Edwards Lifesciences
(NYSE: EW)
today announced new data supporting its heart valve replacement technologies.
Investigators shared findings from multiple studies at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo in Chicago.
Results from the EARLY TAVR trial — the first randomized, controlled FDA pivotal study designed to determine the best strategy for treating asymptomatic severe AS and the benefits of timely intervention with TAVR — were presented and published in The New England Journal of Medicine.
Findings included superior outcomes for asymptomatic severe AS patients randomized to Edwards transcatheter aortic valve replacement (TAVR) compared to guideline-recommended clinical surveillance (watchful waiting). Investigators saw no clinical penalty for timely intervention.
Edwards says the new study evaluated outcomes of patients treated in EARLY TAVR. It segmented subjects by the severity of signs and symptoms once they converted to aortic valve replacement (AVR). Investigators labeled watchful waiting as an ineffective strategy for managing severe AS as a result.
Other findings shared by Edwards
The company also shared new data underscoring the importance of urgently referring patients to a heart team for evaluation once diagnosed.
DETECT AS evaluated the impact of automatic electronic provider notifications (echo alerts) for patients with severe AS. It looked at 939 patients and 285 physicians. Those who ordered an echo for severe AS either receivde an echo alert describing treatment guidelines or no notification. Results were simultaneously published in Circulation.
Findings revealed that echo alerts increased AVR treatment rates by 11% for all patients with severe AS. It increased rates by 14% for symptomatic severe AS patients. Echo alerts also significantly improved AVR treatment rates among older patients and women. Edwards said this reduced age and gender disparities.
Additionally, some hypothesized that cardiac biomarkers can predict the best time for severe AS patients to go from watchful waiting to receiving treatment. Edwards reported a presented study highlighting the opposite. The company said it further underscores the rapid, unpredictable progression of the disease. Edwards stressed the urgency to refer patients to a heart team for evaluation and treatment.
“The data from these new studies confirm that severe aortic stenosis is a complex disease and reiterate the need for urgent referral and evaluation of treatment for patients with or without symptoms,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “We remain committed to advancing high-quality science and delivering life-saving structural heart therapies for patients with our leading SAPIEN valve platform, which has been used to treat more than 1 million patients worldwide.”
