Transvenous defibrillator systems implanted by electrophysiologists in the catheterization laboratory

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• The nonthoracotomy approach for implantable cardioverter-defibrillator (ICD) implantation offers lower perioperative mortality.
• Advancements in transvenous leads and biphasic ICDs have reduced the need for subcutaneous leads, simplifying the procedure.

Purpose of the Study:

• To evaluate the feasibility and safety of ICD implantation performed solely by an electrophysiologist.
• To assess the efficacy of performing the procedure entirely within a catheterization laboratory setting without surgical assistance.

Main Methods:

• 40 consecutive patients underwent transvenous ICD implantation over 28 months.
• Procedures were performed in the catheterization laboratory, with the electrophysiologist operating independently after initial minor surgical assistance for pocket creation in the first two cases.
• Patients received either one-lead or two-lead ICD systems, with generators implanted in abdominal or pectoral pockets.

Main Results:

• The study involved 40 patients (36 male, 4 female, mean age 59 years) with various heart conditions.
• Three complications (8%) occurred: pulmonary edema, lead insulation break, and pocket hematoma. No operative deaths or infections were reported.
• Follow-up averaged 12 months, with 20 patients receiving appropriate shocks and 5 experiencing inappropriate shocks. Three patients died from pump failure, and one from myocardial infarction.

Conclusions:

• Experienced electrophysiologists can safely implant current transvenous biphasic ICD systems independently in the catheterization laboratory.
• The procedure demonstrates a high success rate, even with abdominal generator placement, and negates the requirement for subcutaneous patches.