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Providence St. Patrick Hospital in Missoula, Montana, is leading the way in bringing leading-edge research to rural communities.
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The APOLLO trial offers a new, minimally invasive option for mitral valve replacement for patients who are not eligible for surgery, including those in remote areas who may have trouble getting to the hospital for follow-up.
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Read on to learn how Providence is supporting patient access to these lifesaving techniques.
Clinical trials usually begin in large academic medical centers. That means patients in rural areas hundreds of miles from these locations are often left out of the latest research and advances in care.
Providence is changing that by bringing clinical trials to patients living in rural areas. One clinical trial, the APOLLO trial, aims to give patients across rural Montana access to a new treatment for mitral valve regurgitation.
“Without research like this, patients in Montana won’t have the opportunities for cutting-edge devices and therapies that are available at larger academic centers in bigger cities,” says Daniel Spoon, M.D., an interventional cardiologist at Providence St. Patrick Hospital. “We are one of the few research centers in the region and the only cardiovascular clinical trial center in the state. By bringing these trials to our community, we are providing access to therapies that would otherwise be unavailable.”
This hospital-based research program brings together clinical trials, basic research and collaboration with the University of Montana. Together, this program means Providence can provide a highly specialized level of medicine for patients, wherever they are.
Managing the mitral valve
The mitral valve is one of four valves of the heart. Located between the heart’s left atrium (upper left chamber) and left ventricle (lower left chamber), this valve makes sure blood flows through the heart in the right direction.
Mitral valve regurgitation is a common heart valve condition where the flaps of the mitral valve do not seal properly and blood flows backward to the heart. This condition is usually mild, with many patients not even aware they have it.
However, mitral valve regurgitation can affect cardiac function as it gets more severe, leading to shortness of breath, kidney problems and heart failure. Patients may need more medications to remove fluids. These problems tend to increase as patients get older and their valve regurgitation gets more severe.
“We have an aging population with more heart failure as patients live to be older, and they can’t do many of their daily activities as their symptoms get worse,” says Spoon. “Treating severe mitral valve problems gives us the chance to improve both quantity and quality of life for our patients.”
Treatment for mitral valve regurgitation starts with medication. However, progressive mitral valve disease can require surgical repair or replacement. Patients that are not surgical candidates have traditionally been treated with mitral valve transcatheter edge-to-edge repair, where an interventional cardiologist uses a clip to prevent fluid from going backward through the valve. This procedure is FDA approved, but not all patients are good candidates for it.
“This is where clinical trials are important for patients who are not good surgical candidates or candidates for mitral valve transcatheter edge-to-edge repair,” says Spoon. “We need to provide options for patients who have not had them in the past.”
A minimally invasive approach to the mitral valve
Because many patients are not good candidates for surgery, there is a clear need for a minimally invasive option to help patients with severe mitral valve regurgitation. The APOLLO trial brings just that, using interventional cardiology – non-surgical treatment that uses catheters fed through blood vessels to treat conditions – to replace the mitral valve.
“We’ve always had mitral valve expertise at Providence, but at St. Patrick’s, we’ve treated faulty valves with open surgical intervention,” says Spoon. “This therapy is the first transfemoral mitral valve replacement that doesn’t require surgery.”
This therapy means that patients who cannot have surgery, including older adults or high-risk patients, can still be treated. Compared to surgery, this new procedure is less invasive, requires a shorter hospitalization and reduces complications. Patients are admitted and spend several days in the hospital for observation, but after the procedure can go home with few restrictions.
“For patients who are not surgical repair candidates, this is the first procedure that involves complete transcatheter mitral valve replacement,” says Spoon. “It doesn’t matter why or how much the valve is leaking and means a complete replacement.”
Because patients with mitral valve regurgitation have trouble staying active, they may have a variety of other conditions that are hard to control. This treatment means the chance to not only fix the mitral valve but also help improve other health problems.
“We’re able to give patients their lives back,” says Spoon. “We can help their cardiovascular health and improve their quality of life. For some patients, this treatment means they can receive other medical care, like orthopedic procedures, that wouldn’t have been possible if they didn’t have their valves repaired.”
A less-invasive treatment option for this condition is particularly helpful for patients in rural areas.
“For patients with severe symptoms who are living in rural areas, we are one of the few sites with access to this therapy,” says Spoon. “This is exactly our mission: providing world-class care in an area that hasn’t traditionally had these research options. We’re not bringing this trial to our community for international stardom but to bring devices to patients who don’t have access. It’s personal because it’s our friends and families that are getting access to these therapies.”
Contributing caregiver
Daniel Spoon, M.D., is an interventional cardiologist at Providence St. Patrick Hospital.
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This information is not intended as a substitute for professional medical care. Always follow your health care professional’s instructions.
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