Late-breaking data showing promising results were recently reported from two clinical trials for which researchers at Aurora St. Luke’s Medical Center in Milwaukee were key contributors. Both studies evaluated an investigational heart valve replacement therapy for people with severe, symptomatic mitral regurgitation.
Mitral regurgitation is a common valve disease that affects up to 10% of the population. It occurs when a faulty heart valve allows blood to flow in the wrong direction. If left untreated, mitral regurgitation can lead to heart failure or death. But because of the complexity of the mitral valve and the health of people with mitral regurgitation, there are limited treatment options available.
Medtronic, manufacturer of the Intrepid Transcatheter Mitral Valve Replacement (TMVR) System and sponsor of the clinical trials, released the data from both studies at the 34th Transcatheter Cardiovascular Therapeutics conference, the annual scientific symposium of the Cardiovascular Research Foundation.
Results from the Intrepid TMVR Pilot Study three-year follow-up demonstrated stable valve function with persistent mitral regurgitation reduction in nearly all patients.
“These data add to the growing body of evidence demonstrating the Intrepid TMVR System could be a promising long-term solution for patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery,” said echocardiographer Renuka Jain, MD, Advocate Aurora Research Institute’s sub-investigator for the Intrepid TMVR Pilot Study.
The Intrepid TMVR system integrates self-expanding, dual-stent technology with a replacement tissue heart valve that is delivered through a hollow catheter inserted through a small incision between the ribs. The catheter is carefully threaded through a patient’s blood vessels to the heart using imaging technology at which point the replacement valve is expanded directly into the malfunctioning mitral valve. This less-invasive, catheter-based approach allows doctors to implant the device without open heart surgery.
Medtronic also announced encouraging one-year results with strong valve performance and near elimination of mitral regurgitation in all patients from its Intrepid TMVR Transseptal Early Feasibility Study. Aurora St. Luke’s was one of 11 sites nationwide to participate in this study. Interventional cardiologist Tanvir Bajwa, MD, served as the Research Institute’s principal investigator of the study.
“The Intrepid system was previously designed and investigated for transapical access, which requires an incision in the patient’s chest to access the heart,” Dr. Bajwa said. “The transfemoral-transseptal approach involves an incision in the upper leg to access the femoral vessel, into which the catheter is inserted. This approach is less invasive and has the potential to significantly improve patient outcomes.”
Researchers at Aurora St. Luke’s continue to implant the Intrepid TMVR System in research participants who’ve enrolled in the landmark APOLLO clinical trial, which is designed to evaluate the safety and efficacy of the Intrepid system in a larger population of patients with severe symptomatic mitral regurgitation. The Intrepid TMVR system is available for investigational use only, and it is not approved anywhere for use outside of clinical studies.
Aurora St. Luke’s cardiologists have been leaders in the field of minimally invasive heart valve procedures, beginning with their early participation in transcatheter aortic valve replacement, or TAVR, clinical trials. Today, Aurora St. Luke’s cardiologists have performed more than 3,000 minimally invasive valve procedures.
“Advocate Aurora Research Institute is proud to support the work of Drs. Jain and Bajwa and their fellow investigators at Aurora St. Luke’s cardiac catheterization lab, who continue to advance replacement valve technology through clinical research,” said Amit Acharya, PhD, chief research officer and system vice president for Advocate Aurora Health and the Research Institute. “This is one of the many ways the Research Institute is adding value to patient care and to the reputation of the health system by creating access to such unique clinical studies.”
To learn more about Advocate Aurora’s research, visit aah.org/research.