Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions, took place May 10-12th in Chicago, Illinois. Below is a sampling of just a few of the clinical news highlights from the conference.
New Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation Presented at Heart Rhythm 2017
The Heart Rhythm Society (HRS), in joint partnership with the European Heart Rhythm Association (EHRA), European Cardiac Arrhythmia Society (ECAS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLAECE), issued an international consensus statement that provides a state-of-the-art review of the indications, techniques, and outcomes of catheter and surgical ablation of atrial fibrillation (AF). The 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, first issued in 2007, and again in 2012, represents a state-of-the art review of the field of catheter and surgical ablation of AF. This document is a complete and comprehensive revision of the 2012 statement and was presented at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions.
“The rate of advancement in the tools, techniques, and outcomes of AF ablation continues to increase at a rapid pace. Our writing group worked together to revise the current recommendations to address the medical advancements that have really evolved over the last five years,” said Hugh Calkins, MD, FHRS, CCDS, past president of HRS, Nicholas J. Fortuin MD Professor of Cardiology, and Director of the Electrophysiology Laboratory and Arrhythmia Service at the Johns Hopkins Hospital. “It is our hope that this document can help improve patient care by providing a foundation for everyone involved in the care of AF patients including clinicians who perform catheter or surgical ablations.”
For the first time, the writing group, comprised of 60 experts from international organizations, addresses the important issue of catheter ablation of AF in select asymptomatic patients. The group also addresses the important issues of AF ablation as first-line therapy, the role of AF ablation in patients with heart failure, anticoagulation recommendations for patients undergoing ablation therapy, and the role of AF ablation in subgroups of patients not well represented in clinical trials. Recommendations pertinent to the design of clinical trials in the field of AF ablation and the reporting of outcomes, including relevant definitions, are also covered.
Specifically, the document includes detailed findings within the following topic areas:
- Definitions, Mechanisms, and Rationale for AF Ablation
- Modifiable Risk Factors for AF and Impact on Ablation
- Strategies, Techniques, Endpoints
- Technology and Tools
- Technical Aspects of Ablation to Maximize Safety and Anticoagulation
- Follow-up Considerations
- Outcomes and Efficacy
- Training Requirements
- Surgical and Hybrid AF Ablation
- Clinical Trial Design
The expert consensus statement was written in collaboration with 11 organizations including the HRS, EHRA, European Cardiac Arrhythmia Society (ECAS), APHRS, SOLAECE, Society of Thoracic Surgeons (STS), American College of Cardiology (ACC), American Heart Association (AHA), Canadian Heart Rhythm Society (CHRS), Japanese Heart Rhythm Society (JHRS), and Sociedade Brasileira de Arritmias Cardíacas (SOBRAC).
The final decision regarding care of a patient should be made by health care providers and their patient in light of all the circumstances presented by the patient. It is recognized that this field continues to evolve rapidly, and ongoing research will be needed.
The document was also published in the online edition of HeartRhythm, the official journal of the Heart Rhythm Society.
Heart Rhythm 2017 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe. For more information, visit www.hrssessions.org.
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 5,900 heart rhythm professionals in more than 70 countries around the world. For more information, visit www.HRSonline.org.
New Study Identifies Biomarker That May Indicate Risk of Atrial Fibrillation
Researchers have identified a microRNA biomarker that demonstrates a strong association with the incidence of atrial fibrillation (AF).
The researchers from the Intermountain Medical Center Heart Institute in Salt Lake City have been seeking microRNA biomarkers to guide the diagnosis and potential treatment of troublesome heart conditions, including AF and heart failure.
For the study, the researchers sought biomarkers that could specifically predict the occurrence and severity of AF, said the study’s lead author, Oxana Galenko, PhD, clinical research senior scientist in cardiovascular research at Intermountain Medical Center Heart Institute.
“We wanted to generate specific profiles of the molecules and see if they could be used to distinguish between the risk of atrial fibrillation in different groups of patients,” Galenko said.
The research team identified microRNAs, small, stable, noncoding RNA molecules that negatively control gene expression at a stage called the post-transcriptional level. These markers could potentially indicate which AF patients are most likely to benefit from ablation.
