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Heart attack warning device in trial at Borgess, Spectrum
Lisa Holst, a nurse educator at Spectrum Health’s Meijer Heart Center, is part of Phase II clinical trial testing for the AngelMed Guardian System, developed by cardiologist Dr. Tim A. Fischell, who leads cardiovascular research at Borgess Medical Center in Kalamazoo. He invented the device with his brother, David, and father, Robert, two Ph.D. physicists.
Holst, 44, is a diabetic who suffered a heart attack in 2007 and has eight stents. Currently, she is in the control group — the device is turned off — necessary to measure the effectiveness for those whose devices are activated. After six months, Hulst’s device will be activated, and should she suffer possible heart attack symptoms, it will vibrate in her chest to alert her. She also has an external device that would beep if activated.
“The idea of getting a permanent monitor that will actually tell me if I’m having changes that could indicate a heart attack was very exciting to me,” said Holst, who teaches other nurses how to use electrocardiography, which measures heart function.
Fischell said he expects the Phase II trial to encompass close to 1,200 patients at 50 medical sites in the U.S. The Phase I trial “was spectacular,” he said. “It picked up like six pre-heart-attack plaque ruptures, low heart rates; it picked up a G.I. bleed. The thing was amazing.”
The idea is that the sooner patients know they may be having a heart attack, the sooner they can get to the hospital for treatment, said Dr. David Wohns, principal investigator for the clinical trial at Spectrum Health. Wohns said he thinks the AngelMed Guardian could become an important piece of cardiac care, should it prove to be effective and improve patient outcomes.
“It changes our paradigm of how we do things,” said Wohns, of West Michigan Heart and director of cardiac catheterization at the heart center. “There’s nothing like it with a potential associated with reducing heart attack deaths and the morbidity associated with coronary heart disease.”
Holst is part of a Phase II clinical trial that will involve 1,200 high-risk cardiac patients at 30 medical centers in the U.S. She said the device was installed through a two-inch incision. A wire is placed in the right ventricle and the AngelMed Guardian sits near her collarbone.
“I can feel the slight bump in there, but I don’t think most people would notice that,” she said.
Wohns said the trial is aimed at high-risk cardiac patients who have had a coronary event within the past six months.
Diabetic since her mid-30s, Holst said she experienced atypical heart attack symptoms in 2007 and didn’t accept that she was having one until the paramedics hooked her up to an ECG machine and, as an experienced nurse, could see the results for herself.
“The last symptom I had was chest pain,” she said. Wohns said it’s not uncommon for women to have atypical heart attack symptoms, even when they are known to have heart disease.
Since then, Holst has had eight stents installed, two of them Cypher stents developed by the Fischell family. She also uses an insulin pump. Robert Fischell, father of the Borgess doctor, invented an implantable insulin pump.
“With this device, I’m definitely benefiting from their ingenuity,” Holst said. “And then, also, the first two stents I received were stents that they invented, the Cypher stents. And actually I wear a Medtronic insulin pump, and I know that family was like one of the first inventors of an insulin pump. So in three ways, they affected my life.
“I think that it will end up getting approval — I’m hoping,” Holst said of the AngelMed Guardian. “And then I can have this nice safety net forever.”