In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany

Introduction: The effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-TAVR) has recently been subject of debate. We investigate outcomes of patients treated with balloon-expanding (BE) vs. self-expanding (SE) valves in in a cohort of all these procedures performed in Germany in 2018.

Methods: All patients receiving TF-TAVR with either BE (N = 9,882) or SE (N = 7,413) valves in Germany in 2018 were identified. In-hospital outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, permanent pacemaker implantation, mechanical ventilation > 48 h, length of hospital stay, and reimbursement. Since patients were not randomized to the two treatment options, logistic or linear regression models were used with 22 baseline patient characteristics and center-specific variables as potential confounders. As a sensitivity analysis, the same confounding factors were taken into account using the propensity score methods (inverse probability of treatment weighting).

Results: Baseline characteristics differed substantially, with higher EuroSCORE (p < 0.001), age (p < 0.001) and rate of female sex (p < 0.001) in SE treated patients. After risk adjustment, no marked differences in outcomes were found for in-hospital mortality [risk adjusted odds ratio (aOR) for SE instead of BE 0.94 (96% CI 0.76;1.17), p = 0.617] major bleeding [aOR 0.91 (0.73;1.14), p = 0.400], stroke [aOR 1.13 (0.88;1.46), p = 0.347], acute kidney injury [OR 0.97 (0.85;1.10), p = 0.621], postoperative delirium [aOR 1.09 (0.96;1.24), p = 0.184], mechanical ventilation > 48 h [aOR 0.98 (0.77;1.25), p = 0.893], length of hospital stay (risk adjusted difference in days of hospitalization (SE instead of BE): - 0.05 [- 0.34;0.25], p = 0.762) and reimbursement [risk adjusted difference in reimbursement (SE instead of BE): - €72 (- €291;€147), p = 0.519)] There is, however, an increased risk of PPI for SE valves (aOR 1.27 [1.15;1.41], p < 0.001). Similar results were found after application of propensity score adjustment.

Conclusions: We find broadly equivalent outcomes in contemporary TF-TAVR procedures, regardless of the valve type used. Incidence of major complications is very low for both types of valve.