Cardiac Rhythm News 48

May 2020 | Issue 48

Cardiologists plot “return to normal” as COVID-19 restrictions ease As electrophysiologists worldwide begin the process of restarting elective procedures put on hold due to the COVID-19 pandemic, cardiology departments are braced for a wave of “forgotten” patients whose conditions may have worsened over time. This was among the issues discussed in a virtual session held as part of the Heart Rhythm Society (HRS) 2020 Science—titled COVID-19, returning to normal?—in which electrophysiologists from Asia, Europe and North America detailed their experience of having managed arrhythmia patients during the pandemic. Panellists also discussed what the long-term impact of the virus is likely to be on their clinical practice.

Malcolm Finlay: AI & arrhythmia

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Athena Poppas:

Profile

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PRAETORIAN trial demonstrates non-inferiority of S-ICDs compared to transvenous ICDs Subcutaneous implantable cardioverter defibrillators (S-ICDs) are as protective as transvenous implantable cardioverterdefibrillators (ICDs) in the prevention of sudden cardiac death, but have a better safety profile, the results of a clinical trial presented online in a late-breaking trial session at Heart Rhythm Society (HRS) 2020 Science, have found. The findings of the PRAETORIAN trial, which is an investigator-initiated, international, multicentre, randomised, non-inferiority study, have also been published in The New England Journal of Medicine.

“I

t [COVID-19] has been haunting everybody around the world, but every continent has its own perspective,” said Isabel Deisenhofer (Heart Center Munich, Germany) who moderated the European leg of the three-part COVID discussion.

Deisenhofer was joined by Elena Arbelo (Hospital Clinic De Barcelona, Barcelona, Spain), Angelo Auricchio (Fondanzione Cardioccentro Ticino, Lugano, Switzerland), Paolo Della Bella (Ospedale San Raffaele, Milan, Italy) and Christophe LeClerq (CHRU Pontchaillou, Rennes, France) to consider the impact the virus has had on the treatnent of arrhythmias in healthcare centres across Europe.

Arbelo detailed how practice in her centre has been adapted during the pandemic, noting that procedures had been limited only to emergent cases, and that the outpatient clinic was switched to a telehealth platform to serve patients who could be reached in this way. “My role as an electrophysiologist has mainly been to cover, together with one of my colleagues, all the emergent procedures. The other electrophysiology colleagues we have were sent to the ICUs to treat COVID patients, and I think this is the case in some of the countries that have been hit harder,” she explained.

LeClerq set out a similar picture from France, and outlined steps that his centre is taking to begin to

We need some distance between the patients, we have to decrease the speed of the outpatient clinic.”

Christophe LeClerq

reintroduce elective cases into rotation, noting that social distancing measures will impact the rate at which patients can be seen. “To give you an example, we had to cancel more than 1,000 echocardiographies, and more than 500 hospitalisations, mainly for procedures like TAVI [transcatheter aortic valve implantation] and AF [atrial fibrillation],” he said. “Now we are starting again, but as we need some distance between the patients, we have to decrease the speed of the outpatient clinic. As well, we do not want to put two patients in the same room, so we decrease the number of patients we can have in the institution.”

Considering the impact that a reduction in elective caseload will have on patient outcomes, Deisenhofer Continued on page 2

PRAETORIAN—A PROSPECTIVE, randomised comparison of subcutaneous and transvenous implantable cardioverter defibrillator therapy— conducted by Reinoud Knops, Academisch Medisch Centrum, Universiteit van Amsterdam, (Amsterdam, The Netherlands) and colleagues, is the first to compare the safety and efficacy of S-ICDs to transvenous ICDs. The trial was supported by the device manufacturer, Boston Scientific. According to the study team, the results highlight that S-ICDS are an important treatment option for patients in need of an ICD without pacing indication.

“Transvenous ICDs are effective, but come with major limitations,” Knops said during his presentation of the findings, highlighting in particular a 10–20% lead failure rate after six years follow-up for the devices. “For that reason, subcutaneous ICDs were developed to overcome these lead-related complications,” he explained.

Knops noted in his presentation that currently there is only registry data to demonstrate the outcomes of the use of S-ICDs, which he said mostly come from young patients with relatively preserved left ventricular ejection fraction (LVEF), showing a high shock efficacy and fewer ICDrelated complications, but more inappropriate shocks Continued on page 3

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May 2020 | Issue 48

COVID-19

Cardiologists plot “return to normal” as COVID-19 restrictions ease Continued from page 1

ventured that there is likely to be a knock-on effect on patient health seen in the coming months. “We saw some patients that would not dare to go to the hospital with arrhythmia, and there are a lot of patients coming to the hospital now with severe heart failure because they waited to go to hospital with their atypical [atrial] flutter, with AFib, with tachycardia myopathies [for example],” she explained. “My feeling is that we will have a lot more difficult and severely ill patients that we should treat in parallel to these COVID-19 patients, who are still there and will still be bothering us for a few months.”

Italy, which was the first country to be severely struck by COVID-19 within Europe, has now seen some restrictions eased, and Della Bella detailed what this has meant in practice within his institution. He noted that while remote monitoring and telehealth has been crucial in managing patient health during the height of the pandemic, many cases, particularly longer lasting arrhythmias, cannot be put on hold indefinitely.

“Remote monitoring has been the very important guidance to assess status and progression of these types of arrhythmias,” he told the panel. However, he warned that delaying treatment in some of these cases may cause a backlog further down the line, “the hit will come from, I would not call them forgotten, but timely frozen AF [patients] coming back,” he said.

Speaking from North America, Elaine Y Wan (Columbia University, New York), said it is likely that some complex procedures could be further delayed whilst healthcare resources continue to be tied up in the effort to battle the pandemic. “Generator changes, patients who are symptomatic, who really need urgent care will really be prioritised, while [we] balance the resources and staff members that are available to take care of patients,” she explained. “The physician-patient relationship has changed throughout this COVID-19 era so re-establishing that and having them develop confidence in coming back to the hospital for this procedure is key.”

A further concern for electrophysiologists during the pandemic has been the use of medication for treating COVID-19 patients, which have links to cardiac complications. Hydroxychloroquine and azithromycin have been touted as potential therapies for COVID-19, and are under investigation in clinical trials for preexposure or post-exposure prophylaxis of SARS-CoV-2

infection. Hydroxychloroquine is an oral prescription drug that has been commonly used for the treatment of malaria and certain inflammatory conditions, while azithromycin is an antibiotic that is widely used to treat chest infections. Both drugs have been linked to the possibility of QTc prolongation and torsade de pointes in some cases.

Use of the drugs in COVID-19 care have prompted the HRS, alongside the American Heart Association (AHA) and the American College of Cardiology (ACC) to issue guidance in April detailing critical cardiovascular considerations in their use as a treatment for COVID-19. “Given the potential for increased risks related to combinations of medications that prolong the QT interval, we urge careful consideration to ensure patients with cardiovascular disease or others at increased risk can be monitored appropriately,” stated Andrea M Russo, president of the HRS and director of Electrophysiology and Arrhythmia Services at Cooper University Hospital, Camden, USA. This warning was reinforced through the findings of two studies published in the Journal of the American Medical Association (JAMA) Cardiology, in May, authored by Nicholas Mercuro (Beth Israel Deaconess Medical Center, Boston, USA) and Francis Bessière, (Université de Lyon, Lyon, France) observing the instances of excessive prolongation of QTc in patients receiving the drug treatment for COVID-19.

Summarising these findings in an editorial in the same edition of JAMA Cardiology Robert Bonow (Northwestern University Feinberg School of Medicine, Chicago, USA), writes: “The data showing increases in QTc in more than 90% of patients treated with these agents

by Bessière et al and in most patients reported

We saw some patients that would not dare to go to the hospital with arrhythmia."

Isabel Deisenhofer

by Mercuro et al, coupled with similar findings with chloroquine diphosphate in a Brazilian trial, underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxycholoquine and azithromycin in ambulatory patients with known or suspected COVID-19.

Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed.”

News in brief

The latest stories from the cardiovascular world

n ANTICOAGULANTS MAY IMPROVE SURVIVAL AMONG COVID-19 PATIENTS: Hospitalised COVID-19 patients treated with anticoagulants had improved outcomes both in and out of the intensive care unit setting, according to a study

by Valentin Fuster (New York, USA) and colleagues, published in the Journal of the American College of Cardiology.

For more on this story go to page 7 n ECG RECORDING USING THE APPLE WATCH: Miguel Angel Cobos Gil (Madrid, Spain) details his findings on a novel method of using the Apple Watch to record a multilead, quasi-standard electrocardiogram.

He talks to Cardiac Rhythm News about how the use of a wearable ECG monitor compares to a traditional 12-lead ECG, and also discusses the need for further clinical study to determine the role of wearable devices in the diagnosis and follow-up of patients with known or suspected heart disease.

For more on this story go to page 6 n PINNACLE FLX DATA: Data from the PINNACLE FLX clinical trial, assessing safety and efficacy of the next generation Watchman FLX left atrial appendage closure device for patients with non-valvular atrial fibrillation (AF), were presented at a late-breaking clinical trial session which was livestreamed online as part of HRS 2020 Science. This followed the release of data from the National Cardiovascular Data Registry on Watchman device Watchman procedures performed throughout the USA.

