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Next-generation heart devices hold promise for patients

Several implantable heart devices being evaluated by University of Minnesota Health Interventional Cardiologist Gladwin Das, MD, may help doctors fix damaged hearts without open surgery.
An innovative medical device being evaluated by University of Minnesota Health Cardiologist Gladwin Das, MD, (right) helped Brian Masters, a 52-year-old heart attack survivor (center). Masters is participating in a heart device study run by Das and Emily Caldwell, RN (left).

A massive heart attack in 2001 and at least two more since have left Brian Masters’ heart in rough shape. Masters, 52, has ischemic cardiomyopathy—damage to the heart muscle that leaves the left ventricle enlarged and weak. As a result, his heart has difficulty pumping blood.

“My stamina wasn’t very good,” said Masters, a town clerk and county board supervisor in Balsam Lake, Wis. Even with a pacemaker, he was unable to enjoy his favorite outdoor activities, like tournament fishing.

Then, a year ago, he got a call from the University of Minnesota lab of Cardiologist Gladwin Das, MD. Das had treated Masters’ first heart attack and wanted to know if Masters would participate in a clinical trial that might strengthen his heart with a device that could be implanted without open-heart surgery.

Masters had the surgery last May at University of Minnesota Medical Center. By running a catheter into Master’s groin and up the femoral artery, Das was able to implant a device called a Parachute into the left ventricle of Masters’ heart. The device popped open like an umbrella, lining the lower ventricle and restoring strength and elasticity to the sagging muscle.

The Parachute is one of three implantable, minimally invasive devices that Das is currently evaluating at University of Minnesota. All three appear are likely to be approved by the U.S. Food and Drug Administration, he said. Once approved, they will be commercially available to many heart surgeons and could save or transform thousands of lives, just as the Parachute did for Masters.

“I’m able to do so many things I haven’t been able to do stamina-wise,” Masters said. “I was walking 2 to 3 miles a day down in Florida, fishing tournaments again, not feeling tired when I’m out doing work in my yard. It’s just been great.”

Das, director of interventional cardiology hybrid programs for University of Minnesota Health, has been interested in these lifesaving devices since he joined the University more than 20 years ago.

“It all started out when I used to see patients with holes in the heart who needed open-heart surgery, which was a big procedure,” said Das. “I said, ‘You know, that’s a small hole. There should be a better way of closing it.’”

In 1999 he invented and first implanted the Das Angel Wings, a foldable fabric-and-metal device that could be inserted via catheter and popped open to plug the hole—without open-heart surgery.

Angel Wings represented a huge improvement over existing devices and ushered in a new generation of self-centering devices that have provided a minimally invasive treatment option to hundreds of thousands of patients around the world.

Learn more about University of Minnesota Heart Care services.

The devices Das is evaluating now represent yet another generation. He is principal investigator for clinical trials of the Parachute. “It’s a promising device for patients who might otherwise be considered for a left ventricle assist device or a heart transplant but who are not quite that sick,” said Das.

Das is also the lead investigator in a study of another implantable device called the MitraClip. Slipped through a catheter into the right side of the heart, the device clips damaged heart valve leaflets together, fixing a leak without open-heart surgery. The clip has proved safer than open-heart surgery, with a better quality of life and an increased survival rate, Das said.

He is also testing “bioresorbable” coronary stents—“the holy grail of coronary stent technology,” he said. Conventional stents—metallic screenlike tubes—are routinely placed in arteries to expand the vessels and hold them open. Though needed for only a few months, the stent stays there forever, said Das. A bioresorbable stent, on the other hand, disappears after the artery has healed.

Because of clinical studies like these, new techniques and devices will likely soon be available for thousands of people with poorly performing hearts.

Masters, for one, can’t wait. “I’ve had very good success with this thing,” he said of his Parachute. “They need to get it out there and get it approved. People need this.”