title: Clinical evaluation of defibrillation testing in an unselected population of 2,120 consecutive patients undergoing first implantable cardioverter-defibrillator implant.
abstract: OBJECTIVE
  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).
authors.affiliation: Ospedali del Tigullio, Lavagna, Italy. mbrignole@asl4.liguria.it
authors.forename: Michele
authors.initials: M
authors.lastname: Brignole
authors.forename: Eraldo
authors.initials: E
authors.lastname: Occhetta
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bongiorni
authors.forename: Alessandro
authors.initials: A
authors.lastname: Proclemer
authors.forename: Stefano
authors.initials: S
authors.lastname: Favale
authors.forename: Saverio
authors.initials: S
authors.lastname: Iacopino
authors.forename: Leonardo
authors.initials: L
authors.lastname: Calò
authors.forename: Antonello
authors.initials: A
authors.lastname: Vado
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Buja
authors.forename: Giosuè
authors.initials: G
authors.lastname: Mascioli
authors.forename: Fabio
authors.initials: F
authors.lastname: Quartieri
authors.forename: Massimo
authors.initials: M
authors.lastname: Tritto
authors.forename: Umberto
authors.initials: U
authors.lastname: Parravicini
authors.forename: Antonio
authors.initials: A
authors.lastname: Castro
authors.forename: Corrado
authors.initials: C
authors.lastname: Tomasi
authors.forename: Giovanni Quinto
authors.initials: GQ
authors.lastname: Villani
authors.forename: Matteo Giuseppe
authors.initials: MG
authors.lastname: D'Acri
authors.forename: Catherine
authors.initials: C
authors.lastname: Klersy
authors.forename: Maurizio
authors.initials: M
authors.lastname: Gasparini
mesh_terms: D000368:Aged; D016757:Death, Sudden, Cardiac / Q000453:epidemiology*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004554:Electric Countershock / Q000379:methods*; D005260:Female; D006323:Heart Arrest / Q000209:etiology; D006331:Heart Diseases / Q000628:therapy; D006801:Humans; D015994:Incidence; D007431:Intraoperative Complications; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009026:Mortality; D011183:Postoperative Complications; D015996:Survival Rate; D016896:Treatment Outcome