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A Hole In The Heart As A Solution To Heart Failure? MUSC Thinks It Could Work.
Jimmy McMillan, 69, of West Columbia felt his health growing worse as his heart failure progressed.
"I would have trouble just walking down to the mailbox and back without having to stop and catch my breath," he said.
Then McMillan was accepted into a clinical trial at Medical University of South Carolina in 2016, testing a new type of heart device to address his particular kind of heart failure. Though he was randomized, meaning he had an equal chance of getting the device or a sham treatment as a control, it was pretty apparent to his brother-in-law which one it was when they wheeled McMillan back in after the procedure.
"You wouldn't believe the difference in the color of your face," he told McMillan. Before, he was pale and "looked like death warmed over," McMillan was told. But now, his face was already pinking up.
It turned out he did get the device, known as the Corvia Atrial Shunt, which works by helping relieve pressure through a small hole in a wall in the heart. Testing of the device is ongoing at MUSC and around 60 centers in the U.S., Canada, Europe and Australia.
Heart disease is the leading cause of death in the U.S. For both men and women, and it was the top killer in South Carolina, where it claimed 12,210 lives in 2021. Heart failure, the inability of the heart to pump blood adequately as needed, directly causes 8.5 percent of those deaths, but some estimate it contributes to more than a third of all heart-related deaths. It affects more than 6 million people in the U.S., and more than 900,000 patients are diagnosed with it each year. Unlike heart attacks and other heart-related disease where there has been progress in reducing the burden, heart failure is increasing. One study projected that heart failure overall would increase 46 percent in the U.S. Between 2012 and 2030, mostly driven by an aging population but also by increases in obesity.
About half of those heart failure patients have a condition called preserved ejection fraction, where it appears the heart is pumping out enough blood but the heart can't respond to increased need, such as exertion. The most noticeable symptom may be shortness of breath when the patient tries to walk or climb stairs. Exercise can lead to an increased demand on the heart of twice or four times as much output, and "if the heart is stiff and you can't get that extra blood in, then it backs up" fluid into the lungs, said Dr. Sheldon Litwin, the Alicia Spaulding-Paolozzi Professor of Cardiology at MUSC. "People may be fine at rest, but then they get short of breath with exertion."
It is a more common condition in women, and it has been increasing lately in younger women due to the rise in obesity, Litwin noted. Drugs often don't help these patients as much, which means they may be better candidates for the shunt. Ordinarily, an inadvertent hole between two chambers of the heart could be considered a problem, particularly if it is a larger hole. But in this case, it might be a solution, Litwin said. The problem is the pressure is too high in the left atrium, the left upper quadrant of the heart where oxygenated blood flows in from the lungs. It can't respond to the increased demand from exertion and causes the fluid backup. A hole to the right side would allow blood and pressure to escape as needed. Computer simulations suggested the ideal size would be 8 millimeters, or about the diameter of a pencil, Litwin said.
The Corvia Atrial Shunt is being tested in a clinical trial at Medical University of South Carolina and at sites around the world. Some South Carolina patients have already received it and report good results.
ProvidedDuring a procedure, the cardiologist threads a catheter up to the heart to make the hole, then the shunt is passed up along a wire into the hole to keep it open. Having the ideal size makes it a "smart therapy," only responding when needed, like an insulin pump, Litwin said.
"The beauty of a shunt is that it potentially can give people a targeted therapy only at the time when they need it," he said.
The primary aim is to give them better quality of life and a greater ability to move and exercise without the shortness of breath and fatigue.
"If we can allow people to do more things, to not be as restricted, that's a big benefit," Litwin said. "Maybe we can reverse a downward spiral of being less active, getting out of shape, gaining weight, all of the things that make it worse."
That's exactly what happened with McMillan. He had a heart attack in 2008 at age 53, then triple-bypass surgery the following year. Eventually heart failure set in, limiting his movements and forcing him to retire early. But after getting the Corvia shunt, he found he could exercise more and had much more energy than he expected. He then set off to hike national parks across the country and has conquered 16 so far.
"My favorite was Yellowstone and Grand Teton (National Park)," McMillan said. Mesa Verde National Park in Colorado is also high on his list.
"That was quite a hike," McMillan said.
He tries to walk 2-3 miles and get 8,000 steps in a day and "I've actually been able to play a little golf lately," he said. The chest pain is gone, he takes less medication and his outlook is much different than it was from before.
"My life has turned around drastically," McMillan said. It's also given him milestones he didn't think he would reach.
"I've seen my two grandchildren born," he said — Kensley, 4, and Sawyer, now a year old.
"I'm just incredibly blessed," McMillan said. "Every day, I'm thankful."
Semaglutide May Improve Heart Failure Symptoms, Reduce Need For Diuretics
With the recent popularity of glucagon-like peptide-1 (GLP-1) receptor agonists for treating type 2 diabetes and weight loss, scientists are examining the treatment possibilities of this class of medications for other conditions.
