Aims: In patients undergoing transcatheter aortic valve implantation (TAVI), the high prevalence of peripheral artery disease (PAD) limits femoral access and increases vascular complications that are associated with mortality and morbidity. Our study assessed the ability of a balloon-expandable large-bore vascular sheath to increase access-site availability and to reduce vascular complications.
Methods and results: Among 257 patients from two centres, 43 patients underwent transfemoral TAVI with the use of the SoloPath balloon-expandable sheath due to complex iliofemoral access anatomy. Propensity score matching (2:1) was performed except for the sheath to femoral artery ratio (SFAR). Compared to standard sheath patients, we found no significant difference in 30-day and one-year mortality (SoloPath vs. standard sheath, 9.3% vs. 3.5%; p=0.2, and 18.6% vs. 23.3%; p=0.7), major vascular complications (9.3% vs. 4.7%; p=0.3), and major bleeding (9.3% vs. 10.5%; p=0.5) in the cohort with the balloon-expandable sheath.
Conclusions: The use of a balloon-expandable large-bore sheath in patients with a high risk for vascular complications due to complex access-site anatomy proved to be feasible and safe. However, circumferential calcifications and sheath-to-artery ratios account for vascular access complications even in patients treated with the balloon-expandable sheath.