts were used for pseudoaneurysms of the hepatic, carotid, and lower limb arteries. Five patients (41.6%) underwent selective embolisation with coils. The intervention sites included hepatic artery branches, the deep femoral artery, and the radial artery. One patient underwent simultaneous embolisation and stent-graft implantation. The technical success of the intervention was 100%, without complications in any case. Regression of clinical symptoms was noted in all patients after the intervention.
CONCLUSION
Combat trauma is characterised by extensive, widespread damage to the vascular wall, which significantly complicates traditional surgical correction. Endovascular treatment is a highly effective method of treating post-traumatic pseudoaneurysms and arteriovenous fistulas in patients with mine-explosive trauma. However, the long-term results of this approach are not yet entirely clear.
Reference
1. Furkalo S et al. Endovascular treatment of vascular complications in mine-explosive injuries. Abstract A61041SF. EuroPCR 2025, 20-23 May, 2025.
Improving Large Language Models via Heart Team Simulation: A Prompt Design Analysis
Authors: *Dorian Garin,1 Stéphane Cook,1 Charlie Ferry,1 Wesley Bennar,1 Mario Togni,1 Pascal Meier,1 Peter Wenaweser,1 Serban Puricel,1 Diego Arroyo1 1. Department of Cardiology, University and Hospital Fribourg, Switzerland *Correspondence to dorian.garin@icloud.com
Disclosure: The authors have declared no conflicts of interest.
Keywords: AI, aortic stenosis, Heart Team, large language model (LLM), prompt design.
Citation: EMJ Int Cardiol. 2025;13[1]:37-38. https://doi.org/10.33590/emjintcardiol/EZQC1200
BACKGROUND
Large language models (LLM) show promise in supporting clinical decision making, yet the influence of prompt design on performance in complex cardiology scenarios remains unclear.1 This study introduces Forest-of-Thought (FoT), a novel prompting technique that allows the LLM to simulate a multidisciplinary Heart Team discussion. The authors compared FoT with four other common prompting approaches to determine its impact on LLM treatment decision accuracy in severe aortic stenosis.
METHODS
The authors evaluated five prompting techniques with a single LLM (GPT-4o [OpenAI, San Francisco, California, USA], version 2024-05-13): zero-shot (0-shot), Chain-of-Thought (CoT), few-shot Chainof-Thought (fs-CoT), FoT, and few-shot FoT (fs-FoT). Clinical vignettes were developed for 231 patients with severe aortic stenosis, for whom a Heart Team had recommended transcatheter aortic valve implantation, surgical aortic valve replacement, or medical management. Each vignette was submitted 40 times under each prompting technique, yielding 46,200 total queries.
The self-consistency method determined each technique’s final recommendation by selecting the most frequently generated answer from the 40 outputs. The primary outcome was the mean correct response rate, defined as agreement with the Heart Team’s recommendation. Secondary outcomes included sensitivity, specificity, area under the curve, degree of treatment invasiveness, and relative weighting of clinical variables.
RESULTS
FoT achieved the highest mean correct response rate (94.04%; 95% CI: 90.87–97.21), outperforming all other techniques (fs-FoT: 87.16%; fs-CoT: 85.32%; CoT: 78.89%; 0-shot 73.40%; p<0.001; Figure 1). It also demonstrated the highest sensitivity, specificity, and area under the curve (0.96–0.97). Compared to the Heart Team, the LLM’s recommendations were slightly more conservative, favouring less invasive options (mean invasiveness score: –0.0884; 95% CI: -0.1255– -0.0516; p<0.001).
Additionally, the model assigned greater weight to non-cardiac comorbidities (Cliff’s Delta: –0.231; p=0.04), whereas the Heart Team did not exhibit this preference (Cliff’s Delta: +0.12; p=0.75).
CONCLUSION
Prompt design significantly affects LLM performance in managing severe aortic stenosis. The FoT approach, which simulates a multidisciplinary Heart Team, markedly improves decision-making accuracy and produces recommendations closely aligned with expert opinions. However, the LLM demonstrated a tendency towards more conservative treatment plans, underscoring the importance of carefully designed prompts and clinician oversight when deploying LLM-based decision support systems.
Figure 1: Mean accuracy of prompting techniques.
p<0.001
Prompting techniques
Zero-shot (0-shot)
Chain-of-Thought (Cot)
Few-shot Chain-of-Thought (fs-CoT)
Few-shot Forest-of-Thought (fs-FoT)
Forest-of-Thought (FoT)
Reference
1. Garin D et al. Improving large language models accuracy via Heart Team simulation: a prompt design analysis. Abstract A62792DG. EuroPCR, 20-23 May, 2025.
Prognostic Value of BCIS CHIP-PCI Score in Patients with Non-ST-Elevation Acute Coronary Syndrome
Citation: EMJ Int Cardiol. 2025;13[1]:39-40. https://doi.org/10.33590/emjintcardiol/PUUH2517
BACKGROUND
Complex, high-risk percutaneous coronary interventions (PCI) are increasingly being performed in patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). The British Cardiovascular Intervention Society (BCIS) has developed the complex highrisk and indicated PCI (CHIP-PCI) score, which is a valuable risk stratification tool for non-emergency PCI. A total of 13 factors, each scoring different points based on the observed odds-ratios, were independently associated with in-hospital major adverse cardiac and cerebrovascular events (MACCE), used as a marker of complexity after PCI. Seven patient factors (age ≥80 years, female sex, prior stroke, prior myocardial infarction (MI), peripheral arterial disease, left ventricle ejection fraction ≤30 %, chronic kidney disease) and six procedural factors (left main PCI, 3-vessel PCI, dual arterial access, left ventricle mechanical support, lesion length >60 mm, rotational atherectomy) were ultimately included in the CHIP-PCI score.1 According to another cohort study of more than 20,000 patients, CHIP-PCI score also showed promising results in predicting MACCE at one year. The authors sought to evaluate this score in patients with NSTE-ACS in clinical practice.2
METHODS
The authors retrospectively enrolled 356 consecutive patients with NSTE-ACS who underwent PCI from a single-centre cohort.3 Patients presenting with cardiogenic shock were excluded. The primary outcome was in-hospital MACCE, defined as a composite of all-cause death, periprocedural MI, or stroke. Additionally, bleeding complications and acute kidney injury (AKI) were included in the secondary endpoints. The patients were divided into four groups according to the BCIS CHIP-PCI score: group 1 (score 0), group 2 (score 1–2), group 3 (score 3–4) and group 4 (score ≥5, high-risk patients).
RESULTS
The mean age of this study population was 67±12 years, whereas the mean BCIS CHIPPCI score was 1.92±2.1. Prior MI (37.4%), female sex (18.3%), and total stent length ≥60 mm (16.6%) were the most frequently met CHIP factors in this study. After calculating the BCI-CHIP score, 95 (26.7%), 149 (41.9%), 70 (19.7%), and 42 (11.8 %) patients were finally categorised into groups 1, 2, 3, and 4, respectively. In-hospital MACCE occurred in one patient (one MI, 1%) in group 1; three patients (two deaths, one MI, 2%) in group 2; and two patients (one MI, one stroke, 2.8%) in group 3. In patients with BCIS CHIP-PCI score ≥5, four primary events (three deaths and one stroke, 9.5%) were recorded (p<0.05).
Concerning secondary endpoints, two cases of major bleeding (retroperitoneal haematoma in group 1 and upper gastrointestinal bleeding in group 4), both treated with blood transfusions, were reported. One patient with a BCIS CHIP-PCI score of 1 had minor bleeding (severe bruising after aspirin and ticagrelor combination; switching from ticagrelor to clopidogrel led to clinical improvement). However, the difference in the occurrence of bleeding complications was not statistically significant (p=0.247).
*most frequently met CHIP factors.
CHIP: complex and high-risk intervention in indicated patients; MACCE: major adverse cardiac and cerebrovascular events; MI: myocardial infarction.
Also, a total of 20 cases of AKI (four in group 1, three in group 2, eight in group 3 and five in group 4) were reported. The number of patients with AKI was greater in groups 3 and 4 compared to groups 1 and 2 (p<0.05; Table 1).
CONCLUSION
Calculation of BCIS CHIP-PCI scores is feasible and offers a tailored approach in the management of patients with ACS who undergo a non-primary or emergency PCI. The risk of MACCE increases with
higher score values. Moreover, early detection of risk factors for MACCE could improve in-hospital outcomes.
References
1. Protty M, et al. Defining percutaneous coronary intervention complexity and risk: an analysis of the United Kingdom BCIS database 2006-2016. JACC Cardiovasc Interv. 2022;15(1):39-49.
2. Khandelwal G, et al. Validation of UK-BCIS CHIP score to predict 1-year outcomes in a contemporary United States population. JACC Cardiovasc Interv. 2023;16(9):1011-20.
3. Kalogera V et al. Prognostic value of BCIS CHIP-PCI score in NSTE-ACS patients. Abstract A67644VK. EuroPCR, 20-23 May, 2025.
Table 1: Baseline characteristics and outcomes.
Long-Term Impact on Re-Intervention and Amputation Rates Using a Dedicated Dual-Wire Re-Entry Balloon for Subintimal
Recanalisation: 36-Month Results from the PRAESTO Trial
Authors: *Costantino Del Giudice,1
Roberto Gandini2
1. Interventional Radiology, Institut Mutualiste Montsouris, Paris, France
2. Interventional Radiology, Policlinico Tor Vergata University, Rome, Italy *Correspondence to costantino.delgiudice@gmail.com
Disclosure: The authors have declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:41-42. https://doi.org/10.33590/emjintcardiol/VPMX4098
BACKGROUND AND AIMS
Critical limb ischaemia (CLI) remains a major challenge in patients with peripheral artery disease (PAD),1 particularly when chronic total occlusions (CTO) complicate endovascular revascularisation. Subintimal recanalisation of long CTOs could be challenging, with a risk of failure as high as 25%, necessitating more complicated retrograde recanalisation via distal puncture or surgical conversion.2 Recently, a new dedicated dual guidewire angioplasty balloon (the Presto balloon, APANI Medical Inc, California, USA) was introduced to perform antegrade fenestration re-entry (AFR), with the aim of improving clinical outcomes and reducing procedural times and X-ray exposure.3
The purpose of this study was to evaluate the 36-month safety and efficacy of AFR using the Presto balloon for CTO crossing in patients with CLI, compared with conventional subintimal recanalisation, in the PRAESTO Trial.4
METHODS
This retrospective, score-matched analysis included 392 patients with PAD and CTO. A propensity score analysis, based on cardiovascular risk factors and lesion characteristics, was performed to create two homogenous groups: 40 patients underwent AFR with the Presto device (study group), while 80 matched controls were treated with standard subintimal recanalisation techniques (control group). The assessed outcomes included procedural success, subintimal re-entry rates, need for distal puncture, procedural and fluoroscopy times, radiation exposure (measured by dose area product), and long-term clinical endpoints (primary patency, freedom from amputation, re-intervention, and death).
RESULTS
AFR using the Presto balloon achieved a significantly higher subintimal re-entry success rate (100% versus 78.7%; p=0.001), and eliminated the need for retrograde tibial access (0% versus 21%; p=0.001).
Surgical bypass conversion was required in five control patients. The Presto balloon study group demonstrated significantly shorter procedural times (41.6±11.4 minutes versus 139.8±61 minutes; p<0.0001) and fluoroscopy times (16.9±3.5 minutes versus 32.8±14 minutes; p<0.0001), with drastically lower dose area product (942.2±290 µGym² versus 1935.7±830.1 µGym²; p<0.0001).
At 36 months, the Presto study group showed improved freedom from amputation (p=0.04) and re-intervention (p=0.03), with no significant difference in mortality between groups (Figure 1).
CONCLUSION
AFR with the Presto dual guidewire angioplasty balloon is a safe and effective
1: Kaplan–Meier curves representing the freedom from re-intervention and amputation over time.
BA) Kaplan–Meier curve representing the 36-month follow-up freedom from re-intervention. B) Kaplan–Meier curve representing the 36-month follow-up freedom from amputation.
method for CTO crossing in patients with PAD and CLI. This technique significantly reduces procedural and fluoroscopy times, radiation exposure, and the need for distal puncture, while improving long-term outcomes related to amputation and reintervention. These benefits are achieved without increasing procedural risks, suggesting a valuable advancement in endovascular CLI treatment.
References
1. Karimi A et al. Novel therapies for critical limb-threatening ischemia. Curr Cardiol Rep. 2022;24(5):513-7.
2. Nydahl S et al. Subintimal angioplasty of infrapopliteal occlusions in critically ischaemic limbs. Eur J Vasc Endovasc Surg. 1997;14(3):212-6.
3. Del Giudice C, Gandini R. Subintimal crossing of chronic total occlusions in peripheral arteries with a dual guidewire balloon catheter: the PRAESTO study. J Endovasc Ther. 2024;31(1):45-54.
4. Del Giudice C, Gandini R. Safety and efficacy of presto dual guidewire angioplasty in critical limb ischaemia patients: CLI PRAESTO 36 months follow-up. EuroPCR 2025, 20-23 May, 2025.
Figure
AI-Guided Risk Stratification for Aortic Stenosis using Large Language Models Enhanced with Guidelines
Authors: *Dorian Garin,1 Stéphane Cook,1 Charlie Ferry,1 Wesley Bennar,1 Mario Togni,1 Pascal Meier,1 Peter Wenaweser,1 Serban Puricel,1 Diego Arroyo1 1. Department of Cardiology, University and Hospital Fribourg, Switzerland *Correspondence to dorian.garin@icloud.com
Disclosure: The authors have declared no conflicts of interest.
Keywords: Aortic stenosis, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), large language model (LLM), risk stratification.
Citation: EMJ Int Cardiol. 2025;13[1]:43-44. https://doi.org/10.33590/emjintcardiol/QRFR8070
BACKGROUND
Traditional operative risk calculators, such as the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), may misclassify patients with severe aortic stenosis by insufficiently considering comorbidities and anatomical variables; particularly when guiding between transcatheter aortic valve implantation and surgical aortic valve replacement. The authors developed a guidelinesintegrated large language model (LLM) that incorporates the 2021 European Society of Cardiology (ESC) guidelines for managing valvular heart disease, aiming to determine whether this approach could improve risk stratification compared to a purely EuroSCORE II-based strategy.1
METHODS
The authors retrospectively analysed 231 patients with severe aortic stenosis who underwent formal Heart Team evaluation for low- versus high-operative risk between 1st January 2022–4th December 2024. For each patient, a clinical vignette was created to mimic a Heart Team presentation. A Forestof-Thought prompting technique was then employed, simulating a multi-specialist discussion to yield either a ‘low’ or ‘high’ risk classification. The guidelines-integrated LLM (GPT-4o Version 2024-08-06; OpenAI,
San Francisco, California, USA) received each vignette 40 times, and responses were consolidated using a self-consistency ‘voting’ procedure. The output from this guidelines-integrated LLM was compared to a EuroSCORE II-based approach, which defined low risk as EuroSCORE II <4% and age <75 years, and high risk as EuroSCORE II >8%. The primary endpoint was mean accuracy (proportion of correct low/high classifications versus the Heart Team’s reference), while secondary endpoints included sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve. Logistic regression was used to assess the relative importance of EuroSCORE II versus other clinical variables. A subanalysis evaluated the guidelines-integrated LLM with versus without explicit EuroSCORE II input.
RESULTS
In identifying high-risk patients, the guidelines-integrated LLM achieved 90.05% accuracy (95% CI: 86.07–94.02), notably surpassing the EuroSCORE II-based method at 50.23% (95% CI: 43.58–56.87), with a mean difference of -39.82% (95% CI: -47.96 – -31.68; p<0.0001). For low-risk stratification, it again outperformed the EuroSCORE II-based model (90.05% versus 85.97%; mean difference -4.07%; 95% CI: -7.93 – -0.21; p=0.039). Comparing LLM variants with and without EuroSCORE II information showed a 7.69% mean accuracy gain (95% CI: 2.82–12.56; p=0.002) when EuroSCORE II was omitted. Sensitivity, specificity, and ROC analyses were consistent with these findings (Figure 1).
Logistic regression indicated that excluding EuroSCORE II did not significantly alter the LLM’s overall weighting of EuroSCORE II variables (Mann–Whitney p=0.34). However, the lower performance with EuroSCORE II appeared linked to overemphasis on a limited subset of predictors, notably pulmonary artery systolic pressure (odds ratio [OR]: 1.70; p=0.007), age (OR: 1.39; p<0.001), and kidney disease (OR: 7.64; p=0.032).
AUC: area under the curve; Euroscore II: European System for Cardiac Operative Risk Evaluation II; LLM: large language model.
In contrast, the guidelines-integrated LLM without EuroSCORE II maintained a balanced weighting across multiple variables, except for age (OR: 1.62; p<0.0001) and male gender (OR: 1.11; p=0.038).
CONCLUSION
A guidelines-integrated LLM strategy leveraging ESC guidelines provided superior high- and low-procedural risk stratification of patients with severe aortic stenosis, compared to a EuroSCORE II-based
approach. By encompassing a wider range of clinically relevant factors, this approach may enhance both clinical decision-making and individualised patient management, potentially better identifying candidates for transcatheter aortic valve implantation.
Reference
1. Garin D et al. AI-guided risk stratification for aortic stenosis using large language models enhanced with guidelines. Abstract A62829DG. EuroPCR, 2025 20-23 May, 2025.
Figure 1: Aortic stenosis procedural risk
Age Matters: Comparing Outcomes of Patient Foramen Ovale Closure in Older versus Younger Patients
Citation: EMJ Int Cardiol. 2025;13[1]:45-46. https://doi.org/10.33590/emjintcardiol/BSEE5262
BACKGROUND
Patent foramen ovale (PFO) is frequently identified in patients over 60 years old who present with cryptogenic stroke. However, whether PFO closure benefits older patients with both PFO and cryptogenic stroke is unknown, as randomised controlled trials have predominantly enrolled patients younger than 60 years of age. The authors’ objective was to compare the outcomes of PFO closure in patients over 60 years of age with those under 60 years, to evaluate the safety and efficacy of the procedure for both age groups.1
METHODS
MEDLINE, Cochrane, and Web of Science were systematically searched from inception to December 2024. Only observational studies comparing the efficacy of transcatheter PFO closure between older patients (>60 years) and
younger patients (<60 years) were included.1
RESULTS
A total of 12 studies, comprising 5,909 patients, were included in the analysis. Among them, 2,151 patients were older than 60 years of age, while 3,758 were younger. Over a mean follow-up of 4.32 years, allcause mortality was significantly higher in older group compared to the younger group (odd ratio [OR]: 2.647; 95% CI: 1.561–4.489; p<0.05). The older group had a significantly increased risk of recurrent ischaemic events (OR: 2.453; 95% CI: 1.762–3.417; p<0.001; Figure 1) and developing atrial fibrillation (OR: 2.698; 95% CI: 1.310–5.013; p<0.001). Moreover, older patients had a higher risk of presenting with a residual shunt postprocedure, although this did not reach statistical significance (OR: 1.265; 95% CI: 0.934–1.714; p=0.129). Egger’s regression test showed no evidence of significant publication bias in the meta-analysis.1
CONCLUSION
This meta-analysis reveals notable differences in outcomes between older and younger patients undergoing transcatheter PFO closure for cryptogenic stroke. Older patients exhibited higher rates of all-cause mortality, recurrent ischaemic events, and atrial fibrillation compared to younger individuals. These results underscore the need for careful patient selection and individualised risk assessment when considering PFO closure in older populations. Further randomised clinical trials are needed to clarify the long-term efficacy and safety of PFO closure in older adults.1
Figure 1: Forest plot showing a significantly increased risk of recurrent ischaemic events in elderly patients.
Model: Fixed-effects model
Heterogeneity: H squared=1.12, i-squared=0.11
Homogeneity: Q=11.22, de=10, p value=0.34
Test of overall effect size: z=5.31, p value=0.00
Axis is shown using log scale
OR: odds ratio.
Reference
1. Beneki et al. Age matters: comparing outcomes of PFO closure in older vs. younger patients. Abstract A64727KD. EuroPCR 2025, 19-22 May, 2025.
Effect size of each study
Estimated overall effect size
Estimated overall confidence interval
Confidence interval of effect size
Overall effect size value
Mitral Annular Remodelling Following HighLife Transcatheter Mitral Valve Replacement: A Single-Centre Experience
Authors: *Leonhard Schneider,1 Michael Paukovitsch,1 Jinny Scheffler,1 Dominik Felbel,1
Matthias Groeger,1 Mirjam Kessler,1 Wolfgang Rottbauer1 1. University Heart Center Ulm, Ulm, Germany *Correspondence to Leonhard-moritz.schneider@uniklinik-ulm.de
Disclosure: The authors have declared no conflicts of interest.
Acknowledgements: The authors would like to thank Uta Dichristin for continuous support.
Citation: EMJ Int Cardiol. 2025;13[1]:47-48. https://doi.org/10.33590/emjintcardiol/ TMVD1168
BACKGROUND
Transcatheter mitral valve replacement (TMVR) using the HighLife TMVR system has demonstrated feasibility, an acceptable safety profile, and excellent reduction of mitral regurgitation, as well as functional improvement in symptomatic patients.1 Beyond correction of mitral regurgitation, the two-component HighLife technique potentially exerts annuloplasty by an undersizing docking mechanism, as opposed to several other approaches of anchoring which rely on outward radial force, which can lead to annular oversizing.2,3,4,5
The aim of this investigation was to assess annular remodelling after HighLife implantation using both echocardiographic studies as well as CT imaging.6
METHODS
Pre- and post-procedural transthoracic and procedural transoesophageal echocardiographic studies of 25 patients treated at University Heart Center Ulm (Germany) within the HighLife (HL2018-01-
TS) and HighFLO (HL201-01) clinical trials were assessed by the site. The largest annular diameters were measured in three planes during diastole, both before and after valve implantation. Postprocedural CT was available in five patients.
