A tissue valve built for less structural valve deterioration showed favorable safety and hemodynamic performance at 5 years in surgical aortic valve replacement (SAVR), according to the COMMENCE investigators.
Surgical valves mounted with Resilia (a proprietary bovine pericardial tissue, from Edwards Lifesciences, formulated to reduce the calcification that often leads to valve dysfunction) were associated with “quite satisfactory” safety in 471 patients who had 30-day mortality and stroke rates of 1.2% and 1.6%, respectively, reported Joseph Bavaria, MD, of the Hospital of the University of Pennsylvania in Philadelphia.
By 5 years, patients showed 89.2% freedom from mortality and 94.5% freedom from stroke on top of zero cases of valve thrombosis or structural valve deterioration, Bavaria told the audience at this year’s Society of Thoracic Surgeons (STS) virtual meeting.
The latter is significant because contemporary bioprosthetic aortic valves often begin to show structural valve deterioration around 5 years after SAVR. Bavaria estimated structural valve deterioration rates by then to be about 1.5% with the Magna device and 5% with the Trifecta.
“There continues to be a significant focus placed on tissue valve durability given the increase in life expectancy and lifestyle implications for more active patients who historically would receive mechanical valves,” said Bavaria in a press release. “The latest data from the COMMENCE study are encouraging and speak to the promise of Resilia tissue as a significant advancement in technology for patients with valve disease.”
The first case of structural valve deterioration occurred at 5.2 years in the study and resulted in the patient getting a transcatheter valve-in-valve reintervention.
Additionally, the good hemodynamic performance of the Resilia valves was reflected in the “absolutely stable” echocardiography-derived mean gradients of 10.2 mm Hg at 1 year and 11.5 mm Hg at 5 years, as well as little change in average effective orifice area, from 1.7 cm2 to 1.6 cm2, according to Bavaria.
Transvalvular regurgitation reached only 3.7% of patients at the mild level; there were no moderate cases observed.
“It is heartening to know that the 5-year trial data is incredibly satisfactory,” Bavaria told the STS audience.
Given that valve deterioration is a concern with bioprosthetic devices, both transcatheter and surgical alike, session co-moderator Gilbert Tang, MD, MBA, of Mount Sinai Health System in New York City, asked if the manufacturer would start putting Resilia tissue on its transcatheter aortic valves.
Bavaria’s guess was “probably.”
COMMENCE was a single-arm FDA investigational device exemption trial that included 689 SAVR recipients at 27 clinical sites across the U.S. and Europe.
Investigators tested surgical valves with a Magna Ease design and the tissue of the Inspiris valve (albeit without the vFit feature that facilitates expansion for subsequent valve-in-valve procedures). The aldehyde capping of the Resilia tissue platform prevents calcification by blocking free aldehydes; glycerolization prevents further aldehyde exposure to the valve.
The present analysis was based on the 471 adults with sufficient 5-year follow-up (mean age 66.9 years, 71.8% men). This group entered SAVR with an average STS risk of 2.0%. Roughly a quarter were classified as having New York Heart Association Class I symptoms, half Class II, and another quarter Class III.
People getting concomitant procedures represented about 40% of the cohort. The trial excluded emergency, endocarditis, and multi-valve procedures.
Session co-moderator Jessica Forcillo, MD, MSc, MPH, of Centre Hospitalier de l’Université de Montréal, commended the surgeons for choosing larger valve sizes, as 23- and 25-mm valves were the most commonly used in the study.
Bavaria acknowledged that there is insufficient data on people under age 50 in the study.
A subset of COMMENCE participants will be evaluated through 10 years, he said, adding that a small ongoing study, RESILIENCE, is assessing how calcium deposits on Resilia tissue predict long-term bioprosthetic valve durability.
The study was sponsored by Edwards Lifesciences.
Bavaria reported consulting to Edwards Lifesciences, Medtronic, and Abbott; as well as chairing the data safety monitoring board for Abbott.