Change of Heart: The Potential of the Beating-Heart Transplant

If, God forbid, you ever need a heart transplant, Los Angeles is the place to be. The city and its environs have the largest number of organ donors nationwide. Cedars-Sinai Medical Center does a booming business—75 heart transplants in 2010, more than any other hospital in the country.

If you live in New York state and are between the ages of 50 and 64, your median waiting time is 245 days, according to the nonprofit Organ Procurement and Transplantation Network. But if you live in California, you’ll wait only 124 days.

With heart transplants, time is more valuable than money—it’s what stands between you and the chance for your old life back. When a heart becomes available in your area and you’re next in line for it, that heart needs to be inside you within hours. From the minute it is removed from the donor’s body and deprived of blood, the organ is in decline.

Hearts are typically ferried from one place to the next in a picnic cooler with a bag of ice, no different from what you take to the beach. The method is low-tech and cheap, and it’s been in use since 1967, when the South African Christiaan Barnard performed the first successful human-to-human heart transplant.

But hearts on ice deteriorate if left for more than six hours, and can’t be counted on to function well. For that reason, geography, along with time, is of the essence. Less distance means less time outside a body, which means a healthier organ.

Few people understand those trade-offs better than Bruce Rosengard, A81. A top cardiac surgeon, he is pioneering the use of a new technology that promises to break the barriers of time and distance. Rosengard is among the first few surgeons to have performed so-called beating-heart transplants, where a portable machine keeps the heart warm and beating outside a body until minutes before it is stitched into the recipient’s chest. Perfused with the donor’s blood, this “heart in a box” doesn’t deteriorate the way a cooled heart does.

Surgeons in Germany introduced the world to the beating-heart method in early 2006. Rosengard, known for his expertise in assessing and managing heart donors, was asked to investigate the technique at Papworth Hospital in Cambridge, England (he was chair of cardiothoracic surgery there, as well as a professor at the University of Cambridge).

In May 2006 he led the team that performed the United Kingdom’s first beating-heart transplant. “We had a series of three patients, and the results were unambiguous: this works like clockwork,” he recounts. The apparatus that keeps the donor heart beating is now commercially available in Europe.

In the United States, the machine—known as the Organ Care System and made by a Massachusetts company, TransMedics—is still undergoing clinical trials for FDA approval. Among the participating surgeons: Rosengard. In December 2011, at Massachusetts General Hospital, where he has been surgical director of cardiac transplantation for five years, he performed the first beating-heart transplant in New England.

Have Heart, Will Travel

Rosengard looks the part of the pathbreaking surgeon. He stands well over six feet (his dream as a child growing up in Newton, Mass., was to become an astronaut, until he maxed out the height restriction), and his confidence makes him seem even taller. His deep-blue eyes and commanding presence suggest a man comfortable speaking in packed lecture halls and leading surgical teams in life-or-death operations.

He has received numerous honors—summa cum laude at Tufts, followed by important fellowships as a medical student at Johns Hopkins and as an associate professor at the University of Pennsylvania. He even has his name etched in the entryway of Mass. General’s Lunder Building, a thank-you from a former patient. “It’s not often that you see your own name in granite during your lifetime,” Rosengard jokes.

He will leave his mark in a different way if the transplant technology he is helping to pioneer becomes routine. Hearts will travel farther, spreading out their availability nationwide. And they will arrive in better shape, raising the recipients’ odds of survival. In fact, Rosengard says, “the whole way we do transplants is going to have to be rethought.”

With the current method of transport, cold storage, the ticking clock is a major stressor. Once the heart is removed from the donor and stored, every moment that elapses could damage the organ. “The team runs as fast as it possibly can to reduce the time on ice,” says Neal Beswick, a vice president of TransMedics, the perfusion machine’s manufacturer.

Ideally, ice time is under four hours, including the wait in the operating room while surgeons remove the recipient’s failed heart. That process can take 45 minutes if everything is going well and hours if it’s not, as often happens with patients who have had previous surgeries. “Sometimes you get in there and the scarring is like concrete,” says Rosengard.

In the mad scramble to deliver the heart, there can be mishaps, like one that made news last January. A medic in Mexico City, executing what police described as a “rapid precision maneuver,” raced toward a hospital with a donor heart in a cooler. In his haste, the cooler lid flew off, and the heart fell onto the street. It was later transplanted successfully, but it’s easy enough to imagine a less favorable outcome.

Deadly Delays

The pressure can only be expected to intensify as the shortage of donor hearts becomes ever more critical and the number of new patients diagnosed with end-stage heart failure increases. The size of the waiting list has been trending slightly higher every year, from 2,837 patients at the end of 2006 to 3,147 at the end of 2011. By May 2012, the number of patients actively waiting for a heart had crept up to 3,169. According to the United Network for Organ Sharing (UNOS), an organization tasked with managing the U.S. organ transplant system, 2,322 patients received new hearts in 2011. But another 331 patients died waiting.