RESULTS
Before valve implantation, measurements of anterior-posterior (A-P), anteromedialposterolateral (AM-PL), and septal-lateral (S-L) diameters were comparable between transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE). A-P diameters were 40.2±5.4 mm and 39.6±4.9 mm, AM-PL diameters were 41.4±2.9 mm and 42.2±4.4 mm and S-L diameters were 38.9±3.1 mm and 39.5±3.2 mm in TTE and TEE, respectively. After valve implantation, TTE measurements were slightly larger: 37.5±4.9 mm (A-P), 37.0±2. 3mm (AM-PL), and 34.9±3.9 mm (S-L), compared to TEE: 35.5±4.5 mm (A-P), 38.0±3.4 mm (AM-PL), and 33.6±4.2 mm (S-L). However, both modalities showed significant reductions across all diameters, with pronounced effects on S-L dimensions (TTE: –6.1±9.4% A-P, –12.2±3.4% AM-PL, and –12.2±21.9% S-L, p=0.01 respectively; TEE: –9.9±9.9% A-P, –7.9±5.2% AM-PL, and –15.0±8.0% S-L, p<0.01 respectively; Figure 1). Assessment of available CT scans confirmed these echocardiographic findings.
CONCLUSION
Annular measurements of a relatively small group of patients treated at one German site within the HighLife and HighFLO clinical trials showed significant annuloplasty independent of eliminating mitral regurgitation. A larger cohort should be assessed including CT assessment to confirm these findings and correlate annuloplasty with ventricular remodeling and outcome.
Figure 1: Changes of mitral annular dimension pre- and post-intervention measured in transoesophageal and transthoracic echocardiography.
1. Schneider LM et al. 1-year outcomes following transfemoral transseptal transcatheter mitral valve replacement: the HighLife TSMVR feasibility study. JACC Cardiovasc Interv. 2023;16(23):2854-65.
2. Webb J et al. Transcatheter mitral valve replacement with the transseptal EVOQUE system. JACC Cardiovasc Interv. 2020;13(20):2418-26.
3. Zahr F et al. 1-year outcomes following transfemoral transseptal transcatheter mitral valve replacement: intrepid TMVR early feasibility study results. JACC Cardiovasc Interv. 2023;16(23):2868-79.
4. Genereux P et al. AltaValve atrial fixation system for the treatment of severe mitral regurgitation and mitral annular calcification. Struct Heart. 2024;8(3):100294.
5. Modine T et al. First-in-human implant of the cephea transseptal mitral valve replacement system. Circ Cardiovasc Interv. 2019(9):e008003.
6. Schneider L et al. Mitral annular remodeling after HighLife TMVR: a single-center experience. Abstract A64227LS. EuroPCR, 20-23 May, 2025.
Association of HEART Score with Angiographic Severity of Coronary Artery Disease in Patients with Non-ST-Elevation Acute Coronary Syndrome
Citation: EMJ Int Cardiol. 2025;13[1]:49-50. https://doi.org/10.33590/emjintcardiol/WKYU5809
BACKGROUND
The history, ECG, age, risk factors, and troponin (HEART) score was developed as a rapid risk stratification tool.1 It has five components (history, ECG, age, risk factors, and troponin), each assigned a score of 0, 1, or 2 points.2,3 Due to the wide spectrum of death risk and recurrent events among patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), management guidelines emphasise the importance of early risk stratification.4,5 This study aimed to determine whether the HEART score correlates with the angiographic extent and severity of coronary artery disease (CAD) in patients with NSTE-ACS.
METHODS
This was a cross-sectional observational study conducted in a tertiary care institute. Ethical clearance was taken. Among patients diagnosed with NSTE-ACS who underwent coronary angiography during index hospitalisation, 92 patients were included using consecutive sampling, following the inclusion and exclusion criteria. Evaluations of patients included history, clinical examination, and data collection using a semi-structured questionnaire. Patients were divided into two groups; Group I: low HEART Score (0–6), and Group II: high HEART Score (7–10). Coronary angiogram was performed, and the severity was assessed by the SYNTAX™ (Boston Scientific Way, Marlborough, Massachusetts, USA) score. All coronary lesions with diameter stenosis >50% in vessels with a >1.5 mm diameter were recorded.
For the statistical methods, quantitative data were expressed as mean and standard deviation, and compared using the Student’s t-test. Qualitative data were expressed as frequency and percentage, and compared using the Chi-square test. Logistic regression analysis was performed, and a p value <0.050 was considered statistically significant.
RESULTS
Comparison of the study group according to the lesion severity (N=92) showed that triple vessel disease and left main disease were more prevalent in Group II (high HEART score) than Group I (low HEART score). Conversely, single vessel disease and normal/non-critical CAD were observed more in Group I. These differences were statistically significant (p<0.001).
Comparison of the study group according to the SYNTAX score (N=92) showed that
a low SYNTAX score was observed in patients with a low HEART score (Group I) compared to Group II (97.8% versus 69.6%). Conversely, a high SYNTAX score was observed in patients with a high HEART score (30.4% versus 2.2%). These differences were statistically significant (p<0.001). Again, the median SYNTAX score was significantly higher in Group II compared to Group I (20.0 versus 6.50; p<0.001).
Correlation between the HEART score and SYNTAX score showed that a positive correlation (p=0.665) was observed, which was statistically significant (p<0.001). This suggests that the higher the HEART score, the higher the SYNTAX score.
The receiver operating characteristic (ROC) curve was used for detecting severe coronary artery stenosis. Using the SYNTAX score, the ROC curve showed that a cut-off value of HEART Score 7 had a sensitivity of 80.0%, and specificity of 72.7%, in predicting the severity of CAD. The area under the ROC curve was statistically significant. Multivariate logistic regression analysis to measure predictors of severe CAD revealed that the HEART score was an independent predictor for the development of severe CAD (odds ratio: 1.767; 95% CI: 1.023–3.051; p=0.040).
CONCLUSION
This study demonstrates that the HEART score has a significant positive correlation with the severity of CAD in patients with NSTE-ACS.
References
1. Anwar AFMA et al. Association of HEART score with angiographic severity of coronary artery disease in NST-ACS patients. Abstract A65285AA. EuroPCR 2025, 20-23 May, 2025.
2. Puymirat E et al. Acute myocardial infarction: changes in patient characteristics, management, and 6-month outcomes over a period of 20 years in the FAST-MI program (French registry of acute STelevation or non-ST-elevation myocardial infarction) 1995 to 2015. Circulation. 2017;136(20):1908-19.
3. Roffi M et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: task force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016;37(3):267-315.
4. Vrints CJM. The 12 lead ECG rules the waves in acute cardiovascular care. Eur Heart J Acute Cardiovasc Care. 2018;7(3):197-9.
5. Gulati M et al. 2021 AHA/ACC/ASE/CHEST/SAEM/ SCCT/SCMR guideline for the evaluation and diagnosis of chest pain: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;78(22):e187-285.
Characterising Invasive Biventricular Physiology and Responders After Transcatheter Mitral Repair:
Authors: *Omar Chehab,1 Ronak Rajani,1 Simon Redwood,1 Tiffany Patterson1
1. St Thomas’ Hospital, London, UK
*Correspondence to omar.chehab@nhs.net
Disclosure: The authors have declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:51-53. https://doi.org/10.33590/emjintcardiol/ MLWL2551
BACKGROUND
Mitral valve transcatheter edge-to-edge repair (M-TEER) has transformed the treatment of mitral regurgitation (MR) for high-risk patients. However, 30–50% of patients fail to achieve ventricular and/ or symptomatic recovery, and treatment response heterogeneity is poorly understood. STRESS-MR1 examines the acute and medium-term effects of M-TEER, through invasive characterisation of biventricular physiology and subsequent impact on recovery.
METHODS
STRESS-MR (St Thomas’ Hospital, London, UK; Royal Brompton Hospital, London, UK; and Oxford Heart Centre, Oxford, UK) is a UK multi-centre prospective study enrolling 53 consecutive patients between 2022–24 with primary MR (PMR; n=31) and secondary MR (SMR; n=22) undergoing M-TEER. Invasive biventricular pressure-volume loop (PVL) analysis and right heart catheterisation were performed immediately pre- and post-M-TEER. Serum biomarkers (troponin I, NT-proBNP) and 3D echocardiography were assessed at baseline, post-procedure, and 6-month follow-up. New York Heart Association class and Kansas City Cardiomyopathy Questionnaire scores were measured at baseline and at 6 months.
RESULTS
Whole cohort analysis demonstrated that deterioration of load-independent indices of right ventricular (RV) systolic function (end-systolic elastance [Ees]) and dyssynchrony following M-TEER were associated with the composite endpoint of cardiovascular death (CVD) and heart failure hospitalisation (HFH). A fall in left ventricular (LV) haemodynamic efficiency (the stroke work to pressure-volume area ratio [SW/PVA]) was associated with increased symptom burden (NYHA class ≥3) at follow-up. At baseline, patients with SMR demonstrated significantly lower LV ejection fraction (52% versus 68%; p<0.001), lower invasive ventriculo-arterial coupling (Ees/Ea) (1.07 versus 1.81; p<0.002), and lower SW/ PVA (0.58 versus 0.74; p<0.001) compared to patient with PMR. Patients with PMR also saw greater improvements in intraprocedural cardiac index (CI) (0.5 versus 0.3 L/min/m2; p=0.011; Figure 1).
When investigating the relationship between MR reduction and cardiac physiology, an intraprocedural reduction in 3D vena contracta area of >80% yielded a significant fall in CI (p=0.043) and RV Ees (p=0.025). Furthermore, a 4-grade reduction in MR to Grade 0 yielded no improvement in LV SW/PVA (p=0.22) and a fall in Ees/Ea (β: –0.38; p=0.02).
Haemodynamic responders (defined as an intraprocedural increase in CI) saw improvements in LV Ees/Ea (0.15 versus –0.07; p=0.006) and a reduced incidence of CVD/HFH compared to non-responders (7.4% versus 38%; p=0.007). Patients with a ≥10% reduction in LV end-diastolic diameter had greater improvements in CI (0.68 versus 0.23; p=0.008) and pulmonary artery systolic pressure (–10 versus –1; p=0.006) compared to non-remodelers. Finally, a ≥10-point increase in Kansas City Cardiomyopathy Questionnaire score was associated with greater improvements in CI (0.46 versus 0.22 L/min/m2; p=0.048),
Figure 1: Representative left ventricular pressure-volume loops of primary and secondary mitral regurgitation patients pre- and post-mitral valve transcatheter edge-to-edge repair.
A Left Ventricle, Pre-M-TEER
Primary vs Secondary MR
LV tEa
LV tEa
LV Pressure (mmHg)
LV ESPVR
LV EDPVR
LV Volume (mL)
Primary MR Secondary MR
Left Ventricle, Intraprocedural Change
Primary MR
LV ESPVR
LV Pressure (mmHg)
LV tEa
LV EDPVR
LV Volume (mL)
Pre-M-TEER Post-M-TEER
CLeft Ventricle, Intraprocedural Change
Secondary MR
LV tEa
LV ESPVR
LV Pressure (mmHg)
LV Volume (mL)
LV EDPVR
Pre-M-TEER Post-M-TEER
A) At baseline, patients with secondary MR had significantly higher total afterload and worse ventriculo-arterial coupling. Patients with secondary MR also had worse systolic function on certain indices (ejection fraction and preload recruitable stroke work).
B) Interprocedurally, patients with primary MR had significant decreases in ventricular compliance, as evidenced by the leftward shift in EDPVR. Patients with primary MR also saw greater increases in total afterload but also had improvements in ventriculo-arterial coupling.
C) Patient with secondary MR did not see significant changes in diastolic function. Patients with secondary MR also saw no significant changes in afterload or ventriculo-arterial coupling.
EDPVR: end-diastolic pressure-volume relationship; ESPVR: end-systolic pressure-volume relationship; LV: left ventricle; MR: mitral regurgitation; M-TEER: transcatheter mitral edge-to-edge repair; RV: right ventricle; tEa: total afterload.
RVSW/PWA (0.54 versus 0.36; p=0.013), and Ees/Ea (0.69 versus 0.34; p=0.006).
CONCLUSION
Deterioration in LV efficiency, RV systolic impairment, and dyssynchrony following M-TEER increases the risk of CVD/ HFH, and symptom burden. Patients with PMR and SMR have very distinct baseline physiologies and those with SMR demonstrate less improvement in CI, remodelling, and functional recovery. The authors have also identified an MR
reduction threshold beyond which some patients exhibit deterioration in CI and biventricular haemodynamic performance.
This heterogeneous response to M-TEER highlights the importance of the heart team considering physiological suitability alongside anatomical assessment in identifying the right treatment approach for the right patient.
Reference
1. Chehab et al. Characterising invasive biventricular physiology and responders after transcatheter mitral repair: STRESS-MR. Abstract A61364OC. EuroPCR, 20-23 May, 2025.
Outcomes of Functionally Guided Drug-Coated Balloon versus Drug-Eluting Stent Percutaneous Coronary Intervention:
A Propensity-Matched Analysis
Authors: *Antonio Maria Leone,1,2
Domenico Galante,1 Ciro Pollio Benvenuto,3 Simona Todisco,2 Andrea Viceré,2 Chiara
Giuliana,2 Vincenzo Viccaro,2 Pierpaolo Tarzia,1 Cristina Aurigemma,4 Enrico Romagnoli,4 Antonio Rocco Montone,4 Gennaro Capalbo,1 Carlo Trani,2,4 Francesco Burzotta,2,4 Filippo Crea1
1. Center of Excellence of Cardiovascular Sciences, Ospedale Isola Tiberina – Gemelli Isola, Rome, Italy
2. Università Cattolica del Sacro Cuore, Rome, Italy
3. St. Antonius Ziekenhuis, Nieuwegein, the Netherlands
4. Department of Cardiovascular Sciences, Fondazione Policlinico Agostino Gemelli IRCCS, Rome, Italy
*Correspondence to antoniomaria.leone@unicatt.it
Disclosure: Leone has been involved in advisory board meetings or received speaker’s fees from Abbott, Medtronic, Daiichi-Sankyo, Bayer, Bruno Farmaceutici, and Menarini. Aurigemma has been involved in advisory board meetings or received speaker’s fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Romagnoli has been involved in advisory board meetings or received speaker’s fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Burzotta has been involved in advisory board meetings or received speaker’s fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Trani has been involved in advisory board meetings or received speaker’s fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Crea holds the position of Editor-in-Chief of European Heart Journal (EHJ). All other authors have declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:54-56. https://doi.org/10.33590/emjintcardiol/VHZI6067
BACKGROUND
Percutaneous coronary intervention (PCI), guided by physiological lesion assessment, has been shown to improve
clinical outcomes by optimising the selection and treatment of ischaemiarelated stenoses.1,2 Drug-eluting stents (DES) remain the cornerstone of PCI, yet drug-coated balloons (DCB) offer an attractive alternative in specific clinical contexts, particularly where stent avoidance is desirable, such as diffuse disease, bifurcation lesions, and high bleeding risk patients.3 Despite growing evidence for DCB efficacy, their role in physiology-guided PCI strategies remains underexplored. This study aimed to compare the safety, efficacy, and clinical outcomes of physiology-guided DCB-PCI versus DES-PCI using real-world, propensity-matched data.4
METHODS
This analysis was derived from the post-revascularisation optimisation and physiological evaluation of intermediate lesions using fractional flow reserve (PROPHET-FFR) registry,5 an ambispective registry that included patients with coronary lesions evaluated through functional testing. Starting from patients undergoing physiology-guided PCI with both pre- and post-PCI functional assessment, patients were divided into two groups according to the device used to perform physiology-guided PCI: DES versus DCB. Retrospective data provided the functionally DES-PCI cohort (FS-PCI), while prospective data included patients undergoing physiology-guided DCB-PCI (FB-PCI). All patients had pre- and postPCI functional assessment with fractional flow reserve (FFR). In the DCB group, physiological guidance extended beyond lesion selection, incorporating functional reassessment after lesion preparation and prior to balloon delivery to confirm the appropriateness of a DCB-only approach. Propensity score matching (1:1) was performed using four variables: pre-PCI FFR values, clinical presentation (acute versus chronic coronary syndrome), lesion location
in the left anterior descending artery, and follow-up duration. The primary endpoint was the rate of major cardiovascular events (MACE), defined as a composite of all-cause mortality, myocardial infarction, and target vessel revascularisation.
RESULTS
A total of 180 patients undergoing FS-PCI and 40 patients undergoing FB-PCI were initially screened. Following matching, 39 patients were included in each group. Baseline characteristics were well balanced in terms of age (p=0.357), male sex (p=0.329), diabetes (p=0.109), and clinical presentation (p=0.99). Conversely, hypertension (p=0.018), prior myocardial infarction (p=0.012), and previous PCI (p<0.01) were more prevalent in the DCB group. The DCB group also exhibited a lower left ventricular ejection fraction (54.1±8.6% versus 58.5±7.1%; p=0.016). Lesion location did not differ significantly (left anterior descending artery: 71.8% versus 83.0%; p=0.282). However, lesion morphology reflected clinical practice: instent restenosis was more frequent in the DCB group (53.8% versus 5.1%; p<0.001), while de novo lesions predominated in the DES group (94.9% versus 46.2%; p<0.001). The mean diameter of DCB and DES devices were similar, and close to 3 mm (2.98±0.41 mm versus 3.13±0.35 mm, respecively; p=0.132), indicating treatment of mediumcaliber vessels. In contrast, device length was significantly shorter in the DCB group (26.7±7.6 mm versus 38.3±16.7 mm; p<0.01), suggesting a more conservative therapeutic approach. Pre-PCI FFR values were
comparable (0.72±0.11 versus 0.74±0.07; p=0.398). Pressure microcatheters were more frequently used in the DCB group (76.9% versus 35.9%; p<0.01), likely reflecting caution to avoid rewiring following lesion preparation in the presence of possible dissections. Conversely, pressure wires were more commonly used in the DES group (23.1% versus 64.1%; p<0.01).
Although post-PCI FFR was lower in the DCB group (0.89±0.05 versus 0.91±0.04; p<0.01), at a median follow-up of approximately one year, there was no significant difference in the occurrence of the primary composite endpoint (2.6% in the DCB group versus 7.6% in the DES group; p=0.304), which was driven exclusively by target vessel revascularisation. No cases of all-cause mortality or myocardial infarction were observed in either group (Figure 1A). The incidence of periprocedural myocardial infarction was also comparable (2.6% versus 0%; p=0.314) (Figure 1B). Notably, only one case of bail-out stenting occurred following physiology-guided DCB-PCI, underscoring the procedural safety of this approach.
CONCLUSION
In this propensity-matched analysis, physiology-guided DCB-PCI was associated with clinical outcomes that were comparable to those of physiology-guided DES-PCI. These findings support the potential role of functionally guided DCB-PCI as a viable and safe alternative to stent implantation in appropriately selected patients, warranting further prospective investigation.
Figure 1: Out-of-hospital and in-hospital outcomes following functionally guided drug-coated balloon versus drug-eluting stent percutaneous coronary intervention.
1. Andersen BK et al. Predictive value of postpercutaneous coronary intervention fractional flow reserve: a systematic review and metaanalysis. Eur Heart J Qual Care Clin Outcomes. 2023;9(2):99-108.
2. Hwang D et al. Prognostic implications of fractional flow reserve after coronary stenting: a systematic review and meta-analysis. JAMA Netw Open. 2022;5(9):e2232842.
3. Camaj A et al. Drug-coated balloons for the treatment of coronary artery disease: a review. JAMA Cardiol. 2025;10(2):189-98.
4. Leone AM et al. Outcomes in functionally guided drug coated balloon (DCB) vs drug eluting stent (DES) PCI: a propensity-matched analysis. Abstract A68063dg. EuroPCR 2025, 20-23 May, 2025.
5. Leone AM et al. Safety and effectiveness of post percutaneous coronary intervention physiological assessment: retrospective data from the postrevascularization optimization and physiological evaluation of intermediate lesions using fractional flow reserve registry. Front Cardiovasc Med. 2022;18:9:983003.
Congress Interview
In this exclusive interview, Salvatore Brugaletta, a European Association of Percutaneous Cardiovascular Interventions (EuroPCR) Board Member, discusses key EuroPCR initiatives, the pivotal role of intravascular imaging in optimising PCI outcomes, and the importance of hands-on education and practical simulation in advancing interventional cardiology practice.
Featuring: Salvatore Brugaletta
Salvatore Brugaletta
Hospital Clínic, Cardiovascular Clinic Institute, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
Citation: EMJ Int Cardiol. 2025;13[1]:58-59. https://doi.org/10.33590/emjintcardiol/HTLO1917
Q1
As a European Association of Percutaneous Cardiovascular Interventions (EuroPCR) Board Member, what unique strengths do you believe EuroPCR offers compared to other major interventional cardiology meetings?
outcomes, and what are the main barriers that still limit its routine adoption into clinical practice?
It is important to teach the community about the benefits of intravascular imaging and how to use it properly in daily practice
EuroPCR is formally a course rather than a congress. This means that it offers not only clinical science and late-breaking clinical trials, which have been presented more and more over the last few years, but also several practical sessions on how to perform specific procedures. This helps the interventional cardiology community grow together in clinical practice, standardising our profession with the ultimate goal of achieving good outcomes for patients.
