Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)

Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system.We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

Inclusion Criteria:Eligible Patients are male or female with severe aortic stenosis evaluated by the Heart Team as candidate to TAVR based on the current cardiology guidelines.Exclusion Criteria:Refusal to participate in the study;Inability to provide written consent to the study protocol;Chronic immuno-suppressant therapy;Any concomitant condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological disorder);Enrolment in another study that could confound the results of this study;Life expectancy < 1 year;Any contraindication to TAVR procedure;Non transfemoral TAVR.