A Modular Communicative Leadless Pacing-Defibrillator System
Reinoud E Knops1, Michael S Lloyd1, Paul R Roberts1
1From the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.E.K., L.V.A.B.), and the Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein (L.V.A.B.) - both in the Netherlands; Emory University Section of Cardiac Electrophysiology, Atlanta (M.S.L., F.M.M.); University Hospital Southampton, Southampton (P.R.R.), the Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool (D.J.W.), and Leeds Teaching Hospitals NHS Trust, Leeds (C.P.), and Manchester Heart Centre, Manchester Royal Infirmary, Manchester (C.C.) - all in the United Kingdom; HonorHealth Cardiac Arrhythmia Group, HonorHealth Research Institute, Scottsdale, and the College of Medicine (R.D.) and Banner University Medical Center Phoenix (W.W.S.), University of Arizona, Phoenix - all in Arizona; the Department of Cardiovascular Medicine, Mayo Clinic, Rochester (P.A.F., Y.-M.C.), and Boston Scientific, St. Paul (J. West, E.M., B.S., A.J.B., J. Weinstock, K.M.S.) - both in Minnesota; the Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.); Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (C.B.-L.); Heart Rhythm Clinic, San Rossore Hospital, Pisa, Italy (M.G.B.); CorVita Science Foundation, Chicago (M.C.B.); Departement de Cardiologie, Hôpital Privé du Confluent, Nantes (D.G.), and the Arrhythmia Unit, Cardiology Department, Heart and Lung Institute, Lille (C.M.) - both in France; Cardiac Electrophysiology, Drexel University (S.P.K.), and the Cardiovascular Division, Perelman School of Medicine at the University of Pennsylvania (D.S.F.), Philadelphia, and the Department of Cardiology, Saint Mary Medical Center, Langhorne (S.P.K.) - all in Pennsylvania; OhioHealth Heart and Vascular Physicians, Section of Cardiac Electrophysiology, Department of Cardiology, OhioHealth Riverside Methodist Hospital (A.K.A., E.Y.F.), and the Section of Cardiac Electrophysiology, Division of Cardiovascular Disease, Department of Internal Medicine, Ohio State University Wexner Medical Center (R.A.) Columbus, and the Cardiac Electrophysiology and Pacing Section, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland (T.D.C.); Northwell, Hyde Park (L.M.E.), the Cardiovascular Institute, Northwell Health Manhasset, Manhasset (L.M.E.), and Icahn School of Medicine, Mount Sinai, New York (M.A.M., V.Y.R.) - all in New York; Institut Clínic Cardiovascular, Hospital Clínic, Universitat de Barcelona, and Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, and Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares (CIBERCV), Madrid (J.M.T., L.M.); Baptist Health Lexington, Lexington, KY (J.D.A.); Erlanger Health System, University of Tennessee, Chattanooga (H.M.); the Department of Cardiac Electrophysiology and Research, St. Bernard's Heart and Vascular Center, Arrhythmia Research Group, Jonesboro, AR (D.G.N.); Institut de Cardiologie de Montréal, Montreal Heart Institute, Université de Montréal, Montréal (B.M.); Sentara Norfolk General Hospital, Norfolk, VA (J.G.); and the Department of Cardiology, Kepler University Hospital, Medical Faculty of the Johannes Kepler University Linz, Austria (K.S.).
Background:
The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown.
Methods:
We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%).
Results:
We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure.
Conclusions:
The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).
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