Edwards Lifesciences (NYSE:EW) today announced data supporting transcatheter aortic valve replacement (TAVR) at 10 years.
An analysis of Medicare data showed a low rate of re-intervention after TAVR out to 10 years. Dr. Suzanne Baron, a Boston-based interventional and structural cardiologist, led the analysis. Edwards presented results at the American College of Cardiology ACC.23/WCC.
Of 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 underwent valvular re-intervention. This translated to a 1.63% rate of re-intervention overall when considering the competing risk of death.
Edwards also said it observed the apparent decrease of re-intervention rates with the introduction of next-generation TAVR 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 in a news release. “Certainly, more data are needed, but this is definitely reassuring.”
Edwards says aortic stenosis leads to unnecessary and preventable death
New data reported by Edwards examined mortality rates and cardiac damage associated with early-stage aortic stenosis (AS).
Dr. Philippe Généreux, director of the structural heart program at the Gagnon Cardiovascular Institute at Morristown Medical Center, and colleagues conducted the study. They analyzed more than 1.6 million echocardiograms from 24 U.S. hospitals in the egnite cardiovascular management database.
The study found that, among nearly 600,000 patients with available AS severity assessment, all degrees of untreated AS severity associated with increased mortality risk. Edwards said the two-year all-cause mortality for moderate, untreated AS registered around 20%. That approaches the rate of those with severe AS.
Généreux said the main takeaway centers around the underrecognition and undertreatment of severe AS. This could lead to unnecessary and preventable death.
“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, VP 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.”