Heart Rhythm 2019 Highlights

Compilation by Jodie Elrod

Heart Rhythm 2019 Highlights

Compilation by Jodie Elrod

June 2019

New Global Consensus Statement on Catheter Ablation of Ventricular Arrhythmias Presented

The Heart Rhythm Society (HRS) in partnership with the European Heart Rhythm Association (EHRA), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS), issued an international consensus statement reflecting a worldwide updated review of the indications, techniques, and outcomes of catheter ablation of ventricular arrhythmias (VAs). The expert consensus statement was presented at Heart Rhythm 2019, the HRS’s 40th Annual Scientific Sessions.

The EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias, first issued in 2009, outlined recommendations and best practices for the catheter ablation procedure. The 2019 document is a complete and comprehensive update of the 2009 EHRA/HRS statement and is intended to supplement the 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.

"Over the last decade, the field of electrophysiology has undergone rapid progress and the number of ablations performed across the globe has grown significantly," said document chair, Edmond Cronin, MB, BCh, BAO, FHRS, CCDS, CEPS-A, Hartford Hospital. "From new literature and clinical trials to technology innovations and improved understanding of ventricular arrhythmias, our organizations recognized the overdue need for an updated consensus statement to reflect the vast advancements."

The writing group, comprised of 38 experts from international organizations, addresses the important issue of catheter ablation of VAs. The consensus statement uses a unique systematic review designed specifically for the document as part of HRS’s efforts to adopt the rigorous methodology required for guideline development, and was led by an experienced evidenced-based practice committee. Where possible, the recommendations are evidence based with the intention to set reasonable standards that can be applicable worldwide. The group also addresses the need for appropriate physician training and identified patient suitability for the procedure in the clinical setting.

"The purpose of this much-needed document is to serve as an updated resource guide and comprehensive review of the field for clinicians around the world who are working to improve the care of patients undergoing ablation for ventricular arrhythmias," said document vice-chair, Frank Bogun, MD, University of Michigan. "With knowledge gained from this review, we recognize that moving forward, further research is needed to identify optimal methods of arrhythmia suppression and to understand the influencers of each method on arrhythmia outcomes."

The expert consensus statement on catheter ablation of VAs was written in collaboration with and endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Japanese Heart Rhythm Society (JHRS), the Pediatric and Congenital Electrophysiology Society (PACES), and the Sociedade Brasileira de Arritmias Cardíacas (SOBRAC). It was also endorsed by the Canadian Heart Rhythm Society (CHRS).

The final decisions regarding patient care should be made by health care providers and their patients. The organizations also strongly encourage additional patient-centered, prospective, and randomized trials to move the field forward to promote patient health and minimize confounding biases.

The full document (https://bit.ly/30zJnj5) was published in the online edition of HeartRhythm, the official journal of the Heart Rhythm Society; EP Europace, a journal of the European Society of Cardiology; and the Journal of Arrhythmia, the official journal of the Japanese Heart Rhythm Society and the APHRS.

About the Heart Rhythm Society

The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 6,000 heart rhythm professionals in more than 72 countries around the world. For more information, visit www.HRSonline.org.

About the European Heart Rhythm Association

The European Heart Rhythm Association (www.escardio.org/EHRA) is a registered branch of the European Society of Cardiology (ESC). Its aim is to improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reducing sudden cardiac death. EHRA promotes science and education in the field of cardiac arrhythmias with a special focus on AF. Besides patient engagement programs, EHRA organizes scientific and educational events for physicians and allied professionals. In cooperation with other associations and societies, EHRA promotes the quality of care for patients with atrial fibrillation with the publication of international consensus documents.

The Asia Pacific Heart Rhythm Society (www.aphrs.org) is the international organization specializing in science and education for cardiac arrhythmia professionals. For members, the society regularly offers various educational programs at the state-of-the-art laboratories with excellent lectures.

The Latin American Heart Rhythm Society (https://lahrs.org) was founded in 2017 with the aim of continuing the mission started by Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLAECE) more than 20 years ago, promoting the improvement of the quality of life and reducing mortality related to cardiac arrhythmias in the Latin American population.