For more on this story go to page 10

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Issue 48 | May 2020

Implantable devices

PRAETORIAN trial demonstrates noninferiority of S-ICDs compared to transvenous ICDs Continued from page 1

than transvenous ICDs. There are no randomised, controlled trials comparing the two therapies to date, and so the PRAETORIAN trial was designed to demonstrate the non-inferiority of the S-ICD compared to the transvenous ICD, with respect to acute and longterm device-related complications and inappropriate shocks over a follow-up period of 48 months.

Inclusion criteria for the study were patients of 18 years or above with a class I or IIa indication for ICD therapy for primary or secondary prevention.

Exclusion criteria were indication for pacing therapy: brady, cardiac resynchronisation therapy (CRT) and antitachycardia pacing ), and failed S-ICD vector screening. A total of 849 patients with a class I or IIa indication for ICD therapy and without the need for pacing from 39 centres in the USA and Europe, were randomised and followed until a median of four years. Of the patients, 426 patients were assigned to receive an S-ICD and 423 were assigned to a transvenous ICD, with

similar baseline characteristics in the two groups. The baseline characteristics are comparable to those of other major ICD trials, thereby showing that the trial reflects a general ICD population, Knops said. The trial population was 20% female, with a median age of 63 years (55‒70 years), and 69% had ischaemic cardiomyopathy with a median left ventricular ejection fraction of 30% (25‒35%).

Results presented by Knops show that in a general ICD-population, the subcutaneous ICD is non-inferior to the transvenous ICD with regards to major adverse events with fewer lead-related complications in patients treated with the S-ICD. “At four years, the primary composite endpoint of inappropriate shocks and complications occurred in the transvenous ICD arm in 15.7% of the patients,” Knops said. “I think that the big news of this study, [is that] in the S-ICD arm, there was no difference at four years of the occurrence of the primary endpoint at 15.1% in the S-ICD [arm]. This means that the S-ICD is

non-inferior to the transvenous ICD, with regard to this primary endpoint.”

Breaking these findings down further, Knops said that there was a difference between transvenous ICDs and S-ICDs in terms of the rate of inappropriate shocks. In the S-ICD arm, he said, inappropriate shocks occurred in 9.7% of patients, compared to 7.3% in the transvenous ICD arm (p=0.14). “I think it is important to mention that the main driver of inappropriate shocks in the transvenous-ICD arm was AF and supraventricular tachycardia, and the main driver in the S-ICD arm was cardiac over-sensing,” Knops said. The results showed a lower rate of device-related complications recorded in S-ICD patients (5.9%) compared to transvenous ICDs (9.8%) [p=0.11]. “There were more infections in the transvenous ICD arm,” Knops explained, adding “but this was counterbalanced by more bleedings in the S-ICD arm. The major difference in numbers in the complications was caused by lead-related complications [1.4% S-ICD vs. 6.6% TV-ICD].” There was no significant difference in mortality between the two study groups assessed during the course of the trial, Knops reported.

In his concluding remarks, Knops said: “In a conventional primary and secondary prevention ICD population, S-ICD is

UNTOUCHED study finds improved inappropriate shock rate using S-ICDs Findings from the UNTOUCHED study, presented in a late-breaking trial session at HRS 2020 Science, showed that patients receiving subcutaneous implantable cardioverter defibrillator (S-ICD) therapy experienced a higher inappropriate shock-free rate than in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.

THIS WAS ACCORDING to the study’s principal investigator Michael R Gold (Division of Cardiology, Medical University of South Carolina, Charleston, USA), who presented the findings. The study evaluated the safety and efficacy of the EMBLEM S-ICD System (Boston Scientific), for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35% Gold explained that S-ICDs were designed to provide protection from sudden cardiac death while avoiding complications associated with transvenous lead systems.

However, he noted, relatively high inappropriate shock rates have been reported with first generation devices and implant techniques. No prospective study has evaluated outcomes using modern devices in a traditional primary prevention population, he said.

Gold and colleagues hypothesised that the incidence of inappropriate shocks in primary prevention, LVEF ≤35% patients would be non-inferior to the rate in transvenous ICD patients with similar programming observed in the MADIT-RIT clinical trial, arms B and C. UNTOUCHED was a global, multicentre, prospective non-randomised study, which enrolled de novo implanted patients at 110 sites in the USA and Europe, who were followed for 18 months. Patients were enrolled if they had a primary indication for sudden cardiac death, LVEF ≤35%, without pacing indication, and if they passed the S-ICD screening test.

The study’s primary endpoint was an inappropriate shock-free rate at 18 months, with a performance goal of 91.6%. Secondary endpoints included the all cause shock free rate at 18 months, with a performance goal of 85.8%, and complication rate at 30 days.

Implants were attempted in 1,116 patients, with endpoint analysis reported in 1,111 patients. Patients had an average age of 56, 25.7% (n=286) were female and 87.6% (n=883) had heart failure. “Compared to other S-ICD studies,” remarked Gold, “the UNTOUCHED patient population is sicker, with lower ejection fractions, more heart failure diagnoses and a higher rate of ischaemic aetiology. However, the patient cohort is similar to that in landmark transvenous ICD studies, such as MADIT II, SCD-HeFT and MADIT RIT, except that they were a younger population, presumably due to the pacing indication exclusion criterion.”

Primary endpoint results presented by Gold demonstrated an inappropriate shock-free rate of 95.9%. Patients with a history of atrial fibrillation (AF), non-ischaemic aetiology, and lower ejection fraction, were more likely to experience inappropriate

The inappropriate shock rate is the lowest reported for the S-ICD, and lower than many transvenous device studies using contemporary programming to reduce inappropriate shocks.”

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non-inferior to the transvenous ICD with respect to major ICD-related adverse events.” He added that S-ICDs should be considered in all patients in need of an ICD without a pacing indication.

Since the rate of most lead-related complications of transvenous ICDs occur after more than four years, the patient cohort of the PRAETORIAN study will be followed for a further four years to assess longer-term outcomes. The authors of the study suggest that future results could reflect S-ICD device and programming updates that help prevent inappropriate shocks that may have occurred in earlier stages of the trial.

Commenting following Knops’ presentation on the study’s findings at HRS 2020 Science, Sana M Al-Khatib, professor of medicine, Duke University Medical Center, Durham, USA said it is “great to finally have a randomised controlled trial that compares the S-ICD with the transvenous ICD,” but noted that numerically there were fewer complications with the S-ICD, but that these were counterbalanced by a higher number of inappropriate shocks.

In terms of the clinical implications of the trial, Al-Khatib said that the option of an S-ICD versus transvenous ICD should be presented to patients with ICD indications, no pacing need and who pass the screening test.

shocks, Gold commented.

Procedural characteristics that predicted fewer shocks for the patients, he said, were implantation using the three-incision technique, and implanting devices with a SMART Pass filter. Gold said that when comparing the shock rates from recent S-ICD Michael R Gold studies, there has been a decrease in the number of inappropriate shocks recorded over time. “The one-year inappropriate shock rate for UNTOUCHED is the lowest recorded to date for large multicentre trials,” he said.

The secondary endpoint, the all-cause shock-free rate, stood at 90.6%, meeting its performance goal of 85.8%.

Significant multivariable predictors of all-cause shocks include a history of atrial fibrillation and lower ejection fraction, Gold added.

Discussing the results further, Gold explained that the UNTOUCHED patient cohort experienced a total of 64 appropriate shocks in discrete episodes. The first shock success rate stood at 92.2%, Gold noted, and the final shock success rate was measured at 98.4%.

The one episode with a failed final shock converted spontaneously, Gold noted, adding that these were similar rates of success compared with transvenous studies. Seven subject collectively experienced 58 episodes in nine VT storm events, all of which were successfully converted. The overall survival rate of this cohort was 94.9% at 18 months, according to Gold. Of the 53 deaths recorded during the 18-month follow-up, 26 were recorded to be of cardiac origin, including three arrhythmic deaths.

In conclusion, Gold commented that the UNTOUCHED study shows high S-ICD efficacy and safety “despite the sickest cohort to date”. “The inappropriate shock rate—which is 3.1% at one year— is the lowest reported for the S-ICD, and lower than many transvenous device studies using contemporary programming to reduce inappropriate shocks.”

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May 2020 | Issue 48

Latest news

AI-based ECG analysis reduces false positives in the detection of AF Cardiologs, in partnership with the Valley Health System, has announced the results of a clinical study conluding that by employing an AI-based ECG analysis solution, the number of atrial fibrillation (AF) false positives detected by implantable loop recorders (ILRs), can be reduced by almost 70%.

REMOTE MONITORING of ILRs has become an integral part of the modern cardiology practice said cardiac electrophysiologist Rod Passman, director of the Center for Arrhythmia Research and Jules J Reingold Professor of Medicine (Cardiology) and Preventative Medicine at Northwestern University Feinberg School of Medicine, Chicago, USA, who studied the AI system.

“However, the deluge of data and the challenges in distinguishing real events from false positives can be time consuming and can siphon resources and attention from more pressing needs,” they add.

To address the issue, Cardiologs partnered with the Valley Health System to test an AI-based solution on a cohort of 348 patients who received an ILR for either AF or cryptogenic stroke (CS). The ILR ECG strips with 1,190 detected AF episodes were then uploaded into Cardiologs’ cloud-based platform and filtered through Cardiologs’ AI-based algorithm. The results show Cardiologs reduced the number of false positive episodes by 69.7% and 62% in the CS and

AI and its growing role in arrhythmia Malcolm Finlay Comment & Analysis Malcolm Finlay (Bart's Health Centre, London, UK) discusses the growing role of artificial intelligence (AI) in the diagnosis of arrhythmias.

