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A research collaboration between MedStar Health and NIH scientists shows promise in helping patients get relief from mitral regurgitation and other heart failure symptoms caused by cardiomyopathy.
Working in collaboration with partners at the National Institutes of Health, MedStar Health scientists led by Principal Investigator Toby Rogers, MD have completed an early feasibility study on a device that could bring relief to millions of patients with heart failure who might otherwise have no treatment options.
Heart failure is a common and growing problem in the U.S.—about 6.5 million over age 20 have heart failure, and nearly a million new cases are diagnosed annually. Heart failure directly causes about 8.5% of all heart disease deaths in the U.S. and contributes to 36% more.
Functional mitral regurgitation (FMR) is a heart failure condition in which blood flows backward through the mitral valve, and the heart must work harder to pump blood. The heart is stretched too far for the valve’s leaflets to close correctly, and the shape of the heart has changed (cardiomyopathy) due to health situations such as atrial fibrillation, ischemic heart disease, chemotherapy or radiation to the chest, or chronic alcohol misuse.
Our research suggests that changing the heart muscle's shape might be effective for patients with cardiomyopathy and functional mitral regurgitation.
Scientists from MedStar Health and the National Institutes of Health’s National Heart, Lung and Blood Institute worked together to develop Transcatheter Mitral Cerclage Ventriculoplasty. Similar to the drawstring closure of a hooded sweatshirt or purse, the Cerclage device is placed around the heart and cinched to pull the ventricle inwards. Thus, changing the geometry of the heart and bringing the leaflets closer together. The result is better valve function, less regurgitation, and reduced stress on the heart—all of which can be achieved without open heart surgery.
Changing the heart's shape without surgery.
The device is implanted using a transcatheter technique, in which surgeons’ thread small tubes through the patient's internal jugular vein. Through these catheters, doctors access the base of the heart, implant the cerclage device, and cinch it to change the shape of the heart.
Transcatheter procedures have several significant benefits over open-chest techniques, including less pain, rapid recovery, and quicker improvement of symptoms.
The device was conceived at the National Institutes of Health and initially tested in animals about a decade ago. It was refined and developed in partnership with medical device firm Transmural Systems, which created a version suitable for human trials under a small business innovation contract with NIH.
Our early feasibility study is the first trial in humans. It involves a relatively small group of participants and is intended to assess the procedure's safety and to look for signs that it is effective. The results were more positive than we expected and suggested broader possibilities for treating patients with heart failure.
Early data show significant promise.
We enrolled 19 subjects with heart failure, and 75% had non-ischemic cardiomyopathy. Our study found that the procedure was very safe. No patients experienced significant adverse effects on their heart, none had a stroke, and none died.
Participants reported dramatic improvements in quality-of-life measures. Patients assessed their symptoms using the Kansas City Cardiomyopathy Questionnaire, which measures heart failure symptoms like shortness of breath. Patient scores improved substantially 30 days after the device was implanted and continued to improve almost a year after the procedure.
Other key markers, such as the Six Minute Walking Distance, also improved significantly. These improvements indicate the cerclage device could help relieve symptoms of heart failure above and beyond the improvement in severity of mitral regurgitation.
Designing treatment for heart failure.
We are planning a second clinical trial with a modified device, which we hope will begin in 2023. This early feasibility study will evaluate the device in a broader population of patients with heart failure symptoms even if they do not have concurrent mitral regurgitation, as we believe this device may have a much broader clinical application.
This research is at the forefront of new technology. Remaining at the cutting edge of minimally invasive interventional therapies is critical to our mission to advance care for all heart failure patients.
Our work would not have been possible without MedStar Health’s longstanding collaboration with the NIH National Heart, Lung, and Blood Institute. This relationship has resulted in several research collaboratives pushing the frontiers of medicine to benefit patients across the U.S.
