REC, interventional cardiology · 2023
The MANTA Vascular Closure Device in transfemoral TAVI: a real-world cohort.
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Martinho Sofia, Jorge Elisabete, Marinho Vera, Baptista Rui, Costa Marco, Gonçalves Lino
Аннотация
INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with symptomatic severe aortic stenosis often performed via transfemoral access route (TF-TAVI). Therefore, successful closure of large-bore access sites is essential. This study aims to investigate the safety and effectiveness of the MANTA (Teleflex/Essential Medical, United States) vascular closure device (VCD) in patients undergoing TF-TAVI in an unselected and consecutive cohort of patients.
METHODS: We conducted a single-center, observational study of 245 consecutive patients undergoing TF-TAVI in whom the arterial large-bore femoral access was closed with a MANTA device from March 2020 through February 2022. The primary efficacy outcome measure was the rate of VCD failure according to the VARC-3 definition.
RESULTS: Successful closure of the large-bore access site occurred in 92.2% of the patients (n = 226). According to the VARC-3 definition, no major vascular or bleeding complications related to the plug-based VCD were reported. Patients with failed VCDs (7.8%) had significantly smaller minimal femoral artery diameters (6.6 ± 1.1 mm vs 7.6 ± 1.4 mm; P = .005) and consequently, significant higher sheath-to-femoral artery diameter ratios (0.78 ± 0.16 vs 0.69 ± 0.15; P = .019). No other inter-group differences were found.
CONCLUSIONS: In this single-center, real-world, unselected large cohort of consecutive patients treated with TF-TAVI, a plug-based VCD for large-bore arteriotomy closure turned out effective and safe, and enabled arterial access-site management with a low rate of complications.
METHODS: We conducted a single-center, observational study of 245 consecutive patients undergoing TF-TAVI in whom the arterial large-bore femoral access was closed with a MANTA device from March 2020 through February 2022. The primary efficacy outcome measure was the rate of VCD failure according to the VARC-3 definition.
RESULTS: Successful closure of the large-bore access site occurred in 92.2% of the patients (n = 226). According to the VARC-3 definition, no major vascular or bleeding complications related to the plug-based VCD were reported. Patients with failed VCDs (7.8%) had significantly smaller minimal femoral artery diameters (6.6 ± 1.1 mm vs 7.6 ± 1.4 mm; P = .005) and consequently, significant higher sheath-to-femoral artery diameter ratios (0.78 ± 0.16 vs 0.69 ± 0.15; P = .019). No other inter-group differences were found.
CONCLUSIONS: In this single-center, real-world, unselected large cohort of consecutive patients treated with TF-TAVI, a plug-based VCD for large-bore arteriotomy closure turned out effective and safe, and enabled arterial access-site management with a low rate of complications.