Clinical Trial brings C-Pulse Device to Patients in Kansas City

Seabrun “Candy” Hunter is the co-writer of “Rockin’ Rockin’ Boogie,” one of the songs that brought his cousin Little Richard to the Songwriters Hall of Fame. But for the past 10 years, Hunter has had little to sing about.

Hunter has been living—but not well—with congestive heart failure since a heart attack in 2001.

“It felt like I had a big pocket of air in my chest,” said Hunter. When he was diagnosed with cancer and had half of one lung removed last year, the surgery left his heart even weaker.

“He was on continuous IV medications. If the IV was stopped, he was debilitated,” said Sanjeev Aggarwal, M.D., director of Mechanical Circulatory Support at Saint Luke’s Mid America Heart Institute.

At the rate he was going, said Dr. Aggarwal, Hunter could last maybe a year.

“I said to my doctors, ‘So you’re just going to let me die?’” recounted the 61-year-old Hunter.” They said, ‘We’re going to take care of you.’ And three days later, they did.”

Hunter—who has just published his latest book, called appropriately, “Miracles”—was going to be part of the clinical trial for the C-Pulse. Luckily for him, he was at Saint Luke’s, one of just seven hospitals in the country selected to test the device.

Heavy lifting

C-Pulse, which stands for counter-pulsation, is a new kind of balloon implant for the heart. When the balloon inflates, it delivers more oxygen to the heart by increasing the blood flow to the heart muscle – something that weakened hearts like Hunter’s greatly need. When the balloon deflates, it takes over some of the work of the heart’s pumping. In other words, it is designed to reduce the “heavy lifting” a heart normally does. Plus, C-Pulse offered another benefit that was critical for Hunter.

“The device sits outside the bloodstream,” said Dr. Aggarwal, “so potentially there’s a reduced risk of blood clotting and infection.”

It also meant Dr. Aggarwal wouldn’t have to put his patient on a heart/lung bypass when he implanted the pump. Because he had recently received treatment for cancer, Hunter was not a suitable candidate for a heart transplant. But luckily, the C-Pulse presented a promising option for treating his advanced heart failure. In July 2010, Dr. Aggarwal performed the C-Pulse implant surgery. After nearly 10 years of struggling with an ever-weakening heart, Hunter was pumped.

The cut above at Saint Luke’s

The traditional incision for this type of implant is what Hunter calls “stem to sternum”—a cut all the way down the breastbone.

But Dr. Aggarwal had another idea.

“I was quite confident we could do minimally invasive surgery,” he said. “It dramatically helps to speed up the recovery process.”

When Hunter awoke from his three-hour surgery, he had nothing more than a 3-inch incision—about the same size as for a pacemaker— to show for being under. Until he took a breath.

“Despite having a very weakened heart muscle, I felt 100 percent better in recovery,” said Hunter. “I had no shortness of breath.”

Hunter became the 13th patient to get a C-Pulse implant. Saint Luke’s is the only hospital in the world that has performed a minimally invasive thoracotomy (non-sternal) surgical approach for the procedure (using only a small incision in the chest wall). Hunter was Saint Luke’s third patient.

The C-Pulse is currently in the clinical trial phase. It’s considered investigational, so doctors must continue to test it before the government approves it. If that happens, the C-Pulse may be a potential treatment option for patients with moderate heart failure as well as advanced heart failure like Hunter’s.

Well adjusted

At his home in Grandview, Mo., Hunter is gradually getting his voice back in shape. His finely tuned musician’s ear is becoming accustomed to the constant click-click, click-click of the C-Pulse and learning how to tune it out. He can temporarily turn the machine off—when he wants to shower, for example.

“Candy is now living his life,” said Dr. Aggarwal. “Although tethered to a device, there’s a definite physical and psychological advantage of being able to turn the device on and off. And he’s on fewer medications; there’s no need for a blood thinner or diuretics. We give C-Pulse patients baby aspirin.”

And Hunter thinks the trial itself really rocked. It’s not just that he has none of the symptoms of congestive heart failure when he’s clicking with the C-Pulse. “Being part of this trial,” he said, “is something I can do that helps someone else.”

Sweet.