J

ohnny, a 72-year-old film producer, is meeting clients when his watch gently vibrates notifying him of his irregular pulse. He presses his finger to his strap, and with a swipe sends the single lead ECG to his cardiologist. The AI delivered backbone powering self-diagnostics and wearables is invisible but always present: AI is taking over the medical world. Or so it would seem. What real benefits and implications are there of AI for the hospital treatment of arrhythmia patients? It is one thing to triumph self-screening with an efficient Silicon Valley-powered gizmo for the “worried well”, but another for AI to leverage the skills of the cardiologist—let alone the electrophysiologist.

The “AI” buzz has affected several technologies and disciplines during past decade, the current darling of this buzz is “deep learning”. Data are passed across multiple layers (hence “deep”) of computational nodes, with processing at each level. Patterns within the data are discovered, reinforced, and algorithms adjusted dependent on the output—i.e. data is passed back as well as forward and algorithms modified to improve performance. This can be thought of as analogous to neurological learning;

positive and negative reinforcement drives recognition and behaviour changes within the model.

AI processes are computationally intensive and although the underlying theories are decades old, the acceleration of the field has been thanks to the widespread availability of supercomputing (think Amazon Web Services) and data availability (think social media). Serious excitement comes from the effectiveness at learning from unsorted bulk data, and enabling insights without prespecifying output groupings. Hence these methods can become good at, for instance, labelling pictures of cats without actually knowing what a “cat” is.

State-of-the-art techniques combine both machine learning and statistics, such as multilevel regression or “k-means classification”. Classical AI, oft forgotten but extremely powerful, chiefly refers to algorithms performing rule-based analytics from known data structures.

The forefront of AI implementation is the combination these techniques together.

Ultimately, this leverages distinct advantages of each method to produce far more useful and robust analytical results.

The AI hype in arrhythmia has been “you could take a bunch of ECGs, put

known AF cohorts respectively—with a 1.7% and 0.6% corresponding false negative rate. The findings were first presented at the Heart Rhythm Society in May 2020 and will be published in HeartRhythm.

“The use of ILRs has been a great addition to the long-term heart monitoring tool set. But the large amount of data associated with extended monitoring and specifically the high level of false positive AF detections have created a considerable burden in the management of ILR data. The Cardiologs AI solution offers remarkable promise to alleviating the heavy clinical burden associated with managing ILR patients,” said cardiac electrophysiologist Suneet Mittal, Director of Electrophysiology, Associate Chief of Cardiology, Medical Director of the Snyder Atrial Fibrillation Center, Director of Cardiac Research at Valley Health System, Paramus, USA, and lead investigator of the study.

“We are excited about the continuously expanding use of the Cardiologs AI platform,” said Yann Fleureau, Cardiologs’ co-founder and CEO. “It’s reaffirming to receive even more clinical validation—demonstrating the tremendous value and benefits that come with using the solution. We look forward to working with ILR users around the world in the months to come.”

it through AI and get the answer”, be it in diagnosis, prognosis, or treatment targeting. Unfortunately, the Achilles' heel here is the poor structures and classification of our data. Diagnostic classifications are loose (my atrial fibrillation is not the same as your atrial fibrillation), data structures poor, followup inconsistent and, critically, outcome classifications are weak. In healthcare, we are (mostly) trying to accomplish more than “label pictures of cats” and arrhythmia is a difficult problem indeed.

The number one issue with training AI systems comes from the data; the old line “rubbish in, rubbish out” is as true with machine learning as with any computer science process. And, we do not need much “rubbish”—misclassified ECGs, incorrect patient diagnoses or serendipitous improvements unrelated to recorded treatments—to significantly reduce machine learning performance.

An AI system may be near perfect on a training dataset, yet hopeless in the real world. Compounding this are stringent data handling regulations, and unlike consumer-grade devices, harvested patient data cannot be used to continually improve performance of our systems. Even if this is circumvented, current interpretations of strict medical device regulations stall dissemination of diagnostic or guiding treatment.

So how will medical-grade AI systems change the lives of the humble electrophysiologist? The mass selfscreening for atrial fibrillation by wearables powered by AI will sweep through our clinics. If your waiting list is short—it soon will not be. AI will have its presence felt across the hospital, increasing the “efficiencies” of purchasing, lab list booking and so on. Much of the cath lab hardware will become “intelligent” (think automatic adjustment of fluoro settings and table positions during cases), though it will be a while before we can have a chat about politics with the image intensifier.

The “hard” stuff we do will be made significantly easier, perhaps most

obviously interpretation of complex mapping data. This is the underlying aim of Rhythm AI’s STAR mapping system. Here, we leveraged a combination of patient data with algorithmic and machine learning AI to identify sites driving persistence of atrial fibrillation on intra-cardiac mapping. Preliminary clinical data are very promising, and a multicentre clinical trial will assess formal outcomes against state-of-the-art ablation techniques.

Despite Johnny’s fancy watch, AI is far away from replacing the electrophysiologist. Some low-level advice could seem plausible for such a system to give, yet this is the fringe of the electrophysiologist’s practice. Our role is as a trusted advocate, providing balanced and individualised personal recommendations. The failure of robotics thus far to make inroads into the electrophysiologisy lab also points to the complexities in offloading treatment delivery to intelligent systems. For the near future such systems will still require direct physician supervision. Amongst the earliest inroads, we will notice will be a step change in the interpretation of the complex electroanatomical maps, exactly the niche STAR mapping seeks to fill.

Our world will be changed because of AI, with better patient screening, easier to interpret Electroanatomic maps and lower X-ray doses. But we should not hang up our leads just yet, hard-earned electrogram interpretation and ablation skills will not go to waste. The gulf between AI helping professional efficiency and doing a large majority of our jobs for us is a large one.

As Johnny will testify, there is a long way between labelling cats and performing a successful ventricular arrhythmia ablation.

Malcolm Finlay is the founder and nonexecutive director of Rhythm AI. He is also at William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. STAR Mapping is an investigational device and is not currently approved for commercial sale.

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May 2020 | Issue 48

Atrial fibrillation

Ethanol infusion in vein of Marshall improves catheter ablation outcomes The infusion of ethanol via the vein of Marshall (VOM), coupled with catheter ablation, leads to improved outcomes for patients with persistent atrial ablation, according to the findings of a study presented by Miguel Valderrabano (Baylor College of Medicine, Houston, USA) at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual, 28–30 March).

FINDINGS FROM THE VENUS—Vein Of Marshall ethanol infusion for persistent atrial fibrillation—trial were presented on day two of the virtual conference, which was originally scheduled to take place on 28–30 March in Chicago, USA. Opening his presentation, Valderrabano noted that the treatment of persistent AF remains a challenge due to the limited success of catheter ablation, including low single-procedure success and a frequent need for repeat procedures. Procedural strategies beyond pulmonary vein isolation (PVI) have failed to consistently improve results, he said.

Valderrabano noted that the VOM contains innervation and AF triggers that can be ablated by retrograde ethanol infusion. Therefore, the study team hypothesised, VOM ethanol and de novo catheter ablation of persistent AF could improve the results of persistent AF ablation, as well as increasing the chances of maintaining normal rhythm.

The study was designed with a primary endpoint of freedom from AF or atrial tachycardia (AT) of greater than 30 seconds after a single procedure, without anti-arrhythmic drugs, after a three-month period.

Secondary endpoints included success after more than one procedure, or with drug treatment. Patients aged between 18 and 85 years of age, symptomatic of persistent AF, and refractory to at least one antiarrhythmic agent, were eligible for inclusion in the trial. Patients with previous ablation attempts, with a left atrial diameter or volume exceeding 65mm or 200mL, or an ejection fraction greater than 30%, were excluded.

The study team randomised 343 patients from 11 healthcare centres, in a 1:1.15 ratio to receive either catheter ablation alone, or catheter ablation combined with VOM ethanol. They predict that in around 15% of the Miguel Valderrabano patients randomised to the VOM group, the vein would not be amenable to cannulation. These patients would continue undergoing the catheter ablation, and would remain in the study for analysis.

One hundred and eighty five patients were randomised to the VOM ethanol infusion plus catheter ablation group, and 158 to catheter ablation only. Patients had a mean age of 66 years. Outcomes were tracked at one, three, six, nine and 12 months, with continuous, onemonth monitoring taking place at the six- and 12-month stages. Valderrabano said that ablation failures could be clinical if the patients presented with symptomatic AF or AT after three months, or by monitoring if more than 30 seconds of AF or AT were detected.

Trial procedures, for patients randomised to the VOM group prior to catheter ablation, included coronary sinus venogram to identify the VOM and angioplasty balloon cannulation with up to four injections of 1cc of ethanol from distal VOM to proximal. Left atrial voltage maps were performed before and after the injection of ethanol to quantify the alcohol-induced scar. Catheter ablation

Apple Watch could be used to record a quasistandard ECG

Miguel Angel Cobos Gil (Instituto Cardiovascular, Hospital Clinico San Carlos, Madrid, Spain) outlines in the Annals of Internal Medicine a novel method of using the Apple Watch to record a multilead, quasi-standard electrocardiogram (ECG). He reports that the method is feasible but that a “broad range of clinical studies are needed to determine the role of such devices (that is, the Apple Watch) in the diagnosis and follow-up of patients with known or suspected heart disease. He talks to Cardiac Rhythm News about the use of wearable ECG monitors versus traditional 12-lead ECGs.

What are the benefits of a wearable ECG monitor versus a traditional 12-lead ECG? A wearable ECG monitor—especially if it is as ubiquitous as an Apple Watch— can provide a diagnostic ECG anytime, anywhere.

