Medtronic plc announced results from a research study demonstrating the feasibility of a novel approach to delivering pacing and defibrillation therapy in which a lead is placed under the sternum, outside of the heart and veins. Data from the Acute Extravascular Defibrillation, Pacing and Electrogram (ASD2) study were presented during a late-breaking session at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.
The results of the international ASD2 feasibility study, an important step in the Medtronic extravascular (EV) ICD clinical development program, confirmed that an investigational extravascular ICD lead can sense, pace and defibrillate the heart, thus offering a potential future alternative to traditional transvenous ICD systems.
“Clinicians are highly interested in the potential for an extravascular ICD solution to provide both pacing and lifesaving defibrillation therapy without leads placed inside the heart or vasculature,” said Lucas V.A. Boersma, MD, PhD, cardiologist at St. Antonius Hospital, Department of Cardiology, Nieuwegein, the Netherlands and professor of cardiology, Academic Medical Center (AMC), University of Amsterdam, the Netherlands. “The ASD2 study offers very encouraging clinical insights, which bring us closer to implanting the first chronic investigational system in ambulatory patients.”
The Medtronic EV-ICD System, which currently is in development and not available for use or sale, is a new approach to implantable defibrillation therapy that may offer the benefits of current transvenous defibrillators. In addition, the system may address current limitations of subcutaneous implantable defibrillators, including their inability to provide painless bradycardia pacing or antitachycardia pacing (ATP), and their larger size.
In ASD2, 79 patients who were already scheduled for elective cardiac surgery or a subcutaneous or transvenous ICD implant had an investigational EV-ICD lead inserted temporarily under the sternum and evaluated in conjunction with either a defibrillation patch or a defibrillator emulator. The ICD lead was designed to sense activity in the ventricles, provide pacing to the ventricles, and deliver a 30-joule defibrillation shock after ventricular fibrillation (VF) was induced.
Ventricular pacing was successful in 97 percent of patients, and shocks successfully terminated 83 percent of episodes, consistent with prior clinical studies of existing ICDs.1
Seven adverse events were reported in six of the 79 studied patients. As with any feasibility research evaluating a new procedure, the investigational procedure and lead implantation tools were refined during the study, with further technique training and education provided to all investigators in an effort reduce the adverse event rate in future patients.
“The ASD2 feasibility experience is an important step in our investigational extravascular defibrillation program, and the results give us confidence to continue with this research,” said Mike Marinaro, vice president and general manager of the Cardiac Rhythm Management business, which is part of the Cardiac and Vascular Group at Medtronic. “We look forward to our next clinical evaluation — a first-in-human, chronic study to assess the safety and efficacy of the investigational Medtronic EV-ICD system in an ICD patient population.”
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 84,000 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. ν
- 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;52(7):551-556.
Boston Scientific Announces Real-World Data Demonstrating Success of SMART Pass on the S-ICD System
Boston Scientific announced results from an analysis of the LATITUDE database which evaluated the successful reduction of inappropriate shocks using the SMART Pass sensing filter in patients implanted with the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System. The real-world data were presented during a late-breaking clinical trial at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions, and demonstrated that when the sensing filter was in use, the rate of inappropriate shocks was reduced to 4.3% at one year. The analysis was also published online in the HeartRhythm journal.
The SMART Pass sensing filter is an advanced algorithm within the EMBLEM S-ICD System that filters out certain signals that are the primary reason for inappropriate shocks, while maintaining the ability to accurately detect ventricular tachycardia or ventricular fibrillation and deliver lifesaving therapy. Study authors evaluated the effect of SMART Pass on shocks in ambulatory patients and found that the filter reduced the risk for the first inappropriate shock by 50% and the risk for all inappropriate shocks by 68%, without a negative impact on delivery of appropriate shocks.
“The study data validate the clinical benefit of this sensing methodology to significantly reduce inappropriate shocks by the S-ICD,” said Tom F. Brouwer, MD, presenting author, Department of Clinical and Experimental Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands. “At one year, the inappropriate shock rate for patients with the SMART Pass filter in use was as low as rates observed in studies with transvenous implantable cardioverter-defibrillators employing modern programming strategies.”
The prospective, blinded evaluation reviewed one year of remote monitoring data from 1,984 patients that were implanted with an EMBLEM S-ICD System between 2015 and 2016.
“The positive data presented underscore our commitment to advancing this device and providing protection for patients at risk for sudden cardiac death while avoiding the risks and complications associated with transvenous leads,” said Kenneth Stein, MD, senior vice president and chief medical officer, Global Health Policy and Rhythm Management, Boston Scientific. “We are excited for the future of the S-ICD and results from upcoming clinical trials assessing its value when paired with our forthcoming leadless pacemaker as part of a modular device system.”
The S-ICD was included for the first time in the recently updated guidelines from the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) which recommend the device for the treatment of patients with ventricular arrhythmias and the prevention of sudden cardiac death.1
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.
- Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. Heart Rhythm. doi: 10.1016/j.hrthm.2017.10.036.
Previously Invisible Long QT Syndrome Now Observable With Machine Learning
AliveCor, the leader in artificial intelligence and FDA-cleared personal electrocardiogram (ECG) technology, announced an important milestone in its work with Mayo Clinic on Long QT Syndrome (LQTS).
In an abstract published at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions, investigators from Mayo Clinic presented research showing that artificial intelligence (AI) using deep neural networks can successfully identify patients with congenital LQTS despite having a normal QTc on their electrocardiogram (ECG). As many as 50% of patients with genetically confirmed LQTS have a normal QT interval on the standard ECG, so identifying these patients who are at increased risk of arrhythmias and sudden cardiac death is crucial for correct diagnosis and treatment. This is especially critical when patients are exposed to medications with known QT prolonging potential. The deep neural network employed in the study generated an area under the curve of 0.83, with a specificity of 81%, sensitivity of 73%, and an overall accuracy of 79%.
