title: Postoperative lead-related complications in patients with nonthoracotomy defibrillation lead systems.
abstract: OBJECTIVE
  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.
authors.affiliation: Clinical Electrophysiology Laboratory, Philadelphia Heart Institute, Presbyterian Medical Center of Philadelphia, Pennsylvania 19104, USA.
authors.forename: D
authors.initials: D
authors.lastname: Schwartzman
authors.forename: N
authors.initials: N
authors.lastname: Nallamothu
authors.forename: D J
authors.initials: DJ
authors.lastname: Callans
authors.forename: M W
authors.initials: MW
authors.lastname: Preminger
authors.forename: C D
authors.initials: CD
authors.lastname: Gottlieb
authors.forename: F E
authors.initials: FE
authors.lastname: Marchlinski
mesh_terms: D016010:Binomial Distribution; D016001:Confidence Intervals; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000706:statistics & numerical data; D004567:Electrodes, Implanted / Q000009:adverse effects* / Q000706:statistics & numerical data; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D013908:Thoracotomy; D013997:Time Factors