Transcatheter mitral valve replacement (TMVR) that utilizes transfemoral access appears to be a safe, effective treatment option for patients with mitral valve regurgitation, according to new data presented at TCT 2021.
The analysis, which was also published in JACC: Cardiovascular Interventions, included 15 patients with a median age of 80 years old. All patients received the self-expanding Intrepid TMVR system manufactured by Medtronic.
Overall, researchers found, 14 procedures were successful; one patient did shift from TMVR to surgery once the procedure had already started. Patients reported trace mitral valve regurgitation or no mitral valve regurgitation at all.
The survival rate was 100%. The median procedure time was 46 minutes, and patients spent a median time of five days in the hospital.
After 30 days, there were no reported deaths, strokes or reinterventions among the 14 patients who successfully completed the procedure.
Medtronic is currently evaluating the Intrepid TMVR system as a part of the ongoing APOLLO trial; previous patients had received the system using transapical access, not transfemoral access.
“These data indicate that the new Intrepid Transfemoral Delivery System is a promising option for the delivery of the Intrepid valve with all patients in the study showing almost complete elimination of mitral regurgitation at 30 days,” lead author Firas Zahr, MD, an interventional cardiologist and co-director of the Complex Heart Valve Program at Oregon Health and Science University, said in a statement.
“The development of the Intrepid Transfemoral Delivery System is an important milestone for the Intrepid TMVR program, and we are excited to introduce it into the APOLLO Trial,” added Nina Goodheart, senior vice president and president of Medtronic’s structural heart & aortic business. “We believe this advancement will expand our clinical trial offerings to more patients.”
Read the full study in JACC: Cardiovascular Interventions here.
More information on TCT 2021 is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.