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

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

doi:10.3389/fcvm.2022.832242

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

Front Cardiovasc Med. 2022 Feb 28:9:832242. doi: 10.3389/fcvm.2022.832242. eCollection 2022.

Authors

Giulia Masiero¹, Livio D'Angelo¹, Luca Nai Fovino¹, Tommaso Fabris¹, Francesco Cardaioli¹, Giulio Rodinò¹, Alice Benedetti¹, Mauro Boiago¹, Saverio Continisio¹, Carolina Montonati¹, Tommaso Sciarretta¹, Vittorio Zuccarelli¹, Andrea Scotti¹, Giulia Lorenzoni¹, Andrea Pavei¹, Massimo Napodano¹, Chiara Fraccaro¹, Sabino Iliceto¹, Alfredo Marchese², Giovanni Esposito³, Giuseppe Tarantini¹

Affiliations

¹ Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
² Unit of Cardiology, GVM Care and Research, Anthea Hospital, Bari, Italy.
³ Divisions of Cardiology and Cardiothoracic Surgery, Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy.

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.

Keywords: common femoral artery (CFA); multidetector computed tomography (MDCT); transfemoral transcatheter aortic valve implantation (TF-TAVI); valve academic research consortium (VARC); vascular closure device (VCD); vascular complications.

Copyright © 2022 Masiero, D'Angelo, Fovino, Fabris, Cardaioli, Rodinò, Benedetti, Boiago, Continisio, Montonati, Sciarretta, Zuccarelli, Scotti, Lorenzoni, Pavei, Napodano, Fraccaro, Iliceto, Marchese, Esposito and Tarantini.