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


Journal

Open heart
ISSN: 2053-3624
Titre abrégé: Open Heart
Pays: England
ID NLM: 101631219

Informations de publication

Date de publication:
10 2021
Historique:
received: 24 04 2021
accepted: 23 09 2021
entrez: 13 10 2021
pubmed: 14 10 2021
medline: 24 12 2021
Statut: ppublish

Résumé

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. 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). 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 34642241
pii: openhrt-2021-001703
doi: 10.1136/openhrt-2021-001703
pmc: PMC8513271
pii:
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: Boston Scientific funded the study and had a role in study design, but not in data collection and analysis, decision to publish, or preparation of the manuscript. The authors had full responsibility for data collection, data analysis, for writing the manuscript, and for the decision to submit for publication. Some of the authors serve as a proctor/advisory board member for Boston Scientific (NS, MS, RL and AR), Abbott Vascular (MS), WL Gore (MS), Edwards Lifesciences (AR) and Medtronic (MS and A.R).

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Auteurs

Natalie Glaser (N)

Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden Natalie.Glaser@ki.se.
Department of Cardiology, Stockholm South General Hospital, Stockholm, Sweden.

Crochan J O'Sullivan (CJ)

Department of Cardiology, Bon Secours Hospital, Cork, Ireland.
Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.

Nawzad Saleh (N)

Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Department of Medicine, Karolinska Institutet, Stockholm, Sweden.

Dinos Verouhis (D)

Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Department of Medicine, Karolinska Institutet, Stockholm, Sweden.

Magnus Settergren (M)

Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Department of Medicine, Karolinska Institutet, Stockholm, Sweden.

Rickard Linder (R)

Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Department of Medicine, Karolinska Institutet, Stockholm, Sweden.

Andreas Rück (A)

Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Department of Medicine, Karolinska Institutet, Stockholm, Sweden.

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