Edwards Highlights New Data on Lifetime Management of Aortic Stenosis

March 6, 2023—Edwards Lifesciences highlighted new data examining mortality rates and cardiac damage of early-stage aortic stenosis (AS) patients, along with data examining 10-year transcatheter aortic valve replacement (TAVR) reintervention rates using real-world Medicare data. These studies add valuable insights to the discussion on the lifetime management of patients with AS, stated the company.

The data were presented at ACC.23/WCC, the American College of Cardiology’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana.

Philippe Généreux, MD, presented the first study, entitled “Untreated Aortic Stenosis Mortality by Diagnosis Severity: Results from a Large Real-World Dataset.” Dr. Généreux is Director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center in Morristown, New Jersey.

In the study, Dr. Généreux and colleagues analyzed > 1.6 million echocardiograms from 24 United States hospitals in the Egnite, Inc. cardiovascular management database.

As reported by Dr. Généreux, the investigators found that for the almost 600,000 patients with AS severity assessment available, all degrees of untreated AS severity were associated with increased mortality risk. The mean 2-year all-cause mortality for moderate untreated AS was approximately 20%, approaching the rate of those patients with severe AS.

“The main finding of this analysis is that the severity of AS may be underrecognized and undertreated, leading to unnecessary and preventable death among our patients,” commented Dr. Généreux in Edwards’ press release. “Our study of real-world data highlights the challenges in properly determining the severity of AS by echocardiogram and underlines the high mortality rate associated with a milder degree of AS severity, such as mild and moderate, than previously suspected. Both point to the importance of continued study into the potential benefit of earlier intervention among patients with AS.”

In the second study, Suzanne J. Baron, MD, an interventional and structural cardiologist in Boston, Massachusetts, led an analysis of Medicare data that showed a very low rate of reintervention after TAVR out to 10 years.

According to Edwards, the investigators found that among the 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 patients underwent a valvular reintervention.

When the competing risk of death was considered, this translated to a 1.63% rate of reintervention overall. Additionally, rates of reintervention appear to be decreasing with the introduction of next-generation technologies.

Dr. Baron stated in Edwards’ press release, “The observed, sustained, low reintervention rates, as well as the decrease in reinterventions with advanced technology, are particularly impactful and provide valuable input into the decision-making of heart teams and patients in evaluating TAVR as a treatment option, particularly as younger patients are being treated. Certainly, more data are needed, but this is definitely reassuring.”

Larry Wood, Corporate Vice President and Group President, TAVR and Surgical Structural Heart at Edwards Lifesciences, added, “These data highlight the urgency in studying the right time to intervene in AS disease progression to achieve the best outcome for the patient, and we look forward to additional data that will come from the PROGRESS and EARLY TAVR trials currently underway. Through a potentially outdated treatment paradigm, some patients may be incurring needless cardiac damage or mortality when a proven therapy is available.”