Approval was granted to Edwards Lifesciences for its TAVR based on groundbreaking data from the EARLY TAVR trial, conducted at US and Canadian sites including Ascension Alexian Brothers. The results of the trial demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes* compared to guideline-recommended clinical surveillance (watchful waiting).1 Ascension Alexian Brother’s participation in this trial underscores its commitment to advancing cardiac care for the Chicagoland community.
Ascension Alexian Brothers was one of 75 study sites across North America to enroll patients in EARLY TAVR, the first randomized, controlled trial designed to evaluate early TAVR compared to watchful waiting for patients with asymptomatic severe AS.1 With a median follow-up of 3.8 years, 26.8% of the 455 patients in the TAVR arm experienced death, stroke or unplanned cardiovascular hospitalization,† compared with 45.3% of the 446 patients in the clinical surveillance arm.1 The data were published last year in TheNew England Journal of Medicine (NEJM).
“Early TAVR is a study that has changed the playing field for patients with aortic stenosis. Many patients are deemed asymptomatic - more commonly as people get older. This often leads to undertreatment or delayed treatment, hospitalization and loss of independence. The early TAVR study has shown that treatment is beneficial even if patients have no symptoms.” said Andrei Pop, M.D., system structural director, Ascension Illinois and medical director, cardiac catheterization laboratories at Ascension Alexian Brothers. “This greatly simplifies decision making and should increase access to care and timeliness of treatment. The question "Am I slower because of the valve or because of my age?" - is a tough question and frankly one that even cardiologists often find hard to sort out.”
Heart valve disease, like aortic stenosis, can affect anyone. But people 65 years and older are at higher risk. Learn more about severe aortic stenosis, also known as heart valve failure, at TreatHeartValveFailure.com.