Researchers presented results of the study at Heart Rhythm 2017.
“From the research, we knew certain markers that were cited mostly for heart failure patients, so we knew which microRNAs we were going to look at, because we’ve looked at them before,” said Victoria Jacobs, NP, PhD, a member of the research team.
AF has four subtypes, with two most common: paroxysmal AF is episodic, while persistent AF lasts and has different degrees of severity. The researchers hoped to identify specific microRNAs involved in AF, with an eye toward using them to discriminate between the two subtypes.
The Intermountain Medical Center Heart Institute maintains an extensive bio bank that contains a large amount of biological and medical data that’s collected by taking a small amount of blood from consenting patients, then banking those samples for future research.
For the study, researchers used very small amounts of plasma from the bio bank. Because microRNAs are so small and stable, they can be detected in circulating biological fluids like saliva and blood.
The researchers examined samples from 140 AF patients — 93 paroxysmal and 47 persistent — and 50 people with no identified heart disease who served as a control group.
Researchers then examined several miRs that had been associated with AF, including 21, 291, 133a, 133b, 150 and 328. They were able to narrow it to miR 21.
Researchers looked specifically at the concentration of microRNAs in the patients’ circulating blood and found that risk of AF increased as levels of miR 21 decreased. While having low levels of the microRNA appears to be strongly associated with the development of atrial fibrillation, it wasn’t associated with any differences between paroxysmal and persistent AF.
The researchers believe that means the mechanism of how the disease occurs and its progression are different. In future studies, they hope to find out what initiates the disease.
“As atrial fibrillation progresses, we know there’s more fibrosis in the left atrium,” said Dr. Jacobs. “We have theories of what causes the harmful fibrosis, including which pathways are activated to causes fibrosis. But we really don’t know the cause yet. It’s unclear if the microRNA carries the signals then it progresses to fibrosis or vice versa.”
Other researchers involved in the study include Madisyn Taylor; Matt Grover; Stacey Knight, PhD; Michael Cutler, DO, PhD; Brent Muhlstein, MD; John Carlquist, PhD; Kirk Knowlton, MD; and Jared Bunch, MD.
The Intermountain Medical Center Heart Institute is part of the Intermountain Healthcare system.
Boston Scientific S-ICD System Demonstrates Positive Clinical Outcomes in the Largest Prospective Study of ‘Real-World’ Patients
Boston Scientific announced results from the U.S. post-market approval study evaluating ‘real-world’ patients implanted with the Subcutaneous Implantable Defibrillator (S-ICD) System, the largest S-ICD study to date. Data collected from the study were presented during a late-breaking clinical trial at Heart Rhythm 2017, and demonstrated that physicians are implanting the S-ICD System largely for patients typically treated with transvenous implantable cardioverter defibrillators (TV-ICD) as well as for sicker patients while achieving a high success rate and low complication rate.
Acute results demonstrate the therapy effectively terminated life-threatening heart arrhythmias in 98.7 percent of evaluated patients. The S-ICD System analysis also validated low complication rates, with a complication-free rate of 96.2 percent at 30 days post-procedure.
“The ‘real-world’ population enrolled in the largest S-ICD study to date demonstrates that the device has low complication rates and very high success rates for terminating ventricular fibrillation, thereby serving as an alternative treatment to transvenous ICDs,” said Michael R. Gold, MD, PhD, U.S. principal investigator and Michael E. Assey professor of medicine at The Medical University of South Carolina, Charleston. “The population studied here is more similar to transvenous ICD populations compared to previous S-ICD studies, reinforcing this device can be used in a broad population of ICD-indicated patients.”
The non-randomized registry, initiated in 2012 after the S-ICD System received U.S. FDA approval, included 1,637 patients implanted with the device at 86 U.S. medical centers. Nearly two-thirds of the patients evaluated in the study were primary prevention patients with a low ejection fraction, which represents the highest proportion of patients that are implanted with ICD devices. Additionally, more than half of the patients had comorbidities such as heart failure and hypertension, and more than 13 percent were on dialysis for end-stage renal disease.
