Cardiovascular News - Issue 73 - May 2024 (OUS)

May 2024 | Issue 73

www.cardiovascularnews.com

SMART Trial

It’s not TAVI, ™ it’s Evolut Evolut TAVI is superior at restoring near-normal blood flow in small annulus† patients ™

Compared to the SAPIEN™* platform, the Evolut™ design left patients with : Evolut™ TAVI

SAPIEN™* TAVI

3.2% 32.2%

frequent residual gradients equivalent to pre-AVR moderate AS (≥ 20 mmHg) at 1 year. p < 0.001

SAPIEN™* TAVI

3.5x less

at 1 year vs. SAPIEN™* platform.1

At one year, one third of patients treated with a SAPIEN™* valve did not reach the goal of restoring nearnormal transvalvular flow.2

Evolut™ TAVI

10x less

10.3% 35.1%

≥ moderate prosthesis-patient mismatch (PPM) at 30 days. p < 0.001

1. Herrmann, H. C., Mehran, R., Blackman, D. J., et al. (2024). Self-expanding or balloon-expandable TAVR in patients with a small aortic annulus. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2312573 2. Playford D, Stewart S, Celermajer D, et al. Poor Survival with Impaired Valvular Hemodynamics After Aortic Valve Replacement: The National Echo Database Australia Study. J Am Soc Echocardiogr. September 2020;33(9):1077–1086.e1. †

In patients with small annulus (area ≤ 430 mm2) in all-comers trial, consisting of majority low surgical risk participants (52.1%).

2024-smart-trial-ad-en-gb-emea-12923117 © Medtronic 2024. All rights reserved. ™*Third-party brands are trademarks of their respective owners.

All other brands are trademarks of a Medtronic company.

May 2024 | Issue 73

Featured in this issue:

www.cardiovascularnews.com

6 Global Cardiovasular Awards

Celebrating innovation and excellence

11 Aortic guidelines

Aorta "an

organ in its own right"

16 Profile

Nicolas Dumonteil

22 RELIEVEHF trial Interatrial shunting for heart failure

Photo by © ACC/Brian Powers 2024

Self-expanding valve comes out on top in SMART trial of TAVI in small aortic annuli

DanGer Shock trial shows benefit of micro-axial flow pump in STEMI complicated by cardiogenic shock

Panelists discuss Jacob Møller’s presentation during ACC 2024

Use of the Impella CP (Abiomed) micro-axial flow pump in the treatment of patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock increased the rate of survival at six months compared to standard care alone, results of the DanGer Shock trial have shown.

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ccording to investigators, this is the first trial “in a very long time” to produce a positive result for the management of cardiogenic shock and represents a new treatment option for patients—though they caution that there are risks associated with this approach, and that it may not be generalisable across all risk groups.

Results of the trial were presented by the study’s lead author, Jacob Møller (Odense University Hospital, Odense, Denmark) during a late-breaking trial session at the American College of Cardiology (ACC) 2024 scientific session (6–8 April, Atlanta, USA) and published simultaneously in the New England Journal of Medicine (NEJM). “I think this will be a routine device that will be used in these desperately ill patients,” Møller said of the trial’s findings.

Previous trials evaluating the potential benefits of this and other heart pumps for cardiogenic shock have had mixed results.

DanGer Shock is the first trial powered to examine whether the use of the device can improve survival in STEMI complicated by cardiogenic shock and has taken investigators more than 10 years to complete.

The study team enrolled 360 patients treated for STEMI with cardiogenic shock at 14 centres in Denmark, Germany and the UK. Patients who suffered out-of-hospital cardiac arrest with coma and increased risk of brain damage were excluded from the trial.

Researchers randomly assigned patients to receive standard care or standard care plus treatment with an Impella CP.

Participants were randomised before, during or up to 12 hours after receiving treatment in the cath lab, depending on when cardiogenic shock was diagnosed.

Among 355 patients who were included in the analysis, 58.5% of those who received standard care alone and 45.8% of those who received the Impella pump had died at six months after randomisation: representing an absolute 13% reduction in the rate of death, the study’s primary endpoint, in favour of the device.

Furthermore, the results showed a reduction in a composite endpoint of additional mechanical heart support, heart transplant or death among patients who received the Impella, which appeared to widen after 30 days and up to 180 days, but there was no difference between the two groups in the number of days out of the hospital.

“What was a surprise for us was that the benefit seems to persist beyond 30 days,” Møller said. “It’s not only that we are

I think this will be a routine device that will be used in these desperately ill patients.”

Continued on page 4

RESULTS OF THE SMART trial, comparing two transcatheter aortic valve implantation (TAVI) systems in patients with small aortic annuli, show that a supra-annular self-expanding valve resulted in similar clinical outcomes and superior valve performance at one year compared with a balloonexpandable valve.

The randomised trial compared the upra-annular self-expanding Evolut (Medtronic) family of TAVI valves and balloon-expandable Sapien 3 (Edwards Lifesciences) devices. It is the first trial to focus on patients with small aortic annuli, a group that is primarily women.

The study’s lead author, Howard Herrmann (Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA), presented the results at the American College of Cardiology (ACC) 2024 scientific session (6–8 April, Atlanta, USA). “There was a huge difference—32.2 percentage points— in one-year bioprosthetic valve dysfunction favouring the Evolut platform,” Herrmann said. “The magnitude of the haemodynamic difference was larger than we expected.”

The trial enrolled 716 patients who had a valve annulus of 430mm2 or less and anatomy suitable for either device. Eighty-seven percent of study participants were women.

Researchers found no significant difference for the composite of death, disabling stroke or rehospitalisation for heart failure—which occurred in 9.4% of Evolut patients and 10.6% of Sapien patients.

Evolut was found to be superior in terms of valve function, defined as a composite of structural and non-structural valve deterioration, thrombosis, endocarditis and valve reintervention. This occurred in 9.4% of Evolut patients and 41.6% of Sapien patients. For more SMART trial coverage see advertorial on page 21.

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May 2024 | Issue 73

Top Stories

DanGer Shock trial shows benefit of micro-axial flow pump in STEMI complicated by cardiogenic shock Continued from page 3

saving lives, it looks like we are also saving myocardium so the patients keep surviving, and the survival curves continue to separate beyond the first 30 days.”

However, the results also showed significantly higher rates of complications among patients who received the heart pump, including bleeding, limb ischaemia, renal replacement therapy and sepsis.

“It doesn’t come without a cost—we see significantly more serious complications in the Impella-treated patients,” Møller said. “Overall, we have more complications, but we also save lives.”

Møller said that the study is not generalisable to all cases of cardiogenic shock as the trial was more selective than previous trials in identifying patients who were most likely to be able to benefit from the use of the device, for example, by excluding those with a risk of brain damage.

However, within this patient population, he said the results are likely translatable beyond northern Europe to large centres with the necessary expertise to employ the device.

Subgroup analyses suggested that patients with very low blood pressure and those with lesions in more than one coronary artery may see a greater benefit from the Impella pump.

Møller said that further studies are needed to assess the benefits in more diverse patient populations and to examine how the duration of mechanical support might affect the rate of severe complications and identify opportunities to further optimise practices to minimise complications.

“It is great for the field to finally have some positive randomised controlled trial data to support our clinical observations,” Ajay Kirtane (Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, USA), who acted as a discussant during the presentation at ACC 2024, told Cardiovascular News. “The trial also demonstrates potential future improvements to outcomes especially if we can reduce complications/adverse events.

But we should also remember that careful patient selection likely played an important role in the findings the investigators observed.”

Questions remain, particularly regarding the details of the up-front management of these patients, Kirtane added, when asked how he would prioritise further research in this area. “There are many interventionalists who don’t even take pictures of the non-culprit vessel in a STEMI scenario, even with shock, Impella CP let alone consider doing a heart pump right heart catheterisation prior to opening the

artery. I think that some of the data from the trial specifically regarding the timing of initiation of support would be helpful.”

Commenting on the findings, Eric Cantey (University of Michigan, Ann Arbor, USA), described the apparent separation in the curves after 30 days in favour of Impella as particularly noteworthy.

“One of the key concepts here—which is still yet to be fully determined—is in the benefit of the microaxial pump in ventricular unloading. What that does is decrease the wall stress and therefore decrease oxygen consumption in the heart and allows the heart to rest and to actually promote myocardial recovery, rather than just supporting a patient’s haemodynamics.

“One of the most striking things to me is that early on the curves follow a similar trajectory, but the curves continue to separate up to the endpoint of 180 days. I would say that while this trial does not elucidate exactly why that is; however, it would support the concept of ventricular unloading, even despite the large competing risk of the device.”

In a NEJM editorial accompanying the publication of the results, Sunil Rao (Duke University Health System, Durham, USA) writes that the trial’s findings demonstrate the efficacy of the device in reducing mortality among the study population, but acknowledges that there are still questions to be answered.

It is great for the field to finally have some positive randomised controlled trial data to support our clinical observations.”

“The results of the DanGer Shock trial are clear in that the microaxial flow pump reduced mortality among selected patients with acute myocardial infarction-related cardiogenic shock,” Rao notes.

“However, given the rapidly evolving nature of mechanical circulatory support use, other unresolved issues remain. These include the timing of microaxialflow-pump placement (before primary percutaneous coronary intervention or after opening the infarct-related artery), the incorporation of shock protocols or a “shock team” as a standardised approach, and the combined use of the microaxial flow pump with other mechanical circulatory support such as venoarterial extracorporeal membrane oxygenation.”

Some of these issues are being addressed in ongoing trials, such as RECOVER IV—a two-arm trial that will assess whether percutaneous coronary intervention (PCI), with Impella support initiated prior to the PCI, is superior to PCI without Impella support. The trial enrolled its first patient in November 2023, and it is hoped that up to 548 patients will be randomised to either investigational arm.

Editor-in-chief: Simon Redwood | Publisher: Stephen Greenhalgh Content director: Urmila Kerslake | Global commercial director: Sean Langer Senior editor: Will Date will@bibamedical.com | Editorial contribution: Jamie Bell, Jocelyn Hudson Design: Terry Hawes, Josh Lyon and David Reekie Advertising: Melanie Stevenson melanie@bibamedical.com Subscriptions: subscriptions@bibamedical.com | News or advertising queries Tel: +44 (0)20 7736 8788 Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 Printed by: Buxton Press. Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2024. All rights reserved.

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NEWS IN BRIEF

THE LATEST STORIES FROM THE CARDIOVASCULAR WORLD

n ORBITA-COSMIC: The use of a coronary sinus reducer has been shown to reduce chest pain episodes among patients with refractory angina, but investigators in the ORBITA-COSMIC trial have been unable to demonstrate the mechanism underlying the improvement.

For more on this story go to page 12.

n RADIATION IN THE CATH LAB: New data presented at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA) by David Rizik (HonorHealth Research Institute, Scottsdale, USA) suggest that the use of a radiation shield system could "markedly" cut the exposure of cath lab staff to harmful radiation during interventional procedures.

For more on this story go to page 14.

n PACLITAXEL RESTRICTIONS: Analysis of the restriction on the use of paclitaxelcoated devices in the treatment of peripheral arterial disease, brought about as a result of a meta-analysis on their potential increased mortality risk did cause harm to patients who were relegated to "less durable" device treatment, Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) has reported.

For more on this story go to page 25.

CLARIFICATION: In the article ‘Renal denervation finds new shores following US FDA device approvals’ in Cardiovascular News issue 72 a picture caption failed to identify that David Kandzari was performing the first US procedure using the Symplicity Spyral (Medtronic) device since its approval. Cardiovascular News is keen to clarify that earlier procedures had been performed using the Paradise (Recor Medical) renal denervation system.

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May 2024 | Issue 73

Awards

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GLOBAL CARDIOVASCULAR AWARDS 2024

Past, present and future of cardiovascular innovation celebrated at Global Cardiovascular Awards

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A founding father of transcatheter aortic valve implantation (TAVI), professor Alain Cribier (University of Rouen, Rouen, France), was among the names recoginsed for their tireless efforts in advancing the field of cardiovascular care at the first annual Global Cardiovascular Awards.

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And the winners are:

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1. Siemens Healthineers collected the Best Cardiovascular Product Launch award 2. Medtronic's Tour for Life campaign was named Best Medical Education Campaign 3. Heart Valve Voice's Wil Woan with the Best Public Awareness Campaign award 4. Essex Cardiothoracic Centre won the Digital Innovation award for their work with FibriCheck 5. Edwards Lifesciences collected the Innovation in Interventional Cardiology award for Evoque 6. GE Healthcare picked up the Innovation in Cardiac Surgery award for the Detour system 7. Endologix won the Innovation in Cardiac Surgery award for the Detour system 8. The Innovation in Patient and Operator Safety award went to Radiaction, presented by Aung Oo 9. Bruno Scheller receives the Clinical Research Excellence award 10. Rasha Al-Lamee with her Future Leader award, which was presented by Mirvat Alasnag 11. The James Cook Hopsital team were crowned the Heart Team of the Year 12. Teri Sirset collected CEO of the Year 13. The awards concluded with a tribute to Alain Cribier, recipient of the Lifetime Achievement award

Issue 73 | May 2024

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he awards, hosted by Cardiovascular News with support from industry partners Concept Medical, Endologix, Edwards Lifesciences and GE Healthcare, in partnership with the World Heart Federation (WHF), sought to recognise the innovators and pioneers at the vanguard of efforts to improve the treatment of cardiovascular disease worldwide.

Across 13 categories, awards were presented to some of the individuals, industry leaders and non-profit organisations who are helping to shape the future of cardiovascular care. Each award category was adjudicated by an expert judging panel assembled by Cardiovascular News, and the winners were announced at a lavish ceremony at London’s Grand Sheraton Hotel (14 March) hosted by the comedian and entertainer Naomi Cooper.

Cribier, the TAVI pioneer whose trailblazing work helped to usher in a new era in interventional cardiology, heralding the advent of the transcatheter treatment of valvular heart disease, sadly passed away in February at the age of 79.

Attendees of the Global Cardiovascular Awards heard moving tributes to Cribier from Michael Reardon (Houston Methodist Hospital, Houston, USA) and Lars Søndergaard, the divisional vice president, medical affairs and chief medical officer, Structural Heart at Abbott.

“Alain Cribier will always be seen as one of the greats of cardiology, and one of the greats of cardiovascular medicine in general,” Reardon said of Cribier. “Not only was he a true innovator and a pioneer in multiple areas, but I think he will really be remembered for what a great person he was.”

“Alain Cribier has inspired many people,” added Søndergaard. “If you really believe you have something that can change the treatment of patients, be persistent and keep working. We can learn a lot from what Cribier did in his journey, and it should be an inspiration for young people in this field.”

Among the other winners on the night was Rasha Al-Lamee (Imperial College London and Imperial College Healthcare NHS Trust, London, UK), who received the Future Leader award for her impactful research on the treatment of angina with coronary stenting through the ORBITA and ORBITA-2 trials.

Presenting her the award, Mirvat Alasnag (King

Awards Fahd Armed Forces Hospital, Jeddah, Saudi Arabia), a member of the Global Cardiovascular Awards judging panel, praised Al-Lamee’s practice changing work as having raised the bar for research in the field.

Another interventional cardiology pioneer, Bruno Scheller (University of Saarland, Saarland, Germany), who has led the way in research of the use of drug-coated balloons (DCBs), was recognised for his years of work in this area, picking up the Clinical Research Excellence Award. Scheller’s work on the topic began in the late 1990s, and he and his team continue to work on improving DCB catheters, developing special applications, as well as researching alternative drugs coatings.