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HRS Releases New Expert Consensus Statement on Evaluation, Risk Stratification, and Management of Arrhythmogenic Cardiomyopathy

The Heart Rhythm Society released a first-of-its-kind consensus statement with guidance on the evaluation and management of arrhythmogenic cardiomyopathy (ACM), including findings on genetics and disease mechanisms. On May 9, recommendations included in the 2019 HRS Expert Consensus Statement on Evaluation, Risk Stratification, and Management of Arrhythmogenic Cardiomyopathy were presented at Heart Rhythm 2019, the HRS’s 40th Annual Scientific Sessions.

ACM is a type of hereditary cardiovascular disease that is not explained by ischemic, hypertensive, or valvular heart disease. Patients with ACM are predisposed to sudden cardiac death, especially in young patients and athletes. The presentation of ACM is most common between the ages of 10 and 50 years, with the mean age being 30. The main goal of treatment is the prevention of sudden cardiac death, and an ICD can be a lifesaving therapy option.

The consensus statement defines the broader condition of ACM that incorporates a spectrum of genetic, systematic, infectious, and inflammatory disorders. The designation includes, but is not limited to, arrhythmogenic right/left ventricular cardiomyopathy, ion channel abnormalities, amyloidosis, and left ventricular noncompaction.

"The diagnosis and management of ACM is constantly evolving, and much of that is because of the uncertainty related to various genes. This is intended to serve as one central reference point for the management of any arrhythmogenic cardiomyopathy including therapy options and genetic testing," said document chair, Jeffrey A. Towbin, MS, MD, Le Bonheur Children's Hospital. "We hope that our guidelines will make decisions easier for clinicians and ensure that we are delivering optimal patient care by providing the first-ever set of comprehensive recommendations."

The authors highlight the following key points:

ACM is an inclusive designation referring to an arrhythmogenic disorder of the myocardium characterized by a clinical presentation with documented and/or symptomatic arrhythmia as a distinguishing feature.
Genetic testing is indicated for all disease-associated genes and variants in patients and decedents.
Genetic counseling with a comprehensive three-generation family history should be performed.
Clinical evaluation including electrocardiogram, cardiac imaging, and ambulatory monitoring is recommended for first-degree relatives every 1-3 years beginning at 10-12 years of age. Recommendations for ICD placement for primary and secondary prevention of sudden death are provided.
A shared decision-making approach to ICD placement should be used.
Beta-blocker therapy should be used for sinus tachycardia, supraventricular arrhythmias, atrial fibrillation or atrial flutter with ventricular rates resulting in ICD therapy.
Recommendations for limitation of exercise in patients with a clinical diagnosis of arrhythmogenic right ventricular cardiomyopathy (ARVC) and patients with positive genetic testing for ARVC without phenotypic expression are provided.
Recommendations for pacemaker and ICD placement in patients with cardiac amyloid are provided.
Recommendations for ICD placement and anticoagulation in patients with left ventricular noncompaction are provided.

The members of the expert writing group utilized Population, Intervention, Comparison, Outcome (PICO) questions to evaluate contemporary evidence and provide clinical guidance related to exercise in ARVC. The writing committee also used a systematic literature search with evidence tables. Recommendations were endorsed by the writing group using the Class of Recommendation (COR) and Level of Evidence (LOE) system formulated by the American College of Cardiology (ACC) and the American Heart Association (AHA).

"Moving forward, we need to focus on new approaches to better understand the mechanisms responsible for the development and progression of the disease. Then novel treatment options can potentially be designed and tested," said document vice-chair, William J. McKenna, MD, DSc, University College London, Institute of Cardiovascular Science. "In addition, gene editing could provide new therapies, as could regeneration medicine. It is key for this future research to include the full array of disorders categorized under the umbrella of arrhythmogenic cardiomyopathy."

The expert consensus statement was written in collaboration with the ACC, the AHA, the Asia Pacific Heart Rhythm Society (APHRS), the American Society of Echocardiography (ASE), the European Heart Rhythm Association (EHRA), the Heart Failure Society of America (HFSA), the International Society for Heart & Lung Transplantation (ISHLT), the Japanese Heart Rhythm Society (JHRS), the Latin American Heart Rhythm Society (LAHRS), the National Society of Genetic Counselors (NSGC), the Pediatric & Congenital Electrophysiology Society (PACES), and the Sociedade Brasileira de Arritmias Cardíacas (SOBRAC).

