An image-guided cardiac device designed to repair the mitral valve while a patient’s heart is still beating could provide a safe, effective alternative to traditional open heart surgery, according to research presented Nov. 1 at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Denver.
The new device, known as the Harpoon Mitral Valve Repair System (H-MVRS), is deployed through a small opening in the patient’s ribs, according to a release from the University of Maryland Medical Center, where the technology was developed. The surgical alternative was tested in 30 patients across six medical centers in Europe with a high success rate, though its investigational nature means it hasn’t yet received European CE marking or approval from the U.S. Food and Drug Administration.
“The Harpoon device was found to be remarkably safe and effective,” James S. Gammie, MD, an inventor of the device, said in the Maryland release. “The device allowed the surgeons to precisely and effectively reduce the degree of mitral regurgitation without using an open-heart procedure. There were no deaths. Only one patient needed a blood transfusion, and there were no strokes, no need for pacemakers, no readmission to the ICU and no reintubations.”
Three patients were transferred to conventional open heart surgery due to unclear imaging, but 90 percent of the original cohort reached the study’s primary endpoint. According to the research, mitral regurgitation (MR) was mild or decreased in 85 percent of the patients treated with H-MVRS.
Degenerative MR—the world’s most common heart valve disorder—impairs normal valve function, allowing blood to travel in the wrong direction through the heart’s chambers and causing arrhythmia, fatigue, shortness of breath and fluid retention. The H-MVRS restored regular function, Gammie and colleagues reported.
In the operating room, surgeons use echocardiographic imaging to guide the device to the surface of a patient’s defective mitral valve flaps, making device placement clear. Since the natural cords connecting the patient’s mitral valve flaps and heart muscle are stretched or broken in the case of MR, the H-MVRS implants artificial cords, made of expanded polytetrafluoroethylene, to repair the damage.
According to the release, the technology could undergo testing in the U.S. as early as 2018.