JACKSONVILLE, Fla. (AP) - These days 72-year-old Ken Stoll spends most of his time restoring cars in his Fernandina Beach shop, and, with wife Jennifer, traveling the country in a tour-bus size motor home.
Prior to a medical procedure four months ago, he could hardly summon the strength to get out of bed.
The difference?
A groundbreaking new wireless pacemaker the size of a large grain of rice now resides inside his heart, the small battery and transmitter that powers it implanted under his armpit. He was the first patient in Florida to receive the device, as part of an ongoing clinical trial at Ascension St. Vincent’s Riverside in Jacksonville.
“It’s a miracle … I stay active all the time,” he said. “Without this device, you probably wouldn’t be talking to me.
“It’s made a difference in my heart health that’s night and day,” he said.
After other failed treatments for heart failure, including implantation of a traditional pacemaker three years ago, Stoll’s only option was a transplant. But it was not a realistic option because of his age and deteriorating condition.
“When I had my pacemaker installed, I had a heart function of 52 and it was great and then all of a sudden my heart bottomed out,” he said. “I became very ill with congestive heart failure.”
He was left to ponder the end of his life.
Then Stoll’s cardiologist of five years, Saumil Oza, recommended he join a clinical trial Oza was to lead at Ascension St. Vincent’s. The new device being tested was the WiSE CRT System, the world’s first wireless pacemaker designed to be implanted inside the heart. It was developed for cardiac patients who do not respond to traditional treatments, just like Stoll.
“For the 20 to 30 percent who don’t respond at all or get worse, we really had zero options for them outside of heart transplant or mechanical heart,” said Oza, the Jacksonville hospital’s chief cardiologist. “For many patients they’re not candidates because they’re too old or too frail, so they really had no other options.”
The WiSE CRT System stimulates the heart’s left ventricle, “since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location,” according to Ascension.
The goal was improving the “heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs and body more effectively,” according to the manufacturer, EBR Systems Inc.
The results for Stoll and other trial patients who received the device are “nothing short of miraculous,” Oza said. “It’s definitely game changing.”
In the United States, the WiSE CRT System is currently “an investigational device and not available for sale,” according to Ascension. But because it could be lifesaving for tens of thousands of patients, it was designated in 2019 as a “breakthrough device” by the U.S. Food and Drug Administration, which allows fast-track development.
Stoll is one of about 350 patients nationwide taking part in the clinical trials: Ascension St. Vincent’s is the only site in Florida and one of only two in the Southeast. Some patients received the WiSE CRT device, others a type of defibrillator. In such trials, patients don’t typically know which camp they’re in, but Stoll knew from the start.
“The first few patients in the trial, they allowed us to … get our feet wet,” Ozs said. “It’s a very new device, there’s nothing we’ve done that’s close with this. There’s a learning curve and they want us to see and have faith in the product. It is to get the implanting technique down.”
Such trials are strictly governed by the FDA.
“They have auditors who come in and audit to make sure everything has been done according to strict trial guidelines,” he said. “Then usually you have a six-month or year follow-up. They look at mortality, hospitalizations, improvement of quality of life, improvement of heart function.”
The improvement in Stoll’s quality of life and heart function has been “remarkable,” Oza said.
“No matter what we did before, his heart quality was diminishing,” he said. “He had a severe leakage in his mitral valve and would have needed open heart surgery to fix it. When we put in the (traditional) pacemaker, we hoped it would help. The leak gave a lot of problems, worsening heart failure. When your heart function is already down, fixing the valve really isn’t possible.”
The new device was the “best option,” Oza said.
“When we put it in, his heart leakage went from severe to mild, his heart function started to improve gradually … It’s been possibly lifesaving and definitely life-altering,” Oza said. “To see that big a difference in someone, if you think about it physiologically, when you place this little seed, the electrode, you place it so close to where the left ventricular is on the inside of the heart rather than the outside, you wonder if it’ll make any difference because it’s right there. Even when you know the science behind it, it’s astounding.”
The device’s lack of wires, which in patients wearing traditional pacemakers can cause infections or become dislodged, also is critical.
“There’s a big move toward wireless pacing,” he said. “This is pioneering.”
The trials have not only boosted the health of Stoll, but the profile of Ascension St. Vincent’s.
“I fought very hard for this,” Oza said. “For us to get this trial, one of only a few sites in the country … it’s a very special trial. It … puts us on the map as one of the leading heart centers in the country, to have this trial that is very selective.
“Jacksonville is my home,” he said. “I want to make sure for my friends, and my family and patients, that we have this care.”
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