First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery

Anthony Shannon made history July 30, when he became the first person in the United States to receive a new type of experimental and very high-tech heart-assist device. Called a DuraHeart, it was implanted in his chest, and connected to his failing heart, to help pump his blood and keep him alive.

Shannon, a 62-year-old from Livonia, Mich., is doing well less than one week after the operation, which was performed by a team led by surgeon Dr. Francis Pagani, at the University of Michigan Cardiovascular Center. Shannon is the former director of homeland security and emergency
management for Wayne County, Mich., and holds a Ph.D., in public administration.

The DuraHeart, made by an Ann Arbor, Mich.-based company called Terumo Heart Inc., uses advanced magnetic-levitation technology. This "maglev" approach, as it is called, means that a crucial, constantly revolving part within the hockey puck-sized implanted device never touches the walls of the pumping chamber, according to an announcement from the university.

Instead, it levitates in the middle, suspended in a magnetic field and pushing blood along. The battery-powered device pushes blood from the heart to the body, taking over most of the function of the left side of a severely weakened heart, the announcement says.

As a result, DuraHeart may cause less damage to blood cells and be less likely to allow dangerous blood clots to form, compared with other heart-assisting devices that use mechanical pumps, the university announcement says. It has already been used in 70 patients in Europe, where it received approval for commercial use in 2007 after a clinical trial.

Now, heart failure patients at the University of Michigan and other centers across the United States will have the opportunity to volunteer for a clinical trial of the DuraHeart, which is being co-led by Pagani and by Dr. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York. Michigan is the national training center for the trial, which is funded by Terumo Heart, and teams from Columbia and the University of Louisville have already traveled to Ann
Arbor to learn how to implant the device.

"The DuraHeart gives us a new, third-generation option for patients with advanced heart failure who need help to allow them to survive until they can receive a heart transplant," says Pagani, who leads the U-M Center for Circulatory Support.

He has led other national clinical trials of heart-assist devices, including the HeartMate II, which in April received approval from the U.S. Food and Drug Administration after a clinical trial. U-M now offers heart failure patients nearly a dozen different options to support their heart
function, including heart transplants.

"This trial will test the DuraHeart's potential to overcome some of the issues that have been seen with other devices, including hemolysis caused by shear stress on red blood cells, and clotting risk caused by blood that does not circulate rapidly enough from all areas of the chamber," Pagani explains. "It also remains to be seen if this device offers superior durability, which might make it useful as a destination therapy that could remove the need for a heart transplant."

Shannon, whose heart has been weakening for nearly 20 years after a heart attack and clogged arteries damaged part of his heart muscle, is one of 5.3 million Americans with heart failure.

Although not all heart failure patients are candidates for a heart-assist device or a heart transplant, tens of thousands could be. At any given time, as many as 4,000 Americans are on the waiting list for a heart transplant, but only 2,100 people receive new hearts in the U.S. each
year because of a shortage of suitable donor organs. Hundreds of people each year die while waiting for a heart.

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