Journal of the American College of Cardiology · 2012
Clinical evaluation of defibrillation testing in an unselected population of 2,120 consecutive patients undergoing first implantable cardioverter-defibrillator implant.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Brignole Michele, Occhetta Eraldo, Bongiorni Maria Grazia, Proclemer Alessandro, Favale Stefano, Iacopino Saverio, Calò Leonardo, Vado Antonello, Buja Gianfranco, Mascioli Giosuè, Quartieri Fabio, Tritto Massimo, Parravicini Umberto, Castro Antonio, Tomasi Corrado, Villani Giovanni Quinto, D'Acri Matteo Giuseppe, Klersy Catherine, Gasparini Maurizio, SAFE-ICD Study Investigators
Аннотация
OBJECTIVES: The purpose of this study is to assess the effectiveness of defibrillation testing (DT) in patients undergoing implantable cardioverter-defibrillator (ICD) insertion.
BACKGROUND: Although DT is considered a standard procedure during ICD implantation, its usefulness has not been definitively proven.
METHODS: The SAFE-ICD (Safety of Two Strategies of ICD Management at Implantation) study is a prospective observational study designed to evaluate the outcome of 2 strategies: performing defibrillation testing (DT+) versus not performing defibrillation testing (DT-) during de novo ICD implants. No deviation from the centers' current practice was introduced. In all, 2,120 consecutive patients (836 DT+ and 1,284 DT-) age ≥18 years were enrolled at 41 Italian centers from April 2008 to May 2009 and followed up for 24 months until June 2011. The primary endpoint was a composite of severe complications at ICD implant and sudden cardiac death or resuscitation at 2 years.
RESULTS: The primary endpoint occurred in 34 patients: 12 intraoperative complications (8 in DT+ group; 4 in DT- group) and 22 during follow-up (10 in DT+ group; 12 in DT- group). Overall, the estimated yearly incidence (95% confidence interval) was DT+ 1.15% (0.73 to 1.83) and DT- 0.68% (0.42 to 1.12). The difference between the 2 groups was negligible: 0.47% per year (-0.15 to 1.10). Mortality from any cause was similar at 2 years (adjusted hazard ratio: 0.97 [0.76 to 1.23], p = 0.80).
CONCLUSIONS: In this large cohort of new ICD implants, event rates were similar and extremely low in both groups. These data indicate a limited clinical relevance for DT testing, thus supporting a strategy of omitting DT during an ICD implant. (Safety of Two Strategies of ICD Management at Implantation [SAFE-ICD]; NCT00661037).
BACKGROUND: Although DT is considered a standard procedure during ICD implantation, its usefulness has not been definitively proven.
METHODS: The SAFE-ICD (Safety of Two Strategies of ICD Management at Implantation) study is a prospective observational study designed to evaluate the outcome of 2 strategies: performing defibrillation testing (DT+) versus not performing defibrillation testing (DT-) during de novo ICD implants. No deviation from the centers' current practice was introduced. In all, 2,120 consecutive patients (836 DT+ and 1,284 DT-) age ≥18 years were enrolled at 41 Italian centers from April 2008 to May 2009 and followed up for 24 months until June 2011. The primary endpoint was a composite of severe complications at ICD implant and sudden cardiac death or resuscitation at 2 years.
RESULTS: The primary endpoint occurred in 34 patients: 12 intraoperative complications (8 in DT+ group; 4 in DT- group) and 22 during follow-up (10 in DT+ group; 12 in DT- group). Overall, the estimated yearly incidence (95% confidence interval) was DT+ 1.15% (0.73 to 1.83) and DT- 0.68% (0.42 to 1.12). The difference between the 2 groups was negligible: 0.47% per year (-0.15 to 1.10). Mortality from any cause was similar at 2 years (adjusted hazard ratio: 0.97 [0.76 to 1.23], p = 0.80).
CONCLUSIONS: In this large cohort of new ICD implants, event rates were similar and extremely low in both groups. These data indicate a limited clinical relevance for DT testing, thus supporting a strategy of omitting DT during an ICD implant. (Safety of Two Strategies of ICD Management at Implantation [SAFE-ICD]; NCT00661037).