What are the disadvantages of recording a multilead ECG, as you did, with an Apple Watch?

Our method can be a little cumbersome for some people.

In your study, you sought to record multi-lead quasi-

standard ECG using the Apple Watch. How did you achieve this?

Moving the watch over different places in the body. Lead I is recorded as instructed by Apple: wearing the watch on the left wrist and touching the digital crown with a right-hand finger. Leads II and III are easily obtained by moving the watch to the ankle or any place on the leg and touching the digital crown with a finger on the right

included pulmonary vein isolation in all of the patients.

All patients were required to undergo a final left atrial voltage map to quantify the extent of the total tissue ablated.

The VOM procedure was unsuccessful in 30 patients who underwent catheter ablation, with 155 receiving both VOM ethanol infusion plus catheter ablation. Three patients died, while 10 had missing data, resulting in a final number of 142 included in the per treatment analysis. Valderrabano noted in his presentation that there was a greater presence of hypertension in the VOM group (77% vs. 66%) and a slight difference in atrial diameter between the two groups (44.8mm vs.

47mm). Longstanding persistent AF was present in 54% of VOM plus catheter ablation patients, compared to 52% of catheter ablation only patients.

Discussing the procedural parameters, Valderrabano pointed to differences between the two patient groups, noting that the total fluoroscopy time and procedure time were longer in the VOM group, as well as noting that more patients in the VOM group underwent ablation of the mitral isthmus compared to the catheter ablation group (85% vs. 72%). Bidirectional perimetral block was achieved more commonly in the VOM plus catheter ablation group (74% vs. 51.3%), Valderrabano said.

Ablation success—defined as freedom from AF or AT for more than 30 seconds after three months— Valderrabano said, was achieved in 38% of the patients randomised to the catheter ablation group, and 51.6% among those in the VOM plus catheter ablation group (p=0.015). AF/AT recurrence was seen in 51.9% of the catheter ablation group, compared to 40% of those undergoing VOM infusion plus catheter ablation.

In his concluding remarks, Valderrabano said: “In persistent atrial fibrillation, vein of Marshall ethanol added to catheter ablation reduces the recurrence of atrial fibrillation and tachycardia, reduces the atrial fibrillation and may reduce the need for repeat procedures.” He noted that the limitations of the study include that VOM ethanol infusion could only be completed in 83.8% of patients, and that the procedure may increase the risk of fluid overload.

hand for lead II or the left hand for lead III. To record the precordial leads (V1 to V6), the back of the watch is placed on the chest, in the precise points wired in a traditional ECG, and the digital crown is touched by a right-hand finger. A lead very similar to the precordials (V1 to V6) is recorded.

What were your results?

The ECG recording obtained by the Apple Watch was very similar to the conventional ECG and, thus, could be used to diagnose conditions other than atrial fibrillation (which the Apple Watch ECG can currently diagnose), such as a myocardial infarction.

What further studies are needed?

At present, my colleagues and I are working on methods to simplify the acquisition of the ECG using the Apple Watch.

If we are able to obtain a similar ECG with the Apple Watch as with conventional ECG, what are the potential applications?

Any person with an Apple

Maguel Angel Cobos Gil

Watch can obtain a diagnostic ECG in any place—for example, on a flight or even in an isolated country house.

What advice should be given to patients about collecting and interpreting ECG data (for example, what they should do if the Apple Watch identifies that they have atrial fibrillation)?

The instructions for use in the Apple Watch app are detailed in the Apple brochure. Patients using our method to obtain a quasi-standard ECG should send the recording to a doctor.

Issue 48 | May 2020

COVID-19

COVID-19: Optimising heart failure management in the patient’s home Michael Kiernan Comment & Analysis Physicians already recognised the importance of remote management for heart failure patients long before the COVID-19 pandemic. However, the current situation has heightened the urgency of the transition for this vulnerable population. In this commentary, Michael Kiernan reviews how remote monitoring of heart failure patients could help to reduce heart failure hospitalisations.

H

eart failure patients often have a reduced quality of life with frequent office and emergency room visits and/or rehospitalisations to stabilise worsening symptoms.

Outcomes remain stubbornly poor with 50% of patients dying within five years of diagnosis. Added to that, recent COVID-19 data from China showed a four times higher mortality rate for patients with a history of cardiovascular disease. Given this population’s increased risk of negative outcomes with COVID-19, avoiding unnecessary exposure whenever possible is important.

The risk is real, and thankfully technology options now exist to provide

high quality heart failure management within the patient’s home.

One such technology monitors congestion through increases of intracardiac and pulmonary artery pressures using an implantable sensor, which begin a few days to weeks prior to the onset of overt heart failure signs and symptoms.

Prior investigations have shown that intervening earlier using pulmonary artery pressure-guided management, to inform medication adjustments, has demonstrated a reduction in heart failure hospitalisations while also improving patient quality of life.

Building on that data, in February 2020, our team at Tufts Medical

Anticoagulants may improve survival among hospitalised COVID patients Valentin Fuster (Mount Sinai Heart, New York, USA) and colleagues report in the Journal of the American College of Cardiology that hospitalised COVID-19 patients treated with anticoagulants had improved outcomes in and out of the intensive care unit setting. They add their work outlines an important therapeutic pathway for COVID-19 patients.

RECENT RESEARCH (FROM the Icahn School of Medicine, Mount Sinai, New York, USA) indicated that large numbers of patients hospitalised with COVID-19 develop high levels of blood clots, leading to potentially deadly thromboembolic events.

In their study, Fuster et al evaluated records of 2,773 confirmed COVID-19-positive patients admitted to five hospitals in the Mount Sinai Health System in New York (USA) between 14 March and 11 April 2020. They looked at survival rates for patients placed on anticoagulation versus those not placed on anticoagulation. The authors took certain risk factors into account before evaluating the effectiveness of anticoagulation, including age, ethnicity, pre-existing

Center was excited to be one of the first implanting US sites for the pivotal PROACTIVE-HF trial using the novel Cordella pulmonary artery (PA) sensor (Endotronix). In addition to the sensor, the Cordella system incorporates vital sign data from non-implantable sensors including weight, blood pressure, blood oxygen, heart rate, and patient recorded symptoms. Each day, the patient collects and shares data in less than five minutes, providing a comprehensive clinical picture over time.

Although the recent escalation of COVID-19 has paused elective surgeries, the Cordella system without the sensor has proven clinically useful for the remote management of heart failure patients in our clinic. The US Food and Drug Administration (FDA) approved system enables trend-based management of key non-invasive metrics and provides secure patient communication tools.

After the USA addresses the acute COVID-19 needs, our team is eager to continue the clinical research with the Cordella sensor. The landmark PROACTIVE-HF trial of over 960 patients is designed to support market access and inform a national coverage decision (NCD) from the Centers of Medicare and Medicaid (CMS) for the wireless, implantable Cordella pulmonary artery sensor. The dual arm trial compares heart failure disease management with remote telemonitoring using daily patient vital sign data versus daily vital sign data plus pulmonary artery pressure data. Both groups will adhere to guideline-directed medical therapy for heart failure as well as protocolised PA pressure therapy.

Through this study, we look forward to advancing the research in support

conditions, and those already on anticoagulants.

Of the patients analysed, 786 (28%) received a full-treatment dose of anticoagulants—a higher dose than what is typically given for blood clot prevention.

Treatment with anticoagulants was associated with improved hospital survival among COVID-19 patients both in and out of the intensive care unit setting. Of the patients who did not survive, those on anticoagulants died after spending an average of 21 days in the hospital, compared to the non-anticoagulant patients who died after an average of 14 days in the hospital. The effect of anticoagulation had a more pronounced effect on ventilated patients—62.7% of intubated patients who were not treated with anticoagulants died, compared to 29.1% for intubated patients treated with anticoagulants.

Of the intubated patients who did not survive, those with no anticoagulants died after nine days, while those on anticoagulants died after 21 days.

All patients in the study had blood work done when

Using anticoagulants should be considered when patients get admitted to the emergency room and have tested positive for COVID-19 to possibly improve outcomes.”

7

of pulmonary artery pressure-guided management for heart failure.

The Cordella system and Cordella sensor are designed to improve upon existing therapies for all key stakeholders: the patient, the implanting physician, and the disease management team, which commonly includes a heart failure nurse specialist working in collaboration with a supervising cardiologist. For the managing team, the Cordella system offers comprehensive patient data to facilitate trend-based monitoring in the home. The system provides notifications if metrics fall outside physician-determined limits and is monitored by our heart failure staff using the clinician portal to remotely review patient data. Lastly, the userfriendly patient design makes it easy for patients to use and communicate with our office through secure messaging software. The handheld reader for the sensor makes it easy for patients to regularly transmit their data to our team for close monitoring. Given our early experience with this technology, we are optimistic about the potential benefits of using the Cordella System and Cordella Sensor with our patients.

The Cordella system, without the sensor, is available for commercial use in the USA and EU and is currently in cardiology centres across the USA. The Cordella sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the USA (PROACTIVE-HF IDE Trial).

Michael Kiernan is director of Cardiac Assist at Tufts Medical Center, Boston, USA

they arrived at the hospital, which included measuring various inflammatory markers. The analysis showed patients who received anticoagulants had higher inflammatory markers compared to patients not treated with anticoagulants. This suggests patients with severe illness may benefit from early anticoagulation.

The observational study also explored the association of systemic anticoagulant treatment with bleeding events. Among those who did not receive anticoagulants, 38 (1.9%) patients had bleeding events, compared to 24 (3%) among those who received anticoagulants, p=0.2).

