Edwards’ Sapien 3 TAVR Device Evaluated for Bicuspid Aortic Stenosis in Real-World TVT Registry

May 18, 2021—Edwards Lifesciences announced the results of a real-world study comparing outcomes for patients with bicuspid aortic stenosis (AS) who were treated with the company’s Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) devices and were at low risk of death from surgery. The data show excellent outcomes at 1 year, with low rates of death and stroke and no significant differences in the primary outcomes compared with the overall cohort or those with tricuspid aortic valve disease.

According to the company, the investigators conducted a propensity-matched analysis comparing real-world data of > 6,000 bicuspid and tricuspid AS patients at low surgical risk treated with Sapien 3 TAVR devices. Data were collected from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy (TVT) registry. Raj Makkar, MD, presented the findings in a late-breaking clinical trial session during the virtual EuroPCR 2021 conference.

The all-cause mortality rate for bicuspid valves was low and similar at 1 year when compared to those with tricuspid valve disease (4.6% vs 6.6%), as were stroke rates at 1 year (2% vs 2.1%). In addition to these survival and stroke rates, outcomes data from the TVT registry also demonstrated a low rate of significant paravalvular leak, as well as significant and similar improvements in functional status and quality of life measures.

“I am encouraged to see these data reflect the favorable outcomes we’ve witnessed to date in bicuspid patients treated with Sapien 3 TAVR, including very low rates of death and stroke, significant and similar improvements in functional status and quality of life, and high procedural success rates,” commented Dr. Makkar in the Edwards press release. “With bicuspid aortic valve disease as another anatomical consideration in the treatment of TAVR patients, these Sapien 3 data are encouraging and crucial for guiding treatment, particularly for younger patients.” Dr. Makkar is Director of Interventional Cardiology and Associate Director of the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, California.