Five-year data from the COMMENCE clinical trial, presented at the 57th annual meeting of the Society of Thoracic Surgeons (STS 2021, 29–31 January, virtual) show favourable safety and haemodynamic performance using the Resilia tissue aortic valve (Edwards Lifesciences).
Results were presented at STS 2021 by Joseph Bavaria, principal investigator for the study and vice chief of the division of cardiovascular surgery, University of Pennsylvania, Philadelphia, USA.
The COMMENCE study is a prospective, non-randomised, multicentre, single-arm investigational device exemption (IDE) trial comprised of 689 patients at 27 clinical sites across the USA and Europe. The trial evaluated the safety and effectiveness of Edwards’ Resilia tissue aortic valve in patients aged18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery. Data were collected for a total of five years and a subset of these patients will continue to be evaluated through 10 years. At this stage, the study has recorded data equivalent to 2,989 patient-years of follow-up.
“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. “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.”
Bavaria reported that there were no incidences of structural valve deterioration (SVD) at the five-year review mark, a key safety outcome. SVD can be caused by a build-up of calcium on the valve’s tissue or by other damage that impacts long-term durability of the valve. Resilia tissue is formulated using a proprietary integrity-preservation technology that may eliminate a key factor in calcification leading to valve deterioration.
“Beyond the COMMENCE study, Edwards continues to invest in research to examine different outcome measures to further validate the long-term performance and durability of RESILIA tissue,” Daveen Chopra, Edwards’ corporate vice president, surgical structural heart said in a press release. “Evidence from the COMMENCE trial adds to the growing body of research that demonstrates the value of innovative, Resilia tissue-based technologies in transforming care for patients, especially more active patients.”
Current technologies utilising the novel tissue include the Inspiris Resilia aortic valve and the Konect Resilia aortic valved conduit.