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Device shows promise for heart-failure patients

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Heart failure is characterized by a heart muscle that is weak, stretched out, and flabby, and therefore unable to pump enough blood. iStock


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Tom Avril, Inquirer Staff Writer

Posted: Sunday, October 26, 2014, 2:50 AM

Heart failure is characterized by a heart muscle that is weak, stretched out, and flabby, and therefore unable to pump enough blood. Patients with advanced disease have trouble walking more than a few steps without gasping for breath.
A new cuff-like device is designed to help patients by doing some of the pumping for them.
The cuff is wrapped around the ascending aorta, and it contains a plastic balloon that squeezes in time with the patient's heartbeat, apparently providing relief to some patients in a small study published this month.
The study followed just 20 patients, including one who received the implant at Pennsylvania State University's Hershey Medical Center, and it had a primary goal of showing the surgery was feasible. Still, the results are reason for cautious optimism, said lead author William T. Abraham, an Ohio State University cardiologist.
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Some cardiologists not involved with the research on the cuff, called C-Pulse, are reserving judgment until completion of a larger trial already underway. Regardless of the results, they say, several other promising high-tech innovations are on the horizon for heart failure, including implantable nerve-stimulation devices and sensors to measure heart rate and pressure.
The developments are welcome in a field that had been somewhat stagnant for years, said Lee R. Goldberg, medical director of the heart failure and cardiac transplant program at Penn Medicine.
"Heart failure is all of a sudden exciting again," Goldberg said.
C-Pulse is made by Sunshine Heart, a company with roots in Australia that is now headquartered in Eden Prairie, Minn. Chief executive officer David Rosa grew up in Bridgeport, Montgomery County, and earned a bachelor's degree at Drexel University in the school's joint business and engineering program.
The company went public on the Nasdaq exchange in February 2012. So far, it has limited revenue, but that is starting to change with the follow-up study, which seeks to enroll several hundred patients.
The Food and Drug Administration judged that because C-Pulse is somewhat similar to an approved later-stage therapy called a ventricular assist device, hospitals in the follow-up trial are allowed to bill Medicare for its use, Rosa said.
When commercialized, the C-Pulse device system will cost in the high $60,000 range, about half of the tab for a ventricular assist device, he said. The Medicare reimbursement rate for the C-Pulse procedure varies by region but for now is about $220,000, Rosa said.
Though both devices have a pumping mechanism, C-Pulse is different from a ventricular assist device (VAD) in several ways, chief among them that it does not come into contact with the bloodstream, as it is wrapped around the exterior of the aorta.
A VAD, on the other hand, includes a tube inserted through the wall of the heart.
Sourin Banerji, a heart-failure cardiologist at Einstein Medical Center, said that because C-Pulse does not touch the blood, patients avoid clots that could lead to stroke.
Banerji was not involved with the C-Pulse research but said he was hopeful it would help patients because it appears to reduce the load on the heart.
The device detects the patient's heartbeat by means of a wire attached to the left ventricle so the cuff's pumping action can be aligned with the patient's own. The device is connected through the abdomen to an external pump and battery pack, typically worn on a belt or shoulder strap.
The pilot study of 20 patients was published in the Journal of the American College of Cardiology: Heart Failure. It included patients with advanced heart failure, but not advanced enough to qualify for a VAD.
Patients in this category are quite sick, with 15 percent expected to die within a year.
Indeed, among the 20 patients in the study, three died within a year, but only one of the deaths was judged to be related to the device - due to a serious post-operative wound infection that ultimately led to an unsuccessful follow-up surgery.
Those who survived had mixed results, but some were promising. On average, they were able to walk about 335 meters in six minutes - more than the length of three football fields - up from about 290 meters before the surgery.
The Penn State patient declined to comment, though not for any reason connected to the device, school officials said. The surgery went well, said John Boehmer, medical director of Penn State Hershey's heart failure program.
In addition to the advantage of avoiding strokes, Boehmer said, another plus of the C-Pulse system is that patients can turn it off for brief periods and remove the external battery pack and pump to take a shower. He said Penn State planned to participate in the larger follow-up trial, in which patients are randomly selected to get the device.
Ohio State's Abraham, director of cardiovascular medicine at the university's Wexner Medical Center, said that in some patients, the boost from the device may eventually enable the heart muscle to recover and grow stronger.
Even in the short term, the benefits can be dramatic, he said.
He described one patient who was barely able to walk across a room, his skin typically pale and gray from poor blood flow.
Yet when the man woke up after getting a C-Pulse implant, Abraham said, "he was pink."
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