Cardiovascular News 60 February 2021 OUS edition

February 2021 | Issue 60

Featured in this issue:

www.cardiovascularnews.com

8

New section

Cardiovascular surgery

Rhian Davies

Competency in high risk coronary cases

TAVI overtakes open surgery in US valve registry

2011-2013

13,273 2014

16,312 2015

25,085

With 2021 set to mark the ten-year milestone since the approval of the first device for transcatheter aortic valve implantation (TAVI) in the USA, fresh data show that the transcatheter technique has overtaken open surgery for the first time in the USA as the predominant approach to aortic valve replacement.

2016

38,035 2017

51,002

L

atest data from the Transcatheter Valve Therapy (TVT) registry, a collaboration between the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC), confirms that since 2011 TAVI procedures have increased year-on-year in US centres.

The TVT report on TAVI and surgical aortic valve replacement (SAVR) trends, which includes findings up to and including 2019, was published in the Journal of the American College of Cardiology (JACC) and The Annals of Thoracic Surgery in late 2020. The report also documented that 30-day mortality and stroke rates associated with TAVI have decreased over this time period, while pacemaker need has remained largely unchanged.

According to the data, which were taken from hospitals in 49 US states, the annual volume of TAVI procedures in the USA carried out in 2019 totalled 72,991, exceeding all forms of SAVR, for the first time since data were collected.

“The STS/ACC TVT registry allows us to see major trends occurring in the real-world TAVI patient population, including a rapid growth in both the number of hospital sites performing TAVI and case volume as we treat a broader spectrum of patients. We have also seen TAVI become the leading choice for aortic valve replacement compared to the open surgical approach,” says John Carroll, professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver, USA, chair of the TVT Registry Steering Committee, and the lead author on the report. “Furthermore, the data on outcomes after TAVI document a substantial improvement in quality of care in the last nine years.”

The TVT data show that the number of TAVI procedures performed per site varies, reflecting an increase in the total annual volume of procedures as the number of sites performing TAVI has increased. In 2019, sites each performed 84 TAVI procedures on average with 161 sites performing fewer than 50 cases—the recommended minimum annual threshold for sites performing TAVI by stakeholders including STS and ACC. Data also show the median age of patients undergoing TAVI has decreased from early TAVI experience, as well

page 9-10

2018

58,168 2019

72,991 TAVI volume

as skewing more toward males (56%), representing a shift away from the early TAVI period when there was a nearly equal male/female distribution of patients undergoing the procedure.

From 2011 through to 2018, extreme and high-risk patients remained the largest cohort undergoing TAVI, but in 2019 intermediate-risk was the largest cohort. In 2019, the first year TAVI was FDA-approved for low-risk patients, this population made up 11.5% of all TAVI patients and had a median age of 75.

With understanding and clinical data around the longer-term outcomes of TAVI continuing to develop, recent debate has centred on the decisionmaking process guiding the choice between transcatheter or surgical approaches to aortic stenosis. During a discussion at the PCR Valves 2020 e-course (22–24 November, virtual) cardiothoracic thoracic surgeon Michael Mack (Baylor Scott & White Health, Plano, USA) questioned what evidence is needed for TAVI to become the “gold standard” in aortic stenosis patients. “In some ways I think you can say that TAVI already Data show how transcatheter aortic valve implantation (TAVI) has grown year-on-year in the USA

has become the gold standard,” he comments, pointing to the TVT registry data. However, Mack says that there are several evidence gaps that must be filled in order for TAVI to become more predominant. These include, he details, outcomes in patients under 65 years of age, long-term follow-up data on valve durability, outcomes in aortic regurgitation, treatment of concomitant coronary artery disease and bicuspid valve disease, and further evidence on the role of anticoagulation.

He noted that there are a number of trials being carried out to seek to fill this evidence gap—listing among them: EARLY TAVR, COMPLETE TAVR, REPEAT TAVR, WATCH TAVR, and TAVR

John Carroll

Furthermore, the data on outcomes after TAVI document a substantial improvement in quality of care in the last nine years.”

Continued on page 4

Profile Stephan Achenbach page 12

Pandemic highlights need for “enhanced protection” in cath labs The COVID-19 pandemic has highlighted the personal healthcare risk to cath lab teams and should trigger an “enhanced emphasis” on health protection for those working in interventional cardiology, according to Adrian Banning (John Radcliffe Hospital, Oxford, UK) and colleagues, writing in the European Heart Journal.

REFLECTING ON THE initial months of the COVID-19 pandemic and looking in particular at the impact upon patients, staff, and future percutaneous coronary intervention (PCI) practices, Banning et al write that there is a need for clear, specific advice about limiting in-hospital transmission.

Additionally, they call for the provision of appropriate personal protective equipment (PPE) for cath lab teams that can be worn “without compromising practice”, writing that treatment of patients presenting with acute myocardial infarction has been made more complex due to the need for enhanced PPE. Banning and colleagues note: “Wearing an extra gown and a visor together with lead coat protection resulted in inevitable perspiration with subsequent clouding of glasses and/or visors. This made viewing the angiographic screens difficult and consequently operators chose to try and complete emergency cases as quickly and safely as possible.”

Furthermore, they add: “It is particularly noteworthy that this pandemic has highlighted the personal healthcare risks that cath lab teams take. The risks of radiation exposure have probably been chronically under-emphasised and the risk of blood-borne viruses has almost been completely forgotten in many labs. An enhanced emphasis on protection of the cath lab team is apparent and overdue.”

Banning et al suggest that in the future this may provide an opportunity for the increasing use of robotic or enhanced protective computer technologies within cath labs.

Elsewhere in the article, they highlight changes to methods of patient follow-up instigated by many hospitals in response to the pandemic, including the use of Continued on page 2

2

February 2021 | Issue 60

Top stories

News in brief

Pandemic highlights need for “enhanced protection” in cath labs

The latest stories from the world of Cardiology

Continued from page 1

Orlando Health Heart & Vascular Institute

telemedicine and virtual clinics. Banning et al suggest that this may have contributed to a reduction in elective revascularisation, writing: “One of the interesting consequences of these changes in the consultation environment and circumstances may have been a tendency towards more conservative medical therapy. Recent publication of the ISCHEMIA trial had suggested that revascularisation in asymptomatic patients was probably of less benefit than many clinicians had predicted. These data together with a reluctance to admit patients to hospital probably contributed to a reduction in elective revascularisation.”

With healthcare systems across the globe continuing to feel the strain from high numbers of COVID-19-positive patient admissions during the latest wave of the pandemic across a number of regions, a separate study published in the Journal of Invasive Cardiology in December 2020 has also outlined the scale of the psychological impact the pandemic has had on cath lab nurses and technologists.

Study author Bailey Ann Estes (Hendrick Medical Center, Abilene, USA) analysed responses from a nationwide survey of 450 cath lab nurses and technologists in the USA, and found that as many as 95% had reported decreased morale or increased mental distress during the pandemic. The survey touched on areas including logistical changes to workflow and responsibilities, staff preparedness, and mental health, and found that predictors of depression included relocation status, staff preparedness, and work hours.

Estes notes that working in the cath lab is associated with increased health risks not experienced in other specialty areas, and suggests that alongside the “patient and physician experience”, particular attention and resources should be paid to nurses and technologists for their wellbeing and potential for increased mental and financial distress, focusing in particular on “those in large urban hospitals with high COVID-19 census, those at risk for staff relocation, layoffs and furloughs, and when preparedness and administrative communication is perceived as poor”.

Understanding of the impact of the pandemic on the delivery of cardiovascular care worldwide is continuing to develop as the pandemic enters its second year. A paper published in the Journal of the American College of Cardiology (JACC) in January suggests that the pandemic has caused a “significant and abrupt” reduction in cardiovascular diagnostic testing across the globe and may have an impact on long-term cardiovascular disease outcomes.

The study, authored by Andrew J Einstein, associate professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons (New York, USA), included data from 909 inpatient and outpatient centres performing cardiac diagnostic procedures in 108 countries and reported reductions in transthoracic echocardiography by 59%, transoesophageal echocardiography by 76%, stress tests by 78%, and a 55% decrease in coronary angiography from March 2019 to April 2020.

n TCT CONNECT 2020: "Late-breaking science is alive and well despite the pandemic". This was the conclusion reached following the first virtual edition of the TCT annual symposium, TCT Connect 2020 (14–18 October, virtual).

Cardiovascular News spoke to course directors Juan Granada and Ajay Kirtane for a wrap-up of the four-day event, and a summary of the key trials presented across the late-breaking study programme.

For more on this story go to page 5. n CARDIOVASCULAR SURGERY: Cardiovascular News offers updates on the latest developments in cardiovascular surgery, including a call for more randomised clinical trials, the impact of COVID-19 on the field, as well as a study highlighting disparities in outcomes between patients receiving private healthcare, and those with access only to public healthcare systems.

For more on this story go to page 9.

Interventional cardiology community mourns loss of two leading figures Tributes have been paid to two esteemed figures from within the interventional cardiology community who have died in recent months.

The passing of Anthony Gershlick, professor of Interventional Cardiology at the University of Leicester, Leicester, UK, due to COVID-19, was announced in November 2020. Colleagues recognised his significant contribution to the field of cardiology. Tributes were later paid to David Foley, professor of Interventional Cardiology at Beaumont Hospital, Dublin, Ireland, who passed away on 16 January following illness. Foley was described as a valued and charismatic member of the international cardiology community.

www.cardiovascularnews.com Publisher:

Design:

Content Director:

Advertising:

Roger Greenhalgh Urmila Kerslake

Editor-in-chief: Simon Redwood

Editor:

Will Date will@bibamedical.com

Editorial contribution:

Niamh Curran, Suzie Marshall, Jocelyn Hudson

David Reekie and Terry Hawes Rebecca Djaic rebecca@bibamedical.com

Subscriptions:

subscriptions@bibamedical.com

Please contact the Cardiovascular News team with news or advertising queries Tel: +44 (0)20 7736 8788

Published by:

Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address.

BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788

© BIBA Medical Ltd, 2021. All rights reserved.

BIBA Publishing, which is a subsidiary of BIBA Medical Ltd

BIBA Medical, North America, 155 North Wacker Drive Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323

Printed by: Buxton Press

Write to us!

If you have comments on this issue or suggestions for upcoming editions write to will@bibamedical.com

Make sure you get your copy of

Next issue May

facebook.com/cardiovascularnews linkedin.com/company/cardiovascular-news @cn_publishing

2021

4

February 2021 | Issue 60

Top stories

TAVI overtakes open surgery in US valve registry Continued from page 1

Unload—but cautioned that physicians should: “Mind the gap, before we further expand into TAVI while this evidence is generated.”

Mack’s message echoed that of Tom Nguyen, chief of cardiac surgery at McGovern Medical School, University of Texas, Houston, USA, speaking one month earlier at the 34th European Association for Cardiothoracic Surgery Annual Meeting (EACTS 2020, 8–10 October, virtual). During his presentation, Nguyen sounded a note of caution over what he describes as the “creep” of transcatheter techniques into lower-risk patients for whom he said there is currently little longterm follow-up data.

Despite this warning, Nguyen said that surgeons should embrace the advent of transcatheter technology, and he called for further collaboration between specialists in interventional cardiology and cardiothoracic surgery, as well as research to determine the best treatment options for individual patients. “It should not be surgeon versus cardiologist, it should be surgeons and cardiologists doing what is best for patients,” he said.

said, haemodynamic valve performance maintained superiority after TAVI compared to surgical valve replacement, and that structural valve deterioration and valve failure were similar in both groups.

Summarising the findings, Søndergaard commented: “In these eight-year data from the NOTION I trial, you see the same rate of all-cause mortality and stroke for patients at lower surgical risk undergoing TAVI and surgical aortic valve replacement. Haemodynamic valve performance maintained superiority after TAVI compared to surgical valve replacement, using the Corevalve platform [Medtronic]. Structural valve deterioration and bioprosthetic valve failure are similar for the surgical and self-expanding transcatheter heart valves.”

Following his presentation, Søndergaard was questioned by David Hidlick-Smith (Royal Sussex

It should not be surgeon versus cardiologist, it should be surgeons and cardiologists doing what is best for patients.”

Lars Søndergaard

Tom Nguyen

County Hospital, Brighton, UK) and Sabine Bleiziffer (Heart and Diabetes Center NRW, Bad Oeynhausen, Germany), with Bleiziffer questioning whether the trial results shed light on long-term valve-durability, and the decision between TAVI and surgical intervention in patients suitable for both approaches.

“First of all, when you talk about durability, and if we are going to look at patients with a much younger age, we need longer follow-up than eight years, probably 10 or 15 years to prove that the durability is equal for these two valves,” Søndergaard responded. “But, I think it is reassuring that we can see here at eight years that the rate of heart valve failure is pretty low, around 10% for both arms, so I think that it is reassuring that we do not see any short- or intermediate-term failure of these valves, which was a little bit of a concern in the beginning of the programme.”

Sites performing TAVI

198

277

347

414

488

554

590

669

701*

2012

2013

2014

2015

2016

2017

2018

2019

2020 *Data reported in-year

Nguyen remarked: “We need to be very cautious against creep—we need to know the data, know the limitations, we need non-industry sponsored trials, and we need to be incentivised to treat patients and not generate RVUs [relative value units] and, ultimately, we need to do the right thing.”

