The global trial is designed to compare TAVR systems from Medtronic and Edwards Lifesciences when treating patients with small annuli.
The device is only approved in the United States for investigational use at this time.
The new analysis, published in the Journal of the American College of Cardiology, included findings from more than 1,000 Medicare patients with rheumatic aortic stenosis.
The impact on patients over the age of 65 has been undeniable.
One important detail, however, was that acute kidney injury was more common for kidney transplant recipients. The researchers listed numerous potential explanations for this trend.
The solution’s approval was based on 30-day and six-month data from a clinical study focused on mortality and hemodynamic function.
The new analysis, published in Circulation: Cardiovascular Interventions, focused on data from more than 600 patients who participated in the COAPT trial.
The analysis included eight consecutive pediatric patients who underwent TMVR with the Sapien S3 valve. The median patient age was 9 years old.
“The Ross procedure should be considered in young and middle-aged adults who need AVR and can be referred to dedicated centers with expertise in this operation,” researchers explained.
After two years, TAVR was still linked to a reduction in the study’s primary endpoint, but it was also associated with a greater risk of valve thrombosis.
The funds will go toward establishing the Carol S. O’Neill Structural Heart Disease Research Fund.
Both procedures were a part of a clinical trial—and both occurred at the same facility.