Predictability and Outcome of Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation.

BACKGROUND: Although the efficacy and safety of transfemoral transcatheter aortic valve implantation (TAVI) have been improved with new devices, careful patient selection is essential and awkward complications associated with the procedure persist. Despite a gradual reduction in the delivery system size and the development of access site arterial closure devices, vascular complications remain one of the main challenges of TAVI. The aim of this single-center study was to prospectively evaluate the incidence and predictors of vascular complications in transfemoral TAVI.

METHODS: A total of 211 patients (mean age 77.98 ± 8.20 years) who underwent transfemoral TAVI between 2011 and 2014 at the authors' institution, using two different commercially available devices, was included in the study. Technical success, vascular complications, predictors of vascular complications and mortality were each assessed. Vascular complications were defined by the current Valve Academic Research Consortium-2 (VARC-2) criteria.

RESULTS: The mean logistic EuroSCORE of the patients was 21.04 ± 7.51. An Edwards SAPIEN XT valve was used in 69.7% of cases, and a Medtronic CoreValve in 30.3%. Completely percutaneous transfemoral TAVI was successful in 81.6% of patients. Procedural and 30-day mortalities were 1.4% and 8.5%, respectively. Vascular complications occurred in 16.1% of patients (minor 10.4%, major 5.7%), and necessitated surgical repair in 25 cases (11.8%). Major vascular complications were predictive of 30-day mortality (58.3% versus 5.6% (p = 0.000). Predicted major vascular complications (by multivariate analysis) were female gender (hazard ratio (HR) 5.45; 95% confidence interval (CI) 0.91-32.5, p = 0.063), arterial calcification (HR 2,88; 95% CI 1.14-7.30, p = 0.025) and sheath to iliofemoral artery ratio (SIFAR) (HR 1.91, 95% CI 1.27-2.87, p = 0.001).

CONCLUSIONS: Although vascular preclosure devices have revolutionized transfemoral TAVI, and offer a simple but effective percutaneous procedure, vascular complications are still observed in a considerable number of patients. The major vascular complications were predictive of 30-day mortality, and included female gender, iliofemoral calcification and SIFAR. Further technological and procedural developments are required to reduce vascular complication rates and related mortality.