How Accurate Are Manufacturers' Recommendations in Determining Ineligibility for Transfemoral Transcatheter Aortic Valve Implantation?

Introduction: Up to one-third of patients indicated for transcatheter aortic valve implanta-tion (TAVI) may be unsuitable for transfemoral TAVI (TF-TAVI) according to manufacturers' recommendations and numerous professional societies. Objective: This study aimed to investigate the predictive value of manufacturers' guidelines for major vascular access site complications using the Perclose ProGlide device.Methods: Among 208 patients undergoing TF-TAVI, 144 patients (69.2%) were deemed eligible for TF-TAVI according to the manufacturer's instructions. A minimal lumen diameter (MLD) of the femoral artery below the manufacturer's specified limits and/or the presence of circumferential calcification were the reasons for ineligibility. Calcium score (CS), sheath-to-femoral artery ratio (SFAR) and MLD were estimated from computed tomography imaging. Vascular complications (VCs) (defined according to VARC-2 criteria) were retrospectively compared.Results: Patients in the ineligible group had higher SFAR (1.13+0.15 vs. 0.88+0.107, p<0.001) and CS (1.66+0.99 vs. 1.24+0.73; p=0.003), and significantly lower MLD (7.72+1.03 vs. 6.31+0.96 mm; p<0.001) compared to the eligible group. Major (6.3% vs. 12.3%, p=0.13) and minor VCs (10.4% vs. 15.6%, p=0.29) were similar in the eligible and ineligible groups. The inel-igible group had higher rates of rupture (0.7% vs. 6.3%; p=0.03). SFAR was the only independent predictor of major VCs (OR 469.1, 95% CI 4.95-44 466.57, p=0.008).Conclusion: The TAVI team should not decide whether the patient is suitable for a femoral approach based solely on the manufacturer's criteria, and should incorporate additional factors that could be predictive of major VCs. (R) 2022 Sociedade Portuguesa de Cardiologia. Published by Elsevier Espan tilde a, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).