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And the Beat Goes On
Story Number is : 052612102
By Geraldine A. Collier
Correspondent
Hospital Newspaper

 
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This day – every day - 17 men and women die in the United States because an organ transplant that would have saved their lives wasn’t available.

On April 14, Karen Ruda, was one of them. The 43-year-old woman’s damaged
heart beat its last while she waited at Tufts Medical Center in Boston for a new
one that never came.

There was no miracle for the Massachusetts’s woman, no last minute reprieve that would have continued her life. And there are no miracles for many of the 160,000 people who wait each day for transplants, but who don’t get the winning ticket.

If more people would sign up to be organ donors – in case the unforeseen does happen – if families who mourn the death of a loved one could, for a moment, see past their tears – then Karen’s 12- year-old daughter Haleigh wouldn’t have to grow up without a mom.
Until that day comes – or until the day comes when tissue engineering scientists can grow spare parts to replace worn out ones – every organ available for transplant has to be carefully treated in order to make the best use of a very limited supply.

But, despite the best efforts of everyone in the transplantation world, more than half of all hearts that have been made available for donation go unused.

Time and Distance

Most surgeons will transplant a heart no more than four to six hours after it has been removed from the chest cavity of the donor’s body, according to Anne Paschke, media relations specialist for the United Network for Organ Sharing (UNOS).

Because of that time factor, “hearts are matched first in the local donor service areas of the hospital where the donor died, then within a 500-mile radius, followed by 1,000-mile radius and 1,500- mile radius,” said Paschke. “Medical urgency is the primary factor
in heart allocation.”

But, even with Karen Ruda’s life on the line, if there had been a heart available for her, but the donor patient was in – say San Diego or San Francisco – the match would never have been made because of the time it would have taken to fly that heart 3,000 miles from the West Coast to the East Coast.

Somewhere over the Mid-West that heart would have started to lose its viability. But, time and distance problems may be overcome in the near future.

Probably everyone has seen pictures of a white-coated doctor clutching a picnic cooler that contains a non-beating heart that has been saturated with preservative fluid, then placed in a plastic bag on ice.

On Ice

“With the traditional method, once you have removed the donor heart you put it on ice because you want to keep the heart cold, keep it quiet, not beating, in order to preserve the tissue,” said Dr. Margarita Camacho, surgical director of Heart Transplantation and Mechanical Assist Devices at Newark Beth Israel Medical Center. That reduces the metabolism, the metabolic requirements.

”And that’s what’s we have been doing for 40 years,” she added. But, maybe not much longer. An Andover, Massachusetts medical device company, TransMedics, Inc., has
developed an alternative way to transport hearts.

The company calls it the Organ Care System (OCS). Others, including the writers of one
episode of television’s Grey’s Anatomy, call it the “heart-in-a-box.”

And it could preserve the quality of a donated heart, while lengthening the time the heart can be outside a body.

The “heart in the box” preserves stillbeating hearts by continuously pumping throughout the blood tissue and vessels, the warm, oxygenated, nutrient-rich blood of the donor.

Whether it’s time for change, will be determined through clinical trials in both the
U.S. and Europe that are comparing the outcomes of transplants with hearts that
have been transported by cold storage and those transported using the new technology.

The trials are designed to measure 30- day patient and transplanted heart survival;
incidence of cardiac-related serious adverse events; time spent in the Intensive
Care Unit and incidence of acute rejection episodes.

Evidence gathered in these clinical trails will be used as supporting evidence in the company’s application for approval of the device from the Federal Food and Drug Administration.

Clinical Trial Sites

The clinical trials are now ongoing at several locations across the U.S., including: Ronald Reagan UCLA Medical Center; New York-Presbyterian, Columbia University Medical Center; Cleveland Clinic Foundation; Cedars-Sinai Medical Center; Massachusetts General Hospital; Brigham and Women's Hospital; Tufts Medical Center; University of Miami/Jackson Memorial Medical Center and Newark Beth Israel Medical Center,

The clinical trials have two major goals. “Our hope is that we are going to increase the pool of donor hearts by recovering hearts that are border-line,” said Dr. Camacho.

“There are certain donors who have had CPR, for instance, and the hearts are not always the best,” she said. “But, hearts will often recover after a short period of time; one way to get them to recover is to give them oxygen and nutrients.”

Use of the new technology can also potentially reduce the risk to fragile hearts of injuries sustained during preservation with the current cold preservation techniques. Importantly, since the heart is continuing to beat, the transplant team can evaluate how the donor heart is functioning, by using monitoring equipment built into the new technology. “We can see if the heart has recovered before actually implanting it, said Dr. Camacho.” With cold transportation of a non-beating heart that assessment is not possible.

One of the more fascinating things about heart transplant is that even if the heart has been in cold storage, once it is implanted in the chest cavity, it usually starts beating right away.

Using the OCS technology, the heart is beating but has to be stopped before it is implanted. “Right before we take it off the pump, we stop the heart,” she explained.

”You can’t implant a beating heart.” But, again, the heart starts to beat again as soon as it is hooked up. “Ninety-nine percent of the time there is no problem; you don’t have to do anything else,” said Dr. Camacho. Sometimes, however, the heart will beat with an irregular rhythm, necessitating the use of a defibrillator to steady its electrical system.
Back to the Trials The other major goal of the clinical trials is to see how long “the heart-in-abox” can keep the heart viable, thus increasing the amount of time between removing the donor heart and implanting it in the recipient. “We hope to increase the time up to 10 to 12 hours at least,” said Dr. Camacho. Some see a possibility of maybe even 24 hours.

But, even 10 top 12 hours would open up the pool of donors in the entire country
to be matched with recipients, no matter where each is located.

And that would increase Dr. Camacho’s time in the air in a private jet – private because commercial airlines can’t be used because of the time limitations. “We (Newark Beth Israel) are one of the most aggressive heart transplants centers in the country,” said Dr. Camacho.

“Two-thirds of our hearts come from distant points. So I am on a jet two thirds of the time, getting these hearts,” she added Last year, 63 heart transplants were done at Newark Beth Israel, which has the third largest transplant program in the country. At least 40 of those transplants involved donor hearts from distant points.”

When we talked to Dr. Camacho in early May, there had been three heart transplants done at the hospital in the clinical trials of the OCS. The portable pump – which Dr. Camacho takes on her flight – has worked well for all of them. Hope for Better Stats With half the donor hearts unusable, it’s hoped that the “heart-in-a-box” might be able to reduce that by 25 to 50 percent. “That would be tremendous,” said Dr. Camacho.

Now a half are not usable, maybe with the new technology that figure maybe be reduced to a quarter to a half, she said. “That would be tremendous,” she said. Right now, in the U.S., 3,000 men and women are waiting for a new heart –and nearly half of them have been waiting more than two years.

And they all have families and friends who are hoping for that miracle denied Karen Ruda. If you or your hospital are using a promising new therapy or new technology
to deliver better care to patients and think that it would be suitable for the Cutting Edge column, please email Geraldine Collier, senior staff correspondent, at Gerryc1231-@aol.com.



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