Bioprosthetic surgical aortic valve safe, effective at 5 years
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A bioprosthetic surgical aortic valve was effective and associated with low rates of serious adverse events at 5 years, according to data from the COMMENCE trial presented at the virtual Society of Thoracic Surgeons Annual Meeting.
The bioprosthesis (Model 11000A with Resilia tissue, Edwards Lifesciences) was linked to low mortality rates and was not associated with unexpected early thrombosis or noncalcific structural valve deterioration in a cohort of 689 patients who underwent aortic valve replacement from COMMENCE who were followed for a mean of 4.3 years, Joseph E. Bavaria, MD, the Brooke Roberts-William M. Measey Professor of Surgery and vice chief of the division of cardiovascular surgery at the University of Pennsylvania, said during a presentation.
The findings are important because bioprosthetic valves do not limit patients’ lifestyles to the same extent that mechanical valves do, Bavaria told Healio.
“The lifestyle limitations/issues with mechanical valves are really twofold,” he said in an interview. “The first one, which is the biggest one, is the need for anticoagulation for life. Presently, the anticoagulant is warfarin, which is a drug with its own set of issues and problems over time. That may change in the future, but right now, that is what, for the foreseeable future, is the pharmacological obstacle. The second thing is that the mechanical valve has a noise/sound to it, and sometimes it can be concerning for patients. Not all patients have a problem with it, but some do.”
At 30 days, the rate of mortality was 1.2%, the rate of thromboembolism was 2.2%, the rate of bleeding was 0.9% and the rate of major paravalvular leak was 0.1%, according to the researchers.
Actuarial freedom from all-cause mortality was 97.6% at 1 year and 89.2% at 5 years, Bavaria said.
Also, at 5 years, 59.5% of patients improved at least one NYHA class compared with baseline, effective orifice area was 1.6 cm2 and mean gradient was 11.7 mm Hg, he said.
In addition, he said, no patients had moderate or worse paravalvular insufficiency at 5 years and only one had evidence of structural valve deterioration (SVD) shortly after 5 years.
“All biological/tissue valve trials in the past have had the beginning of SVD by 5 years,” Bavaria told Healio. “This has been in the range of 1.5% to 5%. Therefore, we can deduce the beginning of an SVD curve by 5 years and the COMMENCE trial SVD rate is exceptionally positive. Obviously, we need to wait for 10-year data to more fully elucidate the SVD rate. However, these 5-year results are very heartening for this Resilia tissue platform.”
Also encouraging, he said, was that the gradient has been stable, levels of paravalvular aortic insufficiency were “virtually negligible” and “rates of other adverse events such as endocarditis, thrombosis, stroke and others are quite low, and there is not any signal for concern in these areas compared to historical valve trials and results.”
Editor’s Note: This article was updated on Feb. 16, 2021 with minor adjustments to the data.
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Bavaria JE, et al. Aortic valve/TAVR. Presented at: Society of Thoracic Surgeons Annual Meeting; Jan. 29-31, 2021 (virtual meeting).
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