Cardiovascular News 58 – August 2020 US Edition

August 2020 | Issue 58

www.cardiovascularnews.com

8-9

Featured in this issue:

PCR e-course: Sripal Bangalore: Risk and benefits of routine revascularisation

Meta-analysis puts spotlight on optimal DAPT duration Optimal duration for the application of dual antiplatelet therapy (DAPT) in patients implanted with a drug-eluting stent remains a topic of continued debate within interventional cardiology.

DAPT—involving the dual-use of aspirin and a P2Y12 receptor inhibitor after percutaneous coronary intervention (PCI)—is known to reduce recurrent major adverse cardiovascular events, but comes at the expense of an increased risk of major bleeding in some patients.

I

n August, Safi Khan (West Virginia University, Morgantown, USA), Deepak Bhatt (Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, USA) and colleagues, published in Circulation their findings from the largest network metaanalysis on the topic, including data from 24 randomised controlled trials.

Writing in the study’s introduction, authors Khan and Bhatt acknowledge that debate over the optimal duration of DAPT following PCI remains unsettled, with guidelines from both the American College of Cardiology (ACC) and American Heart Association (AHA), updated in 2016, and separately from the European Society of Cardiology (ESC), updated in 2017, recommending differing lengths of therapy based upon patient bleeding risk.

The 24 trials yielded data from 79,073 patients up to 2019, with treatment strategies including either short-term (less than six-month) DAPT followed by aspirin or P2Y12 inhibitor monotherapy; mid-term (six-month) DAPT; 12-month DAPT; and extended-term (more than 12-month) DAPT after PCI with a drugeluting stent. The co-primary endpoints were myocardial infarction (MI) and major bleeding.

Khan, Bhatt et al’s analysis shows that at a median followup of 18 months, extendedterm DAPT is associated with a reduced risk of MI compared with 12-month DAPT. Additionally, extended-term DAPT is associated with a higher risk of major bleeding compared with all other DAPT groups. Compared with 12-month DAPT, Khan, Bhatt et

Deepak Bhatt

al report no significant differences in the risks of ischaemic endpoints or major bleeding compared with mid-term or short-term DAPT followed by aspirin monotherapy, except noting that short-term DAPT followed by P2Y12 inhibitor monotherapy is associated with a reduced risk of major bleeding.

The study team also note that there are no significant differences with respect to mortality between the different DAPT strategies. In acute coronary syndrome, extendedterm compared with 12-month DAPT is associated with a reduced risk of MI without a significant increase in the risk of major bleeding.

Khan, Bhatt and colleagues write that the principal result of the analysis is that, among patients undergoing PCI with a drug-eluting stent, short-term DAPT followed

by P2Y12 inhibitor monotherapy was non-inferior for MI, major adverse cardiovascular events and mortality, and was superior for major bleeding and net adverse clinical events compared with 12-month DAPT. However, DAPT longer than 12 months, reduced MI.

“These results are the most up-to-date look at the totality of data on this topic, and pending further trials, should provide physicians with confidence in assessing the benefits and risks of different durations of DAPT.”

Profile: J Dawn Abbott

Structural Heart Interventions

page 10

page 12

“Be prepared” for the longterm impact of COVID-19, cardiologists warn “Our contributions have been remarkable, but we must be prepared for the long-term,” warns Christopher O’Connor, editor-inchief of JACC: Heart Failure, in an editorial in the journal’s July edition. Cardiovascular care during the “acute” phase of the pandemic has left many providers “fatigued, tired, burned out, and questioning the future”, he writes, but, with this acute phase beginning to stabilise, “the chronic phase of COVID-19 will continue for years to come,” O’Connor predicts.

THESE WORDS APPEAR PRESCIENT as studies continue to emerge revealing the toll that COVID-19 is taking on the cardiovascular health of some patients to have contracted the virus. In recent weeks, a German study of newly-recovered COVID-19 patients examined using magnetic resonance imaging (MRI) revealed cardiac involvement in as many as 78% of patients, and ongoing myocardial inflammation in 60%.

Published online in JAMA: Cardiology, the study’s findings indicate the need for ongoing investigation of the long-term cardiovascular consequences of COVID-19, according to lead author Valentina Puntmann (University Hospital Frankfurt, Frankfurt, Germany).

The study assessed 100 patients who had recently-recovered from COVID-19 through the University Hospital Frankfurt Registry between April and June 2020. Results showed that the abnormality present among the Continued on page 4

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August 2020 | Issue 58

DAPT duration in the spotlight

Meta-analysis puts spotlight on optimal DAPT duration

stratifying patients at high bleeding risk followed the publication of the LEADERS FREE trial, and the ZEUS HBR sub-study, leading to efforts to set a common definition of high bleeding risk. This resulted in an Academic Research Consortium (ARC) consensus definition, published in 2019. “This ARCContinued from page 1 HBR definition has since been validated by several “Both mid-term and short-term DAPT followed groups, but to the best of my knowledge, it has not yet by aspirin monotherapy had a similar safety and been used to prospectively define the study population effectiveness profile compared with 12-month DAPT, in a randomised controlled trial,” said Urban. and a better safety profile compared with extended-term Asked to comment on the optimal strategy for DAPT; however, these strategies had a higher risk of managing patients at high bleeding risk, Urban said: MI and stent thrombosis compared with extended-term “This is obviously a complex and critically important DAPT,” the study team notes. question. Guidelines in Europe and the USA already The results showed that one-month DAPT followed take high bleeding risk into account for DAPT

by P2Y12 monotherapy was intensity and duration.” superior to three-month “For DAPT,” he DAPT followed by aspirin explained, “the currently monotherapy in limiting ongoing MASTER DAPT “It is critical to bleeding risk. Khan, trial will give us some understand exactly Bhatt et al add that the more definitive answers, why a procedure is current study provides but my own feeling is being done and how to evidence favouring that we will not be able to extended-term therapy define a one-size-DAPTmanage the DAPT for ischaemic events, fits-all high bleeding up front.” which may be appropriate risk. This is indeed the for certain patients who are at a higher risk of cardiovascular events after PCI and with a low risk of bleeding, such as those “My own feeling is presenting with acute coronary syndrome, with diabetes mellitus, or at high ischaemic risk. Nonetheless, the that we will not be study’s authors advocate a “personalised approach able to define a oneconsidering each patient’s relative and absolute risks of size-DAPT-fits-all high ischaemia and bleeding when deciding upon the optimal bleeding risk.” duration of DAPT after PCI”.

Speaking to Cardiovascular News, Bhatt said: “These results are the most up-to-date look at the totality of data on this topic, and pending further trials, should provide physicians with confidence in assessing the benefits and risks of different durations of DAPT. conclusion of Bhatt’s meta-analysis.”

“Careful patient selection is key. For patients at high This question was also put to Ajay Kirtane ischaemic risk and low bleeding risk, durations of (Columbia University Irving Medical Center, New DAPT longer than 12 months are generally warranted, York, USA), who commented: “First, it is very assuming that they have already tolerated DAPT without important to define the risk, and to understand the a problem. For patients at high bleeding risk, even if indications for the procedure being considered. In at high ischemic risk (as many are), a shorter duration other words, even with shorter DAPT regimens, it is of DAPT followed by ADP [adenosine diphosphate] still critical to understand exactly why a procedure receptor antagonist monotherapy seems to strike the best is being done and how to manage the DAPT up balance.” front in a variety of hypothetical scenarios. In some While the Khan, Bhatt et al analysis puts the spotlight extreme risk cases, the answer might be no procedure on duration of therapy, defining the patients at high risk at all. In general, if PCI is undertaken then it should of bleeding is a key area of consideration. Speaking likely be with a device for which we understand the to Cardiovascular News, Philip Urban (Hôpital de la ramifications of shorter durations (and regimens) of Tour, Geneva, Switzerland) explained that interest in DAPT—as studied in clinical trials.”

Ajay Kirtane

Philip Urban

News in brief

The latest stories from the world of Cardiology

n TELEMEDICINE IN LATIN AMERICA: Sameer Mehta details the ST elevation myocardial infarction (STEMI) treatment strategy of the Latin America telemedicine infarct network (LATIN) during the COVID-19 pandemic and shares lessons learnt.

For more on this story go to page 5

Sameer Mehta

n PCR E-COURSE: Catch up on the latest studies and trials presented virtually at PCR e-Course, including full one-year follow-up data from the Evolut Low Risk trial, demonstrating that transcatheter aortic valve implantation (TAVI) is non-inferior to surgical valve replacement for allcause mortality or disabling stroke.

For more on this story go to page 8.

n STRUCTURAL HEART INTERVENTIONS: The 10-year rate of bioprosthetic structural valve failure and valve failure was found to be low in patients who had undergone transcatheter aortic valve implantation (TAVI) with an early-generation balloon-expandable device according to a study published in Catherization & Cardiovascular Interventions. Responding to the findings, John Webb (Vancouver, Canada) told Cardiovascular News: "The choice between transcatheter and surgical valve replacement should be based upon the other factors important to an individual."

For more on this story go to page 12.

John Webb

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August 2020 | Issue 58

COVID-19

Echocardiography findings on COVID-19 patients

1,216

increased susceptibility to infection and an increased risk of severe disease and death. Severe cardiac disease was observed in one in seven patients across the whole cohort and in one in eight patients without pre-existing cardiac disease. This proportion rose to one in five when the indication for imaging included raised cardiac biomarkers.”

As the impact of the pandemic on patients who have contracted COVID-19 mounts, so too does data on the long-term impact of patients who have been unable to receive treatment during the pandemic.

Research published in The Lancet in July assessed admissions to hospitals in England for acute coronary syndrome, noting a decline from mid-February 2020, falling from a 2019 baseline rate of 3,017 admissions per week to 1,813 per week by the end of March 2020,

Total patients

549 (45%)

667 (55%)

305 (25%)

185 (15%)



Source: European Heart Journal - Cardiovascular Imaging

Left ventricular abnormality

Normal echocardiogram

Biventricular failure

Abnormal echocardiogram

Right ventricular abnormality

174 (14%)

“Be prepared” for the longterm impact of COVID-19, cardiologists warned Continued from page 1

patient cohort was myocardial inflammation—defined as abnormal native T1 and T2 measures—detected in 60 patients, followed by regional scar and pericardial enhancement.