“Beyond the positive clinical outcomes, we are also seeing advancements in procedural techniques as physician experience and confidence continue to build,” said Kenneth Stein, MD, senior vice president and chief medical officer, Global Health Policy and Rhythm Management, Boston Scientific. “Physicians are implanting over half of the devices with two surgical incisions rather than the standard three incisions and avoiding use of general anesthesia in more than one-third of patients.”
To further develop the clinical body of evidence in support of the S-ICD System, Boston Scientific initiated a worldwide study called the Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD) last month. The study will evaluate the survival benefit of patients treated with the EMBLEM™ MRI S-ICD System — the latest generation S-ICD system — who are aged 65 and older with a history of prior heart attack, diabetes and moderately reduced left ventricular ejection fraction.
For more information on the EMBLEM MRI S-ICD System, visit www.sicdsystem.com.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 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. For more information, visit www.bostonscientific.com.
First-in-Human Study Shows Investigational Multi-Electrode Radiofrequency Balloon Catheter Is Efficient for Acute Pulmonary Vein Isolation
Biosense Webster, Inc., part of the Johnson & Johnson Medical Devices Companies*, recently announced clinical trial results from a first-in-human study evaluating the acute feasibility of an investigational radiofrequency (RF) balloon catheter in treating patients with atrial fibrillation (AF). The study showed the RF balloon catheter could uniformly achieve pulmonary vein isolation (PVI) in all patients without the need for “touch-up” with a focal ablation catheter.
The PV Isolation with a Novel Multi-electrode Radiofrequency Balloon Catheter that Allows Directionally-Tailored Energy Delivery (RADIANCE) study was a multicenter, single-arm, first-in-human feasibility study conducted between December 2, 2016 and March 8, 2017 in Europe. A total of 39 patients were treated with the RF balloon catheter at four centers with nine different operators from both the U.S. and Europe.
The study showed the RF balloon catheter could deliver directionally-tailored energy using multiple electrodes for efficient acute PVI in patients with paroxysmal AF.
“Existing balloon catheters are limited in a number of ways, the most significant limitation being a single ablative element that delivers identical amounts of energy along the full pulmonary vein ostium circumference,” said Dr. Vivek Y. Reddy, director of Cardiac Arrhythmia Services for the Mount Sinai Hospital and the Mount Sinai Health System and study investigator. “This can lead to over-ablation of thin tissue, under-ablation of thick tissue, and unnecessary complications. The investigational RF balloon is designed to both optimize safety and efficacy and reduce procedure time.”
Data from the RADIANCE study was presented for the first time during a late-breaking clinical trial session at Heart Rhythm 2017.
“Alarmingly, AF increases a patient’s risk of stroke by five times, but millions of patients go untreated year after year,” said Shlomi Nachman, Company Group Chairman of Cardiovascular and Specialty Solutions at Johnson & Johnson. “This latest innovation comes from our obsession with solving the everyday challenges our customers face, so more patients can be treated. We’re thrilled with the results from this first-in-human study and will continue studying the RF balloon catheter’s safety and efficacy.”
About the RADIANCE Study
Paroxysmal AF patients were treated with an investigational Biosense Webster, Inc. RF balloon catheter with 10 irrigated, flexible gold surface electrodes intended to independently deliver varying amount of power. Patients underwent pulmonary vein isolation where RF energy was delivered simultaneously from all electrodes — up to 30 seconds posteriorly and 60 seconds anteriorly.
The primary endpoint was the incidence of primary procedure-related adverse events occurring within seven days of the procedure. Of note, any pulmonary vein stenosis, unresolved diaphragmatic paralysis or atrio-esophageal fistula that occurred also were analyzed as primary adverse events regardless of timing. Secondary endpoints included serious adverse events occurring over the course of the study and the effectiveness of electrical pulmonary vein isolation despite provocative pharmacological challenge.
In addition, the study included:
- Pre-procedure (baseline) testing included: a 12-lead electrocardiogram (ECG), transthoracic echocardiogram, cardiac computed tomography (CT) or magnetic resonance imaging (MRI), a cerebral MRI, and a neurological exam with administration of the NIH Stroke Scale.
