With clinical trials, the big story is always in the numbers. So it was with a heart failure trial called COAPT. The trial considered 614 patients treated at dozens of medical centers around the country. UCHealth University of Colorado Hospital (UCH) at the Anschutz Medical Campus was among the top 10 sites.
All the patients had advanced heart failure. A leaky mitral valve between the heart’s two left chambers was part of the problem. Instead of the left atrium pushing blood down to the left ventricle and the left ventricle pushing blood out to the body, the leaky valve let the ventricle pump some of the blood back up into the left atrium (technically, it’s called mitral regurgitation).
The patients got the best medical treatment available. Half then also received a medical device called a MitraClip. In late September, the study’s leaders reported the results.
Two years into treatment, those who got the MitraClip had 43 percent fewer hospitalizations, 28 percent fewer heart attacks, 61 percent fewer heart transplants, and 14 percent fewer strokes, among other metrics. Nearly half of those just on medical management (46.1 percent) had died within two years; among those with the MitraClip, that figure improved to fewer than one in three (29.1 percent).
“Six patients needed to be treated to prevent one death. Even statins are not that good,” Brieke said. “That’s the impact of this trial on this population.”
The study and its numbers got attention. The prestigious New England Journal of Medicine published the report. The New York Times wrote it up. But numbers can’t tell the whole COAPT story. For that, one must sit down with someone such as Ken Nielsen.
Nielsen, 58, of Colorado Springs, was told two decades ago that he was within a year of needing a heart transplant. It turned out to be a hereditary problem: the electrical pulses driving his heartbeat weren’t synchronized, which had led to heart failure. His heart was supplying about one-third of the blood it was supposed to (its ejection fraction was about 15 percent; 50 percent to 70 percent is considered normal). His kids, Melissa and Erik, were elementary school and preschool. It was, he said, “hard – physically, mentally. You know, just getting diagnosed with that was a baseball bat to the chest.”
Despite a circulatory deficit that would leave many bedridden, Nielsen kept at his job as a supervisor at a mechanical subcontractor. Medications helped, as did a biventricular pacemaker. But his ejection fraction never rose above about 30 percent. He had been listed for a heart transplant, but he wasn’t sick enough to qualify. In 2007, he had to stop working.
Nielsen went back to work in 2013. He had been on the job for about a year when, at the end of a week in April 2014 he hadn’t been feeling well, dialed 9-1-1, opened the door for the paramedics and collapsed. He spent eight days in an intensive care unit at UCHealth Memorial Hospital in Colorado Springs. He was on a ventilator much of the time; his kidneys failed for some of it. It looked like the end, but he pulled through.
Memorial Hospital cardiologists, recognizing that Nielsen’s mitral valve was a big part of the problem – about 35 percent of the ventricle’s output was leaking back up into the atrium – referred him to UCHealth Structural Heart and Valve Clinic. Brieke, interventional cardiologist Dr. John Carroll and cardiac surgeon Dr. Joseph Cleveland had been involved in MitraClip clinical trials for more than a decade. The UCH team had contributed to the study that led to the device’s U.S. Food and Drug Administration initial approval for patients with faulty mitral valves and who were too sick for open-heart mitral-valve replacement, in 2013. The Memorial Hospital cardiology team knew Brieke and colleagues were recruiting patients for COAPT, which was to extend approval to roughly 90 percent of patients whose mitral valve problems come about because of changes to the surrounding heart muscle. Nielsen might be a candidate, they thought. They were right.
Carroll and interventional cardiology colleagues including Dr. Dominik Wiktor have performed about 200 MitraClip procedures in clinical trials and in FDA-approved procedures over the years, by far the most in the region. These procedures are, Carroll says, as difficult as any minimally invasive cardiac surgery he has done. (This from a man who has replaced aortic valves via catheters snaked up through an artery near the groin.)
It’s a team effort, he says, from assessing patients in a Tuesday-afternoon multidisciplinary Mitral Valve Clinic on through the procedure itself, which depends heavily on UCHealth experts in echocardiography and X-ray fluoroscopy as Carroll or Wiktor guide a catheter into the heart. Once there, a clip about the size of a dime opens wide and, at the interventional cardiologist’s command, clamps down on the center of the mitral valve’s opposing flaps (as depicted in this video). Scar tissue forms around the clip, permanently stabilizing the valve, which lets blood through from the atrium around the clipped point in the center while largely preventing backflow. The procedure takes a couple of hours, Carroll says, and usually involves more than one clip. Patients often go home the next day.
Nielsen got three MitraClips during his September 2015 procedure. His mitral regurgitation dropped from 35 percent to 5 percent or less, and his heart’s ejection fraction is up to 38 percent, within shouting distance of normal. The result has been life-changing in many ways, he says.
He has more energy. His skin is no longer gray. He can sleep lying down (before, he had to be propped up or his lungs would fill with fluid) and is off oxygen at night. Before, walking upstairs had been exhausting. After, he was able to hike the 1.4-mile, 1,200-vertical-foot trail to Hanging Lake within months of the procedure. He and wife, Tami, a close high school friend with whom he reconnected a month after the procedure, were married a year later. They recently spent a week in Telluride, walking and hiking at 9,500 feet altitude and above, which would have been unthinkable. He’s got a new granddaughter to dote on. Nielsen intends to try skiing this winter for the first time since his heart failure was diagnosed, he says.
He can do these things, he says, because he never gave up – and because of the care he got at UCHealth.
“I try to make a difference in my wife’s and my kids’ lives,” Nielsen said. “I’ve got long-term friends. They always joke that I’m too stubborn to die”
He benefitted from the COAPT trial. But the COAPT trial benefitted from him, too, Carroll says. Nielsen’s and other patients’ willingness to participate may help many others: mitral regurgitation affects one in 10 adults over 75 and more than 2 million people in the United States.
Carroll and his UCHealth colleagues continue to explore new avenues for these patients. Among the clinical trials include a system that enables mitral valve replacement without open-heart surgery; implantation and testing of a device similar to the MitraClip as well as one that takes a different tack (mechanically reducing the annulus, or ring size, of the gap the mitral valve fills); and a study to confirm the safety and performance of MitraClip devices already approved for use in Europe and the United States.
Participating in these studies is a lot of work for the UCHealth team, he says, but it’s worth it. First, such trials can provide novel treatments to UCHealth patients years before those treatments reach the mainstream. And second, gaudy numbers in journal articles can lead to options that change the lives of large numbers of people like Ken Nielsen.
“We want to participate in the developing and refining of these treatments to bring them to widespread clinical use,” Carroll said.