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Postoperative lead-related complications in patients with nonthoracotomy defibrillation lead systems
D Schwartzman1, N Nallamothu, D J Callans
1Clinical Electrophysiology Laboratory, Philadelphia Heart Institute, Presbyterian Medical Center of Philadelphia, Pennsylvania 19104, USA.
Insights
Postoperative complications are common with nonthoracotomy defibrillation lead systems, often requiring reoperation. System infection also necessitates explantation, highlighting the need for vigilant follow-up.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Complications
Background:
- The frequency of postoperative complications linked to nonthoracotomy defibrillation lead systems remains largely undocumented.
- Understanding these complications is crucial for patient safety and optimizing device performance.
Purpose of the Study:
- To systematically document and analyze postoperative complications associated with nonthoracotomy defibrillation lead systems in a large patient cohort.
- To identify the types and incidence of lead-related issues and infections.
Main Methods:
- A cohort of 170 patients with nonthoracotomy defibrillation lead systems was followed for a mean of 17 months.
- Complications were monitored through regular clinical evaluations and defibrillation threshold testing at multiple time points.
- Systems included intravascular leads and, in most cases, a subcutaneous defibrillation patch.
Main Results:
- A significant complication rate of 15.9% (27 patients) was observed, including lead dislodgement, lead fracture, and subcutaneous patch mesh fracture.
- Subclavian vein thrombosis occurred in 1.8% of patients, and elevated defibrillation thresholds were noted in 5.3%.
- System infection requiring explantation occurred in 4.1% of patients, with 17 patients needing reoperation for complications.
Conclusions:
- Postoperative complications following the implantation of nonthoracotomy defibrillation lead systems are frequent and often necessitate surgical correction.
- The incidence of system infection leading to explantation is substantial.
- Routine postoperative defibrillation testing and diligent outpatient follow-up are essential for ensuring the proper function and longevity of these lead systems.
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 systems 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.