Discussing the significance of the findings, Puntmann and colleagues write: “The results of our study provide important insights into the prevalence of cardiovascular involvement in the early convalescent stage. Our findings demonstrate that participants with a relative paucity of pre-existing cardiovascular condition and with mostly home-based recovery had frequent cardiac inflammatory involvement, which was similar to the hospitalised subgroup with regards to severity and extent.”

Another dimension

In an editorial published alongside the JAMA: Cardiology article, by the publication’s deputy editor Clyde Yancy (Northwestern University Feinberg School of Medicine, Chicago, USA) and section editor Gregg Fonarow (University of California Los Angeles, Los Angeles, USA), the authors said that the findings of the Frankfurt study “could not be dismissed”. “Months after a COVID-19 diagnosis, the possibility exists of residual left ventricular dysfunction and ongoing inflammation, both of sufficient concern to represent a nidus for new-onset heart failure and other cardiovascular complications,” Yancy and Fonarow write. They add that further investigation is needed to “carefully examine existing and prospectively collect new data in other populations to confirm or refute the findings”.

“Given the pressing burden of the ongoing COVID-19 crisis, as well as the initiation of longitudinal care models for those recovering from COVID-19, the concerns we are raising are not theoretical but instead practical and require our due diligence to study and prepare for what may be another dimension of the COVID-19 crisis,” Yancy and Fonarow conclude.

Findings of a prospective international study published in the European Heart Journal-

Given the pressing burden of the ongoing COVID-19 crisis [...] the concerns we are raising are not theoretical but instead practical.”

Cardiovascular Imaging in July showed that around half of COVID-19 patients receiving an echocardiogram in hospital showed abnormalities in heart function, while one in seven showed severe abnormalities likely to have a major effect on their survival and recovery.

The study, authored by Marc Dweck (University of Edinburgh, Edinburgh, UK), looked at echocardiogram results from 1,216 patients with COVID-19 from 69 countries. Results showed that left and right ventricular abnormalities were reported in 479 (39%) and 397 (33%) patients, respectively, with evidence of new myocardial infarction in 36 (3%), myocarditis in 35 (3%), and takotsubo cardiomyopathy in 19 (2%). Severe cardiac disease—severe ventricular dysfunction or tamponade—was observed in 182 (15%) patients. In those without pre-existing cardiac disease (n=901), the echocardiogram was abnormal in 46%, and 13% had severe disease, Dweck and colleagues found.

Risk factors

Discussing the findings, Dweck notes: “Whilst our previous understanding of how COVID-19 affects the heart was limited to case reports and case series, consistent epidemiological data have demonstrated that patients with established cardiovascular disease, risk factors, or elevated cardiac biomarkers have an

a reduction of 40% (95% CI 37–43). This decline was partly reversed during April and May 2020, they reported, such that by the last week of May there were 2,522 admissions, representing a 16% (95% CI 13–20) reduction from baseline.

Marion Mafham (University of Oxford, Oxford, UK) et al, report that reductions were recorded in numbers of admissions for acute myocardial infarction, STelevation myocardial infarction (STEMI), and nonSTEMI (NSTEMI) from the average for 2019 to the end of March 2020, they note, reporting that the percentage reduction in admissions for all acute myocardial infarctions was 35% (95% CI 32–39), with an average of 2,061 admissions per week in 2019, falling to 1,335 per week by the end of March 2020.

For STEMI, there were 621 admissions per week in 2019 and 477 per week by the end of March 2020 (percentage reduction in admissions 23%, 95% CI 16–30), they report. The percentage reduction in admissions for NSTEMI was 42% (95% CI 38–46), with 1,267 admissions per week in 2019 and 733 per week by the end of March 2020. Admissions for both STEMI and NSTEMI rose through April and May 2020, such that, by the last week of May, 2020, admissions were 10% lower than the 2019 baseline for STEMI (95% CI 2–17; 561 admissions per week) and 24% lower for NSTEMI (95% CI 19–28; 966 admissions per week) the researchers report.

Serious concern

Discussing the findings, Mafham et al write: “Taken together, the substantial reduction in admissions for acute coronary syndrome during the COVID-19 pandemic is a serious concern, because patients with symptoms indicative of acute myocardial ischaemia benefit from rapid in-hospital assessment, with the gain being greatest among those with STEMI. Among such patients, there is a substantial risk of out-of-hospital cardiac arrest, and the failure of patients with STEMI to be admitted to hospital so they can receive early reperfusion therapy and other appropriate treatments is likely to have resulted in avoidable deaths and complications, such as fatal arrhythmias and disabling heart failure.

“Although no overall increase in in-hospital mortality was seen among patients admitted for acute coronary syndrome, a direct comparison between mortality rates before and after mid-March 2020, is likely to be confounded by differences in underlying risk of admitted patients and by the duration of hospital stay. Moreover, it is not possible to assess directly the deaths and disability that probably occurred among those patients with acute coronary syndrome who were not admitted to hospital because of COVID-19 and, therefore, did not receive treatment that is known to be effective.”

Issue 58 | August 2020

Telemedicine

Using telemedicine to transform the management of acute myocardial infarction: the Latin America telemedicine infarct network (LATIN) experience Sameer Mehta Comment & Analysis Telemedicine has come into its own during the pandemic. Sameer Mehta details the STEMI treatment strategy of the Latin America telemedicine infarct network (LATIN), and shares lessons learnt.

T

he coronavirus pandemic has led to seismic developments around telemedicine, as its capabilities for optimising healthcare are illustrated and its various attributes become apparent.

After the pandemic recedes, there will not necessarily be a reduction in its popularity. We may find ourselves using it even more to flatten disparities of care and deliver cost-effective healthcare beyond geographical boundaries.

The work of the Latin America telemedicine infarct network (LATIN) provides valuable lessons about the power of telemedicine and its potential for efficient management of populationbased conditions, such as acute myocardial infarction (AMI).

The size of LATIN is unprecedented, and the subjects treated in the programme easily exceed those in other reported telemedicine trials. LATIN has cared for almost 900,000 patients, and its 355 centres provide an umbrella of AMI care to >100 million patients (Figure 1), all of whom received access to experts and a guidelines-based AMI programme.

LATIN uses a “hub and spoke” strategy, and the protocol of AMI care involves urgent reperfusion of patients with thrombolysis, pharmacoinvasive management, or primary percutaneous coronary intervention (PCI). The “spokes” are located in remote regions, often up to 200 miles from the “hubs”, where primary PCI is performed. Expert cardiologists located at command centres use telemedicine to interpret an electrocardiograph (ECG) and to guide the triage and treatment strategy.

LATIN was first launched as a pilot programme in 2012 in Barranquilla, Colombia. This helped to highlight the challenges—technology gaps, cultural barriers, infrastructure deficits, ambulance shortages, lack of PCI facilities, and reimbursement issues. As the programme was expanded to other cities in Colombia, and later to Brazil, Mexico, and Chile, these challenges were gradually overcome, apart from the issue of payment for the procedures—

this was beyond the scope of LATIN and was related to numerous healthcare reimbursement and funding issues.

Almost 900,000 patients have received telemedicine guidance at 355 centres that employ standardised protocols and telemedicine guidance; 72% were treated with primary PCI, and door-toballoon (d2b) times were 48 minutes.

In-hospital mortality was 5.2%, a 55% overall reduction compared to a historic cohort. Time to telemedicine diagnosis (TTD) was used as a metric to monitor telemedicine efficiency (Figure 2), and included the transmission of the ECG from the spoke, elimination of artefacts and incorporation within HIPAA (Health Insurance Portability and Accountability Act of 1996) guidelines, interpretation at the telemedicine centre, notification of diagnosis, and alerts issued for the spoke, the hub, and for ambulance dispatch.

A mean TTD of 3.5 minutes was achieved, both in sites guided from within the country (Colombia and Brazil) and from outside (Mexico and Argentina). Achieving telemedicine efficiency with such low TTD required tremendous expert commitment, meticulous on-site training, and investments in cloud computing and the design of high fidelity platforms.

Savings accrued from avoiding unnecessary transfer and treatment, and by early hospital discharge and reduced medications. Figure 3 is an economic forecast of LATIN that demonstrates cost savings from the programme.

There have been numerous gains— directly, as evidenced by the lives saved and from the cost-savings, and also from the halo effect of LATIN. Before the programme was initiated, policy for AMI care in Central and South America was ad hoc, with scattered centres of excellence and most patients either getting no or delayed perfusion with first-generation lytics. Urgent triage and transportation were rare and d2b times virtually unheard of. There were no community awareness programmes about the need for primary PCI. After

almost a decade of LATIN, stakeholders have been broadened, ST elevation myocardial infarction (STEMI) networks have become available, ambulance structure has significantly improved, and patient awareness is better. At the first LATIN pilot site in Barranquilla, before the programme, 80% of patients selftransported to either the spoke or the hub and presented 7.1 hours after chest pain.

Presently, almost all are being transported by ambulance, and 79% are being treated with primary PCI with short d2b.

We believe LATIN provides a costeffective template for reducing disparities of AMI care and its greatest relevance is in poor regions of the world. In addition to expanding to other regions, there appear to be four future applications: telemedicine guided programmes for other time-dependent clinical entities, such as stroke. LATIN telestroke is testing a pilot programme; integrating telemedicine and artificial

Figure 1: An umbrella of care for >100 million patients

5

intelligence (AI) into a seamless, physician-free management of AMI systems of care; impacting symptom-to-balloon times with self-administered AI-guided tools for AMI detection that are embedded into telemedicine protocols. We are presently testing a single lead, AI algorithm at LATIN sites; remote primary PCI with platforms such as Corindus.

Sameer Mehta is the chairman of the Lumen Foundation in Miami, USA

After the pandemic recedes, there will not necessarily be a reduction in the popularity of telemedicine…we may find ourselves using it even more to flatten disparities of care and to deliver cost-effective healthcare beyond geographical boundaries.”

