The results of two studies by Medtronic indicate improved outcomes at the five-year mark for patients implanted with the Dublin-based company’s CoreValve transcatheter aortic valve replacement device.
Medtronic announced results of the real-world Nordic Aortic Valve Intervention (NOTION) Trial and the CoreValve U.S. Pivotal Extreme Risk Study during this year’s American College of Cardiology’s annual scientific session.
In the NOTION trial, researchers found similar rates of all-cause mortality between TAVR and surgical aortic valve replacement (SAVR) at 27.7% each. The study also showed much improved blood flow rates of a mean aortic valve gradient of 8.22 mm Hg for TAVR compared to 13.71 mm Hg for SAVR.
"These five-year outcomes of the NOTION data add to the mounting body of longer-term evidence supporting the effectiveness of TAVR,” H. Gustav Thyregod, M.D., Ph.D., a cardiac surgeon at the Heart Center, Rigshospitalet, in Copenhagen, Denmark, said in a statement. “We're pleased to see the strong hemodynamic performance maintained over time without any indication of valve deterioration.”
Results from the pivotal study indicated that patients who received the CoreValve TAVR system showed a marked improvement in their quality of life at the post-implant five-year mark. Additionally, they exhibited blood flow rates in sustained low mean gradients of 7.63 mm Hg. The patients in the pivotal study participated in the first U.S. IDE cohort to be treated with the self-expanding CoreValve TAVR system and were considered at high risk for valve replacement.
"It is remarkable to see patients, whose only aortic valve replacement option was to undergo a TAVR procedure, continue to live an improved quality of life five years later," Pieter Kappetein, M.D., a Medtronic vice president, said in a statement. "While the TAVR therapy continues to show promise in less sick patients, it's important to acknowledge that the early pioneers of this therapy were those who truly had very limited treatment options.”