Performance of implantable defibrillator pacing/sensing lead adapters.
The wide variety of implantable defibrillators (ICDs) available from different manufactures and the lack of universal industry standards has resulted in the frequent need for lead adapters at time of ICD implant or change. We analyzed the performance of 81 consecutive ICD sensing/pacing lead adapters used between 1988 and 1993. A total of 66 adapters was used for new epicardial systems, and 15 adapters served as lead connectors during ICD generator replacement. Pacing/sensing lead adapters used were: model LA-201 (n = 28; 34.5%); model 030-308 (n = 26; 32%); model 5866-24 (n = 15; 18.5%); and miscellaneous (n = 12; 15%). After a mean follow-up of 21 +/- 16 months, nine pacing/sensing lead adapters had documented or strongly suspected failure. Most often pacing/sensing lead adapters presented clinically as frequent aborted shocks. Actuarial probability of freedom from failure for model LA-201 was 83% at 1 year, and 72% at 2 and 3 years; this was poorer than for the other sensing leads combined (P = 0.01; hazard ratio = 4.92; 95% confidence intervals = 1.2-20; log-rank test). In conclusion, pacing/sensing lead adapters are a potential source of ICD system complications. Performance is dissimilar among different models; specifically, model LA-201 may not be safe in the long-term, and patients with this lead adapter need to be closely monitored.
Sgarbossa
E B
EB
Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195, USA.
Shewchik
J
J
Pinski
S L
SL
D000206:Actuarial Analysis; D016001:Confidence Intervals; D017147:Defibrillators, Implantable; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D016017:Odds Ratio; D010138:Pacemaker, Artificial; D011336:Probability; D011358:Product Surveillance, Postmarketing