- Repetition of the 12-lead ECG, transthoracic echocardiogram, cerebral MRI and the neurological exam with the NIH Stroke Scale post-procedure (prior to hospital discharge).
- Post-procedure: esophageal endoscopy of all patients to assess for any evidence of thermal esophageal damage.
Results showed the RF balloon catheter was able to achieve electrical isolation of all pulmonary veins with a high rate of first-pass isolation and low evidence of latent pulmonary vein re-conduction. The procedural performance with the device was favorable, with 100 percent of the treated pulmonary veins electrically isolated without the need for a focal ablation catheter.
About Biosense Webster, Inc.
Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is the global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. More information can be found at www.biosensewebster.com.
*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
Medtronic Study Finds High Use of App-Based Remote Cardiac Monitoring Among Older Patients
A new Medtronic plc study shows a high use of app-based remote cardiac monitoring among older patients. Presented at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions, the first-of-its-kind study evaluated 15,595 patients across 1,969 clinics with Medtronic pacemakers who were assigned a MyCareLink Smart™ app-based remote monitor.
The study found that 88.4 percent of patients of all ages who were prescribed this new technology used their smart devices to successfully activate their MyCareLink Smart mobile app, and 89.7 percent remained “adherent” by transmitting data to the Medtronic CareLink™ Network within 12 months, the minimum frequency recommended by the HRS and European Heart Rhythm Association expert consensus.
Age was not a clinically significant factor in activating or adhering the app-based monitoring at 12 months, with 89.4 percent of patients aged 71 and older using the app to transmit data, compared to 86.7 percent of patients 18-50 and 91 percent for those 51-70.
“There is often a misperception that older patients aren’t adapting to newer technologies, but this study shows that is not the case,” Khaldoun Tarakji, MD, MPH, electrophysiologist and director of clinical electrophysiology research at the Cleveland Clinic, who led the study. “Hundreds of thousands of pacemakers are implanted every year in the United States, and the majority of them in patients over 65 years of age. Physicians should discuss the importance of remote monitoring with patients, regardless of their age.” Dr. Tarakji has received compensation from Medtronic as an invited speaker and educator and is a scientific advisory board member.
Approved by the U.S. Food and Drug Administration (FDA) in November 2015, the MyCareLink Smart patient monitor is the world’s first app-based remote monitoring system for patients with implantable cardiac devices. With the MyCareLink Smart monitor, patients can use their own smartphone or tablet technology, with cellular or Wi-Fi service, to securely transmit data from their cardiac device to their physicians, who can then interpret the data to make treatment decisions.
By connecting patients and physicians, remote cardiac monitoring provides many clinical and economic benefits. These include faster time to treatment if the physician detects a problem with the pacemaker based on the transmitted data;1 less time spent at a doctor’s office or clinic for regular checks of the pacemaker;2,3 reduced time spent in the hospital if the physician quickly detects and treats a medical problem;1,4 and a potential increase in patient survival rates.4-6
“The MyCareLink Smart Monitor was designed to provide seamless compatibility with devices that patients use every day,” said Aisha Barry, vice president and general manager for the Connectivity & Insights business, which is part of the Cardiac and Vascular Group at Medtronic. “We are encouraged this study shows such a high rate of patient use of remote monitoring with our app-based offering, particularly among our older pacemaker patients.”
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.
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 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. ■
- Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol. 2011;57:1181-1189.
- Cronin EM, Ching EA, Varma N, Martin DO, Wilkoff BL, Lindsay BD. Remote monitoring of cardiovascular devices: a time and activity analysis. Heart Rhythm. 2012;9:1947-1951.
- Varma N. Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study. Am Heart J. 2007;154:1029-1034.
- Akar J, et al. LB03-03 Presented at HRS 2014.
- Saxon LA, Hayes DL, Gilliam FR, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. 2010;122:2359-2367.
- Mittal S, et al. LB01-05 Presented at HRS 2014.
