Studies Presented at Heart Rhythm 2014 Demonstrate Accuracy of the AliveCor® Heart Monitor and Confirm Patient Satisfaction
AliveCor, Inc. announced that studies presented at Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco, expand the growing body of clinical information evaluating the use of the AliveCor® Heart Monitor.
Three abstracts on the use of the AliveCor Heart Monitor were presented during the conference and continue to reinforce the benefits of using wireless mobile ECG devices.
The iTransmit Study, “Evaluating the Efficacy and Feasibility of a Novel Wireless Recording System Using Smartphone in Monitoring Patients After Atrial Fibrillation Ablation Procedure,” was led and presented by Dr. Khaldoun G. Tarakji of Cleveland Clinic. Dr. Tarakji and his team reported that the AliveCor Heart Monitor had 100% sensitivity and 95% specificity at detecting atrial fibrillation (AF) after an ablation procedure compared to a standard transtelephonic event monitor. The study was conducted with 38 patients with diagnosed AF undergoing pulmonary vein isolation.
Another study with pediatric cardiology patients, the SPEAR TRIAL, “Smartphone Pediatric Electrocardiogram Trial,” was presented by Dr. Hoang Nguyen with Senior Author Dr. Jennifer Silva from Washington University in St. Louis, MO. This prospective trial evaluated the use of the AliveCor Heart Monitor in 30 patients with potential and diagnosed arrhythmias. Preliminary data demonstrated that the AliveCor Heart Monitor can generate accurate tracings in the remote setting in the pediatric population. In addition, patient and parent experience with the device was overwhelmingly positive; 95% of survey responses indicated the device was easy to use and 95% prefer to continue using the device once the study ends.
A third study, “Wireless Smart Phone Equipped ECG Enables Large Scale Screening in Diverse Populations,” presented by Dr. Zach Haberman with Senior Author Dr. Leslie Saxon at the University of California Irvine, Orange, CA and the USC Keck School of Medicine, evaluated the accuracy of the AliveCor Heart Monitor when compared to a 12-lead ECG for detecting AF and other cardiac abnormalities. The AliveCor Heart Monitor demonstrated a sensitivity and specificity for the detection of AF/atrial flutter of 94.4% and 99.3%, respectively. The study was conducted with 382 subjects (USC Division 1 athletes, healthy young adults and electrophysiology clinic patients).
“The clinical benefits of the AliveCor Heart Monitor were well-represented at HRS 2014. Data presented supports the accuracy and patient satisfaction of our device,” said Euan Thomson, president and chief executive officer at AliveCor. “We look forward to working with our customers to learn from their experiences within the cardiac health community and further drive innovation for helping more patients.”
The AliveCor Heart Monitor is the only FDA-cleared mobile ECG recorder that supports both iPhone and Android mobile devices. It records, displays (when prescribed or used under the care of a physician), stores, and transfers single-channel ECG rhythms wirelessly, using the free AliveECG app. AliveCor does not recommend use of the AliveCor Heart Monitor for any pediatric patient weighing 10kg or less. With secure storage in the cloud, users can access their data confidentially anytime, anywhere, and can grant access to their physician. The Heart Monitor is available for purchase in the United States by health professionals and consumers.
A full list of published research studies for the AliveCor Heart Monitor is available at: www.alivecor.com/research.
The AliveCor Heart Monitor can be purchased at www.alivecor.com.
AliveCor, Inc., is a privately held company headquartered in San Francisco. The company is dedicated to enabling users to participate in their heart health through the use of the AliveCor® Heart Monitor, an innovative mobile health solution. For more information, please visit www.alivecor.com.
AliveCor is a trademark of AliveCor, Inc., registered in the U.S. and other countries. iPhone® is a trademark of Apple Inc., registered in the U.S. and other countries. Android is a trademark of Google Inc., registered in the U.S. and other countries.
Study Shows Promising Results with Novel Approach to Medtronic Cardiac Resynchronization Therapy
Medtronic, Inc. released study findings that show heart failure patients who have limited options for implanted device therapy may benefit from a novel implant technique for cardiac resynchronization therapy (CRT) devices. Data from the ALSYNC (Alternate Site Cardiac Resynchronization) study show that pacing from inside the heart’s left ventricle — an alternate site compared to traditional implants — was successful in 89 percent of implant attempts. The data were presented during a Late-Breaking Clinical Trials Session at Heart Rhythm 2014 by Prof. John Morgan, MD, Southampton University Hospitals Trust, Southampton, U.K. The system evaluated in the ALSYNC study is not available for investigational or commercial use in the United States.
