Intermountain Medical Center is participating in a national 40-center clinical trial to see if a new device will reduce mitral valve regurgitation a repair that otherwise requires open-heart surgery.
The mitral valve is a valve between the left ventricle and atrium that, when functioning properly, sends blood to the body. When it regurgitates, some of the blood goes back toward the lungs, which can cause chest pain, shortness of breath, exhaustion, heart failure, stroke, atrial fibrillation and even sudden death.
For the study, an interventional cardiologist inserts Evalve's MitraClip through the groin to fasten together the valve's leaflets and reduce that backflow, says Dr. Brian K. Whisenant, interventional cardiologist and IMC's principal investigator for the study.
IMC is the only Utah hospital participating in the phase 2 clinical trial.
The clinical trial, called Everest II, is looking at the clip's safety and effectiveness in patients with moderate to severe mitral regurgitation, something that afflicts about 4 million Americans a year. It is usually caused by heart-weakening conditions such as heart disease, valve degeneration and cardiomyopathy.
Two-thirds of patients enrolled in the study will be randomized to receive the clip, while one-third have the standard treatment, open-heart surgery.
James Hillyard, 72, of Cottonwood Heights, was scheduled for heart surgery for mitral valve regurgitation last summer. When he learned of the upcoming clinical trial, he opted to wait and hope he would receive the less invasive procedure.
He'd been diagnosed at a level 3 out of 4 for mitral regurgitation. The leaflets around the valve were not closing and about 30 percent of the blood was flowing backward. "I was tired and my heart was working as hard if not harder" than before. He developed congestive heart failure, with shortness of breath, fluid retention and, finally, atrial fibrillation. Doctors performed an ablation, short-circuiting some of his heart's wiring to get him back to a normal heart rhythm. But they diagnosed the valve problem and warned him the erratic heartbeat was apt to return unless it was fixed.
He received a MitraClip in a procedure that takes two to three hours. He was hospitalized overnight, then went home. The only discomfort, he says, was where the catheter was inserted in his groin. Two weeks later, he went golfing. One-month follow-up showed his mitral regurgitation had subsided to less than a level 1.
Not everyone's anatomy will accommodate the clip, Whisenant says. But the procedure is easier on the patient, recovery is simpler and he says there have been very few complications. If the clip doesn't work, surgery is still an option.
"This is the most anticipated and exciting trial I've seen in my career," Whisenant says, adding the clip is the first of a number of new valve therapies that are coming out. "The preliminary data looks outstanding."
Others working with Whisenant on the study include Dr. Stephen Clayson, heart surgeon, and cardiologist Dr. Steven Horton, among others. They hope to enroll about 20 patients over the year.For more information, call IMC's Utah Heart Clinic at 801-507-7000.