Ablation for Atrial Fibrillation Proven Safe and Effective for Patients with Congenital Heart Disease, Penn Study Finds
Congenital heart disease (CHD) includes a range of defects that occur in the heart which patients are born with, such as a hole in the heart’s wall, a leaky valve or even an inversion in the heart’s orientation. CHD was once a severe condition often resulting in early death, but now, more and more CHD patients are living long and healthy lives. Therefore, as this population grows, so does the number of patients who are treated for other complications of their disease, such as early-onset atrial fibrillation (AF), a quivering or irregular heartbeat that can lead to blood clots, stroke, heart failure and other complications. AF is often treated with a catheter ablation, a minimally invasive procedure in which the areas of the heart causing the irregularity are cauterized, but until now, there was limited data to support the safety and efficacy of treating CHD patients with an AF ablation.
In a new study presented at the Heart Rhythm Society’s 38th Annual Scientific Session in Chicago, researchers from the Perelman School of Medicine at the University of Pennsylvania have found that CHD patients — even with complex defects — can safely undergo ablation for AF, with similar success rates as patients with normal hearts.
“Treatment for atrial fibrillation is critical, whether the patient has a normal heart or whether they have complex congenital heart disease,” said the study’s presenter Jackson J. Liang, DO, a third-year cardiovascular disease fellow in the Perelman School of Medicine at the University of Pennsylvania. “In fact, atrial fibrillation can be especially detrimental in patients with complex congenital heart disease since they may be more reliant on the “atrial kick” provided during sinus rhythm. Unfortunately for some CHD patients, AF ablation may be more challenging due to the presence of complex anatomy, and the optimal ablation strategy for these patients remains to be defined.”
In this multicenter study, researchers performed a retrospective analysis of 69 CHD patients who underwent AF ablation, by collecting data from Penn, University of Colorado, University of California San Francisco, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. Researchers looked at those who underwent AF ablation for paroxysmal (intermittent) or persistent AF between 2008 and 2016. They identified the type of CHD, and tracked the ablation strategy — pulmonary vein isolation (PVI), PVI with additional ablation, or non-PV ablation only.
“Some physicians may not be aware that catheter ablation can be performed to treat atrial fibrillation in patients with congenital heart disease, and instead they may prescribe anti-arrhythmic medications,” said David Frankel, MD, an assistant professor of Cardiovascular Medicine at Penn. “We hope this study will increase awareness of catheter ablation as a viable treatment option for atrial fibrillation in these patients.”
Of the 69 patients, 34 had paroxysmal AF and 25 had complex CHD. The team defined complete success as freedom from recurrent AF for one year off antiarrhythmic medications, and partial success as freedom from AF recurrences for one year on previously ineffective antiarrhythmic medications. At one year, researchers concluded that 53 percent of the patients had complete success with an additional 13 percent experiencing partial success. 92 percent of patients underwent a PVI approach, while seven percent had a non-PVI ablation alone.
“We also found that 12 patients needed a repeat ablation within the first year, but most notably, there were no major procedural complications identified and only five minor complications, which is on par with rates in non-CHD patients,” said Liang. “While PVI should remain the cornerstone of ablation, an individualized approach utilizing pre-procedural imaging to help to define the anatomy is necessary to improve outcomes in patients with CHD.”
Researchers conclude that AF ablation in this complex population was safe and effective, with similar outcomes to those seen in non-CHD patients, despite anatomical differences. However, they noted that more research is needed to further define the challenges and optimal ablation strategies in CHD patients.
Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System, which together form a $6.7 billion enterprise.
The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 20 years, according to U.S. News & World Report’s survey of research-oriented medical schools. The School is consistently among the nation’s top recipients of funding from the National Institutes of Health, with $392 million awarded in the 2016 fiscal year.
The University of Pennsylvania Health System’s patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center — which are recognized as one of the nation’s top “Honor Roll” hospitals by U.S. News & World Report — Chester County Hospital; Lancaster General Health; Penn Wissahickon Hospice; and Pennsylvania Hospital — the nation’s first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine.
Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2016, Penn Medicine provided $393 million to benefit our community.