FDA says device helps patients survive while waiting for transplants

An artificial heart developed and tested by UMC cardiologists is set to receive approval from the FDA and is gaining nationwide attention.

An FDA panel concluded Wednesday that the device, called Cardiowest, was effective in treating patients with biventricular heart failure until they could receive a human transplant.

"Results establish that the SynCardia Cardiowest Total Artificial Heart is effective in providing a bridge to transplant circulatory support in cardiac transplant candidates," the FDA's report stated.

Cardiowest is intended for use in patients who are hospitalized awaiting a transplant. Many of these patients would die without Cardiowest, according to Dr. Marvin Slepian, professor of medicine and director of interventional cardiology at University Medical Center.

Dr. Jack Copeland, the co-director of UMC's Sarver Heart Center, has been studying Cardiowest, which he helped develop, for nine years.

Copeland is referred to as a "world-renowned cardiothoracic surgeon" by Cardiowest's Web site, and said he was pleased with the FDA's backing of Cardiowest and its positive comments on the device.

"The FDA said survival is at least as good and probably better (with Cardiowest) than with other FDA-approved devices," he said.

Slepian was also pleased with the FDA's reaction to Cardiowest.

"I think this is a major medical milestone," he said.

Slepian is also the CEO of SynCardia Systems, Inc., the manufacturer of Cardiowest.

Copeland said that FDA approval would make the device, which has been used experimentally at UMC in 76 patients, available to many more patients.

"With approval comes the ability to commercialize the device," he said.

If it is approved, Cardiowest will be used in 120 hospitals across the nation, according to FDA recommendations.

Copeland said medical insurance companies and Medicare would begin to cover the cost of the device, which would make it available to many more patients.

The FDA report describes the Cardiowest device as having two artificial ventricles that fill and eject blood when compressed by air from the external drive console, which is about the size of a washing machine.

Copeland and FDA panelists agree that one large advantage of using Cardiowest over other implanted devices is the large amount of blood that it can pump.

"It pumps more blood than any other implantable device in the world," said Copeland.

Copeland said when functioning properly, Cardiowest pumps 7 to 9 liters of blood per minute, while other devices can only pump 4 to 5 liters per minute.

The increased blood flow also helps other organs in the body to function better, Copeland said.

He said the device drops the venous pressure in the body, allowing the kidney and liver to work more effectively.

The FDA report confirmed this phenomenon.

"Both renal (kidney) and hepatic (liver) function in the core implant population normalized after 3 weeks," the report stated.

Increased kidney and liver function are important, according to Copeland, because they make the patients more eligible for human transplant.

The FDA report does name some significant risks associated with the device. It states that 71.6 percent of the implant recipients had some type of infection, 42 percent experienced bleeding, and 29.6 percent had respiratory dysfunction.

Copeland acknowledges that risks exist when using the device.

"The risks, I think, need to be weighed," he said.

But he said he thinks that using the device is worth the risk, especially since Cardiowest is the only option for patients with biventricular failure waiting for a transplant.

"The survival, or efficacy of the device, outweighs the risks," he said.

Slepian said he thought that the risks associated with the device were fairly minor.

"With any type of medical device, you will have some risk," he said, adding, "The FDA has to be meticulous on the overbearing side."

While Cardiowest is only going to be approved by the FDA as a "bridge to transplant," Copeland said he thinks widespread use of the device will change the way heart transplant centers operate.

"It's going to take time to bring about significant change, but it will happen," he said.

Copeland said he foresees a time when artificial hearts will completely replace human transplants.

He and other cardiologists at UMC and around the country are developing a portable artificial heart that will not require patients to be hospitalized when using it.

This will decrease the cost of the treatment, since hospitalization can cost up to $20,000 a day, according to Copeland.

Copeland predicts the device will be released for study in "a year or so."

He said around eight patients in Germany and France have already been sent home with a "luggable" artificial heart.

Copeland said he thinks the recognition Cardiowest is getting will have a positive impact on UMC and UA.

"It's good for the reputation of the hospital and the heart center," he said, adding, "Potentially it may have more widespread effects on Tucson."