Clinical Evaluation of Defibrillation Testing in an Unselected Population of 2,120 Consecutive Patients Undergoing First Implantable Cardioverter-Defibrillator Implant

被引：52

作者：

Brignole, Michele ^{[1
]}

Occhetta, Eraldo ^{[2
]}

Bongiorni, Maria Grazia ^{[3
]}

Proclemer, Alessandro ^{[4
]}

Favale, Stefano ^{[5
]}

Iacopino, Saverio ^{[6
]}

Calo, Leonardo ^{[7
]}

Vado, Antonello ^{[8
]}

Buja, Gianfranco ^{[9
]}

Mascioli, Giosue ^{[10
]}

Quartieri, Fabio ^{[11
]}

Tritto, Massimo ^{[12
]}

Parravicini, Umberto ^{[13
]}

Castro, Antonio ^{[14
]}

Tomasi, Corrado ^{[15
]}

Villani, Giovanni Quinto ^{[16
]}

D'Acri, Matteo Giuseppe ^{[17
]}

Klersy, Catherine ^{[18
]}

Gasparini, Maurizio ^{[19
]}

机构：

[1] Osped Tigullio, Arrhythmol Ctr, Dept Cardiol, I-16033 Lavagna, Italy

[2] Osped Maggiore La Carita, Novara, Italy

[3] Osped Cisanello, Pisa, Italy

[4] Osped S Maria Misericordia, Udine, Italy

[5] Osped Consorziale Policlin, Bari, Italy

[6] Osped St Anna, Catanzaro, Italy

[7] Osped Casilino, Rome, Italy

[8] Osped Santa Croce & Carle, Cuneo, Italy

[9] Univ Padua Polyclin, Padua, Italy

[10] Osped Gavazzeni, Bergamo, Italy

[11] Osped Santa Maria Nuova, Reggio Emilia, Italy

[12] Osped Mater Domini, Castellanza, Italy

[13] Osped SS Trinita, Borgomanero, Italy

[14] Osped Sandro Pertini, Rome, Italy

[15] Osped Santa Maria delle Croci, Ravenna, Italy

[16] Osped Guglielmo da Saliceto, Piacenza, Italy

[17] Boston Sci, Milan, Italy

[18] Policlin San Matteo, I-27100 Pavia, Italy

[19] IRCCS Ist Clin Humanitas, Rozzano, Italy

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2012年 / 60卷 / 11期

关键词：

defibrillation testing; implantable defibrillators; sudden death; FOLLOW-UP; ICD; TIME; DEATH; BENEFIT;

D O I：

10.1016/j.jacc.2012.05.014

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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) (J Am Coll Cardiol 2012;60:981-7) (C) 2012 by the American College of Cardiology Foundation

引用

页码：981 / 987

页数：7

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