The full document (https://bit.ly/2W0elkU) was also published in the online edition of HeartRhythm, the official journal of the Heart Rhythm Society.

About the Heart Rhythm Society

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Clinical Trial Shows Non-Invasive, Self-Administered Ear-Clip Therapy Suppresses AF

A randomized clinical trial effectively uses nerve stimulation through an ear clip to reduce atrial fibrillation (AF) burden and showcases an emerging noninvasive treatment option for patients. The trial is the first to examine the effect of transcutaneous electrical vagus nerve stimulation on suppressing AF. The results of the TREAT AF clinical trial were presented at Heart Rhythm 2019.

Device vagus nerve stimulation has been successfully implemented to treat epilepsy and is a treatment option approved by the U.S. FDA. Approximately one-third of people do not respond fully to anti-seizure drugs, and nerve stimulation has become an option for these patients.¹ This clinical trial sought to better understand if this treatment option could work for patients suffering from AF.

The TREAT AF trial is a sham-controlled, double-blind, randomized clinical trial designed to examine the effect of low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus (LLTS) on AF burden over a six-month period. LLTS was delivered using an ear clip attached to either tragus (active; n=26) or the ear lobe (sham; n=27). The patients received individual training and used the device for one hour every day for six months. AF burden over two-week periods was assessed by noninvasive continuous ECG monitoring at baseline, three, and six months, and heart rate variability based on five-minute ECG readings and serum cytokines were measured at the respective time points. Baseline characteristics including age, gender, and stroke risk were similar between the two groups.

Adherence to the stimulation protocol was 75 percent in the active arm and 83 percent in the sham arm. At six months, the median AF burden was reduced by 85 percent in the active arm compared to the sham. After combining across the three- and six-month time points, the median AF burden was reduced by 75 percent in the active arm compared to the sham arm.

"Our clinical trial introduces a novel self-administered, non-invasive therapy for patients newly diagnosed with AF. There are cases when drug therapy or surgery are not the optimal options, so this has the potential to serve as another approach for patients," said lead author Stavros Stavrakis, MD, PhD, University of Oklahoma Health Sciences Center. "It was encouraging to see the significant reduction in AF burden and that the device was well received in terms of adherence rate. This approach opens the door to a new way of thinking about AF management and showcases that we can push boundaries to help advance patient care."

The authors of this study call for trials in a multicenter setting with larger populations. Through additional research, the authors also hope to pinpoint exactly which patients would benefit the most from this therapy approach.

Epilepsy Foundation. "Vagus Nerve Stimulation." Epilepsy.com. Available at: https://bit.ly/2Qgc0Nx

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Medtronic Reveals Results of First-In-Human Study for Investigational Extravascular ICD System

Medtronic plc announced findings from a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver lifesaving defibrillation and anti-tachycardia pacing therapy in one system, with a device the same size as traditional, transvenous ICDs. Results from the pilot study were presented during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

The Extravascular ICD pilot study, which represents the first-in-human chronic use of the investigational, first-generation system, showed that the new system can be implanted with no major complications, and can sense, pace and defibrillate the heart. The EV ICD system is investigational worldwide and not approved for sale or distribution.

"I am very encouraged by our pilot experience using the Medtronic EV ICD system in patients out to three months," said Ian Crozier, MD, Department of Cardiology, Christchurch Hospital, and principal investigator (PI) in the pilot study. "This small but important study affirms the potential of this new extravascular approach to provide pacing and lifesaving defibrillation therapy without the risks that accompany transvenous leads implanted inside the heart and veins."

In the pilot study, 21 patients underwent the EV ICD implant procedure at four sites in New Zealand and Australia. Patients were evaluated at implant, two weeks, four to six weeks, and three months after device implant, and continue to be followed. Study investigators characterized the safety of the system and implant procedure, defibrillation effectiveness, and sensing and pacing:

At the time of implant, defibrillation testing was completed on 19 patients. The system successfully terminated induced ventricular arrhythmias in 17 patients (89.5 percent), which is consistent with prior clinical studies of existing ICDs.^1,2
Pacing capture was achieved in more than 95 percent of study patients.
One patient experienced ventricular tachycardia outside the hospital setting, which was successfully detected and treated by the EV ICD system.