Fuster comments: “This research demonstrates anticoagulants taken orally, subcutaneously, or intravenously may play a major role in caring for COVID-19 patients, and these may prevent possible deadly events associated with coronavirus, including heart attack, stroke, and pulmonary embolism. Using anticoagulants should be considered when patients get admitted to the emergency room and have tested positive for COVID-19 to possibly improve outcomes. However, each case should be evaluated an individualised basis to account for potential bleeding risk.”

Senior author Girish Nadkarni (Mount Sinai COVID Informatics Center) comments: “This study is opening the door for a more extensive study that will be carried out with 5,000 COVID-19-positive patients, where we will evaluate the effectiveness of three types of antithrombotic therapy—oral antithrombotic, subcutaneous heparin, and intravenous heparin—and then perhaps engage our data for prospective clinical trial. We are excited about these preliminary results that may have a positive impact on COVID-19 patients and potentially give them a greater chance of survival, although more studies are needed.”

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May 2020 | Issue 48

Interview

Profile

Athena Poppas Athena Poppas is chief of cardiology at the Alpert Medical School of Brown University (Providence, USA) and has recently begun her term as the president of the American College of Cardiology (ACC). She tells Cardiac Rhythm News about her expertise in treating heart disease in pregnant patients, ACC’s commitment to advancing the field of electrophysiology, and the organisation’s response to COVID-19.

Why did you pursue a career in medicine?

Medicine was the intersection of human care and science. To be able to apply deep understanding of the fascinating world of biology to help others to heal is quite a privilege.

What drew you to cardiology?

Cardiology is one of the most dynamic areas in medicine. There are exciting, rapid advances, which are able to be applied to care at the bedside and improve the health of a population and individuals. There are also many aspects to cardiology and the variety of approaches—electrical, structural, haemodynamics—as well as type of work—direct patient care, longitudinal care, hands-on invasive work and complex imaging assessment—which make it so vibrant.

Who have been your career mentors and what have you learned from them?

I have been fortunate to have many mentors along the way, such as Roberto Lang, who instilled in me a passion for the clinical and research aspects of echocardiography; Al Buxton, who encouraged my academic interests and faculty development; Pam Douglas and Minnow Walsh, who were models of women leaders in cardiology and the ACC.

What do you feel have been the most important recent developments in the treatment of arrhythmias?

There have been many advances in electrophysiology, which have built upon prior scientific discoveries, trials and knowledge. In arrhythmia management we have seen a pivot in the treatment from medications to devices and ablations. Having a broad toolkit from which to work has improved the quality of care of patients with arrhythmias.

What advances in echocardiography do you hope to see in coming years, and how could these advance the diagnosis and treatment of arrhythmias?

Echocardiography is also a very dynamic area within cardiology with ongoing innovations which have improved our understanding of cardiovascular structure and function and lead to better patient care. Most recently, 3D imaging to guide surgical and percutaneous procedures and strain analysis of sub clinical disease are notable. Further application to EP procedures including 3D ICE (intracardiac echo) can reduce patient risk, need for anaesthesia and for fluoroscopy.

You are a specialist in the treatment of heart disease during pregnancy. Does pregnancy alter the approach to the treatment of arrhythmias?

Cardiac disorders in pregnancy are the greatest cause of morbidity and mortality and require a multidisciplinary approach to caring for the patient with considerations of the change in physiology and the exposure of the developing foetus. Arrhythmias in pregnancy are treated

with medications which have a known safety profile and may need increasing doses. Ultimately one should never withhold appropriate treatment, such as defibrillation for unstable rhythms, as care of the mother is paramount and required for good foetal outcomes.

You have recently begun your term as president of the ACC, what will be your focus in the role?

As president of the American College of Cardiology, my role is to lead the organisation to accomplish our strategic priorities to generate and deliver actionable cardiovascular knowledge; advance quality, equity and value of care delivery; support of cardiovascular care members and healthcare systems; and ensure organisational growth and leadership development.

In particular, our recently launched efforts to improve diversity and inclusion and strengthen scientific education for the future are at the front of our minds.

At a particularly challenging time for global healthcare, what will your strategy be for steering the organisation through the COVID-19 pandemic?

We know that COVID-19 has a greater impact on patients with existing cardiovascular disease, but there are many unknowns about how to manage these patients and protect healthcare workers while they do so. Before my presidency and during my presidency, ACC has been providing real-time guidance based on the latest scientific evidence available to cardiovascular physicians and care team members in managing their patients during this pandemic. We are also working with lawmakers to address COVID issues impacting the specialty, such as telemedicine coverage.

Echocardiography is a very dynamic area within cardiology with ongoing innovations.”

What role do organisations such as the ACC have to play in tackling the pandemic?

The ACC is working to help members on the front lines best manage their patients. We have a global membership with a wide range of expertise who we are bringing together to disseminate knowledge.

Information is coming out quickly, so ACC has developed a COVID-19 hub on its website to make all the latest clinical guidance, perspectives and front-line experience, regulatory and reimbursement updates, and webinars, available in one place. Since our first COVID-19 bulletin was published in February we have continued to publish clinical documents and guidance, which have been accessed over 1.5 million times.

One of our most popular webinars was on the Chinese experience of the cardiovascular effects of COVID-19.

How can the ACC support advances in electrophysiology?

ACC is committed to continued collaborative work with our sub-specialty societies, such as HRS, to advance the field of electrophysiology. This includes advocacy efforts nationally, personalised educational offerings with self-assessment programmes, live programmes, as well as highlighting breakthrough science at our annual meeting and in JACC journals.

How has ACC sought to encourage diversity within the field?

The ACC has fully committed to improving diversity throughout the field of cardiology as a core component of our five-year strategic plan. We recognise that this is not just an issue for cardiologists, but it is also an issue for quality patient care. We know that that cardiology is not as diverse as the US population and is one of the medical specialties that the lowest percentages of

Issue 48 | May 2020

Interview

9

Fact File

Current appointments

■ Chief, Section of Cardiology, Brown University ■ Director, Echocardiography Laboratory, Rhode Island Hospital ■ Cardiovascular Service Line, RI & Miriam Hospitals ■ University Cardiology Foundation, Testing Committee member

Education and postgraduate training

1979–1983 Bachelor of Science, Brown University 1985–1989 Doctor of Medicine, University of Wisconsin Medical School 1989–1992 Internal Medicine, University of Wisconsin Hospital and Clinics 1992–1995 Cardiovascular Medicine, University of Chicago Hospital

Honours and awards

1994 Outstanding Cardiology Fellow, Upjohn Award, University of Chicago Hospital 1995 Young Investigator Award, American Heart Association, Scientific Conference on Cardiovascular Disease in Women 2006 Outstanding Teaching Award, Department of Medicine, Brown University Medical School 2014 Deans Excellence in Teaching Award, Brown University 2014 Reilly Cardiovascular Fellowship Teaching Award

Prior appointments

women and minorities are entering into after medical school, but we are committed to finding out what barriers exist and making changes that foster a culture of diversity and inclusion. In 2016, the College established a task force on diversity and inclusion, which had an initial goal of addressing the low percentages of women entering the cardiology workforce. That mission has expanded to address all underrepresented groups. Last year, the College named its first director of diversity and inclusion to work with the task force to lead and expand the ACC’s diversity and inclusion initiatives. We have made many strides and we are continuously working towards a fully inclusive organisation and profession.

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

For those who are just starting on their career path in cardiology, I would advise that you always follow

your passions and do what you love. By doing so, it will rarely feel like work. As well as this, you must remember to care for and advocate for yourself, as physician well-being is crucial to the functioning of our healthcare systems.

Outside of medicine, what are your hobbies and interests?

Outside of medicine, I enjoy many outdoor activities with my family and friends whether it is hiking, canoeing, skiing or roasting marshmallows around a lake campfire.

What would you have been if you had not been a medical doctor?

If I had not trained to become a doctor, I think I would have been a basic scientist in a research lab or, worked on healthcare policy for governmental or nongovernmental agencies.

■ Staff Physician, Section of Cardiology, University of Chicago Hospital ■ Assistant Professor of Medicine, Section of Cardiology, University of Chicago ■ Clinical Associate, Department of Medicine, Massachusetts General Hospital ■ Co-Director, Echocardiography Laboratory, Rhode Island Hospital ■ National Center of Excellence in Women's Health, Clinical Care Working Group, member, Women and Infants Hospital ■ Professor of Medicine, Section of Cardiology, Brown University

Society involvement

■ President, American College of Cardiology ■ Journal of the American Society of Echocardiography, Manuscript reviewer ■ American Heart Association, Scientific Sessions Abstract Reviewer/ Moderator

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May 2020 | Issue 48

Conference coverage

Positive 12-month results for nextgeneration Watchman FLX Boston Scientific has announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation Watchman FLX left atrial appendage closure device for patients with non-valvular atrial fibrillation (AF). Presented as a late-breaking clinical trial at HRS 2020 Science, the study evaluated performance of the device as an alternative to oral anticoagulation therapy.

THE PROSPECTIVE, NON-RANDOMISED PINNACLE FLX trial included 400 patients in the USA with non-valvular AF, eligible for anticoagulation therapy to reduce stroke-risk, but had an appropriate rationale to seek a non-pharmaceutical alternative.

The trial met its primary safety endpoint—defined as occurrence of a major procedure-related complication within seven days following the procedure or time of hospital discharge, whichever was later—with a low adverse event rate of 0.5%. The study also met its primary effectiveness endpoint, with data demonstrating a 100% rate of effective left atrial appendage closure at 12 months’ post-procedure with peridevice flow <5mm.

