Charles J. Love

HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices

DavidSlotwiner,MD, FHRS, FACC(Chair),Niraj Varma,MD,PhD, FRCP(Co-chair), JosephG.Akar,MD,PhD, George Annas, JD, MPH, Marianne Beardsall, MN/NP, CCDS, FHRS, Richard I. Fogel, MD, FHRS, Nestor O. Galizio, MD, Taya V. Glotzer, MD, FHRS, FACC, Robin A. Leahy, RN, BSN, CCDS, FHRS, Charles J. Love, MD, CCDS, FHRS, FACC, FAHA, Rhondalyn C. McLean, MD, Suneet Mittal, MD, FHRS, Loredana Morichelli, RN, MSN, Kristen K. Patton, MD, Merritt H. Raitt, MD, FHRS, Renato Pietro Ricci, MD, John Rickard, MD, MPH, Mark H. Schoenfeld, MD, CCDS, FHRS, FACC, FAHA, Gerald A. Serwer, MD, FHRS, FACC, Julie Shea, MS, RNCS, FHRS, CCDS, Paul Varosy, MD, FHRS, FACC, FAHA, Atul Verma, MD, FHRS, FRCPC, Cheuk-Man Yu, MD, FACC, FRCP, FRACP From the Hofstra School of Medicine, North Shore Long Island Jewish Health System, New Hyde Park, New York, Cleveland Clinic, Cleveland, Ohio, Yale University School of Medicine, New Haven, Connecticut, Boston University School of Public Health, Boston, Massachusetts, Southlake Regional Health Centre, Newmarket, Ontario, Canada, St. Vincent Medical Group, Indianapolis, Indiana, Favaloro Foundation University Hospital, Buenos Aires, Argentina, Hackensack University Medical Center, Hackensack, New Jersey, Sanger Heart & Vascular Institute, Carolinas HealthCare System, Charlotte, North Carolina, New York University Langone Medical Center, New York City, New York, University of Pennsylvania Health System, Philadelphia, Pennsylvania, The Arrhythmia Institute at Valley Hospital, New York, New York, Department of Cardiovascular Diseases, San Filippo Neri Hospital, Rome, Italy, University of Washington, Seattle, Washington, VA Portland Health Care System, Oregon Health & Science University, Knight Cardiovascular Institute, Portland, Oregon, Johns Hopkins University, Baltimore, Maryland, Yale University School of Medicine, Yale-New Haven Hospital Saint Raphael Campus, New Haven, Connecticut, University of Michigan Congenital Heart Center, University of Michigan Health Center, Ann Arbor, Michigan, Brigham and Women’s Hospital, Boston, Massachusetts, Veterans Affairs Eastern Colorado Health Care System, University of Colorado, Denver, Colorado, and Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.

Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial

The incidence of unscheduled encounters and problem occurrence between ICD implant and first in‐person evaluation (IPE) recommended at 12 weeks is unknown. Automatic remote home monitoring (HM) may be useful in this potentially unstable period.

Automatic remote monitoring utilizing daily transmissions: Transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial

Aims Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial. Methods and results Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to Conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months. Conclusion Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance. Clinical trial registration ClinicalTrials.gov; NCT00336284.

Rationale and design of a randomized trial to assess the safety and efficacy of MultiPoint Pacing (MPP) in cardiac resynchronization therapy: The MPP Trial

Although the majority of Class III congestive heart failure (HF) patients treated with cardiac resynchronization therapy (CRT) show a clinical benefit, up to 40% of patients do not respond to CRT. This paper reports the design of the MultiPoint Pacing (MPP) trial, a prospective, randomized, double‐blind, controlled study to evaluate the safety and efficacy of CRT using MPP compared to standard biventricular (Bi‐V) pacing.

Impact of magnetic resonance imaging on ventricular tachyarrhythmia sensing: Results of the Evera MRI Study.

BACKGROUND Studies have shown that magnetic resonance imaging (MRI) conditional pacemakers experience no significant effect from MRI on device function, sensing, or pacing. More recently, similar safety outcomes were demonstrated with MRI conditional defibrillators (implantable cardioverter-defibrillator [ICD]), but the impact on ventricular arrhythmias has not been assessed. OBJECTIVE The purpose of this study was to assess the effect of MRI on ICD sensing and treatment of ventricular tachyarrhythmias. METHODS The Evera MRI Study was a worldwide trial of 156 patients implanted with an ICD designed to be MRI conditional. Device-detected spontaneous and induced ventricular tachycardia/ventricular fibrillation (VT/VF) episodes occurring before and after whole body MRI were evaluated by a blinded episode review committee. Detection delay was computed as the sum of RR intervals of undersensed beats. A ≥5-second delay in detection due to undersensing was prospectively defined as clinically significant. RESULTS Post-MRI, there were 22 polymorphic VT/VF episodes in 21 patients, with 16 of these patients having 17 VT/VF episodes pre-MRI. Therapy was successful for all episodes, with no failures to treat or terminate arrhythmias. The mean detection delay due to undersensing pre- and post-MRI was 0.60 ± 0.59 and 0.33 ± 0.63 seconds, respectively (P = .17). The maximum detection delay was 2.19 seconds pre-MRI and 2.87 seconds post-MRI. Of the 17 pre-MRI episodes, 14 (82%) had some detection delay as compared with 11 of 22 (50%) post-MRI episodes (P = .03); no detection delay was clinically significant. CONCLUSION Detection and treatment of VT/VF was excellent, with no detection delays or significant impact of MRI observed.

