Author + information
- Received January 12, 1995
- Revision received April 14, 1995
- Accepted April 27, 1995
- Published online September 1, 1995.
- David Schwartzman, MD*,
- Nasaraiah Nallamothu, MD,
- David J. Callans, MD, FACC,
- Mark W. Preminger, MD, FACC,
- Charles D. Gottlieb, MD, FACC and
- Francis E. Marchlinski, MD, FACC
- ↵*Address for correspondence: Dr. David Schwartzman, Philadelphia Heart Institute, 39th and Market Streets. Philadelphia. Pennsylvania 19104.
Objectives This study sought to document postoperative complications attributable to nonthoracotomy defibrillation lead systems in a 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 a nonthoracotomy defibrillation lead system who were followed up for a mean (±SD) of 17 ± 12 months. Each system incorporated one or more intravascular leads. In 117 patients (69%), the system incorporated a 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 a lead-related complication that either extended the initial hospital period or led to a 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 a spontaneous ventricular tachycardia 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 a 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.
- Received January 12, 1995.
- Revision received April 14, 1995.
- Accepted April 27, 1995.
- American College of Cardiology