Data from the trial also demonstrated an implant success rate of 98.8% and that no patients experienced peri-procedural death, device embolisation or pericardial effusion requiring cardiac surgery, all of which is

favourable in the context of previous clinical studies according to a press release.

Additionally, 96.2% of patients were able to discontinue oral anticoagulation following their 45-day follow-up. Secondary endpoints from the PINNACLE FLX study, including the occurrence of ischaemic stroke or systemic embolism, will be reported after 24 months of patient follow-up.

Shephal Doshi (Providence St John’s Health Center, Santa Monica, USA), the study’s co-principal investigator, comments: “We believe the next-generation Watchman FLX technology contributed to the excellent overall clinical performance seen in this study, notably the very low rate of safety events and high rate of effective closure. In fact, we saw that 90% of patients showed absolutely no detectable leakage around the device at their 12-month follow up, which compares favourably to the rates of peri-device flow observed in the PROTECT-AF and PREVAIL trials with the predicate Watchman device and may translate into improved long-term clinical outcomes.”

Boston Scientific plans to further evaluate the Watchman FLX device for patients with non-valvular

The next-generation Watchman FLX technology contributed to the excellent overall clinical performance in this study.” atrial fibrillation via continued enrolment in the ongoing OPTION trial— comparing the device to oral anticoagulants in patients who also undergo a cardiac ablation procedure—as well as in the CHAMPION-AF clinical trial, which will study a broader anticoagulanteligible patient population to evaluate the device against

Mavacamten “promising” in treatment of non-obstructive hypertrophic cardiomyopathy

non-oral anticoagulation for embolic stroke prevention.

Release of the PINNACLE FLX trial data comes following the presentation of data from the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry presented

by James V Freeman (Yale University School of Medicine, New Haven, USA) at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual, 28–30 March).

The NCDR LAAO registry is a national programme for post-market Watchman surveillance, to which, as of April 2016, US hospitals were required to report all Watchman procedures performed in order to qualify for Medicare reimbursement. The Registry enrolled more than 38,000 patients implanted percutaneously with the Watchman device and reveals a high implant success rate and a low rate of in-hospital complications, Freeman said.

In the ACC.20/WCC Virtual session, Freeman characterised the patient population, performing hospitals, and in-hospital adverse event rates. Patients in the registry were generally older with more comorbidities than in the pivotal trials; however, major in-hospital adverse event rates were lower. Freeman's analysis shows that major in-hospital adverse events occurred in 2.16% of patients with the most common complications being pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), while stroke (0.17%) and death (0.19%) were rare.

“There is clearly a lot of enthusiasm in the postmarket setting in the USA to undertake this procedure as an alternative to blood thinners for these patients, who can be stuck between a rock and a hard place because they are at risk for AF-related stroke but have had prior bleeding or other problems with blood thinners,” said Freeman, the study’s lead author in a press release from the ACC. “Patients getting this procedure in the real world are generally older and sicker than the patients who were in clinical trials, and it is reassuring to see that the procedural safety profile looks good.”

drug, and to explore efficacy endpoints, including changes in N-terminal pro b-type natriuretic peptide (NT-proBNP) and cardiac troponin (cTn) levels. These are seen as biomarkers of elevated left ventricular filling pressure and myocardial injury, and were assessed Results from the phase 2 MAVERICK-HCM clinical trial, presented due to their association with adverse at the American College of Cardiology/World Congress of outcomes in nHCM. Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual, 28–30 The study involved 59 adults with March) suggest that the use of mavacamten (MyoKardia) for the symptomatic nHCM (New York Heart treatment of non-obstructive hypertrophic cardiomyopathy (nHCM) Association Class II/III), left ventricular may be beneficial with longer-term treatment. ejection fraction (LVEF) ≥55%, and NT-proBNP ≥300 pg/mL. Participants indings from the multicentre, and improve symptoms associated with were randomised 1:1:1 to receive a PKdouble-blind, placebo-controlled, nHCM. Ho described mavacamten as a adjusted dose for a target mavacamten dose ranging trial were presented novel drug developed to treat concentration of 200ng/mL

by Carolyn Y Ho (Brigham and Women’s obstructive HCM, adding (n=19), 500ng/mL (n=21), or Hospital, Boston, USA). During her that it is a selective allosteric placebo (PBO) (n=19) for 16presentation, Ho said that, to date, no inhibitor of cardiac myosin, week treatment and an eightpharmalogic therapy has demonstrated which reduces the number of week washout. Initial dose was clinical benefit for patients with myosin-actin cross-bridges, 5mg daily with a dose titration symptomatic nHCM. “In constrast thus decreasing excessive at week six. The study cohort to obstructive HCM, where surgical contractility characteristic of had a mean age of 54 years, myectomy or alcohol septal ablation can HCM. She added that there and 58% were female. reliably improve symptoms, for patients is also evidence that the drug Carolyn Y Ho According to Ho, the results with non-obstructive HCM, who develop may help improve myocardial showed that there was a 53% symptoms refractory to medical therapy, relaxation and energetics, two other decrease in the NT-proBNP geometric cardiac transplant may be the only hallmarks of HCM pathophysiology, mean (pooled mava group; baseline: 713 option,” Ho said. “Thus, there is a great that may be particularly relevant to pg/mL) versus a 1% decrease in the PBO need for effective medical therapy for patients without obstruction. “Therefore group (baseline: 967 pg/mL, p=0.0005). these patients.” it [mavacampten] may be beneficial for There was a 34% decrease in cardiac Ho noted that by altering the patients with non-obstructive HCM,” she troponin-I geometric mean in the pooled contractile mechanics of the posited. mavacamten group versus a 4% increase cardiomyocyte, myosin inhibitors have The MAVERICK-HCM trial aimed to in PBO (p=0.009). In the mavacamtenthe potential to modify pathophysiology assess the safety and tolerability of the treated patients, change in NT-proBNP at

F

week four correlated with change in cTnI at week 16 (rho=0.45, p=0.006).

Ninety per cent of participants on mavacamten versus 68% on PBO experienced an adverse event (AE), of which the majority were mild or moderate, self-limiting, and assessed by the investigator to be unrelated to treatment, Ho said. Serious AEs occurred in 10% (mavacamten) and 21% (PBO).

Five participants on mavacamten had reversible reductions in LVEF to <45% at week 11–12 and met prespecified criteria for treatment discontinuation.

Summarising the key findings from the study, Ho said: “In this phase 2, dose ranging study in patients with symptomatic, non-obstructive HCM, mavacampten was generally tolerated by most participants. Reduction in LVEF can occur, and administration will be guided by clinical parameters, including LVEF, and suitable biomarkers. This was the first study to show an improvement in serum biomarkers of haemodynamic stress and myocardial injury in patients with non-obstructive HCM. There is also a suggestion that patients with more severe disease may benefit the most from mavacampten.”

She concluded: “These results are supporting further study to better characterise the use of mavacampten in non-obstructive HCM, and potentially in heart failure with preserved ejection fraction in general.”

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May 2020 | Issue 48

Ablation

Novel lattice tip catheter safe, feasible, and durable in RF ablation Rapid, high-current, temperature-controlled point-by-point pulmonary vein isolation (PVI) and linear ablation has been shown to be feasible and safe in a first-in-human study of an expandable radiofrequency (RF) lattice tip catheter.

P

ublished in JACC: Clinical Electrophysiology by Elad Anter (Harvard Medical School, Boston, USA) et al, the study evaluated the safety and performance of a novel catheter with an expandable lattice structure and a wide thermal footprint for the treatment of atrial flutter and fibrillation (AF). The catheter incorporates multiple surface thermocouples/mini-electrodes in highresolution mapping and high-current temperature-controlled radiofrequency ablation (RFA).

Anter and colleagues write: “This first-in-human study demonstrates the workflow advantages of integrating high resolution mapping with high-power ablation into a single catheter. But most importantly, this novel lattice-tip catheter highlights the advantages of radiofrequency ablation with a large thermal footprint: one retains both the flexibility of point-by-point catheters and the ease of use of one-shot technologies to create PVI, cavo-tricuspid isthmus (CTI), mitral isthmus and left atrial (LA) roof lines.”

A continuation of this study was presented at a late breaking trial session at AF Symposium 2020 (23–25 January, Washington, DC, USA), and published in JACC: Clinical Electrophysiology by Vivek Y Reddy (Icahn School of

Medicine at Mount Sinai, New York, USA) et al. This found that temperaturecontrolled lattice-tip point-by-point ablation not only resulted in PVI lesion sets that were highly durable, but also durable contiguity of linear atrial lesions.

Patients with typical right atrial flutter or AF were prospectively enrolled in a single arm study at three centres. Flutter patients underwent CTI ablation. Patients with paroxysmal AF underwent PVI, and CTI if desired, and for persistent AF patients, mitral isthmus and LA roof lines were also permitted. Mapping was performed with the lattice (Sphere-9) catheter and a novel compatible electroanatomical mapping system (Prism-1). RFA was performed in a point-by-point fashion. Patients were followed for three months. In all, 71 patients underwent ablation: 65 PVI, 38% persistent AF; 22 mitral isthmus, 24 roof, and 48 CTI lines.

