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Reported mortality with rotating sheaths vs. laser sheaths for transvenous lead extraction
Celso L Diaz1, Xiaofan Guo2, Isaac R Whitman3
1Department of Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
Summary
Laser sheaths used for transvenous lead extraction show a significantly higher mortality risk compared to rotating sheaths. This finding highlights potential safety concerns with laser sheath use in lead extraction procedures.
Area of Science:
- Cardiovascular Medicine
- Medical Device Technology
- Interventional Cardiology
Background:
- Transvenous lead extraction is a critical procedure for managing complications associated with cardiac implantable electronic devices.
- Rotating sheaths and laser sheaths are two primary tools utilized for lead extraction, each with distinct mechanisms of action.
- Comparative safety data, particularly regarding mortality, between these two sheath types is essential for clinical decision-making.
Purpose of the Study:
- To compare the observed mortality rates between patients undergoing transvenous lead extraction using rotating sheaths versus laser sheaths.
- To quantify the relative risk of death associated with each extraction method.
Main Methods:
- Analysis of the Manufacturer and User Facility Device Experience (MAUDE) database from 2011 to 2016 for reported deaths linked to rotating and laser sheaths.
- Estimation of the number of procedures performed for each sheath type using data from an independent analytics firm to calculate market share.
- Calculation of the relative risk (RR) of mortality using various market share scenarios and sensitivity analyses, including adjustments for potential underreporting of deaths.
Main Results:
- An estimated 50,545 lead extractions were performed during the study period.
- Thirteen deaths were associated with rotating sheaths compared to 167 deaths with laser sheaths.
- The relative risk of death was significantly higher with laser sheaths (RR = 7.2; 95% CI 4.1-12.7, P < 0.0001) at the calculated market share of 36% rotating and 64% laser.
Conclusions:
- Transvenous lead extraction using laser sheaths is associated with a substantially higher risk of mortality compared to rotating sheaths.
- Cardiovascular injury was the primary cause of death in both groups (92% rotating, 95% laser).
- Further research is recommended to validate these findings and explore the underlying reasons for the observed mortality difference.
