TAMPA, Fla. — AdventHealth Tampa is taking part in an international clinical trial of the Impella CP System, a device that cardiologist Dr. Oliver Abela said could be a game changer in caring for heart attack patients.

"One of the reasons it's so exciting is that it's going to be changing, possibly, the standard of care for large heart attacks," said Abela.

According to Abela, the Impella is already approved for some heart protective purposes.

"It's a heart pump," he said. "It goes in through an artery, usually in the groin, and it takes a lot of the stress off the heart. So, it's already approved for somebody coming in in shock — very, very sick patient. And what the study is ascertaining is if it's going to be approved for somebody coming in with a heart attack that is not already in shock, meaning very low blood pressures.

"We think that using it even in a straightforward heart attack, it's still going to benefit the patient, preventing them from having heart failure or shock in the future."

The description for this study on ClinicalTrials.gov says its purpose is to assess whether using the Impella for 30 minutes before catheterization can reduce the damage to the heart.

"It goes along with what we would call standard of care treatment, meaning the person is coming to the cardiac catheterization lab, which is the area of the hospital where we can place heart stents to open blocked heart arteries," said Abela. "The difference in the part of the study that will be being researched is that we think putting the heart pump first, taking stress off the heart before we open the artery, will actually lead to a smaller area of heart muscle that is damaged."

Abela told Spectrum News the more damage caused to the heart, the more likely patients will suffer heart failure, shock or other complications in the future. 

Carol Scarborough, of Wesley Chapel, isn't part of the trial, but Abela said she was recently treated with the Impella under one of its approved uses. Scarborough, 67, said she was pretty healthy until this holiday season.

"It was after New Year's that my husband, Ron, started saying, 'You know what? You don't look good. You're sleeping 14 hours a day,' you know, things like that," she said. "Had it not been for him, I would still be laying in bed, or I'd be dead."

Ron Scarborough insisted she go to the hospital. Carol said an at-home test came back positive for COVID, and once hospitalized, she learned she had COVID pneumonia.

But that wasn't all.

Abela said tests showed she had a significant heart attack and had to have stents put in with some help from the Impella.

"The Impella is known to help somebody who has a very large area of heart muscle that's at risk by working on the artery," Abela said. "When we work on the arteries, sometimes there's not blood flow going through the artery. So, during the time when we're fixing the heart artery, it helps the person to have the pump in place and doing some of the work for the heart, and that's the reason it was used in her case."

Carol Scarborough called the research into a new use for the Impella "wonderful." While she was hospitalized for 23 days and is still healing, she said she's doing well today, thanks to her husband and Abela. 

Abela expects the clinical trial to continue for at least the next year. He said participation is voluntary, with patients brought to AdventHealth Tampa with early, ongoing heart attacks and who meet other criteria being asked if they'd like to enroll. 

"We enrolled our first patient in the last month or so, and we've very excited that he's doing excellent after leaving the hospital," Abela said.

Abela said a total of about 100 patients have been enrolled at sites around the country and in Germany.