SOURCE 3 Registry: Design and 30-day results of the european postapproval registry of the latest generation of the sapien 3 transcatheter heart valve

Background —The SOURCE 3 Registry is a European multicentre, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 TM (Edwards Lifesciences, Irvine, CA/USA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. Methods —In this manuscript we present the 30-day outcome of the SOURCE 3 Registry. All data is self-reported and all participating centres have committed to support their consecutive experience with the SAPIEN 3 TM transcatheter heart valve, dependent on patients consent, before the start of the study. Adverse events are defined using Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. Results —A total of 1950 patients from 80 centres in 10 countries were enrolled between 07/2014-10/2015. Of those 1947 patients underwent transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 TM (mean age 81.6 ±6.6 years, 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes (29.5%), chronic obstructive pulmonary disease (16.0%), reporting a mean logistic EuroSCORE of 18.3 ±13.2. Transfemoral access was used in 87.1% (n=1695), non-transfemoral in 252 patients. Conscious sedation was employed in 59.9% of transfemoral procedures and in 50% of patients TAVI was performed without aortic balloon valvuloplasty.Implantation success (one valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low with site reported 30-day all-cause mortality at 2.2%, cardiovascular mortality 1.1%, stroke 1.4%, major vascular complication 4.1%, life-threatening bleeding 5% and post TAVI pacemaker 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. Conclusions —Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when using this third generation TAVI device.