Early Results of the SOURCE 3 Registry
A Source of Encouragement With Some Caveats
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Article, see p 1123
Transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe aortic stenosis. In several randomized trials studying extreme-, high-, and intermediate-risk patients, TAVR has been shown to be superior to medical treatment and noninferior to surgical aortic valve replacement.1–4 The family of SOURCE (SAPIEN Aortic Bioprosthesis European Outcome) and PARTNER (Placement of Aortic Transcatheter Valve) trials have evaluated the use of the balloon-expandable SAPIEN, SAPIEN XT, and SAPIEN 3 transcatheter heart valves (Edwards Lifesciences, Irvine, CA). The SAPIEN 3 valve is the latest generation of balloon-expandable transcatheter heart valves, which contains modifications that improve on the earlier valves. These modifications included a mechanism to reduce paravalvular regurgitation (PVR), the need for a smaller expandable femoral sheath size that accommodates ≈90% transfemoral TAVR use, and a mechanism to permit fine-tuning of the transcatheter heart valve during positioning. These iterations were designed to decrease complication rates, to facilitate deployment, and to expand the indications and application of TAVR to a wider population of patients. With this in mind, it will be paramount to analyze the efficacy and safety of the SAPIEN 3 transcatheter heart valve as we move toward a younger and lower-risk population.
In this issue of Circulation, Wendler and colleagues5 report the 30-day outcomes of the SOURCE 3 registry. This is the largest real-world observation of the safety and performance of the SAPIEN 3 valve in 1947 patients from 80 centers in 10 European countries enrolled between July 2014 and October 2015. They report a high implantation success rate (98.3%) and low rates of conversion to surgery …