“This is a great honour for me,” Scheller told Cardiovascular News, commenting that it supported his persistence with this approach. “We now see that, in the coronary arteries there is interest from more and more interventional cardiologists all over the world in using DCBs, not to replace stents but to limit the number and the lengths of stents to improve

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candidate for the award.

“I felt it was really important being a female CEO and a first-time entrepreneur to share with other women that this is possible,” said Sirset of her motivation for entering the awards in its first year.

In the Best Cardiovascular Product Launch, Siemens Healthineers triumphed for its threepart launch campaign within the ARTIS family of angiography systems which took a digital storytelling approach with messaging tailored to different target groups.

Medtronic picked up the award for Best Medical Education Campaign for its Tour for Life initiative, aimed at bringing hands-on training to more than 3,000 cardiac surgeons in 12 countries throughout Europe and widening access to educational using a training truck that toured 38 locations throughout the campaign.

In the category celebrating the most impactful patient-facing awareness campaign—Best Public Awareness Campaign—Heart Valve Voice collected the prize for its work raising awareness in the over 55s of the red-flag symptoms of heart valve disease.

Judges cited the precision of the campaign and its audience-targeted messaging and delivery, which was backed up by strong data highlighting its reach.

Innovation was a key theme running through the awards, and several categories sought to recognise the ingenuity and novel use of technology to improve outcomes for patients with cardiovascular disease.

The Essex Cardiothoracic Centre was the winner in the Digital Innovation Category for its use of FibriCheck, a smartphone-based monitoring tool for patients with arrhythmias used following patient outcomes.” ablation for atrial fibrillation. Use of the Teri Sirset, the co-founder and CEO tool contributed to improved efficiency in of Dasi Simulations, a company that is the assessment of developing artificial intelligence (AI)AF and was met with a positive driven simulations to improve response from patients. modelling for heart valve GE Healthcare picked up the procedures picked up the CEO of Innovation in Cardiac Imaging the Year Award, with the judging Award for its Vscan Air SL The Global Cardiovascular panel recognising her leadership dual-headed, handheld, wireless Awards will return in 2025 on accomplishments, strong patient ultrasound imaging system 13 March. Pick up the next focus, and active engagement designed for rapid cardiac and edition of Cardiovascular News in the med-tech community vascular assessments at the for details about entering and as having made her a standout point of care. Judges recognised attending the awards. the enormous potential of the technology for expanding access to care.

The full list of winners and highly commended entries In the Innovation in Cardiac Surgery category Endologix collected the award for ● Best Cardiovascular Product Launch Replacement System its Detour percutaneous transmural arterial bypass Siemens Healthineers: ARTIS Family • Highly Commended: system, a unique technology that allows the creation Radiaction Medical: Radiaction System of a fully percutaneous femoropopliteal bypass that ● Best Medical Education Campaign • Highly Commended: is routed through the femoral vein.

Medtronic: Tour for Life Elixir Medical: DynamX The Edwards Lifesciences Evoque transcatheter tricuspid valve replacement system triumphed in the ● Best Public Awareness Campaign ● Innovation in Patient and Operator Safety Innovation in Interventional Cardiology category, Heart Valve Voice: Awareness Campaign Radiaction with judges recognising that the encouraging preliminary data underpinning the use of the device, ● Digital Innovation ● Clinical Research Excellence point towards a meaningful benefits to patients.

Essex Cardiothoracic Centre: FibriCheck Bruno Scheller For its work to shield interventionalists from • Highly Commended: the harmful impact of radiation in the cath lab, GE Healthcare: Vscan Air SL ● Future Leader Radiaction collected the Innovation in Patient • Highly Commended: Rasha Al-Lamee and Operator Safety Award for its technology that Dasi Simulations proactively blocks radiation at the source. ● Heart Team of the Year In one of the biggest draws of the night, the team ● Innovation in Cardiac Imaging James Cook Hospital, Middlesbrough, UK from James Cook Hospital in Middlesbrough (UK) GE Healthcare: Vscan Air SL were named as the heart team of the year, seeing off ● CEO of the Year competition from the team from CHU de Bordeaux ● Innovation in Cardiac Surgery Teri Sirset, Dasi Simulations (Bordeaux, France) after a public vote.

Endologix: Detour System Prior to the Awards ceremony, WHF president ● Lifetime Contribution to David Allan Wood introduced attendees to the ● Innovation in Interventional Cardiology Cardiovascular Care organisation’s Colours to Save Hearts campaign, Edwards: Evoque Tricuspid Valve Alain Cribier addressing rheumatic heart disease in the developing world.

If you really believe you have something that can change the treatment of patients, be persistent and keep working.”

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Better skills, better surgery, better patient outcomes

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Issue 73 | May 2024

Topical application of tranexamic acid “should not be used” during cardiac surgery Administering tranexamic acid (TxA) topically rather than intravenously did not meet its primary endpoint of reducing seizures during cardiac surgery findings of the DEPOSITION trial, presented during the American College of Cardiology (ACC) 2024 scientific session (6–8 April, Atlanta, USA) and published in Circulation, have shown.

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ndre Lamy (McMaster University, Hamilton, Canada), the study’s fist author, reported that the trial was stopped early due to an increased risk of bleeding events among participants. TxA is used in many surgical procedures to prevent excessive bleeding, but it has been observed to cause seizures when used in cardiac surgery.

DEPOSITION was a Canadian Institute of Health Research-funded trial conducted at 16 centres in six countries, and assessed whether applying TxA directly to the heart instead of intravenously could help reduce seizures while maintaining the drug’s benefits.

But the results of a prespecified analysis conducted after the trial reached 75% of its intended number of participants showed that patients who received TxA topically suffered significantly more bleeding events as indicated by an increased need for blood transfusions.

“The signal for harm with topical administration for increased blood transfusions was clearly significant,” said Lamy. “Topical administration in its current form is inferior to intravenous TxA and should not be used.”

Investigators aimed to enrol 3,800 patients but ultimately stopped the trial after 3,224 had been recruited. Procedures involved coronary artery bypass graft (CABG) surgery, heart Andre valve operations, or potentially both.

Lamy Participants were randomly assigned to receive either intravenous TxA and a topical placebo or topical TxA and an intravenous placebo during their procedure. The doses used ranged from 5–10g and were determined by the anaesthesiologist (for intravenous administration) and the surgeon (for topical administration).

A prespecified interim analysis found an elevated rate of bleeding among patients receiving topical TxA that was consistent across all sites and surgical teams. Overall, 35.1% of patients who received topical TxA and 26.8% of patients who received intravenous TxA required blood transfusions, representing a 31% increased risk of bleeding in the topical group. One possible explanation for the difference is that the which researchers analysed all seizures (instead of just those drug may not be as readily absorbed with topical application, that were not considered to be related to strokes), finding Lamy said. that in the more inclusive analysis, topical In total, four patients who received topical TxA (0.2%) significantly reduced seizures in TxA (0.2%) and 11 patients who received comparison to intravenous TxA (0.9%). intravenous TxA (0.7%) experienced seizures.

Looking ahead, the researchers said that new Although the trial did not meet its primary pharmacokinetic studies could help to further endpoint in terms of reducing seizures, Lamy optimise the dosing, timing and administration said the study results could nevertheless help to strategy for TxA to achieve the greatest benefit shed light on the possible mechanisms through while minimising risks. which the drug causes seizures when used in “What we’ve never done is to refine the dose cardiac surgery. needed to have the full action of TxA,” Lamy The researchers observed seizures were said. “The trial is disappointing, but we’ve TOPICAL TXA more common with valve surgery than with learned a lot. I think there is a message that is PATIENTS bypass surgery. Since valve surgery exposes the much broader than just cardiac surgery, in that interior of the heart to air while bypass surgery we have to look at this drug with new eyes and does not, Lamy said these findings could new technologies to improve its performance.” suggest that tiny bubbles of air carry the drug Lamy said that such studies could be past the blood-brain barrier, allowing it to enter particularly beneficial in developing countries, the brain. This suggestion is corroborated by where oral TxA is frequently used in obstetrics INTRAVENOUS the results of an additional analysis, which was as intravenous administration of drugs may be TXA PATIENTS not part of the planned study methodology, in more challenging.

The signal for harm with topical administration for increased blood transfusions was clearly significant.”

BLOOD TRANSFUSIONS

35.1%

Ismail El-Hamamsy named as president of Heart Valve Society ISMAIL EL-HAMAMSY, DIRECTOR of aortic surgery for the Mount Sinai Health System (New York, USA), was named as the new president of the Heart Valve Society (HVS) at the organisation’s 2024 annual meeting (18–21 February, Boston, USA).

As President of HVS, El-Hamamsy will focus on fostering collaboration among cardiologists, surgeons, and researchers, as well as promoting awareness and encouraging innovation to reduce the burden of heart valve disease globally.

He previously served on the HVS board of directors and has led the HVS AVIATOR registry, examining outcomes after aortic valve surgery. At this year’s meeting, he led several sessions focusing on aortic valve/root replacement in young adults and delivered a keynote lecture on the renaissance of the Ross procedure for aortic valve reconstruction.

“I am very excited and honoured to lead the Heart Valve Society and further consolidate its role as a unique society dedicated to valvular heart disease. In the year to come, I aim to further advance awareness about the global burden of valve disease, as well as promote collaborative research initiatives between scientists and clinicians. Furthermore, I hope to leverage the Heart Valve Society as a great educational platform for cardiologists and surgeons, in order to advance best practices for patients worldwide,” says El-Hamamsy.

El-Hamamsy has published numerous studies examining different aortic valve replacement procedures and long-term outcomes of patients. A recent study published in the Journal of the American College of Cardiology (JACC) was the first to compare the Ross procedure to the mechanical and biological valve replacement, showing improved survival and better outcomes in adults.

In addition, his more recent study in JAMA Cardiology showed a survival benefit following the Ross procedure of up to 26 years. The study was the first to demonstrate benefits more than two decades after the operation.

26.8%

Ismail El-Hamamsy performs a Ross procedure

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Issue 73 | May 2024

STS updates risk calculators for tricuspid surgery, CABG and SAVR after TAVI

Patrick W Serruys and Yoshi Onuma in the CORRIB core lab at University of Galway

First-in-human clinical trial demonstrates feasibility of noninvasive guidance system to aid CABG procedures Researchers have demonstrated the safety and feasibility of using computed tomography angiography (CTA) to plan and guide coronary artery bypass graft (CABG) procedures.

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he FAST TRACK CABG study, overseen by the CORRIB Research Centre for Advanced Imaging and core lab at University of Galway (Galway, Ireland), was sponsored by University of Galway and funded by GE Healthcare and HeartFlow and saw cardiac surgeons plan and perform CABG procedures based solely on noninvasive cardiac-CT scan images, using HeartFlow’s artificial intelligence (AI)-powered blood flow analysis of the patient’s coronary arteries. Details of the research have been published in the European Heart Journal.

The first-in-human study has demonstrated 99.1% feasibility of the procedure, indicating that CABG without undergoing invasive diagnostic catheterisation is feasible and safe, driven by the good diagnostic accuracy of the cardiac CT scan and AI-powered blood flow analysis.

In comparing the safety and effectiveness of CABG surgery, the trial had similar outcomes to recent surgical groups of patients who underwent conventional invasive angiogram investigations.

The findings of the trial suggest that the less invasive approach to CABG offers comparable safety and efficacy to established methods. The research team noted that safety issues inherent to invasive investigation can be replaced by a non-invasive technique using CT scan imaging and AIpowered blood flow analysis.

Trial chairman Patrick W Serruys (University of Galway, Galway, Ireland), said: “The results of this trial have the potential to simplify the planning for patients undergoing heart bypass surgery. The trial and the central role played by the CORRIB core lab puts University of Galway on the frontline of cardiovascular diagnosis, planning and treatment of coronary artery disease.”

The study was carried out in cardiac care hospitals in Europe and the USA and involved 114 patients who had severe blockages in multiple vessels. The cardiac CT used in this study (Revolution CT, GE Healthcare) has a resolution that makes the non-invasive images as good or even better than the images traditionally obtained by a direct injection of contrast dye in the artery of the heart through a catheter.

During the trial, the analysis of high-resolution cardiovascular imagery and data was carried out by the CORRIB core lab team and shared by telemedicine with surgeons in trial hospitals. The HeartFlow Analysis, which provides AI-powered fractional flow reserve derived from computed tomography (FFR-CT) and quantifies how poorly the narrowed vessel provides blood to the heart muscle, assisted the surgeon in clearly identifying which of the patient’s vessels should receive a bypass graft.

Serruys added: “The potential for surgeons to address even the most intricate cases of coronary artery disease using only a non-invasive CT scan, and FFRCT represents a monumental shift in healthcare. Following the example of the surgeon, interventional cardiologists could similarly consider circumventing traditional invasive cineangiography and instead rely solely on CT scans for procedural planning.

“This approach not only alleviates the diagnostic burden in cath labs but also paves the way for transforming them into dedicated ‘interventional suites’—ultimately enhancing patient workflows.”

Yoshi Onuma (University of Galway, Galway, Ireland), said: “Exploring the potential for minimising diagnostic catheterisation procedures is important for several reasons— a catheterisation procedure is invasive and it is unpleasant for the patient. It is also costly for the health service. While there is a minimal risk associated with the procedure, it is not entirely risk free.

“CT scan analysis, FFRCT, and guidance from the team in Galway is a world first in bypass surgery. It may become a game-changer, altering the traditional relationship between GP, radiologist, cardiologist and cardiothoracic surgeon for the benefit of the patient.”

THE SOCIETY OF THORACIC Surgeons (STS) has launched new risk calculators covering isolated tricuspid valve repair and replacement, surgical aortic valve replacement (SAVR) after prior transcatheter aortic valve implantation (TAVI), and multi-valve surgery with or without coronary artery bypass graft (CABG) surgery.

The STS rolled out all three interactive, mobile-friendly risk calculators in April 2024, adding to its existing portfolio of risk calculators for adult cardiac surgery.

“As cardiothoracic surgery continues to evolve, STS has responded by adding new risk models to guide treatment decisions and benchmark performance,” said STS president Jennifer C Romano (University of Michigan Medical School, Ann Arbor, USA). “These new risk calculators include complex surgeries not covered in previous risk models, including surgery after transcatheter procedures, expanding risk assessment to include the large majority of all adult cardiac operations.”

Existing literature on national surgical outcomes of isolated tricuspid valve repair or replacement is based on data from over a decade ago and may not reflect current practice results. The STS leveraged contemporary data from the STS Adult Cardiac Surgery Database to develop risk models for surgical tricuspid repair and replacement.

SAVR after prior TAVI is the fastestgrowing cardiac surgery procedure in the USA, STS said in a press release.

The majority require explant of the TAVI device and SAVR, which significantly increases the risk of operative mortality and stroke.The STS used recent national data from the STS Adult Cardiac Surgery Database between 2012 and 2023 to analyse outcomes of SAVR after previous TAVI. The STS used contemporary national data from the STS Adult Cardiac Surgery Database between July 2017 and December 2023 to analyse outcomes of 32,938 patients who underwent multivalve surgery involving replacement of the aortic valve, plus replacement or repair of the mitral valve with and without concomitant CABG. More than 5,500 multi-valve procedures were performed in the USA in 2023, of which 60% included double valve replacements, and 25% involved concomitant CABG.

11

Issue 73 | May 2024

Society guidelines recognise aorta “as an organ in its own right” New guidelines from the European Association for Cardio-Thoracic Surgery (EACTS) and the Society of Thoracic Surgeons (STS) have, for the first time, recognised the aorta as “an organ in its own right”.

