Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial.

Autor:	Olde Nordkamp LRA; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Pepplinkhuizen S; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Ghani A; Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.)., Boersma LVA; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.).; Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands (L.V.A.B.)., Kuschyk J; First Department of Medicine, University Medical Center Mannheim, Germany (J.K.).; German Center for Cardiovascular Research Partner Site Heidelberg, Mannheim, Germany (J.K.)., El-Chami MF; Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.-C.)., Behr ER; St George's University of London, United Kingdom (E.R.B.).; St George's University Hospitals National Health Service Foundation Trust, London, United Kingdom (E.R.B.)., Brouwer TF; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Kääb S; Department of Medicine I, Ludwig-Maximillians University Hospital, München, Germany (S.K.).; German Center for Cardiovascular Research, Munich Heart Alliance, Germany (S.K.).; European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart: ERN GUARD-Heart, Amsterdam, the Netherlands (S.K., A.A.M.W.)., Mittal S; The Valley Health System, Ridgewood, NJ (S.M.)., Quast ABE; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., van der Stuijt W; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Smeding L; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., de Veld JA; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Tijssen JGP; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Bijsterveld NR; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.).; Department of Cardiology, Flevoziekenhuis, Almere, the Netherlands (N.R.B.)., Richter S; Department of Electrophysiology, Heart Center at University of Leipzig, Germany (S.R.).; Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (S.R., M.K.)., Brouwer MA; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (M.A.B.)., de Groot JR; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Kooiman KM; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Lambiase PD; Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre, United Kingdom (P.D.L.)., Neuzil P; Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P. Neuzil)., Vernooy K; Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands (K.V.)., Alings M; Department of Cardiology, Amphia Hospital, the Netherlands (M.A.).; Werkgroep Cardiologische Centra Nederland, Utrecht, the Netherlands (M.A.)., Betts TR; Oxford Biomedical Research Centre, Oxford University Hospitals National Health Service Trust, United Kingdom (T.R.B.)., Bracke FALE; Department of Electrophysiology, Catharina Hospital Eindhoven, the Netherlands (F.A.L.E.B.)., Burke MC; CorVita Science Foundation, Chicago, IL (M.C.B.)., de Jong JSSG; Department of Cardiology, OLVG, Amsterdam, the Netherlands (J.S.S.G.d.J.)., Wright DJ; Liverpool Heart and Chest Hospital, United Kingdom (D.J.W.)., Jansen WPJ; Department of Cardiology, Tergooi MC, Blaricum, the Netherlands (W.P.J.J.)., Whinnett ZI; National Heart and Lung Institute, Imperial College London, United Kingdom (Z.I.W.)., Nordbeck P; University and University Hospital Würzburg, Germany (P. Nordbeck)., Knaut M; Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (S.R., M.K.)., Philbert BT; Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (B.T.P.)., van Opstal JM; Medical Spectrum Twente, Enschede, the Netherlands (J.M.v.O.)., Chicos AB; Division of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.)., Allaart CP; Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Location VUMC, the Netherlands (C.P.A.)., Borger van der Burg AE; Medisch Centrum Leeuwarden, the Netherlands (A.E.B.v.d.B.)., Dizon JM; Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY (J.M.D.)., Miller MA; Icahn School of Medicine at Mount Sinai, Mount Sinaï Hospital, New York, NY (M.A.M.)., Nemirovsky D; Cardiac Electrophysiology Division, Department of Medicine, Englewood Hospital and Medical Center, Englewood, NJ (D.N.)., Surber R; Department of Internal Medicine I, Jena University Hospital, Germany (R.S.)., Upadhyay GA; Center for Arrhythmia Care, Heart and Vascular Institute, University of Chicago Pritzker School of Medicine, IL (G.A.U.)., Weiss R; Division of Cardiovascular Medicine, College of Medicine, The Ohio State University, Columbus (R.W.)., de Weger A; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.)., Wilde AAM; European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart: ERN GUARD-Heart, Amsterdam, the Netherlands (S.K., A.A.M.W.)., Knops RE; Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.).
Jazyk:	angličtina
Zdroj:	Circulation. Arrhythmia and electrophysiology [Circ Arrhythm Electrophysiol] 2024 Dec; Vol. 17 (12), pp. e012836. Date of Electronic Publication: 2024 Dec 03.
DOI:	10.1161/CIRCEP.124.012836
Abstrakt:	Background: Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial. Methods: This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population. Results: In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65-1.52]; P =0.97). There was no significant difference in patients experiencing IAS between both groups ( P =0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05-3.76]; P =0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; P =0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; P =0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34-7.31]; P =0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups ( P =0.046). Conclusions: There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022. Competing Interests: Dr Knops reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cardiac, and has stock options from AtaCor Medical, Inc. Dr El Chami reports consultancy fees from Boston Scientific and Medtronic. Dr Mittal reports consultancy fees from Boston Scientific and Medtronic.Dr Neuzil reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. K.M. Kooiman reports consultancy fees from Boston Scientific. Dr Lambiase reports educational and research grants from and is in the research board of Boston Scientific, and reports research grants from Abbott. Dr Vernooy reports consultancy fees from Medtronic and Abbott. M.C. Burke is a consultant, receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. Dr Wright has consultancy arrangements with Boston Scientific and Medtronic and a research grant from Boston Scientific. Dr Nordbeck reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. Dr Miller reports consultancy fees from Boston Scientific. Dr Whinnett is an advisor for Boston Scientific, on the advisory board for Medtronic and Abbot, and reports speaker fees from Medtronic. The other authors report no conflicts.
Databáze:	MEDLINE
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