Figure 2: Time to telemedicine diagnosis Year

Telemedicine Encounters

#STEMI Diagnosed

#STEMI Reperfused

Avoided Financial Transfers savings (30%) (30%)

Avoided Transfers (10%)

Financial savings (10%)

2014

50,011

551

193 (38%)

14,945

$7.7 mil

4,981

$2.6 mil

2015

120,000

1,440

576 (41%)

35,827

$18.4 mil

11,942

$6.16 mil

2016

370,000

4,810

1.972 (42%)

110,408

$56.9 mil

36,802

$18.9 mil

2019

780,234

8,395

3,872 (44%)

207,765

$119 mil

66,919

$39.6 mil

2020

1,561,930

20,305

8,731 (43%)

465,959

$240.1 mil

155,319

$80.14 mil

2026

5,495,503

71,441

30,719 (43%)

1,639,435

$845.9 mil

546,478

$281.9 mil

2026

5,495,503

71,441

35,729 (50%)

1,637,934

$845.1 mil

546,978

$281.7 mil

2026

5,495,503

71,441

42,864 (60%)

1,635,791

$844.0 mil

545,263

$281.3 mil

Figure 3: Economic forecast of LATIN

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August 2020 | Issue 58

CX Aortic Vienna

Inaugural CX Aortic Vienna to take place online The inaugural CX Aortic Vienna meeting will be livestreamed 8–11 September 2020 to an international, online audience, and will include registrant participation, interaction, and polling.

T

he programme will focus on all matters aortic—from the aortic valve to the iliac arteries. All known pathologies will be included, and imaging, diagnosis and therapeutic options—open, endovascular, hybrid and no intervention—will be applied systematically to the length of the entire aorta, all the while keeping the patient front and centre. On each of the four days, the programme will cover abdominal and thoracic topics.

CX Aortic Vienna 2020 is brought to you with the participation of the Austrian Society of Vascular Surgery (ÖGG), the Italian Society of Vascular and Endovascular Surgery (SICVE), the Swiss Society for Vascular Surgery (SGG), and Aortic Surgery “HOW TO DO IT” (HTDI).

There will be dedicated discussion around open and endovascular choices to treat abdominal aortic aneurysm with a focus on sac size and EVAR follow-up, ultrasound versus CT surveillance after EVAR, current research into the best imaging modalities for EVAR imaging, and juxtarenal issues with challenging abdominal aneurysm neck.

In the abdominal aortic section, there is an enduring fascination with the importance of diagnostic imaging modalities, as well as how to maintain endovascular aortic repair (EVAR) results, or instead turn to open repair.

There is also a separate session on pathologies of the iliac vessels within the pelvis. In the juxtarenal section, the programme will explore methods to overcome the challenging aortic neck, using all manner of open and endovascular means.

In the thoracic aorta, there will be sections dedicated entirely to the aortic arch, and every aspect of dissecting aortic aneurysm, especially with regard to the timing of intervention. All treatment approaches will be considered and comparisons of open and endovascular methods made in a stepwise, methodical manner.

In the thoracoabdominal section, there remains obvious interest in spinal cord ischaemia and how to reduce the risk of this, with or without cerebrospinal fluid drainage.

In an important collaboration, the ÖGG will be joined by the SGG in the creation of a combined livestreamed programme.

The SICVE will also have a livestreamed programme and HTDI will show Arch Techniques & Technologies.

All about the aorta

Roger Greenhalgh (London, UK), the anchor chairman, explains the evolution

of aortic management, contextualising the need for an aortic-specific educational meeting: “What I would like to know is the pathology behind any problems with the aorta. This might be very different: for example, with the ascending aorta, with the arch of the aorta, the great vessels to the brain and risk of stroke, the descending aorta—four different pathologies there, atherosclerosis, dissection, transection, and ulceration.

How do you diagnose those, how do you

endovascular or open. The patient should have the right treatment [speaker’s emphasis]. There should be discussions in centres on whether an open or an endovascular approach is best, it should not be a territorial matter. Let us encourage every patient to be considered with all options, and have an open mind about open surgery and endovascular.”

A focus on decision-making in the patient’s interest

Roberto Chiesa (Milan, Italy) will be specially filming open and endovascular technical procedures of how to best manage the diseases of the arch of the aorta, considering whether to intervene or not based on the underlying pathology.

Chiesa runs an ace team in an academic hospital that relies on both open and endovascular expertise. He will outline the importance of a forwardthinking, non-biased approach and running daily multidisciplinary meetings in the patient interest to decide which, if

Afshin Assadian

Aortic Vienna will showcase HTDI open and endovascular reconstruction of the aortic arch featuring recorded cases.

A comprehensive meeting on aortic therapies

Afshin Assadian (Vienna, Austria), the current president of the ÖGG, describes CX Aortic Vienna as a “comprehensive meeting on aortic therapies” taking in contributions from speakers covering a wide range of specialties.

The meeting is inspired by the historic Austrian capital city Vienna “the pulsating heart of Europe”, but Assadian explains that the 2020 edition of the conference will be “more of a web-based event”, reflecting current circumstances.

He comments: “We would invite all specialties involved in the understanding, development and progression of therapy of aortic pathologies.”

The ÖGG and the SGG will livestream presentations with audience participation

Roberto Chiesa

Martin Funovics

Christoph Neumayer

image those, how do you know which is the best way to treat them in the first place?

“We still live in an era where it is possible for patients to be referred to one hospital and have an open operation for the aorta, and to another hospital and have an endovascular approach. It should not be right for it to depend upon which hospital or specialist you get sent to, whether a patient should have

The CX Aortic Vienna Executive Board welcomes you to the inaugural conference any, is the best treatment.

Leading the discussion on aortic arch reconstruction, Chiesa will look at this “borderline territory” between cardiothoracic and vascular surgery and how treatment of such diseases requires advanced skills and cooperation between specialties.

Delving into the specifics of what delegates can expect from the inaugural meeting, Chiesa highlights that CX

Alexander Zimmermann

and discussion. Alexander Zimmermann (Zürich, Switzerland) comments that this virtual format will enable widespread participation, enabling all colleagues interested in vascular medicine “to participate and actively contribute to this event” easily, wherever they are in the world. “You can be sure that the scientific level will be amazing and the level of discussion hard to find elsewhere,” he adds.

AORTIC VIENNA

8–11 SEPTEMBER 2020 We would like to invite all specialists treating patients with aortic disease to attend the inaugural CX Aortic Vienna meeting, which will be livestreamed 8–11 September 2020 to an international, online audience, and will include registrant participation, interaction, and polling.

Registration open

www.cxaortic.com

8

August 2020 | Issue 58

Conference coverage

PCR e-course

Evolut Low-Risk trial confirms TAVI is non-inferior to surgery, and establishes it is cost-effective Full one-year follow-up from the Evolut Low Risk trial has upheld earlier findings from the study, demonstrating that transcatheter aortic valve implantation (TAVI) is non-inferior to surgical aortic valve replacement (SAVR) for all-cause mortality or disabling stroke at two years. The analysis, presented by Michael J Reardon (Methodist DeBakey Heart & Vascular Center, Houston, USA) on behalf of the investigators at a hotline session at PCR e-Course 2020 (25–27 June), also projected that TAVI is cost-effective for low-risk patients in the USA and, depending on country-specific factors, it may also be the case in Europe.

THE EVOLUT LOW RISK trial is a prospective international multicentre randomised trial. It found that TAVI was non-inferior to SAVR for the primary endpoint of the estimated two-year rate of all-cause mortality or disabling stroke, based on a Bayesian study design. At that time, 850 of the 1,403 as-treated patients had been followed through one year. All eligible patients have now completed follow-up to one year and are included in the current analysis.

At two years’ post-procedure, the rate of the primary endpoint of all-cause mortality or disabling stroke was 4.4% for TAVI versus 6.6% for surgery.

Reardon added: “Time in the cath lab or OR [operating room] was statistically superior for TAVI [p<0.0001]; hospital length of stay was statistically superior for TAVI [p<0.0001]; discharge straight to home was statistically superior for TAVI [p<0.0001].

New pacemaker [implantation rate] was statistically superior for surgery both in year one and year two [p<0.001]. Acute kidney injury was statistically superior for TAVI in year one and year two [p<0.01].”

The investigators created a health economic model of life year and quality adjusted life years (QALY) gains, using different projections: “We made two different assumptions; one was an optimistic assumption of a small observed mortality benefit from TAVI and surgery

with between six and 24 months data continues lifelong.

The other was a more pessimistic assumption that general population mortality prevailed and there was no survival difference between TAVI and surgery beyond 12 months.”

The lifetime benefit of TAVI, depending on survival projections beyond 12 months using the optimistic assumption, gave a gain of 0.32 life years, and 0.57 QALYs. Using the pessimistic assumption, the gain was 0.07 life years, and 0.08 QALYs for TAVI over surgery.

A US economic analysis projects a one-year cost difference of around US$4,000 in favour of surgery, and a lifetime cost difference of US$5,500 to US$12,500.

This suggests, said Reardon, that TAVI is cost effective

DEFINITION II finds twostent approach better than provisional in complex lesions A systematic two-stent approach in complex coronary bifurcation lesions is associated with a significantly greater improvement in clinical outcomes at one year than provisional stenting, according to the DEFINITION II study, presented at a latebreaking trial session at the PCR e-Course 2020 (25–27 June) and simultaneously published in the European Heart Journal.

S

hao Liang Chen (Nanjing Medical University, Nanjing, China) informed the online audience that the lower rate of target lesion failure was “mainly driven by fewer target vessel myocardial infarctions and clinically-driven target lesion revascularisations. The incidence of stent thrombosis was comparable between the two groups.”

The study aimed to assess the benefits of the two-stent technique for patients

with DEFINITION criteria-defined complex coronary bifurcation lesions.

In total, 653 patients with complex bifurcation lesions at 49 centres were randomly assigned to undergo the two-stent technique (two-stent group, n=328) or provisional stenting (provisional group, n=325). The primary endpoint was the composite of target lesion failure at one-year follow-up, including cardiac death, target-vessel myocardial infarction, and clinically

if the incremental cost effectiveness ratio (ICER) is used (from US$21,000 to US$87,000 per QALY gained).

Reardon told the online audience: “Potential drivers for cost effectiveness in Europe are different, and TAVI would be cost effective if lifetime incremental costs for the UK were less than £2,000 to £8,000, depending on whether you are using an optimistic or pessimistic assumption—the optimistic assumption actually costs you more because patients live longer with TAVI—and in Germany, France, Italy, and The Netherlands it would vary between €4,000 to €16,000, depending on whether the assumptions are optimistic or pessimistic. Is this what is going to play out in Europe? We really do not know.”