Some heart failure patients are not suitable for, or do not respond to, traditional CRT because of limitations associated with implanting a lead in veins on the outside of the left ventricle; these limitations may include unique patient anatomy or suboptimal lead placement. As a potential alternative for these patients, the system evaluated in the study implants a lead placed inside the left ventricle by crossing the atrial septum.
“There is a significant need for a new way to pace the left ventricle in patients unable to receive the clinical benefits of standard CRT therapy, and this study suggests left ventricular endocardial pacing is a feasible option,” said Prof. Morgan, lead investigator of the ALSYNC study. “These findings will elevate this new approach from something that is investigational to one that is closer to the mainstream.”
The ALSYNC study, the first of its kind to evaluate the safety and performance of a new delivery system and left ventricular endocardial (LVE) pacing lead for CRT implantation, included 138 patients at 18 centers in Europe and Canada, all of whom were indicated for CRT but were unable to receive a conventional system or did not respond to the therapy at least six months post-implant. LVE pacing was successful in 118 out of 133 (89 percent) implant attempts.
The ALSYNC study assessed the safety and performance of the system and implant procedure. The primary objective was to demonstrate that the complication rates were less than 30 percent at six months in patients with an implant attempt. The objective was met with an observed rate of 17.7 percent (upper confidence bound 24.2 percent), which is comparable to the complication rates of conventional CRT implants.1
“As the leader in CRT, we are committed to continued innovations in heart failure treatment and bringing renewed hope to the many patients who have previously had limited options,” said David Steinhaus, MD, vice president and general manager, heart failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic.
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 that deliver clinical and economic value to healthcare consumers and providers around the world.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
- Van Rees JB, et al. Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices. J Am Coll Cardiol. 2011;58(10):995-1000.
St. Jude Medical Announces TOCCASTAR Clinical Trial Meets Primary Safety and Efficacy Endpoints at Heart Rhythm 2014
St. Jude Medical, Inc., a global medical device company, announced results of the TOCCASTAR clinical trial at Heart Rhythm 2014. Results from the first prospective, randomized study of contact-force ablation technology for the treatment of paroxysmal AF met primary endpoints and supplement the growing body of evidence that supports the safety and effectiveness of contact-force ablation technology.
“The findings from the TOCCASTAR trial further demonstrate the strong safety and efficacy profile of the TactiCath irrigated ablation catheter for the treatment of atrial fibrillation,” said Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Hospital, NY. “The results of this study have significant clinical relevance for optimal cardiac ablation therapy and provide compelling evidence that contact-force ablation procedures are effective in treating paroxysmal atrial fibrillation.”
The TOCCASTAR study is a multicenter, non-inferiority study evaluating 300 patients in the U.S. and Europe. The investigational device exemption (IDE) clinical trial, which followed device performance and assessed patient outcomes through 12 months of follow-up, met its primary safety and effectiveness endpoints. Results demonstrated that the TactiCath™ Irrigated Ablation Catheter exceeded the safety and efficacy non-inferiority benchmarks set forth in the trial by 5.9 percent and 4.3 percent, respectively, based on a 95 percent confidence interval. In addition, approximately 75.9 percent of the patients that were treated optimally with contact-force ablation therapy via the TactiCath catheter were free from paroxysmal AF at the end of the 12-month follow-up period, compared to 58.1 percent of patients who did not receive 10 grams or more of force. Through previous studies, including TOCCATA, EFFICAS I and EFFICAS II, optimal contact-force parameters for the TactiCath catheter has been defined as 10 grams of force or more during ablation procedures.
“Results from the TOCCASTAR study represent an important step forward in contact-force ablation technologies,” said Srijoy Mahapatra, MD, vice president of medical and scientific affairs, global clinical affairs at St. Jude Medical. “We are confident our large and growing body of clinical evidence demonstrates that the use of contact-force ablation safely reduces the rate of AF recurrence and we look forward to making this important technology available to electrophysiologists in the U.S.”
