A team of Washington University physicians at Barnes-Jewish Hospital is participating in a clinical investigation of a transcatheter mitral valve replacement (TMVR) system that offers an alternative to patients who are too high risk for replacement surgery.
As part of the investigation, the team is testing the safety and effectiveness of the TMVR system. Using this system, doctors use a catheter to replace the patient’s defective mitral valve with a bovine valve contained in an implantable frame.
Patients in the trial suffer moderate-to-severe mitral regurgitation (MR), says Alan Zajarias, MD, co-director of the Washington University Valvular Heart Disease Center. Untreated, MR can lead to heart failure or even death. While medication can help alleviate MR symptoms and possibly slow progression, surgical valve repair or replacement are the definitive treatments for advanced mitral valve issues.
However, age, comorbidities, disease progression including mitral annular calcification (MAC), or other factors make some patients high-risk or ineligible for surgery. For these patients, a TMVR procedure could prove to be life-changing, says Dr. Zajarias.
“Treatment options for these patients are limited and are either very high-risk surgery or nothing,” he says.
Investigators at sites across the U.S. hope to enroll about 1,350 patients in the trial over the next two years, says Dr. Zajarias. Candidates for the TMVR procedure must undergo a detailed screening by a multidisciplinary team of Washington University School of Medicine experts. Patients must have moderate-to-severe symptomatic MR with or without MAC and be unsuitable for transcatheter edge-to-edge valve repair (TEER) to be eligible for the treatment.
In the TMVR procedure, doctors guide a catheter loaded with the stent into the heart, either through an incision between the ribs (transapical approach) or by way of the femoral vein entered by an incision in the groin. In the heart, the stent is positioned within the patient’s existing valve and then expanded, deploying the replacement valve.
TMVR patients typically spend about five days in the hospital following the procedure and experience less pain and fewer complications than with surgical valve replacement. Patients go to cardiac rehab after the procedure and come for follow-up visits at one month, six months and one year.
Dr. Zajarias and the team will evaluate the outcomes of patients treated with the TMVR system to determine whether the procedure can reduce mortality from all causes and hospitalization due to heart failure. Smaller studies of the procedure have indicated that outcomes are similar to surgical replacement, with improved heart function and an improved quality of life, including reduction in symptoms such as fatigue and shortness of breath.
With its minimally invasive approach, TMVR is similar to the transcatheter aortic valve replacement (TAVR) procedure, which has become a standard option for aortic valve stenosis patients who are poor candidates for surgical aortic valve replacement.
However, says Dr. Zajarias, the complexity of mitral valve anatomy and the comorbidities often present in MR patients makes TMVR a more technically difficult procedure than TAVR requiring the skills of a highly experienced, multi-disciplinary team, like the Washington University and Barnes-Jewish Heart & Vascular Center team. The specialized valve team includes dedicated valve cardiologists, surgeons and nurses skilled in interventional cardiology, cardiac imaging and cardiothoracic surgery.
Washington University and Barnes-Jewish Heart & Vascular Center is the only institution within about 500 miles participating in the trial, Dr. Zajarias says. The center’s proven track record of pioneering and performing surgical and transcatheter valve procedures, including development and trials of TAVR procedures, also led to it being chosen as one of only 12 centers to participate in the investigation’s early feasibility tests.
Our team of experts are among the region’s most experienced in valve repair and replacement. Offering a full range of catheter-based treatments and minimally invasive surgery, we often have access to advanced techniques to treat patients with moderate-to-severe valve disease.
Learn more about the cutting-edge, advanced treatments available for your patients with complex valvular heart disease. To refer your patient for treatment, or to contact us directly, please call 855.825.8457. The trial is sponsored by Medtronic Cardiovascular, the maker of the transcatheter mitral valve repair system. More information about the study is available on clinicaltrials.gov.