Backgrounds: Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population. Methods: Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated. Results: Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure. Conclusions: In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.

Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications

Masiero, Giulia;D'Angelo, Livio;Fovino, Luca Nai;Fabris, Tommaso;Cardaioli, Francesco;Rodinò, Giulio;Benedetti, Alice;Boiago, Mauro;Continisio, Saverio;Montonati, Carolina;Sciarretta, Tommaso;Zuccarelli, Vittorio;Scotti, Andrea;Lorenzoni, Giulia;Fraccaro, Chiara;Iliceto, Sabino;Esposito, Giovanni;Tarantini, Giuseppe
2022

Abstract

Backgrounds: Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population. Methods: Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated. Results: Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure. Conclusions: In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11577/3441376
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