Importantly, the results were achieved by applying AI to data from lead I of a 12-lead ECG, which suggests that AliveCor’s KardiaMobile and KardiaBand devices may be useful in the mobile detection of patients with concealed LQTS.
Long QT Syndrome is both a congenital and acquired disorder. The inherited form affects 160,000 people in the U.S., and causes 3,000 to 4,000 sudden deaths in children and young adults annually. The acquired form of LQTS can be caused by nearly 100 FDA-approved medications, such as antibiotics and antidepressants.
“There can be no better illustration of the importance of our AI to medical science than using it to detect that which is otherwise invisible,” said Vic Gundotra, CEO of AliveCor.
AliveCor and Mayo Clinic formed a partnership in October of 2016, and announced a joint effort to detect LQTS using AI in July of 2017.
“Building on our previous work using Mayo Clinic’s proprietary T wave fingerprint software, it is stunning that our ‘AI brain’ is distinguishing one patient who has a potentially life-threatening syndrome, LQTS, but a normal QTc, from a normal patient with the same QTc value by just staring at a single lead,” said senior author Michael J. Ackerman, MD, PhD, director of Mayo Clinic’s Genetic Heart Rhythm Clinic and the Windland Smith Rice Sudden Death Genomics Laboratory at Mayo Clinic.
AliveCor, Inc. is pioneering the creation of FDA-cleared machine learning techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared KardiaMobile is the most clinically validated mobile ECG solution on the market. It is recommended by leading cardiologists and used by people worldwide for accurate ECG recordings. KardiaMobile, and KardiaBand, when paired with the Kardia app provide instant analysis for detecting atrial fibrillation (AF) and normal sinus rhythm in an ECG. Kardia is the first AI-enabled platform to help clinicians manage patients for the early detection of AF, the most common cardiac arrhythmia and one that leads to a five times greater risk of stroke. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. AliveCor was named the No.1 artificial intelligence company on Fast Company’s Top 50 Most Innovative Companies, in addition to ranking 20th overall in an evaluation of thousands of companies worldwide. AliveCor is a privately-held company headquartered in Mountain View, California. For more information, visit alivecor.com.
About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, comprehensive care to everyone who needs healing. Learn more about Mayo Clinic at https://mayocl.in/2GwSXYO. Visit the Mayo Clinic News Network at https://newsnetwork.mayoclinic.org/.
The Heart Rhythm Society Releases Communication Strategies for Cybersecurity Threats to Cardiovascular Implantable Electronic Devices
The Heart Rhythm Society (HRS) released communication recommendations to assist health care professionals to understand and prepare for potential cybersecurity vulnerabilities of cardiovascular implantable electronic devices (CIEDs). The proceedings statement outlines four key communication themes: when to notify patients, whom to notify, how to communicate with patients, and what elements to discuss with patients. The statement was presented at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.
The relative novelty of cybersecurity threats in CIEDs is raising questions among patients and the heart rhythm care community. The rapidly changing health care environment and increasing global interconnectivity expose information technology to vulnerabilities. Hackers can potentially use these vulnerabilities to gain unauthorized access to medical equipment.
The proceedings statement includes detailed guidance on patient-centered communication strategies when a specific threat is identified. The authors first call for an assessment of the threat by experts from manufacturers and U.S. federal agencies. If a vulnerability is validated, the discussion between the health care professional and patient should include five topics:
- Potential consequences if the vulnerability is exploited
- Strategies to mitigate the risks
- Technical challenges to exploit the vulnerability
- Long-term solutions to eliminate the threat
- Benefits provided by the CIED compared with the risk if the vulnerability is exploited
The authors note that if the claim of a new vulnerability is released directly to the public, instead of directly to the manufacturer or the U.S. Food and Drug Administration (FDA), there is the potential for a period of uncertainty and anxiety during the evaluation of the claim. U.S. federal agencies and manufacturers must rapidly assess both the validity of the claim and the potential risks to patients to prevent improper action or exploitation of the situation.
“As we look ahead and plan for ways to deal with potential risks to CIEDs, preparedness is the best approach,” said lead author David Slotwiner, MD, FHRS, New York-Presbyterian Queens.
“Like other technology such as smartphones or computers, device software needs to be regularly updated. As health care professionals, we are inclined to first address hardware issues with the battery or leads, but the software is equally important. The health care community must reach a point where routine software updates are considered the standard of care to minimize the threat and ultimately eliminate risks.”
The authors also state the importance of managing patient expectations at the time of implant. Patients should know that CIEDs will require software updates until the battery is depleted. By educating patients prior to CIED implant and in advance of a threat announcement, patients will have a better understanding of the systems and be more prepared to respond to a potential vulnerability. HRS will work with its partners to help educate health care professionals on best practices for patient-centered conversations and mechanisms to minimize cybersecurity risks.
The statement captures the proceedings of the 2017 Leadership Summit on Cybersecurity Vulnerabilities: Communications Strategies for Clinicians and Patients that was attended by patient representatives, subject matter experts, HRS and American College of Cardiology (ACC) leadership, FDA and Federal Bureau of Investigation (FBI) officials, and leadership from CIED manufacturers.
The full document was published with an accompanying editorial commentary in the online edition of HeartRhythm, the official journal of HRS. To review the full document and editorial commentary by FDA, please visit https://bit.ly/2Irro9f.
Heart Rhythm 2018 is the most comprehensive educational program for heart rhythm professionals, featuring more than 200 educational sessions and more than 140 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.