Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial.
Louise R A Olde Nordkamp, Shari Pepplinkhuizen, Abdul Ghani, Lucas V A Boersma, Juergen Kuschyk, Mikhael F El-Chami, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Anne-Floor B E Quast, Willeke van der Stuijt, Lonneke Smeding, Jolien A de Veld, Jan G P Tijssen, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Ward P J Jansen, Zachary I Whinnett, Peter Nordbeck, Michael Knaut, Berit T Philbert, Jurren M van Opstal, Alexandru B Chicos, Cornelis P Allaart, Alida E Borger van der Burg, Jose M Dizon, Marc A Miller, Dmitry Nemirovsky, Ralf Surber, Gaurav A Upadhyay, Raul Weiss, Anouk de Weger, Arthur A M Wilde, Reinoud E Knops
{"title":"Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial.","authors":"Louise R A Olde Nordkamp, Shari Pepplinkhuizen, Abdul Ghani, Lucas V A Boersma, Juergen Kuschyk, Mikhael F El-Chami, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Anne-Floor B E Quast, Willeke van der Stuijt, Lonneke Smeding, Jolien A de Veld, Jan G P Tijssen, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Ward P J Jansen, Zachary I Whinnett, Peter Nordbeck, Michael Knaut, Berit T Philbert, Jurren M van Opstal, Alexandru B Chicos, Cornelis P Allaart, Alida E Borger van der Burg, Jose M Dizon, Marc A Miller, Dmitry Nemirovsky, Ralf Surber, Gaurav A Upadhyay, Raul Weiss, Anouk de Weger, Arthur A M Wilde, Reinoud E Knops","doi":"10.1161/CIRCEP.124.012836","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i>=0.97). There was no significant difference in patients experiencing IAS between both groups (<i>P</i>=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]; <i>P</i>=0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; <i>P</i>=0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; <i>P</i>=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]; <i>P</i>=0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups (<i>P</i>=0.046).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.</p>","PeriodicalId":10319,"journal":{"name":"Circulation. Arrhythmia and electrophysiology","volume":" ","pages":"e012836"},"PeriodicalIF":9.1000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation. Arrhythmia and electrophysiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCEP.124.012836","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/3 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Circulation: Arrhythmia and Electrophysiology is a journal dedicated to the study and application of clinical cardiac electrophysiology. It covers a wide range of topics including the diagnosis and treatment of cardiac arrhythmias, as well as research in this field. The journal accepts various types of studies, including observational research, clinical trials, epidemiological studies, and advancements in translational research.
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