Low incidence of lead related complications associated with nonthoracotomy implantable cardioverter defibrillator systems.
Implantable cardioverter defibrillators (ICDs) are increasingly being implanted without the need for thoracotomy. Long-term lead performance and stability were evaluated in 150 consecutive patients in whom 1 of 3 nonthoracotomy ICD lead systems was implanted over a 3-year period from September 1990.


RESULTS
Twelve (8%) patients (7 males, 5 females) experienced 13 lead complications during a follow-up period of 12 +/- 10 months. Complications were related to intracardiac leads in 7 (4 dislodgments, 2 fractures, 1 right ventricular perforation) and patch leads in 6 (2 folding, 1 fracture, 1 erosion, and 2 hematomas) cases. Freedom from lead related complications at 1 year was 92% (95% confidence interval, 86%-95%). A significant difference in freedom from lead complications between the two most frequently implanted lead systems was observed (P = 0.02). Complication rates were similar in the initial 75 and the more recent 75 implants (P = 0.5). The median time between lead implant and detection of complications was 37 days (range 3-1,147). Complications were diagnosed before hospital discharge in only two cases. In five patients, complications were asymptomatic and in three of these, reoperation was required due to inadequate defibrillation thresholds. Reoperation was necessary in 9 of 12 patients.


CONCLUSIONS
Nonthoracotomy ICD lead systems are associated with a low complication rate. Complications may or may not cause symptoms, usually occur after hospital discharge, and require reoperation. Complications are not related to a "learning curve." There is a significant difference in performance between different lead systems.
Fahy
G J
GJ
Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195.
Kleman
J M
JM
Wilkoff
B L
BL
Morant
V A
VA
Pinski
S L
SL
D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004567:Electrodes, Implanted / Q000009:adverse effects; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012086:Reoperation; D013908:Thoracotomy; D013997:Time Factors