First-in-class SAVR valve from Edwards Lifesciences linked to positive 5-year outcomes
Surgical aortic valve replacement (SAVR) with the Inspiris Resilia aortic valve from Edwards Lifesciences is both safe and effective after five years, according to new real-world data published in The Annals of Thoracic Surgery.[1] The study focused on a relatively young patient population.
“The recently developed Inspiris Resilia aortic valve has been launched on the market with the promise to reduce the risk for accelerated cusp degeneration thanks to its novel tissue integrity preservation technology free of glutaraldehyde,” wrote first author Francesco Onorati, MD, PhD, a cardiac surgeon with the University of Verona Medical School in Italy, and colleagues. “At this time however, mid-term data on this valve are lacking in the literature.”
The Inspiris Resilia aortic valve gained U.S. Food and Drug Administration approval in 2017 and CE mark approval in 2016. At the time, Edwards Lifesciences described the device as “the first in a new class of resilient heart valves,” pointing to its Resilia tissue technology and expandable frame.
For an update on the valve’s performance, Onorati et al. tracked real-world data from 498 SAVR patients treated with the Inspiris Resilia device in Europe. The mean age was 60.1 years old, mean EuroSCORE II was 3.9% and 27.9% of patients were women. Follow-up data from four years or longer was available for all patients.
Overall, the Edwards Lifesciences valve was linked to consistently high rates of freedom from structural valve deterioration (SVD) after five years. While 95.7% of patients were free from stage 1 SVD, 98.6% were free from stage 2 SVD and 99.3% were free from stage 3 SVD. All SVD definitions came from a Valve Academic Research Consortium 3 (VARC-3) manuscript first published in JACC in 2021.[2]
Researchers also found that the valve was associated with a five-year all-cause mortality rate of 6.8% and five-year cardiovascular mortality rate of 2.8%. In addition, the mean aortic valve pressure gradient was 12 mmHg after five years—compared to 11 mmHg at discharge—and the event-free probability moderate/severe paravalvular leak was 97.3% after five years.
“While a younger age at implant is probably the strongest risk factor for subsequent SVD due to the high likelihood for long-term survival, the rates of SVD in our cohort were favorably low, offering promise for continued durability in this patient population,” the authors wrote. “In this light, our data—coming from a population with a mean age of 60 years—might be helpful also in clinical decision making, given that European Guidelines recommend bioprostheses above 65 years of age, while U.S. Guidelines are more permissive, allowing bioprostheses also in the range of 50-65 years old.”
Researchers will continue to follow these patients to learn more about the valve's long-term performance.
Click here to read the full study in The Annals of Thoracic Surgery, an official journal from The Society of Thoracic Surgeons.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.