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.
BACKGROUND
The need to perform defibrillation testing (DT) at the time of implantable cardioverter defibrillator (ICD) insertion is controversial. In the absence of randomized trials, some regions now perform more than half of ICD implants without 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.


RESULTS
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).


CONCLUSIONS
In this randomized trial, perioperative complications, failed appropriate shocks, and arrhythmic death were all uncommon regardless of DT. There was a nonsignificant increase in the risk of death or HF hospitalization with DT.
Population Health Research Institute, Barton St. East, Hamilton, Ontario, Canada. Jeff.Healey@phri.ca
Jeff S
JS
Healey
Lorne J
LJ
Gula
David H
DH
Birnie
Lawrence
L
Sterns
Stuart J
SJ
Connolly
John
J
Sapp
Eugene
E
Crystal
Chris
C
Simpson
Derek V
DV
Exner
Teresa
T
Kus
Francois
F
Philippon
George
G
Wells
Anthony S L
AS
Tang
D000368:Aged; D015897:Comorbidity; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004554:Electric Countershock / Q000379:methods / Q000706:statistics & numerical data*; D022062:Electrophysiologic Techniques, Cardiac / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006333:Heart Failure / Q000175:diagnosis* / Q000401:mortality / Q000601:surgery*; D006801:Humans; D015994:Incidence; D008297:Male; D016343:Monitoring, Intraoperative / Q000379:methods / Q000706:statistics & numerical data*; D009864:Ontario / Q000453:epidemiology; D010865:Pilot Projects; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis* / Q000401:mortality / Q000601:surgery*