Q2
In one session at EuroPCR, you discussed the critical role of imaging in acute coronary syndrome. In your opinion, how does intravascular imaging optimise percutaneous coronary intervention (PCI)
It is well known that intravascular imaging is a big help in optimising PCI outcomes, especially in specific anatomical scenarios such as bifurcations, left main disease, long lesions, and calcified lesions. This was supported by Class I indication with level A of evidence in the latest European and American guidelines. Nevertheless, there are still barriers limiting its adoption, which may be due to the interventional cardiologist or the hospital administration. From an interventional cardiologist’s perspective, we either struggle with learning how to use intravascular imaging, or we have a full schedule in our lab and cannot dedicate time to it. Some of us are still convinced that it is not useful at all, especially those colleagues focused on structural interventional cardiology. Therefore, it is important to teach the community about the benefits of intravascular imaging and how to use it properly in daily practice.
On the other side, there is the issue of cost and, in many countries, the lack of reimbursement. It is important to highlight to our administrators that the use of intravascular imaging is cost-effective, as it may prevent new events and re-hospitalisation.
Q3
EuroPCR 2025 features hands-on imaging workshops, live educational cases, and sessions focused on integrating new technologies into daily practice. Which innovations or educational approaches showcased at this year’s Congress do you believe will have the most immediate impact on improving interventional outcomes?
It is difficult to choose. The handson imaging workshops may have a great impact, as they involve one-to-one interactions with imaging software to understand how to use it in real cases. It may also help us overcome our lack of knowledge when talking about the use of imaging in clinical practice. Another interesting session was the live simulation of a Double Kissing Crush case. It was a session where a virtual patient was treated with a Double Kissing Crush, simulated on a beating heart, showing how each step of the technique should be performed and what happens if something goes wrong.
Q4 Were there any presentations or discussions at the Congress that you found particularly thoughtprovoking or practice-changing?
I have two sessions in mind. One focused on the treatment of vulnerable plaques, which are coronary plaques that have not yet produced any events. There are some data showing that preventive mechanical treatment, through stent implantation, may be useful. In this session, we learnt that the presence of vulnerable plaques warrants close attention so that we can optimise medical treatment and provide our patients with the best possible care. The second session was about cardiogenic shock management. The main message here was the importance of classifying the severity of cardiogenic shock and having different invasive and noninvasive options to manage it.
Q5 As Editor-in-Chief of PCRonline, how do you envision the platform evolving to further support education and collaboration amongst interventional cardiologists worldwide?
The PCRonline platform is a hub for resources from various PCR courses, cases, webinars, and more, all over the world. Our work is built on continuous improvement and sharing experiences with our colleagues. For this reason, education should not be restricted to one event per year but rather promoted throughout the year by using various resources and methods to connect interventional cardiologists worldwide. To me, this is the most important role of a platform like PCRonline.
Q6 What are your three key takeaways from the Congress?
I only have one, but I believe it perfectly summarises the Congress. The main topic of EuroPCR this year was complexity, so my takeaway is: “When things are complex, do not make them even more complex.” Our work is built on continuous improvement and sharing experiences with our colleagues
Interviews
EMJ is delighted to introduce two distinguished leaders in interventional cardiology, Srihari S. Naidu and Arnold Seto, who share their expertise across diverse areas of the field. Srihari S. Naidu offers insights on his groundbreaking advancements in alcohol septal ablation, his journey as a published children’s book author, and his visionary leadership as the new President of the Society for Cardiovascular Angiography and Interventions (SCAI). Meanwhile, Arnold Seto delves into the latest innovations in vascular access and procedural safety, while addressing the distinct challenges of delivering high-quality cardiovascular care to U.S. veterans.
Featuring: Srihari S. Naidu and Arnold Seto
Srihari S. Naidu
System Director, Cardiac Catheterization Labs; Director, Hypertrophic Cardiomyopathy Center; Department of Cardiology, Westchester Medical Center (WMC) & WMCHealth Network, New York; Professor of Medicine, New York Medical College New York; President, Society for Cardiovascular Angiography and Interventions (SCAI), Trustee Emeritus, Brown University, USA
Citation: EMJ Int Cardiol. 2025;13[1]:60-67. https://doi.org/10.33590/emjintcardiol/FWVL2152
Q1As a pioneer of alcohol septal ablation, and the highest-volume operator of this procedure in the USA, can you explain how alcohol ablation compares to surgical myectomy and medical therapy for treating hypertrophic cardiomyopathy?
This has been a 20-year process, because when I first got involved in hypertrophic cardiomyopathy (HCM), we only had traditional medications, such as beta blockers, or open-heart surgery. But it wasn't available widely and was only offered at a few centres in the United States, at a high level.
About 30 years ago, a procedure called alcohol septal ablation (ASA) was invented in Europe, by Ulrich Sigwart. It was considered a novel, albeit outlandish, procedure because it effectively causes a controlled heart attack to a portion of the heart muscle that is otherwise too thick. I was an
early adopter of that within a few years in the USA, as it came out right when I was training. I subsequently became someone who was a go-to person for that procedure in the early days. For some time, it was not really accepted because only a few places were doing it, and surgery was the dominant treatment. But there was definitely a need as patients were struggling with debilitating heart failure symptoms, the medications were not ideal, and surgery was still considered somewhat risky.
On that note, ablation versus myectomy has been a longstanding debate. I remember doing some of these debates in Europe, as well as in the USA, over the years, because people want to know whether a minimally invasive option is actually better. The truth is, it is better in the right population and worse in the wrong population. This means that some
patients achieve a better success and short- and long-term outcome with surgery, and others do so with alcohol ablation. In general, alcohol ablation requires a skill set in interventional cardiology, and a meticulous attention to detail to allow just the ablation of the offending myocardium. Compared to surgery, one of the problems is that we're limited by the arterial tree in the coronary system, meaning that we can only do an ablation targeting the area of the septum that the arteries go to, with some diffusion to some of the neighbouring myocardium. Because of that, it's a little bit more of a hit or miss compared with surgery, where they can essentially surgically remove the myocardium in a more visualised way.
The challenge with myectomy, though, is that since very few people do it, there are a lot of failures, usually caused by not taking out enough muscle or not taking out the muscle in the right location. So, unless you're getting it done at an expert centre, there is a high failure rate. However, if both are done in expert centres,
there are still some noticeable differences. In general, the mortality rate from alcohol ablation is less than the mortality rate for myectomy; it should be less than 0.23% with alcohol ablation, compared to approximately 0.5% with myectomy. But in the real world, the mortality rate could be even higher with the myectomy in particular. So, as one would expect, the minimally invasive procedure has a lower mortality in the real-world setting. On the other hand, alcohol ablation has a higher pacemaker risk, because it's often performed in older patients who have too many comorbidities for surgery, so they tend to have a pacemaker rate somewhere in the 10–20% range. On the flip side, surgery would be ideal for patients who are much younger.
As I mentioned previously, beta blockers were the mainstay, but now we have these medications that target the myosin apparatus itself and reduce contractility. So, over the past couple years in the field, rates of both alcohol ablation and surgery have gone down, probably by about 50% in
expert centres, but they're still available because some patients want a durable result without the need for medication. Now, more patients want to try medication first, and that's kind of how we're doing things right now. There are pros and cons to each of these three modalities, and what's most important is to get to a centre that has all three opportunities for your patients: medications, alcohol ablation, and surgery, so that they can use their experience and their expertise to individualise care for a given patient.
Q2
Your annual proctorship programme trains physicians in ASA techniques. What barriers hinder broader adoption of ASA both in the USA and other countries, and how can the cardiology community address them?
Attitudes clearly differ between Europe and the USA. In the USA, when we do large scale evaluations in the real world, about half of the patient population on medications have surgery, and the other half have alcohol ablation. When you
do a similar analysis in Europe, it's probably 80% receiving alcohol ablation, and if you go to Asia, the percentage undergoing alcohol ablations is even higher. In general, I think there has been a larger adoption of minimally invasive procedures in Europe and Asia, partly for spiritual reasons in Asia, and in Europe, I think it’s more due to lack of availability of surgical centres. Whereas, in the USA, there are many large centres that have shepherded hypertrophic cardiomyopathy care for many, many decades, and so surgery continued on as a primary modality. I do think that in the appropriate hands, the mortality rate is better and the efficacy is similar with alcohol ablation (in the appropriate patients), and so the only detriment really is the pacemaker rate. Mostly, patients over the age of 50 or 60 years typically don't mind this, because if they get a pacemaker at that age, it's usually not too much of a burden. It also allows monitoring of the patient for atrial fibrillation or other arrhythmias that might prevent sudden cardiac arrest down the line.
The problem with both of these procedures is that they are very hard to teach and, like any other procedure, you need to do a certain number of them to maintain the credibility and expertise over time. So, in the 2011 American Heart Association (AHA) guidelines, we recommended that institutions should do 10 procedures a year to maintain certification, credibility, and expertise, but very few places can do that. In our heyday, we were doing about 40 alcohol ablations and 30 myectomies a year here. Now, with the use of mavacamten and other cardiac myosin inhibitors, the volume of procedures done will be cut in half. So, one of the main challenges is,
how do you set up major centres to offer this? With this in mind, we developed a course. It's over 10 years old now; we had a break during the COVID-19 pandemic, but we've done roughly seven courses since its inception, and they have been very popular. The only way to learn this procedure is to see a few of them at once. We usually have about three cases over the course of 2 days, and then, through didactics, we discuss all of the alcohol ablation details, including preprocedural and intraprocedural planning and post-procedure management. We then take attendees through live cases, where we go through the procedure step-by-step on actual patients. Finally, we end with critical care rounds, where we look at the patients afterwards and discuss their ECG, pacemaker requirements, and how to manage them before they go home. It's a very comprehensive course and we’ve probably trained over 100 people who have all gone out to do the procedure. So, it does work and now they have the experience. Even if they don't do 10 per year, they have a network of individuals who they can run cases by and refresh their ideas on the tools and the equipment needed, and how to plan for that procedure for that given patient.
I do think that surgeons should do the same thing. They have not developed a course in this space. I have advised that they do because I think that both these procedures are very important and valuable for the population, including in Europe. About 10 years ago. Barry Maron wrote a paper entitled, ‘Bring Septal Myectomy Back for European Patients’,1 which was essentially a call to action, highlighting that we do need capable surgeons out there to do this. I would be an advocate for that as well.
In the surgery field, they train in their fellowships, but then afterwards there's not a whole lot of training opportunities, from what I can see. I think it's more in the mindset of interventional cardiology to proctor other people and spread these procedures more broadly. But I think within the surgical field, they tend to rely on their societies and their training pipeline, and not necessarily courses like these. Additionally, they tend not to train their competition. Now, you can say the same thing for interventional cardiology, but I specifically bucked that trend by saying: “I'm going to train people to compete with me.” That’s because the greater good is more important. I know it's easy to say that, but the truth is that in any field, people tend to hold on to their trade secrets. Now, with that being said, I will say that our surgeons were trained by the Mayo Clinic surgeons, but that was through a personal relationship. Though I think the Mayo Clinic surgeons have done a good job of going out and training individual surgeons at other institutions, and I give them credit for that, I do wish that somebody would take the mantle and develop an actual course. We did think about expanding our course to include surgeons, but again, it depends on funding and the availability of surgeons who are willing to do it.
Q3 Can you tell us about your book, ‘Lindsay's Big Heart’. How does improving patient/family health literacy correlate with treatment adherence and outcomes in the HCM population?
I'm a creative person; I like doing different things and coming up with new ideas. This idea came out of a desire to spread HCM awareness a lot broader, and
books have a way of spanning globally. In other words, they can be translated to other communities. And actually, we've had some interest from the HCM Foundation in Europe, as well and other places, to translate the book.
The reason for spreading awareness for HCM is that most patients with HCM seek medical attention when they are middleaged, which means that they have probably been living with their HCM for decades. It's known to start in puberty and teenage years, so there's usually a long latency period where they have the disease but no symptoms. We would like to catch people at that stage where they're developing hypertrophy but don't have symptoms, so we can start getting them treated earlier and possibly prevent progression.
The second issue is that a lot of these people have kids, and they have no idea how to talk to their kids about this disease. I feel like if a woman has breast cancer, they sit their daughter down, tell them about breast cancer, and why they need to have mammographies. However, we don't do the same for other genetic diseases, like HCM, and because of that, I wanted to have a tool that parents can read to their kids while they're young, before the HCM even develops, if it even develops. That way,
when they get older and their ECG looks suspicious or they have symptoms, they will not be scared to tell their doctor that there is HCM in their family. At the moment, I do not see that happening, and the only way to get that to happen is to educate people at an age where they can see that this is running in their family and not be scared of it. That's the second part of it, which is something the book really addresses: how to digest this disease as one thing in your family and not be scared of it.
We would like to catch people at that stage where they're developing hypertrophy but don't have symptoms
What you see is a young girl go through this and lead a very happy, normal life. It shows that none of the testing was scary, and she can go on to do all the things she wants to do; she just happens to have this bigger community of physicians, parents, and other people who now know her and how to protect her, including having defibrillators in the school and people around her knowing CPR. So, I think the
book comes out of this genuine idea to have a resource for kids where they can be curious and understand their disease in a way that makes sense to them.
At the same time, we didn't want to water the information down. We made sure that the book has pictures that are accurate, and every picture included has educational value, including having defibrillators visible and showing the different testing that people get throughout their evaluation and management. I spent a lot of time on additional pages for parents at the end: two pages on how to keep your kids safe, and two pages that define all the complicated medical terms that even parents wouldn't understand, so that they're prepared when they go into their doctor's appointment. So, there's a little bit of a dictionary at the end to help people understand the top 20 words that come up in this disease. I wanted to make sure the book really spanned both parents and kids.
If we have the energy and funding, we would like to translate the book into different European languages, certainly Spanish and French, and then eventually Mandarin and Arabic. I'm not sure what else, but those probably cover a large portion of the world. HCM is a disease that spans both genders and all races, and happens
in rich communities and poor communities; I do want to get it to all kids of the world. A 19 USD book is something that you can get everywhere, including for free in libraries, whereas actual healthcare is not quite as egalitarian.
Are you planning on writing any other books?
I’m not writing any at the moment, because I have a lot on my plate right now, but the publisher that we have has already mentioned that they would love to have more of a series. Lindsay Davis is one of my friends with HCM and this book is modelled after when she was around 8 years old, and Kiran, the boy in it, is my son, and it's modelled after when he was also 8 years old. He's sort of the ‘smarty pants’ kid who teaches her a lot whilst in the hospital after having a false alarm. So, I think one of the ideas was to have a Lindsay and Kiran series, where they can each be the protagonist, depending on the disease state. For example, the next book could be about Kiran's peanut allergy. There's so much opportunity to talk about something like that and make different conditions and diseases less scary.
Q4Your work on the 2019/2022 universal cardiogenic shock definitions revolutionised trial design. How have these criteria impacted mortality stratification in recent studies like RECOVER III?
My other passion is cardiogenic shock, and thank you for the kind words. When you do something, you don't think anything's going to revolutionise anything. But certainly, there was a void that felt palpable in that we didn't really know what we were treating. We've done a good job of treating heart attacks and basic heart
failure, but patients in cardiogenic shock have historically had a 40–50% survival rate, which is very, very low.
Patients in cardiogenic shock have historically had a 40–50% survival rate
It turned out that when they were doing a lot of these clinical trials, you could look at them and see very clearly that some of them included very sick patients with cardiogenic shock, and others had more lenient requirements for inclusion into cardiogenic shock groups. Then what happens is, it's hard to know if the devices and the protocols that we choose are failing because the patients are going to fail no matter what, or because the patients are going to do well no matter what. It became very clear that we had to have more granularity in the definition of cardiogenic shock.
In 2019, I was fortunate enough to have the Society for Cardiovascular Angiography and Interventions (SCAI) do this commission and get some leading experts across the different fields that deal with cardiogenic shock. One thing unique about shock is that whilst it's cardiogenic, it's not just cardiology that is involved in its management; there's critical care, emergency medicine, the emergency medical services (EMS) system, pulmonologists, renal physicians, and surgeons. There are so many different people dealing with this disease state that need to be involved, and because of that, we put together a consortium of individuals spanning all those different societies to get
the different angles on how to treat this. Together, we came up with this definition of five different stages: A, B, C, D and E. C is the classic shock; E is extreme shock; D is in between, where you're failing despite manoeuvres; B is pre-shock, meaning you don't have any malperfusion, but you have signs that things are not going the right direction; and A is the broad base of patients that have the potential to develop shock, in that they have a phenotype problem, such as a decreased ejection fraction or abnormal valve, that could be a trigger for shock to be watchful for later down the line.
We were fortunate that trials started using this definition and looking at which patients benefit, which patients do worse, and which patients we should be studying. The big one that really made the news more recently is the DanGer Shock trial that came out of Europe with Jacob Eifer Møller et al.,2 which showed that if you include only stage C and D patients predominantly, there was a significant mortality reduction with use of the Impella microaxialflow pump (Abiomed, Danvers, Massachusetts, USA). So, for the first time, it was demonstrated that by narrowing the shock definition to who we think would really need and benefit from interventions or protocols, we see a positive outcome. As such, I would give as much credit to the devices and protocols as I will to the inclusion criteria, and the fact that these weren't patients with anoxic brain injury, which the definition provides as well.
The second thing is you alluded to the RECOVER study, and there's been more and more data coming out of that. The most recent substudy looked at stage E patients in a lot of other
databases. I, myself, was saying that if you're in stage E, certainly if you have cardiac arrest, the mortality is very, very high. Discussions started to come up regarding whether treatment for such patients should be deemed futile. It turns out that the stage the patient is at 24 hours is more important, which is great because it means that we have a day, which I've been calling ‘The Golden Day’ to try to improve their clinical state and improve their shock stage.
A recently published study by Ivan Hansen et al.,3 showed that more than half of patients in the RECOVER III trial were stage E, and stayed in stage E, but the other half improved to stage C or D. Furthermore, the ones that improved actually had a much higher survival rate of over 60%, compared to 30% in the ones who did not. Thus, if you stay in stage E, you may have kind of a long course, and it may be hard, but if you get them to stage C or D, they do much better. Again, the staging is to be used as an active tool. Patients should be restaged frequently, with the aim to get them down within the first 24 hours, then you can expect a better survival. This is something I have recently named the ‘DLC’ for Door to Lactate Clearance.4
Now, how we do that is unclear, but there are some clues from that study, such as decreasing pressors, using Impella (Abiomed, Massachusetts, USA) before the percutaneous coronary intervention and trying to fix as many lesions as possible, which, of course, goes against the guidelines right now. But, at least in some subsets it looks like it might be beneficial, so, I'm very proud of the definition.
We are now in the starting stages of revising it for the second time, to come up with the 3.0 staging
criteria. We have put together a larger consortium with similar individuals to take a look at the definition, identify the current gaps, and discuss how can we make it more granular and more appropriate and more prognostic, without losing its simplicity. Hopefully it will continue to move the field forward from there. So, about a year from now we will probably have that published.
Q5
As SCAI PresidentElect, what specific initiatives will you prioritise during your upcoming presidency?
I'm very humbled about it because it's been a 20-year journey; not to become SCAI President, but rather to be participating in SCAI. The organisation has given me a lot of opportunities, and I do feel that I was someone who would not have been discovered or embraced more widely if it weren't for the society. In my clinical role I moved from academic places to more community hospitals, and traditionally, there's less opportunities to be academic at these other hospitals. However, I think one thing that is wonderful about SCAI, and the interventional community as a whole, is that it doesn't really matter where you practise, it matters that you practise, and it matters that you practise well.
What I also love about the SCAI is that it's a global organisation, and even though it's very clear that it was based in the USA and started here, I do think we have tried very hard to embrace interventional cardiologists across the globe, including Asia and Europe. Now of course, Europe has its own strong societies and programmes, but we are always here, available and willing to work with European colleagues as they see fit. As such, one of the things that I want to do within SCAI is to build some of the global community a little bit more. We've always had an international community, and as a committee, we do a lot of global educational sessions. But I do think that there are opportunities to do more combined documents, more combined scientific publications, more combined educational activities, and so on. We want to move the field in the same direction globally, as opposed to country-by-country. Thus, one of my initiatives is to be more strategic in our alliances. Firstly, within the USA with areas outside of cardiology, such as the American Hospital Association (AHA), insurance companies, and the government, and secondly, more broadly across the world, where it makes sense to improve care more globally by using minimally invasive procedures that we know are beneficial in certain subsets.
It doesn't really matter where you practise, it matters that you practise, and it matters that you practise well
The second thing that I want to do is to really focus on wellbeing. For about 40–50 years now, since the invention of angioplasty, we've been working in leaded, burdensome physical environments with radiation exposure. It's very clear now, that there are significant risks of orthopaedic injuries and cancer that we all didn't want to believe, but when there's cancers only on one side of your body, it's
a problem. When brain tumours are always on one side of your body, it's clearly related to the side that's affected by radiation. I do not think this is a sacrifice individuals should make for the greater good. Therefore, one thing we want to do is continue working with companies to really broaden the penetration of the lead-free environment in Cath Labs across the world, so that we can remove the lead, and also remove the cancer risks at the same time. This is one thing that my predecessor, James B. Hermiller, had been promoting.
The second part of it though, which I think is also important, is that there's a huge amount of burnout, mental health problems, and fatigue in our field. We are working at night, we're working during the daytime, and we're expanding our field further, into work on stroke and pulmonary embolism, etc.; so, we're doing more and more. Today, if you look at what surgeons do versus what interventional cardiologists do, almost everything is becoming minimally invasive. We are happy to be that workforce and do that good for society, but at the same time, we have to make sure that we take care of the caretaker, so to speak. That means we need to embrace this as a career that allows us to breathe our life into it.