“RECOGNISING THE AORTA AS AN ORGAN puts it on a par with the heart, lungs or brain. This is a big step,” says Martin Czerny (University of Freiburg, Freiburg, Germany), chair of the writing committee responsible for putting the new guidelines together.

“The new guidelines clearly recommend bundling the treatment of the aorta in a separate speciality, naturally in close coordination with other specialities.

We have been practicing this integrative approach at

the Medical Center-University of Freiburg for a long time and I am delighted that our work is now also being recognised internationally,” said Czerny. “I am certain that this will improve the treatment of patients with aortic rupture and other serious diseases.”

Published simultaneously in the European Journal of Cardio-Thoracic Surgery and The Annals of Thoracic Surgery, the guidelines take into consideration the impact and risk of different diagnostic or therapeutic

Martin Czerny performs an aortic surgery

New research points to need to minimise anaemia during CABG in female patients Women are at higher risk of death when undergoing coronary artery bypass graft (CABG) surgery than men, a disparity that is mediated, to a large extent, by intraoperative anaemia, researchers have reported in a paper published in the Journal of the American College of Cardiology (JACC).

STRATEGIES FOR MINIMISING anaemia that occurs during CABG procedures could lead to better outcomes for women with cardiovascular disease, the authors of the study, led by senior author Mario Gaudino (Weill Medical College, New York, USA), have stated.

The study set out to discover why women are less likely to survive CABG, analysing sata obtained from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database on more than one million patients.

Lamia Harik a fellow in cardiothoracic surgery research at Weill Cornell Medicine, was first author on the paper.

Gaudino, Harik and colleagues examined patient demographics (such as age and ethnicity), risk factors (including disease severity, previous heart attacks and the co-occurrence of other health conditions) and surgical data (including the time spent on the bypass machine and the volume of the components of blood, such as red blood cells).

The team previously confirmed

methods for the treatment of aortic disease, and are designed to serve as a support tool for physician decision-making in the treatment of diseases such as aortic aneurysm.

The aorta is responsible for transporting oxygen-rich blood from the heart to the rest of the body. In recent years, it has become increasingly clear that it also plays an important role in regulating blood pressure and blood flow velocity. In addition, it is involved in the production of certain hormones and has its own layer of smooth muscle cells that help to maintain its structure and function.

“Our understanding of the aortic organ is continually evolving, especially in regard to its pathophysiology, the timing for treatment and the application of current and the development of new therapeutic strategies. Aortic disease has emerged as a specialty with significant health economic relevance. Several components of this guideline already establish the foundational structure necessary to meet the needs of treating the aortic organ within a specialised centre by a dedicated interdisciplinary aortic team,” the document states.

Our understanding of the aortic organ is continually evolving, especially in regard to its pathophysiology, the timing for treatment and the application of current and the development of new therapeutic strategies.”

that women had a higher mortality associated with the procedure than men (2.8% vs. 1.7%). Now, using statistical analyses to assess all the possible variables, the researchers found that a substantial portion of this enhanced risk—38%—could be attributed to severe intraoperative anaemia.

This depletion of red blood cells is a side effect of using blood-diluting fluids to prime the heart-lung bypass machine that takes over the job of pumping blood throughout the body during surgery.

Women may be even more susceptible to the effects of intraoperative anaemia because they tend to arrive in surgery with lower red blood cell counts and have smaller body size compared to their Mario Gaudino male counterparts.

The study does not establish that intraoperative anaemia

is causing greater female mortality, but the two factors are associated, researchers state. It suggests that clinicians and researchers should consider interventions to prevent or minimise severe intraoperative anaemia, which can lead to dangerously reduced oxygen delivery.

Using heart-lung bypass machines with shorter circuits, for example, would limit the volume of blooddiluting solution needed to run the pump. Randomised trials to assess whether methods for curtailing anaemia could improve outcomes for women undergoing heart bypass surgery are “urgently needed,” wrote Gaudino.

Gaudino is an investigator in ROMA Women a global trial of over 2,100 female patients undergoing primary isolated non-emergent CABG comparing either single or multiple arterial grafts.

May 2024 | Issue 73

12 Refractory Angina

ORBITA-COSMIC

Coronary sinus reducer cuts chest pain in angina patients, but questions still remain Patients with refractory angina who were treated using a coronary sinus reducer (CSR, Shockwave Medical) experienced significant reductions in daily chest pain episodes but did not show evidence of increased overall blood flow to the heart compared with patients who received a placebo procedure, six-month results from the ORBITACOSMIC trial, presented at the American College of Cardiology (ACC) 2024 scientific session (6–8 April, Atlanta, USA), have shown.

INVESTIGATORS IN THE TRIAL SAY THAT the results indicate that they can tell patients who are receiving the device that their symptoms are more likely to improve, although the precise mechanism behind this improvement remains unclear.

The study, which was published simultaneously in The Lancet alongside its presentation at ACC 2024

by Michael Foley (Imperial College Healthcare NHS Trust, London, UK), met one of its primary endpoints by showing symptom improvements with the CSR but did not meet the main primary endpoint that was designed to determine the mechanism by which the therapy might work. The findings show no difference between groups in terms of a magnetic resonance imaging (MRI)-based assessment of overall myocardial blood flow.

“We don’t have a positive endpoint in terms of the primary hypothesis of how this device works, but it does seem to reduce angina frequency in patients with refractory angina,” said Rasha Al-Lamee (Imperial College Healthcare NHS Trust, London, UK), the study’s senior author. “This is a population of patients who are very symptomatic and have no further options for treatment.”

The Reducer is a balloon-expandable, hourglassshaped device that is designed to establish a narrowing in the coronary sinus which is intended to result in an increase in back pressure. This in turn will lead to a redistribution of blood into the ischaemic myocardium to help reduce angina symptoms.

ORBITA-COSMIC was intended to build on previous studies which have suggested that the CSR can improve angina symptoms, with investigators seeking to use more robust placebo-controlled methodology and endpoints assessing the impact of the device on blood flow. The researchers randomised 51 patients at six UK hospitals to receive either a Reducer implant or a placebo procedure, which involved sedation but no implant.

All participants enrolled in the trial had symptomatic angina, ischaemia and coronary artery disease with no further medical or interventional options at the start of the study. Participants underwent cardiac MRI and treadmill exercise tests before their procedure and at the end of a blinded six-month follow-up period. Patients also recorded their angina symptoms daily with a smartphone application.

Secondary endpoints

Rasha

Results for the trial’s secondary Al-Lamee endpoints showed that angina frequency lessened among those who received CSR across several measures, including the Seattle Angina Questionnaire, although no difference was found for other measures such as treadmill exercise time.

Patients who received CSR also saw

Verheye reported that the six-month results demonstrated an improvement in ≥1 CCS class in 70% of patients, and ≥2 CCS classes in 24% of patients, while the proportion of patients with CCS class III/IV declined from 72% at baseline to 18% at six months, with a mean change in CCS class of -0.9±0.8 (p<0.0001).

Reduction in symptoms of angina was consistent at longer-term follow-up, with CCS class III/IV symptoms experienced by only 15% of patients at two years and 11% at three years (p<0.0001). Rates of SAE and MACE were low at 1.1% and 1.6%, respectively.

“What we have seen in our registry of 400 patients is that we have very similar results to what we found in the COSIRA I trial, published back in 2015 in The New England Journal of Medicine, where we had a one or more CCS class 1 reduction in about 71% of the treatment group,” Verheye tells Cardiovascular News.

an improvement in sub-endocardial to sub-epicardial ratio of stress myocardial blood flow, which may suggest some redistribution of myocardial blood flow but no difference in terms of other factors assessed with the cardiac MRI. Most of the patients who received the CSR implant REDUCER-I study did not experience complete elimination of angina Weighing up the findings of REDUCER-I against symptoms but did report reductions in the number of those of ORBITA-COSMIC, Verheye says they daily pain episodes and the number of days on which “basically show the same thing,” with both they experienced pain. demonstrating improvements in quality of life for “For a patient, what they want to know is whether patients. On the question as to why the ORBITAthe device will help them to feel better. With the COSMIC trial could not show a mechanism for the results of this placebo-controlled trial, we can tell improvement, however, he comments: “From the them that their symptoms are more likely to improve beginning we have always said the mechanism as to with the reducer,” Al-Lamee said. “However, we still why people improve is there is a redistribution from need to work out why.” epi- to endocardial and I think they confirmed that, The CSR device was they were able to show that there was found to be generally an absolute flow improvement. safe. Two patients in the From what I hear it wasn’t CSR group experienced really the right protocol blood clots, but no to look at absolute Coronary sinus heart attacks or deaths or regional flow reducer occurred. The device is differences.” already approved for use Asked whether he in Europe and believes these data confirm the UK, so the the Reducer as an important findings could treatment option for patients with refractory potentially increase its use there, Al-Lamee said. angina, Verheye comments that the safety of the

Next steps

The researchers plan to conduct further analyses to determine whether particular groups of patients may be more likely to benefit from CSR implantation.

They also plan to conduct more detailed analyses to further investigate the mechanism of action involved.

Alongside ORBITA-COSMIC, results on the real-world use of the Reducer system were presented at the ACC meeting, with Stefan Verheye (ZNA Middelheim Hospital, Antwerp, Belgium) outlining six-month data from the REDUCER-I postmarket, multicentre observational study, including insights from 400 patients.

The primary effectiveness endpoint for the study was the percentage of patients experiencing improvement in their symptoms of angina defined as a reduction in Canadian Cardiovascular Society (CCS) grade at six months compared with baseline. The primary safety endpoints were the rate of device- and/ or procedure-related periprocedural serious adverse events (SAEs) and major adverse cardiac events (MACE) up to 30 days post implant.

We don’t have a positive endpoint in terms of the primary hypothesis of how the device works, but it does seem to reduce angina frequency in patients with refractory angina.” procedure coupled with the improvements in quality of life for patients suggest that it does have a role.

“These patients have a miserable life, but they have a modest mortality. What you do is improve quality of life and the Reducer does, so I think that is important,” he comments. “For the patient there are two extremely important findings here. One, it is safe. Two, it improves quality of life and there is a reduction in angina.”

The device is not yet approved by the US Food and Drug Administration (FDA) for use in the USA, although an FDA-approved trial—CORSIRA-II—is currently underway. Further to this, Verheye points to ongoing research to assess the use of the device in the treatment of microvascular angina as likely to be an important development for the therapy.

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May 2024 | Issue 73

14 CRT 2024

Shield system cuts operator exposure to radiation during cath lab procedures The use of a radiation shield system—Protego (Image Diagnostics)—could markedly cut the exposure of cath lab staff to radiation during coronary and structural heart procedures, new research suggests.

DAVID RIZIK (HONORHEALTH RESEARCH Institute, Scottsdale, USA) presented at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA) the findings of a three-year study investigating the use of the Protego system in 300 cases.

Use of the shield system was compared to 150 cases performed using standard protection, which includes the use of a personal lead apron by operators, as well as a thyroid collar and leaded glasses together with a drop-down shield.

The Protego system consists of a combination of rigid shields above and below the cath lab table, integrated with inter-connecting flexible radiationresistant drapes designed to provide a comprehensive radiation barrier that minimises radiation exposure from the X-ray source, as well as patient scatter.

Radiation exposure was measured using real-time dosimetry, which analysed total body exposure at waist and thyroid levels.

Rizik reported that the use of the Protego system reduced operator radiation exposure by >99% compared to standard protection. The median exposure at the waist with Protego was 0.0 (0.0, 0.0) vs. 10.0 (5.0, 16.6) mSv, with standard protection (p< 0.001).

The median “head level” radiation exposure measured

at the thyroid with Protego was 0.0 (0.0, 0.0) vs. 10.0 (5.0, 16.6) mSv with Standard Protection (p<0.001).

This level of operator radiation exposure with the Protego system is lower than levels ever reported previously with any radiation protection strategy, Rizik noted.

Rizik also reported that coronary and structural procedural success was 100% with the Protego system; there were no cases in which the advanced shielding system limited C-arm angulations, impaired procedural performance, limited catheter manipulation or limited

David Rizik and his team performing a case using the shield system

US DCB approval provides “important treatment option” for in-stent restenosis The first US Food and Drug Administration (FDA) approval of a drug-coated balloon (DCB) for the treatment of coronary in-stent restenosis will ensure that the therapy becomes “an important new treatment option for patients with coronary stenosis in the USA”, an investigator in the trial that supported the approval has said.

ROBERT W YEH (BETH ISRAEL Deaconess Medical Center, Boston, USA) presented the primary outcomes from the full population of the AGENT IDE [investigational device exemption] trial—comparing the use of the Agent DCB (Boston Scientific) to conventional balloon angioplasty in patients with coronary in-stent restenosis—during a late-breaking trial session at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA), and published in the Journal of the American Medical Association (JAMA).

The FDA approved Boston Scientific’s premarket approval application for the device, a paclitaxelcoated balloon, in early March 2024, a move that has been welcomed by many coronary interventionists in the country where around 10% of percutaneous coronary intervention (PCI) procedures are carried out for in-stent restenosis.

Yeh had presented initial data from the IDE trial, covering 480 of the 600 patients enrolled in the trial across 40 US sites, at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting (23–26 October, San Francisco, USA) where he reported that the study had met its primary endpoint of target lesion failure (TLF)—defined as a composite of target lesion revascularisation, target vessel myocardial infarction (MI) or cardiac death—at 12 months with the AGENT DCB demonstrating statistical superiority to uncoated balloon angioplasty (17.9% vs. 28.7%; p=0.006).

At CRT 2024, Yeh presented data from the full 600-patient trial cohort, reporting the occurrence of the primary endpoint in 18.2% of patients in the Agent DCB arm at one year, compared to 29% in the conventional balloon angioplasty arm (p=0.003). This

communication with the patient.

‘Zero’ exposure—whereby no detectable radiation exposure was picked up at both heights—was recorded in 64% (n=32) of transcatheter aortic valve implantation (TAVI) cases and 73.2% (n=183) of coronary cases undertaken using the shield system, whereas no cases using standard protection were able to achieve this level. The significantly lower operator exposure in the Protego arm of the study was achieved despite higher fluoroscopy times.

“We’ve known about this for decades and yet we have not done anything to improve workplace safety in the cardiac catheterisation laboratory,” Rizik was quoted as saying of the results in a press release issued by his institution following the presentation at CRT 2024. “It’s time for us to get with it, and hospitals aren’t doing it.”

In his concluding remarks, Rizik said that the Protego shield provides “exceptional” total body radiation exposure protection for operators performing both coronary and structural heart procedures, and would allow procedural performance without the need for personal lead aprons, meaning that it has the further potential to reduce occupational health hazards such as orthopaedic problems associated with catheterisation procedures.

We’ve known about this for decades and yet we have not done anything to improve workplace safety in the cardiac catheterisation laboratory.” represented a reduction of around 40% of the primary endpoint on the relative scale, and an absolute risk reduction of 10.8%, Yeh noted.

Looking at the primary endpoint over time, there continued to be a separation of the two treatment arms in the first 12 months of follow-up, Yeh added.

Among the components that drove the primary endpoint, target lesion revascularisation was reduced by around 50% (p=0.0005), as well as a 50% reduction in target vessel MI. Patients were also followed for the occurrence of definite and probable stent thrombosis with six stent thromboses occurring within the conventional balloon angioplasty arm and none within the investigational arm.

