The Food and Drug Administration approved on Friday a first-of-its-kind neck implant designed to improve quality of life for an estimated 5.8 million patients who suffer from a common heart failure diagnosis. It was tested, among many clinical trial sites in the United States, at the Medical University of South Carolina in Charleston.
Dr. Michael Zile, a cardiologist at MUSC, said the neck implant is unique because it is one of the first to undergo an expedited approval process set up by Congress to get breakthrough medical devices to patients more quickly. That process was established by the 21st Century Cures Act, signed into law by former President Barack Obama in 2016.
The device is nicknamed "BeAT" in most medical literature, an acronym short for "Baroreflex Activation Therapy with the Barostim Neo System." It is manufactured by CVRx, a Minneapolis company.
The device works by regulating adrenaline, said Zile, who serves as the principal investigator for the device. He was paid about $130,000 by CVRx between 2013 and 2016 for his work as a consultant. (Zile received more than $300,000 from various drug and device manufacturers for consulting and speaking engagements during the same time frame, according to ProPublica's Dollars for Docs database.)
Zile explained when the heart muscle weakens, it pumps blood less vigorously. This sets off the release of hormones by the adrenal gland to strengthen the contractions. When patients develop heart failure with this "reduced ejection fraction," the hormonal response overcompensates for the weakness, Zile said. Symptoms include swelling in the feet and legs, shortness of breath and fatigue.
The results of the recent clinical trial demonstrate that when a tiny wire lead is implanted next to the baroreceptor along the neck's carotid artery, these hormones are better regulated. Patients with the device experience fewer symptoms associated with heart failure. They're able to walk longer distances and exercise more.
Zile wrote a manuscript outlining these results. The paper is under review for publication by the Journal of the American Medical Association.
James Chamberlain, one of Zile's patients, said the device improved his shortness of breath.
"I can breathe a lot better than I could before," he said.
Chamberlain, 67, was diagnosed with heart failure in the 1990s. He already has a defibrillator implanted in his chest. When Zile recommended that he sign up for the neck implant, too, Chamberlain was confused. He didn't understand how a device in his neck would help his heart function.
"Every single patient we talk to has that reaction," said Melissa Lamicq, a clinical research coordinator at MUSC.
Nearly 6 million Americans have heart failure. The condition contributes to 1 in 9 deaths, according to the Centers for Disease Control and Prevention. In South Carolina, more than 50,000 patients were hospitalized with heart failure and 10,000 died from the condition in 2015. Roughly half of all patients diagnosed die within five years.
The condition is treated with a combination of therapies — exercise, medicine, a low-sodium diet, implantable pacemakers and defibrillators.
Zile said these treatments keep heart failure patients alive, but their quality of life is often poor.
"I think this is a game changer in the sense that it takes patients for whom we've done everything, and now lifts them to the point where they will have a marked reduction in symptoms," he said.
Pre-market approval was granted by the FDA on Friday. The device is now subject to further post-market study before it can be widely used. Zile said MUSC is actively recruiting up to 77 more heart failure patients to participate.
"We need more patients to sign up for the post-market approval study," Zile said. "The point of the post-marketing study is to look at mortality — cardiovascular mortality and heart failure hospitalizations." Zile said he believes the device will improve both metrics. Patients who enroll are compensated for their time and are not required to pay for the device.
Zile said the trial is recruiting patients with clinical heart failure, who are exhibiting symptoms, with an ejection fraction less than 35 percent. (Normal ejection fraction is at least 55 percent.)
The next phase of the trial should be finished before May, Zile said. At that point, the device will be evaluated by the Centers for Medicare & Medicaid Services.
Its price has not yet been set. Zile expects the implant will cost about the same as a pacemaker.
Chamberlain, a retired Department of Corrections officer, will participate in the clinical trial's next phase. He travels back and forth from his home in Columbia for his MUSC appointments. In Columbia, he and his wife have taken to walking around the indoor track at the YMCA — exercise he couldn't have accomplished a couple of years ago.
"My wife is up to 30 minutes. I try to do at least half a mile, three-quarters of a mile," he said. "I can walk up and down stairs. The problem going down the stairs is the knees."