First experience with a new nonthoracotomy defibrillation lead system.
The clinical efficacy and safety of a new nonthoracotomy defibrillation lead system (TVL lead system, Ventritex, inc., Sunnyvale, Calif.) was studied in patients with ventricular tachycardia or fibrillation. Implantation of the TVL lead system and a Cadence pulse generator (Ventritex, Inc.) was attempted in 27 patients. A subcutaneous patch lead was added if required to achieve adequate defibrillation energy. Patients were monitored for an average of 6 +/- 4 months (range 1 week to 14 months). Implantation was successful in 26 patients (96%). Twenty-three of those patients (88%) were implanted in a lead-alone configuration; the remaining three (12%) required a subcutaneous patch lead. The mean defibrillation threshold was 401 +/- 120 V (12 +/- 7 J) at implantation, 467 +/- 134 V (15 +/- 8 J) at predischarge testing, and 452 +/- 151 V (14 +/- 9 J) at 4-month follow-up. The mean defibrillation threshold at 4 months was not significantly different from that at implant. No deaths, sensing anomalies, infections, lead fractures, or lead dislodgments occurred. One patient required addition of a subcutaneous patch 4 months after device implantation because of an elevated defibrillation threshold. Eight patients (31%) experienced 545 spontaneous arrhythmic episodes, and all episodes were successfully terminated by the device. In conclusion, the TVL lead system combined with Cadence tiered-therapy defibrillator has a high success rate and low complication rate, and it can be recommended for treatment of patients with life-threatening ventricular tachyarrhythmias.
Trappe
H J
HJ
Department of Cardiology, University Hospital, Ruhr-University Bochurn, Herne, Germany.
Pfitzner
P
P
Wenzlaff
P
P
Fain
E
E
Fieguth
H G
HG
D000328:Adult; D000368:Aged; D002304:Cardiac Pacing, Artificial; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock; D017097:Electric Impedance; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D010351:Patient Discharge; D017180:Tachycardia, Ventricular / Q000628:therapy; D013908:Thoracotomy; D014693:Ventricular Fibrillation / Q000628:therapy