He concluded: “At one year, the rate of disabling stroke and AV [aortic valve] hospitalisations are significantly lower with TAVI compared to SAVR. For the USA, TAVI is projected to be cost-effective for low risk patients; this may hold true in the European context depending on country cost differences and willingness to pay.”

At one year, the rate of disabling stroke and AV [aortic valve] hospitalisations are significantly lower with TAVI compared to SAVR. For the USA, TAVI is projected to be costeffective for low risk patients; this may hold true in the European context depending on country cost differences and willingness to pay.”

driven target lesion revascularisation.

The safety endpoint was definite or probable stent thrombosis.

The researchers hypothesised a oneyear target lesion failure rate of 14% in the provisional group versus 7% in the two-stent group.

At one year, target lesion failure occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and twostent groups, respectively (77.8%, DK crush; hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.30–0.90, p=0.019), largely driven by increased target vessel myocardial infarction (7.1%, HR 0.43, 95% CI 0.20–0.90, p=0.025), and clinically driven target lesion revascularisation (5.5%, HR 0.43, 95% CI 0.19–1.00, p=0.049) in the provisional group. One year after the index procedure, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31–2.37, p=0.772).

Chen said: “A systematic two-stent

approach is associated with a lower rate of one-year target lesion failure for patients with complex coronary bifurcation lesions, compared to the provisional approach. The underlying mechanisms for increased target vessel myocardial infarction after provisional stenting are unclear and further study is warranted.”

Assessing the significance of the findings for Cardiovascular News, Chen said: “Previously, there was no universally accepted stratification for defining the complexity of coronary artery bifurcation lesions—the DEFINITION criteria were built in our previous study. In the current study, among patients with DEFINITION criteria-defined complex coronary artery bifurcation lesions, a systematic two-stent approach (mainly DK crush stenting) demonstrates tremendous benefits. DEFINITION criteria could be used to differentiate simple from complex coronary artery bifurcation lesions.”

Issue 58 | August 2020

Mitral valvein-valve and valve-in-ring strategies often require repeat procedures A comprehensive evaluation of mitral valve-in-valve (ViV) and valve-in-ring (ViR) procedures has found that residual mitral stenosis and/or mitral regurgitation were “relatively common”, and that both were associated with a need for repeat valve replacement.

Significant residual mitral regurgitation occurred more often in ViR patients, with lower survival at four years.

R

esearchers Matheus Simonato (Federal University of Sao Paulo, Sao Paulo, Brazil), Danny Dvir (Shaare Zedek Medical Centre, Israel and University of Washington Medical Center, Seattle, USA) et al from the Valve-in-Valve International Data (VIVID) Registry said that strategies to improve post-procedural haemodynamics in mitral ViV and ViR should be further

Conference coverage

explored. The results were presented virtually by Simonato in a late-breaking trial session at the PCR e-Course 2020 (25–27 June).

He explained: “There are limited data on the clinical significance of valve haemodynamics after transcatheter mitral valve-in-valve and valve-inring procedures. Our objective was to describe predictors for residual mitral stenosis and residual mitral regurgitation after these procedures, and to determine whether there is a possible influence on meaningful long-term clinical outcomes.”

The study consisted of a retrospective multicentre data collection looking at patients undergoing mitral ViV and ViR between March 2006 and March 2020.

Clinical endpoints were defined according to the Mitral Valve Academic Research Consortium (MVARC).

Significant residual mitral stenosis was defined as mean gradient ≥10mmHg and significant residual mitral regurgitation as ≥ moderate.

In all, 1,079 patients (857 ViV, 222 ViR; mean age 73.5 years±12.5, 40.8% male) from 90 centres were included. Median Society of Thoracic Surgery Predicted Risk of Mortality (STS-PROM) score was 8.6%, and median clinical follow-up was 492 days (Interquartile range [IQR] 76–996 days]; median echocardiographic follow-up for patients that survived one year was 772.5 days (IQR 510–1211.75 days).

The four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (p<0.001). Mean gradient across the

mitral valve post-procedure was 5.7±2.8 mmHg (≥5mmHg, 61.4% of patients).

Significant residual mitral stenosis occurred in 8.2% of the ViV and 12% of the ViR patients (p=0.09). Significant residual mitral regurgitation was more common in ViR patients (16.6% vs.

3.1%, p<0.001), and was associated with lower survival at four years (35.1% vs.

61.6%; p=0.02).

The rates of MVARC-defined device success were low for both procedures (39.4% total: 32% ViR vs. 41.3% ViV, p=0.01), and were mostly related to having a post-procedural mean gradient ≥5mmHg. Correlates for residual mitral stenosis were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual mitral stenosis (subhazard ratio [SHR] 4.67, 95% confidence interval [CI] 1.74–12.56, p=0.002) and significant residual mitral regurgitation (SHR 7.88, 95% CI 2.88– 21.53, p<0.001) were both independently associated with repeat mitral valve replacement.

Summing up, Simonato said: “Mitral ViR patients had higher mortality and required more redo mitral valve replacement at four-year follow-up.

Residual mitral regurgitation was associated with higher mortality […] residual mitral stenosis was not predictive of patient mortality, but was associated with repeat mitral valve replacement.”

Further, he advised: “Operators of ViV and ViR procedures should aim for

Routine revascularisation confers no survival advantage over initial medical therapy in patients with stable disease Sripal Bangalore (New York University Grossman School of Medicine, New York, USA) presented the results of a late-breaking meta-analysis of randomised trials (including the recently published ISCHEMIA and ISCHEMIA-CKD) that compared routine revascularisation with an initial conservative strategy at PCR e-Course 2020.

BANGALORE MADE THE POINT that revascularisation is often performed in patients with stable ischaemic heart disease (SIHD) to improve survival, prevent other cardiovascular events, and improve quality of life. A press release from PCR emphasises that it remains uncertain whether revascularisation reduces death and other outcomes.

Cumulative evidence from this meta-analysis, which includes data from 14 randomised controlled trials and 14,877 patients followed for a weighted mean of 4.5 years, suggests routine revascularisation when compared to initial medical therapy results in similar survival, reduced non-procedural myocardial infarction, reduced unstable angina, but greater freedom from angina at the expense of higher rates of procedural myocardial infarction. Previous trials have not shown a mortality benefit with the use of revascularisation over medical therapy, but Bangalore said guidelines continue to recommend revascularisation to improve survival in

certain subgroups of patients.

With regard to methodology, investigators excluded trials that enrolled patients within 48 hours of acute coronary syndrome and also those that only enrolled post myocardial infarction patients (such as ALKK and SWISSI-2).

Sripal Bangalore Bangalore outlined that trials were categorised as “no stent” trials if less than half of the patients in the intervention group received a stent, and grouped into “stent” trials if half or more received a stent. Further, trials were categorised into “no statin” trials if less than half of the patients in the medical therapy group received a statin and as “statin” trials if half or more of the patients in the medical therapy group received a statin. Statistical analysis was performed on an intention-to-treat basis.

The outcomes that the researchers looked at included

9

achieving optimal haemodynamics in these procedures.”

Analysing the findings for Cardiovascular News, Simonato commented: “This is the first time that the clinical relevance of residual mitral stenosis and mitral regurgitation are extensively evaluated in the mitral valvein-valve/valve-in-ring population.

“Our findings are relevant as we show that gradients between 5mmHg and 9mmHg are not associated with suboptimal clinical outcomes, even though they are considered device failure in current MVARC definitions. Gradients ≥10mmHg are not associated with mortality, but may lead to increased rates of mitral valve replacement.

“Strategies to improve post-procedural haemodynamics probably involve better device positioning, improved sizing algorithms, and balloon dilatation.

However, there is little data supporting these techniques, and further studies on the topic are still needed.”

Dvir told Cardiovascular News: “Suboptimal haemodynamics of mitral valve-in-valve and mitral valvein-ring should lead to procedural strategies to improve post-implantation haemodynamics in order to optimise device durability.”

Dvir also mentioned that, since the suboptimal survival of patients having mitral valve-in-ring procedures extends to four years with approximately 50% mortality, alternative therapies to mitral valve-in-ring in patients with mitral valve failure after surgical repair should be considered.

death, cardiovascular death, both procedural and nonprocedural myocardial infarction, overall myocardial infarction, unstable angina, heart failure, stroke, and freedom from angina.

“The risk benefits of routine revascularisation versus initial medical therapy should be used in shared decision making for the management of patients with stable ischaemic heart disease. Longer-term follow-up of trials is needed to assess whether reduction in nonfatal spontaneous events improves long-term survival,” the press release advocated.

Bangalore qualified that the limitations of the dataset included clinical heterogeneity in the studies despite lack of statistical heterogeneity for most endpoints.

He also pointed to the variability in the definitions of outcomes, especially for myocardial infarction.

The risk benefits of routine revascularisation versus initial medical therapy should be used in shared decision making for the management of patients with stable ischaemic heart disease.”

August 2020 | Issue 58

10 Interview

Profile

J Dawn Abbott J Dawn Abbott is the director of interventional cardiology and an associate professor of medicine in the department of medicine at the Warren Alpert Medical School of Brown University (Providence, USA). She talks to Cardiovascular News about her career in interventional cardiology, the importance of personalised medicine, and how the field has changed in light of COVID-19. Abbott also discusses her work as part of the Women in Innovations (WIN) committee at the Society for Cardiovascular Angiography & Interventions (SCAI) and its work to improve opportunities for women in interventional cardiology.

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

My personal experiences with doctors as a child were very positive and I was interested in a career in the medical field before high school. By age 16, I took the Emergency Medicine Technician (EMT) course and was volunteering on the ambulance in my hometown.

My family was always supportive and I was the first to attend college. At University of Chicago Pritzker School of Medicine, I was drawn to the operating room and doing research in vascular surgery. As a third year medical student I was placed on an inpatient cardiology rotation and at the end of the month the attending remarked that I would be a terrific interventional cardiologist. I did not know much about the field at that time, particularly that there were few women in the specialty, but the ability to treat patients in a minimally invasive way through an endovascular approach seemed novel and challenging. Interventional cardiology suited me and I have never looked back on that decision.

Who were the biggest influences on your early career?