I'm very much someone who likes to maintain hobbies, health and fitness, and family and friends, which is very hard to do in our field. But these are the things that help to avoid burnout, because they allow us to minimise repetitive tasks and have a life outside of our careers. So, during my term as SCAI President, I will certainly increase the wellness aspect and allow people to really focus on what makes them happy, so that they can be better interventional
cardiologists inside the lab, but also better family members, colleagues, and friends outside the lab. I post songs on Twitter that I sing, I post about my book, and every once in a while, I'll post some fitness things, and I certainly post about time with my son and whatnot. I'm also a basketball fan, so I'm somebody who tries to promote the other aspects of my life. This is mainly to show people that they're allowed to do that, and so during my term I will certainly explore allowing people to be who they truly are, and to not forget who they are.
I also think that we need to retire. Our prior generation didn't retire, and it's partly because they don't know what to retire to. But if they maintain these hobbies and these other outside interests and happiness, it becomes very obvious that at some point you want the last 10 or 15 years to yourself, to really re-explore who you are, maintain some of those hobbies and passions, and be able to relish and look back on the career you had, and the service you gave.
I also want SCAI to increase its scientific output and do more guidelines that are specific to the procedures that we do, such as procedures in the transcatheter aortic valve replacement space, and in the patent foramen ovale space. These are areas where we are on the ground, and we need more in-depth information beside what the American College of Cardiology (ACC) and European Society of Cardiology (ESC) can do. For our members, I think we can dive in deeper there and do a better job of that. And so, I will be promoting more publications and a higher reach for the Journal of the Society for Cardiovascular Angiography & Interventions
There are also a couple of other things to prioritise. One is the phenomenon called ‘the leaky pipeline’ for women and for midcareer men as well; where in the middle of your career, usually 10–20 years out, oftentimes people can get lost. They get busy, and there's less resources for them. So, we are going to double down on the SCAI emerging leader mentorship (ELM) programme and enable more training and leadership skills for people in the mid-career stage. The idea is to get those people re-engaged with the SCAI. Some of them will be ELM alumni, but others will be people who are just doing phenomenal jobs around the world, and we want to encourage them to come on in and get maybe a 2 day course on how to lead large scale trials, how to be chiefs and directors of major institutions, how to get big grants, and other things that move the field forwards and also ensure we don't lose track of people who need those resources and don't have them locally.
And then finally, I will say that since I've been involved in the cardiogenic shock space, the simplistic five tier definition has blossomed out, and has become more and more complex. Now we have different phenotypes and different perfusion markers, different metabolic states, congestion profiles, and it has become confusing again. When things get confusing, you lose sight of the prize, so I'm trying to bring back the prize, which is that, as I alluded to in the RECOVER III trial above, it is far more important to know where the patient is at 24 hours than it is when you first see them.
As discussed, I'm calling it the ‘door to lactate clearance’, or the DLC. I'm challenging the whole field to focus on the lactate and getting
it clear within 24 hours, because if you do that, mortality will be much lower, probably less than 20%. This is similar to the call for door to balloon times of 90 minutes in the heart attack population, which revolutionised that process.
The data is showing that all roads lead to Rome, in that if you can get the lactate down, these patients will do better and survive more. Now, how you do that is going to be up to individual teams, the individual tools, individual medications, or whatever you have, because everybody has different things. You have rural parts of India and you have very fascinatingly complex technological parts of metro areas, but they all should be able to focus on something that they can do
References
1. Maron BJ et al. Controversies in cardiovascular medicine. Benefits of surgery in obstructive hypertrophic cardiomyopathy: bring septal myectomy back for European patients. Eur Heart J. 2011;32(9):1055-8.
to get the lactate down with the resources that they have available. Some places will go straight to surgery, whereas other places will go straight to Impella, and others will do extracorporeal membrane oxygenation. I want to be agnostic to all those things and focus on the prize, which is getting the survival up. At the same time we will have to provide guidance on how to use the DLC, make sure that people don’t find shortcuts that are on balance negative, and aren’t also unnecessarily aggressive; these will all be developed during the next year. So, overall I will be challenging people to focus on cardiogenic shock as an important final frontier in cardiology. And SCAI will have several educational initiatives and publications in this space over the year.
2. Møller JE, Gerke O.; DanGer Shock Investigators. Danish-German cardiogenic shock trial-DanGer shock: trial design update. Am Heart J. 2023;255:90-3.
3. Hanson ID et al. Acute Myocardial Infarction and Stage E Shock: Insights from the RECOVER III Study.
I'm calling it the ‘door to lactate clearance’, or the DLC
Any final comments?
Just like SCAI embraced me, I think that sometimes as organisations get bigger, they may seem impenetrable in a way, but I would tell people to contact me, or anyone they know working at SCAI, and tell them what they’re passionate about, and how they can contribute to the organisation. SCAI will always find a role for people who are interested, and who are team players.
4. Naidu SS. Carrying the torch and fanning the flame: my vision and hope for SCAI. Journal of the Society for Cardiovascular Angiography & Interventions. 2025;DOI:10.1016/j. jscai.2025.103651.
Arnold Seto
Division of Cardiology, Long Beach Veterans Administration Healthcare System, California; Clinical Professor, Charles R. Drew University of Medicine and Science, California; Associate Clinical Professor, University of California, Irvine; Treasurer and Executive Committee Member, Society for Cardiovascular Angiography and Interventions (SCAI), USA
Citation: EMJ Int Cardiol. 2025;13[1]:68-71. https://doi.org/10.33590/emjintcardiol/HVDJ4077
Q1As a cardiologist treating veterans at the Veterans Administration (VA) Long Beach Healthcare System, can you describe the unique challenges and considerations in caring for this patient population, and highlight some of the specialised cardiology programmes and services available to veterans at this facility?
There has always been a consensus that the U.S. government had a moral and financial obligation to take care of veterans. Being able to work with the veteran population is the reason most physicians work for the VA. The veterans who are within the VA system consistently rate it highly.1 Even thought we need to ensure veterans have access to community care for things that we can’t take care of, no one else can provide for the comprehensive social, mental health, and medical needs of veterans with complex health needs, let alone the housing, disability, and drug treatment that the VA also provides.
Patients and their families sometimes get the impression that the VA provides minimal or lower quality care, or that
the providers are somehow substandard. I have had people (patients and staff) ask me why I work for the VA when I went to Harvard Medical School (Boston, Massachusetts, USA) and could work almost anywhere in the country. The reality is that I have the best equipment available (for instance, the ProtegoTM radiation protection system [Image Diagnostics Inc., Fitchburg, Massachusetts, USA] and AlluraClarity [Philips, Andover, Massachusetts, USA]), while my university hospital had 15-year-old catheterisation laboratories that regularly dose patients with over 3 Gy of radiation. I have access to the latest devices without worrying about delays in reimbursement, such as the AgentTM drug-coated balloon (Boston Scientific, Marlborough, Massachusetts, USA) and Recor Medical renal denervation equipment (Recor Medical, Palp Alto, California, USA). Our catheterisation laboratory staff are experienced and worked in the community for years before joining the VA. I am sure that all of my patients are getting the best care available, in a timely fashion, and if we can’t provide it, I know I can send them out to someone who can.
We have national pacemaker device tracking with remote monitoring, which is a highquality intervention; we have heart failure clinics that provide longitudinal care and reduce rehospitalisations; and we have our own national catheterisation laboratory database, CART-CL, which is tied into hospitalisation and mortality statistics for monitoring. Almost every systemsbased intervention for improving health care quality is present in at least some VA facilities.
Q2
Your work has largely focused on cardiac procedural safety, including your work as lead investigator for the Femoral Arterial Access With Ultrasound Trial (FAUST), which demonstrated that ultrasound guidance improves safety and efficiency in vascular access procedures. What emerging technologies or techniques could further improve the safety and efficiency for both radial and femoral approaches?
Despite over 30 years of vascular access research and relative maturity in the field, there remain opportunities for improvement. Sometimes, the simplest interventions have the greatest potential, as they tend to be less expensive. I personally think that the StatSeal potassium-ferrate hemostatic patch (Biolife, LLC., Sarasota, Florida, USA) is a potential gamechanger for vascular access. We’ve had other haemostatic patches with chitosan, kaolin, or other materials, but this one is qualitatively different, as it does not attempt to work through the coagulation cascade and forms a strong seal over the arteriotomy. This is helpful in rapidly providing haemostasis. As our STAT2 and STAT II3 trials have demonstrated, using the StatSeal in radial
access can improve the safety and efficiency of our procedures by providing consistent 1-hour haemostasis. I am convinced that the StatSeal would probably perform well in other applications, such as femoral access, especially in large-bore venous access and post-Perclose (Abbott, Chicago, Illinois, USA) groin oozes.
Q3
What areas of interventional cardiology do you think still need improvement in terms of procedure safety?
I think that our procedures are quite safe for patients, but that there are inherent risks to invasive procedures. Softer or more gentle wires and equipment that can avoid scraping against the aorta and sending emboli to the brain are still an area for improvement.
Despite over 30 years of vascular access research and relative maturity in the field, there remain opportunities for improvement
Another technology I am intrigued by is the Early Bird® femoral sheath (Saranas, Inc., Houston, Texas, USA) that can detect occult femoral artery bleeding.
From a technique perspective, I think that ultrasound can be more optimally used in femoral access, by utilising both the longitudinal and axial views before and after access. This would enable ultrasound to precisely image the femoral head, inguinal ligament, bifurcation, and femoral insertion location. Not only would this potentially enable more precise punctures, but it could also eliminate the need for contrast femoral angiography. With the newer radiation protection systems (such as Rampart [Rampart ic, Birmingham, Alabama, USA] and Protego), femoral angiography is challenging to perform, and I think that ultrasound could easily replace the femoral angiogram.
Thanks to the leadership of James Hermiller, we at the Society for Cardiovascular Angiography and Interventions (SCAI), are focused on the occupational safety in terms of radiation exposure and orthopaedic risks of lead this year. There is a great opportunity here to reduce the burden of radiation and the lead garments we use to protect ourselves from it. I have been very impressed with the radiation reductions I have experienced with modern fluoroscopic equipment compared with older machines, and am astounded by the new lead-free Protego system in our lab. These improvements needed to be built upon to improve the safety for our patients and ourselves.
A major concern I have in terms of procedure safety is that some organisations take a good patient safety idea and then take it too far, in the absence of demonstrated risk, or evidence of benefit of an intervention. We, like many catheterisation laboratories, have been increasingly held to operating room standards from the Association of perioperative Registered Nurses (AORN), who understandably want to reduce operating room infections. However, when AORN requires ‘any visible hair’ to be covered and shoe covers to be used; it really goes too far in the absence of evidence of risk of infection.
Similarly, we are all subject to anaesthesia requirements for patients to be nil per os (NPO) for hours, even when multiple studies have shown that the risk of aspiration is low in cardiac catheterisation procedures, and an NPO requirement increases the risk of dehydration, and potentially contrast nephropathy.
Q4
You recently published a commentary entitled, ‘Closing the loop in cath lab communication: avoiding the tower of babble’. Can you discuss how laboratories can overcome the challenges of maintaining high levels of closed-loop communication (CLC) beyond initial education and training efforts, particularly in hybrid operating room environments with multidisciplinary teams?
CLC is probably one of the most demonstrably beneficial tools in reducing communication errors. It simply requires the recipient to repeat what verbal request/order they heard, and preferably to repeat it again when the task is completed. CLC is required in air traffic communications and all military radio communications to avoid the risks of miscommunication that everyone can recognise from the old game of ‘Telephone’. As there are only verbal orders in the catheterisation laboratory environment, the risks and immediate consequences of misunderstandings can be quite acute, as the examples from a paper by AJ Doorey et al.4 demonstrate.
The challenges of maintaining high levels of CLC in the catheterisation laboratory include:
1. lack of training in CLC: most staff are not former military or aviation experts where CLC is standardised;
2. lack of accountability for non-standard communication: airline pilots who don’t callback an order are assumed to have missed it;
3. catheterisation laboratory staff turnover and variability (especially with anaesthesia and surgeons present);
4. Routinisation: ironically, the converse of overfamiliarity of the staff with each other, the physician, or the work may become a risk when uncommon/atypical situations or orders arise;
5. latent risks, including time pressures and financial pressures; and
6. distractions, such as the presence of trainees and vendors, noise, or cell phones.
Overcoming these challenges requires making CLC part of the communication culture of the catheterisation laboratory, including providing training in how it is performed, holding people accountable for when it is not used (e.g. operator repeats an order when it was not read back, or staff are re-educated/ counselled if they repeatedly
fail to use CLC), and practicing in simulated situations (as in emergency drills). Latent risks have to be addressed individually, for example distractions can be minimised by limiting the number of people in the catheterisation laboratory. Physicians have just as much responsibility for CLC as staff members; for example, they need to acknowledge they have received information such as activated clotting time results or warnings when the activated clotting time is due, or when the ECG/pressure waveforms have changed. Everyone needs to be focused on the patient during procedures, so we have banned personal cell phone use in the catheterisation laboratory, and mostly avoid extraneous conversations during critical parts of the procedure.
Q5As SCAI Treasurer and Executive Committee Member, what key research areas or clinical trials is SCAI particularly focused on supporting to advance the field?
SCAI has only recently developed the capacity to directly support clinical research via the SCAI Early Career Research Grant, through the vision and leadership of our past-President, Sunil Rao. These three 50,000 USD onetime grants are sponsored by our industry partners, and support clinical research in coronary, structural, and peripheral vascular interventions. SCAI does not specifically focus on supporting one particular area, and we invite proposals within any of these
fields. The proposal review process is blinded, collaborative, and as fair as I could possibly imagine. I have been happy to participate as a reviewer in multiple cycles.
Q6
With over 200 peerreviewed publications, and 20 book chapters, what do you consider your most significant research contribution to the field of interventional cardiology?
I think that I would look back and still focus on the FAUST trial5 as my most significant research contribution. Despite interventional cardiologists invariably having high confidence in their skills in vascular access, what they were really doing was puncturing a large femoral artery
References
1. Veterans Administration (VA) News. VA health care outperforms non-VA care in two independent, nationwide quality and patient satisfaction reviews. 2024. Available at: https:// news.va.gov/press-room/va-healthcare-outperforms-non-va-care-intwo-independent-nationwide-qualityand-patient-satisfaction-reviews/. Last accessed: 14 April 2025.
blindly, anticoagulating patients, and hoping for the best in terms of bleeding. By 2008, when we conducted the study, ultrasoundguided access was already the standard for central venous access and frequently used for arterial access by interventional radiologists and vascular surgeons. So, in that respect, we had strong suspicions that our trial would work out, and it became just a matter of someone taking the time and effort to conduct the study. We were able to perform this without any research funding, and just based on the hard work and dedication of our team.
Some of the best clinical research in my mind addresses practical problems in the
2. VA Long Beach Healthcare System. Radial hemostasis is facilitated with a potassium ferrate hemostatic patch (Statseal): the randomized controlled statseal with TR band assessment trial (STAT). NCT03028025. https:// clinicaltrials.gov/study/NCT03028025? term=NCT03028025&rank=1.
3. VA Long Beach Healthcare System. Radial hemostasis is facilitated with a potassium ferrate hemostatic patch (Statseal): the randomized controlled
catheterisation laboratory. When I look back, if there is a theme of my research, it has been to try and resolve day-to-day issues, such as patient safety and catheterisation laboratory efficiency. Along with research, I was very involved in SCAI society statements on the length of stay after percutaneous coronary intervention and percutaneous coronary intervention at noncardiac surgery hospitals. Many people have many more papers than I have, but when I consider what changes have been made in practice from our teams’ studies or our SCAI consensus documents, I feel like I have made an impact on how we practice interventional cardiology.
statseal with TR band assessment trial (STAT) II. NCT04046952. https:// clinicaltrials.gov/study/NCT04046952.
4. Doorey AJ et al. Safety gaps in medical team communication: closing the loop on quality improvement efforts in the cardiac catheterization lab. Catheter Cardiovasc Interv. 2022;99(7):1953-62.
5. University of California, Irvine. Femoral arterial access with ultrasound trial (FAUST). NCT00667381. https:// clinicaltrials.gov/study/NCT00667381.
Role of Intravascular Imaging in Optimising
EMJ Int Cardiol. 2025;13[1]:72-73. https://doi.org/10.33590/emjintcardiol/VCRM1120
Types of Intravascular
Imaging:
IVUS and OCT
Techniques like OCT and IVUS are revolutionising PCI guidance.1
OCT and IVUS provide more detail on plaque composition, vessel size, and stent optimisation.1
Improving PCI Outcomes
Summary of Characteristics1,2
Plaque Characterisation High-resolution imaging fibrous, calcific, and lipid-rich
Quick acquisition
High resolution (10 – 20 μm)
Near infrared light
Requires clearance of blood from coronary artery
Detailed characterisation of the intimal feature
Stent Optimisation Improves stent positioning; malapposition and edge dissection
Thrombus Visualisation Excellent for intracoronary thrombus, especially in acute coronary syndromes
Ultrasound transducers
1,604 patients underwent PCI with drug-eluting stents for complex lesions
Deep tissue penetration (1–2 mm) for better visualisation or larger plaques and the vessel wall
Technical Advantages Superior surface detail resolution and faster acquisition
Special Applications
Less useful for ambiguous caps or subintimal navigation
OCT-guided PCI resulted in a lower incidence of MACE at 1 year compared with angiography guidance
OCT resulted in a larger minimum stent area, but did not significantly reduce target vessel failure at 2 years. ILUMIEN IV Randomized Controlled Trial4
1,233 underwent OCT-guided PCI
1,254 underwent angiographyguided PCI
Optimising PCI Outcomes
Cost Effective?
High Costs
IVUS generally more accessible and cost-effective than OCT.2
IVUS
imaging of lipid-rich plaques
Effective for calcified/fibrotic plaques; measures plaque burden; deeper penetration aids ambiguous caps detects dissection
Assesses stent expansion/apposition; measures vessel size and lesion length for optimised deployment
thrombus, syndromes
Limited thrombus visualisation resolution acquisition Greater tissue penetration for deeper vessel assessment ambiguous navigation Guides antegrade/retrograde wire positions; useful in reverse CAR-T and subintimal navigation
Operator Expertise
Needed for IVUS, especially in subintimal approaches.1
AI Algorithms
May mitgate the need for operator expertise and enhance diagnostic accuracy.1
Blood Clearance
Needed for OCT; can cause procedural complications.1
Benefit in High-risk Groups
Very cost effective in Type 2 diabetes, chronic kidney disease, distal left main coronary artery lesions, and acute coronary syndromes.6,7
ADAPT-DES Study5
In 8,582 patients, IVUS lowered rates of stent thrombosis (0.7% vs. 1.0%), MACE (8.4% vs. 11.2%) and myocardial infarction (2.9% vs. 4.6%).
Other studies with real world data include the ULTIMATE trial, the IVUS-XPL, trial, and the RENOVATE COMPLEX PCI trial.
In patients with complex coronary lesions, intravascular imaging guidance reduced the risk of TVF. The greatest benefits were observed in Stage 3 CKD.8
Abbreviations
These patients are prone to procedural complications like stent thrombosis or restenosis, so stent placement optimisation with OCT/IVUS reduces procedural complications through superior vessel assessment.6,7
Compared to angiography alone, IVUS-guided PCI has an incremental costeffectiveness ratio of 3,649 GBP to 5,706 GBP per quality-adjusted life year gained.9
IVUS may be preferred in chronic kidney disease as OCT requires additional contrast to clear the blood pool.1,2
1. Panuccio G et al. J Cardiovasc Dev Dis. 2024;11(9):295.
2. Apostolos A et al. J Clin Med. 2024;13(23):7087.
3. Hong SJ et al. Lancet. 2024;404(10457):1029-39.
4. Ali ZA et al. N Engl J Med 2023;389:1466-1476.
5. Maehara A et al. Circ Cardiovasc Interv. 2018;11(11):e006243.
6. Alberti A et al. Eur J Health Econ. 2016;17(2):185-93.
7. Sarwar M et al. J Geriatr Cardiol. 2024;21(1):104-29.
8. Kwon W et al. JAMA Netw Open. 2023;6(11):e2345554.
9. Sharp ASP et al. Eur Heart J Qual Care Clin Outcomes. 2024;10(8):677-88.
Transcatheter Aortic Valve Implantation in Patients with Pure Non-Calcified Aortic Regurgitation
Editor's Pick
This is a new and somewhat controversial indication, based on the data available so far. Nevertheless, there are some off-label indications and some compassionate use for these devices in clinical practice. Therefore, this review is an important piece of information to advancing knowledge in the field.
Authors: Andrea Marrone,1 *Alfonso Ielasi1 1. U.O. Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant’Ambrogio, Milan, Italy *Correspondence to alfonso.ielasi@gmail.com
Disclosure: The authors have declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:74-85. https://doi.org/10.33590/emjintcardiol/YVTI2127
Abstract
Background: While transcatheter aortic valve implantation (TAVI) is a well-established therapy for elderly patients with aortic stenosis, its role in treating pure non-calcified aortic regurgitation (AR) remains limited due to anatomical challenges, device limitations, and off-label use.
Methods: This review examines current evidence from registries and meta-analyses focusing on TAVI outcomes in patients with pure native AR, highlighting technical considerations, patient selection criteria, and device performance.
