Edwards’ five year data favourable for surgical aortic valve

MedTech News: Edwards Lifesciences’ five-year follow-up data for its bioprosthetic surgical aortic valve show favourable safety and hemodynamic performance.

“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 Joseph E. Bavaria, M.D., lead enroller and site principal investigator for the COMMENCE study and the Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania.

“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,” he added.

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 specially 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,” said Daveen Chopra, Edwards’ corporate vice president, surgical structural heart.

“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.”

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 United States and Europe. Data were collected for a total of five years and a subset of these patients will continue to be evaluated through 10 years.

Current technologies utilising this novel tissue include the INSPIRIS RESILIA aortic valve and the KONECT RESILIA aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures. In addition to its anti-calcification properties, RESILIA tissue also allows the valve to be stored under dry packaging conditions, facilitating ease of use in the operating room.

Additional RESILIA tissue studies include:

• European feasibility study:  a prospective, single-arm observational clinical trial that evaluated SVD in a cohort of 133 patients. There were no events of structural valve deterioration throughout the study period of five years.
• RESILIENCE clinical trial: an ongoing, first-of-its-kind study designed to assess calcium deposits as a way to potentially predict long-term bioprosthetic valve durability. The study will enroll up to 250 patients under the age of 65 at the time of surgery to examine incidence of valve deterioration from year five to 11 after surgery.

The data were presented at the 57th annual meeting of the Society of Thoracic Surgeons.