Can some patients see their congestive heart failure symptoms abate? Sunshine Heart's heart-assist device has achieved those results in some patients. A pivotal trial is underway.
|The C-Pulse Heart Assist System|
What if a device could assist a failing heart struggling to pump blood and help it recover?
That is the tantalizing prospect of Sunshine Heart and its C-Pulse Heart Assist System, a non-blood contacting, implantable device aimed at patients with moderate to severe heart failure. The Minnesota-based company is currently enrolling patients in a pivotal trial in the U.S. to test how the device may help to improve the quality of life of patients who complain of shortness of breath, dizziness and retain fluid in their bodies, all symptoms of congestive heart failure. The C-Pulse system is approved in Europe, but hasn't won solid reimbursement yet.
|C-Pulse Extra Aortic Cuff|
Sunshine Heart’s minimally invasive device uses a balloon counter-pulsation technology to help relieve pressure on the diseased heart, which has to work overtime to pump blood throughout the body in patients with moderate to severe heart failure. The system comprises an extra aortic cuff that is implanted above the aortic valve, implantable ECG and percutaneous interface leads that exit the skin and are connected to an external driver that provides the energy for the pumping mechanism. The driver is essentially housed in a shoulder-carried bag.
The hope is that the C-Pulse with its inflation and deflation of the balloon can increase oxygen to the heart muscle, lower the workload for the heart and increase blood flow from the heart, explains Dave Rosa, CEO of the company, in a recent interview with MD+DI.
The device is intended to be a better alternative to LVADs or left ventricular assist devices made by the likes of Thoratec and Heartware. LVADs work well but are known to have complications that include stroke, bleeding and clotting. Such risks are not there with the C-Pulse device because it is doesn’t contact the blood, Rosa said, and so outcomes for patients are not dependent on physicians' anti-coagulation strategies.
Sunshine Heart’s COUNTER HF clinical trial, currently underway, is expected to enroll 385 patients at 35 medical centers in the U.S. It’s a two-year endeavor, and already institutional red tape has hampered the pace of medical centers committing and signing purchase agreements for the device to begin the process of enrolling patients, Rosa said. Patients need to be either deemed to be in Class III heart failure stage according to the New York Heart Association or in Class IV but able to move around.
The stock price of the company took a big hit following a corporate update in January that showed that enrollment of patients and activation of sites that would run the trial were slower than expected. The price has slid from more than $11 to about $5.75.
Why the glowing references?
They are based on data from a pilot trial of 20 patients in the U.S who were in Class III and Class IV stage of heart failure, but the Class IV patients were still ambulatory and not late-stage Class IV.
|Dave Rosa, CEO of Sunshine Heart|
After the 20 were treated with the C-Pulse device, most of them were able to come down a point or two in heart failure class. In other words, some heart patients went from being Class III heart failure patients to Class II or Class I, some from Class IV to Class I and some stayed in their class and the disease didn’t progressively worsen, Rosa said. The data also showed increased oxygen to the heart and improved cardiac function.
On lengthy, standardized questionnaire, patients reported that their quality of life had improved. Sunshine Heart needed to show a 7-point improvement in its pilot trial, and results indicated that it showed a 20+point improvement at six months and 24-point improvement at 12 months following the procedure, Rosa said.
“With every heartbeat you get more energy, more blood and your heart has to work less,” he said of the device's effect on the heart.
But perhaps the paramount achievement was that a few patients’ heart recovered enough to be able to be “weaned off” the device.
In other words, the device has been switched off and the patient’s own heart is doing all the work. The investor who described the company's stock as a buying opportunity went to some lengths to describe the product's efficacy.
Suffice it to say that in C-Pulse's 20 patient feasibility trial, 60% of these NYHA (New York Heart Association) Class III and ambulatory Class IV advanced HF patients improved by at least one NYHA Class (a very significant improvement in quality of life) and 25% of the 20 patient cohort have become asymptomatic for Heart Failure (HF) and have been weaned off the device.
This result is unheard of with drug therapy where generally the best that can be expected is a slowing in the worsening of the condition.
One such patient who has been weaned off the therapy is Emmette and is featured on Sunshine Heart’s website.
“Emmete has been off the device three years this January,” Rosa said noting that the device wasn’t designed to be a cure for heart failure. So if at some point in the future, symptoms return, the device can be switched back on.
But seeing patients being weaned off the therapy leads Rosa to conclude that “if we treat patients earlier, before they are too sick, before their left heart is dead in essence, maybe you will have a chance to recover the muscle, because the heart is a muscle.”
A Carnegie Mellon adjunct professor also developing a heart assist device said that he is rooting for Sunshine Heart.
"I am certainly rooting for them," said Dennis Trumble, Adjunct Assistant Professor of Biomedical Engineering. "I think they have a wonderful device."
That isn’t to say that there aren’t risks to the device. The pilot trial in the U.S. had eight exit site infections where the tube connects to the external, shoulder-carried driver.
But Rosa said that has been addressed by a design change and by telling patients that they could only disconnect from the external driver in order to take a shower. In an European trial that followed the pilot U.S. trial, whose 12 month follow up data was presented in 2013, the company had a grand total of zero infections out of 9 patients, he said.
Now all eyes are on how the enrollment in the U.S. trial goes, and ongoing data from a European trial called OPTIONS HF. Rosa will be releasing data from the OPTIONS trial on a regular basis to keep investors interested in Sunshine Heart, Rosa said.
Aside from fully enrolling the U.S. pivotal and European post-market trials, Rosa has another goal in 2014. Make physicians more aware of the device.
“I want to create more awareness in the physician community,” Rosa. “There are more investors that know about us than doctors. It's great when you are raising money. It's not great when you want to get your trial going.”
Meanwhile a fully implantable system is being developed that would eliminate the need for patients to carry around the driver, Rosa says.