Results: TAVI in AR presents unique procedural challenges due to the lack of annular and leaflet calcification, frequent aortic root dilation, large and elliptical annuli, and high stroke volumes. These features compromise prosthesis anchoring and fluoroscopic visualisation, increasing the risk of prosthesis migration, paravalvular leak, and procedural failure. Both off-label transcatheter heart valves, originally designed for aortic stenosis, and dedicated on-label devices have been used, each with specific advantages and limitations. However, the most critical determinant of procedural success is not the type of device per se, but rather a thorough understanding of the anatomical challenges inherent to AR. Accurate preprocedural imaging, appropriate oversizing strategies, and tailored implantation techniques are essential to achieve optimal outcomes.
Conclusions: TAVI is an emerging option for selected patients with pure AR, using either off-label or on-label devices. Success depends primarily on recognising and addressing the anatomical and technical complexities that differentiate AR from aortic valve stenosis, underscoring the importance of individualised patient assessment and procedural planning.
Key Points
1. Transcatheter aortic valve implantation (TAVI) is a well-established treatment for elderly patients with aortic stenosis but remains off-label in pure non-calcified aortic regurgitation (AR). As there is a significant number of patients with AR that are high-risk or inoperable referred for treatment, there is an emergent clinical need for less invasive alternatives.
2. This review provides a comprehensive overview of the current evidence and technical considerations surrounding TAVI in pure AR. It highlights anatomical challenges unique to AR, compares off-label and dedicated devices, and discusses procedural planning and patient selection strategies to optimise outcomes.
3. The success of TAVI in AR depends on both the prosthesis type and understanding the anatomical differences from aortic stenosis. Careful preprocedural imaging, individualised oversizing, and recognition of anchoring difficulties are crucial. Both, off-label and on-label transcatheter heart valves can be used effectively in appropriately selected patients that are high-risk. On-label devices are associated with a higher technical success but to date, they’re not extensively available on the market.
INTRODUCTION
Transcatheter aortic valve implantation (TAVI) is now an established treatment option for elderly patients with severe aortic valve stenosis (AS). On the other hand, few data are available on TAVI in patients with aortic regurgitation (AR).
1-3 The incidence of AR increases with age, affecting nearly 5% of individuals aged ≥75 years.4 It is not uncommon for these patients to be at high surgical risk, particularly due to advanced age and comorbidities. Once patients with AR become symptomatic, the mortality rate among those who do not undergo surgical intervention reaches 20% per year.5 Furthermore, according to data from The Euro Heart Survey on valvular heart disease, only 5% of these patients receive surgical aortic valve replacement.6 It is therefore evident that there is a pressing need for a less invasive approach to treat this patient population. Despite the widespread adoption of TAVI for AS, its use in AR remains limited. This discrepancy is mainly related to the anatomical features of AR (few or no calcium on the aortic valve leaflets, no fluoroscopic markers, and an enlarged aortic root/left ventricular outflow tract). As a result, the transcatheter heart valves (THV) may be prone to malpositioning, migration, embolisation, and incomplete annular sealing, leading to significant residual paravalvular leak
(PVL).7 The available data on TAVI in pure AR are mostly deriving from the off-label use of various THVs.8,9 More recently, dedicated THVs have shown improved outcomes compared to off-label devices.10,11 However, these dedicated THVs still have some limitations in terms of sizes and unavailability in everyday clinical practice.
The aim of this review is to summarise the existing data and evidence on TAVI as a treatment option for patients with AR who are high-risk/inoperable. Furthermore, specific technical aspects on TAVI in AR will be discussed.
PATIENT SELECTION AND INDICATIONS TO TREATMENT
According to the 2022 European Society of Cardiology /European Association for Cardio-Thoracic Surgery guidelines, patient selection for intervention in severe chronic AR is primarily guided by the presence of symptoms, left ventricular (LV) function and dimensions, and associated aortic root dilation. In patients who are symptomatic, intervention is strongly recommended regardless of LV ejection fraction (LVEF), provided that the surgical risk is not prohibitive. In patients who are asymptomatic, the decision to intervene is influenced by LV dysfunction (LVEF ≤50%) or significant LV dilation (LV end-
systolic diameter; LVESD >50 mm), as these parameters are associated with adverse outcomes (Class I, level of evidence B).12 Recent evidence suggests that indexing LVESD to body surface area may refine patient selection, with proposed cut-offs of 20–22 mm/m², although these criteria currently support a Class IIb recommendation.13,14 In such cases, intervention may be considered (Class IIb, level of evidence C) In addition, progressive LV dilation or a gradual decline in LVEF, particularly in patients with significant LV enlargement (LV end-diastolic diameter; LVEDD >65 mm), may also prompt consideration of intervention, even in the absence of symptoms. Comprehensive evaluation by a multidisciplinary heart team is emphasised, accounting for age, comorbidities, and overall risk profile.12 For patients who are not suitable candidates for surgical aortic valve replacement ,TAVI may be considered at selected centres. In this context, TAVI is typically reserved for patients at high or prohibitive surgical risk, with careful consideration of anatomical and procedural feasibility. Overall, patient selection for TAVI in severe AR relies on an integrated approach, balancing the severity of regurgitation, LV remodeling and dysfunction, symptom burden, and operative risk, with final decisions supported by a heart team-based consensus.12,15
TECHNICAL AND ANATOMICAL CHALLENGES
TAVI was designed and validated as a treatment for severe AS. Based on the different anatomical scenario, this approach cannot be immediately applied to pure non-calcified AR. AS is often characterised by extensive calcifications at both the annulus and leaflet levels, which facilitate the anchoring of both self-expanding (SE) and balloon-expandable (BE) THVs, as well as provide a fluoroscopic landmark for guiding the implant. Patients with pure non-calcified AR often exhibit little to no calcium, elliptical and large annulus, dilation of the aortic root and ascending aorta, and a large stroke volume with turbulent regurgitant jet. This may also be associated with a bicuspid aortic valve anatomy. These
characteristics represent a challenge in the transcatheter treatment of this valvular heart disease. The main issue when dealing with pure non-calcified AR is anchoring the THV to the annulus. Due to the lack of calcium, a significant THV oversizing (15–25%) and a deeper landing into the left ventricular outflow tract (particularly in ‘tubular’ and ‘flared’ anatomies) are necessary to secure the THV and reduce the risk of migration, embolisation, and/ or significant AR. As a result, the required THV size is often beyond the range of most commonly available devices. The need for substantial oversizing is also theoretically associated with a higher risk of advanced conduction disturbances, potentially necessitating permanent pacemaker implantation. Furthermore, the regurgitant volume can complicate the identification of correct implantation views, especially in cases of leaflet prolapse. All these technical challenges may explain the higher rates of surgical crossover and peri-procedural mortality compared to AS cases.16-18
TRANSCATHETER HEART VALVES IN PURE NON-CALCIFIED AORTIC REGURGITATION
TAVI for pure non-calcified AR has evolved significantly over the past decade. THVs currently used in this context are broadly categorised into: off-label, originally developed for AS but repurposed in selected AR cases; and on-label, which are specifically designed and approved for AR.19 Figure 1 provides an overview of THVs used in patients with pure native AR, highlighting off-label and on-label THVs, categorised into SE and BE devices. It includes sizing ranges in terms of diameters, perimeters, and annulus area. Although the clinical application of TAVI in AR is expanding, available data remain limited compared to AS, with most evidence derived from retrospective registries or small prospective studies.
Off-Label THVs in Pure Aortic Regurgitation
The CoreValve™ (Medtronic, Minneapolis, Minnesota, USA) was the most widely
first-generation SE, supra-annular, nonrecapturable/retrievable THV used for the treatment of pure native AR. The nitinol structure of the frames provided an acceptable stability during implantation, even in the absence of calcification. Moreover, this THV was believed to allow for a considerable degree of oversizing (3 sizes available: 23 mm, 26 mm, and 29 mm; covering perimeters up to 84.8 mm) with a low-risk of annular rupture. However, CoreValve was associated with a significant rate of second THV deployment and more than moderate residual AR due to an incomplete annular sealing.17 The introduction of the SE supra-annular THVs Evolut R, and Evolut Pro/Pro+ (Medtronic, Minneapolis, Minnesota, USA)20 not only enabled the use of a recapturable and repositionable bioprosthesis, but also offered a wider option of sizes (23 mm, 26 mm, 29 mm, and 31/34 mm) to accommodate larger annular perimeters. The external cuff on the Pro/Pro+ models helped minimise PVL.17,21 Indeed, the most
commonly Evolut implanted size in AR cases was the 34 mm.22 Early experiences with first-generation SE THVs reported procedural success rates ranging from 74% to 100%, with frequent complications such as moderate-to-severe post-procedural AR (9%) and second THV implantation (7%). 23,24
Another SE supra-annular THV used offlabel for pure AR is the ACURATETM family (Boston Scientific, Natick, Massachusetts, USA). Its main limitation is the limited number of sizes available (23 mm, 25 mm, and 27 mm) provided by the ACURATE neo and neo 2 models (the latter featuring a taller external skirt). This restricts treatment to ‘small annuli’ only. Studies on the ACURATE neo THV for pure native AR showed device success rates ranging from 87.5% to 100%, influenced by oversizing and implant height. Oversizing ≥10% (commonly using the 27 mm ‘L’ size for the ACURATE) improved outcomes but was associated with increased pacemaker implantation rates. The newer ACURATE
Figure 1: Transcatheter heart valves types used in patients with pure non-calcified aortic regurgitation.
Prime XL (29 mm) offers broader anatomical compatibility, although no data are currently available for its use in either AS or AR.24-27
Early evidence on a BE THV performance for treating pure native AR emerged in 2016. Urena et al.28 reported successful outcomes in three inoperable patients treated with the SAPIEN 3 THV (Edwards Lifesciences, Irvine, California, USA), emphasising the importance of oversizing (ranging from 16% to 27%) to ensure THV stability and prevent displacement, with all patients demonstrating improved New York Heart Association class and no residual AR.28 More extensive data come from the multicenter French S3AR study (2015–2021), involving 49 patients, which reported a procedural success rate of 94.6%. Four cases of THV embolisation occurred, all associated with <15% oversizing. These findings reinforced the recommendation for at least 15% oversizing and lower implantation depth, which may also explain the 35% permanent pacemaker rate. Notably, 70% of the enrolled patients received a 29 mm SAPIEN THV, implantable in annular areas up to 683 mm², while the largest annular area among the enrolled patients was 605 mm².29 Since 2019 when received CE mark, the Myval BE THV (Meril Life Sciences, Vapi, India) expanded annular sizing up to 840 mm ² (diameter of 32.7 mm), addressing the anatomical demands of AR.30,31 In the study by Sanchez-Luna et al.32 113 patients, treated with this novel BE THV, achieved a 94.7% technical success rate, with oversizing averaging 17.9%. Moderate or greater residual AR occurred in 8.9% of cases, while THV embolisation (3.5%) was associated with unfavourable left ventricular outflow tract (LVOT) morphology, specifically a tapered anatomy where the LVOT is larger than the annulus.32
The technical (e.g., operator skills) and technological (e.g., THV repositionability/ retrievability and external sealing skirt) improvements over the past decade have been associated with higher success rates (61.3–81.1%; p<0.001), a reduced need for implantation of a second THV (12.7% versus 24.4%; p=0.007), a lower incidence of at least moderate residual AR (4.2% versus 18.8%; p<0.001), and decreased 1-year
cardiovascular mortality (9.6% versus 23.6%; p=0.008)21,22 following the off-label use of THVs in pure AR.19,21
Similarly, Sawaya et al.33 found Valve Academic Research Consortium-2 device success improved from 54% to 85% (p=0.01), and 30-day clinical efficacy increased from 46% to 75% with newer generation THVs (p=0.01).33
Among the studies evaluating the performance of first versus novel generation off-label THVs in pure native AR, Yoon et al.,18 FRANCE TAVI,19 and the PANTHEON34 studies are the most representative. The FRANCE TAVI, and PANTHEON studies showed technical success of 85.5% and 83.6% respectively, according to Valve Academic Research Consortium (VARC)3 criteria. While both studies identified the need for a second THV implantation and THV embolization/migration as the main complications, FRANCE TAVI (which enrolled the older population) reported a higher permanent pacemaker implantation (36% versus 22%) and a worse long-term mortality (53.5% at 4 years). In contrast, PANTHEON had a lower (17.1%) 1-year composite endpoint (all-cause mortality and heart failure rehospitalisation) and emphasised the prognostic impact of THV embolisation or migration. It also provided a detailed comparison of BE versus SE THVs, finding similar efficacy but differences in anatomical suitability and procedural characteristics. FRANCE TAVI highlighted oversizing as beneficial yet risky, while PANTHEON identified post-dilation as a predictor of THV migration. Both studies stressed the need for dedicated THVs to overcome the unique anatomical challenges of pure non-calcified AR.19,34 Table 1 summarises the most relevant data on outcomes, technical and device success, as well as complication rates reported above.
On-label THVs
in Pure Aortic Regurgitation
One of the main limitations of first and newer generation THVs used off-label was the lack of anchoring structures to secure the prosthesis to the annulus in the absence of calcium on the leaflets. To
overcome this issue, specifically designed THVs have been developed to be used in patients suffering from severe pure noncalcified AR. The two main AR dedicated THVs are the JenaValve Trilogy™ (JVT) system (JenaValve Technology, Irvine, California, USA) and the J-Valve™ system (JC Medical, Burlingame, California, USA), both featuring dedicated anchoring mechanisms to compensate for the lack of valvular calcification. Table 2 summarises the most relevant evidence, showing how these devices have demonstrated promising outcomes with high procedural success rates and reduced complications,
particularly regarding PVL.10,11 JVT is the only CE-marked THV approved specifically for AR. It is a SE prosthesis delivered via an 18 Fr transfemoral system, with a nitinol frame supporting a porcine pericardial valve. This THV is available in three sizes (23 mm, 25 mm, 27 mm). Its key innovation lies in the integrated ‘feelers’ that align the THV with the native cusps, and enable anchoring by clamping the cusps between the frame and locator elements. This design enables secure fixation without relying on calcification or other anatomical landmarks.35 Initial outcomes for the JVT came from a German
Table 1: Main characteristics and outcome of transcatheter heart valve used off-label in aortic regurgitation.
Table 2: Main characteristics and outcome of transcatheter heart valve used off-label in aortic regurgitation.
registry involving nine patients treated via transapical access, reporting a 97% procedural success rate, and 30-day and 6-month mortality rates of 13% and 19%, respectively.36 These findings were later confirmed in additional transapical studies.37,38 In 2023, Adam et al.39 reported outcomes from 58 patients who underwent transfemoral JVT implantation, achieving 100% technical success and 98% device success at 30 days, with no cases of
moderate or severe PVL.39 The ALIGN-AR study further validated these results in 180 patients (mean age 75.5 years), showing 95% technical success, 30-day mortality of 2%, and significant improvement in New York Heart Association class and left ventricular mass at 1-year.40 The potential benefits associated with the on-label use of a dedicated THVs with AR were explored in the PURPOSE study. JVT was compared with off-label THVs in 256
patients with inoperable AR. JVT showed superior VARC-3 technical success (98% versus 81%; p<0.001), and device success (95% versus 73%; p< 0.001) compared with off-label THVs. JVT significantly reduced complications such as THV embolisation (1.1% versus 15%; p<0.001) and moderate or greater residual AR (1.1% versus 11%; p=0.007). However, 1-year clinical outcomes, including mortality and heart failure rehospitalisation, were similar between groups (17.2% versus 14.4%).41
The J-Valve shares technical and functional characteristics with the JenaValve. Specifically, the J-Valve also aligns with the native aortic valve cusps, followed by a grasping phase facilitated by protrusions in the THV structure. The anchoring phase then involves the release of the bioprosthesis via a self-expanding system. The J-valve consists of two main components: the valve-locating feature, composed of three U-shaped anchor rings designed to lodge in the sinuses of Valsalva, and a self-expanding nitinol frame with bovine pericardium leaflets and a polyester skirt covering the entire outer surface of the valve.17 As with the Jena, the first J-Valve implants were performed via the transapical route, with the first transfemoral (18 to 21F) cases conducted only in 2019.42–44 More recent data come from authors including Liu et al.45 and, more recently, Garcia et al.46 who reported outcomes of J-Valve use for treating pure native AR in 2018 and 2023, respectively, both showing positive procedural success rates (97.7% and 81%, respectively). An interesting finding reported by Garcia et al.46 concerns the approach, which was transfemoral in 75% of cases, and the perimeter, which exceeded 85 mm in 38% of cases, a parameter that represented an exclusion criterion in previous studies with the JVT.
A recent meta-analysis by Samimi et al.47 encompassing 2,162 patients with high-risk AR (mean STS score 5.6 ± 0.1%) reported lower 30-day (3% versus 9%) and 1-year (6% versus 24%) mortality in patients treated with dedicated THVs (n=588 patients with JVT, and n=605 with J-Valve) versus off-label THVs. Device success was higher (93% versus 82%), with fewer
complications, including residual AR (2% versus 5%), valve embolisation (2% versus 8%), and pacemaker implantation (11% versus 20%).47 Another meta-analysis of 1,851 patients echoed these findings and provided deeper insights into anatomical considerations, access routes, and anchoring mechanisms, emphasising higher device success according to VARC-3 (97.8% versus 89.9%), lower 30-day mortality (2.6% versus 5.1%), and fewer complications including PVL and pacemaker implantation with on-label versus off-label THVs.7 Both studies confirm the superiority of on-label, new-generation THVs in managing patients with severe AR in high-risk, particularly within the early post-procedural window.7 However, the main current limitation of dedicated THVs for AR is their size range (JVT covers perimeters from 66–90 mm, while the J-Valve ranges from 57–104 mm), which does not allow for sufficient oversizing in large and extra-large native annuli. Furthermore, both THVs are yet not available for routine clinical use.
CLINICAL AND TECHNICAL IMPLICATIONS
The data presented thus far highlight the numerous technical challenges associated with TAVI in pure native AR, the potential complications, and the procedural characteristics that may be linked to unfavourable technical or clinical outcomes. When performing preprocedural planning, it is essential to understand the anatomical characteristics of each individual patient in order to anticipate potential technical limitations of the available devices and select the THV best suited to the specific case. Key factors to always consider include: aortic valve morphology (bicuspid versus tricuspid), annular (perimeter and area) and calcific burden (leaflets), the underlying mechanism of AR (cusp prolapse or retraction versus coaptation defect due to ascending aorta dilation), left ventricular size and function including measurements of the left ventricular outflow tract, and finally the dimensions and of the aortic root and ascending aorta. Regarding prosthesis sizing, selection should be based on either the annular perimeter or area, depending
on whether a BE or SE THV is used. In most cases of pure native AR, a significant degree of oversizing is recommended (15% to 25%). One commonly described method for calculating the degree of oversizing involves comparing the THV diameter to that of the annulus in order to derive the prosthesis-to-annulus coverage index.22,48 An appropriate degree of oversizing is crucial to achieve sufficient anchoring and optimal annular sealing, both of which are necessary to ensure favourable procedural outcomes.49 Another challenge to consider is the need for device stability. The lack of fluoroscopic markers due to absent annular calcification can complicate the procedure. In this context, it is important to underline that SE bioprostheses offer multiple anchoring zones: one in the ascending aorta; one at the level of the cusps; and another at the annulus. On the other hand, actually available SE THVs do not provide enough sizes to allow an adequate oversizing, particularly in large annuli. BE THVs instead, and Myval in particular, cover larger areas. In some cases, the implantation views are not easy to be found because of the regurgitant volume. Positioning two pigtail catheters, one in the left coronary cusp and the other in the non-coronary cusp, or placing three fluoroscopic markers (e.g., a pigtail catheter and two J-starter 0.035 inches wires), can provide valuable anatomical reference points, thereby reducing both the number of aortograms required and the total contrast medium dose.5 Furthermore, TAVI procedures in AR often require prolonged ventricular pacing, typically ‘fast’ pacing up to 140 bpm during SE valve deployment and ‘rapid’ pacing up to 220 bpm during BE implantation, to reduce systolic arterial pressure and regurgitant volume, thereby enhancing THV stability during deployment.50
In cases of at least moderate residual AR, it is important to note that post-dilation is associated with a higher risk of device embolisation. In such scenarios, implantation of a second THV may be considered.22
A structured algorithm considering valve morphology, annular dimensions, calcific burden, and ventricular function enables appropriate device selection and sizing. Oversizing strategies and deployment
techniques must be tailored to anatomical challenges, especially in the absence of calcification. The use of SE- versus BE THVs depends on anchoring requirements and annulus size. Ultimately, the clinical and economic viability of TAVI in AR hinges on optimising patient-device matching through precise preprocedural assessment. Figure 2 presents a detailed case of a BE THV used off-label for treating AR, illustrating pre-procedural anatomical assessment via MSCT, challenges posed by non-calcified leaflets, and significant aortic angulation. Hemodynamic and aortographic images highlight baseline and final outcomes, while fluoroscopic markers guide optimal valve positioning.
While TAVI has demonstrated costeffectiveness in AS, its application in pure native AR is complicated by higher procedural costs, increased use of multiple valves per case, and higher rates of valve malpositioning or embolisation, which elevate the overall economic burden. Furthermore, pure native AR patients often require on-label THVs, which are more expensive, especially if compared to off-label devices. A recent cost-utility analysis reported that, under current clinical conditions, TAVI for pure native AR may exceed commonly accepted willingness-to-pay thresholds in both U.S. and European models. Additionally, the absence of long-term durability data in this population undermines assumptions used in economic modelling. Although early clinical outcomes are favourable, from a health economics perspective, TAVI in this population is still currently considered cost-effective when compared to SAVR.51,52
CONCLUSION
Pure non-calcified AR represents a complex clinical and anatomical entity, for which percutaneous treatment could be considered as an alternative to the traditional surgical approach in selected patients, particularly when cardiac surgery entails an excessively high risk or when conservative management may be associated with a poor prognosis. Although dedicated THVs
for AR have been associated with better performance as compared to devices used off-label, they are associated with size limitations and poor availability in everyday clinical practice. Based on this, currentgeneration (off-label, non-dedicated) THVs are the only alternative for AR patients during this time period.
