Sapien devices

All TAVR procedures were performed using either the SAPIEN devices (Edwards Lifesciences, Irvine, California) or the CoreValve Evolut R/PRO devices (Medtronic, Minneapolis, Minnesota). Optimal type and size of transcatheter heart valve were determined using preprocedural multidetector CT measurements evaluated with 3mensio Structural Heart software (3mensio Medical Imaging BV, Bilthoven, The Netherlands). Pre-dilatation and post-dilatation were left to the physician’s discretion. During the TAVR procedure, unfractionated heparin was administered to achieve an activated clotting time of 250–300 s. Closure of the vascular access was usually performed using two Perclose ProGlide™ vascular closure systems (Abbott Laboratories, Chicago, IL, USA).

From March 2015 to April 2022, all patients affected by severe aortic stenosis undergoing transapical transcatheter aortic procedures at the Division of Cardiac Surgery of University Hospital in Verona were enrolled. The balloon expandable SAPIEN devices (Edwards Lifesciences, Irvine, CA, USA) were used for both TAVR and Valve-in-Valve (ViV) procedures in the aortic position. The interdisciplinary Heart-Team selected patients for the TA approach according to the latest European and American guidelines for the management of valvular heart diseases [1 (link),2 (link)]. The appropriate prosthetic size was determined on computed tomography findings. All patients underwent general anesthesia, and all the procedures were carried out in the catheterization laboratory by an expert cardiac surgeon together with a proficient interventional cardiologist that took care of the actual valve positioning and deployment.
Pre-procedural, intra-procedural, and post-procedural data were retrospectively collected in a dedicated and anonymized database. Follow-up clinical data were gathered by querying the Electronic Clinical Chart (retrieving data from the Regional Health Database) or the patients. The clinical follow-up was complete for 100% of the patients. Informed consent was obtained from all of the patients.