Transvenous defibrillator systems implanted by electrophysiologists in the catheterization laboratory.

BACKGROUND

A significantly lower perioperative mortality has established the nonthoracotomy approach as the preferred technique in implantable cardioverter defibrillation (ICD) implantation. With the currently available transvenous endocardial leads in combination with the expanded use of biphasic ICD devices, the need for use of an additional subcutaneous lead has almost been eliminated. Thus, implantation of these systems has been simplified and reports have appeared in the literature that the procedure can now be performed by an electrophysiologist alone without surgical assistance in the electrophysiology or catheterization laboratory.

HYPOTHESIS

The purpose of this study was to investigate the feasibility and safety of ICD implantation by an electrophysiologist in a procedure performed entirely in the catheterization laboratory without the assistance of a surgeon.

METHODS

Over a period of 28 months, we implanted transvenous ICDs in 40 consecutive patients with (n = 34) and without (n = 6) use of general anesthesia in the catheterization laboratory with minor surgical assistance in abdominal pocket fashioning for the first two cases and then working alone for the remainder. The study included 36 men and 4 women, aged 59 +/- 12.5 years, with coronary artery (n = 22) or valvular heart disease (n = 4), cardiomyopathy (n = 12), and long QT syndrome (n = 1) or idiopathic ventricular tachycardia (n = 1), and a mean left ventricular ejection fraction of 34%, who presented with ventricular tachycardia (n = 30) or ventricular fibrillation (n = 10).

RESULTS

One-lead ICD systems (Endotak, n = 21; Transvene, n = 8; or EnGuard, n = 1) were used in 30 patients, and 2-lead (EnGuard, n = 5 or Transvene, n = 5) systems in 10 patients. Generators were implanted in an abdominal (n = 17) or pectoral (n = 23) pocket. Active can devices were employed in 17 patients. The defibrillation threshold averaged 9 J. All implants were entirely transvenous with no subcutaneous patch. Biphasic ICD devices were employed in all patients. There were three complications (8%); one pulmonary edema that responded to drug therapy, one lead insulation break that required reoperation on the third day, and one pocket hematoma in a patient receiving anticoagulation, with no need for evacuation. There were no operative deaths and no infections. After implant, patients were discharged at a mean of 3 days. All devices functioned well at predischarge testing. During follow-up (12 +/- 8 months), 20 patients received appropriate and 5 patients inappropriate shocks. Three patients died of pump failure at 3, 7, and 19 months, respectively; they had received 0, 42, and 15 appropriate shocks, respectively, over these months. Another patient succumbed to a myocardial infarction at 9 months. At 6 months, one patient developed subacute subclavian vein thrombosis which resolved with anticoagulation therapy.

CONCLUSIONS

Current transvenous biphasic ICD systems allow experienced electrophysiologists to implant them safely alone in the catheterization laboratory without surgical assistance, even for abdominal implants, with a high success rate and no need for use of a subcutaneous patch.