Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction
Open accessAbstract
AIMS: 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. METHODS AND 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. CONCLUSION: 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.
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Once implanted, the pacemaker lead-tissue interface develops fibrosis and adhesion to the cardiac chamber, rendering lead removal a life-threatening procedure.
“Once implanted, the pacemaker lead-tissue interface develops fibrosis and adhesion to the cardiac chamber, rendering lead removal a life-threatening procedure7.”
From Inductively powered wireless pacing via a miniature pacemaker and remote stimulation control system (2017) · cites this paper as [7]
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References 23 · Cited by 264
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- Authors
- Hauser, R. G., Katsiyiannis, W. T., Gornick, C. C., Almquist, A. K., & Kallinen, L. M.
- Affiliations
- Minneapolis Heart Institute Foundation (US)
- Corresponding author
- Hauser, R. G.
- ORCID
- Hauser, R. G.
- Venue
- Europace
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-11-27
- Volume
- 12
- Issue
- 3
- Pages
- 395-401
- ISSN
- 1099-5129 (ISSN-L)
- 1532-2092
- PMC
- PMC2825385
- OpenAlex
- W2109852870
- Cited by
- 264
- References
- 23
- Citations by year
- 2026: 9 · 2025: 13 · 2024: 8 · 2023: 8 · 2022: 14 · 2021: 16 · 2020: 13 · 2019: 19 · 2018: 24 · 2017: 28 · 2016: 18 · 2015: 19 · 2014: 12 · 2013: 14 · 2012: 13
- FWCI
- 10.02
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- EP Europace (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Minneapolis Heart Institute
- Minneapolis Heart Institute Foundation
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Epidemiology › Infective Endocarditis Diagnosis and Management
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Keywords
- implantable cardioverter-defibrillator leads, pacemaker leads, lead extraction complications, procedural mortality, cardiovascular damage, superior vena cava injury, myocardial perforation, emergency surgical repair, cardiothoracic surgery, adverse event reporting
- MeSH terms
- Arrhythmias, Cardiac, Electrodes, Implanted, Equipment Safety, Heart Injuries, Humans, Pacemaker, Artificial, Product Surveillance, Postmarketing, Risk Factors, United States, United States Food and Drug Administration, Databases, Factual, Death, Sudden, Cardiac, Defibrillators, Implantable, Equipment Failure Analysis, Prosthesis Implantation
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