Barnes-Jewish is chosen to implant the improved version of Jarvik artificial heart

By Mary Jo Feldstein, St. Louis Post-Dispatch, November 19, 2006

Critically ill heart patients in the St. Louis region may have a new chance at life.

Barnes-Jewish Hospital has been chosen as one of nine hospitals nationwide to implant the temporary total artificial heart.

The $100,000 device is designed as a bridge to transplantation. It will replace the patient''s diseased heart with the goal of improving blood pressure and organ function so the recipient becomes healthy enough to receive a new heart. Patients cannot leave the hospital while the device is in place.

"These are patients that currently we don''t have any options for treating," said Dr. Nader Moazami, surgical director of heart transplant at Barnes and the Washington University School of Medicine. "I''m talking about people at the end stages, the sort of patients that have impending organ failure and death."

This artificial heart, the first such device to receive Food and Drug Administration approval, is an improved version of the Jarvik-7 artificial heart. The Jarvik-7 first was implanted nearly 25 years ago.

However, perfecting the device and finding enough suitable patients for a trial took decades. The device did not receive FDA approval for use outside of clinical trials until October 2004.

Since then, SynCardia Systems Inc., the device maker, and a team from the University of Arizona, the primary researchers of the device, slowly have been training teams of surgeons, nurses and other specialists.

In the 1980s, Dr. Jack G. Copeland, a cardiothoracic surgeon at Arizona and the lead researcher on the study, was the first surgeon in the world to successfully use the device as a bridge to transplantation.

The technology used in the device eventually was transferred to SynCardia, a company founded by Copeland and other researchers, including Richard Smith. Smith directs the transplant program at Arizona and is chief technical officer for SynCardia.

Smith said SynCardia chose Barnes as one of the first hospitals to receive the technology because of its reputation as a transplant center, its team of surgeons and its experience with other heart devices.

Once chosen, hospitals must agree to use certain best practices shown to limit complications. The training process takes more than a month and members of the University of Arizona''s team will fly to St. Louis to observe the first procedure, Smith said.

Training to implant the new device at Barnes began earlier this month. The hospital hopes to implant at least two of the devices in the next 12 months. The number of the devices implanted at Barnes will depend primarily on how many patients fit the strict criteria.

Patients receiving the device have to be so sick no other treatment or device will work. Yet, they can''t be too sick too qualify for a transplant.

To qualify for a transplant, patients'' age, weight, health history and family support systems are considered as well as whether use of alcohol or drugs contributed to the patients'' condition, said Gene Ridolfi, director of the transplant center at Barnes.

The cost of the device is not a factor in deciding whether to use it, Ridolfi and Moazami said.

"If you have a 40-year-old patient and the family''s all out in the waiting room, I can''t go up to them and say, ''This technology is too expensive for your son,''"..." Moazami said. "This device is reserved for patients where this is the only option."

Surgery to install the artificial heart is expected to cost $20,000 to $30,000.

The transplant center at Barnes has performed more than 500 heart transplants since 1985; nearly half of those patients are alive.

There are 72 patients in Missouri and 81 in Illinois waiting for heart transplants. A few of those patients could receive one of these artificial hearts to keep them alive and healthy enough to stay on the transplant list. A nine-year study of the device at the University of Arizona showed patients who received it had a one-year survival rate of 70 percent, compared to a survival rate of 31 percent for those who did not receive the device.

The study, published in the New England Journal of Medicine in August 2004, helped the device receive FDA approval.

Despite the results, experts said, it''s important to remember this device is only for a very select group of patients.

Most of the nearly 5 million Americans with congestive heart failure can be treated with medications. Others can be implanted with devices that allow the patient to go home until a transplant is available or indefinitely if the patient is not a transplant candidate, said Dr. Clyde Yancy, a spokesman for the American Heart Association.

Fewer than 100 patients nationwide are expected to receive one of the artificial hearts each year.

Earlier this year, the FDA approved a permanent artificial heart for terminally ill patients who are not candidates for transplants. To be eligible for this device, a patient must be expected to live less than a month without it. It has been shown to increase a patient''s life by several months.