“AGENT IDE is the first randomised trial conducted in the USA examining the efficacy and safety of drug-coated balloons in the coronary circulation,” said Yeh. “The Agent DCB significantly reduced the occurrence of target -lesion failure at one year compared with conventional balloon angioplasty in patients with coronary in-stent restenosis.

“This is an FDA-designated breakthrough device and [the trial] was the primary evidence used to support FDA approval given the markedly superior results over conventional balloon angioplasty. It’s likely to become an important new treatment option for patients with coronary stenosis in the USA.”

MAGICALISR study of MagicTouch sirolimus DCB commences Concept Medical has announced the start of its investigational device exemption (IDE) study, MAGICAL-ISR using the MagicTouch sirolimus drugcoated balloon (DCB), for in-stent restenosis in coronary disease.

MagicTouch has been granted a breakthrough device designation for in-stent restenosis and US Food Drug Administration (FDA) IDE approval. The first patient was enrolled at the AtlantiCare Institute (Atlantic City, USA) by Said Ashraf.

The study aims to assess the safety and efficacy of the DCB for in-stent restenosis, focusing on patients avoiding target lesion failure (TLF) within one year postprocedure. The study was initiated under the guidance of Martin Leon (Columbia University, New York, USA), Azeem Latib (Montefiore Health Systems, New York, USA) and Ajay Kirtane (Columbia University Irving Medical Center/ NewYork-Presbyterian Hospital, New York, USA).

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References 1. Böhm M, et al. Lancet 2020;395(10234):1444-1451 2. Kandzari DE, et al. J Am Coll Cardiol. 2023 ;82(19) :1809-18233 3. Mahfoud F, et al. Hypertension. 2023;80(8):1759-17704 4. Mahfoud F, et al. Lancet. April 9, 2022;399(10333):1401-1410.

5. Medtronic Symplicity SpyralTM Instructions for Use. 6. Medtronic data on file. RDN Catheter Historical Data, June 2023. Data includes both Symplicity Flex and Symplicity Spyral.

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For distribution only in markets where the Symplicity Spyral™ multi-electrode renal denervation catheter and Symplicity G3™ renal denervation RF generator have been approved. Not for distribution in the USA, Japan or France.

May 2024 | Issue 73

16 Interview

PROFILE but we are already seeing an important shift towards the structural part of interventional cardiology, in particular valvular interventions. While the coronary field is not shrinking, it is getting quite stable, and we have more and more robust evidence showing that percutaneous coronary intervention (PCI) saves lives in the context of acute coronary syndrome, while for chronic coronary syndrome, it is more for symptom improvement, and so the potential for development is smaller. On the valvular side, TAVI has opened the door, and we are seeing development in mitral and tricuspid technologies. If I had to bet, I would put more money on tricuspid techniques coming through than on mitral.

NICOLAS DUMONTEIL

Medicine and indeed interventional cardiology were not initially on the radar for Nicolas Dumonteil (Clinique Pasteur, Toulouse, France), but he was attracted into the field by the dynamism of the interventionists he encountered during his early career. With a keen interest in structural heart interventions, Dumonteil is well known for his work in transcatheter aortic valve implantation (TAVI) and is also a course director for the EuroPCR meeting. He spoke to Cardiovascular News about his expectations for the evolution of the field, and what to look out for at EuroPCR 2024.

What drew you initially to medicine and why did you decide to become an interventional cardiologist?

Medicine was not something I had thought about when I was young, my real passion was aeroplanes and aviation. I was able to fly a plane before I was legally allowed to drive a car, and initially I wanted to become a commercial pilot but that did not work out.

After that I thought about pursuing a career that could have some intellectual interest for me, and I decided to change direction towards medicine.

Then I tried medical school, and I liked it.

The choice of interventional cardiology came later. I had to choose between becoming a general practitioner or a specialist and my choice was mainly influenced by the fact that the interventional cardiology department at the university hospital I was in at the time was very dynamic. I had good examples of senior physicians showing how they enjoyed their work, and that is why I went in that direction, without really knowing that it would be something that I would do for the rest of my life.

Who have been the biggest influences on your career?

There are three names who come to mind at different stages of my career. While I was a medical student a colleague who is not at all known in the field of interventional cardiology, Bruno Francois, an anaesthesiologist, was the first person I really admired for his high levels of medical knowledge, skill, empathy with patients, and also for the relationship I developed with him as a mentor. That helped me to trust myself and gain confidence in pursuing this career.

When I became an interventional cardiologist at the University Hospital in Toulouse and was a really young member of the team, my boss, Professor Didier Carrié, gave me the opportunity to develop the TAVI programme. When I look at what I am doing in meetings or my publications, I would not have gone down this path without this.

The third person to mention is Jean Fajadet of the Clinic Pasteur group. Some years after I decided to move from the University Hospital, he was the one who welcomed me and opened up the PCR universe and helped me to engage myself in this organisation.

What has been the biggest change in the field of interventional cardiology since you began practicing?

It was total luck that I became a senior interventional cardiologist in the University

Hospital staff around 2006, not long after Alain Cribier did the first-in-man TAVI case in 2002. At that time TAVI was only in Rouen, and then it started to develop in other countries. I had the chance to start my career at that period and to develop the TAVI programme at my hospital.

Have there been any disappointments?

I took some time to think about this, and also took a poll with my colleagues. I think the first reply that came from everybody was bioresorbable vascular scaffolds. When it first appeared, it was seen as a revolution in the coronary part of interventional cardiology, but at the end of the day it was a huge disappointment. I don’t think that the story is over, and the concept is still there, but the devices that were proposed in the first or second generations were not mature enough.

However, we have new devices coming now that continue this concept and I think that some of those are promising.

What is the current area of focus of your research?

In my general practice I am quite polyvalent, but from a scientific standpoint I focus mainly on structural parts of the interventional cardiology field and mostly on TAVI. My major point of interest currently, which I would also say is a point of concern, is the TAVI-in-TAVI pathway and the lifetime management of patients with aortic stenosis— the option to treat a patient from the first intervention with a transcatheter aortic valve, and then in case of degeneration, come back with a new transcatheter option.

Perhaps the community went a little too fast in adopting TAVI for really young patients with long life expectancy. I was a part of that 15 years ago believing that if the valve degenerates, we will come back with a new TAVI, but we are currently learning that it is not so simple. I think we have some work to do to educate the community on that.

A lot of this is patient anatomy driven.

We need to explain to the community that if you want to treat patients with long life expectancy who will probably outlive their first TAVI implant, from the planning of the first intervention you have to anticipate the potential second one. If you think that the second intervention might not be possible then perhaps you should change direction towards surgery.

How will interventional cardiology evolve in the next decade?

It is always difficult to predict the future,

FACT FILE CURRENT APPOINTMENTS 2016–present: Senior Staff Member, Groupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France Course Director, EuroPCR Organising Committee Member, High Tech Cardio

TRAINING AND EDUCATION 2009–2016: Rangueil University Hospital, Toulouse, France 2001–2009: Toulouse Medical School, Toulouse University, Toulouse, France

Which trials have caught your attention in the last 12 months?

I would say that the TRILUMINATE randomised trial has been important because it was the first of its kind to demonstrate that a tricuspid repair device positively impacted the lives of patients by improving their quality of life over optimal medical therapy. It has opened the way for transcatheter therapy on the tricuspid side, and many other studies are enrolling or about to be published. A similar trial performed in France, Tri.fr, will be reported this year at the European Society of Cardiology (ESC) meeting (30 August– 2 September, London, UK).

What is it about EuroPCR that makes it a unique meeting?

PCR has a mantra, that it is ‘by and for’, meaning that everything is made by the interventional cardiology community to share knowledge, experience and practice, for the needs of the physicians, wherever they are from, and also for the patients’ needs. You can share experience and learn by watching live cases being done in selected centres, by going to sessions where you are able to learn techniques from A–Z, or by going to casebased sessions where you are going to learn how to manage complications.

What can attendees expect from EuroPCR 2024?

This year there will be a focus on the crucial role of imaging to guide cardiovascular interventions. Without X-ray guidance interventional cardiology would not exist, and while we started from having only this imaging tool in the early ages, now when I look at what I am doing in a single day, I use different imaging modalities for any intervention. It starts with ultrasound guidance for vascular puncture, then you have the computed tomography (CT) analysis to plan your intervention. You have X-ray guidance integrated with artificial intelligence (AI), physiology information, and procedural echocardiography guidance. Imaging is everywhere and it is for the benefit of our patients. If outcomes have improved over the years, it is because we understand how to guide our interventions more accurately with imaging.

This will be a recurrent and common theme throughout the programme, and we will have an imaging learning centre, a dedicated space for learning about intracoronary imaging in different anatomical situations and also imaging for structural interventions.

Issue 73 | May 2024

alisonlang.com

Interview 17

Does interventional cardiology need to do anything differently to attract and keep young doctors?

This is a specialty that is very attractive for young colleagues, and we do not currently have a lot of concerns about low attractivity.

But I think as a community we have to do better to attract and keep women in the field.

Thinking about the environment I was trained in 25 years ago, there was a lot of male chauvinism and this specialty was not welcoming for female colleagues. Although that has evolved in a positive way, we still have to keep this spirit ongoing and also to keep on improving conditions for our female colleagues. When you are an interventional cardiologist, pregnancy can be a real issue, and we have to improve that. I feel personally engaged in that, my wife is a physician and had to struggle a lot to simply keep on doing her job when she was pregnant. As a father to two daughters, I would like that if they were interested in becoming interventional cardiologists, they do not experience any kind of limitation because they are female.

Looking back over your career, are there any memorable cases that stand out?

I had the opportunity to treat both a husband and wife with an innovative device, the Tendyne mitral valve replacement device (Abbott). I treated the husband during the early stages of the development of the valve, in the context of a clinical study. The procedure went well, and the patient was really positively transformed by the procedure in terms of quality of life. Then, some years later, his wife required the same kind of intervention, and the nice thing about it was that the husband had explained everything to her, so she arrived at the intervention really relaxed and confident, even though she was in a really critical medical state. She was also really positively transformed by the outcome of the intervention, and they were able to live their life together for some years after, which would not have been possible without the procedure.

What are your hobbies and interests outside of medicine?

As soon as I am outside of work, I try to

"If outcomes have improved over the years it is because we understand how to guide our interventions more accurately with imaging.”

dedicate as much time to my family as I possibly can. Sport is also a very important part of my life—I used to play rugby when I was younger, but as you are getting older it is not something that you can keep doing! More than 10 years ago I found English boxing as a substitute, as it has the same level of intensity as rugby.

Something I like to do to spend time with my kids is surfing. It is hard, but I like it! I am still at the stage where I am struggling, but when I catch a good wave, it can make my day, week or even my year.

I also really enjoy cooking, and I believe that is another important family activity. I like to train my kids in how to cook. French cooking is quite rich, you have a lot of recipes to go through. When you can spend one or two hours preparing a meal and see the whole family participating in that and enjoying that, it is nice and I think it is an important part of our culture, and I want my kids to enjoy that. It is also a way for them to learn how to take care of themselves, preparing fresh food and cooking.

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Structural Heart Interventions 19

Issue 73 | May 2024

Structural Heart Interventions Promising mortality and PVL data reported for Navitor TAVI system Findings at one year from the Navitor investigational device exemption (IDE) study, assessing the safety and efficacy of Abbott’s Navitor transcatheter aortic valve implantation (TAVI) system have demonstrated a lower rate of mortality compared to contemporary TAVI approval studies in high and extreme surgical risk patients.

TriClip has gained US FDA approval

TriClip’s US FDA approval expands transcatheter options for tricuspid regurgitation patients The first quarter of 2024 has seen the US Food and Drug Administration (FDA) approve two transcatheter devices for the treatment of tricuspid regurgitation (TR), with Abbott’s TriClip system the latest to gain approval from the regulator.

T

he TriClip transcatheter edge-to-edge repair (TEER system) works by clipping together a portion of the leaflets to repair the tricuspid valve and help blood flow in the right direction without the need for openheart surgery.

TriClip leverages the same clip-based technology as Abbott’s MitraClip device, which has treated more than 200,000 people with mitral regurgitation (MR), but was specifically designed to treat the tricuspid valve’s complex anatomy. TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020.

“The US approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” said Paul Sorajja (Minneapolis Heart Institute, Minneapolis, USA), co-principal investigator of the TRILUMINATE pivotal trial that compared TriClip to medical therapy in TR patients at intermediate or greater risk for surgery.

“With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”

Prior to approval, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee confirmed 13 to 1, with 0 abstentions that the benefits of system outweighed the risks for the treatment. The panel’s decision was based on clinical data from the TRILUMINATE pivotal trial, as well as expert testimony.

Results of TRILUMINATE suggest that the therapy was effective in reducing TR and led to improvements

in quality of life at one year. However, the results did not show any significant difference in survival or heart failure hospitalisation between patients treated with the interventional approach or with medical therapy, the study’s control arm, with the superiority of the device in meeting its composite primary endpoint primarily driven by improvements in quality of life for patients.

Approval of the TriClip device comes shortly after Edwards Lifesciences’ Evoque transcatheter valve replacement therapy was granted approval for the treatment of patients with symptomatic severe TR despite optimal medical therapy.

Unlike TriClip, Evoque’s technology replaces the native tricuspid valve. Evoque is comprised of a nitinol selfexpanding frame, intra-annular sealing skirt and tissue leaflets made from bovine pericardial tissue.

The Evoque system received CE mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to receive regulatory approval to treat TR. Outside of surgery treatment options for patients with TR include diuretics and drugs aimed at easing symptoms. Left untreated, TR can lead to atrial fibrillation, heart failure, kidney disease and death.

The US approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation.”

THIS WAS THE HEADLINE reported by Paul Mahoney (East Carolina University, Greenville USA) at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA), where he presented the one-year outcomes from the prospective, multicentre, international, single-arm study.

The US Food and Drug Administration (FDA) approved the Navitor system for the treatment of severe aortic stenosis among high or extreme risk patients in January 2023. The device features a fabric cuff—NaviSeal—intended to reduce or eliminate paravalvular leak (PVL), and Abbott has described the device as the only self-expanding TAVI system with leaflets within the native valve; a feature intended to improve coronary access.

The Navitor IDE study enrolled 260 patients at 26 sites across the USA, Europe and Australia between September 2019 and August 2022. Patients had a mean age of 83.4 years and 57.3% were female.

Mahoney reported that at one year, the rate of all-cause mortality was 6.6% seen in the trial and the rate of moderate or greater PVL was 0.5%. The composite safety endpoint—comprising all-cause mortality, disabling stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), and major vascular complication—was 13.1%.

CRT attendees also heard data up to five years on Portico, Abbott’s predecessor valve to Navitor, in high and extreme surgical risk patients treated for severe, symptomatic aortic stenosis, demonstrating the safety and efficacy of the device out to this timepoint. Rishi Puri (Cleveland Clinic, Cleveland, USA) presented findings of a pooled analysis of three clinical studies which showed that the valve performed favourably in terms of durability and haemodynamics out to the midterm endpoint.

Two trials, VANTAGE OUS and ENVISION, are evaluating the short, intermediate and long-term clinical and haemodynamic performance of the Navitor TAVI valve across the low and intermediate risk patient populations.

20 Structural Heart Interventions

May 2024 | Issue 73

Performance of singleleaflet transcatheter heart valve “encouraging”, first-inman results indicate Insights from the first-in-human study of the DurAVR (Anteris Technologies) biomimetic transcatheter heart valve system provide “encouraging” evidence of improved haemodynamics and normalised flow characteristic associated with the device’s singlepiece leaflet design.

