Differences in survival outcomes and LVEF of self-expanding versus balloon expandable valves after TAVI in patients with severe cardiac dysfunction
A Matta, J Rodes cabau, L Nombela, A Masri, J B Masson, A Regueiro, M Urena, M Avvedimento, S Maisenti, M Del Trigo, A Khoury, L Dandach, A Alcaraz-Guzman, T Lhermusier, F Campelo-ParadaAbstract
Background
The existing evidence on TAVI outcomes in patients with depressed left ventricle ejection fraction (LVEF) is limited, as most major clinical trials excluded this population. At present, there is no evidence available to guide the choice of transcatheter heart valve type in the setting of severely altered LVEF.
Methods
An observational cohort study was conducted on 631patients with LVEF≤35% who underwent TAVI in different European centers (France, Canada and Spain). Data concerning baseline characteristics, TAVI procedures and transthoracic echocardiography were analyzed. The present study aims to evaluate differences in survival outcomes and changes in LVEF according to valve type (self-expanding (SEV) versus balloon-expandable (BEV)) after TAVI in patients with LVEF ≤35%.
Results
Baseline characteristics of study population and TAVI procedures were almost comparable between study groups. The rates of TAVI success (97.8% vs 98%), per-TAVI complications and in-hospital complications including death (4.3% vs 2%), vascular complications (2.6% vs 4% for major events, 8.2% vs 7.5% for minor events), stroke (1.3% vs 0.8%), pacemaker implantation (12.9% vs 15.3%), bleeding (6.2% vs 1.9% for major events, 6.8% vs 3.3% for minor events) and severe paravalvular leak (4.7% vs 5.5%) were comparable between groups, except for per-TAVI valve migration, which was more frequent (3% vs 0.5%) in SEV-group (N=232). At hospital discharge and at last follow-up, LVEF was significantly higher in SEV-group vs BEV-group (37.2±11.2 vs 34.9±11.1, 43.2±13.8 vs 39.9±14.6, respectively). The mean trans aortic gradient was significantly lower in patients treated with SEV (8.0±4.5 vs 9.9±4.2) only at hospital discharge. The difference in change of LVEF over 3.5 years tends to be significant in favor of SEV (Δ=14.7±13.1 vs Δ=12.3±13.2, p=0.070). Over a mean follow-up of 3.5±2.4 years, the all-cause mortality rate was 47.4%. No difference in survival outcomes according to valve type was observed despite the difference in LVEF (p=0.39).
Conclusion
A sustained improvement in LVEF after TAVI in patients with severe cardiac dysfunction was observed. The valve type itself was not associated with differences in survival outcomes after TAVI. However, SEV may be associated with greater improvement in LVEF.