Following leads to improve patient outcomes: It's about time

As lifesaving devices, implantable cardioverter-defibrillators (ICDs) and leads used with ICD systems require the highest possible standards of reliability. Despite meticulous design, careful manufacturing, and rigorous testing, ICDs and leads have finite rates of failure. ICD leads are designed to transfer information to, and life-sustaining therapy from, the ICD in the hostile and mechanically stressful intravascular and cardiac environment of the human body. With the high-profile failure of multiple ICD lead models over the last several years, they now are considered a “weak link” in the ICD systems, just as pacemaker leads are in pacing systems. The result has been to undermine trust in ICD therapy. Recommendations for timely detection, characterization, communication, and correction of product lead performance issues were developed to provide a systematic approach to improve lead reliability. Definitions of ICD lead malfunction, performance, and reliability have been standardized to allow comparison of leads. Lead reliability represents the measure of freedom of a specific lead from structural or functional failure as a function of time. This time dependence of assessing lead performance represents 1 of many ongoing challenges. Manufacturer product performance reports and independent registries are significantly limited by underreporting of lead malfunction, insufficient patient follow-up, lack of uniform definitions, lack of returned product for fault analysis, and a passive monitoring system based on voluntary reporting. Multiple recommendations related to lead performance, communication, premarket evaluation, postmarket surveillance, lead advisories, and clinical management have been advanced. The responsibilities of the many stakeholders in addressing acknowledged limitations of ICD lead design, testing, manufacturing, surveillance, reporting, and improvement are clearly specified. Cooperation among manufacturers, regulatory agencies, physicians, and patients is critical to establish and maintain trust in all of these areas.

Lead Management and Lead Extraction

Management of patients with cardiac implantable electronic devices (CIEDs) has become complex given the complications that can occur with implanted lead systems. Clinical problems such as infection, lead failure, and occluded vessels create situations that demand intervention to remove leads. Due to adhesions that occur in the venous system and at the endomyocardial attachment site, simple traction to remove a lead is often not sufficient. Infection is a mandatory reason to remove the entire CIED system. Tools and techniques are now available that enable a skilled operator to extract leads with a great deal of efficacy and safety.

Palliation and Nonextraction Approaches

Although definitive therapy for infected cardiac implantable electronic device systems requires removal of all hardware in the infected areas with extraction of intravascular components as well, there are situations where extraction is not available or appropriate. Palliative procedures and chronic suppressive antibiotics may be used in these cases. There are also options that may in some cases result in long-term freedom from infection.

Rise in defibrillation threshold after postoperative cardiac remodeling in a patient with severe Ebstein’s anomaly

Introduction Implantable cardioverter-defibrillators (ICDs) are considered standard of care for patients with life-threatening cardiac arrhythmias. In small children and patients with venous anatomy that prohibits placement of traditional transvenous leads, nontransvenous coil positions have been used and can be characterized as epicardial, pleural, subcutaneous, or a hybrid of any of the 3 positions. Based on the critical mass hypothesis, the defibrillation threshold is attained when a sufficient mass of excitable cells are simultaneously depolarized, which interrupts activation wavefronts. Defibrillation is thus dependent on reaching a threshold current density in the myocardium. In transthoracic defibrillation, the magnitude of myocardial current density is dependent on the transcardiac current fraction (Fc), which is the ratio of the transcardiac threshold current (IC) to the transthoracic threshold current (IT). Over 95% of the transthoracic current is shunted by the thoracic cage and the lungs, with approximately 4% of the current traversing the heart. Rise in defibrillation threshold may be due to use of certain medications, electrolyte abnormalities, underlying cardiac disease, ischemia, or increase in tranthoracic threshold current. We report a case of rise in defibrillation threshold associated with cardiac remodeling after surgical repair in a patient with Ebstein’s anomaly.

Transesophageal Echocardiography Monitoring During Lead Extraction Procedures Sound Advice

The number of transvenous lead extraction procedures has increased steadily over the past 3 decades, going from a niche procedure practiced by a handful of pioneers to a more mainstream and available operation. Lead extraction is generally a very safe and effective procedure with a mortality risk of