title: Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction.
abstract: OBJECTIVE
  An estimated 10,000-15,000 pacemaker and implantable cardioverter-defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective.
  
  
  RESULTS
  We searched the US Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008 using the search terms 'lead extraction and death' and 'lead extraction and injury'. Additional product specific searches were performed for the terms 'death' and 'injury'. Between 1995 and 2008, 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported to the FDA. Owing to underreporting, the FDA database does not contain all adverse events that occurred during this period. Of the 105 events, 27 deaths and 13 injuries occurred in 2007-2008. During these 2 years, 23 deaths were linked with excimer laser or mechanical dilator sheath extractions. The majority of deaths and injuries involved ICD leads, and most were caused by lacerations of the right atrium, superior vena cava, or innominate vein. Overall, 62 patients underwent emergency surgical repair of myocardial perforations and venous lacerations and 35 (56%) survived.
  
  
  CONCLUSIONS
  These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown, the results of our study imply that device-assisted lead extractions should be performed by highly qualified physicians and their teams in specialized centres.
authors: Minneapolis Heart Institute Foundation, 920 East 28th Street, Suite 300, Minneapolis, MN 55407, USA. rhauser747@aol.com
authors: Robert G
authors: RG
authors: Hauser
authors: William T
authors: WT
authors: Katsiyiannis
authors: Charles C
authors: CC
authors: Gornick
authors: Adrian K
authors: AK
authors: Almquist
authors: Linda M
authors: LM
authors: Kallinen
mesh_terms: D001145:Arrhythmias, Cardiac / Q000401:mortality* / Q000628:therapy*; D016208:Databases, Factual; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000209:etiology; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000009:adverse effects / Q000706:statistics & numerical data; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data; D004869:Equipment Safety / Q000706:statistics & numerical data; D006335:Heart Injuries / Q000209:etiology / Q000401:mortality; D006801:Humans; D010138:Pacemaker, Artificial / Q000009:adverse effects* / Q000706:statistics & numerical data*; D011358:Product Surveillance, Postmarketing; D019919:Prosthesis Implantation / Q000401:mortality; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data