Clinical trial provides last-chance heart failure treatment for avid outdoorsman

Don Notch is an avid outdoorsman, from fishing to bear hunting with his family. When he began experiencing shortness of breath a few years ago, it affected not only his ability to get outdoors, but his ability to spend time with loved ones.

“I couldn’t do anything physical for an extended period of time,” said Notch, noting that even included everyday household chores. “My body was extremely weak, and I was always short of breath. When I went to see my doctor in St. Cloud, he suspected these symptoms might be related to heart failure.”

Notch’s cardiologist referred him to Tamas Alexy, MD, an advanced heart failure cardiologist with M Health Fairview, for specialized treatment. Alexy and his team with our C.O.R.E. Clinic for Heart Failure Management confirmed the diagnosis Notch feared.

Heart failure means the pumping action of the heart is not effective enough to meet the body’s demand. In adults, this can be caused by a wide variety of diseases. In Notch’s case, it was due to blockages in the heart arteries which led to an enlarged left ventricle (one of the lower chambers of the heart).

“When the ventricle is enlarged, the heart becomes inefficient,” said Alexy, who is also an assistant professor in the Cardiovascular Division at University of Minnesota Medical School. “We want to find a way of supporting the ventricle by getting it closer to its original size and shape, increasing the heart’s efficiency and ultimately relieving symptoms because the heart is no longer having to work so hard. 

In Notch’s case, testing also revealed that he wasn’t a good candidate for a left ventricular assist device (LVAD), an implanted mechanical pump that may often be used to help patients with a weak and enlarged heart. At that point, Alexy introduced Notch to a unique option.

M Health Fairview University of Minnesota Medical Center is one of about 50 sites across the country participating in a clinical trial to test the AccuCinch System, a new device designed with hooks that pull together, or “cinch,” the walls of the left ventricle using a loop.

“The primary purpose of the device is to prevent the heart from getting larger, and provide structural support to help the heart continue pumping blood,” said Ganesh Raveendran, MD, an interventional cardiologist with M Health Fairview and professor in the Cardiovascular Division at University of Minnesota Medical School.

“It’s hard to think about now, but it was my last chance,” said Notch. “I was already on all the best medication that you can get to manage my different health conditions, including diabetes and heart failure. This was the last-chance effort for my heart, and I decided I had to go for it.”

A team of interventional cardiologists at M Health Fairview University of Minnesota Medical Center placed the AccuCinch System in Notch’s heart via catheter in September. The team was led by Raveendran and Gregory Helmer, MD, who trained for AccuCinch implantation earlier this year.

“The group leading this clinical trial knew of me through my previous relationships with structural heart trials and reached out to see if we’d be interested,” said Helmer. M Health Fairview is one of only two participating sites in Minnesota. Helmer and Rebecca Cogswell, MD, a cardiologist and heart failure specialist with M Health Fairview and associate professor in the Cardiovascular Division at University of Minnesota Medical School, are leading our involvement in the trial.

Notch’s device was implanted without a hitch and now, Alexy and his team will monitor Notch over the coming months to ensure his symptoms are improving. Fortunately, Notch says he’s noticed an immediate difference in his quality of life.

“I don’t have the same shortness of breath when I’m doing things,” said Notch, who spent three days in the hospital for the procedure. “It’s amazing – I don’t feel the device, it’s just there.”

The hope is that Notch’s experience can be replicated for others who lack heart failure treatment options. With over 6 million Americans living with heart failure, the trial’s results will have significant implications.

“This device is still under investigation without proven effectiveness at this time,” said Cogswell. “Our participation in the clinical trial will help determine if this treatment gets approval for widespread use.”

“It has the potential to serve a significant portion of people living with heart failure whose needs aren’t currently being met,” added Helmer. “It also doesn’t preclude further treatment down the road. It’s non-interfering, so if a patient goes on to need an assist device or transplant, they’ll have that option.”

For the Notch family, a solution to heart failure means having their husband, father, and grandfather around for hunting trips and everything in between. Next year, Notch will be eligible for a bear hunting license. If his hunt is successful, his family will preserve and cook the meat, make rugs out of the hide, and cherish the memories made around the campfire.

With his heart failure under control, Notch can tell his grandchildren, “Grandpa’s going to be back in bear camp again.”

Learn more about our dedicated heart failure clinic here.