When I was in medical school and training at Yale I was very focused on each rotation and research project, trying to gain knowledge and skills. At that point I was more influenced by the culture of the institutions than specific individuals. Faculty and role models were almost exclusively in academic medicine with careers in research or as educators in addition to some level of patient care. David O Williams, who I met in my first faculty position at Brown, was the biggest influence early in my interventional career.

He acted as a mentor and sponsor, helping me with grant applications, introducing me to collaborators and colleagues, providing me opportunities to present at conferences, and recommending me for committees and editorial responsibilities. He was also a skilled cath lab operator, being one of the first in the country to perform percutaneous coronary intervention (PCI). I respected him and wanted my career to be similar. Being selected for the Emerging Leadership programme (ELM) and the Women in Innovations (WIN) committee through the Society for Cardiovascular Angiography & Interventions (SCAI) were also very influential. The mentors and peers I interacted with in these organisations were inspiring and remain important to me to this day.

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

As an interventional cardiology fellow, about 15% of the PCI cases were brachytherapy for bare metal stent restenosis. When we participated in the first drug-eluting stent (DES) trial and early reports of the effectiveness of these devices were emerging, I knew the landscape was changing. The eventual development of thinner and more biocompatible DESs has allowed performance of PCI in the most complex anatomy. Of course, most would say that structural interventions really pushed

the limits of catheter-based therapies and have rivalled surgical approaches in remarkable ways.

What are your current research interests?

Since my involvement in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry of PCI, Iâ&#x20AC;&#x2122;m always looking to harness the power of registry and administrative data to understand the landscape of interventional cardiology. The methods used to assess trends, outcomes, and subgroup associations can generate hypotheses and identify areas to further investigate. Contributing to randomised clinical trials is also a priority and I am currently a co-investigator on an NIH funded study comparing a liberal to restrictive transfusion strategy in patients with anaemia that suffer a myocardial infarction.

What do you feel has been your biggest contribution to interventional cardiology?

Biggest is an intimidating word. Being a patient advocate, educator, clinical researcher, and volunteering in cardiovascular societies have defined my contributions. One of the recognitions I am most proud

I think we will see the increasing use of artificial intelligence, such as automated pressure derived indices and coregistration algorithms.

This information should be routinely available to patients undergoing PCI.â&#x20AC;? of is being considered one of the Top Doctors in Rhode Island in Cardiovascular Medicine.

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

There needs to be more attention to research in personalised medicine and focusing treatment on individuals in addition to diseases.

What do you think the next breakthrough innovation in interventional cardiology will be?

There have been so many important innovations that need to be optimised such as bioresorbable scaffolds and percutaneous mitral valve therapies. Another trend I think we will see is the increasing use of artificial intelligence, such as automated pressure derived indices and co-registration algorithms. This information should be routinely available to patients undergoing PCI.

You have been involved in the SCAI WIN-CHIP Fellowship; how has this helped to further the representation of women in the field of interventional cardiology?

This tremendous opportunity ensures women can obtain advanced interventional training. It takes down barriers by providing mentorship and procedural training with flexibility in programme location. The skills and professional relationships that are developed during this year jumpstart a career. SCAI WIN is thankful to our industry partners for providing unrestricted funding and to the programmes that sponsor the awardees.

What impact has the COVID-19 pandemic had on your practice?

The most difficult aspects were the inability to perform

Issue 58 | August 2020

Interview 11

elective PCI when the hospital was near capacity and deciding the best way to care for patients with COVID-19 and cardiovascular manifestations. We developed protocols and cath lab staff trained on proper use of personal protective equipment (PPE). Patients were scared and many were avoiding the hospital, so our ST-elevation myocardial infarction (STEMI) volume was highly variable and many patients were presenting critically ill. Thankfully, telemedicine provided a way to care for and communicate with patients.

What are the implications of COVID-19 for the management of patients with structural heart disease?

Since structural heart procedures utilise a team approach, the stress on hospital resources and personnel during a pandemic limit the ability to maintain procedural volumes. Therefore, it is necessary to prioritise patients that need the procedure on an urgent or emergent basis. Unfortunately, there can be unanticipated consequences of postponing elective procedures in these patients. Catheter-based procedures have a shorter length of stay compared with surgery, and should be preferred in patients with both options during COVID-19 surges.

What advice would you give to someone who was starting out in cardiovascular medicine?

There are so many quotes about “paths” for a reason.

Find your own interests and your definition of success.

Cardiovascular medicine is a phenomenal career choice for any person because of all the subspecialty options.

Women should not be discouraged; interventional cardiology is a rewarding career and we need more diversity in the field. Lastly, do not postpone your personal life—take care of yourself and enjoy time with your family and friends.

What are your hobbies and interests outside of medicine?

One of my bad habits is that I am not good at relaxing.

To disconnect, I find travel and sports with my husband and daughter are the best activities. In the winter we ski and snowshoe. The summers in Rhode Island are spent on the water, sailing and boating the coast and islands.

I find international travel and learning about ancient civilisations fascinating. Prior to COVID-19, we travelled to Egypt, Peru, Turkey, and several European cities. I am looking forward to finding new adventures in the future.

Fact file Current appointments

Director, Interventional Cardiology Fellowship, Brown University, Providence, USA Associate Chief, Faculty Development and Academic Advancement, Cardiovascular Division, Brown University, Providence, USA Staff Physician, Cardiology/ Interventional Cardiology, Rhode Island & Miriam Hospitals, Providence, USA

Fellowships

Fellow of the Society of Coronary Angiography and Interventions (SCAI) Fellow of the American College of Cardiology (ACC)

Memberships

American Heart Association (AHA)

Medical education

Medical School:University of Chicago, Pritzker School of Medicine, Chicago, USA Residency: Yale New Haven Medical Center, New Haven, USA Fellowship: Yale New Haven Medical Center, New Haven, USA

Issue 58 | August 2020

13

Structural Heart Interventions First 10-year report of TAVI durability indicates a low rate of structural valve deterioration

Janarthanan Sathanathan (Center for Heart Valve Innovation, St Paul’s Hospital, Vancouver, Canada) and others report in Catheterization & Cardiovascular Interventions that the 10year rate of bioprosthetic structural valve failure and valve failure was low in patients who had undergone transcatheter aortic valve implantation (TAVI) with an early-generation balloon-expandable device. They say that these findings provide “insights into the long-term performance of transcatheter heart valves”.

S

athanathan et al observe that when TAVI was first introduced, for inoperable and high-risk patients, “there was no expectation of 10-year survival, the let alone possibility of assessing late durability”. However, they add that as TAVI has become more accepted for lower-risk populations, durability has become more pertinent. “While transcatheter heart valve durability to five to eight years appears favourable, the long-term performance of transcatheter heart valves ≥10 years is unknown,” they note. Therefore, they reviewed the rate of structural valve deterioration and bioprosthetic valve failure following TAVI with an early-generation valve.

Of 235 patients who underwent TAVI at the Center for Heart Valve Innovation (Vancouver, Canada) between 2005 and 2009, 19 patients were still alive at 10 years— including three patients who had undergone valve-invalve TAVI during follow-up. The mean of age of these survivors was 78.2±11 years, 42.1% had a Society of Thoracic Surgeons (STS) score of >8%, 89.5% received a Sapien valve (Edwards Lifesciences), and 10.5% received a Cribier-Edwards valve. Overall, at 10-year follow-up, the mean age of patients was 88.5±11.2 years.

Of the total cohort, 15 patients had evidence of structural valve deterioration “with a cumulative incidence at 10-years at 6.5%”. “The rate of structural valve deterioration/bioprosthetic valve failure at four, six, eight, and 10 years was 0.4%, 1.7%, 4.7%, and 6.55, respectively,” Sathanathan et al explain. They add that the median time to develop structural valve deterioration/ bioprosthetic valve failure was 6.7 years. Furthermore, nine patients had moderate structural valve deterioration and six had severe deterioration. Of the six cases of severe deterioration, one was identified at the 10-year follow-up echocardiogram. The deterioration was managed with redo TAVI using a Sapien 3 valve. “At 30-day followup, the patient was symptomatically well with New York

Heart Association (NYA) class I symptoms and an echocardiogram that demonstrated a mean gradient of 10mmHg,” Sathanathan et al comment.

The authors note that their findings provide insights into the long-term performance of John Webb transcatheter heart valves, but state that “patient and device factors must be considered when interpreting these results”. “Although the long-term transcatheter heart valve performance documented here is promising, poor late survival due to comorbidities does not allow for speculation in the larger group as a whole,” they comment. Sathanathan et al also make the observation that the valves reviewed in their study are “not identical to currently available balloon expandable frames of today”. “Ultimately, the performance of each transcatheter heart valve design and iteration must be assessed individually” .

John Webb (St Paul’s Hospital, Vancouver, Canada) a senior author on the paper, told Cardiovascular News: “We now know that these newer transcatheter valves can last as long as surgical valves. The choice between transcatheter and surgical valve replacement should be based on the other factors important to an individual.”

We now know that these newer transcatheter valves can last as long as surgical valves.”

Low one-year rate of mortality found in mitral valve-in-valve replacement using Sapien 3 One-year outcomes of mitral valve-in-valve replacement using the Sapien 3 (Edwards Lifesciences) transcatheter heart valve have been published in JAMA: Cardiology.

IN THE STUDY, Brian Whisenant (Intermountain Medical Center, Salt Lake City, USA) et al report low all-cause mortality at 30 days (5.4%)

and one-year (16.7%), and a 96.8% procedural success rate using the device.The study team analysed data from 1,529 patients entered into the

Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy Registry from June 2015 to July 2019, receiving the Sapien 3 valve.

The study team noted that transseptal access was associated with lower one-year all-cause mortality than transapical access (15.8% vs 21.7%; p=0.03).

Transcatheter mitral valve-invalve replacement led to early, sustained, and clinically meaningful improvements in heart failure.

TAVI or surgical valve replacement “similarly effective” in men and women Aortic valve replacement, using either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) approaches appear to be similarly effective for males and females at intermediate surgical risk, a post hoc analysis of the randomised SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial has concluded.

The analysis, which was conducted

by Nicolas van Mieghem (Erasmus University Medical Centre, Rotterdam, The Netherlands) and colleagues, was published online ahead of print in EuroIntervention.