Meticulous preprocedural planning, based on multimodality imaging, is essential to ensure accurate patient selection and the identification of the most appropriate THV for the specific anatomical context.
Baseline Haemodynamics
Final Haemodynamics
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Drug-Coated Balloons in Percutaneous Coronary Interventions: Insights into Device Design and Translation to the Clinic
Citation: EMJ Int Cardiol. 2025;13[1]:86-100. https://doi.org/10.33590/emjintcardiol/TLMY4046
Abstract
Percutaneous coronary intervention has evolved significantly due to advancements in interventional strategies and device technologies. Drug-coated balloons (DCB) have emerged as drug delivery devices that don’t use a metallic scaffold, delivering antiproliferative drugs directly to the arterial wall. Paclitaxel-coated balloons have demonstrated efficacy in treating in-stent restenosis and small vessel disease; however, there is still limited evidence regarding their efficacy and safety in treating bifurcation and large vessel de novo lesions. Sirolimus-coated balloons (SCB) have shown promising outcomes in preclinical studies, exhibiting reduced smooth muscle cell loss and lower downstream embolisation. SCBs have demonstrated efficacy in treating in-stent restenosis and small vessel disease in clinical trials, but long-term outcome studies remain limited. This review explores preclinical and clinical data on DCBs, highlighting the vascular response, pharmacokinetics, and comparison of effectiveness between paclitaxel-coated balloons and SCBs. Furthermore, novel technologies, including everolimus and dual-drug formulations, are being investigated to enhance therapeutic outcomes. While DCBs provide a viable alternative to drug-eluting stents for specific indications, further research is needed to establish optimal patient selection, refine drug delivery mechanisms, and evaluate long-term outcomes. The evolution of DCBs continues to shape future percutaneous coronary intervention strategies, potentially offering a scaffold-free approach with equivalent or improved clinical outcomes.
Key Points
1. Drug-coated balloons provide an approach to percutaneous coronary intervention that doesn’t involve a metallic scaffold by delivering antiproliferative drugs directly to the arterial wall. This prevents restenosis and preserves future treatment options. Emerging data suggest that the balloons may be a viable alternative to drugeluting stents, especially for the treatment of in-stent restenosis, small vessel disease, and bifurcation disease.
2. Paclitaxel-coated balloons were the first drug-coated balloons used in clinical practice. They are primarily composed of an excipient, meant to enhance delivery, and the antiproliferative drug paclitaxel. First-generation paclitaxel-coated balloons mainly contain a dehydrated crystalline coating, which promotes drug retention and extends bioavailability, preventing restenosis. However, this design also generates substantial particulates of varying size, and may be associated with downstream emboli and tissue injury to non-target organs.
3. Sirolimus-coated balloons (SCB) offer the potential of well-tolerated cytostatic agents, but require the use of drug carriers to prolong arterial wall levels. In experimental models, SCBs are associated with fewer embolic non-target organ effects and decreased tissue injury. While SCBs have demonstrated efficacy in treating in-stent restenosis and small vessel disease, larger outcome studies remain limited. Larger, better-designed, and definitive trials are needed.
INTRODUCTION
Percutaneous coronary intervention (PCI) has achieved remarkable progress due to advances in technology, including the devices themselves, ancillary equipment, and pharmacological therapies. Although balloon angioplasty initially proved effective in restoring blood flow, it was associated with restenosis in 50–60% of patients within a year post-procedure due to vessel recoil, constrictive remodelling, and neointimal proliferation.1,2 Advances in stent technology have effectively addressed these issues, and second-generation drug-eluting stents
(DES) have become the gold standard for the treatment of coronary artery disease (CAD). However, clinical studies have indicated that DESs are associated with an increased risk of late events and neoatherosclerosis, with approximately 2% of patients annually experiencing very late ischaemic events, and ischaemiadriven target lesion revascularisation (TLR) occurring in 4.4% of subjects during a follow-up period of 1–5 years.3,4 Furthermore, leaving a permanent metallic scaffold may not be an optimal strategy for complex lesions and could limit future treatment options.
Drug-coated balloons (DCB) have recently attracted attention as a novel interventional therapy.5 The primary advantage of this technology lies in its ability to transfer antiproliferative agents to the luminal surface of the vessel without requiring permanent scaffolds. Numerous preclinical studies, which primarily utilise crystalline formulations of paclitaxel-coated balloons (PCB) in animal models, have evaluated the biological response of the vasculature to the drug and the safety of DCB therapy.6-9 Medial smooth muscle cell (SMC) loss and detectable particulate debris in downstream organs are hallmarks of this technology, with clinical consequences that are currently unclear. With continuous advancements in DCB technology, sirolimus-coated balloons (SCB) have more recently emerged as a promising alternative. Two of the most advanced programs, the MagicTouch™ (MT)-SCB (Concept Medical, Tampa, Florida, USA) and SELUTION SLR™ (SEL)SCB (MedAlliance, Nyon, Switzerland), which both use microcarriers, have been reported to induce minimal arterial injury and downstream effects.10 Furthermore, clinical data have demonstrated the efficacy and safety of these and other SCBs in small vessel disease (SVD) and in-stent restenosis (ISR),11,12 although larger studies are needed and are currently underway. In this review, the authors comprehensively examine the role of DCBs in PCI from both preclinical and clinical perspectives.
MECHANISTIC UNDERPINNINGS OF DCBS
The primary mechanisms underlying late luminal loss following plain old balloon angioplasty (POBA) include the formation of a fibrocellular neointima at the injury site and negative arterial remodeling.13 Mechanical stress induced by POBA disrupts endothelial cells and the medial wall, leading to restenosis. This triggers a cascade of repair mechanisms involving platelet-fibrin deposition, inflammation, growth factor release, SMC proliferation, and extracellular matrix deposition. The activation of cell cycle proteins and mitosis constitutes a final common pathway, ultimately resulting in neointimal proliferation.14
As there is no scaffold from which to elute antiproliferative agents, the key to DCB success lies in its ability to efficiently and safely transfer the drug into the vascular tissue. The drug must also be able to sustain its therapeutic effects for an adequate duration. Unlike DESs, the transfer of the drug must take place during the initial inflation. The two principal drugs utilised in DCBs are paclitaxel and sirolimus, both of which act as antiproliferative agents by inhibiting SMC proliferation, but work by a distinct mechanism (Figure 1).
Paclitaxel stabilises microtubules and arrests the cell cycle at the G2/M phase, leading to cell death,15,16 which thereby suppresses neointimal hyperplasia, a key contributor to restenosis. The physical state of solidphase paclitaxel on the balloon surface varies from amorphous (non-crystalline) to crystalline forms.17 Amorphous paclitaxel exhibits high vascular adherence and facilitates effective drug transfer into the arterial wall, but has limited long-term retention and bioavailability. In contrast, crystalline paclitaxel demonstrates a slower dissolution rate, leading to prolonged drug bioavailability and sustained biological effects.18 By optimising the balance between these properties and selecting appropriate excipients, passive absorption and retention of the drug within the arterial wall can be achieved, ensuring sustained therapeutic concentrations that prolong the antiproliferative effect.6 Despite this, most commercially available paclitaxel DCBs utilise crystalline paclitaxel as a primary ingredient, which helps improve tissue drug retention.
Sirolimus exerts its potent, sustainable antiproliferative effects by reversibly binding to FKBP12, forming a complex with the mammalian target of rapamycin and inhibiting the G1/S cell cycle transition, which reversibly induces cells to enter the G0 quiescent phase.19, 20 Compared to paclitaxel, sirolimus exhibits superior antirestenotic and anti-inflammatory properties, which is one of the reasons why paclitaxeleluting stents are no longer used for patients with CAD.21 However, since tissue absorption of sirolimus is lower than that of paclitaxel, drug transfer necessitates the development of innovative excipients and
Figure 1: The features of sirolimus and paclitaxel.
Cytotoxic High
Cell Cycle
Cytostatic Low lipophilicity
Sustainable antiproliferation
Safer drug range
G0 phase
The increased stability of microtubules in the presence of paclitaxel at G2/M phases results in cell apoptosis (cytotoxic), leading to the inhibition of neointimal hyperplasia. Paclitaxel has high lipophilicity and tissue affinity, inhibiting cell proliferation. Sirolimus (rapamycin) inhibits the G1/S cell cycle transition by forming a complex with FKBP12 (FK506-binding protein 12), which then binds to and inhibits the mammalian target of rapamycin. This reversibly induces cells to enter the G0 quiescent phase (cytostatic), resulting in a potent and sustainable antiproliferative effect. Unlike paclitaxel, sirolimus has low lipophilicity and tissue affinity.
carriers to optimise drug delivery for SCB treatment. Advanced formulation strategies enhance drug retention and bioavailability within the arterial wall. To overcome these issues, microcarriers are used for SCBs to facilitate drug dissolution over time. MT-SCB uses phospholipids comprising one hydrophilic head and two lipophilic tails, improving the adhesion properties of encapsulated sirolimus.22 Microreservoirs in the SEL-SCB are advanced drug-delivery systems composed of a biodegradable polymer (i.e., poly[lactic-co-glycolic acid]) intermixed with sirolimus, ensuring consistent and predictable drug release for up to 90 days.23 Furthermore, Cell Adherent Technology (CAT™ [MedAlliance, Nyon, Switzerland) enhances drug retention and bioavailability by securely binding these
microreservoirs to the balloon surface, enabling a lower drug dose while optimising sirolimus transfer and uptake.24 These advances in microparticle and nanoparticle technologies have the potential to improve drug delivery and reduce embolic risks. Newer experimental systems, such as those from Advanced NanoTherapies (Santa Clara, California, USA), use nanoparticle carriers to encapsulate sirolimus and paclitaxel (bench testing of the Philips Stellarex™ DCB [Amsterdam, the Netherlands], the Becton Dickinson Lutonix™ DCB [Franklin Lakes, New Jersey, USA], and the Advanced NanoTherapies SirPlux Duo DCB has been performed. Data are on file at Advanced NanoTherapies), but more work is needed to explore the safety and efficacy of these systems.
PRECLINICAL STUDIES FOR PCBS AND SCBS
DCB Response and Pharmacokinetic Levels in the Treated Area
Animal experiments for DCBs have predominantly been conducted based on the clinical indication sought. These evaluations look for evidence of systemic toxicity, distal emboli, and vascular changes, as well as some indirect measures of efficacy such as histological drug effects and pharmacokinetics. In 2004, Scheller B et al.25 were the first to evaluate differences in neointimal formation following the implantation of a bare-metal stent (BMS) crimped onto either conventional uncoated balloons or onto three types of PCBs differing in drug dose. A histopathological evaluation was performed five weeks after implantation. As a result, DCBs utilising an acetone-based coating demonstrated a significant, dose-dependent reduction in late lumen loss and neointimal area.25 Furthermore, in a preclinical study evaluating plain balloons and PCBs using iopromide or urea as carriers, with dose ranges from 1 to 9 µg/mm² and triple application of balloons coated at the standard dose (3 µg/mm²), the neointimal area in the uncoated control group was 6.8±2.2 mm². In contrast, at a dose of 1 µg/ mm², the neointimal area was significantly reduced to 3.1±1.1 mm² with iopromide as the carrier, and to 3.0±0.5 mm² with urea as the carrier. At 3 µg/mm², the neointimal area was further reduced to 2.0±0.4 mm² with iopromide and 1.7±1.1 mm² with urea. This indicates that efficacy was observed even at the lower dose of 1 µg/mm². However, increasing the dose beyond 3 µg/mm² did not yield additional benefits.26 These studies served as early proof of concept supporting the efficacy of DCBs, and stimulated further research in the field.
A preclinical study comparing LutonixPCB (Lutonix® 035 [Becton Dickinson]) with POBA for treatment of the superficial femoral artery7 demonstrated that at 28 days post-DCB treatment, no fibrin deposition or endothelial cell loss was observed in the intima, and extensive destruction of the media or external elastic lamina was
rarely noted. However, compared to the POBA, Lutonix-PCB exhibited significant inflammation at 28 days, which resolved by 90 days. Additionally, SMC loss, as well as proteoglycan and collagen deposition, was more pronounced in Lutonix-PCB versus POBA at all time points, with the area of SMC loss peaking at 90 days. The extent of adventitial fibrosis progressively increased from 28 to 90 days and persisted up to 180 days, presumably due to paclitaxel-induced high tissue permeability. Moreover, a study comparing histological changes among commercially available DCBs approved for above-the-knee disease6,8 found that at 28 days, the total medial SMC loss score in DCB-treated segments was significantly higher with IN.PACT-PCB (IN.PACT™ Admiral™ [Medtronic, Dublin, Ireland]) as compared to Lutonix-PCB. Localised medial SMC loss was associated with increased proteoglycan accumulation, which was more pronounced in IN.PACT-PCB.6 Among the Ranger-PCB (Ranger™ [Boston Scientific, Marlborough, Massachusetts, USA]), IN.PACT-PCB, and Stellarex-PCB, the depth and circumferential extent of medial SMC loss yielded similar findings.8 Table 1 summarises FDA-approved DCBs for above-the-knee disease.
While different PCBs have been compared to each other, little published preclinical evidence exists after treatment with SCBs compared to PCBs. The authors first evaluated the vascular, myocardial, and pharmacokinetic effects of PCBs and SCBs in the hearts of swine after the treatment of coronary arteries with MT-SCB, SEL-SCB, Agent-PCB (Agent™ [Boston Scientific]), and POBA.10 In the histological assessment of coronary arteries, the arterial stenosis rate was comparable, and there were no late lumen enlargements in the AgentPCB compared to the two types of SCB in 28 days. The Agent-PCB exhibited the highest score for SMC loss in the media among the four treatment groups, whereas endothelial cell loss, inflammatory score, and fibrosis were similar among the groups. This is shown in the representative histological images of the coronary arteries after treatment with the two types of SCBs, PCB, and POBA in Figure 2. These findings showed that sirolimus exhibits lower cytotoxicity compared
Table 1: Features of FDA-approved DCBs for peripheral above-the-knee interventions.
IN.PACT™ Admiral™ Medtronic, Dublin, Ireland
Becton Dickinson, Franklin Lakes, New Jersey, USA
Philips, Amsterdam, the Netherlands
Boston Scientific, Marlborough, Massachusetts, USA
DCB: drug-coated balloon.
The citation source from Sato Y et al.27 was modified.
Figure 2: Representative histology of coronary arteries after treatment with different types of drug-coated balloons. A B C D POBA MT-SCB SEL-SCB PCB
Histological images of coronary arteries treated with (A) POBA, (B) MagicTouch™-SCB (Concept Medical, Tampa, Florida, USA), (C) SELUTION SLR™-SCB (MedAlliance, Nyon, Switzerland), and (D) PCB. Boxed areas in upper images are shown magnified in the middle images. Dotted boxed areas in the middle images are shown as magnified images in the bottom row. All histology sections showed no stenosis with little intimal formation. The histology section from the coronary artery treated with PCB shows focal loss of SMCs in the media (red arrows), while there is no loss of SMCs in the media of the other groups. Arrowheads indicate cutting artifacts.
to paclitaxel. However, the response of PCBs and SCBs in atherosclerotic lesions or neoatherosclerosis in DES or BMS restenosis is still relatively unproven.
The pharmacokinetic levels of the AgentPCB in coronary arteries (648.3–3149 ng/g) at 28 days were similar to those previously reported in the lower extremity arteries (300–3000 ng/g).7,28 However, vascular tissue concentrations of SCBs (median in MT-SCB group: 21.3 ng/g; median in SELSCB group: 51.1 ng/g) were significantly lower than those for Agent-PCB at 28 days.10
Impact on Non-target Downstream Tissue Beds
The loss of drug into the body increases the potential for embolisation of the drug and excipients into downstream tissue. Some clinical cases have documented the occurrence of vasculitis after DCB treatment for peripheral artery disease.29,30 Whether this can be directly attributed to embolisation remains uncertain. Transient slow flow after PCB treatment31 and decreased coronary flow reserve are more commonly observed.32 The lack of approval of PCBs for below-the-knee interventions underscores the importance of this issue, with some analyses showing greater amputations in DCB groups.33 In preclinical studies, histological changes of downstream tissue following DCB treatment are predominantly identified as single or clustered multiple small vessels exhibiting varying degrees of fibrinoid necrosis, SMC apoptosis and loss, and adventitial inflammation or vasculitis, primarily composed of lymphocytes. How these findings translate to humans, where longer and larger DCBs are often used, remains uncertain.
In preclinical models, the overall percentage of distal emboli in skeletal muscle after DCB treatment for peripheral artery disease ranged from 25% to 42.9%.8 The downstream levels of paclitaxel concentration in skeletal muscle were comparative among the IN.PACTPCB, Ranger-PCB, and Stellarex-PCB (216.5 versus 91.5 versus 101.9 ng/g, respectively).6,8 In the comparison of SCBs and PCBs in treated porcine coronary
arteries,10 the frequency of identified downstream emboli was 36% for AgentPCB, 15% for MT-SCB, and 25% for SELSCB. In the PCB group, 23% of histological sections presenting with emboli showed tissue injury (i.e., myocyte necrosis/ scarring). There was no tissue injury in the MT-SCB and SEL-SCB groups. At 28 days post-treatment, median sirolimus concentration in the myocardium was 52.9 ng/g in the MT-SCB group, 0.0 ng/g in the SEL-SCB group, and 185.4 ng/g in the Agent-PCB group. An important factor when considering the impact of particulates generated by DCBs is their size. For the MTSCB and SEL-SCB groups, particulate sizes ranged from 0.3 μm and 4 μm, respectively. Particulates from crystalline PCBs were 50 μm or greater.10,34 Thus, the size of the generated particulate is important in terms of effects on non-target organs. Although it is unknown how the degree of embolisation affects health conditions in the clinical setting, it is necessary to perform DCB treatments while acknowledging the preclinical data and tracking risks.
CLINICAL STUDIES
In-stent Restenosis
DCBs have been an established treatment option for ISR in most countries outside of the USA.35 However, the European Society of Cardiology (ESC)’s published 2024 guidelines36 have demonstrated a controversial shift, leading to a first-line recommendation for DESs over DCBs for ISR. The change in the newly published ESC guideline was driven in part by further negative data that showed higher rates of target vessel revascularisation (TVR) in patients treated with DCBs versus DESs for ISR when follow-up duration was extended beyond one year. The 36-month TLR and major adverse cardiac event (MACE) rates were significantly lower for PCBs compared with POBA in the PEPCAD-DES study.37 However, DCBs were as effective as DESs for the treatment of BMS-ISR, and less effective for DES-ISR when comparing rates of 3-year TLR in the other meta-analysis.38-40 The American College of Cardiology (ACC) and American Heart Association (AHA)41
do not have clear statements regarding the indication of DCB for ISR in the latest guidelines, likely because the first DCB (Agent) for ISR received approval just last year. Repeated stent implantation could have a significant negative impact on future treatment strategies, but this remains in the realm of theory. The future trends in DESISR treatment warrant close attention.
The first-in-man comparison of a novel SeQuent®-SCB (B. Braun, Melsungen, Germany [4 μg/mm2]) showed similar angiographic outcomes in the treatment of DES-ISR compared with a clinically proven SeQuent-PCB (SeQuent® Please NEO, B. Braun [3 μg/mm2]). After 6 months, insegment late luminal loss was 0.21 ± 0.54 mm in the SeQuent-PCB versus 0.17 ± 0.55 mm in the SeQuent-SCB (p=0.794). Clinical events up to 12 months also did not differ between the groups.42 Furthermore, angioplasty with SCBs compared with DESs is associated with comparable rates of TLR, TVR, myocardial infarction (MI), and all-cause mortality at 2 years.43 Differences in effectiveness between DCBs and DESs for ISR may also be related to specific histopathologic and timing characteristics of neoatherosclerosis in the BMS- and DESISR subsets.44,45 In BMS-ISR, the neointimal tissue is composed of vascular SMCs and extracellular matrix with predominantly homogenous high-signal tissue echogenicity. In contrast, DES-ISR is more commonly associated with a layered pattern with heterogeneous tissue composition. This suggests that the preferred anti-restenotic and anti-inflammatory effectiveness of sirolimus compared to paclitaxel might be more advantageous for the treatment of DES-ISR. The MAGICAL ISR IDE study and SELUTION4ISR trial46 are ongoing studies that are investigating the effectiveness of SCB for ISR compared with the standard of care, such as DES and/or POBA.
Although the outcome of PCB treatment for BMS-ISR is promising, the use of DCBs for DES-ISR remains controversial. Accumulating clinical evidence that demonstrates the non-inferiority of SCB treatment compared to DES treatment for ISR, depending on the results, may help to establish the firstchoice therapy for DES-ISR in the future.