AN UPDATE FROM THE STUDY was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 scientific sessions (2–4 May, Long Beach, USA)

by Azeem Latib (Montefiore Health System, New York, USA).

Design features of the device include a single-piece leaflet geometry, intended for optimal haemodynamics and flow characteristics, an anti-calcification treatment to reduce structural valve deterioration, and a balloon-expandable platform with a large open-cell structure to facilitate coronary access.

The prospective, non-randomised, single-arm, single-centre, first-in-human study, designed to evaluate safety and feasibility in patients with severe symptomatic aortic stenosis, included clinical, echo, computed tomography (CT), and cardiac magnetic resonance imaging (MRI) assessments up to one year.

A total of 28 patients were enrolled in the study, with a mean age of 73 years, and 75% of the study cohort was female.

Latib reported a 100% success rate across all of the cases, and all patients showed excellent post-procedural haemodynamic results, despite a small mean annulus size. No moderate or severe paravalvular leak or central aortic regurgitation were observed.

One-year transthoracic echocardiogram (TTE) completed for the first 12 patients confirmed sustained haemodynamics, while laminar flow was consistently displayed on transoesophageal echocardiography (TEE) and TTE. DurAVR showed a favourable safety profile in all patients at the latest follow-up, Latib reported, and there were no valve-related complications, strokes, bleeding, or reoperations.

One patient died as a result of a car accident (noncardiac death) on postoperative day (POD) 343,

Atrial fixation TMVR device may have reduced risk of LVOT obstruction Results of the early feasibility study evaluating outcomes of the AltaValve (4C Medical) sub-valvular transcatheter mitral valve replacement (TMVR) system indicate that the device may be effective at reducing mitral regurgitation (MR) with a lessened risk of left ventricular outflow tract (LVOT) obstruction.

VLASIS NINIOS (INTERBALKAN MEDICAL Center, Thessaloniki, Greece) presented results from the trial at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA).

Limitations with current sub-valvular TMVR technologies include high screen failure rates, in particular due to the increased risk of LVOT obstruction, Ninios detailed, noting that the AltaValve system is designed to treat a broad population of mitral regurgitation (MR) patients and minimise the

three had access site complications, and a pacemaker was implanted in a patient with pre-existing conduction disturbances. No cases of moderate or severe prosthesis-patient mismatch were observed.

Latib is the national principal investigator in the early feasibility study (EFS) of the device in the USA, having enrolled the first patient in summer 2023.

“In the field of TAVI, the understanding of haemodynamics has become increasingly important, especially as TAVI is now being performed on younger patients,” Latib tells Cardiovascular News. “The recent SMART trial [see page 3] has shed light on the fact that not all TAVI valves are created equal. The data from the trial suggests that by using an intraannular balloon-expandable valve, we may be able to achieve supra-annular haemodynamics.”

Latib adds that the data for DurAVR appear to be positive, particularly in terms of haemodynamics, though he cautions that further studies will need to confirm whether, as these initial results suggest, the valve holds potential for improving patient outcomes in the future.

“As for specific scenarios or patients in whom this device may have a particular advantage, I believe that this could be a workhorse TAVI device that could be used in all patients, having the reproducibility and ease of use of balloon-expandable valves with the haemodynamics of supraannular valves.

“However, further research and clinical experience are necessary to fully understand the potential Azeem benefits and limitations of Latib the DurAVR.”

risk of LVOT obstruction.

The device, which is currently limited to investigational use only, is a transseptal TMVR system with AltaValve’s prosthetic valve positioned above the native mitral valve via an atrial-only fixation that is intended to ensure that cardiac structures are retained within the left ventricle. The AltaValve is also designed in a way that allows future left atrial access for other procedures.

The prospective, multicentre, single-arm early feasibility study enrolled 24 patients with severe MR who were considered high risk for mortality and morbidity with surgery. Ninios reported that all patients had severe MR, with 33% classified as having degenerative or mix MR, and 67% functional MR. Additionally, Ninios reported that left ventricular

The atrial fixation TMVR technology of AltaValve may help reduce risk of LVOT obstruction and increase patient eligibility.”

Robotic TAVI performed successfully in an animal Caranx Medical has announced the successful completion of a robotic transcatheter aortic valve implantation (TAVI) procedure in an animal using its Tavi-Pilot system.

The assisted heart valve implantation was performed by Stéphane Lopez (Institut Arnault Tzanck, Saint Laurent du var, France), alongside the Caranx Medical’s chief medical officer, Eric Sejor, chief technical officer, Pierre Berthet-Rayne, and the Caranx team.

“This groundbreaking achievement is the result of hard teamwork,” said Berthet-Rayne, a co-founder of the company.

“This successful transcatheter robotic aortic valve implantation marks the first step toward a new generation of intelligent robots guided by artificial intelligence (AI), set to transform healthcare as we know it.”

“This major medical first lies not only in the technical achievement of Caranx Medical’s engineers, but also in the impact that this technology will have on interventional cardiology practice.

By simplifying and standardising a complex procedure, the robot we have developed opens up new possibilities for improving the performance and safety of TAVI procedures,” says Sejor.

function was preserved in most patients (ejection fraction, 53.0±6.4%), whilst 79% of subjects were New York Heart Association (NYHA) class III/IV at baseline.

Technical success was reported in 96% of cases, whilst relief of MR was complete with no patient having mitral regurgitation, including no paravalvular leak (PVL).

Post-procedure mean mitral valve gradient was 2.2±1.1mmHg and left ventricular ejection fraction (LVEF) was unchanged. At 30-day follow-up, 95% of subjects had none/trace PVL, with one other patient having mild PVL. NYHA assessment at the 30-day follow-up marker showed 96% of subjects as having improved to class I/II. No patient had thrombus, embolisation, erosion, new onset of atrial fibrillation or need for pacemaker placement.

The findings led Ninios to conclude that outcomes with AltaValve TMVR allow a clinically significant reduction in MR, sustained implant performance, and notable improvements in NYHA class. “The atrial fixation TMVR technology of AltaValve may help reduce risk of LVOT obstruction and increase patient eligibility,” Ninios reported.

A large pivotal study is being designed to further assess longer term safety and performance of AltaValve system.

Issue 73 | May 2024

Advertorial 21

THIS ADVERTORIAL IS SPONSORED BY MEDTRONIC

TAVI in small aortic annuli: SMART trial underscores importance of choosing the right device Transcatheter aortic valve implantation (TAVI) has been a game-changing therapy for the treatment of aortic stenosis, providing a minimally invasive therapy for patients who may previously have had no other option. As the valve technologies and implant techniques continue to mature, there is an increasing recognition of the need to tailor the therapy to respond to the differing needs of specific patient populations.

T

o date, there has been very little research conducted on TAVI performance in the population of patients with small aortic annuli— believed to represent up to 40% of patients who undergo a TAVI procedure. More significantly, this is a subset of patients that is overwhelmingly female, a population that has been acknowledged as underdiagnosed and undertreated for aortic stenosis.

“Among all the countries in Europe fewer females are treated for aortic valve stenosis than males, and among treated females, a higher percentage than males receive TAVI,” Sabine Bleiziffer (Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany) tells Cardiovascular News, setting out the scale of this disparity and pointing to factors that may contribute to differences in the diagnosis, treatment and outcomes between male and female aortic stenosis patients. “Females and males have the same incidence of aortic valve stenosis, so there seems to be a clear [indication of] undertreatment.”

SMART Trial: Comparing TAVI devices in small aortic annuli

Bleiziffer is among the investigators in the SMART trial, the first randomised trial to compare two of the most commonly used TAVI valves in the world today: the supra-annular self-expanding Evolut (Medtronic) family of TAVI devices, which includes the Evolut PRO, PRO+ and FX systems, against the balloon-expandable Sapien 3 and Sapien 3 Ultra (Edwards Lifesciences) suite of devices. The trial was conducted in patients with small aortic annuli—defined in this context as a valve annulus measuring 430mm2 or less—and uniquely for a trial in the cardiovascular arena investigators enrolled an overwhelmingly female population with 87% of the 716 patients taking part in the study being women.

“I think there was a little bit of an under recognition of these patients because they certainly represent a very challenging population for aortic valve replacement,” Sabine Bleiziffer says Bleiziffer. The challenging nature of TAVI in small annuli means that valve selection in this patient population is an important step in achieving the best haemodynamic results from the procedure. Patientprosthesis mismatch, where an implanted prosthetic valve is too small for the patient, is one of several factors

that can impact outcomes, for example.

Headline findings from the SMART trial at one year were among the most hotly-anticipated data presented at the American College of Cardiology (ACC) 2024 scientific session (6–8 April, Atlanta, USA) and the findings were published simultaneously in the New England Journal of Medicine.

In the trial, patients treated at one of 83 sites in 13 countries worldwide (mean age: 80 years), were randomised 1:1 to receive either an Evolut supra-annular valve or a Sapien EvolutTM balloon-expandable valve.

TAVI Investigators comparing platform the two devices against the co-primary endpoints of a composite of death, disabling stroke, or rehospitalisation for heart failure, tested for non-inferiority at one year, and a composite of bioprosthetic valve dysfunction, tested for superiority.

Results showed that the supra-annular Evolut TAVI platform met the co-primary endpoint of clinical noninferiority, with a reported incidence rate of 9.4%, compared to 10.6% in the Sapien arm of the study (p<0.001 for non-inferiority).

Significantly, the Evolut TAVI valve also demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year, occurring in 9.4% of patients in the Evolut arm versus 41.6% in the Sapien treatment group (p<0.001 for superiority).

“The SMART trial for the first time really shows that the physician can influence results by the choice of valve type,” says Bleiziffer of these results, which could be significant for TAVI practice worldwide.

Prosthesis mismatch, valve gradient and other factors influencing valve choice

SMART trial investigators also reported several secondary endpoints, which included patient-prosthesis mismatch at 30 days, reported to have occurred in 11.2% of the patients in the supraannular Evolut valve group and 35.3% of those in the balloon-expandable Sapien valve group (p<0.001).

“Patient-prosthesis

mismatch is a parameter that can be influenced and valve choice is an important factor to this,” says Bleiziffer, reflecting on this finding in particular.

Also of note, patients in the Evolut TAVI group had an aortic-valve mean gradient of 7.7mmHg at 12 months compared to 15.7mmHg in the Sapien balloon-expandable valve group, whilst the percentage of patients with haemodynamic structural valve dysfunction stood at 3.5% in the Evolut group and 32.8% among Sapien patients.

“In my world it was already usual to choose supraannular valves in patients with a small annulus, but now we have the data to prove what we are doing,” says Bleiziffer, weighing up how these results could impact her practice.

Commenting on the mechanism that may make supra-annular the suitable choice in the treatment of aortic stenosis in patients with small annuli, Bleiziffer comments that the placement of the valve leaflets above rather than inside the annulus is likely to be the important difference in design that confers an advantage.

“The valve configuration is not disturbed by any annular asymmetric calcifications, because the leaflet function is not influenced, as the leaflet sits above the annulus,” she says. “The intra-annular or balloon-expandable valve sits inside the annulus and can be constricted by a small annulus and not develop its full possible function.”

Exercise subanalysis among the future SMART trial updates to watch

TAVI operators can expect to see more data from the SMART trial coming down the track, with investigators following patients out to five years to assess outcomes, as well as further sub-analyses in specific components of the trial assessing other ways that TAVI device choice may impact patients.

“I personally am very interested to see the data from the exercise sub-study of the SMART trial,” comments Bleiziffer. “In the past we could demonstrate in a subset of patients with biological surgical aortic valve replacement that patients with mismatch have an impaired exercise capacity. I expect that we will find the same thing from patients within the SMART trial.”

Assessing comparative performance of both valves in terms of valve deterioration will also be important going forward, and Bleiziffer describes this as “something we will have to look at in the future”.

“There are some signs that good valve function can influence long-term outcomes and will have less valve deterioration, if you have a low gradient and a good valve function from the beginning. I think that is something we still need to evaluate and the SMART trial gives us the opportunity to add data to this topic,” she concludes.

The SMART trial for the first time really shows that the physician can influence results by the choice of valve type.”

Sabine Bleiziffer

May 2024 | Issue 73

22 Heart Failure

Patients with heart failure who had an interatrial shunt inserted between the left and right atria did not see any significant benefits overall compared with those who received a placebo procedure after a median of 22 months follow-up, a study presented at the American College of Cardiology’s (ACC) 2024 annual scientific session (6–8 April, Atlanta, USA).

THE TRIAL, RELIEVE-HF, IS A RANDOMISED placebo-procedure controlled trial of interatrial shunting using the Ventura (V-WAVE) device that included patients with both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).

Researchers have suggested that though the trial failed to meet its primary endpoint, it does offer some signals that the benefits and risks of interatrial shunts may vary by heart failure type.

“When you examine the outcomes in patients with heart failure across a broad range of left ventricular ejection fraction, the Ventura interatrial shunt was extremely safe but did not improve outcomes compared with no treatment. However, in a prespecified analysis, data suggest that the shunt may be beneficial in patients with HFrEF and worsen outcomes in patients with HFpEF,” said Gregg Stone (Icahn School of Medicine at Mount Sinai, New York, USA), the study’s first author. “We believe further studies are warranted to confirm the benefits we observed in patients with reduced ejection fraction.”

The shunt is designed to create a small amount of blood flow from the left atrium to the right atrium sufficient to lower elevated left atrial pressure while protecting the right heart from failing due to blood volume overload. High left atrial pressure is a primary cause of shortness of breath and hospitalisations related to heart failure.

The trial randomised 508 patients at 94 sites in North America, Europe, Israel, Australia and New Zealand.

All participants had symptomatic heart failure despite taking medications at maximally tolerated doses. About 40% of participants had HFrEF and 60% had HFpEF. Participants were randomly assigned to undergo a procedure to insert the Ventura shunt or a placebo procedure. Operators were aware of which procedure each patient received but patients, their families and the rest of the medical teams taking care of the patient after the procedure were not. Researchers tracked outcomes in each participant for at least one year and up to two years.

The results showed no significant difference between groups in terms of the trial’s primary endpoint, a

hierarchical composite ranking of death from any cause; heart transplant or left ventricular assist device; heart failure hospitalisations; worsening of outpatient heart failure events; and change in quality of life, as measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). This hierarchical composite approach for assessing efficacy allows diverse types of outcomes to be incorporated in ranked fashion into an overall “win ratio” reflecting the overall outcome of a drug or device.

In a pre-planned analysis focused on heart failure type, patients with HFrEF who received the shunt

Gregg Stone at ACC

were found to have improvements across all outcomes assessed (especially fewer hospitalisations for heart failure), while those with HFpEF who received the shunt were found to have increased rates of death and heart failure hospitalisations. This difference could be attributed to the greater compliance or flexibility of the heart muscle with HFrEF, potentially allowing it to more easily accommodate the extra blood flowing into the right atrium, Stone said.

There were no device-related or procedure-related major adverse cardiovascular or neurologic events in either group during the duration of the trial.

PROACTIVE-HF pivotal trial of Cordella pulmonary artery sensor demonstrates “significant” quality of life improvements Six-month results from the PROACTIVE-HF pivotal trial, evaluating the Cordella pulmonary artery (PA) sensor (Endotronix) in New York Heart Association (NYHA) class III heart failure patients at risk of congestion, show that the trial met primary safety and efficacy endpoints.

THE RESULTS DEMONSTRATED a low rate of heart failure hospitalisations in addition to showing a clinically significant improvement in patient quality of life, increased physical activity, and improvement in the NYHA functional class, Endotronix said in a press release.