This message was shared by Davide Capodanno (University of Catania and Policlinico G Rodolico-San Marco, Catania, Italy), who chaired the discussion session at the EACTS meeting. “As a cardiologist, I totally share the message that we want to know as much as possible about the procedures that we offer to the patients, and the heart team, as well as the patients, must be informed about the pros and cons of each procedure,” he commented. “Surely one of the things we want to know about TAVI is the long-term data, especially when it comes to lower-risk populations and younger patients.”

Among the studies to seek to shed light on questions around long-term outcomes associated with TAVI is the NOTION I trial, from which eight-year findings were presented at the PCR Valves e-course in November.

NOTION I is the first all-comers trial to randomise lowrisk patients to TAVI or SAVR, and was conducted at centres in Denmark and Sweden between 2009–2013.

The findings, presented at PCR Valves by Lars Søndergaard (The Heart Centre, Rigshospitalet, Copenhagen, Denmark), showed that at eight years, patients undergoing TAVI had a comparable rate of allcause mortality and stroke compared to those receiving a surgical procedure. Additionally, Søndergaard

New valvular heart disease guidelines recognise expanding role of TAVI New joint clinical practice guidelines on the treatment of patients with valvular heart disease have been issued by the American College of Cardiology (ACC) and the American Heart Association (AHA), and highlight the expanding indications for transcatheter valve implantation (TAVI).

Published in the journal Circulation and in the Journal of the American College of Cardiology, the clinical guidelines replace 2014 guidelines and a focused update from 2017.

Reflecting recent studies, the guidelines state: “The choice of type of intervention for a patient with severe aortic stenosis should be a shared decision-making process that considers the lifetime risks and benefits associated with type of valve (mechanical versus bioprosthetic) and type of approach (transcatheter versus surgical).”

Catherine Otto, co-chair of the guideline writing committee, and director of the Heart

Valve Clinic at the University of Washington School of Medicine, Seattle, USA, comments: “Current research and new technology continue to transform the treatment of heart valve disease, as updated lifestyle and medication guidance evolve, and less invasive procedures have replaced traditional surgery for many patients.”

The writing committee notes that the optimal timing of intervention depends on the severity of the valve condition, as well as the safety and long-term effectiveness of treatment options.

As ongoing clinical research data evolves, the recommended timing of interventions will shift to earlier in the disease course for some patients, it is noted in the guidelines.

“Clinical studies over the past decade have increased awareness of the prevalence and importance of valvular heart disease in contributing to excess mortality, morbidity, and a reduced quality of life, particular in older people,” says Otto. “Simultaneously, clinical studies have demonstrated the safety and effectiveness of new, less-invasive approaches for treatment of heart valve dysfunction. Integration of this expanded evidence base, in conjunction with expert clinical experience, will furnish both providers and patients with the guidance needed to ensure optimal outcomes for patients with heart valve conditions.”

Issue 60 | February 2021

Conference coverage

TCT CONNECT

XIENCE trials demonstrate non-inferiority of shorter-term DAPT regimens A shorter course of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) was found to be non-inferior to standard DAPT up to 12 months, results of the XIENCE 90 and 28 clinical trials, presented at TCT Connect 2020 (14–18 October, virtual) by Roxanna Mehran (Icahn School of Medicine, New York, USA) suggest. The XIENCE 28 and XIENCE 90 trials were prospective, single-arm, multicentre, open-label non-randomised trials conducted to evaluate the safety of one-month (28) or three-month (90) DAPT in high bleeding risk patients undergoing PCI with the XIENCE everolimus-eluting stent (Abbott).

E

xtended duration of DAPT after PCI increases the risk of bleeding, which is associated with worse outcomes and quality of life, especially among patients at high bleeding risk (HBR). Recent clinical trials on newer generation drug-eluting stents have shown an acceptable safety profile with a short course of DAPT. However, the optimal DAPT duration in HBR patients undergoing PCI remains unknown.

The primary endpoint in the two XIENCE trials evaluated safety (allcause death or myocardial infarction) of a short DAPT regimen (one or three months) compared to DAPT up to 12 months. The secondary endpoints were the incidence of clinically relevant bleeding (BARC 2‒5) and stent thrombosis (definite/probable) against a performance goal (only for XIENCE 90). The XIENCE V USA post-approval study served as the historical control group through a propensity score

stratified analysis.

After successful PCI, enrolled patients in XIENCE 28 were prescribed one month of DAPT while patients in XIENCE 90 were prescribed three months of DAPT. Those who were free from ischaemic events and adhered to the antiplatelet regimen during the first one month or three months received “one-month” or “three-month” clear assessments. Clear subjects were eligible

Roxanna Mehran presents findings from the XIENCE clinical trials at TCT Connect

to be placed on antiplatelet monotherapy (aspirin) from one or three months to 12 months.

XIENCE 90 involved a total of 2,047 high bleeding risk subjects from 106 sites across the USA. According to Mehran, the trial demonstrated similar rates of all death or MI between three and 12 months in the test group versus the control (5.4% vs. 5.4%, one-sided 97.5% UCL: 2.23%, p noninferiority=0.0063).

XIENCE 28 enrolled a total of 1,605 high bleeding risk subjects, and according to Mehran also demonstrated non-inferiority of death or MI in the test group between one and six months (3.5% vs. 4.3%, one-sided 97.5% UCL: 0.97%, p non-inferiority=0.0005). For the secondary endpoint, the incidence of bleeding (BARC 2-5) was 5.1% vs. 7% (p superiority=0.0687 in XIENCE 90 and 4.9% vs. 5.9% (p superiority=0.19) in XIENCE 28. Major bleeding (BARC 3–5) was significantly reduced in both trials (XIENCE 90: 2.2% vs. 6.3%, p superiority <0.0001; XIENCE 28: 2.2% vs. 4.5%, p superiority=0.0156).

One-year follow-up results of the randomised SOLVE-TAVI trial showed similar rates of all-cause death, cardiovascular death, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation in balloon-expandable valves and self-expandable valve treated patients, but found that stroke occurred more frequently in the balloon expandable valve group. The findings were presented by Hans-Josef Feistritzer (University Hospital, Leipzig, Germany) during a late-breaking clinical science session at TCT Connect 2020 (14–18 October).

OPENING HIS PRESENTATION, Feistritzer said that during the last decade transcatheter aortic valve implantation (TAVI) has developed as the standard strategy in patients with severe symptomatic aortic stenosis at high to intermediate risk.

Regarding anaesthesia strategy, he said, it is important to note that around 50% of TAVI procedures are performed under local anaesthesia with conscious sedation, and registry data has shown that this strategy is associated with lower morbidity and mortality, shorter intensive care unit (ICU) and overall hospital stays, and shorter procedure times.

In the randomised SOLVE-TAVI trial, 447 patients with severe, symptomatic aortic stenosis were assigned to transfemoral TAVI using either the

“Among high bleeding risk patients undergoing PCI with the XIENCE stent, a short DAPT regimen of one or three months compared with standard DAPT up to 12 months resulted in non-inferior ischaemic outcomes and similar rates of clinically relevant (BARC 2–5 ) bleeding, with a significant reduction in major (BARC 3–5) bleeding,” said Mehran. “Additionally, there was a very low incidence of stent thrombosis.”

In a press release issued alongside the XIENCE 90 and 28 results, Nick West, divisional vice president, medical affairs, and chief medical officer in Abbott’s vascular business, says: “Since the initial launch more than ten years ago, the XIENCE family of stents has become the gold-standard in coronary drug-eluting stents. With the Short DAPT programme, our goal is ultimately to find the optimal duration of use of blood thinning medication for individual patients by providing tailored treatment options to minimise the risk of potentially fatal bleeding events and to help them return to their daily lives as quickly as possible.”

Among high bleeding risk patients undergoing PCI with the XIENCE stent, a short DAPT regimen of one or three months compared with standard DAPT up to 12 months resulted in non-inferior ischaemic outcomes and similar rates of clinically relevant bleeding, with a significant reduction in major bleeding.”

SOLVE-TAVI shows higher rate of stroke for balloon-expandable valve

Sapien 3 (Edwards Lifesciences) balloon-expandable device, or the CoreValve Evolut R (Medtronic) self-expandable valve, as well as being randomised to either general or local anaesthesia. Patients were followed-up for one year for clinical outcome assessment and evaluation of echocardiographic valve function. The trial was powered to show equivalence of the primary endpoint for the valve comparison strategy as well as for the anaesthesia comparison.

The primary endpoint of the valve comparison strategy was the combined endpoint of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. For the anaesthesia strategy, the primary endpoint at 30 days was also a composite endpoint: it included all-cause mortality, stroke, myocardial

5

infarction, infections requiring antibiotic treatment, and acute kidney injury.

The results showed that at one-year follow-up, rates of all-cause death (17% vs. 17.6%; hazard ratio [HR] 0.96; 95% confidence interval [CI] 0.6 to 1.55), cardiovascular death (1.8% vs. 0.5%; HR 3.89; 95% CI 0.44 to 34.67), moderate or severe prosthetic valve regurgitation (4.5% vs. 7.0%; HR 0.63, 95% CI 0.27 to 1.45), and permanent pacemaker implantation (20.2% vs. 24.7%; HR 0.79; 95% CI 0.53 to 1.16) were similar between the balloon expandable and self-expandable valve groups, but the stroke rate was higher in the balloon expandable valve treated patients (6.9% vs. 1.0%; HR 7.13; 95% CI 1.62 to 31.32).

Feistritzer said: “We showed in the SOLVE TAVI trial that in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI, newer generation self-expanding compared to balloon expandable valves showed similar rates of a composite endpoint of all-cause death, stroke, paravalvular leakage and permanent pacemaker implantations. However, the stroke rates were higher in the balloon expandable valves.”

Regarding the anaesthesia strategy, Feistritzer noted that the results showed that local anaesthesia with conscious sedation compared to general anaesthesia resulted in a similar rate of all-case death, cardiovascular death, stroke, infarctions, infections and acute kidney injury.

6

February 2021 | Issue 60

Conference coverage

TCT CONNECT

PCI of non-flow-limiting vulnerable plaques is safe and enlarges follow-up lumen area A pilot randomised trial of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques in native coronary arteries—PROSPECT ABSORB—has found that PCI is safe, substantially enlarges follow-up lumen areas, and is associated with favourable long-term clinical outcomes. The findings were presented during a late-breaking trial session at TCT Connect 2020 (14–18 October, virtual) by Gregg Stone (Icahn School of Medicine, Mount Sinai, New York, USA).

PROSPECT ABSORB WAS AN investigator-sponsored, multicentre, single-blinded, active-treatmentcontrolled randomised trial embedded into the PROSPECT II study. Between June 2014 and December 2017, 902 patients at 16 sites were enrolled to validate the use of near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) imaging in identifying non-obstructive lipid-rich plaques prone to cause future cardiac events. Data from PROSPECT II were also presented during the TCT session.

Stone reported that acute coronary syndromes (ACSs) commonly arise from plaque rupture and thrombosis of coronary artery lesions that angiographically appear mild, but pathologically contain large plaque burden (PB) with an organised lipid-rich necrotic core that is separated from the lumen by a thin fibrous cap. Known as vulnerable plaques, these put patients at risk for future adverse events, including acute myocardial infarction (MI) and cardiac death.

During the study, three-vessel imaging was performed with a combination of IVUS and NIRS catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with MI. Among these, 182 patients at 15 centres with an angiographically non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65% were randomised to treatment of the lesion with an Absorb (Abbott) bioresorbable vascular scaffold (BVS) plus guidelinedirected medical therapy (GDMT) (n=93) vs. GDMT alone (n=89).

The primary effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at 25-month follow-up. The primary (non-powered) safety endpoint was target lesion failure (TLF).

The follow-up MLA in BVS-treated lesions was 6.9±2.6mm2 compared with 3±1.0mm2 in GDMT-alone-treated lesions. TLF at 24 months occurred in similar rates of BVS-treated and GDMTtreated patients (4.3% vs. 4.5%; p=0.96).

“The results from PROSPECT ABSORB indicate that PCI of

Acurate neo fails to meet non-inferiority compared to Evolut in SCOPE II trial Findings of the SCOPE II clinical trial, which were presented during a late breaking trial session at TCT Connect 2020 (14–18 October, virtual), have shown that the Acurate neo (Boston Scientific) transcatheter aortic valve failed to demonstrate non-inferiority compared to the CoreValve Evolut (Medtronic) valve.

The findings were presented by Corrado Tamburino (University of Catania, Catania, Italy) and were simultaneously published in Circulation.

ACCORDING TO TAMBURINO, THE TWO valves differed in technical characteristics, such as degree of aortic regurgitation, and the need for new permanent pacemaker implantation.

SCOPE II enrolled a total of 796 patients aged 75 years or older with symptomatic severe aortic stenosis and indication for transfemoral transcatheter aortic

(l-r) Gregg Stone and David Erlinge present at TCT Connect 2020

vulnerable plaques may safely enlarge the lumen and change the structure of the lesion, theoretically reducing its propensity for thrombosis and progression,” said Stone, who served as study co-chair alongside David Erlinge (Lund University, Lund, Sweden).

The favourable lesion-related MACE rates observed after BVS treatment warrants investigation in a randomised trial to determine whether PCI treatment of vulnerable plaques improves patient outcomes, Stone added.

