Real-world NOTION trial shows CoreValve TAVR offers improved quality of life in aortic stenosis.- Medtronic.

Medtronic has released outcomes from the CoreValve U.S. Pivotal Extreme Risk Study and the real-world NOTION trial (Nordic Aortic Valve Intervention Trial), both of which examined patients with the CoreValve transcatheter aortic valve replacement (TAVR) system at five years post-implant. Results from the studies demonstrated that patients implanted with the CoreValve TAVR system showed strong hemodynamic performance (blood flow) and improved quality of life out to five years.

The physician-initiated NOTION trial studied an all-comers population of 280 patients at least 70 years old who were randomized to surgical (SAVR) or transcatheter aortic valve replacement using the CoreValve System. Results at five-year follow-up showed similar rates of all-cause mortality (27.7 percent for TAVR versus 27.7 percent for SAVR) and superior hemodynamic performance for TAVR (mean aortic valve gradient of 8.22 mm Hg) compared to surgery (13.71 mm Hg).

Also presented at the meeting were the final five-year results from the CoreValve U.S. Pivotal Extreme Risk Study, which enrolled the first US IDE cohort of patients ever to be treated with the self-expanding CoreValve TAVR system. Results from the study continued to show positive outcomes at five years for the surviving patients - all of whom were deemed to be facing considerable harm or mortality with a surgical valve replacement. Patients implanted with the CoreValve system maintained a notable improvement in quality of life (mean change from baseline in KCCQ of greater than 20 points at 5 years) and sustained low mean gradients (7.63 mm Hg). Results were presented at the American College of Cardiology (ACC) 67th Annual Scientific Session.