SOURCE 3 Registry: Design and 30-Day Results of the European Post Approval Registry of the Latest Generation of the Sapien 3TM Transcatheter Heart Valve
Background—The SOURCE 3 Registry is a European multicentre, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3TM (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 3TM 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 3TM (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.
- aortic valve stenosis
- transcatheter aortic valve implantation
- balloon expandable valve
- prosthetic heart valve
- aortic stenosis
- transcutaneous aortic valve implantation
- heart valve problems
- heart valve surgery
- Received August 20, 2016.
- Revision received December 8, 2016.
- Accepted December 27, 2016.