Cyborg cow heart to undergo human trials

This artificial heart contains high-tech software and microelectronics—along with cow tissue for strength.

 

France-based company Carmat will soon test the artificial heart on patients with heart failure, according to a report on The New York Times.

 

Aside from cow tissue to be used on surfaces of membranes that touch the blood, the heart will have sensors as well as two external wearable lithium-ion batteries.

 

In the new artificial heart, cow tissue will replace artificial materials like plastic, which the NYT report said may cause problems like clotting.

 

“The way they’ve incorporated biological surfaces for any place that contacts blood is a really nice advantage. If they have this design right, this could be a game changer,” said Dr. Joseph Rogers, an associate professor at Duke University and medical director of its cardiac transplant and mechanical circulatory support program.

 

Such a heart may lessen the need for anticoagulation medicines, he added.

 

Also, the new heart is the first to use tissue from the pericardial sac that surrounds the heart.

 

Rogers noted biological tissue had been used in earlier mechanical blood pumps only in valves.

 

15 years in the making

 

Dr. Piet Jansen, medical director at Carmat, said the new heart was 15 years in the making, and has been approved for clinical trials in Belgium, Poland, Saudi Arabia and Slovenia.

 

He added animal tests are continuing in France, where the heart is not yet cleared for human implantation.

 

Jansen said the Carmat heart may cost $200,000 and may not reach the market in Europe before the end of 2014.

 

Once the company gains momentum with European clinical studies, it plans to start working through the regulatory process in the United States, he said.

 

Heart chambers

 

The Carmat heart has two chambers, each divided by a membrane.

 

That membrane has cow tissue on one side, which is in contact with blood; and polyurethane on the other side, which touches the miniaturized pumping system.

 

Embedded electronics and software adjust the rate of blood flow, even as patients can wear the batteries under the arm in a holster, or in a belt.

 

On the other hand, the cow tissue is chemically treated so that it is sterile and biologically inert.

 

Jansen said the heart’s design and development relied heavily on aerospace testing strategies by EADS, the European Aeronautic Defense and Space Company.

 

EADS is one of Carmat’s backers.

 

Yet, Dr. Robert Kormos, director of the artificial heart program at the University of Pittsburgh Medical Center and co-director of its heart transplant program, admitted duplicating the durability of a human heart will not be easy.

 

“We can test these pumps on the bench in the laboratory, and in animals, but there is no true long-term data until you implant them in people for trials,” he said.

 

Replacement heart

 

Dr. Lynne Warner Stevenson, a professor at Harvard Medical School and director of the cardiomyopathy and heart-failure program at Brigham and Women’s Hospital in Boston, said thousands of people in the US need a replacement heart.

 

Stevenson said that while transplants work best, "we have only 2,000 or so adult hearts” available each year. “It’s a huge problem,” she said.

 

But she said there are options for patients while they await transplants, including an artificial heart until a donor heart is available.

 

She said it is too early to know if the Carmat heart will be valuable.

 

“The whole history of mechanical devices is that people thought they had devices where blood wouldn’t clot. But they didn’t,” she said.

 

Yet, she is optimistic about the new device.

 

“Innovation is what we need. This new device is exciting. I applaud the pioneers who developed it, and the patients and families who will go down this path for the first time,” she said. — TJD, GMA News