Safety, feasibility and long term follow-up of a non-thoracotomy defibrillation system in patients with inducible sustained ventricular tachycardia/fibrillation.

UNLABELLED: A non-thoracotomy lead system CPI-ENDOTAK, a transvenous lead used alone or combined with a subcutaneous patch (SQ-P), was evaluated as an alternative to epicardial patches/electrodes in patients at high risk for sudden cardiac death undergoing implantable cardioverter-defibrillator (ICD) surgery. Fifty nine patients, 62 +/- 11.4 years with CAD (83.0%) cardiomyopathy (11.9%) other (5.1%), mean ejection fraction 31.8 +/- 14%, with inducible sustained VT/VF underwent testing of either lead alone or lead/SQ-P. Four configurations of NTL were tested. Fifty one patients had NTL implanted (lead alone = 60.8% and lead/SQ-P = 39.2%). Eight patients required non-NTL approaches, due to high DFT (7) or anatomic anomaly (1). DFT's were 19.1J (lead alone) and 20.8J (lead/SQ-P). Acute complications: pulmonary embolism 1, lead dislodgement 3, sensing malfunction 1. [table: see text]

CONCLUSION

A NTL system using either a single transvenous lead alone or combined with SQ-P can be implanted successfully in high risk patients with a low incidence of acute complications. Non-arrhythmic survival is lowest in patients receiving defibrillation shocks. Arrhythmic survival is high in all patients.