Two-Year Clinical Outcomes Following SAPIEN 3 20-mm Transcatheter Aortic Valve Implantation in Patients with Symptomatic Severe Aortic Stenosis—Comparison of the Smallest Size Valve against Larger Transcatheter Aortic Valve

Abstract

Objective: Transcatheter aortic valve implantation (TAVI) has become a cornerstone treatment for elderly or high-risk surgical patients with symptomatic severe aortic stenosis. The continuous evolution of TAVI techniques and technology has significantly improved its safety and efficacy. This study aims to deepen our understanding of the safety and effectiveness of the smallest size balloon-expanding transcatheter heart valve (BE-THV): SAPIEN 3 20 mm, through extensive utilization at our institution, with the goal of further refining TAVI procedures in the future.

Methods: This retrospective single-center observational study included 456 consecutive patients who underwent TAVI with SAPIEN 3 valves between June 2017 and October 2022. The short-term outcomes, adverse events such as stroke, new pacemaker implantation (PMI), paravalvular leak (PVL), prosthesis-patient mismatch (PPM), 30-day mortality, and 2-year mortality associated with the 20-mm THV were analyzed and compared with those of the 23-mm THV or the 26-/29-mm THV.

Results: The most commonly used THV size was 23 mm, accounting for 55.7% (254 cases), followed by the 26-/29-mm THV at 32.0% (146 cases) and the 20-mm THV at 12.3% (56 cases). There were no instances of new PMI or moderate or severe PVL observed in the 20-mm THV group. The 30-day mortality rate was 1.8% in patients who underwent the 20-mm THV, 1.6% in those with the 23-mm THV, and 0% in those with the 26-/29-mm THV, with no significant difference observed (P = 0.3012). However, the incidence of moderate PPM in patients who underwent the 20-mm THV implantation was 24.1% (13 out of 55), compared to 5.3% in those with the 23-mm THV and 4.3% in those with the 26-/29-mm THV, showing a statistically significant increase (P <0.0001), but severe PPM was not observed in any THV groups. The prevalence of a postprocedural transvalvular mean pressure gradient (MPG) ≥20 mmHg in the 20-mm THV group was higher compared to other size groups (20 mm: 14.3% vs. 23 mm: 2.0% vs 26/29 mm: 1.4%, P <0.0001). There was no significant difference in 2-year all-cause mortality rates (20 mm: 14.3% vs. 23 mm: 11.5% vs. 26/29 mm: 9.7%, P = 0.6491) among the different THV sizes.

Conclusion: The short-term outcomes associated with the 20-mm THV were reasonably satisfactory. While the occurrence of moderate PPM was significantly higher in patients receiving the 20-mm THV compared to other THV sizes, there were no significant differences in the 2-year mortality rate.