COMPARISON OF RESULTS IN 2 IMPLANTABLE DEFIBRILLATORS

The Jewel 7219D was the first non-thoracotomy implantable cardioverter -defibrillator (ICD) with biphasic shock capability small enough to be placed in the prepectoral subcutaneous position. Size reduction of IC Ds is desirable, but safety and efficacy of smaller devices must be de monstrated. Outcomes of patients treated with the Jewel 7219D defibril lator (n = 1,781) and with its precursor model PCD 7217B (n = 2,637) w ere compared. To use PCD patients (n = 2,637) as historical (n = 2,574 ) and concurrent controls (n = 63), statistical adjustments using the Cox proportional-hazards regression model were mc;de. Jewel recipients (n = 1,781) treated in 106 US and 32 non-US centers exhibited similar characteristics including a mean age of 59 years, 78% men, ejection f raction of 34%, history of aborted sudden cardiac death in 41%, and co ronary artery disease in 70%. Implantation was completed in 1,777 of 1 ,781 (99.9%) attempts and success with the first electrode configurati on and polarity was 89.5%. Kaplan-Meier cumulative first-year survival s for cardiac and all-cause mortality were 98.5% and 93.3%. Complicati on-free first-year survival for Jewel implants in prepectoral subcutan eous (n = 582), subpectoral submuscular (n = 366), and abdominal (n = 449) positions did not differ (p >0.05). First-year survival free of p ocket-related complications exceeded 98% in all locations. Adjusted ca rdiac and all-cause first-year mortality, and efficacy in terminating spontaneous tachyarrhythmias did not differ between the 2 device group s. In conclusion, the safety and efficacy of Jewel model 7219D in the prepectoral subcutaneous position are at least equal to either those o f Jewel models implanted in different positions or to those of the pre viously extensively characterized PCD 7217B. (C)1998 by Excerpta Medic a, Inc.