Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial.
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Olde Nordkamp Louise R A, Pepplinkhuizen Shari, Ghani Abdul, Boersma Lucas V A, Kuschyk Juergen, El-Chami Mikhael F, Behr Elijah R, Brouwer Tom F, Kääb Stefan, Mittal Suneet, Quast Anne-Floor B E, van der Stuijt Willeke, Smeding Lonneke, de Veld Jolien A, Tijssen Jan G P, Bijsterveld Nick R, Richter Sergio, Brouwer Marc A, de Groot Joris R, Kooiman Kirsten M, Lambiase Pier D, Neuzil Petr, Vernooy Kevin, Alings Marco, Betts Timothy R, Bracke Frank A L E, Burke Martin C, de Jong Jonas S S G, Wright David J, Jansen Ward P J, Whinnett Zachary I, Nordbeck Peter, Knaut Michael, Philbert Berit T, van Opstal Jurren M, Chicos Alexandru B, Allaart Cornelis P, Borger van der Burg Alida E, Dizon Jose M, Miller Marc A, Nemirovsky Dmitry, Surber Ralf, Upadhyay Gaurav A, Weiss Raul, de Weger Anouk, Wilde Arthur A M, Knops Reinoud E, PRAETORIAN Investigators
Аннотация
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.