Experience of cardioverter-defibrillators inserted without thoracotomy: evaluation of transvenously inserted intracardiac leads alone or with a subcutaneous axillary patch.

OBJECTIVES: To compare the efficacy of a purely transvenous cardioverter-defibrillator (ICD) system with that of a system with a supplementary subcutaneous patch. To evaluate clinical follow up of these lead arrangements that do not require thoracotomy.
DESIGN: A simplified defibrillation protocol to test two different lead arrangements during implantation, with routine clinical follow up after implantation.
SETTING: Tertiary referral centre for treatment of arrhythmia. PATIENTS: 22 consecutive patients selected for implantation of an ICD because of life-threatening ventricular arrhythmias (ventricular fibrillation or sustained ventricular tachycardia) of whom 20 entered the test protocol. INTERVENTION: Implantation of an ICD with transvenously inserted intracardiac leads and a subcutaneous patch and assessment of effective defibrillation followed by testing of the purely transvenous approach. MAIN OUTCOME MEASURES: Reproducible conversion of ventricular fibrillation to sinus rhythm at a certain energy level, providing a safety margin of at least 10 J for both lead arrangements. Confirmation of efficacy during clinical follow up (mean 6 months).
RESULTS: A transvenous lead system combined with a subcutaneous axillary patch was implanted in 20/22 patients and it provided adequate and acceptable energy levels. In 10/20 tested patients a purely transvenous lead configuration provided an acceptable safety margin as well. Nine patients had clinical recurrences: all these arrhythmias were successfully converted.
CONCLUSION: A transvenous lead system was sufficient in 50% of the patients at the time of implantation. Data on long-term clinical follow up of this arrangement are not available. The approach without thoracotomy with a subcutaneous patch is feasible and effective in most patients selected for ICD treatment.