NEW ORLEANS, March 6, 2023 — Edwards Lifesciences (NYSE: EW) today highlighted new important data examining mortality rates and cardiac damage of early-stage aortic stenosis (AS) sufferers, along with data examining 10-year transcatheter aortic valve replacement (TAVR) re-intervention rates using real-world Medicare data. Together these studies, presented at the American College of Cardiology ACC.23/WCC, add valuable insights to the discussion on lifetime management of patients with AS.
AS Mortality
In the study, “Untreated Aortic Stenosis Mortality by Diagnosis Severity: Results from a Large Real-World Dataset,” Philippe Généreux, M.D., director of the structural heart program at the Gagnon Cardiovascular Institute at Morristown Medical Center, and colleagues analyzed more than 1.6 million echocardiograms from 24 U.S. hospitals in the egnite, Inc., cardiovascular management database.1,2 The study 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. For example, the mean 2-year all-cause mortality for moderate untreated AS was ~20%, approaching the rate of those 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,” Généreux said. “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.”
TAVR 10-Year Re-intervention
An analysis of Medicare data, led by Suzanne J. Baron, M.D., MSc, an interventional and structural cardiologist in Boston, Mass., showed a very low rate of re-intervention after TAVR out to 10 years. Among 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 underwent a valvular re-intervention. When the competing risk of death was considered, this translated to a 1.63% rate of re-intervention overall. Additionally, rates of re-intervention appear to be decreasing with the introduction of next-generation technologies.
“The observed, sustained low re-intervention rates as well as the decrease in re-interventions 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,” Baron said. “Certainly, more data are needed, but this is definitely reassuring.”
“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,” said Larry Wood, corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart, Edwards Lifesciences. “Through a potentially outdated treatment paradigm, some patients may be incurring needless cardiac damage or mortality when a proven therapy is available.”
1 egnite’s CardioCare software was incubated at Edwards Lifesciences.
2Dr. Généreux is a paid consultant for Edwards Lifesciences.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.
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