A cost-effectiveness analysis demonstrated the positive economic value of TAVR using Evolut in low-risk patients. It compared Evolut to surgical aortic valve replacement (SAVR). Then, Medtronic had contemporary data from its Evolut low-risk trial reinforcing long-term TAVR outcomes compared to SAVR.
Medtronic presented data at the Cardiovascular Research Technologies (CRT) 2024 Conference. The data follows Medtronic’s TCT presentation highlighting the success of TAVR when pitted against SAVR last October.
“At Medtronic, we continue to emphasize that valve design matters. These data further exemplify Medtronic’s dedication to providing differentiated treatment options like the Evolut TAVR platform to reach the growing population of low-risk symptomatic severe aortic stenosis patients,” said Nina Goodheart, SVP and president, Structural Heart & Aortic, part of the Cardiovascular Portfolio at Medtronic. “We are proud of the excellent clinical outcomes and sustained valve performance, effectiveness, and economic benefits of Evolut TAVR and are committed to advancing evidence around the long-term clinical and economic patient benefits.”
Cost-effectiveness data shared by Medtronic at CRT
Medtronic shared four-year data analyzed to determine the cost-effectiveness of TAVR versus SAVR across the spectrum of surgical mortality risk. The outcomes showed a “strong benefit of Evolut” for low-risk patients in the U.S. healthcare system.
The study found that Evolut TAVR resulted in a lifetime incremental cost-effectiveness ratio (ICER) of $2,119 per quality-adjusted life year (QALY) gained. That falls in line with high economic value, according to Medtronic.
At 30 days, the estimated cost was $5,189 below SAVR ($45,887 versus $51,075, respectively). Those costs include procedure, hospitalization, and rehabilitation.
“As more and more patients are diagnosed with aortic stenosis and undergo TAVR, it is important to use devices that offer exceptional results for patients, while also delivering economic value to the healthcare system. These data complement the extensive body of clinical evidence for Evolut TAVR and demonstrate that it is a solution that provides substantial benefit to our patients in a highly cost-effective manner,” said Dr. David J. Cohen, director of clinical and outcomes research at the Cardiovascular Research Foundation.
TAVR outshines SAVR in another study
Investigators studied four-year data comparing TAVR and SAVR in patients with severe aortic stenosis, re-evaluating results with the exclusion of Trifecta surgical valves. Those valves, made by Abbott, had durability concerns. The company withdrew the valve from the market last year.
Medtronic said the analysis included the evaluation of 1,292 attempted implants in randomized patients. Those patients either received TAVR with a self-expanding, supra-annular CoreValve/Evolut R/PRO valve or SAVR.
In the analysis, all-cause mortality or disabling stroke rates at four years came in at 10.7% in the Evolut TAVR cohort. That compared to 14.2% in the SAVR cohort. TAVR also demonstrated significantly better hemodynamics — an indicator of valve durability — compared to SAVR.
“The Evolut TAVR System continues to demonstrate positive clinical outcomes compared to SAVR. This new data supports the growing body of evidence for TAVR at a time when aortic stenosis is the most common surgically managed heart valve disease,” said Dr. Basel Ramlawi, system chief of cardiothoracic surgery at Main Line Health System and Co-Director of the Lankenau Heart Institute. “We are encouraged by the results of this contemporary data, showing that we can help improve outcomes in patients with less risk of mortality and disabling stroke compared to the surgical option.”