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 implantation (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 ineligible 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 4.95-44466.57, 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.