"The successful pilot study revealed valuable insights to inform our EV ICD clinical program, and we are eager to incorporate the learnings from this study into a pivotal trial," said Rob Kowal, MD, PhD, vice president and chief medical officer of the Cardiac Rhythm and Heart Failure division at Medtronic.

The Medtronic EV ICD system is intended to provide the benefits of traditional, transvenous ICDs including lifesaving defibrillation therapy; anti-tachycardia pacing to terminate arrhythmias; post-shock pacing to protect from sudden cardiac death; and temporary, back-up, bradycardia pacing to address abnormally slow heart rates. It is the same size (33 cc) and shape, and is expected to have similar longevity as traditional ICDs, but without any leads in the veins or heart. The EV ICD device is implanted in the left mid-axillary region below the left armpit, and the lead is placed under the sternum. New procedure tools guide the delivery of the system.

Medtronic research teams developed the EV ICD System and have completed multiple early research and acute feasibility studies, including the ASD³ (Acute Sensing and Defibrillation), SPACE⁴ (Substernal Pacing Acute Clinical Evaluation), and ASD2⁵ studies. The current EV ICD pilot study continues to generate long-term data on this first-in-human experience.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies — alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Blatt JA, Poole JE, Johnson GW, et al. No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2008 Aug 12;52(7):551-6.
Neuzner J, Hohnloser SH, Kutyifa V, et al. Effectiveness of single- vs. dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study. J Cardiovasc Electrophysiol. 2019 Apr 4.
Chan JYS, Lelakowski J, Murgatroyd FD, et al. Novel Extravascular Defibrillation Configuration With a Coil in the Substernal Space: The ASD Clinical Study. J Am Coll Cardiol EP. 2017;3:905-10.
Sholevar DP, Tung S, Kuriachan V, et al. Feasibility of extravascular pacing with a novel substernal electrode configuration: The Substernal Pacing Acute Clinical Evaluation Study. Heart Rhythm. Published online 29 Nov 2017.
Boersma LVA. Feasibility of Extravascular Pacing, Sensing And Defibrillation From A Novel Substernal Lead: The Acute Extravascular Defibrillation, Pacing And Electrogram (ASD2) Study. Presented Heart Rhythm Society Scientific Sessions, May 11, 2018.

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Late-Breaking Trial Data Highlight Continued Clinical Success of Boston Scientific EMBLEM^™ S-ICD System

Boston Scientific announced acute results from the UNTOUCHED study evaluating safety and efficacy of the EMBLEM^™ Subcutaneous Implantable Defibrillator (S-ICD) System for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35%, the most common population to be indicated for ICD therapy.The data were presented during a late-breaking clinical trial at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions, and demonstrated S-ICD therapy had a complication-free rate of 95.8% at 30 days post-procedure and high conversion efficacy (99.2%) of induced ventricular fibrillation, rates comparable to those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies. The analysis was also published online in HeartRhythm.

The UNTOUCHED study authors also reviewed procedure techniques and 30-day outcomes in patients implanted with the EMBLEM S-ICD System and found that the majority (69%) of procedures were performed using a two-incision technique. The two-incision technique data demonstrated a mean implant time of 55.8 minutes, which was 8 minutes faster than the mean 63.8 minutes for procedures that leveraged a three-incision implant technique, with comparable complication and conversion success rates.

"We found that the complication rate within this primary prevention population was as low as in prior S-ICD registries, despite the patients having much lower LVEF, more hypertension, and diabetes — underscoring that sicker patients do well with this device for the prevention of sudden death," said Lucas V.A. Boersma, MD, PhD, study principal investigator and electrophysiologist at St. Antonius Hospital. "These acute outcomes also validate the advantages of the two-incision implant technique, which has continued to gain worldwide adoption in the last few years."

The global, prospective, non-randomized study evaluated data from 1,116 patients with a low LVEF, the majority of whom (54%) had ischemic heart disease.

"The data presented reiterate the value of the EMBLEM S-ICD System for a broad group of ICD-indicated patients, enabling them to avoid the long-term complications associated with TV-ICD leads," said Kenneth Stein, MD, senior vice president and chief medical officer, Global Health Policy and Rhythm Management, Boston Scientific.

The final results of the UNTOUCHED study, including an analysis comparing inappropriate shock rates of the S-ICD to rates found in previous TV-ICD studies, will be reported after 18 months of patient follow-up.

