Background:
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 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, mechanical ventilation >48h, length of hospital stay, and reimbursement. Logistic and 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 [95% 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 (aOR 0.97 [0.85;1.10], p=0.621), postoperative delirium (aOR 1.09 [0.96;1.24], p=0.184), mechanical ventilation >48h (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). Similar results were found after application of inverse probability of treatment weighting using the propensity score.

Conclusion:
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.


Figure: Outcomes of self- vs balloon-expanding TF-TAVR