High lipid content, along with large plaque burden and small lumen area, may be added as prognostic indices of vulnerable plaques that put patients at risk for adverse outcomes.”

valve implantation (TAVI) from 23 tertiary heart centres located in Denmark, France, Germany, Italy, Spain and the UK. Participants in the study were randomly assigned (1:1) to receive either the Acurate neo or CoreValve Evolut devices. The primary safety endpoint of the trial, powered for non-inferiority of the Acurate neo valve using a non-inferiority margin of 6%, was the composite of all-cause mortality or stroke at 12 months. The primary efficacy endpoint, powered for superiority, was new permanent pacemaker implantation at 30 days.

Secondary endpoints included clinical efficacy and safety endpoints at 30 days and 12 months.

In the intention-to-treat analysis, death or stroke at one year was 15.8% in the Acurate neo group compared to 13.9% in the CoreValve Evolut group, while in the per-protocol analysis it was 15.3% vs.

14.3%. Non-inferiority of the Acurate neo was not met for the primary endpoint in the intent-to-treat analysis, while it was met in the per-protocol analysis.

Based on the pre-specified statistical plan, due to these inconsistent results, non-inferiority was not established for the primary endpoint.

New pacemaker implantation at 30 days was 10.5% with Acurate neo compared to 18% with CoreValve Evolut (Risk Difference -7.5%, 95% confidence interval [CI] -12.4–-2.60, p= 0.0027). Cardiac death at 30 days (2.8% vs 0.8%, p=0.03) and one year (8.4% vs 3.9%, p=0.01) was greater in the Acurate neo group.

Earlier in the session, Erlinge presented data from the PROSPECT II study, which found that NIRS-IVUS intracoronary imaging could be a useful tool in identifying angiographically non-obstructive lesions with high-risk characteristics for future adverse cardiac outcomes. According to Erlinge, recent studies have suggested that lipid-rich plaques detected by intracoronary NIRS imaging are associated with adverse outcomes, and identifying these vulnerable plaques before they progress may help to inform pharmacologic or other strategies to stabilise the plaque.

PROSPECT II involved imaging of all three coronary arteries using a combination NIRS-IVUS catheter in patients with recent myocardial infarction who had undergone successful treatment of all flow-limiting lesions.

The lipid content of non-culprit lesions was assessed by NIRS, and IVUS assessment was also performed.

“In PROSPECT II, lipid-rich plaques, as detected by NIRS, identified angiographically mild non-flow limiting lesions responsible for future coronary events,” said Erlinge. “High lipid content, along with large plaque burden and small lumen area, may be added as prognostic indices of vulnerable plaques that put patients at risk for adverse outcomes.”

TAVI with the Acurate neo valve did not meet noninferiority compared with the CoreValve Evolut bioprosthesis with respect to a composite of death or stroke at one year.”

The rate of moderate-severe aortic regurgitation was 9.6% vs. 2.9% (p<0.0001) at 30 days and 4% vs. 3.3% (p<0.0001) at one year.

“TAVI with the Acurate neo valve did not meet non-inferiority compared with the CoreValve Evolut bioprosthesis with respect to a composite of death or stroke at one year,” Tamburino told TCT Connect attendees. “In a secondary analysis with limited statistical power, cardiac death was increased at one year in patients who received the Acurate neo valve.

The two valves also differed with respect to technical characteristics such as degree of aortic regurgitation and need for new permanent pacemaker implantation.”

Issue 60 | February 2021

Conference coverage

TCT CONNECT

Late-breaking science is alive and well despite the pandemic Late-breaking science is alive and well despite the COVID-19 pandemic. That was the conclusion drawn from the first virtual edition of the Cardiovascular Research Foundation (CRF) annual scientific symposium—TCT Connect 2020 (14–18 October, virtual)—which continues to be an important fixture in the interventional cardiology calendar, despite being the latest in a long line of virtual meetings in 2020.

I

n the aftermath of the symposium, Cardiovascular News spoke to TCT faculty and attendees to gather their views on the takeaways from the meeting.

“At the beginning, we were a little bit concerned that people are digitally tired, and because of this perhaps people would not really be interested in digital platforms,” said Juan Granada, president and chief executive officer of CRF. “But, I have to tell you that the response was overwhelming, it was a very positive response.”

According to Granada, the digital platform enabled many attendees to join the meeting who may have been unable to attend in a physical format. He said: “Thanks to the digital platform, a big proportion of the attendees were people that never actually participated in TCT before, which is extremely exciting because it removes the limitation of coming to these meetings.”

Picking out the important messages from the research presented across the four-day event, Granada commented that the “concept of vulnerable plaque is back”, referring to late-breaking studies including PROSPECT II and PROSPECT Juan Granada ABSORB. Granada said: “The concept of having some plaques that are not recognised by angiography and actually are going to cause events, that concept is back and I really think that is going to reignite the field of vulnerable plaque research—a field that has been dormant since PROSPECT.” Granada also pointed to head-to-head studies comparing transcatheter aortic valve implantation (TAVI) platforms, including the SCOPE II and SOLVE TAVI trials. “I really think these trials are necessary, as happened with stents, to be able to pick up the technical and outcome difference between these different technological platforms,” Granada said. In terms of data on drug-eluting stents, Granada noted the significance of the XIENCE 28/90 study, presented on day two of the symposium by Roxana Mehran (Icahn School of Medicine, New York, USA).

Furthermore, Granada highlighted two proof-of-principle studies involving the Mitraclip (Abbott) device: one on the viability of treating patients with cardiogenic shock in acute mitral regurgitation—“The fact that we have a technology that could potentially help those patients is very encouraging”—and a second on the use of Mitraclip in patients with end stage heart failure undergoing transplant.

According to Granada’s fellow TCT course director Ajay Kirtane (Columbia University Vagelos College of Physicians and Surgeons, New York, USA), “first and foremost, it was just so great to be able to see new science and to connect with colleagues around the globe. So much has been missed—in life—during the pandemic, and while our focus should always be on COVID-19, we know that we can help people in so many ways through the diagnosis and treatment of cardiovascular disease. So in this way, it was great to feel invigorated with our field again.”

Turning to the scientific programme, Kirtane said: “On the coronary side, I really felt that the emphasis on adjunctive imaging and physiology guidance was palpable.

We want to optimise outcomes for our patients and more data are emerging that this is the way to ensure it.”

Speaking to Cardiovascular News, Davide Capodanno (University of Catania and G Rodolico-San Marco, Catania, Italy) commented that the wealth of research on display is proof that, despite the pandemic, research in

cardiovascular medicine remains strong.

“The first take-home message for me is that latebreaking science is alive and well despite the pandemic,” he said. “One would have expected a major impact on the number of trial submissions, which did not happen: good news.” He also pointed to a trend of trials returning neutral results, as seen in coronary device trials. “Event rates are so low in control arms that it is difficult for an investigational arm to improve: this explains why we are seeing more and more non-inferiority designs and neutral results. There is a need for some breakthrough concepts and technologies in the quest for improvement, but for me these results speak also for the great achievements of medical therapy in secondary prevention nowadays, and the benefit of appropriate revascularisation according to the heart team principle.”

Mamas A Mamas (Keele University, Stroke-on-Trent, UK) described the FORECAST randomised trial, investigating the use of fractional flow reserve management derived from Ajay Kirtane computed tomography (FFRCT), as “big news”. He said: “CT FFR was compared to routine algorithms for assessment of stable coronary disease with resource utilisation as a primary endpoint. The study showed no differences in this outcome, or angina, or clinical endpoints such as major adverse cardiac and cerebrovascular events (MACCE). It is still an important study in that it showed a 20% reduction of coronary angiography for patients, thereby potentially reducing radiation dose, but also procedural risks from an angiogram, which may be low but are still significantly higher than a non-invasive test.”

Mamas highlighted the PROSPECT studies as opening “an important avenue of focus”, adding that trials targeting high-risk lesion phenotypes “must be in the wings”.

Elsewhere, he also pointed to the ULTIMATE trial, which compared intravascular ultrasound (IVUS)-guided versus angiography-guided implantation of drug-eluting stents.

Summing up his thoughts he said: “To my mind the takehome message is that interventional meetings will never be the same again. We had late-breaking trials, live cases, state-of-the-art technology, and scientific contents and CPD all delivered in a virtual environment, available to anyone across the globe in real-time but also on demand. This meeting will change how we deliver educational content.”

The first take-home message for me is that late-breaking science is alive and well despite the pandemic. One would have expected a major impact on the number of trial submissions, which did not happen: good news.”

Highlights from TCT Connect 2020 A quick-fire round-up of some of the stories you might have missed from TCT Connect 2020.

DISRUPT CAD III meets safety and effectiveness endpoints Results from Disrupt CAD III—the coronary Investigational Device Exemption (IDE) study of intravascular lithotripsy (IVL) for the management of heavily calcified coronary arteries using the Shockwave Coronary IVL system (Shockwave Medical)— showed that the study met primary safety and effectiveness endpoints.

The study enrolled 384 patients at 47 sites in the USA, France, Germany, and the UK, including 100 patients in an optical coherence tomography (OCT) sub-study.

DISRUPT CAD III

92.4% Procedural success

MITHRAS trial finds interventional iASD closure non-superior to conservative therapy Interventional closure of an iatrogenic atrial septal defect (iASD) driven by transcatheter mitral valve repair (TMVR) was not superior to conservative medical treatment with regard to the primary endpoint of change in six-minute walking distances, according to the findings of the MITHRAS randomised clinical trial presented during a late-breaking clinical trial session at TCT Connect 2020.

7

8

February 2021 | Issue 60

Coronary interventions

Raising the bar for competency in high-risk coronary procedures Rhian Davies

Chronic total occlusion (CTO) PCI is arguably the most challenging subset managed by high-risk coronary operators.

While the CTO PCI success rates have been relatively stagnant at around 50‒60% for all-comers, the goal of additional training is to produce operators with the ability to achieve >80% success rates that have been demonstrated in CTO PCI registries.6,17–22 rAlthough there are limited data on the learning curve of CTO PCI, there appears to be an inflection point at which improvements in technical success occurred around 120‒125 cases/CTO operator.23

Complications

Comment & Analysis Rhian Davies (University of Washington Medical Center, Seattle, USA) discusses a recent paper considering the importance of training in high-risk percutaneous coronary intervention (PCI) procedures, as well as a renewed interest in both the development of this skillset outside of fellowship and maintenance of competency.

T

he objective of our recent article in Catheterization and Cardiovascular Interventions, “Training in high-risk coronary procedures and interventions: Recommendations for core competencies,” was the desire to standardise the experience of fellowship training in high-risk interventions.1 As fellows leave their respective interventional fellowships, a wide variation of skillsets exists. Therefore, the goal of a high-risk fellowship was to ensure operators interested in highrisk intervention would receive the full complement of skills to successfully perform appropriately indicated PCI in a safe and effective manner with the ultimate desire to improve patient care and outcomes. Of note, these recommendations were developed from review of available data and input from a cohort of high-volume high-risk operators, proctors, high-risk fellowship directors, former and current high-risk fellows.

Development

With the release of this article, there has been renewed interest in both the development of this skillset outside of fellowship and maintenance of competency. Importantly, this article only addresses the skillsets and volume necessary to attain competency during a dedicated coronary fellowship training year in addition to the conventional Accreditation Council for Graduate Medical Education (ACGME)-approved year. We acknowledge that several operators (including several of the authors) have developed successful programmes without this additional fellowship and that there are multiple ways to attain competency in high-risk intervention, including a combination of courses, books, instructional videos, and proctorship.2–4 However, for a junior operator to safely tackle the complexity of these cases that are typically only performed by the most experienced

operators, we felt that the bar needed to be set high.

Apart from procedural volume, maintaining competency is dependent on developing an infrastructure that supports the maintenance of skill and an operator’s desire for further growth. Some components of a successful programme include administrative support, buyin from colleagues, dedicated time, dedicated cath lab staff, and a referral network. Additionally, the field of interventional cardiology is rapidly evolving—therefore it is important to be engaged in mentorship, teaching, and research.

Procedural volume

Numerous reports from databases, such as the National Commissioning Data Repository (NCDR), demonstrate a clear association between improved outcomes, particularly for high-risk interventions, and higher operator procedural volume.5–8 To produce outcomes exhibited in clinical trials and registries, it is imperative that operators have the procedural volume to develop and maintain a high-risk skillset.

These recommendations were made based on available data to provide the best care for patients who are at higher risk of experiencing an adverse event but also potentially have the most to gain from high-risk intervention.9 In regard to our unprotected left main (ULM) recommendations, data suggest a difference in mortality based on an operator volume of 15 ULM PCI cases per year.10 The DKCRUSHV trial, which evaluated ULM with distal bifurcations, required operators perform ≥300 PCIs per year for five years with at least 20 ULM PCIs per year.11 As target lesion revascularisation has been an ongoing challenge for PCI, it is imperative that operators are facile with both use and understanding of intravascular imaging. Imaging, more specifically intravascular ultrasound (IVUS), has been shown to change PCI strategy and reduce MACE.12–16

Given it is more commonly encountered in the peri-procedural period with highrisk intervention, it is important that operators are well-versed in both the institution of haemodynamic support and management of heart failure and cardiogenic shock. While occurrence of complications should decrease with proficiency, complications may

Apart from procedural volume, maintaining competency is dependent on developing an infrastructure that supports the maintenance of skill and an operator’s desire for further growth.” arise more frequently with high-risk interventions. Therefore, the ability to manage complications can contribute significantly to reduction in morbidity and mortality. However, it is possible that not all of the complications— including urgent pericardiocentesis, coil embolisation, fat embolisation, and snaring—can be directly observed or managed during the course of a single year of training. We therefore emphasise the importance in developing algorithms to manage these conditions.