These include sleep apnea, high blood pressure, nonalcoholic fatty liver disease, polycystic ovary syndrome (PCOS), Alzheimer's disease, and cardiovascular diseases such as stroke and heart failure.
For instance, a recent study found that semaglutide — the active ingredient in Ozempic and Wegovy — may help reduce symptoms of heart failure with preserved ejection fraction (HFpEF) in people with obesity and type 2 diabetes.
Now, new research presented May 11–14 at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC), reports that semaglutide reduces the need for and dose of loop diuretics in people with HFpEF.
The scientists found that semaglutide provided a positive impact on the symptoms, physical limitations, and body weight of people with HFpEF regardless of their use of diuretics.
This study pooled data from two trials — "Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity" published in August 2023, and "Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes" published in March 2024 — for a combined 1,145 study participants with an average age of 70.
In both trials, participants had obesity-related HFpEF and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) of less than 90. This questionnaire assesses the quality of life of people with heart failure.
Study participants randomly received either semaglutide or a placebo for 52 weeks. Participants were divided into those not receiving diuretics, a subset receiving non-loop diuretics only, and a subset receiving loop diuretics.
After analyzing the pooled data, researchers found that participants who took semaglutide improved their KCCQ-CSS regardless of taking diuretics or not. However, the improvement was greater in participants receiving loop diuretics compared to those not taking them.
In those taking semaglutide and receiving loop diuretics, their loop diuretics dose decreased by 17% after 52 weeks.
"Diuretics can help with fluid overload, but they don't necessarily target the underlying mechanisms behind HFpEF," Rigved Tadwalkar, MD, a board certified consultative cardiologist at Providence Saint John's Health Center in Santa Monica, CA — not involved in this study — told Medical News Today.
"To see the diuretic data that these individuals can potentially reduce their diuretic dose, they need to escalate their diuretic dose less, and they just have a lesser need to have diuretics at all once they're treated with semaglutide is excellent because it moves their care forward."
Scientists found that semaglutide helped participants lose weight during the 52 weeks.
Participants not taking diuretics lost an average of 8.8% of their starting weight. The participants in the highest loop diuretic dose category lost 6.9% of their body weight on average.
"Semaglutide improved symptoms, physical limitations, and led to greater weight loss across diuretic use categories in patients with HFpEF," study author Kavita Sharma, MD, associate professor of medicine in Advanced Heart Failure/Transplant Cardiology in the Division of Cardiology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Heart Failure with Preserved Ejection Fraction Program, said in a news release.
"There was evidence of a significant reduction in average loop diuretic dose, a lower likelihood of diuretic treatment escalation, and a greater likelihood of diuretic treatment de-escalation with semaglutide versus placebo — parameters that indicate disease-modifying effects of semaglutide, and are associated with better long-term clinical outcomes in this patient population."
— Kavita Sharma, MD, study author
Heart failure occurs when the heart is pumping abnormally and it cannot support the circulation demanded by the body.
HFpEF is a specific type of heart failure in which the heart muscles stiffen and cannot properly fill with blood. In HFpEF, the left ventricle of the heart cannot relax and fill with blood as it normally should.
"Heart failure with preserved ejection fraction … involves a stiffening of the heart muscle over time and it's much more common than people understand," Tadwalkar explained.
"In this particular situation, the heart function remains normal. It's just the stiffness of the heart that can lead to a backup of fluid into the body and cause symptoms similar to the standard or heart failure with reduced ejection fraction patient, which includes fatigue, shortness of breath, body swelling, (and) leg swelling."
Current treatment options for people with HFpEF include medications such as sodium-glucose cotransporter 2 (SGLT2) inhibitors and loop diuretics. These help remove excess fluid buildup to achieve healthy blood volume in the body, medically known as euvolemia.
As past research has shown that about 84% of HFpEF is caused by overweight or obeity, lifestyle changes such as reduced salt intake, increased physical activity, and weight loss can also assist with HFpEF.
After reviewing this study, Mir Ali, MD, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, told MNT it was not surprising that semaglutide medications where people lose weight would improve heart conditions, such as heart failure.
"We've seen this in our surgical patients as well — as they lose weight a lot of these things improve," Ali continued.
"I think this will broaden the indications for use of these medications that may not just be for diabetes or weight, but maybe for heart-related conditions, such as heart failure or coronary artery disease, that there may be some benefit to these medications," he said.
"What would be interesting to see is if this effect is independent of weight loss. So if they could somehow structure a study that compares patients on these types of medications and their need for diuretics versus patients on other medications and similar weight loss (and) compare their use of diuretics to see if there's a benefit that's independent of the weight loss."
— Mir Ali, MD, bariatric surgeon
Tadwalkar noted he would like to see additional studies looking at even bigger endpoints.
"The big endpoints of heart failure are frequency of hospitalization or a rate of re-hospitalization, and then, of course, mortality — are people living longer because of this?" he continued.
"Anything that we can do to move that needle forward for these HFpEF patients is of high importance — we need to look at those endpoints in another trial or other studies."
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