The company previously announced the submission of its premarket approval application, which included the trial results. Liviu Klein (University of California, San Francisco, USA) presented the results during a latebreaking session at the Technology and Heart Failure Therapeutics (THT)

The Ventura interatrial shunt was extremely safe but did not improve outcomes compared with no treatment.”

conference (4–6 March, Boston, USA).

“These results are very encouraging and provide strong evidence in favour of heart failure management using PA pressure-guided therapy, along with vital sign data, to remotely optimise guideline-directed medical therapy and improve heart failure outcomes,” stated Klein, the national principal investigator of the PROACTIVE-HF trial. “Cordella offers a novel patient-friendly system that includes a handheld PA pressure reader and allows patient visibility to health data. In my opinion, these key differentiators helped drive high levels of engagement for patients and supported them to make healthy lifestyle choices. Combined with the clinicians’ targeted medication adjustments using the system’s comprehensive view of patient health status, we achieved great

patient outcomes overall and when compared to the same period before sensor implant.”

The multicentre, prospective trial implanted 528 NYHA class III HF patients across 75 US and European sites. Over half of the implanters were heart failure specialists and the trial showed high rates of patient compliance (>6 avg Cordella submissions/week) and clinician engagement (>2 avg reviews/week). The six-month singlearm results met primary safety and efficacy endpoints as well as several clinically significant secondary efficacy endpoints.

Cordella pulmonary artery sensor

Photo by © ACC/Brian Powers 2024

Interatrial shunt fails to meet primary endpoint in RELIEVE-HF trial

Surprisingly, a marked improvement in quality of life as measured with KCCQ was observed across all groups—including those who received a placebo procedure, both with HFrEF and HFpEF—suggesting that the metric may not be a reliable indicator for quality-of-life outcomes in this context, Stone said.

“There was a tremendous placebo effect,” he said.

“These observations, especially the fact that quality of life improved in HFpEF patients who were more likely to be hospitalised for heart failure and had reduced survival after shunt treatment, raise questions about the interpretation of this quality-of-life measure in these kinds of trials.”

Although the observed differences in outcomes among people with different types of heart failure may inform future research and development for interatrial devices, the researchers said that the trial was not powered to show differences in the two types of heart failure. As such, these results should be considered exploratory. They also said that the results may not be applicable to other interatrial shunts beyond the Ventura shunt.

Though the study failed to meet its primary endpoint, proponents of the emerging field of atrial shunting have been quick to point out some of the potential signals of benefit seen in the trial.

Corvia Medical, which is bringing the Corvia atrial shunt to market, issued a statement in the wake of the presentation of RELIEVE-HF trial data in which it said that the data support the evidence base around atrial shunt therapy.

“In this emerging field, it's crucial to recognise the nuances of different studies with respect to patient demographics and trial methodologies to prevent misinterpretation of findings,” said Martin Leon (Columbia University Irving Medical Center, New York, USA), a co-principal investigator of the RESPONDER-HF which is assessing the Corvia device, said. “We know shunting is safe and has a positive effect in appropriately selected patients with HFpEF, and we have three-year data to prove it. We're confident the ongoing RESPONDER-HF trial will be a definitive step forward in bringing atrial shunt therapy to millions of HFpEF patients.”

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May 2024 | Issue 73

24 Coronary Interventions

Preventive PCI in vessels with non-flow limiting vulnerable plaques cuts cardiac events Preventive percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques significantly reduced the risk of adverse cardiac events compared with medical therapy alone, findings of the PREVENT trial have shown.

SEUNG-JUNG PARK (ASAN MEDICAL CENTER at the University of Ulsan College of Medicine Seoul, South Korea) the study’s lead author presented the results at the American College of Cardiology (ACC) 2024 scientific session (6–8 April, Atlanta, USA). The PREVENT trial is the largest study on preventive PCI to date and the first with a large enough sample size to assess clinical outcomes in vulnerable plaques.

Investigators found that, at two years, people who underwent preventive PCI were 89% less likely to experience the composite primary endpoint of cardiac death, heart attack in the target vessel, revascularisation due to ischaemia in the target vessel or hospitalization for unstable or progressive chest pain compared with people who received medications alone.

“PREVENT has now shown that preventive PCI may reduce the two-year and long-term risks of major cardiac events arising from vessels containing vulnerable plaques,” said Park. “These findings demonstrate that the focal treatment of high-risk vulnerable plaques may improve patient prognosis beyond optimal medical therapy alone.”

The idea behind preventive PCI is that a stent could help to stabilize a high-risk plaque lesion and thus reduce its risk of rupture before a heart attack occurs. To test this strategy, researchers enrolled 1,606 patients treated for coronary artery disease (CAD) at 15 centres

in four countries. Participants had plaques that were considered vulnerable to rupture, as assessed with intravascular imaging, but were not limiting blood flow, as indicated by a fractional flow reserve greater than 0.80. Patients were 64 years old, on average.

Half of the participants were randomly assigned to receive PCI plus medical therapy and half received medical therapy alone. Optimal medical therapy for CAD includes lifestyle modifications and intensive pharmacologic interventions, according to the contemporary guideline-directed medical therapy for secondary prevention. High-dose statin therapy was strongly recommended in both groups.

At two years, the composite primary endpoint occurred in three patients who received PCI (0.4% of the PCI group) and in 27 patients who received medications alone (3.4% of the controls), representing an 89% lower risk of the composite primary endpoint among those who received PCI. The cumulative incidence of this composite endpoint remained significantly lower in the PCI group through long-term follow-up over a median of 4.4 years (maximum up to 7.9 years), with patients receiving PCI showing a 46% lower risk of the composite endpoint across this period.

Rates for each component of the composite primary endpoint were also lower in the PCI group, as were the composite Park rate of death from any cause or heart Seung-Jung attack in the target vessel or any

One in 10 deaths after PCI found to be “preventable”, US statewide analysis suggests Around 10% of all deaths following percutaneous coronary intervention (PCI) are potentially preventable, the authors of a study published in PLOS ONE which used data on in-hospital deaths after PCI at 39 centres in the US state of Michigan, have suggested.

“DEATHS IN THE HOSPITAL after PCI are rare and mostly occur in patients who arrive after a heart attack, especially if their cases involve shock,” said senior author Hitinder Gurm (University of Michigan Health, Ann Arbor, USA). “The vast majority of deaths after PCI are unpreventable and related to patients’ underlying conditions for which they are undergoing the procedure. This is a stark change from the 1990s when the majority of deaths were traceable to procedural complications.”

The research team analysed deaths after PCI occurring at 39 hospitals participating in BMC2, a Michiganwide cardiovascular consortium of healthcare providers, between 2012 and 2014. These hospitals use procedural and outcome data to inform quality projects to improve care and

patient outcomes.

Procedural complications contributed to 20% of the nearly 1,200 deaths reported during the study period, the investigators report in their PLOS ONE paper. Just over one quarter of the patients who died were considered low risk, meaning a PCIrelated mortality risk score estimated they had a 95% or greater chance of survival.

Left ventricular failure was the most common cause of death, occurring in 52% of cases, and the circumstance of death was most commonly related to prior acute cardiovascular condition (61% of cases). Procedural complications were considered contributing to mortality in 235 (20%) cases.

Of the deaths that were considered preventable, 10.1% in total,

revascularisation.

As participants and clinicians were aware of which treatment they were assigned to receive, the lack of blinding could have influenced the study results, researchers said. Park added that the study was limited to patients with non-flow-limiting plaques that were detected with intravascular imaging and is not necessarily generalisable beyond this patient population.

“Further research is necessary to provide better identification of which patients or lesions can most benefit from invasive or non-invasive imaging evaluation for detection of vulnerable plaques, optimal risk-stratification and the application of preventive PCI,” Park said.

PREVENT has now shown that preventive PCI may reduce the two-year and long-term risks of major cardiac events arising from vessels containing vulnerable plaques.”

Researchers also said that the observed rates of the primary outcome were lower than expected in both groups. This could be related to factors including the relatively low proportion of study participants with acute coronary syndromes; improvements in medical therapy and in PCI equipment and techniques, including the use of intravascular imaging-guided PCI; and effective control of risk factors such as low-density lipoprotein (LDL) cholesterol.

angioplasty and stenting was deemed to be of low value and potentially avoidable nearly one third of the time.

Researchers say the data suggest there is a need to focus on optimising appropriateness of PCI to ensure providers are limiting rare, preventable deaths from this common procedure.

“Our data may help inform how cath labs conduct morbidity and mortality conferences, a common quality improvement practice at many hospitals, by focusing on patients with low predicted risk of mortality who subsequently experienced an adverse event,” said first author Francesco Moroni (University of Virginia, Charlottesville, USA). “Such a focus may be an effective method of identifying on periprocedural practices, as opposed to patient-related factors, that may have played a role in a patient’s adverse outcome.”

PCI performed in a cath lab

PCI for stable coronary disease can be performed before during or after TAVI Percutaneous coronary intervention (PCI) can be safely performed before, during, or after transcatheter aortic valve implantation (TAVI) for patients with stable coronary artery disease (CAD), analysis shared at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 scientific sessions (2–4 May, Long Beach, USA) has shown.

A TVT REGISTRY analysis of 49,344 patients with stable coronary disease who underwent PCI before, after or alongside TAVI, between 2015 and 2024. showed that a composite of all-cause mortality and stroke were similar at three years of follow-up.

PCI performed before TAVI had a slight advantage over concomitant PCI with TAVI at three years.

Issue 73 | May 2024

Peripheral Interventions 25

CX 2024: Paclitaxel device restrictions “did cause harm” “Unfortunately, we are doing worse for our patients today,” were the sobering words of Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) during a late-breaking presentation at the Charing Cross (CX) International Symposium (23–25 April, London, UK).

A

mong several speakers to address the controversy on paclitaxel safety at CX 2024, Secemsky reported that regulatory restrictions subsequent to the 2018 Katsanos et al meta-analysis on paclitaxel-coated devices did cause harm through relegating patients to “less durable” device treatment, increasing the incidence of adverse events post-revascularisation.

In a session focused on reaching resolution on the paclitaxel controversy, early presentations given by Thomas Zeller (Heart Centre Bad Krozingen, Bad Krozingen, Germany) and Peter Schneider (University of California San Francisco, San Francisco, USA)— concerning paclitaxel-coated balloon safety in femoropopliteal occlusive disease and paclitaxel mortality across randomised controlled trials— established the “lack” of paclitaxelcoated device mortality risk in recently available data.

Secemsky gave a timeline of the use of paclitaxel-coated devices, noting that there had been a “significant, rapid” change in practice in the USA, corresponding to a sharp decline in the use of these devices following the 2018 meta-analysis which reported an increased mortality risk, leading to subsequent regulatory restrictions in the USA and Europe.

Using both Medicare data and the IQVIA: Medical Device Supply Audit database, Secemsky and colleagues looked at paclitaxel device use in US hospitals between Q3 2013 and Q3 2023. He reported that, following the pivotal Katsanos et al meta-analysis,

drug-coated balloon (DCB) and drug-eluting stent (DES) use did not recover to pre-meta-analysis levels until Q3 2023—a period of four and a half years—showing the “parallel” trajectory between device use and data, Secemsky said. Furthermore, of note, the speaker displayed a “shrunken” downward trend in overall femoropopliteal procedural counts in the USA following the controversy, despite peripheral arterial disease (PAD) -related amputations remaining “stable” in the same period.

Then, Secemsky and colleagues followed 275,009 Medicare beneficiaries who underwent femoropopliteal intervention, comparing the risk of major amputation and death in the period prior to and following the paclitaxel controversy. Risk of amputation or death was reported in 40.4% and 43.2% of patients in the pre- and post-paclitaxel period, respectively.

Secemsky also reported a 43.9% risk of major amputation and death in the post-COVID-19 period, establishing that risks following femoropopliteal intervention were “not driven by COVID-19 alone”, he said.

“Did the paclitaxel meta-analysis cause harm? There are many data here to support that it did, and you can see that global restrictions resulted in less durable treatment, more amputation and death post paclitaxel controversy, [and] an increase in economic burden,” said Secemsky.

Although the meta-analysis and regulatory restrictions on paclitaxel devices caused harm, Secemsky stated

LIFE-BTK shows “clear superiority” of bioresorbable scaffolds over PTA Analysis of the LIFE-BTK trial shows the “absolute” superiority of drug-eluting bioresorbable scaffolds when compared to percutaneous transluminal angioplasty (PTA). This was the finding shared in a first-to-podium presentation at the Charing Cross (CX) International Symposium (23-25 April, London, UK).

RAMON VARCOE (PRINCE OF WALES Hospital and University of New South Wales, Randwick, Australia) described the “excellent” results that have been observed with bioresorbable scaffolds, giving them “inherent advantages” over permanent

that it also resulted in some positive outcomes by underscoring the need for better clinical trial practices and complete study participant follow-up.

“The paclitaxel controversy not only instigated interest in non-paclitaxel therapies such as sirolimus-based treatments, but it also demonstrated that the vascular community could quickly band together to address a dispute, and particularly displayed the collaborative nature of [the] US Food and Drug Administration [FDA] who ensured regulatory concerns were addressed,” Secemsky finalised. “These lessons can help guide the vascular community through the next controversy and to further develop evidence to shape clinical practice.”

The discussion was then opened to the FDA and UK Medicines and Healthcare products Regulatory Agency (MHRA) to provide a conclusive perspective on the matter. Representing the FDA, Ariel Ash-Shakoor stated that, based on the “totality of available

evidence” the FDA has determined that the data do not support an excess mortality risk for paclitaxel-coated devices.

Ash-Shakoor noted that lessons can be learned from the paclitaxel mortality controversy, including the importance of long-term follow-up, prespecified plans concerning missing data, and proactive patient monitoring to ensure “complete” reporting.

Providing the perspective of the MHRA, Alexander McLaren confirmed that no increased risk in mortality with paclitaxel-coated devices has been observed in their review of available randomised trial data.

In his view, as “quality, robust data were slow to emerge”, delays in decision-making were inevitable.

Taking what has been learnt forward, McLaren said that the MHRA intends to improve premarket clinical investigation and ensure studies are “sufficiently powered and supported” to collect real-world follow-up data.

Eric Secemsky (centre)

Global restrictions resulted in less durable treatment, more amputation and death post paclitaxel controversy, [and] an increase in economic burden.”

metallic implants. “Demonstrated through the litany of failed trials for drug-coated balloons below the knee, we know that [bioresorbable] scaffolds work,” said Varcoe. Now, backed by large-scale randomised controlled trial data such as LIFE-BTK, he underlined the “promise” of bioresorbable scaffolds for treating chronic limb-threatening ischaemia (CLTI).

Brian DeRubertis (NewYork-Presbyterian/Weill Cornell Medical Center, New York, USA) delivered a late-breaking subset analysis of the 12-month data from LIFE-BTK, which evaluated limb salvage and primary patency between the Esprit BTK (Abbott) bioresorbable scaffold and PTA for the treatment of infrapopliteal artery disease in patients with CLTI. Showing a “striking difference” between the Esprit BTK scaffold and PTA, the primary endpoint of limb salvage and primary patency at one year was 74.2% and 47.9% respectively, DeRubertis reported. The secondary endpoint of binary restenosis of the target lesion at one year also showed statistical significance at 24.2% and 46.5%, respectively.

DeRubertis confirmed the “clear superiority” of the

Esprit BTK scaffold, reiterating the 30% absolute risk difference between the two arms, which was “driven by multiple components of the primary endpoint and was reliably preserved across various subgroups, including sex, age, race and indication”. He concluded that the technology may provide a new option for infrapopliteal interventions.