Occasionally, some of these skills can be learned in non-emergent situations—for example: coiling an unnecessary graft when competitive flow is present from a newly re-opened native coronary vessel.

Fellowship

One pathway to allow operators to develop a high-risk skillset is through a high-risk PCI fellowship. Fellowship provides a safe environment that allows trainees high procedural volume, teaching, and mentorship to attain competency in a shorter timeframe. It goes without being said that the field of interventional cardiology opens the door

to a lifelong learning opportunity with a personal overall goal of improving our skills in order to provide the best possible patient care.

I gratefully acknowledge all the coauthors who participated in this initiative.

I would also like to give special thanks to Ajay Kirtane (Columbia University Irving Medical Center, New York, USA) and William Lombardi (University of Washington Medical Center, Seattle, USA) for their mentorship.

References 1. Davies RE., Prasad M, Alaswad K, et al. Training in high-risk coronary procedures and interventions: Recommendations for core competencies. Catheter Cardiovasc Interv 2020.

2. Riley RF, Henry TD, Kong JA, et al. A CHIP fellow’s transition into practice: Building a complex coronary therapeutics program. Catheter Cardiovasc Interv 2019:ccd.28599.

3. Riley RF. Complex, Higher-Risk, and Indicated PCI (CHIP) Fellowship: Putting Training Into Practice. J Am Coll Cardiol 2020:980–4.

4. Tajti P, Brilakis ES. Chronic Total Occlusion Percutaneous Coronary Intervention: Evidence and Controversies n.d.

5. Fanaroff AC, Zakroysky P, Wojdyla D, et al. Relationship between Operator Volume and Long-Term Outcomes after Percutaneous Coronary Intervention: Report from the NCDR CathPCI Registry. Circulation 2019;139(4):458–72.

6. Brilakis ES, Banerjee S, Karmpaliotis D, et al.

Procedural Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention: A Report From the NCDR (National Cardiovascular Data Registry). 2015.

7. Beohar N, Kaltenbach LA, Wojdyla D, et al. Trends in Usage and Clinical Outcomes of Coronary Atherectomy: A Report from the National Cardiovascular Data Registry CathPCI Registry. Circ Cardiovasc Interv 2020; 13 (2).

8. Valle JA, Tamez H, Abbott JD, et al. Contemporary Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention in the United States: An Analysis of the National Cardiovascular Data Registry Research to Practice Initiative. JAMA Cardiol 2019; 4 (2): 100–9.

9. Kirtane AJ, Doshi D, Leon MB, et al. Treatment of higher-risk patients with an indication for revascularization. Circulation 2016; 134 (5): 422–31.

10. Xu B, Redfors B, Yang Y, et al. Impact of Operator Experience and Volume on Outcomes After Left Main Coronary Artery Percutaneous Coronary Intervention. JACC Cardiovasc Interv 2016.

11. Chen SL, Zhang JJ, Han Y, et al. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. J Am Coll Cardiol 2017.

12. Hong SJ, Mintz GS, Ahn CM, et al. Effect of Intravascular Ultrasound–Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial. JACC Cardiovasc Interv 2020; 13 (1): 62–71.

13. Witzenbichler B, Maehara A, Weisz G, et al.

Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: The assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study.

Circulation 2014; 129 (4): 463–70.

14. Elgendy IY, Mahmoud AN, Elgendy AY, Bavry AA. Outcomes with intravascular ultrasound-guided stent implantation. Circ Cardiovasc Interv 2016; 9 (4).

15. Zhang J, Gao X, Kan J, et al. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol 2018; 72 (24): 3126–37.

16. Choi KH, Song Y Bin, Lee JM, et al. Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC Cardiovasc Interv 2019; 12 (7): 607–20.

17. Young MN, Secemsky EA, Kaltenbach LA, et al. Examining the Operator Learning Curve for Percutaneous Coronary Intervention of Chronic Total Occlusions: A Report from the National Cardiovascular Data Registry. Circ Cardiovasc Interv 2019; 12 (8): 1–10.

18. Mashayekhi K, Nührenberg TG, Toma A, et al. A Randomized Trial to Assess Regional Left Ventricular Function After Stent Implantation in Chronic Total Occlusion. JACC Cardiovasc Interv 2018; 11(19): 1982–91. Doi: 10.1016/j.jcin.2018.05.041.

19. Werner GS., Martin-Yuste V., Hildick-Smith D., et al. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J 2018;39(26):2484–93..

20. Maeremans J., Walsh S., Knaapen P., et al. The Hybrid Algorithm for Treating Chronic Total Occlusions in Europe. J Am Coll Cardiol 2016;68(18):1958–70. Doi: 10.1016/j.jacc.2016.08.034.

21. Sapontis J, Salisbury AC, Yeh RW, et al. Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty. JACC Cardiovasc Interv 2017; 10 (15): 1523–34.

22. Tajti P, Karmpaliotis D, Alaswad K, et al. The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention. JACC Cardiovasc Interv 2018; 11 (14): 1325–35.

23. Thompson CA, Jayne JE, Robb JF, et al. Retrograde Techniques and the Impact of Operator Volume on Percutaneous Intervention for Coronary Chronic Total Occlusions. An Early U.S. Experience. JACC Cardiovasc Interv 2009; 2 (9): 834–42.

9

Issue 60 | February 2020

Cardiovascular surgery More randomised trials needed in cardiothoracic surgery, says EACTS president

The president of the European Association For Cardiothoracic Surgeons (EACTS) has called upon cardiothoracic surgeons to participate in more randomised controlled trials to elevate the quality of research carried out in the specialty. Peter Licht (Southern Danish University, Odense, Denmark) made the comments in his presidential address at the 34th EACTS annual meeting (EACTS 2020, 8–10 October, virtual).

“F

or years the level of evidence has been poor in many surgical specialties,” Licht commented, highlighting a 1996 editorial in The Lancet, which compared surgical research to a “comic opera”, stating that “although surgeons have many questions, they provide few answers”.

In the article, explained Licht, the journal's editor Richard Horton compared the output of nine major surgical journals, and found that the majority of published manuscripts were case series. “Only 7% of original research papers reported data from clinical trials,” commented Licht.

“Case series are without a doubt an important contribution to surgical research but Horton questioned whether we can trust this study method to yield valid results. The answer is no,” the EACTS president added.

“Although many landmark surgical innovations have been reported for the first time as a case report or small case series, these initial studies do not demonstrate clear evidence of efficacy. And, as we will be increasingly required to demonstrate and document the safety and effectiveness of our surgical treatments, the best way to provide this is through randomised trials that are at the peak of the evidence tree.

“Randomised trials, however, are rare in cardiothoracic surgery and unfortunately, even when they are completed, many are, by virtue of design, sample size and insufficient power, incapable of answering the questions that researchers aim to address.

“I looked at the methodology used in general thoracic papers as it appeared in the three highest ranking journals in cardiothoracic surgery. During the first three

months issued from each journal 10 years after the publication of editorial in The Lancet, only 5% of original thoracic papers reported data from a clinical trial. And, apart from one study that reported secondary outcomes from a previously reported large clinical trial, most of them were small in numbers,” he said.

Over 20 years on from the publication of the article, and the picture has not improved vastly, Licht commented. “In this month’s issue of all three journals there was not a single clinical trial. So the majority of thoracic research continues to be non-randomised, [and] non-controlled, which Horton in his Lancet editorial was concerned about, because they are the weakest scientific evidence, and may be regarded hopelessly invalid because of uncontrolled bias.”

However, Licht did acknowledge that randomised trials can be challenging in a surgical field, due to difficulties in standardisation of approach. “Valid conclusions can only be achieved if the intervention of a study is standardised and that is rare in surgery because skills and expertise vary between surgeons.

It is much easier when a drug is investigated, because the drug is the same every time, and blinding is trivial when you use placebo drugs, but almost impossible in surgery, where it may be unacceptable not to operate, or unethical to perform a sham operation.”

Furthermore, he called for more collaboration among healthcare centres and societies to advance surgical research. Licht said: “To retain our academic reputation thoracic surgeons in Europe should explore new ways to collaborate, not just for educational opportunities, but also for research.

“Our associations should explore ways to provide the necessary infrastructure to facilitate research networks among thoracic surgeons.

Platforms where we can recruit more centres and where trialists, experts, and epidemiologists can advise us on how to improve our research.”

To retain our academic reputation thoracic surgeons in Europe should explore new ways to collaborate, not just for educational opportunities, but also for research.”

EACTS president Peter Licht has called for more randomised trials in cardiothoracic surgery

Cardiothoracic surgery “stifled” during COVID-19 pandemic Reduced effectiveness of treatment and increased running costs are likely to have driven down the cost‐effectiveness of cardiac care during the COVID‐19 pandemic, according to an editorial published in the Journal of Cardiac Surgery.

THE PAPER, AUTHORED

by Fatima Osman and Mohamad Bashir (Royal Blackburn Teaching Hospital, Blackburn, UK), suggests that the delivery of cardiovascular care has been stifled during the pandemic to adhere to infection control measures as a way of protecting patients and the workforce at large.

They note that a combination of postponement of elective cardiovascular surgeries, reduced acute care, and long-term cardiac damage directly resulting from COVID-19 will likely have increased the demand for cardiac care, particularly from patients presenting with more severe symptoms.

The combination of increased demand and inhibited supply will likely result in huge backlog of unmet patient needs, they write.

Writing from a UK-perspective, the authors of the study suggest that the long-term impact of the COVID-19 pandemic on the field of cardiothoracic surgery will include stunted development of the field in the UK, with trainees experiencing delayed progression as a result of reduced operative exposure and cancellation of examinations and teaching.

The authors also point to limitations to remote consultations, including not being able to examine patients, inability to measure real-time basic observations such as heart rate and blood pressure, and connectivity issues, which all reduce the amount of information available to capture.

Furthermore, they add, clinical research has seen significant delays due to the challenges of monitoring and recruiting study participants whilst conforming to social distancing guidelines.

Additionally, they note that a combination of postponement of elective cardiovascular surgeries, reduced acute care and long-term cardiac damage directly resulting from COVID-19 will likely cause increased demand for cardiac care, particularly from patients presenting with more severe symptoms.

They write: “There is robust evidence that COVID-19 has bottlenecked the supply of cardiac care; for example, a recent survey has shown that 36% of primary PCI [percutaneous coronary intervention] centres have needed to close during the pandemic.

The combination of increased demand and inhibited supply means that it will likely take a number of years for cardiology to recover from the impact of the pandemic.”

10

February 2021 | Issue 60

Cardiovascular surgery Paying patients less likely to develop complications after cardiac surgery Paying patients are 20% less likely than NHS patients to die or develop major complications, such as reintervention or stroke, after cardiac surgery, according to a study published in The Lancet Regional Health – Europe. Researchers say that the findings cannot be explained by socioeconomic factors alone.

THE STUDY, LED BY Benedetto. academics at the University of Researchers used data from Bristol (Bristol, UK), looked at the National Adult Cardiac data from over 280,000 patients Surgery Audit (NACSA) who underwent adult cardiac registry. They looked at several surgery over a ten-year period outcomes including in-hospital from 2009‒2018 at 31 NHS mortality, incidence of in-hospital cardiac units. Of these 5,967 were postoperative cerebrovascular private payers and 274,242 were accident (CVA), renal dialysis, government-funded. sternal wound infection, and rePrivate payers are treated by the exploration. same clinical teams but To eliminate can request their surgeon socioeconomic status as and when to have the sole or primary cause surgery. They also have of difference in clinical access to ‘Cinderella outcomes between private services’. and NHS payers, they Umberto Benedetto, used information on associate professor socioeconomic status Umberto Benedetto linked to the Iteration of in cardiac surgery at Bristol Medical School: the English Indices of Translational Health Sciences Deprivation (IoD).

(THS), at the University of Bristol, Arnaldo Dimagli, honorary is an NHS cardiac surgeon and research fellow at the University joint lead author of the research. of Bristol and joint lead author He said the study posed important said: “Our findings support questions about why there is a the hypothesis that a complex significant disparity in health interaction between socioeconomic outcomes between governmentand health system-related factors funded patients and those accessing exists for patients undergoing NHS healthcare through a cardiac surgery. This should private-payer scheme, even after stimulate further investigations socioeconomic factors had been in order to identify interventions considered. which can tackle health “These are patients who are inequalities. For example, it is treated in the same hospitals, by possible that NHS payers have to the same clinical teams, and yet wait longer to get their operation. we have found stark differences This can expose them to the risk of in survival between those who deterioration before surgery which pay and those who do not,” said can affect their outcomes.”

It is tempting to assume this is due to private payers having a more affluent and therefore better quality of life with fewer comorbidities. However, after analysing the data, we found evidence supporting the hypothesis that private patients receive a better care.”

Early feasibility study of pulmonary valved conduit shows positive results in paediatric patients WL Gore has announced encouraging clinical results from its early feasibility study evaluating the safety and performance of its pulmonary valved conduit (PVC), an investigational device. Six-month data for 16 patients enrolled across three sites in the USA were presented in a moderated poster session at the American Heart Association 2020 Scientific Sessions (13–17 November, virtual).

E

arly feasibility study subjects ranged in age from six to 17 years old with an average age of 11.5±3.7 years old.

There were seven males and nine females with various forms of underlying congenital heart disease requiring an operation for initial or repeat replacement of the pulmonary valve and right ventricular outflow tract (RVOT). The primary endpoint, a composite of freedom from valve-related mortality and device-related reintervention at six months, was successfully achieved in all patients.

