To determine the incidence of complications of third-generation implantable
cardioverter defibrillator (ICD) therapy, 144 patients were prospectively
studied who underwent first implant of third-generation devices (i.e., ICD
systems with biphasic shocks, ECG storage capability and nonthoracotomy lea
d systems). During 21 +/- 15 months of follow-up, 42 (28%) patients had one
or more complications. No patient died perioperatively (30 days) and no IC
D infection was observed during follow-up. Complications included bleeding
or pocket hematoma (hemoglobin drop > 2 g/dL) in 5 (3%) patients, prolonged
reversible ischemic neurological deficit in 1 (1%) patient, postoperative
deep venous thrombosis of leg in 1 (1%) patient, pneumothorax in 2 (1%) pat
ients, difficulty to defibrillate ventricular fibrillation intraoperatively
in 2 (2%) patients, generator malfunction in 1 (2%) patient, arthritis of
the shoulder in 3 (2%) patients, and allergic reaction to prophylactic anti
biotics in 2 (1%) patients. A total of seven lead related complications wer
e observed in six (4%) patients including endocardial lead migration in fou
r (3%) patients. Twenty-three (16%) patients received inappropriate shocks
for supraventricular tachyarrhythmias (n = 13), nonsustained ventricular ta
chycardia (VT) (n = 7), or myopotential oversensing (n = 3). We conclude th
at serious complications such as perioperative death or ICD infection are r
are in patients with third-generation ICDs. Lead-related problems and inapp
ropriate shocks during follow-up are the most frequent complications of thi
rd-generation ICD therapy. Recognition of these complications should promot
e advances in ICD technology and management strategies to avoid their recur
rence.