A randomized-controlled pilot study comparing ICD implantation with and without intraoperative defibrillation testing in patients with heart failure and severe left ventricular dysfunction: a substudy of the raft trial
Journal of Cardiovascular Electrophysiology, 07/27/2012
Healey JS et al. – In this randomized trial, perioperative complications, failed appropriate shocks, and arrhythmic death were all uncommon regardless of defibrillation testing (DT). There was a nonsignificant increase in the risk of death or HF hospitalization with DT.Methods
- During the last year of enrolment in the Resynchronization for Ambulatory Heart Failure Trial, a substudy randomized patients to ICD implantation with versus without DT.
- Among 252 patients screened, 145 were enrolled; 75 randomized to DT and 70 to no DT.
- Patients were similar in terms of age (65.9 ± 9.3 years vs 67.9 ± 8.9 years); LVEF (24.7 ± 4.6% vs 23.6 ± 4.6%), QRS width (154.8 ± 23.5 vs 155.8 ± 23.6 ms), and history of atrial fibrillation (5% vs 6%).
- All 68 patients in the DT arm tested according to the protocol achieved a successful DT (≤25 J); 96% without requiring any system modification.
- No patient experienced perioperative stroke, myocardial infarction, heart failure (HF), intubation or unplanned ICU stay.
- The length of hospital stay was not prolonged in the DT group: 20.2 ± 26.3 hours versus 21.3 ± 23.0 hours, P = 0.79.
- One patient in the DT arm had a failed appropriate shock and no patient suffered an arrhythmic death.
- The composite of HF hospitalization or all–cause mortality occurred in 10% of patients in the no–DT arm and 19% of patients in the DT arm (HR = 0.53, 95% CI: 0.21–1.31, P = 0.14).