Balloon-Expandable Versus Self-Expandable Valve in Transcatheter Aortic Valve Replacement: A Nation-Wide Study.

A few studies have reported comparative analysis of clinical outcomes between balloon-expandable valve (BEV) and self-expandable valve (SEV) after transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis using newer-generation devices. However, they were mostly limited to short-term outcomes and Western populations. In the present study, data of patients with severe AS who underwent TAVR between March 2016 and December 2018 were obtained from the National Health Insurance Service in Korea. The primary endpoint, defined as all-cause mortality, was compared between BEV (SAPIEN 3) and SEV (Evolut R) groups using a propensity-score matching (PSM) analysis. Cumulative event rates of ischemic stroke, repeat procedures, and permanent pacemaker insertion (PPI) were evaluated as secondary outcomes. All events were followed up to a maximum 3 years. A total of 1,172 patients underwent transfemoral TAVR, of whom 707 (60.3%) were treated with BEV and 452 (38.6%) with SEV. After 1:1 PSM, the BEV group showed lower all-cause mortality after a median follow-up of 12.0 months (mean: 13.1 ± 9.3 months) based on Cox proportional hazard model analysis (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.45-0.99; p = 0.04). Cumulative incidence of ischemic stroke was not statistically different between the two groups (HR: 0.68; 95% CI: 0.29-1.59; p = 0.37). PPI occurred less frequently in the BEV group (HR: 0.4; 95% CI: 0.25-0.64; p < 0.01). Repeat procedures were rare (one patient in BEV and two patients in SEV group). In conclusion, Korean nation-wide data analysis showed that BEV was associated with lower all-cause death and incidence of PPI after TAVR compared to SEV using a newer-generation device.