1Kath. St. Paulus Gesellschaft Klinik für Innere Medizin I Dortmund, Deutschland; 2Kath. St. Paulus Gesellschaft Klinik für Herz-, Thorax- und Gefäßchirurgie Dortmund, Deutschland; 3Klinikum Oldenburg AöR Klinik für Kardiologie Oldenburg, Deutschland
Background: Challenging vascular anatomies and comorbidities have impact on success in transcatheter aortic valve implantation (TAVI). The transfemoral approach is preferred over alternative approaches such as transapical or transsubclavian/transaxillary. Over the last few years, there has been a gradual improvement regarding introducers diameter and technical properties with a reduction in vascular complication rates even in small and calcified access vessels. Data on transcatheter heart valve (THV) success in small femoral diameters, especially outside the IFU (< 5.5 mm), are scarce.
Methods: Data from 904 patients with severe native aortic valve stenosis (AS) treated with either the SAPIEN 3 Ultra (Ultra; n=201) or the ACURATE neo2 (Neo2; n=739) THVs from January 2017 to October 2023 were included. The population was divided in patients with small femoral access diameter (<5.5mm; n=203) and normal femoral access diameter (>5.5mm; n=704). Clinical and procedural outcome were evaluated according to VARC-3 recommendations.
Results: Technical success (91.4% vs. 93.4%, p=0.396) and device success (93.6% vs. 93.6%, p=1.000) were high in both groups. The rate of failed access was very low irrespective of vessel diameter (0.4 vs. 0.9%, p=1.000). Major (12.0 vs. 5.2%, p=0.001) and minor vascular complications (5.2 vs. 1.2%, p=0.001) occurred more often in small access vessels, while the rate of acute (periinterventional: 3.9 vs. 1.8%, p=0.128) and delayed vascular therapy (postinterventional: 7.7 vs. 8.1%, p=908) did not differ. Multivariate logistic regression revealed admission antiplatelet therapy (OR 1.97, 95% CI 1.09-3.57), severe iliofemoral kinking (OR 7.34, 95% CI 3.41-15.79) and usage of second closure devices (OR 0.47, 95% CI 0.23-0.97) as independed predictors for major vascular complications. The SFAR (sheat-to-femoral artery-ratio) and vessel diameter showed no independent influence on the occurrence of major vascular complications.
Conclusion: Transfemoral TAVR in patients with severe native aortic stenosis and small femoral access even below 5.5 mm is feasible and safe using the 14F eSheath (Ultra) and 14F iSleeve (Neo2) introducer system. Although the use of TAVI in vessels outside the IFU is associated with an increased rate of vascular complications, this is not reflected in higher acute or delayed treatment rates. The use of a second closure device has a protective effect, an existing dual antiplatelet therapy and severe kinking favor major vascular complications.