COMMENCE: Surgical AVR with bioprosthetic valve confers improved outcomes at 4 years
Patients who underwent surgical aortic valve replacement with a bioprosthetic valve with novel tissue was safe with favorable hemodynamic performance at 4 years, according to data presented at the American Association for Thoracic Surgery 99th Annual Meeting
“This is a technology that ... sets patients up for either a potential re-operation down the road depending on the age that they have a valve put in or for TAVR down the road,” Lars G. Svensson, MD, PhD, chairman of the Heart & Vascular Institute at Cleveland Clinic, told Cardiology Today. “This is a valve that a lot of young people will be asking for. So far, everything looks good with the valve.”
Bartley P. Griffith, MD, professor of surgery at University of Maryland School of Medicine in Baltimore, and colleagues analyzed data from 689 patients (mean age, 67 years; 72% men) from 27 centers who underwent surgical AVR.
“This is a biological valve that we deliberately tried to put into younger patients,” Svensson said in an interview. “About 20% of the patients were lower than the normal recommended age of putting in a biological valve.”
A bioprosthetic valve with novel tissue (Resilia, Edwards Lifesciences) was used in these patients.
“Those were a couple of important advantages: dry storage, potential better long-term durability, especially in younger patients, and the ability to expand the valve down the road,” Svensson told Cardiology Today.
Clinical events and hemodynamic performance were assessed during a mean follow-up of 2.9 years and 2,018.5 patient-years.
Of the procedures performed in this study, 59% were isolated AVR.
All-cause mortality within 30 days after the procedure occurred in 1.2%. During follow-up, thromboembolism occurred in 2.3% of patients, 0.7% had major bleeding and major paravalvular leak was seen in 0.1% of patients.
One-year freedom from all-cause mortality occurred in 97.7% of patients (95% CI, 96.5-98.8), and 91.1% had 4-year freedom from all-cause mortality (95% CI, 88.3-93.9). NYHA class improved from baseline to 4 years in 62.2% of patients.
The mean transvalvular gradients was 10.8 mm Hg at discharge, 10.2 mm Hg at 1 year, 10.3 mm Hg at 2 years, 10.9 mm Hg at 3 years and 10.2 mm Hg at 4 years. In addition, the mean effective orifice area was 1.8 cm2 at discharge, 1.7 cm2 at 1 year, 1.6 cm2 at 2 years, 1.6 cm2 at 3 years and 1.5 cm2 at 4 years.
There were no events associated with structural valve deterioration during the study.
“We’re now out to 4 years and we obviously have a very good population to follow over time,” Svensson said in an interview. “We’ll then look at long-term durability. Typically in younger patients, so in their 50s, we start seeing valve deterioration about 5, 6 years after insertion. In older patients, it’s much later, so the older the patient, the better the durability, so it’s going to take some time on a regular basis to follow patients and see if it holds up better. By 10 years, we’ll have a good idea if it’s a lot better than the older biological valve. Usually that’s about the time period when we see discrepancies between various biological valves.”
“The Resilia tissue platform was created with a vision to extend valve durability for a more active patient population while reducing the need for long-term use of blood-thinning medication,” Daveen Chopra, corporate vice president of surgical structural heart for Edwards Lifesciences, said in a press release from the company. “These encouraging COMMENCE trial data suggest that we are on the path toward realizing that vision.” – by Darlene Dobkowski
Griffith BP, et al. Abstract 339. Presented at: American Association for Thoracic Surgery 99th Annual Meeting; May 4-7, 2019; Toronto.
Disclosures: Chopra is an employee of Edwards Lifesciences. Svensson reports no relevant financial disclosures. Cardiology Today could not confirm relevant financial disclosures for Griffith at the time of publication.