Evidence for Safetiness and Feasibility of Transapical Aortic Valve Implantation without Pre-Ballooning: a Propensity Score Matched Analysis
Alexander Meyer, Jörg Kempfert, Won-Keun Kim, Mani Arsalan, Arnaud van Linden, Helge Möllmann, Johannes Blumenstein, Thomas Walther.
Kerckhoff Clinic, Bad Nauheim, Germany.
OBJECTIVE: A new delivery system for the SAPIEN XT prosthesis has been recently introduced. Adding a nose-cone to the device seems to facilitate direct valve implantation without pre-ballooning. Here, we report our first experience.
METHODS: In total, 128 patients have been included into this analysis (2012-2013). 68.8% of procedures had been performed with pre-ballooning (“BAV group”, n=88, all SAPIEN XT). Since July 2012 all patients have been treated without pre-ballooning (“no-BAV group”, n=40, all SAPIEN XT + Ascendra II+). To adjust for baseline variables partial exact propensity score (PS) based pair matching has been used.
RESULTS: The model for propensity score calculation had a c-statistic of 0.845 and the p-value of the Hosmer and Lemeshow goodness-of-fit test was 0.14. Subsequent propensity score nearest-neighbour matching resulted in 40 matched pairs and yielded a good bias reduction. Absolute standardized mean difference among all baseline covariates were below 0.2, indicating good balance. Especially highly unbalanced covariates before matching such as sex, history of stroke and insulin dependent Diabetes were effectively balanced in the matched pairs.
Antegrade crossing of the stenotic native valve was feasible in all no-BAV patients without any events. Overall, all valves could be implanted successfully. There were no significant differences in the primary endpoints (BAV-group n=40 vs. non-BAV group n=40) leak ≥ 2+ (4 vs. 3 cases, p=0.70), major stroke (0 vs. 0 cases, p=1.00), TIA (3 vs. 3 cases, p=1.00), requirement for re-dilatation (4 vs. 6 cases, p=0.52), and necessity for new onset post-operative pacemaker implantation (1 vs. 2 cases, p=0.56). As expected, fluoroscopy time was significantly lower in no-BAV patients (median 306 vs. 341 sec, p=0.04). Also the outcome variables amount of contrast dye, Valve-in-Valve rescue implantation, and 30 day mortality showed no significant differences between groups. Especially, transvalvular mean gradients did not differ in patients without or with prior BAV (p=0.53).
CONCLUSIONS: Direct transapical implantation of the SAPIEN valve without pre-ballooning is feasible and safe. It does not compromise functional outcomes and leads to an even easier transapical procedure.
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