Anter et al noted that PVI was achieved in 64/65 (98.5%) using the lattice alone, and required 2.7±0.7 RFA minutes. Mitral block was achieved in 100% using 11.5±10.7 applications and 1±0.92 RFA minutes; only one patient required adjunctive epicardial coronary sinus ablation. Roof line and CTI block were achieved in 95.8% and 100% of patients, using 4.9±1.9 and 5.9±3.1

applications for 0.4±0.16 and 0.5±0.24 RFA minutes, respectively. At three months, there were no deaths, strokes, tamponade or atrioesophageal fistula.

Reddy and colleagues found that the pulmonary veins (PVs) remained durably isolated in all but one reconnected PV, translating to durable isolation in 99.1% of PVs, or 96.3% of patients with all PVs isolated. Of 47 linear atrial lesions initially placed during the index procedure, durability was observed in 10 of 11 (90.9%) mitral isthmus lines, all 11 (100%) roof lines, and all 25 (100%) CTI lines. After a median follow-up of 270 days, the 12-month KaplanMeier estimate for freedom from atrial arrhythmias was 94.4%±3.2%.

Anter et al highlight the low rate of safety events, saying: “Over three months’ follow-up, there were no primary adverse events. Specifically, there was no instance of atrioesophageal fistula, cardiac tamponade, death, severe

These latticetip outcomes suggest that durable ablation lesion sets—PVI for PAF and PVI plus linear lesions for PerAF—are crucial missing variables to achieving high success of AF ablation.”

Contact force sensing catheters “safe and effective” in persistent AF ablation

pericarditis, valvular damage, major vascular access complication or bleeding, intra-procedural device complications requiring cardiac surgery, myocardial infarction, phrenic nerve paralysis, PV stenosis, stroke, thromboembolism or transient ischaemic attack.”

However, as the focus of the first-inhuman study was on safety and acute efficacy of the technology, they say: “Data from long-term follow-up will be necessary to evaluate the true clinical efficacy of this technology.”

Anter and colleagues concede that the small sample size, short follow-up and the observational design of the study “precludes robust direct comparison to other ablation technologies”, and suggest that a multicentre study should be conducted.

On lesion durability, Reddy et al also note: “Foremost is a tendency of the catheter tip to remain in stable contact with the target tissue during ablation. This seems related to both the compressibility of the spherical mesh, and the fact that the surface topography of this tip may mitigate sliding/ dislodgement of the catheter away from the target site.”

They also comment: “These lattice-tip outcomes suggest that durable ablation lesion sets—PVI for PAF and PVI plus linear lesions for PerAF—are crucial missing variables to achieving high success of AF ablation.”

They conclude: “This first-in-human study shows that the novel lattice-tip catheter, by virtue of its large thermal footprint, creates contiguous pointby-point temperature-controlled RFA lesions with high rates of linear lesion durability—for PVI, for LA linear lesions at the mitral isthmus and roof, and for CTI ablation.”

ablated with a non-study catheter.

According to the results presented by Mansour, the Kaplan-Meier estimate of primary effectiveness at 15 months stood at 61.7% [95% CI: 56.2-67.2%] of patients reporting freedom from recurrences of AF, Contact force (CF) sensing catheters have been shown to be safe and effective in AT or AFL, acute procedural failure, use of non-study persistent atrial fibrillation (AF) ablation, according to the findings of the PRECEPT study, catheter, repeat procedures, use of new/higher dose presented online during a late-breaking clinical trial session at Heart Rhythm 2020 Science. AAD or surgical ablation. This meant that the study’s The findings were presented by the study’s lead author, Moussa Mansour (Massachusetts performance goal 40% for primary effectiveness General Hospital, Boston, USA). The findings of the study were published simultaneously in was met. Clinical success, defined as freedom from the Journal of the American College of Cardiology (JACC): Electrophysiology. documented symptomatic AF, AT or AFL recurrence, was reported in 80.4% of patients, Mansour stated.

DURING HIS PRESENTATION, Mansour noted that endpoint was freedom from documented recurrence On the safety outcomes, Mansour and colleagues note while the safety and effectiveness of catheter ablation of AF, atrial flutter (AFL) or atrial tachycardia (AT) that overall, 14 primary adverse events were reported of paroxysmal AF has been long established, there are episodes of 30 seconds or longer and freedom from for 13 participants. The primary adverse event rate was limited data on outcomes in patients with persistent an additional five failure modes at 15 3.8% and one-sided exact 97.5% upper AF, and no ablation catheter is currently approved by months, which included: acute procedural confidence bound was 6.4%, significantly the FDA for persistent AF ablation. The PRECEPT failure, use of non-study catheter, repeat less than the specified performance goal study sought to evaluate the safety and effectiveness of procedures, use of new/higher dose AAD of 16%. catheter ablation of persistent AF using a CF sensing or surgical ablation.

In conclusion, Mansour and radiofrequency catheter (Thermocool Smarttouch SF, A total of 381 patients were enrolled colleagues wrote: “The PRECEPT Biosense Webster). in the study between 27 July 2016, and study demonstrated the clinical safety The study was a prospective, multicentre, non6 February 2018, of which 348 had the and effectiveness of PsAF ablation randomised trial, taking place at 27 sites in the USA investigational catheter inserted and using CF-sensing technologies with and Canada, involving patients who had documented comprised the safety population. All protocol-defined effectiveness of 62% symptomatic persistent AF, defined as continuous AF participants in the safety population Moussa Mansour and clinical success of 80%. The PAE sustained beyond seven days but less than one year, and underwent RF ablation. Four participants [primary adverse event] rate was within nonresponsive or intolerant to at least one antiarrhythmic had missing three-month data for safety assessment and the acceptable and expected range and similar to that drug (AAD) (Class I or III). The trial’s primary safety thus were removed from the primary safety endpoint for paroxysmal AF ablation. Comparison with other endpoint was the incidence of primary adverse events analysis. The effectiveness population comprised 333 multicentre studies suggests individualised ablation occurring within seven days of the initial and repeat participants after exclusion of 14 participants who did approach base on patient’s clinical presentation may ablation procedures, and the primary effectiveness not meet inclusion criteria and one participant who was optimise treatment outcome.”

14

May 2020 | Issue 48

Market watch

Product News US FDA approval granted for HeartLight X3 endoscopic ablation system CardioFocus has announced that the US Food and Drug Administration (FDA) has approved the next-generation HeartLight X3 endoscopic ablation system for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF).

Approval of the HeartLight X3 system came as a result of a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients, CardioFocus said in a press release. In this pivotal confirmatory study, the company said, the X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single pulmonary vein.

“The HeartLight X3 System introduces a new level of speed, control and predictability for physicians – making it an ideal tool for AF ablation,” said Vivek Y Reddy, director of Cardiac Electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai (New York, USA). “This is a transformational technology when it comes to AF ablation. Introducing direct visualisation of the pulmonary veins and combining it with the ability to create continuous lesions is compelling.”

“FDA approval of the HeartLight X3 System represents a substantial milestone for CardioFocus and is a promising new treatment option for the millions of Americans suffering from paroxysmal AF,” said Burke T Barrett, chief executive officer at CardioFocus.

“By pairing the most compliant and dynamic balloon technology with the ability to deploy titratable laser energy at unprecedented speed while using direct visualisation, we are able to offer a completely unique ablation technology to cardiac electrophysiologists. With this approval in hand, we will initiate a focused rollout of HeartLight X3 across the USA.”

Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs Medtronic has received US Food and Drug Administration (FDA) approval for its Cobalt and Crome implantable cardioverterdefibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D).

ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest.

CRT-Ds, a treatment option for some individuals with heart failure, send small electrical impulses to the lower chambers of the heart to help them

Medtronic's Crome ICD

beat in more synchronised patterns and reduce patient symptoms.

In a press release, Medtronic said that these were its first “high power” devices to offer connected health, including the ability for clinicians to programme them from a physical distance, thereby reducing potential exposure to the virus that causes COVID-19.

The devices received CE mark approval in January 2020.

Cardiac Insight launches Heart@Home ECG test kit

Cardiac Insight has announced the launch of the Heart@Home electrocardiogram (ECG) test kit to address new telehealth demands placed on cardiology practices by the COVID-19 response.

The kit enables physicians to prescribe the arrhythmia diagnosis technology of the Cardea SOLO Sensor which is shipped directly from Cardiac Insight to the patient’s home, along with instructions. The patient then mails the single-use sensor to the cardiologist’s office in the included shipping envelope after wearing the sensor for the prescribed time period.

Clinicians can retrieve data from the device to inform diagnoses using Cardea SOLO’s smart cable and proprietary algorithm-based ECG software, provided with the purchase of the Heart@Home ECG test kit. The process in the office takes less than five minutes to create a complete ECG report.

Robert Odell, president and chief operating officer of Cardiac Insight, said: “We believe the new Heart@ Home programme further strengthens the physician and patient relationship in a time when trust and privacy is more critical than ever, by fostering direct interactions and removing third-party data analysis vendors from the equation.”

The Cardea SOLO ECG System allows physicians to reduce the diagnostic timeline of patients potentially at risk of Heartlight cardiac arrhythmias Excalibur from weeks to days. balloon These arrhythmias include atrial fibrillation (AF). If left undiagnosed, AF can lead to debilitating stroke, heart failure, and sudden cardiac death.

The Cardea SOLO Heart@ Home ECG Test Kit is currently available for office-based practices and hospital clinics in the USA and is designed to address the needs of electrophysiologists, cardiologists, internal medicine and family medicine physicians.

Philips gains FDA clearance for the use of its ultrasound portfolio to manage COVID-19 cardiac complications

Royal Philips has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related cardiac and lung complications. As a result of this regulatory clearance, Philips can provide detailed, practical guidance to support clinicians using its systems and software for patients affected by COVID-19.