Later, the FDA’s Ariel Ash-Shakoor provided a regulatory perspective on clinical trials for CLTI. She detailed the importance of ensuring patients enrolled in trials are representative of the real-world population and that device benefit evaluation reflects its intended procedural role. “As [CLTI] is an immature space, there remains ample opportunity for learning,” said Ash-Shakoor.

Panelists were asked what role drug-coated balloons have below-the-knee, to which DeRubertis answered “complimentary”, explaining that the anatomic exclusions of LIFE-BTK prevented scaffold placement in the distal lower leg, and this is where he expects drug-coated balloons, if proven effective, to be “especially useful and complimentary”.

May 2024 | Issue 73

26 Viewpoint

Challenges establishing minimally invasive cardiac surgery in the developing world

Attaulah Khan Niazi Point of View Attaulah Khan Niazi (King Edward Medical University, Lahore, Pakistan) documents the major challenges standing in the way of establishing minimally invasive cardiac surgery techniques in the developing world. Greater international cooperation is needed, if these techniques are going to take hold outside of the developed world, he writes.

L

iving in a developing country and trying to treat structural heart disease in an endemic area for rheumatic fever is an ever-growing challenge. Pakistan is located in South Asia, an area that is home to at least one quarter of the world’s population, and as much as half of its population has suffered from under-nourishment or malnutrition. There is not only a huge patient load, but a lack of resources, trained staff and infrastructure.

The main bulk of valvular heart disease in the region still arises from rheumatic heart disease, and much of that is in a younger population, below 40 years of age, which tremendously affects the country’s workforce.

Pakistan’s health system relies on subsidising major teaching hospitals or tertiary care centres without any comprehensive insurance coverage, which means that most patients have to pay for their treatment out of their own pocket. Many large cardiac centres cover bigger volumes of cardiac surgery workload, with 10 large cardiac centres covering almost 1,500 open heart surgeries per year, albeit with a higher wound infection rate, sternal dehiscence and extravagant antibiotic use.

As well as other important factors, including the disease pattern in our South Asian patient population, we have observed late surgical interventions, with poor prognosis due to late diagnosis, and a time delay between diagnosis and surgery. In addition, we have found a high rate of postoperative infection, leading to a prolonged hospital stay and extensive use of intravenous (IV) antibiotics.

Minimally invasive cardiac surgery brings with it a major ray of hope for addressing some of these challenges in the form of swifter recovery time, reduced cost, and earlier return to work, as well as other benefits in kind for a young population.

Efforts to establish minimally invasive surgical techniques are a challenge due to the small number of cardiac surgeons operating in Pakistan, with only 196 cardiac surgeons for a population of 240 million. Additionally, there is no structured training programme for local surgeons on new minimally invasive cardiac surgery techniques, and surgical team members have lacked the incentive and interest to participate due to low salaries and poor retention of highly trained medical personnel.

We also face the challenge of poor

Images provided by the author provide an insight into the role of the surgeon as a trainer and in community outreach.

Pakistan has 196 cardiac surgeons for a population of over 240 million.

financial sustainability, the lack of a reliable medical record system, lowquality equipment and maintenance, a lack of hospital infrastructure and capacity for new programmes, and relatively few research facilities.

Alongside this, patients have poor levels of health and literacy resulting in difficulties with compliance with physician instructions or understanding of operative risk, compounded by low

levels of patient follow-up. Outside of this, there is poor local governance and a lack of commitment to cardiac care from politicians, creating problems with the growth and expansion of minimally invasive cardiac surgery programmes.

From the outset our plan was to form a team comprising cardiovascular surgeons, interventional cardiologists, cardiovascular imaging specialists and cardiac anaesthesiologists to execute advanced cardiac surgery at our centre.

The team played an important role in planning, supervising the purchase of new equipment (assembled locally), and developing a departmental policy for minimally invasive procedures and its financial aspects. We worked very closely with local industry to arrange onsite proctoring and invited international faculty to conduct workshops on innovated procedure and live case sessions.

Our aims are to minimise cost by decreasing hospital stay, to advance minimally invasive access approaches, minimise the use of antibiotics, and offer incentives to junior surgeons with a focus on a structured training

programme of minimally invasive procedures.

Since the introduction in 2021 of a new national health insurance system in Pakistan—the Sehat Sahulat Program—our patients have been able to get standard treatment from any government and private sector provider, giving us all an equal chance to deliver.

With this new standardised insurance system we are able to generate funds for these procedures, which gives us a greater opportunity to be able to sustain a structured minimally invasive cardiac surgery programme in this country.

We strongly recommend a collaborative effort from the international cardiovascular community, non-governmental organisations, local governments, and private benefactors to facilitate minimally invasive cardiac surgery in developing countries in order to improve surgical result in our centres and serve our people better.

Attaulah Khan Niazi is the associate professor of cardiac surgery at the King Edward Medical University in Lahore, Pakistan.

There is no structured training programme for local surgeons on new minimally invasive cardiac surgery techniques, and surgical team members have lacked the incentive and interest to participate due to low salaries and poor retention of highly trained medical personnel.”

Issue 73 | May 2024

Market Watch 27

MEDTECH INSIGHTS

Transcatheter tricuspid therapies “on the cusp of becoming standard of care”

forward for everyone else who is coming into this space.”

Elmouelhi says that a strength of the Topaz device is that it has been designed specifically to fit tricuspid valve anatomy, unlike others that have been retrofit from other applications.

“The tricuspid valve is very The advance of transcatheter tricuspid replacement and repair different to the mitral or the aortic technologies mark this segment as one of the most exciting valve—its proximity to the conduction areas within the cardiovascular medtech space, the incoming mechanisms and the atrioventricular president and CEO of TRiCares tells Cardiovascular News. node in particular, the fact that it is very flaccid, and there is not a lot of AHMED ELMOUELHI IS A who for a long time were the forgotten real estate to put radial force up against veteran of the medtech industry with valve patients,” Elmouelhi comments. are things that have been taken into the around 20 years of experience from “The fact that now there are options design,” he explains. organisations including AtriCure, where valves can be placed minimally With technologies being brought Medtronic and AGA Medical (now a invasively is tremendous.” to market encompassing either valve part of Abbott). He has recently joined The market for transcatheter repair or replacement, Elmouelhi TRiCares, the developer of the Topaz tricuspid interventions has been buoyed says there is likely to be a need for transfemoral tricuspid heart valve by the news of recent US Food and physicians to have robust options for replacement system, to replace the Drug Administration (FDA) approvals either avenue, given the unmet need for retiring president and CEO Helmut for Edwards Lifesciences’ Evoque the treatment of tricuspid regurgitation.

Straubinger, who has left the business valve replacement technology and “This is such a big need and following eight years in the role.

Abbott’s TriClip repair system. there are different stages at which The company is progressing the “There have been really great the patients present. Some are Topaz valve replacement system regulatory milestones in the tricuspid extremely sick, they are not all through first-in-human studies, with a space, whether it is replacement candidates for surgery at this view to future regulatory approvals in or repair,” says Elmouelhi point, and a reduction to Europe and later the USA. who is positive that these a certain grade of TR is “This space in particular is really at approvals will open the acceptable.

Ahmed the cusp of taking off and becoming door for other contenders.

“Others [patients] are Elmouelhi standard of care for tricuspid patients, “That paves the way maybe at an earlier stage

and they need a total reduction of TR. That can be one of the differentiators - amongst many - between repair and replacement. What has been shown already, is that replacement has a profound impact in terms of complete elimination of TR for these patients,” says Elmouelhi, adding that ultimately physicians will decide which patients should be eligible for a complete therapy or at which point an adjunct would be sufficient.”

There have been really great regulatory milestones in the tricuspid space, whether it is replacement or repair. That paves the way forward for everyone else who is coming into this space.”

Johnson & Johnson agrees acquisition of IVL developer Shockwave Medical Johnson & Johnson is to acquire Shockwave Medical, the developer of intravascular lithotripsy (IVL) technology for the treatment of calcified coronary artery disease (CAD) and peripheral arterial disease (PAD).

IVL IS A MINIMALLY INVASIVE, CATHETERbased treatment for calcified arterial lesions, which can reduce blood flow and cause pain or heart attack.

Under the terms of the transaction, Johnson & Johnson will acquire all outstanding shares of Shockwave for US$335 per share in cash, corresponding to a value of approximately US$13.1 billion. The transaction was approved by both companies’ boards of directors.

The acquisition of Shockwave extends Johnson & Johnson MedTech’s position in cardiovascular intervention and accelerates its shift into highergrowth markets, Johnson & Johnson said in a press release, expanding its portfolio into CAD and PAD. The transaction follows Johnson & Johnson MedTech’s acquisitions of Abiomed, developer of the Impella heart pump technology, and Laminar, an innovator in left atrial appendage elimination for patients with non-valvular atrial fibrillation (AF).

Shockwave also acquired Neovasc, developer of the Reducer system, focused on symptom relief of refractory angina. The Reducer is undergoing clinical studies in the USA and is CE marked.

Joaquin Duato, chairman and chief executive officer of Johnson & Johnson, said: “With our focus

Shockwave is the maker of IVL for coronary and peripheral applications

on innovative medicine and medtech, Johnson & Johnson has a long history of tackling cardiovascular disease—the leading cause of death globally.

The acquisition of Shockwave and its leading IVL technology provides a unique opportunity to accelerate our impact in cardiovascular intervention and drive greater value for patients, shareholders and health systems.”

Tim Schmid, executive vice president and worldwide chairman of Johnson & Johnson MedTech, said: “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional highgrowth segments, and ultimately transform the future of cardiovascular treatment. Shockwave’s IVL technology for treating CAD and PAD, and its strong pipeline, are in a class of their own. We look forward to bringing Shockwave’s solutions into Johnson & Johnson MedTech and the hands of more physicians

around the world.”

“Shockwave has transformed the treatment of complex calcified arterial disease through the pioneering development of intravascular lithotripsy, and it is our mission to make this remarkable technology available to patients worldwide,” said Doug Godshall, president and CEO of Shockwave.

“As part of a larger, more diverse organisation, with broad expertise and a core focus on improving patient outcomes, we are confident we will be able to further solidify IVL as the global standard of care for patients.

“I am deeply grateful to our team members and colleagues whose efforts have made today’s milestone possible; their accomplishments and passion have been extraordinary. I could not think of a better partner and home than Johnson & Johnson as the Shockwave team prepares to write its next exciting chapter.”

May 2024 | Issue 73

28 Market Watch

Product News

Agent DCB

Agent DCB becomes first drugcoated balloon to gain a US FDA coronary approval

Boston Scientific has announced that it has received US Food and Drug Administration (FDA) approval for the Agent drug-coated balloon (DCB), which is indicated to treat coronary instent restenosis (ISR) in patients with coronary artery disease.

“With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the USA,” said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific. “The Agent DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering US physicians the opportunity to treat their patients with this novel device.”

Following breakthrough device designation granted for the technology by the FDA in 2021, the approval was supported by positive results from the multicentre, prospective, randomised controlled AGENT IDE trial, which enrolled 600 patients at 40 US sites.

The Agent DCB is available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease.

Boston Scientific plans to launch the technology in the USA in the coming months.

Health Canada licenses Symplicity Spyral radiofrequency renal denervation system to treat hypertension

Medtronic has received a license from Health Canada for its Symplicity Spyral multi-electrode renal denervation system.

This is indicated for the management of essential hypertension in patients for whom blood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated.

The procedure is a minimally invasive technique that uses radiofrequency ablation to calm the nerves near the kidneys that can become overactive and contribute to high blood pressure. Nearly one in four Canadian adults are affected by hypertension, and it’s estimated that 90% of individuals will develop high

blood pressure at some point during their lifetime.

“As the pioneer in renal denervation, we are looking forward to making a difference for hypertension patients in Canada,” said Maisie Cheung, director of marketing, Medtronic Canada. “This means more choices for patients—and offers physicians an adjunctive option along with lifestyle changes and medications to help manage patients with high blood pressure.”

“As we look to improve options to help manage patients with hypertension, we’re encouraged by this latest approval of the Symplicity Spyral renal denervation system,” said Sheldon Tobe, nephrologist and hypertension specialist, Sunnybrook Health Sciences Centre (Toronto, Canada). “There is a big unmet need in Canada for the subset of patients who can’t fully control hypertension with medication and/or lifestyle changes.

This innovative procedure will help to fill that gap by potentially helping to improve blood pressure control.”

PerQseal Elite

First large bore venous patient treated with PerQseal Elite vascular closure system

Vivasure Medical has announced the treatment of the first large bore venous patient with the PerQseal Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device.

The first successful implant was completed by Nicolas Van Mieghem (Thoraxcentre, Erasmus Medical Centre, Rotterdam, The Netherlands) as part of the company’s ELITE Venous Clinical Study—a prospective, multicentre, single-arm clinical study evaluating the safety and efficacy of the vascular closure system.

Leveraging Vivasure Medical’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants.

Currently, there are no sutureless options available for vessel closure following large-bore venous procedures, the company says.

“Current venous closure methods are not indicated for large hole venous access applications like Transcatheter

edge-to-edge repair (TEER), TMVR and TTVR. As these procedures become more common, there’s a need for closure options that can effectively address these emerging clinical applications,” said Van Mieghem, principal investigator of the ELITE study. “I’m looking forward to further study the PerQseal ELITE technology for venous closure and assess its performance for patients.”

Tria valve

Tria valves with calcium resistant polymer surpass 200 patient life years

Foldax has announced that its Tria valves have surpassed 200 patient life years in human recipients.

Patient life years represent the cumulative time the valve has been implanted in patients, offering insight into the duration of its use and its impact on cardiac function over time.

Tria valves are intended to improve the lifetime management of heart valve disease in patients. They incorporate a proprietary polymer—LifePolymer— that is used in computer-designed leaflets shown to resist calcification.

The novel polymer material enables Tria valves to be robotically produced, minimising manpower and process, and maximising product quality and precision.

“The LifePolymer material exhibits ideal biomaterial properties for flexible leaflets in a totally synthetic heart valve replacement, and it is encouraging to see the continued durability and performance in patients,” said David Grainger, department chair of Biomedical Engineering at the University of Utah (Salt Lake City, USA) and chairman of Foldax’s scientific advisory board. “Synthetic polymer leaflets in prosthetic cardiac valves hold the potential to reduce calcification and blood clotting while improving blood flow and durability.”

Tria valves have been studied in clinical trials in the USA and India approved by the US Food and Drug Administration (FDA) and the Drugs Controller General of India (DCGI).

Acolyte system for guidewire positioning and placement in CTOs given US FDA breakthrough device status

Simpson Interventions has announced that its Acolyte image-guided crossing and re-entry catheter system has been granted breakthrough device designation by the US Food and Drug Administration (FDA).

The Acolyte image-guided crossing and re-entry catheter system is designed to facilitate the placement and

positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions (CTOs) who continue to experience symptoms following medical therapy.

This breakthrough device is intended to significantly change the approach to treating coronary CTOs by providing real-time optical coherence tomography (OCT) visualisation, enabling precise guidewire placement within the target vessel’s true lumen and subsequent revascularisation.

CTOs occur when a coronary artery is completely blocked by plaque buildup, posing significant challenges for interventional cardiologists who struggle to traverse these lesions with current standard of care options.

If a physician fails to cross a CTO, minimally invasive revascularisation options such as angioplasty and stent placement cannot be performed. Hence, in the USA, many CTO patients are instead sent for bypass surgery.