In addition, there was no calcification and/ or endocarditis detected on the valves or conduits and excellent haemodynamic performance was demonstrated. Subjects will be followed clinically and with yearly echocardiograms up to five years to further assess long-term performance. Data from this study will be submitted to the US Food and Drug (FDA) to support future consideration of a pivotal investigational device exemption study, potentially leading to commercial approval.

“As has been demonstrated in the literature, current treatment options using biologic tissue leaflets for these procedures have very high failure and reintervention rates particularly in younger patients,” said Mark Galantowicz, the presenting investigator and chief of Cardiothoracic Surgery and co-director of The Heart Center at Nationwide Children's Hospital, Columbus, USA. “These early results are quite encouraging and indicate patients, especially paediatric patients who have traditionally needed multiple open replacements of traditional biologic tissue valves, may soon have a new option available.”

The early feasibility study evaluated Gore’s PVC device in patients whose native pulmonary valve or previously repaired RVOT required replacement or reconstruction with a valved conduit. Patients in need of RVOT reconstruction are most often younger patients and have underlying complex congenital heart defects. If left untreated, native pulmonary valve regurgitation or progressive RVOT obstruction typically leads to shortness of breath, lower quality of life and damage to the right ventricle. Even

after effective initial replacement, many patients with these conditions will undergo multiple open heart surgeries for replacement of failed or outgrown conduits throughout their childhood and teenage years. Early conduit failure necessitates additional conduit replacements which further contribute to the adverse effects of the underlying disease on quality of life and long-term survival.

Gore is hopeful the potential calcification resistance and durability of its biosynthetic leaflets could reduce risks related to premature graft failure in these patient populations. “Having been a paediatric heart surgeon, I appreciate the need for durable options to treat these challenging patients,” commented John Laschinger, Gore’s cardiac chief medical advisor. “Today, even using the best options available, conduit failure can occur in under two years, and multiple reoperations are often necessary. We are hopeful this purpose-built heart valve solution may provide step-wise improvement for patient care.”

Gore's PVC device

These early results are quite encouraging and indicate patients, especially paediatric patients who have traditionally needed multiple open replacements of traditional biologic tissue valves, may soon have a new option available.”

CONTROVERSIES

CHALLENGES

CONSENSUS

Vascular & Endovascular

Controversies Update

19â&#x20AC;&#x201C;22 APRIL 2021 MOND AY-TH U RSD AY Aortic Controversies

Peripheral Arterial Controversies

Venous & Lymphatic Controversies

Acute Stroke Controversies

Interdisciplinary Leg Initiative

Vascular Access Controversies

Controversies

DIGITAL EDITION WWW.CXSYMPOSIUM.COM REGISTR ATION NOW OPEN Early bird rates available until 21 March 2021

CX 2021 will be streamed live daily with audience participation, discussion and polling

EDUCATION

INNOVATION

EVIDENCE

February 2021 | Issue 60

12 Interview

Profile

Stephan Achenbach Stephan Achenbach is professor of medicine at the University of Erlangen, Erlangen, Germany and president of the European Society of Cardiology (ESC). A specialist in cardiac imaging, he talks to Cardiovascular News about how imaging techniques have evolved over the course of his career, and the biggest developments he has witnessed in interventional cardiology.

Why did you decide to become a doctor and why, in particular, did you choose to specialise in cardiology?

While I initially set out to study physics, working in a hospital for a few weeks convinced me that medicine would be much better—so I dropped physics, signed up for medical school and never looked back! An enigmatic cardiology lecturer in medical school, Kurt Bachmann, got me so interested in the subject that I selected a cardiology topic for my doctoral thesis and it has been cardiology ever since. As usual, it was a mixture of the subject itself and the people I met which drew me in that direction.

Who have been your career mentors?

Werner Moshage, who was passionate about a thorough approach to patient care, was an early mentor in clinical cardiology. Also influential were the two department chairs under whom I received my cardiology training, Professor Kurt Bachmann and Professor Werner Daniel. I also owe a lot to Tom Brady (Massachusetts General Hospital, Boston, USA) and Christian Hamm (Bad Nauheim and Giessen, Germany), as well as my colleague Holger Nef who was inspirational in his enthusiastic attitude towards innovation in interventional cardiology. However, I find it particularly important to mention the countless peers and co-workers during my many years of training and practice and who, through thousands of encounters—directly or indirectly—taught me countless little lessons.

What has been the most important development in cardiology during your career?

There are so many important developments to mention.

I was able to witness first-hand the development of interventional cardiology, from the availability of simply coronary balloon angioplasty, all the way up to transcatheter valve repair. Another very impactful development I have witnessed is the disappearance of thrombolysis, replaced by primary percutaneous coronary intervention (PCI). Also, I was lucky to be part of the tremendous development of cardiac imaging during the past quarter of a century. These more technological advances were accompanied by unimaginable developments in drug treatment— recognising the value of statins or the advent of new heart failure medications to mention just two. When I started my training in 1993, ACE inhibitors had just come out and prescribing them was a courageous adventure that included having to perfom a “captopril test” in every patient. Also, and hard to imagine today, statin therapy was not a given. The 4S study, establishing simvastatin for lipid-lowering treatment in patients with established coronary disease, was only published in 1994 and I witnessed the ever-deeper penetration of statins and ever decreasing goals for LDL-cholesterol. I would estimate that statins had the strongest impact on the outcome of heart disease patients during the three decades of my career.

What has been the biggest disappointment? Something you hoped

would change practice but did not?

Lots of valuable lessons have been learned from bioresorbable vascular scaffolds. It is very difficult to improve something that is already very good. And, very early data is frequently also very optimistic data.

You have been a pioneer of cardiovascular imaging – what has been the biggest development in this area in the last decade, and what will be the biggest development of the next decade?

All imaging modalities continue to evolve—often quietly. I am convinced that echocardiography, magnetic resonance, and computed tomography will continue to do so, providing constant improvements in image quality. The biggest development will certainly be the use of artificial intelligence in image interpretation, detecting more than the human eye can see.

What are your current research interests?

Currently, my main areas of interest are a combination of cardiac imaging and coronary as well as structural

One does not have to be a genius to be a good doctor. It is those who are thorough, accurate and meticulous, and who show true empathy for their patients who are the best doctors.

And if you are good at what you do, you´ll almost certainly enjoy it” heart intervention. Here, I can combine my research interests and clinical passion.

What are the key unanswered questions around the field that future research should prioritise?

There are so many, but I can name a few obvious ones: can we identify patients who benefit from revascularisation—maybe by combining information on ischaemia with “plaque vulnerability”? Who really needs a statin and how intensively? Who benefits from aspirin? Who is a good candidate for transcatheter aortic valve implantation (TAVI), and who is better served with open heart surgery? It all boils down to the use of imaging to allow us to practice “precision” or “personalised” medicine.

What has been the most important paper published in the past year?

Again, I can only name an example. EXPLORER-HCM impressed me deeply due to the fact that basic science taught the way to a targeted drug that seems to strongly influence patient outcome.

How has the COVID-19 pandemic impacted the field of cardiology?

In Germany, so far we have been able to practice cardiology and treat almost all of our patients according to usual practice in spite of the COVID-19 pandemic.

I am very grateful for this and for the strength of the German healthcare system. Let´s hope we will still be able to say this when this winter is over.

You are currently serving as the president of the European Society of Cardiology (ESC)—what will be your main areas of focus in this role?

At the moment, we have to keep the ESC strong in

Issue 60 | February 2021

Interview 13

the COVID-19 pandemic and we have to do whatever we can to serve and help our members as well as the cardiovascular community as a whole. The turn towards digital education is a small part of the issue. Otherwise, I will place focus on good communication and collaboration with the 57 national cardiac societies— from Iceland and Portugal to Russia and Kazakhstan, as well as from Sweden and Norway to Egypt and Morocco—that make up the ESC.

ESC has opted to host all of its events digitally in 2021. How has the advent of digital congresses changed medical education?

We had 120,000 registrants at the digital ESC 2020 congress. Online education has, for now, substantially increased the reach of educational offers. We simply reach more people. But, once we learn to use digital formats to their full potential, they will also increase educational impact through new modes of delivery, interactive design, focused and higher-intensity learning. The process has only just started. It was not caused by, but substantially accelerated by the COVID-19 pandemic. However, I am certain that physical congresses will “come back”, even though it will take quite a few years. The group experience of exchanging and learning jointly with others is very much appreciated by many.

Looking back over your career what has been your most memorable case?

I do remember several specific patients, not so much as “cases”, usually because of specific circumstances or personalities.

What advice would you give to someone looking to start a career in medicine?

One does not have to be a genius to be a good doctor. It is those who are thorough, accurate and meticulous, and who show true empathy for their patients, who are the best doctors. And, if you are good at what you do, you will almost certainly enjoy it.

alisonlang.com

Outside of medicine, what are your hobbies and interests?

Fact file Appointments

n Chairman, Department of Cardiology, University of Erlangen, Erlangen, Germany n Professor of Medicine, University of Erlangen, Erlangen, Germany n President, European Society of Cardiology (ESC) n Editor-in-Chief, Journal of Cardiovascular Computed Tomography

Education

n Doctor of Medicine, University of Erlangen, Erlangen, Germany

Awards

n Jan Brod Award for Clinical Research of the Medical School of Hannover, Germany (1999) n Thomas C Cesario Distinguished Visiting Professorship Award, University of California Irvine School of Medicine (2007)

n Simon Dack Award, American College of Cardiology (2009) n Gold Medal of the Society of Cardiovascular Computed Tomography (2015) n Sir Godfrey Hounsfield Award of the British Institute of Radiology (2016)

I have quite a few interests, which include photography, sports (running, swimming), and nature. And, I have good hopes for a future with enough spare time to enjoy all of these and more.

February 2021 | Issue 60

14 Antiplatelet therapy

Optimising pharmacology after transcatheter aortic valve replacement: Lessons from the POPular TAVI trial Harold Dauerman Rony Lahoud Newton Phuong Comment & Analysis Writing for Cardiovascular News, Harold Dauerman, Rony Lahoud and Newton Phuong from the University of Vermont Larner College of Medicine, Burlington, USA, reflect on the implications of the POPular TAVI trial and how it is shaping approaches to antiplatelet therapy after transcatheter aortic valve implantation (TAVI).

P

atients undergoing TAVI face dual risks: platelet dysfunction, thrombocytopenia and acquired von Willebrand’s disease are associated with enhanced bleeding complications yet platelet activation and thrombotic complications may also occur. During the first decade of TAVI, the default pharmacologic approach has been defined by the history of coronary intervention, foreign body mediated platelet activation and thrombosis concerns: thus, post TAVI patients are prescribed dual antiplatelet therapy for three‒six months (in situations that do not require oral anticoagulation).

This approach, though, may ignore two unique facts related to TAVI technology and patients: (1) Patients undergoing surgical bioprosthetic aortic valve replacement do not require dual antiplatelet therapy—why would a transfemoral bioprosthetic aortic valve require a different post procedure pharmacology than an open sternotomy bioprosthetic aortic valve? (2) Patients with severe aortic stenosis have a long, unique history of bleeding risk related to gastrointestinal dysplasia and acquired von Willebrand’s disease.

This enhanced bleeding risk is not routinely encountered in patients with acute coronary syndromes and coronary stenting. We have previously shown that patients undergoing TAVI have a unique haemostatic defect demonstrated by less thrombin generation and a significant prolongation of clotting-time consistent with a differential risk of bleeding compared to patients undergoing PCI for AMI. Randomised clinical trials are just now beginning to clarify optimal pharmacology with respect to the unique population and risk set, inherent in the severe AS population.

Recently, the POPular TAVI trial reported important findings from the randomised cohort A: 665 TAVI patients (with no indication for oral anticoagulation) were randomised to oral single versus dual antiplatelet therapy

(DAPT) for three months. The results are consistent with the hypothesis that TAVI patients present a unique and heightened risk of bleeding: 15.1% of patients receiving aspirin alone and 26.6% of patients receiving aspirin plus clopidogrel had bleeding events within 12 months of the procedure (p=0.001). It should be noted that a dual antiplatelet regimen resulted in increased bleeding across multiple severity classifications: minor, as well as major, life-threatening or disabling bleeding. The dual antiplatelet regimen also increased non-procedural bleeding (15.1% vs. 24.9%; p=0.005), somewhat strangely defined as nonBARC 4 related severe bleeds even if they occurred at the access site. A

While methods to safely prevent valve failure, thrombosis and stroke continue to be unclear, the clarity of these recent trials regarding bleeding risks and TAVI pharmacology have already changed our practice.” composite secondary outcome of nonprocedural bleeding and thromboembolic events (cardiovascular death, stroke, myocardial infarction) demonstrated superiority for aspirin vs. aspirin and clopidogrel (23% vs. 31%, p=0.04).

In addition to the somewhat unusual method of classifying procedural vs nonprocedural bleeding, two caveats should be noted: (1) The trial was not adequately

powered to compare thromboembolic complications alone. (2) The results can not comment on the influence of antiplatelet or anticoagulation therapy on potential valve failure due to leaflet thickening or thrombosis.

What if we used a shorter duration (ie, 30 days instead of three months) of dual antiplatelet regimen in an effort to mitigate thrombotic and bleeding risks simultaneously? POPular TAVI would not support such an approach. Nearly all bleeding events occurred in the first 30 days, with a majority of events actually occurring in the first 48 hours (67.4% and 76% of all bleeding events on dual or single antiplatelet regimen respectively).

