Key result
Transvenous lead extraction with laser sheaths was associated with a significantly higher risk of mortality compared to rotating sheaths (RR 7.2; 95% CI 4.1-12.7; P<0.0001).
Why the study?
Rotating sheaths and laser sheaths are commonly used for transvenous lead extraction, but observed mortality between both approaches had not been directly compared.
Does the use of laser sheaths compared to rotating sheaths increase mortality in patients undergoing transvenous lead extraction?
Observational (n=50,545)
Does the use of laser sheaths compared to rotating sheaths increase mortality in patients undergoing transvenous lead extraction?
Relative Risk: 7.2 (95% CI 4.1–12.7)
p-value: p=< 0.0001
Analysis of the MAUDE database suggests that transvenous lead extraction with laser sheaths is associated with a significantly higher risk of mortality compared to rotating sheaths.
Laser sheath use was associated with higher mortality; leaves open confounding versus causal risk, warranting RCTs before practice change.
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.
No takes yet. Share an insight, caveat, or question.
Diaz et al. (2019) conducted an observational in Transvenous lead extraction (n=50,545). Laser sheaths vs. Rotating sheaths was evaluated on Mortality (RR 7.2, 95% CI 4.1-12.7, p=< 0.0001). Transvenous lead extraction with laser sheaths was associated with a significantly higher risk of mortality compared to rotating sheaths (RR 7.2; 95% CI 4.1-12.7; P<0.0001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: