In 2019, the Evolut Low Risk demonstrated similar outcomes for TAVR and surgical aortic valve replacement (SAVR) in low-risk patients with aortic stenosis, an outcome the FDA cited when it approved an expanded indication for several devices. The findings presented Saturday, June 20, at TVT Connect compared outcomes from the Evolut Low Risk trial with 432 patients from continued access study (CAS) and 543 real-world patients from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry.
Bruce Rutkin, MD, of Northwell Health in Manhasset, New York, presented the findings. Sunil Rao, MD, editor in chief of Circulation: Cardiovascular Interventions, chaired the session.
Overall, the outcomes between the three patient cohorts were similar. Pacemaker implantations did drop over time, a finding believed to show an increasing comfort among operators, and vascular complications saw a similar decline.
In addition, Rutkin noted, the median time from procedure to discharge was “consistently low” for all patients.
“We always talk about what’s going to happen when these patients are enrolled in a real-world, commercial setting and if we are going to see differences compared to the stringently controlled randomized trial,” Rutkin said. “I think it’s reassuring that all three groups had similar outcomes, if not slightly improved for certain categories in the registry patients, albeit self-reported.”