Importantly, the risk of bleeding within 48 hours of the procedure was higher for patients on a dual vs. single therapy (18% vs. 11.5%, p=0.02).

These findings are consistent with three other recent trials that suggest no benefit for more intense antiplatelet therapy or anticoagulation as a routine strategy after TAVI: ARTE8, POPular TAVI cohort B9 and GALILEO trials10.

The ARTE trial included 222 TAVI patients randomised to single vs. double antiplatelet therapy. Patients on aspirin and clopidogrel had a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the aspirin group, p=0.038). The composite of death, MI, stroke, transient ischaemic attack, or major/life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065)8. In the randomised POPular TAVI cohort B (n=326)), there was a higher one-year incidence of bleeding among TAVI patients receiving oral anticoagulation plus clopidogrel than among those receiving oral anticoagulation alone (34.6% vs. 21.7%, p=0.01)9. Finally,

the GALILEO trial (N=1,644) of rivaroxaban plus three months of aspirin as compared with clopidogrel plus three months of aspirin after TAVI was stopped prematurely because of excess mortality in the rivaroxaban group10.

TAVI patient populations, technology and procedural simplifications have expanded dramatically over the past decade. As these recent trials demonstrate, it is time for post-TAVI pharmacology to similarly grow and clarify. The high burden of bleeding will continue to be a challenge in the severe aortic stenosis population. While methods to safely prevent valve failure, thrombosis and stroke continue to be unclear, the clarity of these recent trials regarding bleeding risks and TAVI pharmacology have already changed our practice. We currently use aspirin alone following TAVI, unless patients have had recent coronary stenting or indications for oral anticoagulation. We believe that the POPular TAVI trial will heighten clinical awareness of bleeding risks with routine intensive antiplatelet therapy after TAVI and lead to a future modification of both guidelines and clinical practice with respect to optimal post TAVI pharmacology.

Harold L Dauerman is professor of medicine at the University of Vermont Medical Center, Burlington, USA. Rony Lahoud is an assistant professor of Interventional Cardiology at The University of Vermont Medical Center, Burlington, USA. Newton Phuong is a cardiology fellow at The University of Vermont Medical Center, Burlington, USA. The authors report no relevant financial disclosures.

POPular TAVI was the cover story in the last issue of Cardiovascular News.

The results of the study challenge current recommendations on antiplatelet treatment, its authors claim.

October

2020 | Iss ue

Featured this issue:in

59 Conferen coverag ce e: ESC 2020 Congress

page 6

8

POPular T for aspir AVI trial prompts in-only a call n strategy post-TAV tiplatelet I

Authors of transcath a study looking at differe ete reflect the r aortic valve nt approa imp in these ir finding that asp lantation (TAVI) ches to antiplatele patients, rather tha irin alone leads to say that guideline t therapy after n using bo s should few be rewritt th aspirin er bleeding and his was amo en and clopid thrombo ng the find embolic to TAVI tria ings of the ogrel. events l, presente POP

T

ular d during a at the 202 Hot Line 0 European (ESC) Con session Society of gress (29 Cardiology August–1 by coordin Sep ating inve stigator Jorn tember, virtual) Antonius Hospital, Brouwer Nie (St published uwegein, sim The Netherl ands) and of Medicin ultaneously in the New England e. The tria l found that alone afte Journal r TAVI, com the use of aspirin pare clopidogrel, significantly d to dual use of asp and did not irin and reduced blee incr ding events thromboemb ease the rate of olic events.

The POPular TAVI tria investigated l the optimal antithrombo tic therapy in two coh orts: patients without an indication for oral anticoa gulants (coh A) and pati ort ents on chro nic

Jorn Brouwer

www.card

iovascularn

ews.com

Commen Assessin t: g nonobstructive artery dis coronary ease

Profile: Michael Reardon

IVUS linke favourab d to le outcome PCI s, uptake is but low A study of US Me

page 10

dicare pat undergoin interventiog percutaneous ients cor use of intr n (PCI) has found onary resulted avascular ultraso that the in a lower und myocardia long-term (IVUS) mortality revascula l infarction (MI), and repeat ,

by Amgadrisation. However , Carver Co Mentias (Unive the study rsit USA) and llege of Medicine y of Iowa , col Iow league a Cit Cardiova scular Inte s, published in y, JACC: that ove rall use of rventions, also found was low, IVUS gui hav all PCI pat ing been use dance cases d its use am ients “with a wid in just 5.6% of e var ong differe nt faciliti iation of es”.

WITH

AN AIM TO UNCO in real-wo VER IF IVU rld patients S USE is associat long-term oral anticoa ed outcomes gulation (coh of PCI, Me with improved studied Me had been ort B). Res ntias and dicare pati published colleagues ults of coh Jan in early 202 uary omission ort B 2009 to Dec ents who underwent 0 and sho of clopidog PCI from ember 201 of the stud wed that the rel was asso in bleeding 7. y was long The main ciated with events and outcome -term allsecondary a reductio events. Bot no cause mor outcomes n h were pow increase in thrombo tality, incl and repeat outcomes. ered separat embolic revasculari uded hospitalisation while ely for the sation. for MI, In total, the study The current included 1,87 study population had undergo study (cohort A) exc 7,177 pati ne coronary luded pati und ents erwent PCI IVUS eluting sten ents who who during the t within thre artery stenting usin usage in period, with study ga within one e IVUS use month, prio months, or bare met drugPCI cases of these. The d in 105,787 r to TAVI. al stent IVUS-guide The investig group had initiated, 5.6% atora higher prev d PCI randomi most com alence of trial, which sed, open-label orbidities, was carried Me including out in heart failure ntias and colleagues 17 centres across Eur wri coronary (28.6% vs. ope arte 25.8%), prio te, involved 665 patients , stroke (5.1 ry disease (22.8% r vs. 21.8%), % without an prior (21.1% vs. vs. 4.2%), chronic indi kidney 19.3%), chro oral anticoa cation for vs. 20.9%), nic lung dise disease gulation, who and were rand 3.9%;p<0.00 pulmonary hyperte ase (22.9% omly allo cated to receive nsion (4.8 1 for all). also a had aspirin alon % vs.

The IVUS-g higher prev e uided PCI alence of Continue d on page complex PCI group 2 as

Jurrien ten Berg

Continue

d on page

3

Issue 60 | February 2021

17

Structural Heart Interventions EXPAND registry data add to mounting evidence for newergeneration MitraClip

Data from two studies evaluating the use of the MitraClip (Abbott) mitral valve, including the NTR and XTR and G4 iterations of the device, were presented at the PCR Valves 2020 e-course (22–24 November, virtual).

O

ne-year findings from the EXPAND registry, evaluating real-world use of newer-generation MitraClip (Abbott) devices for the treatment of secondary mitral regurgitation, are comparable to the results witnessed in the COAPT randomised study of an earlier generation of the device, according to Jörg Hausleiter (Klinikum der Universität München, Munich, Germany), who presented the contemporary, real-world clinical outcomes with the next generation MitraClip (NTR/XTR) system in patients with secondary mitral regurgitation (MR), in a latebreaking trial session at the virtual meeting in November 2020.

The COAPT study has demonstrated the significant clinical benefit of the Mitraclip in patients with secondary MR, but the COAPT patient population was highly selected and only the first generation of MitraClips was used, Hausleiter said in the introduction to his presentation. The EXPAND registry was initiated to study the outcomes of MitraClip procedures and evaluate the use of the third generation with the smaller NTR and the larger XTR clip systems.

The EXPAND study included a total of 1,041 patients from the USA and Europe, with Hausleiter’s presentation focusing on the one-year outcomes of 413 patients treated with a MitraClip for secondary MR. Outlining the results, Hausleiter commented that the oneyear mortality rate seen in EXPAND, of 70.7%, compared well to the observed rate of 90.1% in COAPT. The rate of heart failure hospitalisations was 26%, “which also compares well with the data from COAPT of 24.9%”, said Hausleiter.

Furthermore, he added, the rates for myocardial infarction, stroke and repeat interventions were similar.

Hausleiter commented that the study, which is the first contemporary report of outcomes in patients with secondary MR treated with the MitraClip NTR and XTR systems, showed that a durable MR reduction was achieved in the EXPAND population, which appeared numerically higher than in COAPT. In summary, Hausleiter said that the EXPAND study confirms that mitral valve repair, in a real-world contemporary setting, with two Mitraclip sizes is associated with favourable one-year outcomes, that are comparable to the randomised COAPT results.

Later in the event, Bassem Chehab (Kansas Heart Hospital, Wichita, USA) presented findings from the EXPAND G4 study, evaluating the performance of the Mitraclip G4, which he said demonstrate that the device has a similar level of procedural effectiveness, without an increase in adverse events, to earlier generations.

Chehab noted that the fourth generation MitraClip G4 system features four-clip sizes, with the option for independent leaflet grasping through a controlled gripper actuation, an improved clip deployment sequence and continuous left atrial pressure monitoring.

EXPAND G4 looked at 101 consecutive consented patients receving the MitraClip at 14 US sites followed through baseline, discharge and 30 days. Key outcome measures included MR severity, major adverse events (MAE), survival, procedural outcomes, quality

Jörg Hausleiter

Bassem Chehab

of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and functional capacity assessed using the New York Heart Association (NYHA) functional class.

The primary objective of the study was to report on core lab-adjudicated 30-day real-world outcomes with the G4 system, which was compared against data from the EXPAND study looking at the NTR/XTR systems.

The number of clips was around 1.4 per patient in EXPAND G4, compared to 1.5 in EXPAND. The majority (45%) of clips were NTW (a wider clip size). NT clips were used in 28% of cases, XTW In 24% and XT in only 3%.

Chehab explained that 87% were treated with at least one wider clip, and 60% were treated with NTW alone followed by another clip.

In terms of outcomes, Chehab commented that the implant rate, procedural time and hospital length of stay were “on par” with the equivalent data from the EXPAND study. Of note, he said, was the higher acute procedural success rate in EXPAND G4—99% compared to 95.9% in EXPAND—while device time and fluoroscopy time were also reduced.

Looking at 30-day adverse events, all-cause death was seen in 2% of patients, compared to 2.3% in EXPAND, and there were no MitraClip G4 recorded incidences of myocardial infarction, stroke or ischaemic events.

Regarding the mitral valve gradient, Chehab said that although wider clips were used more frequently in EXPAND G4, there was no observation of increased mitral valve gradient post procedurally compared to the third generation clip sizes.

Staged strategy may be associated with improved outcomes when treating mitral regurgitation post-TAVI The first international registry of patients undergoing transcatheter mitral interventions after transcatheter aortic valve implantation (TAVI) has shown that a staged interventional strategy is feasible, safe, and associated with significant improvement in mitral regurgitation grade and New York Heart Association (NHYA) functional class in these patients.

THE RETROSPECTIVE international registry study, published in JACC: Cardiovascular Interventions, authored by Guy Witberg (Rabin Medical Center, Petach-Tikva, Israel) and colleagues, sought to describe the baseline characteristics, periprocedural and midterm outcomes in patients undergoing transcatheter mitral valve interventions after TAVI, using data from 23 TAVI centres.

Researchers reported data from 106 of 24,178 patients (0.43%) who underwent mitral interventions post-TAVI (100 staged, six concomitant), at the 23 sites, the most common of which was percutaneous edgeto-edge mitral valve repair (PMVR). The median interval of the interventions postTAVI was 164 days.

Patients had a mean age of 79.5±7.2 years and mitral regurgitation (MR) was moderate or greater in 97.2%.

The reported technical success was 99.1%, and the 30-day device success rate was 88.7%. In total there were 18 periprocedural complications (16.9%) including four deaths, and during a median follow-up of 464 days, the cumulative risk for three-year mortality was 29%.

MR grade and NYHA functional class improved dramatically, the study team reported; at one year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n=156), but this was not statistically significant (hazard ratio: 1.75; p=0.05).

The study team concluded that for patients who continue to have significant MR, remain symptomatic post-TAVI, and are anatomically suitable for transcatheter interventions, these procedures are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class.

18 Structural Heart Interventions

February 2021 | Issue 60

“Positive outlook” for transcatheter edge-toedge treatment of mitral regurgitation Emerging data support transcatheter techniques to treat primary mitral regurgitation, according to KK Yeo (National Heart Center, Singapore) who presented at PCR Valves 2020 ecourse (22–24 November, virtual) discussing the latest developments in edge-toedge repair for primary mitral regurgitation.

YEO DISCUSSED DATA FROM the EXPAND registry, as well as looking ahead to further studies and technological developments in the field.

“What is important and impressive is that procedure time had improved from 135 minutes to 82 minutes in the EXPAND registry, and the length of stay has improved from three days to one day in terms of the median duration,” said Yeo, commenting on data initially presented at the American College of Cardiology/ World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual) in March, with further data also presented during a late-breaking session at PCR Valves.

Further evidence on the efficacy of the device are expected to be gathered through the REPAIR MR trial, Yeo said, which will compare the clinical outcomes of the Mitraclip to surgical repair in patients with severe primary mitral regurgitation (MR) who are at moderate surgical risk. Additionally, Yeo highlighted data from the CLASP trial, evaluating the safety and performance of the Pascal system (Edwards Lifesciences), which were presented in the summer, and found that the device was associated with a low complication rate and high survival rate in the treatment of MR. These developments lead Yeo to conclude that new-generation devices “offer more treatment options” and added that through the emergence of the Pascal device, competition has arrived in the mitral device market. Following Yeo, Stephan Baldus (University Heart

Center Cologne, Cologne, Germany) appraised the evidence for edge-to-edge repair in secondary mitral regurgitation patients. “Within the last couple of years, we have witnessed a sound body of evidence showing that secondary mitral regurgitation is not only a bystander, but it is a driver of disease in patients with systolic heart failure,” he said, in the opening slide of his presentation.