The Acolyte system aims to overcome these challenges by providing clinicians with this breakthrough device that has enhanced visualisation and navigation capabilities, ultimately improving CTO crossing, procedural success rates, and patient outcomes.

“We are thrilled to receive FDA’s breakthrough device designation for our Acolyte image-guided crossing and re-entry catheter system,” said John B Simpson, founder and CEO of Simpson Interventions. “This designation recognises the transformative potential of our technology in addressing a critical unmet need in the treatment of patients with coronary chronic total occlusions. We are committed to advancing the field of interventional cardiology and improving patient outcomes through innovation.”

Latest-generation Evolut TAVI system gains US regulatory approval

Medtronic has announced that the US Food and Drug Administration (FDA) has approved the Evolut FX+ transcatheter aortic valve implantation (TAVI) system for the treatment of symptomatic severe aortic stenosis.

The latest Evolut FX+ TAVI system maintains the valve performance of the legacy Evolut TAVI platform and is designed to facilitate coronary access.

The Evolut FX+ TAVI system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of Evolut. Evolut FX+ provides increased space for catheter manoeuvrability to facilitate access to coronary arteries of varying patient anatomies.

The Evolut FX+ TAVI system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the USA. Early commercial experience is planned for spring 2024 with full product launch anticipated in summer 2024.

Issue 73 | May 2024

Market Watch 29

Clinical News

Navitor

ENVISION trial of Navitor TAVI valve in low-risk patients enrols first patient

Abbott has announced that the first patient has been enrolled in the ENVISION investigational device exemption (IDE) clinical trial.

The global, randomised trial, taking place at 95 sites, will evaluate the safety and effectiveness of Abbott’s Navitor transcatheter aortic valve implantation (TAVI) system in approximately 1,500 patients at intermediate or low surgical risk with severe aortic stenosis.

The trial will be used to support expanded indication for the Navitor TAVI system’s treatment of aortic stenosis across surgical risk categories.

The Navitor Vision valve recently launched in the USA.

New data on outcomes with Sapien TAVI platform

Results from two large, real-world studies assessing outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) with the Sapien (Edwards Lifesciences) valve platform have been presented at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA).

The first assessed outcomes with the latest-generation, Sapien 3 Ultra Resilia valve, reporting lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients and larger effective orifice areas across all valve sizes when compared to the Sapien 3 and Sapien 3 Ultra valves. These data were presented during a podium presentation and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

In a second study, small Edwards Sapien TAVI valves demonstrated equally excellent outcomes at three years as compared to larger Sapien TAVI valve sizes. Using data from the TVT registry, researchers compared the outcomes of more than 10,000 patients across more than 800 sites in the USA treated with the Sapien 3 Ultra Resilia valve to those receiving Sapien 3 Ultra and Sapien 3 valves using procedural and haemodynamic data and clinical outcomes for propensitymatched cohorts.

The study found that all Edwards TAVI platforms demonstrated excellent PVL results. Notably, there was a statistically significant reduction in PVL for the 29mm Sapien 3 Ultra Resilia valve as compared to the 29mm

Sapien 3, with 88.3% of patients exhibiting no PVL and only 10.7% of patients exhibiting mild PVL. The Sapien 3 Ultra Resilia valve was also associated with significantly lower echocardiography-derived mean gradients and larger effective orifice areas across all four valve sizes with low rates of all-cause mortality, cardiac death, all stroke, life-threatening bleeding, major vascular complications, and permanent pacemaker implantation in-hospital or at 30 days.

An analysis of 8,100 propensity matched patients across more than 800 sites in the USA found that patients treated with a 20mm Edwards Sapien valve demonstrated excellent all-cause mortality and stroke outcomes at three years, equivalent to those receiving 23, 26 and 29mm Sapien valve sizes.

Among mortality indicators, researchers concluded that while PVL and new permanent pacemaker implantation were both associated with increased mortality, the relationship between post-procedural echo-derived mean gradients and clinical outcomes is non-linear and more complex.

“This examination of these realworld data gives us important insights into the actual performance of small Edwards valves and reaffirms the excellent outcomes for patients receiving Sapien TAVI, regardless of valve size,” said Amr Abbas (William Beaumont University Hospital, Royal Oak, USA) and principal investigator in the small Sapien valve study.

PROTEMBO randomised trial of three-vessel cerebral embolic protection device enrols first patient

Protembis has announced the enrolment of the first patient in the PROTEMBO investigational device exemption (IDE) pivotal trial, investigating transcatheter aortic valve implantation (TAVI) procedures with the Protembo cerebral embolic protection (CEP) system.

The randomised trial will enrol between 250 and 500 patients undergoing TAVI in the USA and Europe with the Protembo system. The device is designed to provide threevessel coverage of the cerebral arteries.

The PROTEMBO study aims to show superiority of the Protembo System against a hybrid control group: half receiving no cerebral embolic protection and half receiving the Sentinel (Boston Scientific) device.

The primary diffusion-weighted magnetic resonance imaging (DWMRI) efficacy endpoint will use a novel adaptive statistical approach that includes pre-specified interim analyses with the possibility of early study completion in the instance of superiority.

The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30 days.

The trial will be led by Susheel Kodali (New York Presbyterian Hospital, New York, USA), Raj Makkar (Cedars Sinai, Los Angeles, USA) and Stephan Haussig (Herzzentrum, Dresden, Germany), as the designated global co-principal investigators, with Roxana Mehran (Mount Sinai, New York, USA) as the chair of the study executive committee.

“The novel adaptive statistical design of this clinical study will answer several important unanswered questions about the role of threevessel cerebral protection in reducing new lesions in all areas of the brain,” said Mehran. “The results will give the physician community increased confidence in offering patients cerebral protection when they undergo their TAVI procedures.”

“We are proud to be the first centre to enrol a patient into this innovative international study,” said Kodali.

“The requirement for DW-MRI assessment means that we will be able to accurately quantify the fundamental effect of the technology on reducing the size and frequency of new cerebral lesions, which are very common during the TAVI procedure.”

The Protembo cerebral protection system is an intra-aortic filter device that protects the entire brain from embolic material liberated during TAVI. It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery.

SAFE-MCS finds reduction in bleeding for high-risk PCI patients with bleed monitoring system Saranas has announced results of SAFE-MCS, a multicentre clinical study evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird bleed monitoring system (EBBMS).

Babar Basir (Henry Ford Health System, Detroit, USA), co-principal investigator of SAFE-MCS, presented results of the trial as part of the late-breaking clinical trial sessions at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA).

“I am pleased to announce a significant reduction in BARC (Bleeding Academic Research Consortium) type III or V access site bleeds in patients monitored with the EBBMS was shown compared to the historical control (4.2% vs. 12.5% in PROTECT II) which corresponded to a relative reduction in risk of 66.3%,” noted Basir. “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.

These findings are clinically significant and endorse the use of EBBMS for high-risk PCI patients who are receiving MCS support.”

The study enrolled 203 patients across multiple centres in the USA. Patients undergoing complex high-risk

PCI with MCS via Impella (Abiomed) and transfemoral arterial approach were enrolled. The EBBMS was used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“The SAFE-MCS study highlights the importance of prompt bleed detection and continuous monitoring to prevent severe complications and improve clinical outcomes, especially as the use of MCS increases globally,” stated Philippe Genereux (Morristown Medical Center, Morristown, USA) and co-principal investigator of SAFE-MCS. “We now have a deeper understanding of the frequency of bleeding events during such procedures with improved strategies to enhance patient safety during protected PCI.”

Heartlfow FFRCT

HeartFlow shares ten-year data from DISCOVER-FLOW study

HeartFlow has announced that 10-year follow-up data from its DISCOVERFLOW study have been published in the Journal of Cardiovascular Computed Tomography.

At 10 years, HeartFlow’s FFRCT Analysis, a non-invasive test for coronary artery disease (CAD), showed strong long-term risk stratification and displayed the risk continuum as effectively as invasive fractional flow reserve (FFR).

DISCOVER-FLOW was the first trial evaluating the HeartFlow FFRCT Analysis and aimed to determine the long-term prognostic implications of lesion-specific FFRCT in patients with suspected or known CAD. Findings from the study indicate that FFRCT was as predictive of patient outcomes through 10 years as invasive FFR, lesions with lower FFRCT values were associated with ever-higher rates of cardiovascular death, heart attack, or a need for revascularisation (stenting or bypass surgery) over the 10-year period. FFRCT was superior to coronary computed tomography angiography (CCTA) stenosis severity alone for diagnosis of lesion-specific flow impairment.

“It’s rare to have the opportunity to follow patients for 10 years in clinical trials and we are delighted to confirm the long-term prognostic value of FFRCT through the DISCOVERFLOW study,” said Campbell Rogers, chief medical officer, HeartFlow.

“These data are a reflection of our commitment to providing comprehensive clinical evidence on the diagnostic accuracy, safety, efficacy, and utility of the HeartFlow Analysis.”

May 2024 | Issue 73

30 Market Watch

Cardiac surgeon and interventional cardiologist join egnite’s medical advisory board

Industry News Olivier Pierron joins Cardiawave SA as chief executive officer

Cardiawave SA has appointed Olivier Pierron as its new chief executive officer. The company is developing Valvosoft, a breakthrough technology that allows for the remote application of a focused therapeutic ultrasound beam to restore valve function in patients with aortic stenosis.

Pierron brings Cardiawave expertise in the development and international commercialisation of new medical technologies at a crucial time in the company’s growth, following the announcement of positive clinical trial results, the company stated.

Pierron commented: “The approach developed by Cardiawave is unique and complements the existing range of cardiology treatments. Being entirely non-invasive, it expands the treatment options of patients suffering from severe symptomatic aortic valve stenosis. I am very honoured to be joining this visionary team and to be working with them to bring this disruptive solution to market, in order to treat the largest number of people as quickly as possible.

“Cardiawave’s technology represents a major step forward, one that is acknowledged by the international medical community, and our clinical results are very promising. I am determined to make this innovation a success in our various markets.”

Pierron will be tasked with deploying Valvosoft in the European market, starting clinical trials in the USA under premarket approval, strengthening strategic partnerships to

Olivier Pierron

bolster its international footprint, and leading its series B funding.

Cardiawave has recently filed its CE-mark application and completed the enrolment of 60 patients in the Valvosoft Pivotal study, taking the total number of severe symptomatic calcific aortic stenosis patients being treated to 100, across 12 centres. The sixmonth first-in-human results have been published in The Lancet.

Transverse Medical restructures board as it seeks to bring cerebral embolic protection system to market

Transverse Medical, developer of the Point-Guard cerebral embolic protection device to protect the patient from stroke during transcatheter aortic valve implantation (TAVI) has reorganised its board of directors following the recent closing of a series B1 financing.

The company has announced the appointment of David C Blowers to the board of directors, while Eric Goslau will remain as president and chief executive officer and a board member.

Sharma said: “I’m looking forward to joining the board and contributing my clinical expertise to the success of the next generation Point-Guard and the company’s future clinical plans and strategy. The Point-Guard solution for full brain protection is critically needed to address the risk of Stroke during TAVI and which fully meets the success criteria for cerebral embolic protection.”

“I’m impressed with our operating team and their ability to persevere and drive the Point-Guard programme forward. We are grateful for our investors that have continued to support and rally behind the company and the Point-Guard solution for full brain protection. The leadership team and our impressive medical advisory members are passionate and committed to our company mission. Transverse Medical is now recharged, primed, and ready to achieve key milestones,” said Goslau.

research brings a wealth of experience to egnite’s medical advisory board.

“We are honoured to welcome Vinod and Nick to egnite’s medical advisory board,” said Joel Portice, president and chief executive officer of egnite.

“Their collective expertise will play a pivotal role in shaping the future of digital health for cardiovascular patients. I look forward to Vinod and Nick’s partnership as we continue to develop innovative solutions in the cardiovascular community.”

Egnite, a digital health company specialising in cardiovascular care, has announced the addition of Vinod Thourani (Piedmont Heart Institute, Atlanta, USA) and Nicholas Amoroso (Medical University of South Carolina, Charleston, USA) to its medical advisory board.

Their expertise in cardiovascular care and dedication to innovation will significantly contribute to egnite’s mission to improve cardiovascular Mobile clinical research patient care nationwide, the company specialist Hawthorne Effect said in a press release. appoints new CEO Thourani is the Bernie Marcus Hawthorne Effect, a specialist in chairman of the Department of technology-enabled mobile clinical Cardiovascular Surgery for Piedmont research, announced the appointment Heart Institute and Piedmont of Josh Rose as new CEO. Healthcare and the Marcus Heart The organisation describes Rose as Valve Center. Over his career, he has a clinical trial industry veteran with held key leadership positions as the over 14 years of executive leadership past-president of the Southern Thoracic experience with companies such as Surgical Association, past-president IQVIA, CVS Health and others. of the Heart Valve Society, past“I’ve always been attracted to president of the International companies that have a Society of Minimally unique approach to Invasive Cardiothoracic solving significant Surgery, president-elect industry challenges,” of the 21st Century said Rose. “Driving Cardiothoracic Surgical greater patient access Society, past-president and participation in of the South Atlantic clinical trials is one Cardiovascular Surgery, of the most pressing and the Treasurer challenges for pharma of the Society of sponsors. Hawthorne Josh Thoracic Surgeons.

Effect’s pioneering approach to Rose Amoroso is an interventional rapidly enabling study visits in cardiologist and director of the Medical the patient’s home at attractive unit University of South Carolina’s Adult economics, eliminates the barrier for Cardiac Catheterization Laboratory who greater adoption of mobile visits in brings expertise in structural heart and hybrid or any clinical trial.” coronary artery disease to the advisory Hawthorne Effect has also board. Amoroso is an emerging leader strengthened its board of directors in the field, serving as an investigator with three new appointments for several landmark structural heart bringing over 50 years of clinical clinical trials and as a proctor for trials, biotechnology and patient novel structural heart interventions. services experience.

Amoroso’s prominent background in New directors include Jon cardiology includes medical training at DiVincenzo, EVP & president, George Washington University as well Central Laboratories Services and as residency and fellowship programs International, Labcorp, Tony Clapsis, at New York University (NYU) and former SVP at CVS Health, and Ingo Mount Sinai Beth Israel, egnite says.

Chakravarty, operating partner at His involvement in novel clinical trials Northpond Ventures and former CEO and contributions to leading cardiology of Mesa (sold to Fisher Scientific).

Conference calendar 14–17 May EuroPCR 2024 Paris, France

pcronline.com/Courses/EuroPCR

5–7 June New York Valves: The Structural Heart Summit New York, USA

nyvalves2024.crfconferences.com

2–3 August Interventional Complications 2024 Seattle, USA

complications2024.crfconferences. com

30 August–2 September European Society of Cardiology (ESC) Congress London, UK

escardio.org/Congresses-Events/ ESC-Congress

7–8 October CX Aortic Live Vienna, Austria cxaortic.com

9–12 October European Association of Cardio-Thoracic Surgery (EACTS) 2024 Lisbon, Portugal eacts.org/annual-meeting

27–30 October Transcatheter Cardiovascular Therapeutics (TCT) 2024 Washington, DC, USA

25–27 January 2025 Society of Thoracic Surgeons (STS) 2025 annual meeting Los Angeles, USA

24–26 November PCR London Valves London, UK

8–11 March 2025 Cardiovascular Research Technologies (CRT) 2025 Washington, DC, USA

tct2024.crfconferences.com

pcronline.com/Courses/PCRLondon-Valves

sts.org/education/

crtmeeting.org/attend-crt/

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