VAN MIEGHEM AND COLLEAGUES note that female sex is a risk factor for mortality after surgical valve replacement according to the Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) calculator, and add that in previous studies TAVI appeared to have a favourable efficacy and safety profile compared to SAVR, particularly in women at high operative risk. The study team sought to identify sexspecific differences in outcome for patients at intermediate risk in the international SURTAVI trial, which saw 1,746 patients with symptomatic, severe aortic stenosis randomised in a 1:1 ratio to TAVI with a self-expanding valve (CoreValve or Evolut R device) or surgical valve replacement.

Outcomes were analysed for 1,660 intermediaterisk patients (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438), with the primary endpoint defined as a composite of allcause mortality or disabling stroke at two years.

Compared to men, Van Mieghem et al find that women had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs. 4.3±1.6%, p<0.01), and more frailty. Men required more concomitant revascularisation (23% vs. 16%), they noted. All-cause mortality or disabling stroke at two years was similar between TAVI and surgical valve replacement for females (10.2% vs. 10.5%, p=0.90) and males (14.5% vs.

14.4%, p=0.99); the difference between women and men was 10.2% vs. 14.5%, for TAVI (p=0.08) and 10.5% vs. 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI for women than men, they noted.

Discussing the findings, van Mieghem et al note that there are no sex-specific differences in the two-year rate of all-cause death or disabling stroke in elderly patients after TAVI using a selfexpanding or surgical valve replacement.

In conclusion, the paper notes: “Aortic valve replacement, either by surgical or transcatheter approach, is equally effective and safe for males and females at intermediate surgical risk.

Functional status appears to improve most in females after TAVI.”

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14 Structural Heart Interventions

August 2020 | Issue 58

Higher volume of mitral valve repair procedures is associated with lower mortality rates

linked to the Centers for Medicare and Medicaid Services.

The primary outcome was 30-day inhospital operative mortality after isolated MVRR for primary mitral regurgitation.

Secondary outcomes were 30-day composite mortality plus morbidity (any occurrence of bleeding, stroke, prolonged ventilation, renal failure, or deep wound infection), rate of successful mitral valve US national hospital- and surgeon-level inverse volume–outcome repair of primary mitral regurgitation associations were observed for 30-day and one-year mortality after (residual mitral regurgitation of mild mitral valve surgery for primary mitral regurgitation, according to [1+] or better), and one-year mortality, a study published in JAMA Cardiology. Authors Vinay Badhwar reoperation, and rehospitalisation.

(Department of Cardiovascular and Thoracic Surgery, West Virginia In all, 55, 311 patients, 1,094 hospitals, University, Morgantown, USA) and colleagues say the findings may and 2,410 surgeons were identified. help to define access to experienced centres and surgeons for the Increasing hospital and surgeon volumes management of primary mitral regurgitation. were associated with lower risk-adjusted 30-day mortality, lower he investigators explain that observational study aimed 30-day composite mortality surgery for severe primary to assess national 30-day plus morbidity, and a degenerative mitral regurgitation and one-year outcomes of higher rate of successful is recommended even in asymptomatic mitral valve surgery, and repair. The lowest versus patients, provided optimal outcomes define the hospital- and highest hospital volume are achievable. However, say Badhwar surgeon-level volume– quartile had higher oneet al, “despite recent advances in outcome association year risk-adjusted mortality surgical and transcatheter mitral therapy, with mitral valve repair (hazard ratio [HR] 1.61, the contemporary volume–outcome or replacement (MVRR) 95% confidence interval association in mitral valve surgery has in patients with primary [CI] 1.31–1.98), but not not been assessed nationally, nor have mitral regurgitation. The Vinay Badwar mitral reoperation (odds rigorous data been provided to assist in researchers used the ratio [OR] 1.51, 95% CI defining a mitral reference centre. This Society of Thoracic Surgeons Adult 0.81–2.78) or hospitalisation for heart important information has the potential Cardiac Surgery Database to identify failure (HR 1.25, 95% CI 0.96-1.64). The to shape quality improvement, patientpatients undergoing isolated MVRR for surgeon-level one-year volume-outcome physician referral patterns, and resource primary mitral regurgitation in the USA. associations were similar for mortality allocation regarding the management of Operative data were collected from 1 July (HR 1.6, 95% CI 1.32–1.94) but not primary mitral regurgitation.”

2011 to 31 December 2016, and analysed significant for mitral reoperation (HR The multicentre cross-sectional from 1 March to 1 July 2019, with data 1.14, 95% CI 0.6–2.18) or hospitalisation

T

Bicuspid TAVI outcomes as good as those for tricuspid Clinical and echocardiographic outcomes at 30 days and one year were similar between patients with bicuspid and tricuspid aortic stenosis following transcatheter aortic valve implantation (TAVI) with a self-expanding valve in a recent analysis from the TVT Registry.

Researchers also noted that, in patients at increased surgical risk, TAVI for bicuspid aortic valve stenosis had acceptable safety outcomes with low complications rates.

WRITING IN JACC: Cardiovascular Interventions, John K Forrest (Yale School of Medicine, New Haven, Connecticut) and colleagues say: “In this analysis, among 929 pairs of propensity-matched patients undergoing TAVI in the United States between July 2015 and September 2018, there was no significant difference in all-cause mortality or stroke at 30 days or one year between patients with bicuspid versus tricuspid aortic valve anatomy. However, there was a small but increased number of patients in the bicuspid group who required aortic valve reintervention as compared with the tricuspid group at 30 days and at one year.”

Forrest et al point out that TAVI has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves. The objective of their study was to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing TAVI. They used the Society of Thoracic Surgeons/American College of Cardiology TVT Registry to analyse patients who underwent TAVI with the Evolut R or Evolut PRO valves (Medtronic).

Clinical and echocardiographic outcomes were analysed through one-year follow-up.

Between July 2015 and September 2018, a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVI with the self-expanding Evolut R or Evolut PRO valve. These patients were compared

with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVI during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality (PROM) scores (5.3±4.2% vs. 6.9±4.8%, p<0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs.

Given intrinsic differences in bicuspid and tricuspid aortic valve anatomies and a lack of data around lowrisk patients with bicuspid aortic valves, randomised studies evaluating TAVI in low-risk patients with bicuspid aortic valve disease are needed.”

for heart failure (HR 1.17, 95% CI 0.91–1.5).

The authors write: “For the surgical management of primary mitral regurgitation, this national clinical registry analysis provides … documentation that hospital and surgeon volume–outcome associations exist for rates of successful mitral valve repair and one-year mortality, but not for one-year mitral valve reoperation or one-year hospitalisation for heart failure.

These findings may assist efforts to define access to experienced centres and surgeons for primary MR or complex primary MV disease.”

They add: “The data generated from this analysis may provide further support for efforts to regionalise mitral valve surgery for primary mitral regurgitation, especially for patients who may be asymptomatic but meet guideline criteria for mitral valve repair, in whom the pathology may be deemed complex, or for patients seeking innovative mitral valve repair approaches, such as minimally invasive or robotic surgery.

Such cases may be better suited to experienced mitral valve surgeons and centres based on volume. But importantly, higher volumes centres and surgeons in the USA are far more accessible than previously recognized.”

Badhwar et al concede the “inherent limitations of any analysis of a large clinical registry”, and that the “ascertainment of aetiology may be imprecise”.

Among the propensity score–matched patients, there were no significant differences in procedural characteristics except for procedure time, which was longer for patients with bicuspid valves than for those with tricuspid valves (113.6±61 minutes vs. 105.1±51.2 minutes; p=0.001). The type of anaesthesia used (general anaesthesia in circa 58%) and route of valve delivery (iliofemoral approach in circa 92%) did not differ between the groups. The size and type of valve implanted, as well as device success rates, were also not different between the two groups.

There was no significant difference in all-cause mortality between the bicuspid and tricuspid groups at 30 days (2.6% vs. 1.7%; p=0.18) or one year (10.4% vs.12.1%; p=0.63). The incidence of stroke was also not different at 30 days (3.4% vs. 2.7%; p=0.41) or one year (3.9% vs. 4.4%; p=0.93). There was no significant difference in the incidence of pacemaker implantation, coronary intervention, or life-threatening bleeding between the bicuspid and tricuspid propensity-matched groups. There were more patients in the bicuspid group who required aortic valve reintervention as compared with the tricuspid group at both 30 days (0.8% vs. 0.1%; p=0.03) and one year (1.7% vs. 0.3%; p=0.01).

Examining by valve type, Evolut PRO versus the prior generation Evolut R, there was significantly less moderate or severe AR seen in patients who were implanted with the Evolut PRO valve. In addition, in patients implanted with the Evolut PRO valve, there was no difference seen in greater than mild AR at 30 days between the bicuspid and tricuspid groups (2.2% bicuspid vs. 1.5% tricuspid; p = 0.71).

The authors conclude: “Given intrinsic differences in bicuspid and tricuspid aortic valve anatomies and a lack of data around low-risk patients with bicuspid aortic valves, randomised studies evaluating TAVI in low-risk patients with bicuspid aortic valve disease are needed.”

They concede that the study’s retrospective design, using the TVT Registry, is a limitation.

August 2020 | Issue 58

16 Market watch

Clinical News

AccuCinch

Ancora Heart receives IDE approval for study of AccuCinch

Ancora Heart has been given US Food and Drug Administration (FDA) approval of its investigational device exemption (IDE) application for the CorCinch-HF pivotal study, which is designed to evaluate the safety and efficacy of the AccuCinch Ventricular Repair System in patients with heart failure and reduced ejection fraction (HFrEF).

A company statement says the AccuCinch System is the first completely percutaneous device designed to directly reshape the left ventricle of the heart, thereby addressing the fundamental issue in the progression of systolic heart failure.

The CorCinch-HF pivotal study is a prospective, randomised, open-label, multicentre, international, clinical safety and efficacy investigation of the AccuCinch System, which is designed to enrol 400 patients at up to 80 centres worldwide. The study design is for an initial analysis of safety and clinical efficacy for premarket approval (PMA) submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. The study will ultimately follow patients through five years post treatment to track long-term results.

