Postoperative lead-related complications in patients with nonthoracotomy defibrillation lead systems

Objectives This study sought to document postoperative complications attributable to nonthoracotomy defibrillation lead systems in large cohort. Background The incidence of postoperative complications specifically associated with nonthoracotomy defibrillation lead sys. tems is unknown. Methods Postoperative lead-related complications were evaluated in 170 patients with nonthoracotomy defibrillation lead system who were followed up for mean (±SD) of 17 ± 12 months. Each system incorporated one or more intravascular leads. In 117 patients (69%), the system incorporated subcutaneous defibrillation patch. All implantations were performed in an operating room by cardiothoracic surgeons. Defibrillation thresholds were measured at implantation, before hospital discharge (mean 3 ± 2 days) and at 4 to 18 weeks after implantation. Patients were evaluated every 2 to 3 months after implantation or as indicated by clinical exigency. Results Twenty-seven patients (15.9%) were diagnosed with lead-related complication that either extended the initial hospital period or led to second hospital admission. Complications included endocardial lead or subcutaneous defibrillation patch dislodgment in eight patients (4.7%), which was diagnosed between 2 and 345 days after implantation; endocardial or subcutaneous patch lead fracture in six (3.5%), which was diagnosed between 53 and 600 days after implantation; subcutaneous patch mesh fracture in one, which was diagnosed at 150 days after implantation; subclavian vein thrombosis in three (1.8%), which was diagnosed at 2 to 50 days after implantation; and unacceptably elevated defibrillation threshold (within 5 J of maximal device output) in nine (5.3%), which was documented at one of the two postimplantation evaluations in eight patients or at the time of failure to terminate spontaneous ventricular tachycardi in one. Seventeen of the 27 patients required reoperation for correction of their complication. In addition, system infection requiring complete explantation occurred in seven other patients (4.1%) at an interval from implantation ranging from 14 to 120 days. Conclusions Postoperative complications related to nonthoracotomy defibrillation lead system were common and frequently required reoperation for correction. The rate of system explantation due to infection was also significant. Postoperative defibrillation testing and vigilant outpatient follow-up evaluation are necessary to ensure normal lead function.