Efficacy of a 16 Fr sheath strategy during Impella support to reduce access site bleeding in patients with cardiogenic shock.

Abstract

Access site bleeding is a complication which may occur during Impella support (Abiomed, Danvers, MA, USA), possibly due to unstable fixation of the device in the groin. Using a large-bore sheath for Impella insertion may reduce this complication. However, the efficacy and safety of this strategy are still unknown. The main aim of this study was to assess whether employing a large-bore sheath during Impella insertion mitigates access site bleeding without increasing limb ischemia. All consecutive patients who received either the Impella 2.5 or CP for cardiogenic shock from September 2019 to February 2023 were included in this study. We compared patients who underwent Impella insertion using the conventional peel-away introducer and the attached sheath (repositioning sheath) and patients in whom the Impella was inserted using a 16 Fr sheath. All patients received antegrade perfusion with a 4Fr sheath to prevent limb ischemia at the Impella site. The primary outcome was access site major bleeding: 36 patients were treated with a 16 Fr sheath and 39 were treated with a conventional sheath. The use of a 16 Fr sheath was associated with a significant reduction in major bleeding (33.0% vs. 64.0%, p = 0.01) in comparison to the conventional sheath. After adjusting for covariates, the risk of major bleeding at the access site in the 16 Fr sheath group was significantly lower than that in the conventional sheath group (adjusted odds ratio, 0.294; 95% confidence interval 0.087-0.991; p = 0.048). The insertion of Impella through a 16 Fr sheath significantly reduced the risk of major bleeding at the access site in comparison to the conventional sheath.