De Novo Lesions – Small Vessel
Since stent implantation is challenging in SVD, with increased rates of restenosis compared to large vessel stenting, DCBs may have an advantage in the treatment of small vessels. Previous studies suggest that TLR rates and the risk of acute vessel occlusion were not significantly different between DCB and DES treatment at 12 months,47,48 supporting the use of DCBs in small vessel (<3.0 mm diameter) disease. In patients undergoing PCI for SVD, PCB angioplasty is associated with a reduction in MACE and a non-significant difference in target lesion failure (TLF) at 3-year followup compared with DES implantation.49,50
Furthermore, a meta-analysis of 20 studies comparing DCBs and DESs in patients with SVD demonstrated no significant difference in the risk of MACE, with incidence rates of 9.4% in the DCB group and 9.9% in the DES group.51 In acute coronary syndrome (ACS), a prespecified analysis of the BASKETSMALL 2 trial demonstrated no interaction between the indication for PCI (ACS versus chronic coronary syndrome) and the treatment effect of PCBs versus DESs in patients with SVD.
The TRANSFORM I trial compared MT-SCBs to SeQuent-PCBs for the treatment of de novo SVD. The MT-SCB failed to achieve noninferiority for angiographic net lumen gain at 6 months compared to the SeQuent-PCB, and less frequent late lumen enlargement (30.0% versus 53.7%; p=0.014) was observed with the SCB compared to the PCB.52 Paclitaxel, with high tissue permeability, likely facilitates late lumen enlargements caused by positive vascular remodeling. This effect may compensate for the lower acute gains in luminal dimensions that are initially observed with PCBs compared to DESs.53 Notably, clinical endpoints did not differ between the two devices in this trial; however, it is important to note that the TRANSFORM I trial did not include ACS with elevated cardiac biomarker values.
PCBs could be more effective than SCBs regarding SVD due to their greater facilitation of late lumen enlargement. However, there are still no long-term data after SCB treatment for de novo lesions, particularly regarding the efficacy in patients with ACS.
De Novo Lesions – Large Vessel DCB angioplasty treatment of de novo lesions in large coronary vessels (>2.75 mm) remains controversial. A systematic review and meta-analysis of nine studies comprising patients with stable angina and ACS compared TLR between DCB and DES treatment. It showed that the incidence of TLR at a follow-up of 25.8±2.7 months was 4.3% versus 6.9%, and appeared to be similar between DCB and DES. Additionally, there were no differences in the incidence of cardiac death and myocardial infarction (MI).4 Meanwhile, the study from Gitto et al.,54 which is included in the meta-analysis,4 reported that the 2-year incidence of TLR and composite TLF were significantly higher in the DCB group compared to the DES group (TLR: 14.6% versus 3.5%; TLF: 18.2% versus 3.5%). However, the authors primarily attributed these findings to the greater lesion length in the DCB group, which reached up to 65 mm (median 40–82 mm), compared to 56 mm (median 46–66 mm) in the DES group. Regardless, these data suggest a higher risk of ISR in diffuse atherosclerosis and long lesions.4,54 In the DCB group, most TLR events occurred within the first 6 months and then remained stable, whereas in the DES group, the incidence of TLR gradually increased over time, likely reflecting the natural course of stent-related vascular remodelling. According to one analysis of 13,380 patients treated with second-generation DES, approximately 2% per year experienced very late ischaemic events, with an ischaemia-driven TLR incidence of 4.4% over a follow-up period of 1–5 years.3
In the REC-CAGEFREE I trial, the strategy of combining PCBs with rescue stenting did not achieve non-inferiority compared with intended DES implantation in terms of cardiovascular death, MI, and clinically and physiologically indicated TLR at 2 years.55 However, this study was designed to compare two devices: the Swide PCB (Shenqi Medical, Shanghai, China) and the Firebird 2 sirolimus-eluting stent (MicroPort, Shanghai, China), both of which are not widely used in Western countries. Furthermore, the appropriateness of DCB treatment following lesion preparation was defined as the absence of evidence
of Type D, E, or F dissection. According to the international consensus group recommendations, any dissection classified as Type C or higher should be treated with stent implantation.56
Regarding the outcomes of DCBs for ACS, the REVELATION trial (including 120 patients) demonstrated that the DCB strategy for patients with ST-elevation MI was non-inferior to DES for those patients in terms of fractional flow reserve assessed at 9 months.57 The meta-analysis data consist of 13 studies, including the REVELATION trial, comparing DCBs and DESs for patients with acute MI on both de novo lesions and ISR. The analysis demonstrated that DCB was not inferior to DES treatment in terms of all-cause mortality (odds ratio [OR] 0.88; 95% CI: 0.43 to 1.8; p=0.73), cardiac mortality, (OR 0.59; 95% CI: 0.22 to 1.56; p=0.29), MI (OR 0.88; 95% CI: 0.34 to 2.29; p=0.79), stent thrombosis (OR 1.21; 95% CI: 0.35 to 4.23; p=0.76), TLR (OR 0.9; 95% CI: 0.43 to 1.93; p=0.8), and late luminal loss (mean difference –0.6; 95% CI: –0.3 to 0.19; p=0.64).58 This suggests that there is some, albeit limited, evidence for the use of PCBs in the treatment of ACS lesions.
Some other randomised controlled trials are ongoing, and their results will be crucial in better evaluating the performance of DCBs for large vessel de novo lesions in this clinical setting.23 The SELUTION DeNovo trial will compare a PCI strategy of SEL-SCB and provisional DESs to a PCI strategy of systematic DESs on target vessel failure at one and five years. Major exclusion criteria include lesions in the left main coronary artery, CTOs, ST-segment elevation MI, and non-ST-segment elevation MI. This is the largest randomised trial to date, and results are expected to be presented later this year.23 Regarding the efficacy of DCBs in CTO, the Co-CTO trial, which is the first randomised controlled trial to explore this topic, is an ongoing study investigating whether treatment with DCB is non-inferior to complete stenting of the CTO body.59
In DCBs for de novo large vessel disease, it may be essential to recognise the optimal lesion indications for DCB treatment, considering not only vessel size and ISR,
but also plaque characteristics for the interventionalists. Further clinical trials evaluating PCB and SCB treatment for patients with CAD, especially ACS or CTO, are warranted in the future.
Bifurcation Lesions
PCI for bifurcation lesions is associated with a higher incidence of procedural complications and worse clinical outcomes, such as restenosis, compared to PCI for non-bifurcation lesions. A provisional one-stent strategy for bifurcation lesions decreased treatment time, contrast burden, and radiation exposure compared to a two-stent strategy.60 To address this, it has been recommended as the default strategy in ESC guidelines;61 however, it still results in relatively frequent restenosis, which may require revascularisation of the side branch. Recently, a randomised DCBBIF trial of bifurcation lesions undergoing main vessel stenting with a severely compromised side branch showed that DCBs for side branch treatment resulted in a lower 1-year rate of the composite outcome compared with POBA treatment.62 Although the difference in this composite outcome was driven by spontaneous MI occurring more than 48 hours after the procedure, there were no significant differences between POBA and DCB groups in terms of success rate, all-cause mortality, clinically driven TVR, or stent thrombosis. Considering that spontaneous MI occurred early, whereas TLR developed relatively late, it is possible that most MIs were not eligible for revascularisation, and those that did not lead to revascularisation are of uncertain clinical significance.
Looking ahead, the ultimate goal of PCI for bifurcation lesions should be to avoid leaving any permanent metallic implants in the vessel, ideally achieving revascularisation with DCB treatment alone for both the main and side branches. The PEPCAD-BIF trial demonstrated that the restenosis rate was 6% at 9 months after PCB-alone, in which a PCB was used for both the main and side branches.63 Bruch et al.64 compared a PCB-alone treatment with a PCB treatment supplemented with additional BMS implantation as bailout for
the main and/or side branches, reporting TLR and MACE in PCB-alone as 4.5% and 6.1%, respectively, at 9 months.64 The DEFINITION II trial compared a provisional one-stent strategy (using POBA for the side branch) with two-stent strategies such as the double kissing crush technique or culotte stenting techniques for complex bifurcation lesions. At one year, TLF occurred in 11.4 % using the one-stent strategy, and in 6.1% of patients using twostent strategies.65 The authors summarise the recent evidence from the literature regarding the PCB and SCB in Table 2, and the ongoing important trial in Table 3.
DCB-alone treatment for the main and side branches is likely to show non-inferiority compared to the stent implantation treatment; however, direct comparative data between DCB-alone and DES are currently lacking. More data regarding the DCB-alone strategy are needed in the future.
NEWER DRUG-COATED BALLOONS
In clinical studies, only PCBs and SCBs have been investigated until recently; however, other types of innovative DCBs have evolved, such as the everolimus-coated balloon (ECB), the Biolimus A9™ (Biosensors International, Singapore), and a dual active pharmaceutical ingredient (API) DCB, which consists of both sirolimus and paclitaxel. In the preclinical data, ECBs with 2.5 μg/ mm2 of drug per balloon surface showed low intimal area and intimal mean thickness, while ECBs with 7.5 μg/mm2 showed low stenosis compared to bare balloon and MTSCB.70 The Chansu Vascular TechnologiesISR trial, which was a small clinical study, demonstrated the superior efficacy of the new ECB compared with POBA in the treatment of patients with ISR.71 A clinical trial evaluating the use of biodegradablecoated balloons in patients with CAD who require PCI for BMS- and DES-ISR will serve as a first-in-human experience.72 The dual API-DCB exhibited comparable inhibition of cell proliferation to the PCB, albeit at a markedly reduced total drug dose. The results of animal experiments demonstrated that the dual API-DCB is more effective in inhibiting intimal cell proliferation with
Table 2: The evidence for paclitaxel-coated balloons and sirolimus-coated balloons in percutaneous coronary interventions from representative literature.
BMS-ISR PCB versus DES A pooled analysis from 5 RCTs. 3 years TLR, all-cause death, MI,
insignificant downstream embolic effects and myocardial damage compared with the PCB. These findings indicate the potential for improved clinical outcomes and a greater safety profile than PCBs.73
CONCLUSION
In this review, the authors summarised the evolution of DCB technology based on preclinical data, as well as the vascular response, efficacy, and safety of DCBs.
Furthermore, the authors examined the positioning of SCBs and PCBs within PCI strategies by incorporating clinical data. One of the major challenges of sirolimus is its lack of sustained tissue wall pharmacokinetics; however, advancements in DCB technology have addressed this issue, allowing sirolimus to become an integral component of DCB therapy. Compared to paclitaxel, sirolimus exhibits fewer late lumen enlargements, but it is considered to have superior anti-restenotic and anti-inflammatory properties.
Small vessel
Table 3: Upcoming clinical trial.
Prevail Global study68
2–2.75 mm, mall vessel
Prevail-PCB (Medtronic, Dublin, Ireland) versus Agent™-PCB (Boston Scientific, Marlborough, Massachusetts, USA)
Prevail-PCB Single-arm -
MT™-SCB (Concept Medical, Tampa, Florida, USA) versus POBA
SLR™-SCB (SEL-SCB [MedAlliance, Nyon, Switzerland]) versus SOC
The characteristics of PCBs may explain their well-established efficacy in the treatment of SVD. However, clinical data supporting which lesions sirolimus may potentially treat are currently lacking, and no definitive conclusions can yet be drawn. Moreover, each DCB formulation (whether PCB or SCB) needs to be tested for specific clinical indications before its efficacy and safety can be established. There should be no class effect given the enormous differences in how DCBs are formulated. For now, DCB-only strategies should be considered for selected lesions where outcomes are anticipated to be non-inferior to DESs, taking into account patient and lesion characteristics, the
quality of lesion preparation, presence or absence of thrombus, bleeding risk, and other procedural factors.
Ongoing research is exploring the use of other drugs, such as everolimus, in DCB therapy. The impact of these nextgeneration devices remains to be elucidated in future investigations. The treatment strategies in PCI may need to be tailored to the characteristics of the lesion and the speed of cell proliferation, similar to cancer treatment. Regardless, DCBs are here to stay, and as data evolve, their exact role in coronary intervention will continue to develop, as will the technology itself. Ultimately, all of this will drive the next wave of innovation in interventional cardiology.
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7. Yazdani SK et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. 2014;83(1):132-40.
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24. Zeller T et al. Six-month outcomes from the first-in-human, singlearm SELUTION sustained-limusrelease drug-eluting balloon trial in femoropopliteal lesions. J Endovasc Ther. 2020;27(5):683-90.
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27. Sato Y et al. What are the pathological concerns and limitations of current drug-coated balloon technology? Heart Int. 2019;13(1):15-22.
28. Gongora CA et al. Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: A comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv. 2015;8(8):1115-23.
29. Ibrahim T et al. Downstream panniculitis secondary to drug-eluting balloon angioplasty. JACC Cardiovasc Interv. 2016;9(17):e177-9.
30. Thomas SD et al. Vasculitis resulting from a superficial femoral artery angioplasty with a paclitaxel-eluting balloon. J Vasc Surg. 2014;59(2):520-3.
31. Ikenaga H et al. Slow-flow phenomenon after Paclitaxel-coated balloon angioplasty: findings from optical coherence tomography and coronary angioscopy. JACC Cardiovasc Interv. 2015;8(4):e59-62.
32. Young M et al. PTCA with drugcoated balloons is associated with immediate decrease of coronary flow reserve. Catheter Cardiovasc Interv. 2013;81(4):682-6.
33. Katsanos K et al. Comparative effectiveness of plain balloon angioplasty, bare metal stents, drug-coated balloons, and drugeluting stents for the treatment of infrapopliteal artery disease: systematic review and bayesian network meta-analysis of randomized controlled trials. J Endovasc Ther. 2016;23(6):851-63.
34. Brandt-Wunderlich C et al. Acute drug transfer and particle release of drug coated balloons within a porcine in-vitro model. Curr Dir Biomed Eng. 2017;3(2):465-8.
35. Windecker S et al. 2014 ESC/ EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541-619.
36. Vrints C et al. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024;45(36):3415-537.
37. Rittger H et al. Long-term outcomes after treatment with a paclitaxel-
coated balloon versus balloon angioplasty: insights from the PEPCAD-DES study (treatment of drug-eluting stent [DES] in-stent restenosis with SeQuent Please paclitaxel-coated percutaneous transluminal coronary angioplasty [PTCA] catheter). JACC Cardiovasc Interv. 2015;8(13):1695-700.
38. Elgendy IY et al. Drug-eluting balloons versus everolimus-eluting stents for in-stent restenosis: a meta-analysis of randomized trials. Cardiovasc Revasc Med. 2019;20(7):612-8.
39. Giacoppo D et al. Drug-coated balloon angioplasty versus drug-eluting stent implantation in patients with coronary stent restenosis. J Am Coll Cardiol. 2020;75(21):2664-78.
40. Alfonso F et al. 3-year clinical follow-up of the RIBS IV clinical trial: a prospective randomized study of drug-eluting balloons versus everolimus-eluting stents in patients with in-stent restenosis in coronary arteries previously treated with drugeluting stents. JACC Cardiovasc Interv. 2018;11(10):981-91.
41. Virani SS et al. 2023 AHA/ACC/ACCP/ ASPC/NLA/PCNA guideline for the management of patients with chronic coronary disease: a report of the American Heart Association/American College Of Cardiology Joint Committee on clinical practice guidelines. J Am Coll Cardiol. 2023;82(9):833-955.
42. Ali RM et al. Treatment of coronary drug-eluting stent restenosis by a sirolimus- or paclitaxel-coated balloon. JACC Cardiovasc Interv. 2019;12(6):558-566.
43. Wańha W et al. Long-term outcomes following sirolimus-coated balloon or drug-eluting stents for treatment of in-stent restenosis. Circ Cardiovasc Interv. 2024;17(9):e014064.
44. Shlofmitz E et al. Restenosis of drugeluting stents: a new classification system based on disease mechanism to guide treatment and state-of-theart review. Circ Cardiovasc Interv. 2019;12(8):e007023.
45. Pelliccia F et al. In-stent restenosis after percutaneous coronary intervention: emerging knowledge on biological pathways. Eur Heart J Open. 2023;3(5):oead083.
46. Cutlip DE et al. Prospective randomized single-blind multicenter study to assess the safety and effectiveness of the SELUTION SLR 014 drug eluting balloon in the treatment of subjects with in-stent restenosis: Rationale and design. Am Heart J. 2025;284:11-9.
47. Jeger RV et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label
48. Cortese B et al. Drug-coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical Trial. JACC Cardiovasc Interv. 2020;13(24):2840-9.
49. Fezzi S et al. Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study. Eur Heart J. 2025;46(17):1586-99.
50. Jeger RV et al. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKETSMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020;396(10261):1504-10.
51. Abdelaziz A et al. Drug-coated balloons versus drug-eluting stents in patients with small coronary artery disease: an updated metaanalysis. BMC Cardiovasc Disord. 2025;25(1):339.
52. Ninomiya K et al. A prospective randomized trial comparing sirolimuscoated balloon with paclitaxelcoated balloon in de novo small vessels. JACC Cardiovasc Interv. 2023;16(23):2884-96.
53. Latib A et al. 3-year follow-up of the balloon elution and late loss optimization study (BELLO). JACC Cardiovasc Interv. 2015;8(8):1132-4.
54. Gitto M et al. Drug-coated balloon angioplasty for de novo lesions on the left anterior descending artery. Circ Cardiovasc Interv. 2023;16(12):e013232.
55. Gao C et al. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024;404(10457):1040-50.
56. Jeger RV et al. Drug-Coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020;13(12):1391-402.
57. Vos NS et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial. JACC Cardiovasc Interv. 2019;12(17):1691-9.
58. Abdelaziz A et al. Drug-coated balloons versus drug-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention: an updated meta-analysis with trial sequential analysis. BMC Cardiovasc Disord. 2023;23(1):605.
59. Somsen YBO et al. Design and rationale of the drug-coated balloon coronary angioplasty versus stenting for treatment of disease adjacent to a chronic total occlusion (Co-CTO) trial. Am Heart J. 2025;288:65-76.
60. Maeng M et al. Long-term results after simple versus complex stenting of coronary artery bifurcation lesions: Nordic Bifurcation Study 5-year follow-up results. J Am Coll Cardiol. 2013;62(1):30-4.
61. Neumann FJ et al. 2018 ESC/ EACTS guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165.
62. Gao X et al. Drug-coated balloon angioplasty of the side branch during provisional stenting: the multicenter randomized DCB-BIF Trial. J Am Coll Cardiol. 2025;85(1):1-15.
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64. Bruch L et al. Results from the international drug coated balloon registry for the treatment of bifurcations. Can a bifurcation be treated without stents? J Interv Cardiol. 2016;29(4):348-56.
65. Zhang JJ et al. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020;41(27):2523-36.
66. Giacoppo D et al. Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drugeluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. Eur Heart J. 2023;44(15):1343-57.
67. Berland J et al. DANUBIO - a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention. 2015;11(8):868-76.
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69. Greco A et al. Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial. Catheter Cardiovasc Interv. 2022;100(4):544-52.
70. Katsouras CS et al. Safety and efficacy of an innovative everolimus-coated balloon in a swine coronary artery model. Life (Basel). 2023;13(10):2053.
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72. Traynor BP et al. Design and rationale of a prospective, randomized, noninferiority trial to determine the safety and efficacy of the Biolimus A9™ drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM). Cardiovasc Revasc Med. 2023;56:75-81.
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Transverse Stent Fracture Diagnosis and Management: A Case Report and Review of the Literature
Authors: *Tamer Elkhayat,1 Adel Elhoseiny1,2
1. Cardiac services department, King Salman Armed Forces Hospital in the Northwestern Region, Tabuk, Saudi Arabia
2. East Surrey Hospital, Redhill, UK
*Correspondence to Dr.Tamer.el.khayat@gmail.com
Disclosure: The authors have declared no conflicts of interest.
Citation: EMJ Int Cardiol. 2025;13[1]:101-111. https://doi.org/10.33590/emjintcardiol/HYKZ1926
Abstract
Stent fractures are rare but significant complications following percutaneous coronary intervention (PCI), particularly in the treatment of chronic total occlusions using advanced techniques like the reverse-controlled antegrade and retrograde tracking method. This case is unique due to the occurrence of a rare Type IV stent fracture after such a procedure, which adds valuable insights to the scientific literature on prevention and management strategies for this complication.
A 59-year-old male with hypertension and ischaemic heart disease presented with exertional dyspnoea. Coronary angiography revealed a chronic total occlusion of the right coronary artery. He underwent successful PCI using the reverse controlled antegrade and retrograde tracking technique, which involved the placement of five overlapping drugeluting stents. At 2 months post-procedure, follow-up angiography detected a rare Type IV stent fracture in the mid-right coronary artery. A repeat PCI was performed to bridge the fractured stent segments, restoring vessel patency. The patient was discharged on optimised medical therapy, advised on lifestyle modifications, and scheduled for regular follow-up to monitor his cardiovascular health.
This case highlights the critical importance of meticulous procedural planning and consideration of vessel dynamics in complex PCI procedures to prevent stent fractures. Early detection through vigilant post-procedural monitoring enabled prompt management of the complication. The main takeaway is that careful stent deployment strategies and diligent follow-up are essential for improving patient outcomes in interventional cardiology.
Key Points
1. Stent fractures, though uncommon, pose significant clinical risks, such as in-stent restenosis and thrombosis. This is especially true in complex percutaneous coronary intervention cases involving long, overlapping drugeluting stents in mobile vessels like the right coronary artery.
2. This article presents the unique case of a Type IV stent fracture. It was incidentally detected 2 months after reverse-controlled antegrade and retrograde tracking-guided percutaneous coronary intervention for a chronic total occlusion of the right coronary artery. It also details the combined use of an additional drug-eluting stent and a covered stent to restore vessel integrity, alongside a comprehensive literature review of risk factors, diagnostic modalities, and management strategies.
3. Healthcare professionals should prioritise meticulous stent selection and deployment techniques, employ routine post-procedural imaging (e.g., StentBoost [Philips, Amsterdam, the Netherlands], intravascular ultrasound, optical coherence tomography) for early fracture detection, and maintain vigilant follow-up, especially in chronic total occlusions and overlapping-stent scenarios, to optimise patient outcomes.
INTRODUCTION
This case is unique because it documents a rare occurrence of a Type IV stent fracture following percutaneous coronary intervention (PCI), which was performed for a chronic total occlusion (CTO) of the right coronary artery (RCA) using the reverse controlled antegrade and retrograde tracking (CART) technique. The fracture was discovered incidentally during routine angiographic follow-up in a 59-year-old male patient who was asymptomatic, highlighting the importance of vigilant post-procedural monitoring even when patients are symptom-free. The stent fracture occurred at the site of a Xience Skypoint™ (Abbott, Abbott Park, Illinois, USA) stent within a series of five overlapping drug-eluting stents (DES), which is a complex stenting strategy that is seldom reported in the literature.
Furthermore, the management of this case involved an innovative approach: deploying an additional DES to bridge the fractured segments, followed by the placement of a covered stent due to concerns about potential aneurysm formation or coronary perforation. The combination of a rare complication, an asymptomatic presentation, and a unique intervention strategy enhances our understanding of stent fractures. It underscores the need for meticulous procedural planning, consideration of vessel dynamics, and the use of advanced imaging techniques for early detection and effective management of such complications in interventional cardiology.
Patient Information
A 59-year-old male patient, who smokes and has a history of hypertension and ischaemic heart disease, previously underwent stenting of the left anterior descending artery. He arrived at the cardiology clinic with exertional dyspnoea, although both the ECG and resting echocardiogram results were normal. Following the acquisition of informed consent, the patient underwent PCI to the RCA, during which five overlapping DESs were placed in the CTO of the RCA. Utilising the reverse CART approach, they were positioned from distal to proximal as follows: Orsiro® Mission (BIOTRONIK, Berlin, Germany) 2.25x26 mm, Onyx Frontier™ (Medtronic, Dublin, Ireland) 2.5x38 mm, Resolute Onyx™ (Medtronic) 3.0x30 mm, Xience Skypoint 3.0x28 mm, and Synergy Megatron™ (Boston Scientific, Marlborough, Massachusetts, USA) 3.5x8 mm. This mix of stents was due to the availability and sizing, and at the end of the procedure, the StentBoost (Philips, Amsterdam, the Netherlands) was used to ensure optimal opposition. The patient was scheduled for elective admission to undergo follow-up coronary angiography after two months. After giving informed consent, the patient underwent coronary angiography via the right radial artery using a diagnostic 5F Judkins Left (JL) 3.5 catheter, which revealed a non-obstructed left coronary system. Upon visualising the RCA with a diagnostic 6F Judkins Right (JR) 4.0 catheter, a Type IV stent fracture was revealed at the midsegment where the Xience Skypoint stent was located. The diagnosis was made with StentBoost and confirmed by intravascular ultrasound (IVUS) (Figure 1).
A) Final result of the first procedure (after stent implantations in RCA). B) coronary angiography of the left system showing no obstructions. C) RCA showing a Type IV stent fracture at the mid-segment. D) StentBoost (Philips, Amsterdam, the Netherlands) to fractured stent. E) IVUS showing minimal stent area of 7.02 mm².
IVUS: intravascular ultrasound; RCA: right coronary artery.
TIMELINE
Stent fracture (SF) is an uncommon complication of PCI that can lead to adverse clinical outcomes such as in-stent restenosis (ISR), thrombosis, and acute coronary syndromes.1-3 The introduction of coronary stents revolutionised the treatment of coronary artery disease by providing a scaffold that prevents vessel closure post-angioplasty.3 However, the mechanical integrity of these stents is crucial for their long-term efficacy.
SF refers to a partial or complete separation of the stent struts, which can compromise the vessel’s patency and lead to significant clinical implications.4,5 A recent meta-analysis reported that the type of stent, implantation technique, and patient-specific factors influence the incidence of coronary stent fractures, which varies widely in the literature between 4.8–5.5%.6
Coronary stents are produced using diverse platforms that considerably influence their mechanical characteristics, biocompatibility, and long-term efficacy. The platforms consist of three categories of stents: bare-metal stents (BMS), DESs, and bioresorbable stents. Every stent platform has distinct advantages, limits, and hazards, including the potential for stent fractures, which significantly affect the stent’s efficacy.6,7
BMSs are predominantly constructed from stainless steel, cobalt-chromium, or platinumchromium alloys. The design consists of a basic iron framework lacking any further medicinal coating. The benefits of employing quick mechanical support to avert vascular collapse during angioplasty include decreased costs and an uncomplicated design.8 However, it has disadvantages, including the increased likelihood of restenosis, which is a re-narrowing of the artery caused by tissue regrowth referred to as intimal hyperplasia.
Figure 1: Multimodality imaging of a mid-right coronary artery Type IV stent fracture after primary stenting.
Nonetheless, there exists a possibility of SF. SFs are less common with contemporary BMSs than with DESs; a 2022 meta-analysis of 36 studies (39,953 patients) reported pooled DES-related fracture rates of 5.5% per patient, 4.8% per lesion, and 4.9% per stent, with the incidence rising over the past 20 years,6 especially in long stents or in vessels that move substantially, such as the RCA. Cobalt-chromium BMSs exhibit greater flexibility and reduced susceptibility to fractures compared to earlier stainless steel BMSs. This can be attributed to the improved strength-to-weight ratio and thinner struts.9
DESs are typically comprised of cobaltchromium, platinum-chromium, or newer alloys, such as titanium-nitride-oxide. Furthermore, a polymer is incorporated that elutes drugs (such as paclitaxel, sirolimus, everolimus, or zotarolimus) to impede tissue renewal and reduce restenosis. The advantage of drug elution in DESs is that it significantly diminishes the incidence of restenosis compared to BMSs by reducing smooth muscle cell proliferation. This enhances therapeutic outcomes, especially in high-risk patients with complicated lesions. However, delayed endothelialisation may result in late stent thrombosis, necessitating an extended course of dual antiplatelet therapy to reduce the risk of thrombus development.10
The incidence of SFs and their therapeutic implications have evolved with the advancement of newer-generation stents.
Initial Generation of the DES Sirolimus-Eluting Stents (SES)
The fracture rate of first-generation stents, such as the Cypher stent (Cordis Corporation, Hialeah, Florida, USA), was elevated, ranging between 2–9%11 due to their closed-cell design. This architecture rendered them less adaptable and more vulnerable to mechanical stress in regions of vascular flow.12 The incidence of stent fractures in Cypher stents showed a significant association with ISR and stent thrombosis, resulting in adverse clinical outcomes. A study indicated that all reported SFs were linked to SES and were associated with binary restenosis
and target lesion revascularisation (TLR).13 Factors such as vessel tortuosity, overlapping stents, and placement in highly mobile channels, particularly the RCA, significantly elevate the likelihood of SFs.1
Paclitaxel-eluting stents, such as the Taxus stent (Boston Scientific), deliver paclitaxel to inhibit the restenosis of blood arteries. The Taxus stent, a first-generation DES, demonstrated a reduced but still notable incidence of SFs relative to the Cypher stent, with rates ranging between 0.5–1.5%.11 The Taxus stents exhibited enhanced pliability due to their open-cell architecture, leading to a reduced incidence of fractures, though not completely eradicating them.14
The Importance of Fractures in Clinical Practice
Fractures of first-generation DESs often led to ISR. SFs exacerbate this issue, especially in instances involving extensive lesions or arterial segments subjected to considerable stress. Stent thrombosis denotes the development of a thrombus within the stent, which can potentially lead to a life-threatening myocardial infarction. TLR frequently necessitates further procedures, such as balloon angioplasty or the placement of supplementary stents, as a result of fractures.15,16
Second-generation DESs, exemplified by the cobalt-chromium everolimus-eluting Xience platform, show markedly lower fracture rates than first-generation DESs. A large angiographic series reported SFs in roughly 2.9%17 of lesions, thanks to the thinner struts and more flexible design of these devices. Studies have shown that the occurrence of SFs in Xience stents is somewhat lower than in Cypher or Taxus stents.18,19 Fractures in everolimus-eluting stents (EES) might still lead to restenosis and require TLR; however, the latest stents demonstrate a reduced incidence of restenosis relative to their predecessors.20, 21
The fracture incidence of zotarolimuseluting stents (ZES), including Medtronic’s Endeavour (1–2%) and Resolute (0.8–4.0%)22 models, demonstrates superior durability in intricate and convoluted blood vessels due
to the open-cell structure and adaptability of the ZESs. Reports indicate fractures, particularly in extended or overlapping stents within the RCA.23,24 Similar to EESs, fractures in ZESs may lead to restenosis and sometimes necessitate revascularisation. A recorded case indicated that a ZES fracture led to ISR, which was successfully addressed with further angioplasty.25
Determinants that elevate the probability of SFs in second-generation DESs include: 1) geographical position, as the placement of stents in highly mobile arteries, such as the RCA, remains a considerable risk factor for fractures, similar to first-generation stents; 2) the length of the stent and overlap, as the utilisation of longer stents and overlapping configurations increases the mechanical stress on the stent, consequently augmenting the likelihood of fractures; and 3) complex lesions, particularly those involving angulated or tortuous arteries, have an elevated risk of SFs, irrespective of the stent generation.26-29
Finally, bioresorbable stents are constructed from bioresorbable materials such as poly-l-lactic acid or magnesium alloys. These provide temporary structural support and subsequently degrade, which potentially averts late-stage complications such as stent thrombosis. The stent fully dissolves after offering temporary support to the blood vessel, allowing the artery to regain its natural function. It may reduce the probability of long-term problems such as delayed stent thrombosis or ISR. Nonetheless, the disadvantages include heightened vulnerability to premature fractures owing to the inferior material properties compared to metallic stents.30-32
First-generation bioresorbable stents, exemplified by ABSORB (Abbott), had issues pertaining to strut thickness. This led to heightened chances of SFs and restenosis. The market removal of the ABSORB Bioresorbable Vascular Scaffold (BVS), Abbott, was necessitated by the emergence of these complications. There is a considerable probability of fractures arising in early bioresorbable stents, especially in the first-generation ABSORB stents, where a fracture rate of 1.3–8.4%
was reported.33 Fractures predominantly manifested in regions of elevated stress or vascular mobility, which is attributable to the amalgamation of robust struts and inferior materials.34-36
Researchers are presently engaged in the development of advanced bioresorbable stents, including those made from magnesium. The objective of these stents is to reduce the probability of fractures. Nonetheless, they remain in the experimental phase and have not been extensively adopted in medical practice.37,38
The pathophysiological mechanisms that lead to SF are multifactorial. Fractures may be caused by mechanical stresses such as twisting, compressing, and stretching, which occur during cardiac cycles. Stents placed in arterial segments that are already under a lot of mechanical stress are particularly vulnerable. This is why platinum-chromium alloy stents, developed to improve radial strength and flexibility compared to earlier generations, potentially reduce the risk of SF.16
We can classify coronary SFs based on their degree of severity, anatomical site, and fracture pattern. Type I, which is the simplest form of SF, involves only one strut and may not have significant clinical consequences. In Type II, the fracture of multiple struts occurs without any separation between the stent segments. Type III involves the fracture of multiple struts with separation between stent segments, and can lead to more serious complications such as ISR or stent thrombosis. In Type IV, the stent has a transverse break, leading to complete division into two parts. This can be a serious complication with a significant clinical impact. Lastly, in Type V, the stent maintains its continuity but undergoes deformation, potentially altering the flow dynamics within the stent. These fractures have varying incidence and clinical impact, with more complex fractures (Types III and IV) associated with higher rates of adverse cardiac events.39
SF is the result of a complex interplay between biomechanical stresses and material fatigue. Repetitive mechanical
stress, whether due to physiological vessel movement or external compression, can lead to metal fatigue and eventual fracture. The type of stent material and design also plays a critical role, with certain alloys and thinner strut designs being more susceptible to fracture. Hinged points in the artery, long stented segments, the RCA location, and metal overlap all represent contributing factors to SF.39-41
Coronary SFs have a range of clinical consequences, from asymptomatic cases detected incidentally on imaging to significant events such as ISR, thrombosis, and acute myocardial infarction. The presence of an SF increases the risk of adverse cardiac events, underscoring the importance of early detection and management.42,43
The diagnosis of coronary SF primarily relies on imaging modalities, including coronary angiography, IVUS, and optical coherence tomography (OCT). Each modality has its advantages and limitations regarding sensitivity and specificity for detecting SFs. Recent advancements in imaging technologies have improved the detection rates of these fractures.44-47
The management of coronary SF depends on the severity of the fracture, associated symptoms, and the presence of concomitant ISR or thrombosis. Options range from clinical observation for patients who are asymptomatic to percutaneous interventions or even coronary artery bypass grafting in cases with significant associated complications.7,48
Preventive strategies focus on minimising the risk factors for SF, including optimising stent selection based on vessel size and anatomy, avoiding excessive stent length and overlapping stents, and using imaging guidance to ensure optimal stent deployment. Advances in stent technology, including the development of stents with improved flexibility and fracture resistance, also contribute to reducing the incidence of SF.49,50
Ongoing research aims to further understand the mechanisms behind SFs, develop more resilient stent materials and
designs, and improve diagnostic techniques for early detection. Although their role in preventing SFs is not fully elucidated, the advent of bioresorbable vascular scaffolds presents a potential avenue for reducing the long-term risks associated with permanent metallic stents.51,52
THERAPEUTIC INTERVENTION
The previously deployed stent at the midsegment showed a complete SF. The SF occurred a few millimetres away from the overlapping segment, which was 2 mm in length itself. The minimum lumen area was measured at 7.02 mm². After changing the diagnostic catheter with a 6F Judkins Right (JR) 4.0 guiding catheter, the patient underwent IVUS-guided PCI to the RCA. Initially, an Onyx Frontier DES 3x18 mm was deployed, followed by a covered stent (PK Papyrus® [BIOTRONIK] 3.0x15 mm), deployed at 16 atm, achieving Thrombolysis in Myocardial Infarction (TIMI) flow Grade 3 end results (Figure 2). The authors started by deploying one DES to repair the disintegrated and fractured segment. Although the immediate result was still not satisfactory, given that contrast extravasation remained even after taking conservatory steps, the authors felt it would be safer to tackle this problem immediately. After deploying the covered stent, there was no more extravasation. Post-procedure minimal stent area was 9.72 mm² (Figure 3).
FOLLOW-UP AND OUTCOMES
The repeat PCI and deployment of an additional DES and a covered stent was followed by post-dilation with a Sapphire II NC™ balloon (OrbusNeich, Hong Kong, China; size 3.5x15 mm) up to 18 atm. The patient was also closely monitored during his hospital stay. Important follow-up diagnostics included an echocardiogram, which confirmed the absence of pericardial effusion, and IVUS imaging, which showed a satisfactory post-procedure minimal stent area of 9.72 mm², indicating the successful restoration of vessel patency.
Figure 2: Intravascular ultrasound sequence demonstrating a double-lumen stent fracture and its resolution with drug-eluting stent-plus-covered-stent therapy.
A) Arrows show SF and dislocation resembling double lumen. B) SF site after deploying the DES. C) SF site showing single lumen after deploying the covered stent.
DES: drug-eluting stent; SF: stent fracture.
A), B), C), and D) show serial RCA angiography after stent deployment with TIMI flow Grade 3. E) IVUS showing minimal stent area of 9.72 mm2
IVUS: intravascular ultrasound; RCA: right coronary artery; TIMI: thrombolysis in myocardial infarction.
Figure 3: Serial right coronary artery angiograms.
The patient’s adherence to optimised medical therapy was assessed through regular consultations and medication reviews. He was compliant with the prescribed dual antiplatelet therapy (aspirin 100 mg daily and ticagrelor 90 mg twice daily), antihypertensive medication (perindopril 5 mg daily), lipidlowering agents (atorvastatin 40 mg daily and evolocumab 140 mg every 2 weeks), and heart rate control medication (bisoprolol 2.5 mg daily). Tolerability was excellent, with the patient reporting no adverse effects from the medications during follow-up visits.
There were no adverse or unanticipated events during the follow-up period. The patient remained asymptomatic, with no episodes of chest pain or exertional dyspnoea. Routine follow-up angiography performed 2 months later demonstrated maintained vessel patency without evidence of restenosis or new SFs. The patient continued to abstain from smoking and adhered to lifestyle modifications aimed at improving his cardiovascular health.
DISCUSSION
Reports indicate that the incidence of SFs in EESs ranges from 0.5–2.9% of lesions and is a significant risk factor for major adverse cardiac events, primarily due to increased TLR and stent thrombosis.50 Factors such as stent length, vessel movement, and lesion calcification influence SF more frequently in certain anatomical locations, such as the RCA.45 In the authors’ case, the most likely causes of SF were the length of the stent and its location on the RCA’s hinge point.
The long-term results of clinical trials show that scaffold fracture after EES placement increases the risk of major adverse cardiac events and TLR, especially in the first year after implantation. However, the occasional peri-stent contrast staining after DES implantation does not appear to be associated with negative outcomes,52,53 a finding that was also observed in the authors’ case.
In terms of clinical management, SF is primarily detected through angiographic follow-up and fluoroscopy, especially with
StentBoost,54, 55 IVUS, and OCT. These advanced imaging techniques provide detailed information about stent integrity, the level of fracture, and the potential impact on vessel patency. This information plays a crucial role in guiding subsequent management decisions.56 In the authors’ case, the angiographic appearance suggested the presence of SF, which was then confirmed by StentBoost and IVUS.
When coronary SFs are detected, the clinical context and the extent of the fracture determine the treatment options. Conservative management is possible for minor asymptomatic fractures, which may not require immediate intervention. However, more severe fractures necessitate intervention to address the underlying pathology and restore adequate blood flow.57,58 In the authors’ case, they observed the SF during routine follow-up, even though the patient was asymptomatic and had a complete transverse fracture with dislocation.
Among the possible treatments are stent repositioning, stent overlap, extra stent placement to improve stent deployment,56,57 or balloon angioplasty with drug-eluting balloons that deliver antiproliferative drugs without adding another layer of metal, which might lower the risk of breaking the stent again.59 In this case, the authors initially deployed a second DES that overlapped with the two parts of the fractured and dislocated segments. They then placed an additional covered stent at the site of the fractured stent due to concerns regarding the formation of an aneurysm or coronary perforation, especially since there was still extravasation staining at the site of SF.57 In complex cases where the SF is extensive or associated with additional complications, such as aneurysm formation, coronary artery bypass grafting may be considered. This is particularly relevant in cases where percutaneous approaches are not feasible or have failed.41
By carefully evaluating the lesion, selecting the appropriate stent, implementing optimal stent placement techniques, and potentially utilising imaging guidance such as IVUS to ensure proper stent fit and expansion, one can prevent SF. Moreover, patient-specific
factors such as optimising medical therapy, especially antiplatelet therapy, are crucial for preventing thrombotic complications associated with SF.58
Continuous follow-up is crucial for patients with SF. This includes clinical evaluation; imaging studies, including coronary angiography to monitor the stent and coronary artery; and adherence to a strict regimen of antiplatelet therapy to prevent thrombotic events.59,60
While we focus on patients CTO due to their longer stent segments and higher stent complexity (which predisposes them to fractures), vigilant follow-up imaging can also benefit many high-risk patients who have undergone PCI.39 In general, a followup angiogram or non-invasive imaging at 3–6 months is advisable in complex CTO cases. For standard-risk patients, decisions can be individualised based on clinical presentation. At 6–12 months, the use of imaging such as IVUS, OCT, or advanced fluoroscopic techniques can detect silent fractures before they manifest clinically.39
The authors advise patients to make healthy lifestyle changes and manage risk factors for coronary artery disease, such as quitting smoking and managing blood pressure, cholesterol, and diabetes. This will improve their overall cardiovascular health and prevent future coronary events. In this case, the authors optimised the patient’s medications before discharge.60
CONCLUSION
SF is a rare but significant complication of PCI that can lead to adverse clinical outcomes such as ISR, stent thrombosis, and acute coronary syndromes. This case underscores the importance of early SF detection through routine follow-ups using advanced imaging modalities, such as intravascular ultrasound and OCT, which are critical for confirming stent integrity and guiding management decisions. In this instance, a Type IV fracture was identified during follow-up angiography in a patient who was asymptomatic. It was effectively managed by deploying a second DES
and a covered stent to restore vessel patency and prevent complications such as restenosis and coronary perforation. The case highlights key risk factors for SF, including stent length, overlapping stents, and placement in highly mobile or calcified arterial segments. It reinforces the importance of personalised treatment planning, appropriate stent selection, and optimised medical therapy, including dual antiplatelet therapy, to minimise the risk of SF. While advancements in stent technology have reduced fracture incidence, continuous follow-up and lifestyle modifications, such as smoking cessation and better management of cardiovascular risk factors, remain crucial for improving patient outcomes.
PATIENT PERSPECTIVE
The patient was initially surprised to learn about the stent fracture during his routine follow-up, especially since he had been asymptomatic. However, he expressed relief that the issue was detected early before it could lead to more serious complications. He appreciated the clear explanations provided by his medical team about the nature of the complication and the steps needed to address it.
After the successful repeat PCI, the patient felt reassured by the prompt and effective treatment he received. He recognised the importance of adhering to his medication regimen and was motivated to make the recommended lifestyle changes, such as quitting smoking and managing his hypertension. The experience reinforced his commitment to regular medical follow-ups and proactive management of his cardiovascular health.
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