The clinical efficacy and safety of a new nonthoracotomy defibrillatio
n lead system (TVL lead system, Ventritex, Inc., Sunnyvale, Calif.) wa
s studied in patients with Ventricular tachycardia or fibrillation. Im
plantation of the TVL lead system and a Cadence pulse generator (Ventr
itex, Inc.) was attempted in 27 patients. A subcutaneous patch lead wa
s added if required to achieve adequate defibrillation energy. Patient
s were monitored for an average of 6 +/- 4 months (range 1 week to 14
months). Implantation was successful in 26 patients (96%). Twenty-thre
e of those patients (88%) were implanted in a lead-alone configuration
; the remaining three (12%) required a subcutaneous patch lead. The me
an defibrillation threshold was 401 +/- 120 V (12 +/- 7 J) at implanta
tion, 467 +/- 134 V (15 +/- 8 J) at predischarge testing, and 452 +/-
151 V (14 +/- 9 J) at 4-month follow-up. The mean defibrillation thres
hold at 4 months was not significantly different from that at implant.
No deaths, sensing anomalies, infections, lead fractures, or lead dis
lodgments occurred. One patient required addition of a subcutaneous pa
tch 4 months after device implantation because of an elevated defibril
lation threshold. Eight patients (31%) experienced 545 spontaneous arr
hythmic episodes, and all episodes were successfully terminated by the
device. In conclusion, the TVL lead system combined with Cadence tier
ed-therapy defibrillator has a high success rate and low complication
rate, and it can be recommended for treatment of patients with life-th
reatening ventricular tachyarrhythmias.