Background: Transcatheter aortic valve replacement (TAVR) is a first-line treatment for severe symptomatic aortic stenosis (AS) patients, and the preferred approach for TAVR is transfemoral. The double-ProGlide preclose technique offers an effective and safe method for closure of transfemoral access site after TAVR. However, the debate is still ongoing whether a single-ProGlide strategy is equal or even superior to a double one in terms of hemostasis and vascular complications.
Aims: The aim of this study is to examine the safety and efficacy of a single- versus double-ProGlide strategy for vascular closure during transfemoral TAVR.
Methods: Patients with severe AS who underwent transfemoral TAVR in the second affiliated hospital Zhejiang university school of medicine in the period from June 2021 to December 2023 were included and divided by the number of ProGlide device. The primary outcome of this study was a composite of in-hospital main access route related vascular complications, main access route related bleeding, and vascular closure device failure in accordance with Valve Academic Research Consortium-3 (VARC-3) criteria. The propensity-score matched (PSM) analysis was used to account for differences in baseline characteristics, and binary logistic regression was used to determine the predictive factors for the primary outcome.
Results: A total of 347 patients were included, of which 154 (44.0%) had a single ProGlide device used for arteriotomy closure, and 193 (56.0%) had a double one. After PSM, the incidence of primary composite outcome was significantly lower in the single-ProGlide group (7.7% vs. 17.9%, p = 0.023), while the incidence of in-hospital vascular complications (6.0% vs. 11.1%, p = 0.210) and bleeding (1.7% vs. 6.8%, p = 0.109) related to the main access route was lower but not significant. Multivariate logistic regression showed that single-ProGlide (for double-ProGlide, OR = 0.408, 95% CI = 0.182-0.914, p = 0.029) and an increase in the minimal lumen diameter of main access route (per 1.0 mm, OR = 0.618, 95% CI = 0.416-0.919, p = 0.017) were protective factors for the primary outcome.
Conclusions: A single-ProGlide device is a safe and effective mean of vascular closure after transfemoral TAVR and may have important clinical benefits compared to the commonly used double-ProGlide technique.
Keywords: bleeding complications; transcatheter aortic valve replacement; vascular closure; vascular complications.
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