Implantable defibrillation: eight years clinical experience.

Implantation of the first automatic defibrillator occurred in February 1980. Incorporation of cardioversion capability in 1982 resulted in the AICD automatic implantable cardioverter defibrillator. Between April 1, 1982 and April 15, 1988, 3610 patients in 236 U.S. and 84 international centers received AICD pulse generators. Patient population consisted of 2904 males and 683 females with recurrent ventricular tachycardia and/or fibrillation, mean age 59 yrs. (range 9-96 yrs.). Primary diagnoses reported for the patient group were: coronary artery disease (63.5%), nonischemic cardiomyopathy (12.9%), other (6.4%) and unspecified (17.2%). Mean reported LV ejection fraction was 32.8%. Follow-up averaged 12.2 mo. (range 0-72 mo.). Of 385 deaths, 94 (24%) were sudden. Cumulative percentage survival (+/- S.E.) from sudden cardiac death (SCD) was 98.0 +/- 0.3%, 96.5 +/- 0.5%, 95.2 +/- 0.7%, 93.7 +/- 1.0%, 93.7 +/- 1.0% and 89.7 +/- 4.0% at 12, 24, 36, 48, 60 and 72 months, respectively. Operative mortality (less than or equal to 30 days) was 2.5%. Reported side effects/complications were similar to those of pacemakers. To date, 33% of the patients received spontaneous device countershocks. AICD pulse generator survival from electrical and mechanical failures was 92.8 +/- 0.5%, 88.4 +/- 0.7%, 86.7 +/- 0.8% and 86.4 +/- 0.9% at 12, 18, 24 and 30 mos. Data analysis demonstrates that the AICD has had a significant impact on patient survival from SCD.