Incidence, Predictors, and Mid-Term Outcomes of Percutaneous Closure Failure After Transfemoral Aortic Valve Implantation Using an Expandable Sheath (from the Optimized Transcatheter Valvular Intervention [OCEAN-TAVI] Registry).

The aim of this study was to evaluate the incidence, predictors, and outcomes of percutaneous closure device (PCD) failure during transfemoral transcatheter aortic valve implantation (TAVI) with an Edwards Sapien-XT prosthesis using an expandable sheath (eSheath). From October 2013 to April 2016, 1,215 patients who underwent TAVI were prospectively enrolled in the Optimized Transcatheter Valvular Intervention (OCEAN-TAVI) registry. Of these, 478 patients underwent transfemoral TAVI with Sapien-XT prosthesis using an eSheath and percutaneous closure with a Perclose ProGlide system. We evaluated the predictors of PCD failure and whether it affected the clinical outcomes. Patients were aged 85 years (interquartile range 82 to 88 years). PCD failure occurred in 36 patients (8%). Sheath-to-femoral artery ratio (SFAR) (per 1 increase) (odds ratio 5.40, 95% confidence interval 1.28 to 22.92, p = 0.022) predicted PCD failure in a multivariate model. The sensitivity-specificity curves identified an SFAR threshold of 1.03; the area under the curve for SFAR as a predictor of PCD failure was 0.629. The PCD failure group did not have a higher rate of 30-day mortality (0% vs 1%, p = 0.52) or mid-term (365-day) mortality (log-rank test p = 0.85) compared with the PCD success group in the Kaplan-Meier analysis. In conclusion, PCD failures occurred in 8% of the patients and were not associated with 30-day or mid-term mortality rates after percutaneous transfemoral TAVI. The SFAR threshold of 1.03 was useful for predicting PCD failures.