“The approval of the IDE for the CorCinch HF pivotal trial represents a major milestone as we continue to gather data to evaluate the safety and effectiveness of the AccuCinch System,” states Jeff Closs, president and CEO of Ancora Heart in a press release. “We look forward to working with study sites to initiate patient enrolment as soon as possible.”

Japanese study finds high survival rates with use of Impella heart pump

A three-year, investigator-led, prospective study of Japanese patients who received an Impella heart pump (Abiomed) has found that the use of Impella is associated with a 77% survival rate at 30 days in acute myocardial infarction cardiogenic shock patients. The historic survival rate for cardiogenic shock is 50%.

The study, conducted with oversight by 10 Japanese professional societies, including the Japanese Circulation

Society (JCS), is the first to use the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) to investigate the efficacy and safety of Impella. J-PVAD data is independently monitored and shared with the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Lead investigator Yoshiki Sawa, Osaka University, Osaka, Japan, presented the interim analysis as a late-breaking clinical study at the Annual Scientific Meeting of JCS. The interim analysis examined 819 patients treated with Impella for a variety of conditions, including cardiogenic shock and fulminant myocarditis, at 109 hospitals in Japan.

Other findings include that Impella therapy is a highly effective treatment for fulminant myocarditis, with an 88% survival rate at 30 days. Overall, investigators conclude the favourable 30-day survival data indicates Impella is a beneficial therapy.

“This data demonstrates early use of Impella in drug-resistant acute heart failure patients can consistently achieve high rates of survival and native heart recovery for those in cardiogenic shock and other serious life-threatening conditions,” said Sawa. “This was accomplished by closely following best practices for Impella use. I thank my colleagues in the Japanese clinical community for following protocols and guidance from the Impella Committee to safely introduce a new therapy for the benefit of our patients.”

A previous analysis of cardiogenic shock survival rates in Japan by Ueki et al found a 32% survival rate at 30 days in patients who received venous-arterial extracorporeal membrane oxygenation (V-A ECMO). The comparatively high survival rates with Impella were achieved by following established best practices that include placing Impella pre-PCI, identifying cardiogenic shock early, using a right heart catheter, and reducing use of inotropes, the company said in a press release.

Carag Bioresorbable Septal Occluder approved for US IDE trial

US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval has been granted for the Carag Bioresorbable Septal Occluder (CBSO).

The CE-marked CBSO is a transcatheter septal occluder with a bioresorbable, metal-free framework.

Carag’s first US trial is designed to enroll up to 250 patients in a staged study approach, the largest clinical trial for the company to date.

“Based on the data seen so far, we are very hopeful that a metal-free bioresorbable framework has the potential to reduce the risk of late complications for patients,” said Larry Latson, a specialist in adult congenital

heart disease at Joe DiMaggio Children’s Hospital (Hollywood, USA) and who, along with Saibal Ka (Los Robles Medical Center, Thousand Oaks, USA), is national co-principal investigator for the trial. “With heart procedures requiring septal crossing on the rise, a framework that dissolves when no longer needed would improve future treatment options. Both benefits would represent major advancements in ASD [atrial septal defect] treatment,” he added.

The prospective, multicentre, US clinical trial is designed to enroll up to

Carag CBSO

250 patients in a staged study approach to evaluate the safety and efficacy of the CBSO in patients with clinically significant ASD.

First coronary patient enrolled in FDA IDE study of drug-eluting balloon

MedAlliance has announced enrolment of the first patient in its study of Selution SLR 014” drug eluting balloon (DEB) for the treatment of in-stent restenosis.

According to the company, this is the first DEB to be accepted by the US Food and Drug Administration (FDA) for its Breakthrough Programme. The Selution SLR (sustained limus release) is a novel sirolimus eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

The prospective, randomised, single-blind multicentre study aims to demonstrate the safety and efficacy of Selution SLR in treatment of in-stent restenosis with either drug-eluting or bare metal stents (BMS). The study will support submission for FDA approval.

A press release details that up to 418 subjects will be recruited into the study at approximately 60 sites across the USA and Europe. Subjects need to have a BMS or DES in-stent restenosis involving a native coronary artery with a reference vessel diameter (RVD) of 2–4.5mm to qualify for inclusion.

Subjects will be randomised to receive either Selution SLR or standard of care (SOC), a control group with a current DES or a non-drug eluting balloon angioplasty.

The primary endpoint for effectiveness of the study is target lesion failure (TLF), defined as all cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR) at 12 months. Subjects will be followed up at

one month, six months, 12 months, and then annually through five years.

“This is a particularly important study for MedAlliance”, explains chairman and CEO Jeffrey B Jump in the press statement. “No coronary drug-eluting balloon has yet been approved in the USA, where ISR currently represents 11% of all stent implantations. We are excited to introduce this breakthrough technology to help patients around the world.”

MedAlliance says that Selution SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained limus release of the drug.

It says extended release of sirolimus from stents has been demonstrated to be highly efficacious in both coronary and peripheral vasculatures.

MedAlliance’s proprietary CAT (cell adherent technology) enables the MicroReservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.

Selution SLR was awarded the CE mark for the treatment of peripheral artery disease in February 2020, and for the treatment of coronary arterial disease in May 2020.

Biosensors announces enrolment of first patient in REFORM pivotal trial

Biosensors has announced the enrolment of the first patient in REFORM—a prospective, randomised, non-inferiority trial to determine the safety and efficacy of the Biolimus A9 drug coated balloon for the treatment of in-stent restenosis: first-in-man trial.

The trial is targeting CE mark approval for the Biolimus A9 drug coated balloon (DCB) and will include 34 sites in Germany, Italy, Ireland, Spain, the UK and South Korea.

The trial is being conducted under the leadership of Robert Byrne, director of cardiology, Mater Private Hospital, and chair of Cardiovascular Research at RCSI University, Dublin, Ireland who said: “The REFORM trial is testing the first ever Biolimus A9 coated balloon and builds on the success of the LEADERS and LEADERS FREE trials which demonstrated the excellent safety and efficacy of Biolimus A9 eluting coronary stents.

If successful, this new drug coated balloon will expand the treatment options for patients with in-stent restenosis undergoing repeat PCI” Ralph Tölg, Segeberger Kliniken GmbH: Heart Center, Bad Segenberg, Germany enrolled the first REFORM patient—a 53-year-old male who had developed in-stent restenosis (ISR) >10 years after his initial percutaneous coronary intervention (PCI). He said: “After lesion preparation delivery of the BA9 DCB was smooth, with good angiographic result. We are all very excited to see the clinical and angiographic long-term results of this FIM-trial with a novel limus-DCB.”

Issue 58 | August 2020

Market watch 17

Inspiron sirolimus eluting stent receives CE mark approval

Product News Keystone Heart announces first case using TriGUARD 3 CEP device

Keystone Heart has announced completion of the first worldwide commercial case using the TriGUARD 3 cerebral embolic protection (CEP) device. Pieter Stella, assistant professor, Medical Department of Cardiology, at UMC Utrecht, Utrecht, the Netherlands, performed the transcatheter aortic valve implantation (TAVI) procedure using the TriGUARD 3 device, which is designed to minimise the risk of cerebral damage during transcatheter heart procedures.

“Although we have seen improvement in mortality and morbidity rates during TAVI procedures, the risk of periprocedural stroke has not changed,” commented Stella. “As a physician, I am driven to do anything possible to prevent this rare but terrible complication. I am pleased we can now routinely use the TriGUARD 3 CEP device in all of our TAVI cases to protect patients from stroke, delirium, and neurocognitive decline.”

Keystone Heart's TriGUARD 3

The CE-marked TriGUARD 3 CEP device is designed to cover and protect all three major cerebral aortic arch vessels. The Nitinol frame with domeshaped mesh deflector is delivered transfemorally and designed to “selfposition” in the aortic arch. This design allows the TriGUARD 3 CEP device to conform to a variety of patient anatomies, Keystone Heart said in a press release.

“Our team is thrilled to commercially launch the only CE-marked device designed to cover and protect all three cerebral vessels,” stated Chris Richardson, Keystone Heart president and CEO. “Our primary objective is to ensure a controlled launch that provides physicians the training and tools necessary to safely and consistently treat all patients undergoing transcatheter heart procedures with the TriGUARD 3 CEP device.”

Richardson further commented: “As TAVI procedures continue to expand into treating lower-risk patient groups, the need to protect patients’ brains will also grow. Strokes and minor cognitive events can have devastating outcomes for patients and their families; Keystone Heart is committed to helping physicians minimise those occurrences.”

Keystone Heart began commercialisation of the TriGUARD

3 CEP device in TAVI centres of excellence throughout Europe in July 2020.

Abiomed gains approval for data streaming from the Impella console

The US Food and Drug Administration (FDA) has approved one-way digital data streaming during patient support from Abiomed’s Automated Impella Controller (AIC), the external console used with Impella heart pumps.

The data streaming capability is facilitated through the Impella Connect interface, a HIPAA-compliant, cloudbased remote monitoring platform that is currently installed at more than 200 hospitals. The approval means console data could be streamed live via Impella Connect to a secure server where artificial intelligence (AI) could provide predictive clinical information to the patient’s physician, according to an Abiomed press release.

As an example of how this technology might be used in future clinical practice, Abiomed has trained an AI algorithm to predict the next five minutes of a patient’s arterial pressure based on the prior five minutes of console data. Abiomed has also developed AI algorithms to predict other parameters, such as stroke volume, left ventricular pressure and cardiac output. The AI algorithms are not yet cleared or approved for patient use. Once fully developed, they will be submitted for regulatory review.

Predictive analytics are possible by integrating Impella clinical study data with Impella console data from thousands of cases and training AI networks on the co-registered data.

AI networks could then receive and analyse console data in real-time and send patient-specific predictions to that patient’s medical provider.

“Artificial intelligence networks, properly trained using large volumes of streaming data, can be powerful tools to aid in clinical decision-making,” said Chuck Simonton, Abiomed’s chief medical officer. “One day, using artificial intelligence, physicians may be able to confidently predict a patient’s future haemodynamics. That would make clinical decision-making more efficient and improve patient outcomes.”

Caption Health gains FDA approval for updates to its cardiac AI system

Caption Health, a developer of medical artificial intelligence (AI) technology, has received US Food and Drug Administration (FDA) 510(k) clearance for an updated version of Caption Interpretation, which enables clinicians to obtain quick, easy and accurate measurements of cardiac ejection fraction (EF) at the point of care.

