Abstract
Background/Objectives: The optimal method to facilitate femoral access in patients with aortic stenosis and severe peripheral arterial disease (PAD) undergoing transcatheter aortic valve implantation (TAVI) remains unclear. This study compared the safety and efficacy of percutaneous transluminal angioplasty (PTA) versus Shockwave(®) intravascular lithotripsy (IVL) in patients with severe PAD undergoing TAVI via the trans-femoral route enrolled in the Hostile TAVI registry trial. Methods: Patients with severe PAD from 28 international centers were enrolled in the registry. This sub-study analyzed patients who underwent transfemoral TAVI facilitated by PTA (n = 352) or IVL (n = 166). Primary endpoints included rates of survival, major vascular complications, and major bleeding. Outcomes were also stratified according to the severity of PAD using the novel Hostile risk score. Results: Patients in the PTA group were older and had lower rates of prior stroke/TIA. All-cause mortality at 3 years was similar between PTA and IVL groups (34.9% vs. 38.6%; p = 0.27, respectively). However, IVL was associated with fewer major vascular complications (21.7% vs. 13.3%; p = 0.033, respectively), less major bleeding (14.0% vs. 7.0%; p = 0.024, respectively), and shorter hospital stays (7.06 ± 6.69 vs. 4.29 ± 4.78 days; p < 0.001; 95% CI: 1.63-3.91, respectively). Cox regression analysis showed that at low (≤8.5) Hostile Scores, PTA was associated with higher rates of major vascular complications and major bleeding than IVL. Conclusions: In patients with aortic stenosis and severe PAD undergoing TAVI via the transfemoral route, IVL is safer than PTA, with fewer vascular and bleeding complications but similar intermediate-term survival.