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Background: Increasing numbers of individuals with diabetes are adopting use of continuous glucose monitoring (CGM) in their daily self-management. Many of these individuals have advanced heart disease. Implantable cardioverter defibrillator (ICD) devices can effectively reduce arrhythmic death and all-cause mortality in individuals with advanced heart disease.

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A Modular Communicative Leadless Pacing-Defibrillator System.

N Engl J Med

October 2024

From 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.

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Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support.

Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented.

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Background: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) and leadless pacemakers (LPs) are intended to diminish transvenous lead-related complications. However, S-ICDs do not deliver antibradycardia pacing or antitachycardia pacing, and currently, there is no commercially available coordinated leadless option for patients with defibrillator and (expected) pacing needs.

Objective: We evaluated the performance, safety, and potential replacement strategies of a novel modular cardiac rhythm management (mCRM) system, a wirelessly communicating antitachycardia pacing-enabled LP and S-ICD in a preclinical model.

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In this short communication we briefly describe a 69-year-old man with dilated cardiomyopathy and an implantable cardioverter defibrillator who suffered a prolonged episode of palpitations. The interrogation of the device revealed an episode of ventricular tachycardia successfully treated with antitachycardia pacing. However, just before ventricular tachycardia termination, atrial fibrillation ensued.

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