Survival outcomes of TAVR and self-expanding versus balloon-expandable valves in patients with advanced cardiac dysfunction

Abstract

Aims: There is a growing body of literature on long-term outcomes post-transcatheter aortic valve replacement (TAVR), but to our knowledge, few research have focused on patients with advanced cardiac dysfunction. This challenging category of patients was excluded from the Partner 3 clinical trial. There are no data to guide the choice of valve type in patients with severely depressed ejection fraction. This study evaluates the safety, efficacy, and outcomes of TAVR in patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) ≤ 35%. It compares post-TAVR survival outcomes with self-expanding (SEV) versus balloon-expandable (BEV) valves in the context of cardiac dysfunction.

Methods and results: A retrospective cohort was conducted on 977 patients who underwent TAVR at Toulouse University Hospital between January 2016 and December 2020. The study population included two groups: LVEF ≤ 35% (N = 157) and LVEF ≥ 50% (N = 820). The group of LVEF ≤ 35% was divided into two subgroups according to the type of implanted device: self-expanding (N = 66) versus balloon-expandable (N = 91). The living status of each of study's participants was observed in December 2022. Patients with low ejection fraction were younger (82 vs. 84.6 years) and commonly males (71.3% vs. 45.6%). Procedural success was almost 98% in both study groups (97.5% vs. 97.9%). The prevalence of all in-hospital post-TAVR complications [acute kidney injury (3.8% vs. 2.2%), major bleeding events (2.5% vs. 3.2%), stroke (1.3% vs. 1.6%), pacemaker implantation (10.2% vs. 10.7%), major vascular complication (4.5% vs. 4.5%), new onset atrial fibrillation (3.2% vs. 3.4%), and in-hospital death (3.2% vs. 2.8%)] were similar between groups (LVEF ≤ 35% vs. LVEF ≥ 50%). No difference in long-term survival has been revealed over 3.4 years (P = 0.268). In patients with LVEF ≤ 35%, except for post-TAVR mean aortic gradient (7.8 ± 4.2 vs. 10.2 ± 3.6), baseline and procedural characteristics were comparable between SEV versus BEV subgroups. An early improvement in LVEF (from 29.2 ± 5.5 to 37.4 ± 10.8) was observed. In patients with LVEF ≤ 35%, the all-cause mortality rate was significantly higher in BEV than that in SEV subgroups, respectively (40.7% vs. 22.7%, P = 0.018). Kaplan-Meier curve showed better survival outcomes after SEV implantation (P = 0.032). A Cox regression identified BEV as independent predictor of mortality [HR = 3.276, 95% CI (1.520-7.060), P = 0.002].

Conclusions: In the setting of low LVEF, TAVR remains a safe and effective procedure not associated with an increased risk of complications and mortality. SEV implantation may likely result in superior survival outcomes in patients with advanced cardiac dysfunction.

Keywords: Balloon expandable; LVEF; Self‐expanding; TAVR.