A new cardiac surgical procedure to treat mitral valve disease, which is minimally invasive, does not require open-heart surgery, and offers faster recovery, is being tested in an upcoming clinical trial.
Mitral valve disease occurs when the heart’s mitral valve — which has two flaps that open and close to allow blood to flow — cannot close or open properly.
There are two types of mitral valve disease: stenosis, when the valve does not open enough to allow sufficient blood flow; and regurgitation, when the blood leaks backward, preventing blood flow from the lungs to the rest of the body, making the heart work harder.
Without timely treatment, mitral valve disease can lead to several complications, including pulmonary hypertension (PH).
Patients with PH have a higher risk of complications when they undergo conventional cardiac surgery. However, a study reported that if these patients undergo the less invasive valve surgery, they have fewer complications, along with faster recovery times and shorter hospital stays.
The ReChord trial (NCT02803957) is now testing the effectiveness and safety of a new minimally invasive surgery to treat regurgitation by fixing the mitral valve flaps.
Estimated enrollment for the trial is 585 participants, and it is currently recruiting at locations across the U.S. The trial will be randomized, with some participants undergoing the new surgery and others receiving standard surgical mitral valve repair.
The new procedure, called NeoChord, involves the insertion of a catheter about the size of a pencil into the heart while it’s beating. The device is threaded with artificial chords to replace the ones tethering the mitral valve that are defective and causing valve leakage.
Surgeons use ultrasound imaging to guide them inside the heart.
“Under ultrasound imaging, we then adjust the length of the chords we put in using the NeoChord system to re-establish a normal leaflet motion and resolve the regurgitation,” Matthew Romano, MD, cardiac surgeon at Michigan Medicine and leader of the ReChord trial at the University of Michigan Frankel Cardiovascular Center, said in a press release.
Contrary to conventional mitral valve surgery, NeoChord does not require open-heart surgery or a heart-lung bypass machine, and takes about one hour to complete — much faster than typical surgeries.
Mitral valve treatment typically allows patients to return to an active lifestyle if performed early in the disease course. And recovery from an incision only a few centimeters wide makes the process even quicker, compared with open-heart surgery, Romano said.
“This is a significant advance in treating mitral valve disease in a less invasive way with less pain and faster recovery,” he said.
Romano also emphasized that in contrast to other procedures on trial to treat mitral regurgitation, NeoChord is an option for both low- and high-risk surgical patients.