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

Olde Nordkamp, Louise R A
Autor Olde Nordkamp, Louise R A ORCID 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, Shari
Autor Pepplinkhuizen, Shari ORCID 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, Abdul
Autor Ghani, Abdul Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.)
Boersma, Lucas V A
Autor Boersma, Lucas V A ORCID 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, Juergen
Autor Kuschyk, Juergen ORCID 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, Mikhael F
Autor El-Chami, Mikhael F ORCID Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.-C.)
Behr, Elijah R
Autor Behr, Elijah R ORCID 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, Tom F
Autor Brouwer, Tom F ORCID 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, Stefan
Autor Kääb, Stefan ORCID 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, Suneet
Autor Mittal, Suneet ORCID The Valley Health System, Ridgewood, NJ (S.M.)
Quast, Anne-Floor B E
Autor Quast, Anne-Floor B E ORCID 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, Willeke
Autor van der Stuijt, Willeke ORCID 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, Lonneke
Autor Smeding, Lonneke ORCID 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, Jolien A
Autor de Veld, Jolien A ORCID 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, Jan G P
Autor Tijssen, Jan G P ORCID 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, Nick R
Autor Bijsterveld, Nick R ORCID 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, Sergio
Autor Richter, Sergio ORCID 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, Marc A
Autor Brouwer, Marc A Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (M.A.B.)
de Groot, Joris R
Autor de Groot, Joris R ORCID 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, Kirsten M
Autor Kooiman, Kirsten M ORCID 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, Pier D
Autor Lambiase, Pier D ORCID 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, Petr
Autor Neuzil, Petr ORCID Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P. Neuzil)
Vernooy, Kevin
Autor Vernooy, Kevin ORCID Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands (K.V.)
Alings, Marco
Autor Alings, Marco ORCID Department of Cardiology, Amphia Hospital, the Netherlands (M.A.) Werkgroep Cardiologische Centra Nederland, Utrecht, the Netherlands (M.A.)
Betts, Timothy R
Autor Betts, Timothy R ORCID Oxford Biomedical Research Centre, Oxford University Hospitals National Health Service Trust, United Kingdom (T.R.B.)
Bracke, Frank A L E
Autor Bracke, Frank A L E ORCID Department of Electrophysiology, Catharina Hospital Eindhoven, the Netherlands (F.A.L.E.B.)
Burke, Martin C
Autor Burke, Martin C ORCID CorVita Science Foundation, Chicago, IL (M.C.B.)
de Jong, Jonas S S G
Autor de Jong, Jonas S S G ORCID Department of Cardiology, OLVG, Amsterdam, the Netherlands (J.S.S.G.d.J.)
Wright, David J
Autor Wright, David J ORCID Liverpool Heart and Chest Hospital, United Kingdom (D.J.W.)
Jansen, Ward P J
Autor Jansen, Ward P J ORCID Department of Cardiology, Tergooi MC, Blaricum, the Netherlands (W.P.J.J.)
Whinnett, Zachary I
Autor Whinnett, Zachary I ORCID National Heart and Lung Institute, Imperial College London, United Kingdom (Z.I.W.)
Nordbeck, Peter
Autor Nordbeck, Peter ORCID University and University Hospital Würzburg, Germany (P. Nordbeck)
Knaut, Michael
Autor Knaut, Michael ORCID Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (S.R., M.K.)
Philbert, Berit T
Autor Philbert, Berit T ORCID Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (B.T.P.)
van Opstal, Jurren M
Autor van Opstal, Jurren M ORCID Medical Spectrum Twente, Enschede, the Netherlands (J.M.v.O.)
Chicos, Alexandru B
Autor Chicos, Alexandru B ORCID Division of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.)
Allaart, Cornelis P
Autor Allaart, Cornelis P ORCID Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Location VUMC, the Netherlands (C.P.A.)
Borger van der Burg, Alida E
Autor Borger van der Burg, Alida E ORCID Medisch Centrum Leeuwarden, the Netherlands (A.E.B.v.d.B.)
Dizon, Jose M
Autor Dizon, Jose M ORCID Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY (J.M.D.)
Miller, Marc A
Autor Miller, Marc A Icahn School of Medicine at Mount Sinai, Mount Sinaï Hospital, New York, NY (M.A.M.)
Nemirovsky, Dmitry
Autor Nemirovsky, Dmitry Cardiac Electrophysiology Division, Department of Medicine, Englewood Hospital and Medical Center, Englewood, NJ (D.N.)
Surber, Ralf
Autor Surber, Ralf ORCID Department of Internal Medicine I, Jena University Hospital, Germany (R.S.)
Upadhyay, Gaurav A
Autor Upadhyay, Gaurav A ORCID Center for Arrhythmia Care, Heart and Vascular Institute, University of Chicago Pritzker School of Medicine, IL (G.A.U.)
Weiss, Raul
Autor Weiss, Raul ORCID Division of Cardiovascular Medicine, College of Medicine, The Ohio State University, Columbus (R.W.)
de Weger, Anouk
Autor de Weger, Anouk ORCID 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, Arthur A M
Autor Wilde, Arthur A M ORCID 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, Reinoud E
Autor Knops, Reinoud E ORCID 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.)
PRAETORIAN Investigators
Autor PRAETORIAN Investigators

Circulation. Arrhythmia and electrophysiology. 2024 Dec ; 17 (12) : e012836. [epub] 20241203

Circ Arrhythm Electrophysiol
ISSN 1941-3084
Zdroj

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, srovnávací studie

Perzistentní odkaz https://www.medvik.cz/link/pmid39624908

PubMed 39624908
DOI 10.1161/circep.124.012836
Knihovny.cz E-zdroje

Klíčová slova
arrhythmia, ventricular, defibrillators, implantable, electrophysiology, tachycardia, supraventricular,
MeSH
časové faktory MeSH
defibrilátory implantabilní * MeSH
elektrická defibrilace * přístrojové vybavení škodlivé účinky MeSH
lidé středního věku MeSH
lidé MeSH
prospektivní studie MeSH
rizikové faktory MeSH
senioři MeSH
výsledek terapie MeSH
Check Tag
lidé středního věku MeSH
lidé MeSH
mužské pohlaví MeSH
senioři MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH
multicentrická studie MeSH
randomizované kontrolované studie MeSH
srovnávací studie MeSH

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.

1st Department of Medicine University Medical Center Mannheim Germany

Cardiac Electrophysiology Division Department of Medicine Englewood Hospital and Medical Center Englewood NJ

Center for Arrhythmia Care Heart and Vascular Institute University of Chicago Pritzker School of Medicine IL

CorVita Science Foundation Chicago IL

Department of Cardiology Amphia Hospital the Netherlands

Department of Cardiology Amsterdam Cardiovascular Sciences Amsterdam UMC Location VUMC the Netherlands

Department of Cardiology Amsterdam UMC Location University of Amsterdam Heart Center Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias the Netherlands

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Center the Netherlands

Department of Cardiology Flevoziekenhuis Almere the Netherlands

Department of Cardiology Homolka Hospital Prague Czech Republic

Department of Cardiology Isala Heart Centre Zwolle the Netherlands

Department of Cardiology OLVG Amsterdam the Netherlands