To evaluate prospectively the safety and feasibility of the implantation of cardioverter/defibrillator systems under local anaesthesia. Conventionally, cardioverter/defibrillator systems are implanted under general anaesthesia. With the development of single-lead transvenous unipolar cardioverter/defibrillator systems for subpectoral implantation a pacemaker-like approach for device implantation appears applicable.Implantation of a single-lead transvenous unipolar cardioverter/defibrillator under local anaesthesia with sedation for defibrillation threshold testing was performed in 37 consecutive patients. The presenting arrhythmia was ventricular fibrillation in 13 patients, and monomorphic ventricular tachycardia in 24 patients. A 1% lidocaine solution was used for local anaesthesia, and midazolam was applied for sedation to perform defibrillation threshold testing. Arterial blood pressure, arterial oxygen saturation and heart rate were monitored throughout the procedure. The patient's tolerance of the implantation procedure was evaluated with a standardized questionnaire.The unipolar transvenous cardioverter/defibrillator system was implanted successfully in all patients under local anaesthesia. During defibrillation threshold testing, sufficient sedation was achieved with 12.5 +/- 3.7 mg midazolam. For determination of the defibrillation threshold 5.9 +/- 1.4 episodes of ventricular fibrillation were induced. The mean defibrillation threshold was 13.1 +/- 5.5 J, and the mean duration of the implantation procedure was 68 +/- 30 min. Mean heart rate, mean arterial blood pressure and arterial oxygen saturation were not significantly different before and after defibrillation threshold testing. Twenty-six patients (70%) were symptom-free throughout the implantation procedure; most of the remaining patients reported minor symptoms. There were no complications, and patients were discharged 2.2 +/- 0.7 days after implantation. In 12 patients, post-implant testing of the implantable cardioverter/defibrillators was performed successfully, without sedation, 2.8 +/- 1.4 days after as an outpatient procedure.Single-lead unipolar transvenous implantable cardioverter/defibrillator systems can be safely implanted under local anaesthesia with mild sedation for defibrillation threshold testing. The procedure is well tolerated.