Single or double suture-based devices with additional endovascular plug for vascular closure after transfemoral transcatheter aortic valve implantation.

Abstract

Background: Procedure-related vascular and bleeding complications after transcatheter aortic valve implantation (TAVI) still represents an important issue that impact on patients' mortality and morbidity. The aim of this study was to compare the effectiveness of single or double suture-based devices (SBDs) combined with a plug-based device to obtain large bore arteriotomy hemostasis after transfemoral (TF) TAVI.

Methods: Consecutive patients with available preprocedural computed tomography angiography (CTA) assessment undergoing 14Fr TF-TAVI from February 2018 to May 2023 at our Institution were considered. Patient receiving single or double SBD combined with a plug-based device were compared after propensity score matching. The primary outcomes were major vascular complications and type 2 to 4 bleeding due to endovascular closure system failure according VARC-3 criteria.

Results: Among a total of 490 patients, 130 matched pairs of patients were compared. At 30 days, there was no difference in major vascular complications (0.0% vs. 2.3%, P=0.25) and in type 2 to 4 bleedings (4.6% vs. 6.2%, P=0.78) between two matched groups. No difference in 30-day (1.5% vs. 3.8%, P=0.45) and one-year (12.0% vs. 9.5%, P=0.60) all-cause death was observed.

Conclusions: A simpler strategy with single SBD had comparable safety and effectiveness to the use of double SBD when combined to a plug-base device after 14 Fr TF-TAVI.