Baldus commented on the rapid adoption of transcatheter mitral techniques in functional mitral regurgitation patients, commenting that the edge-to-edge repair is the “driving procedure for these patients in functional mitral regurgitation”.

Baldus commented that in terms of safety, the procedure has been shown to be safe out to five years: “If we combine all of this we can bascially say that mortality throughout these registries is below 4% nowadays, the stroke rate is below 1% and single leaflet detachment is below 2%, so it is a really safe procedure for secondary mitral regurgitation.” With respect to efficacy, edge-to-edge repair is non-inferior to mitral valve surgery in patients with functional mitral regurgitation, Baldus commented. “The TVT registry, the EXPAND registry, as well as randomised trials in these patients, show that procedural success has increased to over 90%, with 75% or more indicative of a mitral regurgitation grade below 1 or 90% of these patients showing an MR grade of below 2 in functional regurgitation.

“We have to be good at reducing mitral regurgitation because we know that the

ACTIVATION trial finds no difference in one-year mortality or rehospitalisation from PCI prior to TAVI The first randomised trial comparing a course of preprocedure percutaneous coronary intervention (PCI) versus no PCI in patients undergoing transcatheter aortic valve implantation (TAVI) with significant coronary artery disease (CAD) found no difference in the primary endpoints of death or rehospitalisation at one-year follow-up between the two treatment strategies.

(l-r) Martine Gilard, Fabien Praz and KK Yeo

We have witnessed a sound body of evidence showing that secondary mitral regurgitation is not only a bystander, but it is a driver of disease in patients with systolic heart failure.” grade of residual MR determines the fate of the patient. Patients who are leaving the hospital with an MR grade of 1 or below actually have the best prognosis.

It is interesting to see that we need to be sure that this is sustained over the next 12 months.”

In a later session, focused on innovations in surgical and transcatheter mitral valve intervention, Paul Sorajja (Minneapolis Heart Institute, Minneapolis, USA) discussed the latest developments in transcatheter mitral valve technology.

“While we all know that transcatheter mitral valve replacement was pioneered

with transapical devices, many new technologies have been moving towards the transseptal approach,” Sorajja commented. He noted that Sapien M3 (Edwards Lifesciences), Evoque (Edwards Lifesciences), and Alta (4C Medical) are among the devices to have been implanted using this approach.

“One of the newest entrants is the Medtronic Intrepid system,” he said.

“This is the same valve that was used in a transapical approach as part of the feasibility study and this is now a transseptal system that is 35 French, and the first patient was treated in February.

There are plans for an early feasibility study of 15 patients who are not eligible for surgery.” Sorajja also mentioned the HighLife Valve (HighLife Medical)— describing this as a hybrid approach of a transvenous and a transarterial system in which a ring is used to manage the mitral leaflets and also anchor the device. “This approach helps to minimise device profile and potentially enables patients who were previously excluded due to potential LVT obstruction,” he said For repair technologies, he highlighted the Millipede system (Boston Scientific) which he said is shortly to be subject of an early feasibility study. “This highlights a strong desire for a toolkit approach for catheter interventions akin to open surgery,” he commented, adding that “percutaneous angioplasty could be an adjunct, as it is a permissive technology, or a standalone therapy”.

F

indings of the prospective, multicentre, ACTIVATION—The percutaneous coronary intervention prior to transcatheter aortic valve implantation—trial were presented by Simon Redwood (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) during a late-breaking trial session at the PCR Valves 2020 e-course (22–24 November, virtual).

Involving patients at 17 sites in the UK, France and Germany, the trial had a primary endpoint comparison of all-cause mortality and rehospitalisation at 12 months following TAVI. Secondary outcome measures included mortality, major adverse cardiac and cerebrovascular events (MACCE), cerebrovascular accident (CVA), acute myocardial infarction (AMI) and hospitalisation for heart failure at 30 days and 12 months. Repeat revascularisation, procedural success and complications, major and minor bleeding, access site complications and angina burden were also assessed.

A total of 235 patients were enrolled in the study, 119 of whom underwent PCI and 116 who did not. The study

Simon Redwood

reported no difference in the primary endpoint of death and rehospitalisation at one year—41.5% in the PCI group vs. 44% in the no-PCI group (p=0.067)—meaning that the study failed to reach its 7.5% non-inferiority margin. Additionally, the study reported a higher rate of bleeding in the PCI group (44.5% vs. 28.4%, p=0.02).

February 2021 | Issue 60

20 Market Watch

Investigational device exemption granted for Tria biopolymer mitral valve

Product News Boston Scientific discontinues Lotus Edge TAVI device

Boston Scientific has announced a global recall of all unused inventory of its Lotus Edge transcatheter aortic valve implantation (TAVI) system due to complexities associated with the product delivery system.

In a statement, the company said that the recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant, adding that there is no safety issue for patients who currently have an implanted Lotus Edge.

Given the additional time and investment required to develop and reintroduce an enhanced delivery system for the valve, the company has chosen to retire the entire Lotus product platform immediately. All related commercial, clinical, research and development and manufacturing activities will also cease.

“While we have been pleased with the benefits the Lotus Edge valve has provided to patients, we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific.

“The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform. We will instead focus our resources and efforts on our Acurate neo2 aortic valve system, Sentinel cerebral embolic protection system and other high-growth areas across our portfolio.”

Resolute Onyx

Medtronic’s Resolute Onyx approved for one-month DAPT labelling by US FDA

Medtronic has announced that it has received US Food and Drug Administration (FDA) approval for new one-month of dual-antiplatelet therapy (DAPT) labelling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The Resolute Onyx DES is the only DES in the USA that has been proven safe and effective utilising a one-month regimen of DAPT—the combination of aspirin and an anticoagulant—following a percutaneous coronary intervention (PCI) in patients at high bleeding risk.

Patients that are at risk for high bleeding include older patients, those

with history of bleeding, or those on oral blood-thinning drugs, and account for up to 40% of PCI patients. Clinical studies have demonstrated that Resolute Onyx DES and its biocompatible polymer and stent design promote fast vessel healing and is well-suited for patients who may benefit from a DAPT duration as short as one month.

Biosensors gains CE mark approval for BioFreedom Ultra stent system

Biosensors has announced the award of CE mark for the BioFreedom Ultra drug-coated coronary stent. BioFreedom Ultra is a thin strut (84µm) CoCr polymer and carrier-free stent with Biosensors’ proprietary Biolimus A9 drug. BA9 is Biosensors’ proprietary highly lipophilic anti-restenotic drug, developed specifically for use in coronary vascular applications.

The BioFreedom Ultra stent will optimise the percutaneous coronary intervention (PCI) procedure for high bleeding risk (HBR) patients by simplifying stent choice preprocedure based on the LEADERS FREE legacy, enhancing procedure success thanks to the stent design and maximising outcomes for HBR patients treated with one-month DAPT, Biosensors said in a press release.

The LEADERS FREE III trial enrolled 400 HBR patients at 18 sites, using the same inclusion criteria as the LEADERS FREE randomised trial.

LEADERS FREE III is a single-arm trial with all patients being treated using the BioFreedom Ultra device. The data were compared to the BioFreedom stainless steel drug-coated stent (DCSStS) and bare metal stent (BMS) groups from LEADERS FREE. The primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction or definite/probable stent thrombosis and the primary efficacy endpoint was clinically-driven target lesion revascularisation. BioFreedom Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis, at one year in this HBR population was only 1%.

Biosensors chief medical officer Keith G Oldroyd, said: “Biosensors are looking forward to further increasing their interventional cardiovascular portfolio by making another Biolimus A9-eluting device available for the treatment of patients with coronary artery disease. In addition, and as a testament to our commitment to making new treatment options available to our clinicians and their patients, Biosensors’ parent company have expanded into the rapidly growing field of structural heart disease intervention through the acquisition of New Valve Technology, the developers of the Allegra TAVI device.”

Foldax has announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for the company to initiate a clinical study of its Tria biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.

The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and meets a large clinical need based on the prevalence of rheumatic fever worldwide.

The first of the company’s products— an aortic surgical heart valve—is currently enrolling a US clinical study as a result of FDA approval of an expanded study last October. The third valve product is a transcatheter aortic valve implant (TAVI), which is in the preclinical testing phase.

The Tria valves incorporate a new, proprietary biopolymer—LifePolymer— with valve designs intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants, Foldax said.

“There is a great need for a more durable mitral valve, as tissue valves tend to be much less durable in the mitral position than in the aortic position, yet there have been very few

Foldax Tria

mitral valve clinical studies in the past decade,” stated Frank Shannon, chief of Cardiovascular Surgery at Beaumont Hospital in Royal Oak, USA and head of the Foldax Medical Advisory Board. “The Tria biopolymer valve offers the potential to be an important new therapeutic option with enhanced durability that is intended to allow patients to avoid taking the blood thinning medication required by mechanical valves.”

“We are gratified that the FDA has now approved two of our valves for clinical investigation. This latest approval is an important milestone in our mission to develop a portfolio of surgical and transcatheter biopolymer heart valves designed to last a lifetime,” stated Foldax CEO Frank Maguire. “We view the Tria mitral valve as a product with global appeal that is capable of meeting the durability needs of both advanced and developing countries, while addressing the consequences of rheumatic fever and challenges of managing mechanical valve-related anticoagulation therapy in developing regions.”

Abbott launches virtual reality training programme for cardiologists using OCT imaging technology

Abbott has announced the global release of its first virtual reality-based training programme, which has been designed to change training for interventional cardiologists in the use of optical coherence tomography (OCT) imaging technology.

The new training programme incorporates virtual reality (VR) with traditional training techniques to increase experience and expertise in using Abbott’s OCT imaging and improve outcomes in patients needing a stent to open clogged arteries.

OCT is an intracoronary imaging platform designed to help physicians view and assess coronary arteries from inside the vessel with high precision.

This allows for an improved look at the nature of a patient’s coronary artery disease to improve treatment decisions and the quality of stent deployment, Abbott said in a press release.

Recent data show that in 88% of percutaneous coronary intervention (PCI) procedures managed with OCT workflow, physician decisionmaking changed compared with initial, angiographically-guided strategy, demonstrating that OCT imaging can help to drive better clinical outcomes.

“It is undeniable that OCT imaging technology is unlocking new opportunities to improve outcomes for our patients. Abbott’s new VR training programme has provided my team the experience of being in the cath lab and understanding OCT technology quickly and efficiently,” said Vamsi Krishna, director, Ascension, Seton Hays Medical Center, Kyle, USA. “The OCT VR programme enhances training for OCT imaging technology through innovative educational programmes. Virtual reality is truly the next wave of training that will ultimately improve patient outcomes and I am very excited to be a part of the new programme.”

Abbott’s OCT VR-based training programmes, powered by Oculus Go, will enhance decision-making for physicians who utilise OCT instead of angiography, the company said in a press release announcing the launch of the programme. The training is based on the comprehensive OCT experience and input of Richard A Shlofmitz, chairman of Cardiology at St Francis Hospital, The Heart Center, Roslyn, USA. “Abbott’s new OCT training enables interventional cardiologists to receive more in-depth, experiential training to encourage more precise diagnoses, while healthcare systems will experience cost savings through a reduction in the number of staff training courses needed,” said Harvinder Singh, vice president, global commercial operations of Abbott’s vascular business. “Furthermore, the VR training programme will not only enhance accuracy to improve patient outcomes, but it also furthers the industry’s adoption of innovative technologies in healthcare.”

Issue 60 | February 2021

Market watch 21

Clinical News Harpoon

First US patient treated in trial of Harpoon mitral valve repair system

Edwards Lifesciences has announced that the first patient has been treated in the RESTORE clinical trial, which will evaluate the safety and effectiveness of the investigational Harpoon beating heart mitral valve repair system in the USA and Canada. The Harpoon system is used to treat severe degenerative mitral valve regurgitation. The procedure took place at the University of Maryland Medical Center, Baltimore, USA. “Symptomatic patients with severe degenerative mitral valve regurgitation can experience limitations in their day-to-day life ranging from reduced physical activity to more serious complications,” said Vinod Thourani, national principal investigator of the RESTORE trial and Marcus chief of Cardiovascular Surgery for Piedmont Healthcare, the Marcus Heart and Vascular Center and Marcus Heart Valve Center, Atlanta, USA. “Utilising less invasive approaches, we can potentially reduce the need for traditional openheart surgery and the hardships associated with a patient’s healing and recovery process.”

The Harpoon system, which was developed by researchers at the University of Maryland Heart and Vascular Center, requires a small incision to repair the mitral valve. The procedure is conducted while the heart is still beating.

Medtronic announces plans for head-to-head TAVI device study

Medtronic has announced plans to launch a randomised, head-to-head study comparing two transcatheter aortic valve implant (TAVI) devices in patients with severe symptomatic aortic stenosis (ssAS). The SMART (Small annuli randomised to Evolut or Sapien) postmarket trial will compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR systems against the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves manufactured

by Edwards Lifesciences.

