Patients implanted with the CoreValve transcatheter aortic valve replacement showed strong blood flow and improved quality of life at five years post-implant, according to results from two Medtronic studies.
1. Medtronic presented results from the Nordic Aortic Valve Intervention Trial and the CoreValve U.S. Pivotal Extreme Risk Study at the American College of Cardiology 67th Annual Scientific Session.
2. The NOTION trial randomly assigned 280 patients ages 70 and older to surgical aortic valve replacement or transcatheter aortic valve replacement using the CoreValve System.
3. Five years after the implantation, both groups in the NOTION study showed 27.7 percent rates of all-cause mortality. TAVR with the CoreValve System resulted in better hemodynamic performance compared to surgery.
4. "We're pleased to see the strong hemodynamic performance maintained over time without any indication of valve deterioration," said H. Gustav Thyregod, MD, PhD, a cardiac surgeon in the department of cardiac surgery at The Heart Center, Rigshospitalet, in Copenhagen, Denmark.
5. The CoreValve U.S. Pivotal Extreme Risk Study treated patients with the self-expanding CoreValve TAVR system. The surviving patients all faced considerable harm or mortality with a surgical valve replacements, yet showed positive outcomes five years after the procedure.
6. The TAVR therapy shows promise in less sick patients, according to Pieter Kappetein, MD, vice president and chief medical officer of the Heart Valve Therapies business of Medtronic's Cardiac and Vascular Group.
"It's important to acknowledge that the early pioneers of this therapy were those who truly had very limited treatment options. It's satisfying to see that many of these early patients continue to do well with the self-expanding TAVR platform, especially as the therapy expands to lower-risk patients who are expected to live longer," Dr. Kappetein said.
7. The CoreValve System launched in the U.S. in 2014. The CoreValve Evolut R System — a recapturable and repositionable TAVR device for severe aortic stenosis patients at a high or extreme risk for surgery — was approved in the U.S. in 2015. The third-generation Evolut PRO TAVR system gained U.S. approval in 2017 for patients at extreme, high and intermediate risk.