A 64-year-old Painesville resident was the first person in the world to receive a new medical treatment for heart disease when earlier this month he had a medical device implanted to simultaneously provide two therapies to treat heart failure.
The implantable device includes therapies to both improve the contraction of the heart to prevent heart failure, which affects an estimated 6.2 million Americans, and treat life-threatening arrhythmias, one of the most common causes of death in the nation, according to the Cleveland Clinic, who said the surgery is the first of its kind in the world.
"Instead of implanting two devices, we implant one device, instead of implanting multiple leads ... we're only putting in two leads," said Dr. Bruce Wilkoff, the clinical trial's principal investigator and one of the surgeons who implanted the device.
The device could have a significant impact on patient health, he added.
"What we're talking about is we're giving more therapy, making people live longer and feel better and less toxicity," he said.
The new device's battery will last two decades, Wilkoff said. That's much longer than the five to 10 years previous implants lasted.
"So once it's implanted, it should be a maybe for the lifetime of the patient, but certainly for an extended period of time, fewer operations," he said.
Having a device address these two issues made sense as both are prevalent in people with heart disease, he said.
"Now it turns out that people who need implantable defibrillators usually have heart failures," he said. "We're taking a device that can do both, can do both a defibrillator and a heart failure situation, save their life, but make them feel better."
The surgery lasted an hour or so and marked the beginning of patient testing, one of the last steps before the U.S. Food and Drug Agency (FDA) decides whether to approve a device for broader use, Wilkoff said.
The Cleveland Clinic will lead a nationwide effort to test the device in between 200 and 300 patients at 75 sites across the country to ensure it is safe and effective, Wilkoff said.
He said researchers are confident in the device.
"This is sort of like the final exam where you're pretty sure you're prepared, you put it in, but there's always the potential for unanticipated impact of a new device," Wilkoff said.
Potential FDA approval of the device for widespread use is a year or more away, he said.
