Reported mortality with rotating sheaths vs. laser sheaths for transvenous lead extraction

Abstract

Abstract Aims Rotating sheaths and laser sheaths are commonly used for transvenous lead extraction. This study aims to compare observed mortality between both approaches. Methods and results The Manufacturer and User Facility Device Experience database was searched from 2011 to 2016 to determine number of deaths associated with each sheath. An independent analytics firm provided estimates for number of cases done, allowing calculation of market share. A sensitivity analysis was performed to determine relative risk (RR) of mortality at the calculated market share (36% rotating/64% laser) and two others. Additional sensitivity analyses assumed underreporting of deaths associated with rotating sheaths. An estimated 50 545 extractions were performed. Thirteen deaths were associated with rotating sheaths compared to 167 with laser sheaths. Of these, 92% (rotating) and 95% (laser) were due to cardiovascular injury. At the calculated market share, the RR of death was 7.2 times greater with laser sheaths [95% confidence interval (CI) 4.1–12.7, P < 0.0001]. At market share estimates of 25% rotating/75% laser and 45% rotating/55% laser, the RR of death with laser sheaths was 4.3 (95% CI 2.4–7.5, P < 0.0001) and 10.5 times greater (95% CI 6.0–18.5, P < 0.0001), respectively. The RR of death remained significant when assuming deaths with rotating sheaths were underreported and when deaths using both sheaths were attributed to the rotating sheath. Conclusions Lead extraction with laser sheaths appears to be associated with a higher risk of mortality compared to rotating sheaths. Further studies are warranted to confirm this finding.