Enrolling approximately 700 patients globally, the study will evaluate valve performance in patients with small annuli and those who are candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined, represent more than 40% of the global TAVI market. Due to its focus on small

annulus patients, the SMART trial will enrol predominantly women, which will provide important clinical insight into a currently underrepresented patient population in TAVI literature, Medtronic said in a press release. The study includes prespecified endpoints of haemodynamic (blood flow) superiority and clinical non-inferiority with the Evolut platform for mortality, stroke, or rehospitalisation at 12 months.

“Haemodynamic performance is particularly important in many patients with aortic stenosis, including those with small annuli, surgical aortic valves needing a TAV-in-SAV procedure, patients with left ventricular dysfunction, and those who are young and most active. For many of these and other TAVR [transcatheter aortic valve replacement] patients, valve design matters,” said Howard C Herrmann, the John Winthrop Bryfogle professor of Cardiovascular Diseases and director of Interventional Cardiology in the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA and principal investigator and chair of the steering committee of the SMART trial. “The outcome of this important head-to-head study will allow heart teams to more selectively tailor clinical decisionmaking to ensure the right valve is selected for the right patient.”

VersaCross RF transseptal device found to be efficient for TMVR procedures

Baylis Medical has announced the publication of data demonstrating procedural efficiency for MitraClip (Abbott) transcatheter mitral valve repair (TMVR) with use of its VersaCross RF transseptal device, reporting guide delivery from femoral access in under 7.5 minutes.

The VersaCross device features a single radiofrequency (RF)-tipped wire used to introduce the transseptal sheath into the superior vena cava (SVC), gain transseptal access and act as an exchange wire in the left atrium to facilitate MitraClip guide delivery. Typically, this process involves exchanging multiple devices to achieve and maintain transseptal access. The VersaCross platform is an exchangeless solution for access-to-delivery of left heart therapy devices.

The publication in Catheterization and Cardiovascular Interventions was led by Anita W Asgar, interventional cardiologist in the Cardiology Division of the Montreal Heart Institute, Montreal, Canada.

Initial findings concluded procedural efficiency, citing 3.3 minutes to gain transseptal access and a subsequent 3.8 minutes to achieve MitraClip guide delivery, with a 100% success rate. Previously published data cited 16 minutes to gain transseptal access

with use of other transseptal solutions.

Additionally, researchers noted a reduced number of wire exchanges required, with the ability to reposition puncture location on the fossa ovalis without the need to rewire.

Enrolment in Dan-NICAD II study of non-invasive diagnostic testing system completed

Acarix has announced enrolment of the final patient in the Dan-NICAD II study of non-invasive diagnostic testing in patients with suspected coronary artery disease (CAD).

The study has enrolled 1,726 patients referred to coronary computed tomography (CT) with symptoms suggestive of stable CAD from four hospitals in Denmark and was initiated in January 2018 to further establish the diagnostic accuracy of the CADScor system compared to other stratification alternatives commonly used today in parallel with securing more validated clinical data for further sophistication of the CADScor algorithm.

Combining Dan-NICAD I and II, the CADScor data have been collected from 3,401 patients, which facilitates significant substance and precision of the underlaying algorithm.

The study also includes patients below the age of 40, which provides the opportunity of a possible significant expansion of the currently identified patient group.

“We are very pleased to be able to close the inclusion period for the Dan-NICAD II study and that we have collected comprehensive data from more than 1,700 patients with suspected heart disease; data that will allow us to further ennoble the CADScor algorithm and provide further data to support the CADScor system as a clinically documented first-line diagnostic tool for ruling out chronic CAD ” said Morten Böttcher, Aarhus University Hospital, Aarhus, Denmark.

Corvia completes randomisation in REDUCE LAP-HF II trial

Corvia has announced completion of randomisation in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia atrial shunt (IASD)—a novel, transcatheter implant—to reduce elevated left atrial pressures (LAP), the primary cause of heart failure (HF) symptoms, in patients with heart failure preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also announced authorisation by the US Food and Drug Administration (FDA) to continue evaluation of the Corvia atrial shunt under a continued access protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021.

REDUCE LAP-HF II is a large, prospective, multicentre, randomised, sham-controlled trial to evaluate interatrial shunting. The study randomised 626 patients at 109 sites

across 15 countries, with the aim being to improve quality of life, reduce HF symptoms and decrease HF-related hospitalisations. Primary outcomes will be evaluated after the last patient completes 12-month follow-up. Sanjiv Shah, from Northwestern University Feinberg School of Medicine, Chicago, USA, and Martin Leon, from the Columbia University Irving Medical Center, New York, USA, serve as lead principal investigators.

“The outcome of the landmark REDUCE LAP-HF II trial has the potential to revolutionise how we treat these heart failure patients, which is the greatest unmet need in cardiology today,” stated Shah. “Treating this population is challenging, and often frustrating, because standard treatments for heart failure do not work well. Data from this study evaluating the efficacy of the Corvia atrial shunt will provide valuable information regarding this novel therapy in this underserved patient population.”

First patients treated with the Impella ECP heart pump

Abiomed has announced the treatment of the first two patients using the Impella ECP expandable percutaneous heart pump—a device described by the company as the smallest heart pump in the world. Impella ECP measures 3mm in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5L/min.

The first Impella ECP patient was treated by Amir Kaki, an interventional cardiologist and director of Mechanical Circulatory Support at Ascension St John Hospital in Detroit, USA. The patient had severe narrowing of his coronary arteries. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP including atherectomy and two one-minute-long balloon inflations.

The second patient was treated at The Christ Hospital, Cincinnati, USA

by Timothy Smith, an interventional cardiologist and director of the Cardiovascular Intensive Care Unit, Cardiogenic Shock and Extracorporeal Membrane Oxygenation (ECMO) programmes. The patient had severe narrowing of the coronary arteries, including complex left main bifurcation disease and low ejection fraction.

Percutaneous coronary intervention (PCI) was successfully performed with support from Impella ECP. The primary endpoint of the study is successful delivery, initiation and maintenance of adequate haemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. The study protocol will enrol and treat up to five US patients who require revascularisation. If successful, enrolment will be expanded to additional patients, pending approval.

Impella ECP is an investigational device, limited to investigational use only.

February 2021 | Issue 60

22 Market watch

Industry News Damien McDonald, chief executive officer of LivaNova. “For LivaNova, the divestiture of our HV business is an important milestone in the execution of our strategy to optimise our portfolio so that we are best positioned to serve our patients and deliver value to our shareholders. In particular, we intend to focus more directly on our key growth drivers and continuously improve our operational excellence.”

LivaNova

LivaNova reaches agreement to sell its heart valve business LivaNova has entered into an agreement with investment firm Gyrus Captial whereby entities funded and controlled

by Gyrus will acquire the LivaNova heart valve (HV) business.

The LivaNova board of directors unanimously approved the divestiture, which it believes will enable the company to sharpen its focus within its primary platforms, neuromodulation and cardiovascular, and to dedicate increased resources toward executing its promising pipeline opportunities.

Once the transaction is complete, Gyrus intends to focus management attention and investment on the heart valve business to position it to become a leading player in the surgical heart valve market globally.

“The LivaNova heart valve business is a global player in surgical heart valves with world-class products and compelling growth opportunities,” said Guy Semmens, managing partner at Gyrus Capital. “This business fits squarely within our strategy to invest in transformational projects in the healthcare and sustainability sectors. We believe that, with a focus on the core products, this new independent company can maximise its potential through our investment in its products and people.”

“We believe that LivaNova and Gyrus will benefit from this transaction and, that under Gyrus ownership, the HV business will thrive and grow,” said

Medtronic agrees to invest in TMVR device development

Medtronic has announced a partnership with The Foundry—a medical device company incubator—to invest in and create a company to develop transcatheter mitral repair (TMVR) technology.

The arrangement provides for structured investment tranches from both Medtronic and The Foundry and includes an exclusive right for Medtronic to acquire the resulting company, Half Moon Medical, contingent upon the achievement of certain technical and clinical milestones.

Half Moon recently received US Food and Drug Administration (FDA) approval of an early feasibility study of patients with severe, symptomatic mitral regurgitation.

“We have been encouraged by Half Moon’s development to date, leveraging Medtronic’s investment and intellectual property coupled with decades of mitral valve therapy experience at The Foundry through their development of repair and replacement technologies, including the Medtronic Intrepid valve,” said Nina Goodheart, president of the Coronary & Structural Heart division, which is part of the Cardiac and Vascular Group at Medtronic. “We believe this technology is promising and differentiated from other approaches to mitral valve repair.”

Half Moon Medical’s TMVR device restores function in a diseased mitral valve by filling the regurgitant orifice, creating a new coaptation surface for the native anterior leaflet. The device is fully repositionable and recoverable

during deployment using a transfemoral delivery catheter, which assists physicians in navigating the vasculature and delivering the device to the diseased native mitral valve.

“The result of testing more than 30 early concepts and design iterations, the Half Moon mitral repair device is a truly innovative solution that is designed to address multiple mitral regurgitation aetiologies,” said Hanson Gifford, president and CEO, The Foundry. “Most importantly, similar to mitral valve replacement, this repair device has the potential to fully eliminate mitral regurgitation.”

ACC.21 to offer remote COVID-19 screening

solution for continuous vital sign and symptom monitoring for COVID-like infection. ACC.21 is the first medical conference to use the BioButton.

James Mault, CEO of BioIntelliSense, commented: “Together with the ACC, we can provide the cardiology community with medical-grade monitoring devices, clinically-validated algorithms and RPM education that will have a profound impact on routine patient care globally. The inclusion of the BioButton COVID-19 screening programme to the safety measures for the ACC Scientific Session will also serve to provide their cardiovascular professional membership an opportunity to experience the simplicity of virtual care and effortless remote monitoring.”

“The ACC—and the cardiovascular community as a whole—has a long history of advancing innovative solutions to transform cardiovascular care and patient outcomes,” said ACC President Athena Poppas, MD, FACC. “We are excited by the opportunity to partner with BioIntelliSense and be on the cutting edge of an innovative technology with real-time health data and feedback.”

The American College of Cardiology (ACC) has partnered with BioIntelliSense, a continuous health monitoring and clinical intelligence company, to advance remote patient monitoring (RPM) programmes for cardiac care. The partnership will see BioIntelliSense provide the use of its BioButton COVID-19 screening solution for the ACC’s 70th Annual Scientific Session in May (ACC.21, 15 – 17, Atlanta, USA).

The BioSticker and medical-grade Free registration for virtual BioButton wearable devices allow for JIM 2021 continuous vital sign monitoring of Organisers of the Joint Interventional temperature, heart rate and respiratory Meeting (JIM) have announced that rate at rest to enable early detection of the 2021 edition of the symposium adverse vital sign trends through its will take place as a virtual event due proprietary biosensor technology and to COVID-19, with delegates able to advanced analytics. register to attend for free.

In a statement, ACC said that its 2021 Running across the two days of 11–12 scientific session will bring together February the event’s organisers say that cardiologists and cardiovascular JIM 2021 will feature educational, specialists from around the challenging and interactive BioButton world to share the newest live cases led by Antonio discoveries in treatment Colombo (Humanitas and prevention. ACC Reasearch Hospital, Milan, added that it is committed Italy), Eberhard Grube to creating a healthy (University Hospital, Bonn, and safe environment for Germany) and Nicolas Van attendees, exhibitors, and Mieghem (Thorax Centerstaff in line with all current Erasmus University Medical directives and recommendations Center, Rotterdam, The Netherlands), that will enable attendees to make supported by a world class faculty. informed and safe decisions about their The virtual event will be concentrated attendance. on the practical and educational aspects In addition to all COVID-19 safety associated with case demonstrations and protocols, ACC.21 conference attendees more emphasis will be given to the learning will have the option to participate in process and to live cases. The programme the BioButton COVID-19 screening will also be available on-demand.

Calendar of events Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

11–13 February JIM 2021 Virtual jim-vascular.com/

13 February–24 April CRT 2021 Virtual crtmeeting.org/

19–22 April CX 2021 Vascular and Endovascular Controversies Digital Edition Virtual cxsymposium.com/

28 April–1 May SCAI 2021 Scientific Sessions Virtual scai.org/scai-2021-scientificsessions

15–17 May ACC 2021 Scientific Sessions Atlanta, USA

9–12 June TVT 2021 Chicago, USA

acc.scientificsession.acc.org

tctmd.com/node/34295

18–20 May EuroPCR Paris, France

27 August–1 September ESC Congress 2021 Virtual

pcronline.com/Courses/EuroPCR

escardio.org/Congresses-&Events/ESC-Congress

Video is revolutionising medical education Stay in touch with the cardiovascular community, especially in these difficult times. The Cardiovascular News in-house video production team can expertly help achieve and support your year-round digital education and video needs.

Our team can remotely record and produce short, shareable video projects to emphasise the core messages from new research and developments in the field.

Juan Granada (New York, USA) and Ajay Kirtane (New York, USA)

Philippe Pibarot (QuĂŠbec, Canada)

We also conduct live and on-demand digital education projects and webinars on topics trending in the cardiovascular world.

A snapshot of your latest research delivered straight into the heart of the cardiovascular community Cardiovascular News can offer a full distribution service to the cardiovascular community on our website and social media platforms.

Digital education as it should be We capture the latest news, views and practice trends from all the major global conferences in the cardiovascular space. We work with physicians and industry partners.

Can we help you realise your dream video project?

Email: anthony@bibamedical.com Visit us at https://cardiovascularnews.com/videos/

CARDIO

Sahil Parikh (New York, USA)

Won-Keun Kim (Bad Nauheim, Germany)