Edwards Sapien 3 TAVR Device Demonstrates Cost Effectiveness in PARTNER 3 Analysis

November 5, 2021—Edwards Lifesciences announced that a cost-effectiveness analysis comparing transcatheter aortic valve replacement (TAVR) to surgery demonstrated that TAVR with Edwards’ Sapien 3 is an economically dominant treatment strategy, offering improved outcomes and reduced cost.

This analysis from the PARTNER 3 trial was presented during the late-breaking clinical trials at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online and in Orlando, Florida, on November 4-6.

According to Edwards, the study compared health care costs, life expectancy, and quality-adjusted life expectancy for patients with severe aortic stenosis at low risk for surgery, who were treated with TAVR or surgery in the PARTNER 3 trial.

The company reported that a formal cost-effectiveness analysis conducted for the study found the following:

• TAVR using the Sapien 3 valve resulted in cost savings of > $2,000 per patient through the 2-year study period. This was achieved through marked reductions in hospital length of stay and substantially lower follow-up costs, which overcame higher index hospitalization and procedural costs for TAVR.
• Over the 2-year follow-up period, TAVR also led to a small but significant improvement in quality-adjusted life expectancy, driven by improved early quality of life as well as survival.
• The probability that TAVR is highly cost-effective versus SAVR is approximately 95%.

“In addition to the outstanding clinical results compared with surgery, the finding that TAVR with Sapien 3 is also a lower-cost strategy for low-risk patients empowers both cardiologists and patients with real choice in determining the right treatment option for severe aortic stenosis,” commented David J. Cohen, MD, in the company's press release. “TAVR is a unique technology with advantages over surgery from the perspective of both the patient and the health care system.” Dr. Cohen is Director of Clinical and Outcomes Research at the Cardiovascular Research Foundation and Director of Academic Affairs at St. Francis Hospital in Roslyn, New York.

The PARTNER 3 trial randomized 1,000 patients at 71 centers between March 2016 and October 2017. Patients were assigned to undergo either TAVR with the Sapien 3 valve or surgery with any commercially available surgical valve. In 2019, clinical results from the PARTNER 3 trial were presented and published by Michael J. Mack, MD, et al in The New England Journal of Medicine (2019;380:1695-1705).