Transcatheter aortic valve replacement using the iSleeve expandable sheath in small femoral arteries

Open Heart. 2021 Oct;8(2):e001703. doi: 10.1136/openhrt-2021-001703.

Abstract

Background: Small femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries.

Methods: In this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5-9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9-5.4).

Results: There was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter.

Conclusion: Transfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis.

Keywords: aortic valve stenosis; epidemiology; heart valve prosthesis implantation; transcatheter aortic valve replacement.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't
  • Video-Audio Media

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiography / methods*
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / surgery*
  • Cardiac Catheterization / instrumentation
  • Equipment Design
  • Feasibility Studies
  • Female
  • Femoral Artery / diagnostic imaging*
  • Femoral Artery / surgery
  • Follow-Up Studies
  • Humans
  • Male
  • Retrospective Studies
  • Risk Factors
  • Transcatheter Aortic Valve Replacement / instrumentation*