The clearance applies to Philips ultrasound systems including the EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasound systems, and to off-cart solutions like QLAB Advanced Quantification Software.

“Many healthcare providers have

in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation. A prolonged QTc can lead to a potentially fatal side effect of drug-induced sudden cardiac death that is associated with the use of several medicines now being used in the treatment of COVID-19.

AliveCor is a provider of artificial intelligence (AI)-based, personal ECG technology, including KardiaMobile 6L, which it describes in a press release as the world’s only six-lead personal ECG. The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system. Abnormal prolongation of the QTc can stem from congenital long QT syndrome, many disease states, electrolyte abnormalities, and >100 FDA-approved medications that have the potential for unwanted QT prolongation. Patients with a prolonged QTc are at greater risk of the potentially dangerous arrhythmia Torsades de Pointes, which can lead to sudden cardiac arrest and SCD. Several drugs being used off-label to treat COVID-19, such as antidepressants and antibiotics and including hydroxychloroquine and azithromycin, have the potential for unwanted QT prolongation and drug-

Philips ultrasound products can be used for monitoring cardiac health in COVID-19 patients

told us that our handheld and portable ultrasound solutions are playing a valuable role in their efforts to combat COVID-19,” said Bich Le, senior vice president and general manager ultrasound at Philips. “With this regulatory clearance we can offer clear guidance to ensure safe and effective use of ultrasound to manage COVID-19related lung and cardiac complications.

At the same time, we are investing significantly to ramp up production globally, including at our ultrasound manufacturing plants in the US.” The new guidance highlights the specific presets, transducers, quantification tools and other capabilities available on Philips’ ultrasound systems that are relevant in assessing and managing COVID-19related cardiac and lung complications.

For example, the EPIQ CVx premium cardiology ultrasound system includes automated applications for 2D assessment of the heart, as well as robust 3D right ventricle volume and ejection fraction measurements.

KardiaMobile 6L can be used to measure QT duration in COVID-19 patients AliveCor has announced that its KardiaMobile 6L is now allowed for use

induced sudden cardiac death.

In a press release from the company, AliveCor CEO Priya Abani, said: “At AliveCor, we are committed to providing life-saving cardiological services to those who need them most.

The benefits of remote, personal ECG measurements have never been clearer.

We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of COVID-19 during this global health emergency.”

Michael J Ackerman (genetic cardiologist and director of Mayo Clinic’s Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory, Rochester, USA) says in the company statement: “AliveCor’s KardiaMobile 6L technology can play a key role in obtaining the patient’s QTc as a vital sign to help guide the rapid and safe use of these drugs. In addition, the patient’s QTc can be obtained without exposing ECG technicians to affected patients which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of our strained medical resources. We are encouraged by the progress being made by regulatory authorities in allowing us to rapidly respond to the COVID crisis.”

Issue 48 | May 2020

Market watch

Clinical News

Cardiologs' AI platform

AI study launched to monitor cardiac safety of COVID-19 patients receiving hydroxychloroquine

Cardiologs has announced the launch of a clinical study using the company’s artificial intelligence (AI) solution to remotely monitor the cardiac safety of COVID-19 patients during hydroxychloroquine treatment via analysis of electrocardiogram (ECG) data gathered from smartwatches.

The trial will study patients with COVID-19 at the University Hospital of Marseille (France) who are being treated with hydroxychloroquine and azithromycin, a drug combination currently being evaluated as a therapy for the coronavirus (SARS-CoV-2).

These drugs can cause QT prolongation as a side effect.

ECG assessment to monitor the QT interval is the current standard of care to ensure cardiac safety in clinical settings. With COVID-19, monitoring is challenging to implement because of the risk of contamination. It is also highly unlikely that it could be applied as a standard to a large population within a short period of time because of the strain on hospital resources.

“The objective of our study is to evaluate a new method for QT measurement using Cardiologs’ AIbased solution and ECG data collected via smartwatches,” added Jean-Claude Deharo, head of the cardiac arrhythmia department at the University Hospital

of Marseille (France) and the principal investigator of the study. “Smartwatches are already used in the clinical setting but do not have validated QT analysis available. Combining these technologies will enable clinicians to overcome the practical limitations in the context of COVID-19 of the standard cardiac safety strategy that requires heavy patient interaction.”

Each patient in the study will receive a Withings Move ECG Watch linked to Cardiologs’ AI platform, which is already CE marked and US Food and Drug Administration (FDA) cleared for QT interval analysis. Throughout the course of treatment, daily ECG readings will be sent directly from the smartwatch to Cardiologs’ AI platform, where the data will be compared to the gold standard ECG measure.

Fitbit to enrol patients in AF detection study

Fitbit has launched a large-scale, virtual study to validate the use of its wearable technology to identify episodes of irregular heart rhythm suggestive of atrial fibrillation (AF), the Fitbit Heart Study. This study is part of a broader strategy to make easy-to-use tools that accelerate detection of a range of conditions more accessible.

“Until recently, tools for detecting AF had a number of limitations and were only accessible if you visited a doctor,” said Steven Lubitz, principal investigator of the Fitbit Heart Study, cardiologist at Massachusetts General Hospital and Associate Professor of

Fitbit has launced a study of atrial fibrillation

15

Medicine at Harvard Medical School (Boston, USA). “My hope is that advancing research on innovative and accessible technology, like Fitbit devices, will lead to more tools that help improve health outcomes and reduce the impact of AF on a large scale.”

To track heart rate, Fitbit’s devices use photoplethysmography (PPG) technology to measure the rate of blood flow directly from a user’s wrist.

Theoretically, these measurements can be used to determine a user’s heart rhythm, which Fitbit’s algorithm will analyse for irregularities in the study.

Study participants who receive a notification about an irregular heart rhythm will be connected with a doctor for a virtual appointment and may receive an electrocardiogram (ECG) patch in the mail at no cost to confirm the notification.

will ultimately be followed for 12-months post-ablation.

Results of the PULSED AF study suggest that PFA delivers ablation as effective as RF ablation, while providing a safer and more efficient procedure.

Results show acute electrical isolation was achieved in 100% of patients to-date and there were no tamponades, strokes or phrenic nerve injuries. Upon conclusion, the study will report the rate of arrhythmia-free survival at 12 months, and prespecified secondary and ancillary endpoints, including: procedural outcomes, quality of life and arrhythmic symptoms.

The authors of the study point to a future presentation of full, 12-month patient follow-ups results. This trial will be followed by FDA submission for an international, pivotal trial to provide additional clinical data.

Results of PULSED AF trial presented at HRS 2020 Science

Atricure announces publication of CONVERGE IDE trial results

Initial results of the PULSED AF trial, the first-in-human results for paroxysmal or persistent atrial fibrillation (AF) treated with pulsed field ablation (PFA) were presented as part of a late breaking clinical trial session at Heart Rhythm 2020. According to the study’s authors, the trial demonstrates the safety and efficiency benefits of using PFA to target abnormal heart rhythms through pulmonary vein isolation (PVI).

PULSED AF is a non-randomised, prospective, multicentre, global, premarket clinical study performed in Australia, Canada, USA and Europe.

The study evaluates the Medtronic PulseSelectTM system, a PFA system that delivers bipolar, biphasic pulsed electric fields through a circular multielectrode array catheter to perform PVI. “As ablation technology evolves, we saw the opportunity to improve upon the procedure to treat this growing patient population,” said lead author Atul Verma, Southlake Regional Health Center, (Toronto, Canada).

Patients included in the study were undergoing first-time ablation for either paroxysmal or persistent AF (less than one year). The study endpoints include AF recurrence >30 seconds and procedural safety. AF monitoring is being performed by weekly transtelephonic transmission and intermittent Holters at six and 12 months. Patients

AtriCure has announced results from the CONVERGE IDE clinical trial, which showed an 18% difference in favour of the hybrid Convergent procedure as compared to endocardial catheter ablation in the treatment of atrial fibrillation (AF). The results were presented as part of the late-breaking clinical trial session at the Heart Rhythm Society’s (HRS) 2020 Science.

“The CONVERGE study is a monumental step forward in the market focused on the most difficult to treat AF patients, those with persistent or long-standing persistent forms of the disease,” said Michael Carrel, president and chief executive officer at AtriCure.

“This patient population represents many millions of patients and more than two-thirds of all diagnosed Afib patients.

The study results presented at HRS mark a major milestone for the CONVERGE study and we look forward to working with the FDA moving forward.”

The CONVERGE IDE trial’s primary effectiveness endpoint is freedom from AF, atrial tachycardia (AT), and atrial flutter (AFL), absent class I and III anti-arrhythmic drugs (AADs) except for a previously failed or demonstrated intolerance to class I or III AADs, with no increase in dosage following the three-month blanking period through the 12-months post procedure follow-up visit.

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.

2020 12 June

HRS 2020 Science Release Two Virtual

hrsonline.org/HRS2020Science

Heart Rhythm Congress

2021 14–16 January

28 August–1 September

heartrhythmcongress.org

New York, USA

www.escardio.org/Congresses-&-

27–30 September Virtual

14–16 November

AF Symposium 2021 afsymposium.com

29 August–2 September

AHA Scientific Sessions 2020

28–30 March

Virtual

heart.org/professional/

escardio.org/Congresses-&-Events/

EducationMeetings

EHRA-Congress

ESC Congress 2020

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

Dallas, USA

EHRA Congress Barcelona, Spain

ESC Congress 2021 London, UK

Events/ESC-Congress