For Immediate Use March 23, 1198

Roxanne Yamaguchi Moster

UCLA MEDICAL CENTER SAVES PATIENT WITH REVOLUTIONARY HEART-ASSIST DEVICE

A temporary heart device used by cardiac doctors at UCLA Medical Center saved a 24-year-old patient dying from heart failure. The cardiac-assist device avoided the need for an emergency heart transplant.

Jennifer Weldon (Granada Hills), now 25, thought she had the flu and had been diagnosed with bronchitis a week earlier by a family physician. As her condition worsened, Weldon was rushed to a community hospital where she was given a 2 percent chance of survival. Doctors told Weldon's parents she was dying, and a priest was brought in to give last rites. She was rushed to UCLA Medical Center as her only hope for survival.

Weldon was admitted to UCLA on Dec. 23, 1997, and diagnosed with a severe case of viral myocarditis, an infection of the heart muscle. UCLA cardiologist Dr. Michelle Hamilton, co-director of the UCLA Heart Failure Program, immediately recognized the rare condition. Hamilton knew about a cutting-edge cardiac-assist device -- Weldon's only chance of survival -- and quickly called in UCLA cardiothoracic surgeon Dr. Daniel Marelli.

Marelli determined the patient required emergency surgery, and when he opened the chest cavity, the heart stopped beating. Marelli placed Weldon on a temporary heart-assist device known as the BVS 5000 Bi-Ventricular Support System. Manufactured by ABIOMED Inc., the external device assumed the work of both the right and left side of Weldon's heart, pumping blood to her lungs and the remainder of her body in a manner similar to the way her own heart would work.

The result was a modern-day miracle. Only four days later, Weldon's heart had recovered sufficiently to maintain circulation in her lungs. Twelve days later, her heart had improved enough to permit complete removal of the device. Weldon was released from the hospital about four weeks later and is now well enough to begin cardiac rehabilitation therapy. Her long-term follow-up will take place with Hamilton at the UCLA Cardiomyopathy Center.

"In the past, a patient this sick would have died," said Marelli, director of the UCLA Mechanical Cardiac Assist Program. "Without the medical-assist device, Jennifer would have required an immediate heart transplant. And hearts are in short supply. Her end result could have been devastating."

The newly developed BVS 5000 helps patients suffering from acute heart failure and viral infections of the heart. Unlike other mechanical ventricular support devices, the surgeon does not carve out part of the patient's heart to use it. The device connects to the veins and arteries leading to the heart, and reproduces the heartbeat with excellent results. The device is approved as a bridge to recovery, but is sometimes used as a bridge to transplant in those patients whose heart does not recover.

"The device is designed to allow the patient's heart to rest, recover and even repair some of its own damage," Hamilton said. "It buys precious time for doctors to make a more informed decision regarding the prognosis of the patient's own heart."

The device offers a non-scientific benefit as well. Before doctors had to take more drastic measures, Weldon's family had time to offer their emotional support, which Hamilton believes contributed to her recovery.

UCLA's Heart Transplantation Program experience with the device is the largest in the country. More than 40 patients have received treatment with the BVS 5000 over the past three years at UCLA Medical Center.

The use of the BVS 5000 device also is growing across the nation. According to ABIOMED Inc., more than 1,600 BVS 5000 implants for all indications have been performed in the United States. Approximately 50 percent of patients like Weldon placed on the device recover and have gone on to lead normal lives. According to Marelli, if such patients were not placed on this or another type of mechanical-assist device, it is likely that none would have survived.

"This external artificial heart technology is a life-saving circulatory support system," said Dr. Hillel Laks, chief of UCLA's Division of Cardiothoracic Surgery. "By decompressing the heart during the acute phase of cardiac inflammation, it seems to help the heart to recover. It prevents some patients from requiring heart transplantation and also saves precious donor hearts for those patients whose last hope for life is transplantation."

Such an approach for acute myocarditis was presented by Marelli and Laks at the Annual Meeting of the American College of Cardiology in 1996 and published in the Journal of Cardiac Surgery in 1997.

Last year, more than 3,500 Americans were on waiting lists for heart transplantation, and the lists become larger each year. Since only 2,400 received donor hearts, many patients died while waiting.

In June 1997, the Food and Drug Administration approved ABIOMED's heart-assist device for all patients who appear likely to recover use of their heart muscle if the heart has an opportunity to rest. Until then, FDA approval was only for severe failure after heart surgeries.

In the near future, patients will have the option of an implantable replacement heart, which will be intended as end-stage therapy or as an alternative to heart transplantation. UCLA anticipates participation in the first clinical trials for this treatment approach.

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