Abstract
IntroductionThe 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.MethodsAll 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).ResultsBaseline 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.ConclusionsWe 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.
Highlights
The effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-Transcatheter aortic valve replacement (TAVR)) has recently been subject of debate
The two most widely used valve types are the BE Edwards Sapien and the SE Medtronic Evolut/Corevalve. Both valve types showed convincing results compared to surgical valve replacement (SAVR) in randomized controlled trials for high, intermediate and low-risk patients suffering from severe aortic valve stenosis [5,6,7,8,9,10]
The present study aims to provide further evidence from clinical practice by analyzing results from BE and SE TAVR performed in Germany—a country with a high rate of TAVR procedures
Summary
The effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-TAVR) has recently been subject of debate. The two most widely used valve types are the BE Edwards Sapien and the SE Medtronic Evolut/Corevalve Both valve types showed convincing results compared to SAVR in randomized controlled trials for high, intermediate and low-risk patients suffering from severe aortic valve stenosis [5,6,7,8,9,10]
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