Left ventricular ejection fraction is

Caption AI software in action

one of the most widely used cardiac measurements and is a key measurement in the assessment of cardiac function across a spectrum of cardiovascular conditions.

Caption Interpretation applies end-toend deep learning to automatically select the best clips from ultrasound exams, perform quality assurance and produce an accurate EF measurement.

The technology incorporates three ultrasound views into its fully automated ejection fraction calculation: apical 4-chamber (AP4), apical 2-chamber (AP2) and the readily-obtained parasternal long-axis (PLAX) view—an industry first. While ejection fraction is commonly measured using the more challenging apical views, the PLAX view is often easier to acquire at the point of care in situations where patients may not be able to turn on their sides, such as intensive care units, anaesthesia pre-operative settings and emergency rooms.

“Developing artificial intelligence that mimics an expert physician’s eye with comparable accuracy to automatically calculate EF—including from the PLAX view, which has never been done before—is a major breakthrough,” said Roberto M Lang, professor of medicine and radiology at the University of Chicago Medicine (Chicago, USA).

“Whether you are assessing cardiac function rapidly, or looking to monitor changes in EF in patients with heart failure, Caption Interpretation produces a very reliable assessment.”

“We are pleased to have received FDA clearance for our latest AI imaging advancement—our third so far this year,” said Randolph P Martin, chief medical officer of Caption Health, emeritus professor of cardiology at Emory University School of Medicine (Atlanta, USA). “An accurate EF measurement is an indispensable tool in a cardiac functional assessment, and this update to Caption Interpretation makes it easier for time-constrained clinicians to incorporate it into their practice.”

Caption Interpretation works in tandem with Caption Guidance, cleared by the FDA earlier this year, as part of the Caption AI platform. Caption Guidance emulates the expertise of a sonographer by providing over 90 types of real-time instructions and feedback.

These visual prompts direct users to make specific transducer movements to optimise and capture a diagnosticquality image. In contrast, use of other ultrasound systems requires years of expertise to recognise anatomical structures and make fine movements, limiting access to clinicians with specialised training.

Scitech has announced that the Inspiron coronary sirolimus-eluting stent has received CE mark approval. The device is a third generation drug-eluting stent designed to create a fast and homogeneous endothelialisation.

According to a press release from Scitech, the device’s design, material (CoCr), thin struts (75μm) and delivery system gives it good navigability, flexibility, good crossover profile, moderate radiopacity and high balloon rupture pressure. Inspiron’s abluminal coating is composed of a mixture of polylactic acid polymers and a low Sirolimus dosage resulting in a moderate drug elution profile (60% in 10 days and 100% in 45 days), complete coating degradation between six and nine months and in a fast and homogeneous endothelialisation. “[The] Inspiron drug-eluting stent has shown late lumen loss comparable with the most important global brands,” says Alexandre Abizaid, (Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil).

Preclinical and clinical studies have proven the efficacy and safety of the INSPIRON Drug-Eluting Stent, Scitech adds. The nine-month followup of the Destiny Trial, a multicentre, randomised study comparing Inspiron to a Biolimus-eluting stent, demonstrated noninferiority for in-stent late lumen loss. Optical Coherence Tomography (OCT) analysis showed a high strut coverage rate at nine months (99.49%), also corroborated by the REPAIR study (97% of the struts covered at three months).

US FDA approval for Edwards Lifesciences’ Konect Resilia aortic valved conduit

Edwards Lifesciences received approval from the US Food and Drug Administration (FDA) for the Konect Resilia aortic valved conduit (AVC), for bio-Bentall procedures, a surgery that involves replacement of a patient’s aortic valve, aortic root and the ascending aorta.

The device offers the advanced Resilia tissue, which incorporates integritypreservation technology that may help improve valve durability, Edwards Lifesciences said in a press release. The Resilia tissue technology also allows devices to be stored under dry packaging conditions, facilitating ease of use during patient care.

“Until now, surgeons did not have a pre-assembled option that was FDA approved, so those utilising bovine tissue valves for Bentall procedures needed to manually assemble a valve with a conduit in the operating room,” said Joseph E Bavaria, vice chief of the division of cardiovascular surgery, University of Pennsylvania (Philadelphia, USA). “The Konect device represents a meaningful advancement that offers surgeons a preassembled device with two leading

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August 2020 | Issue 58

Market watch

Product News Evolut gets CE mark in low-risk patients and new labelling for bicuspid use

Medtronic has gained CE mark approval for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk.

The Evolut TAVI platform has also received a new indication approval for the treatment of patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

With this approval, the Evolut TAVI platform is now indicated in Europe for severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low), and the new labelling allows for the treatment of patients with bicuspid aortic valves who are at extreme, high and intermediate risk of surgical mortality. The Evolut TAVI platform is indicated in the USA for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low).

Bicuspid valve patients at intermediate risk or higher may be candidates for TAVI in the USA. A press release from the company states that the expanded low-risk indication approval is based on clinical data from the global, prospective, randomised, multicentre Evolut Low Risk Trial, which evaluated three valve generations (CoreValve, Evolut R and Evolut PRO) against SAVR in more than 1,400 patients. The data showed TAVI to have an excellent safety profile and be an effective treatment option in

Evolut PRO

low-risk patients with shorter hospitals stays and improved 30-day qualityof-life scores compared to SAVR. In addition to a lower rate of the composite of all-cause death or disabling stroke with TAVI at 30 days, Medtronic says the Evolut system demonstrated superior haemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger EOAs (effective orifice area) compared to surgery at one year—factors that may

almost 40% of the intermediate and high risk severe symptomatic aortic stenosis patient population, according to the Medtronic statement.

Pieter Kappetein, vice president and chief medical officer for the Structural Heart and Cardiac Surgery businesses, part of the Cardiac and Vascular Group at Medtronic, says: “With these approvals, more patients will now be candidates for the Evolut TAVI system, while surgical aortic valve replacement will evolve to serve a more complex patient population. Medtronic is well positioned to provide a variety of therapy options to meet the varying needs of patients with heart valve disease.”

LivaNova launches Perceval Plus sutureless heart valve in Europe

Perceval

be important for more active patients.

The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVI group.

“It is important that we expand access to a less invasive treatment option to this low-risk patient population. It is also encouraging that we now have new labelling to address a large portion of bicuspid valve patients, too,” says Didier Tchétché (Clinique Pasteur, Toulouse, France), investigator in the Evolut Low Risk Trial. “Based on excellent data from the STS/ACC TVT Registry, bicuspid patients (excluding low risk), will for the first time, be indicated for TAVI, which is another big win for patients and the future of the therapy.”

Bicuspid aortic valves are a congenital heart defect affecting 1–2% of the general population, and is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid).

Bicuspid aortic valve stenosis represents

LivaNova has announced that the advanced Perceval Plus sutureless surgical aortic heart valve is now available for commercial release in Europe. This comes following the completion of a one-year limited launch of the device with initial real-world clinical data gathering.

The valve facilitates minimally invasive cardiac surgery (MICS) and makes sutureless aortic valve replacement available to a wide patient population, LivaNova said in a press release. Key innovations with Perceval Plus include the anticalcification treatment—FREE—for valve durability, along with design changes intended to improve patient outcomes.

“Continual innovation for tissue heart valves is important for two primary reasons. First, our patients have a longer life expectancy, so we have to provide them with valves that have solid longterm performance. Second, we are using tissue valves more and more frequently in relatively younger patients,” said Bart Meuris, head of clinic of the University Hospital in Leuven, Belgium. “We have very good long-term clinical experience with the current Perceval platform,1 and we expect Perceval Plus to deliver even better long-term outcomes with the FREE anticalcification treatment.”

“We are already seeing very promising initial results with Perceval Plus, contributing to the strong body of evidence for Perceval,” said Jens Wippermann, clinical director of the Cardiothoracic Surgery department at University of Magdeburg, Magdeburg,

Germany. “PPI has also been found to be substantially reduced with modified intraoperative approaches and an emphasis on proper valve sizing.”

Philips introduces OmniWire for coronary artery procedures

Royal Philips has announced the introduction of OmniWire, a solid core pressure wire for coronary artery interventional procedures. With a solid core construction, physicians can more easily manoeuvre the wire in the patient’s circulatory system to measure blood pressure along the vessel and guide the delivery of catheters and stents, Philips said in a press release.

The wire supports instant wavefree ratio (iFR) measurements, as well as fractional flow reserve (FFR) measurements. It also integrates with the Philips IntraSight interventional applications platform, which can coregister iFR data onto the angiogram to precisely identify the parts of vessels requiring treatment.

Traditional pressure wires use a hollow metal tube to house the wiring that transmits the pressure information.

Due to their thin walls, these wires can be challenging to manoeuvre and can sometimes kink, potentially becoming damaged during the procedure.

OmniWire is the world’s first solid core pressure guidewire, using advanced conductive ribbons embedded in its outer polymer layer to communicate pressure information, Philips said in its press release.

“I have been very impressed with the handling of OmniWire, the new solid core design performed beautifully, and I was able to navigate the difficult case easily,” said Jasvindar Singh, director of the catheterisation lab at Barnes Jewish Hospital and associate professor at Washington University, St Louis, USA, who performed the first human case with OmniWire in the country. “We used iFR co-registration and found that the patient needed a stent. I was then able to perform the whole procedure working over OmniWire. This is truly an innovation in percutaneous coronary interventions.”

OmniWire is available in the USA and Japan and has received clearance from the US Food and Drug Administration (FDA) and approval from the Japan Pharmaceuticals and Medical Devices Agency.

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.

29 August–1 September ESC Congress Virtual

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

8–11 September CX Aortic Vienna Virtual

www.cxsymposium.com/cxaortic

8–10 October 34th EACTS Virtual

www.eacts.org/annual-meeting/

14–18 October TCT Connect Virtual www.crf.org/tct

22–24 November PCR London Valves Virtual

www.pcronline.com/Courses/PCRLondon-Valves

2021 30 January–2 February STS annual meeting Austin, USA https://sts2021.com/

11–13 February JIM Milan, Italy

www.jim-vascular.com/

27 February–2 March CRT 2021 National Harbor, USA www.crtmeeting.org/

Issue 58 | August 2020

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