For more information on the EMBLEM S-ICD System, visit www.sicdsystem.com.

About Boston Scientific

Boston Scientific (www.bostonscientific.com) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

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Duration of External ECG Monitoring is Critical to Detecting AF

Preventice Solutions announced the presentation of data showing the critical impact the length of the monitoring period has when using ambulatory remote ECG monitoring to detect AF. While the Preventice BodyGuardian^® Remote Monitoring System has the capability and reimbursement to support patient monitoring for up to one month, it is common practice with many currently available monitoring technologies to limit the monitoring period to one to two weeks. This truncated duration of monitoring is associated with "missed" AF in more than 10 percent of patients, many of whom have greater than one hour of AF. The data was presented Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions, by Suneet Mittal, MD, FHRS from The Valley Hospital, and Pooja Mehta and Michael McRoberts from the Preventice data science team.

"In the case of AF, data on the appropriate use of monitoring technologies, including the prescription of a sufficient monitoring period out to a full 28 days, is an important consideration," said Dr. Mittal. "Medicine is moving away from the transactional approach, which involves the doctor only thinking about the patient when the patient is in the clinic. Remote monitoring is changing that paradigm because there is physiologic data that can be captured between visits and used to inform clinical decisions that will optimize care. With AF, there are different patient populations. It is critical to ensure the monitoring technology is fully leveraged to make an appropriate diagnosis and gauge the burden on the patient, which informs our treatment approach."

The study was a retrospective analysis designed to compare the incremental yield of AF detection when ambulatory remote ECG monitoring is extended from 14 to 28 days. In the study, data was evaluated from 25,457 randomly selected patients who had undergone monitoring with the BodyGuardian^®Remote Monitoring System. The results show at least one AF episode was present for 4,033 patients (15.8 percent) during the 28-day monitoring period. Of those who had AF, 424 patients (10.5 percent) would have been missed if the monitoring period had been truncated at 14 days. From those 424 patients, 352 (or 8.7 percent of the 4,033 patients with AF) had AF for greater than 1 hour, and 181 (or 4.5 percent of the 4,033 patients with AF) had AF for greater than 6 hours.

"We have developed the BodyGuardian^® Remote Monitoring System to address the critical needs of patients and physicians. We continue to understand, advance, and validate the system based on clinical data," said Jon Otterstatter, Chief Executive Officer, Preventice Solutions. "This study shows the importance of leveraging full capabilities of the technology that can lead to complete actionable data and achieve the best outcomes for patients."

Dr. Mittal has received no compensation from Preventice for his involvement in this project.

About the BodyGuardian^® Remote Monitoring System

BodyGuardian Heart is a small, lightweight, wireless monitor in the BodyGuardian family of monitors. It records important physiological data such as heart rate, ECG, respiratory rate, and related activity. Through Bluetooth^®, the smartphone can also capture additional physiological measurements such as blood-oxygen, glucose levels, blood pressure, and weight, anytime, anywhere. The system creates a virtual connection between patients and their care teams, allowing physicians to monitor vital signs outside the clinical setting.

The BodyGuardian^® Remote Monitoring System includes integration of the BodyGuardian family of monitors and additional third-party sensors, the BodyGuardian Connect smartphone patient application and the PatientCare Platform. The system utilizes machine learning to remotely recognize AF and integrate data into the electronic health record. Patients wear cardiac monitors, which feed real-time data into the cloud-based health platform that physicians can access. Growing clinical use resulting from increased incidence of cardiac disease and a rising aging population forces a greater reliance on algorithms in order to provide high-quality reporting in a timely manner. These factors are amplified in the case of mobile cardiac telemetry (MCT), where ECG is streamed directly to data processing centers, annotated, and may be used to quickly alert clinicians of potentially critical cardiac events.

About Preventice Solutions

Preventice Solutions (www.preventicesolutions.com) is a leading developer of mobile health solutions and remote monitoring services that connect patients threatened by cardiac arrhythmias with their care team. Using insights to create revolutionary monitoring technologies, this tech-enabled, service-based approach can ultimately reduce the cost of care and improve health outcomes. The Preventice wearable portfolio includes the PatientCare Platform and BodyGuardian family of monitors.