The TactiCath irrigated ablation catheter is designed to give physicians a real-time, objective measure of the force applied to the heart wall during a catheter ablation procedure. Without contact-force data, physicians must estimate the amount of force applied to the heart wall during an ablation. If too little force is applied, there is a risk of incomplete lesion formation that could result in AF recurrence, potentially requiring additional treatments. If too much force is applied, there is a risk of tissue injury, which can lead to serious procedure-related complications.
Data that are produced by the TactiCath irrigated ablation catheter is displayed on the EnSite™ Velocity™ System, a cardiac mapping and navigation system via the EnSite™ Contact Force Module. The EnSite Contact software module, which recently received CE Mark approval, seamlessly integrates contact-force ablation technology and 3D mapping and navigation capabilities.
The study has been conducted to gather data in support of U.S. FDA approval and is the basis for the company’s premarket approval (PMA) submission that has been filed with the FDA. TactiCath has received CE Mark approval and is commercially available in Europe. In the United States, TactiCath is available for investigational use only. The EnSite Contact Force Module is not approved for use in the U.S.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive, epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, MN, St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
Study of Boston Scientific Latitude™ Remote Patient Management System Presented at Heart Rhythm 2014 Demonstrates Significant Reduction in Mortality and Hospitalization
Patients using the Boston Scientific Corporation LATITUDE™ Remote Patient Management system with wireless telemetry demonstrated significantly lower mortality and fewer hospitalizations than patients with LATITUDE-compatible devices who were not followed on the system, according to results from the PREDICt-RM study (Patient RElated Determinants of ICD Remote Monitoring Utilization and Outcomes). The results were presented at Heart Rhythm 2014.
PREDICt-RM demonstrated a 33 percent relative reduction in the risk of death in patients with Boston Scientific ICDs and CRT-Ds who were remotely monitored via the LATITUDE wireless remote monitoring system, compared to Boston Scientific ICD and CRT-D patients who were not remotely monitored. Additionally, these patients experienced a 19 percent relative reduction in hospitalizations for any cause. The study outcomes were presented by Dr. Joseph Akar, associate professor of medicine at Yale University and the Center for Outcomes Research and Evaluation (CORE) in New Haven, CT, and are a result of a research collaboration between Yale CORE, the American College of Cardiology (ACC) and Boston Scientific.
“The PREDICt-RM results demonstrate improved outcomes for those ICD and CRT-D patients using the LATITUDE wireless Remote Patient Management system,” said Dr. Joseph Akar. “Despite the widespread availability of this technology, we know that it is underutilized. Our hope is that this study may inform clinical practice guidelines and promote the routine use of this technology in daily practice.”
PREDICt-RM builds on Boston Scientific’s innovation and leadership in clinical science. These results were made possible via a unique research design that linked three large health care databases, illuminating the potential for “big data” and healthcare analytics to advance patient care. PREDICt-RM combined the National Cardiovascular Data Registry (NCDR) from ACC, CMS data from Medicare, and the Boston Scientific LATITUDE system.
“No single database could have answered this question effectively. Through an innovative collaboration with ACC and Boston Scientific, we were able to leverage the strengths of each database to develop a deeper understanding of the association of remote monitoring with patient outcomes. We believe the PREDICt-RM experience should serve as a model for this type of investigation,” said Dr. Jeptha Curtis, associate professor of medicine at Yale University and CORE.
“PREDICt-RM demonstrates that wireless remote monitoring using the LATITUDE system provides a significant benefit to patients and the overall healthcare system,” said Kenneth Stein, MD, chief medical officer, Rhythm Management, Boston Scientific. “We are very excited to have such strong data demonstrating substantially improved survival and reduced hospitalization rates in the patients followed on LATITUDE.”
The LATITUDE Remote Patient Management system connects a home communicator to the patient’s implanted Boston Scientific device through wireless telemetry, enabling automatic collection of patient data. The system capabilities include transmitting physiologic data, as well as data gathered from the implanted device to the healthcare team’s LATITUDE website. Boston Scientific provides wireless telemetry across all pacemaker, ICD, and CRT-D implantable devices. The LATITUDE system is the only implanted-device monitoring system with integrated physiologic monitoring of weight and blood pressure in the United States.
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 30 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.