Supply can’t keep up with demand, especially since keeping up is not a simple matter of finding 3,169 hearts. UNOS maintains a national database with information on patients’ blood type, height, weight, age and, of course, location. Every time a donor organ becomes available, a computer shuffles through possible matches, with first dibs given to patients who are most at risk of dying. And even when a match is found, the donor heart might turn out to have suffered damage from coronary heart disease or blockages. Or it may just function poorly. In all, 70 percent of donor hearts prove unsuitable.

The beating-heart technology could change all that. It could take geography out of the equation and allow time for more testing, for better matching and perhaps for doctors to treat the heart with drugs to improve its function.

Since donor hearts arrive in better condition, the proportion that are usable could rise from 30 percent to 50 or 60 percent, according to TransMedics’ Beswick. Because the heart remains beating except during 75 minutes of surgery to remove and implant it, the time window for getting the organ from donor to recipient opens up considerably—perhaps to as long as 12 hours, Beswick says.

Chris Curran, organ operations and surgical recovery manager at New England Organ Bank, says the machine could increase the reach of organizations like his. “It might allow us to find suitable recipients great distances away,” he says—a heart in Los Angeles might travel to Boston, for example.

These are all hopes for the machine somewhere in the future. The randomized clinical trial that Rosengard is working on will continue through 2012. It will use data on 128 patients to compare the efficacy of the new transport device with that of current cold-storage methods.

Abbas Ardehali, a transplant surgeon at UCLA, is heading up the study, and surgeries are taking place all over the country, with collaborators at Tufts Medical Center, Columbia University Medical Center, Washington University Hospital and elsewhere.

With cold storage, about 92 percent of heart transplant patients survive for 30 days or more. If European experience is a guide, the current trial could yield results significantly better than that. “When we did the first series of patients in Europe,” says Rosengard, “19 out of 20 patients were out of the intensive care unit in under 24 hours. The 20th patient was out in under 48 hours.” And after 30 days? Data on 138 European patients shows a survival rate of 97 percent.

A New Life

Amy DeStefano, a 40-year-old New Hampshire social worker, was on the transplant waiting list for 32 months. When she met with Rosengard at Mass. General about participating in the trial, he laid out those statistics, along with one more: 50 percent, which was the chance that her donor heart would be coming from the perfusion device rather than from a cooler.

DeStefano says she expected to be intimidated by the doctor, but his down-to-earth manner quickly put her at ease. On a cabinet in his office, for example, patients are treated to a poster-size cartoon that shows Rosengard peering into a linen basket, a red-and-white Igloo cooler beside him, and exclaiming in a dialogue bubble, “Holy cow!” The drawing fixes a moment from his training at Johns Hopkins, when the bag in which he was carrying a donor heart to the operating table split open, dunking the heart into the linen basket. (There was no harm done.)

As for the prospect of getting a new heart, DeStefano wasn’t nervous but ecstatic. Her own heart, damaged by pneumonia, had been working so poorly that she’d been sleeping all the time, lacking even the energy to pick her two small children up from school. She’d just reached her lowest point a few days after Christmas, when she passed out and ended up at Mass. General.

She had reluctantly agreed it was time to implant a left ventricular assist device, a battery-operated pump that would keep her failing heart stable for a while (former Vice President Dick Cheney had one before his recent transplant). But hours later, she was told not to eat or drink anything, because a heart might be available. Sitting there in Rosengard’s office, she knew one thing for sure: she wanted the heart, whether it was going to come from the experimental machine or not. She wanted her life back.

As she was wheeled into the operating room, Rosengard beamed at her. She says she will never forget that smile. DeStefano, in fact, was about to become the first patient in New England to receive a heart transported with the new high-tech system.

The donor organ was waiting for her, beating, in a device about the size of an office copier, a sort of mini-heart-lung machine on wheels. The apparatus keeps the heart “alive” by sending 1.2 liters of the donor’s blood through the coronary artery in a closed circuit that constantly supplies nutrients and oxygen. The heart is beating, but not pumping. It’s actually resting. A wireless monitor allows the physician to observe the organ’s vitals.

When the time comes for the transplant itself, the procedure closely resembles the one performed with conventionally transported hearts. The sole difference is that the beating donor organ is stopped briefly with potassium chloride—the solution that some prisons use for lethal injection—immediately before being sewn into the recipient.

Rosengard then follows a long-familiar sequence: the left atrium is attached first, then the inferior vena cava, the pulmonary artery, the aorta and finally, the superior vena cava. “There is nothing extremely technically challenging about sewing large structures,” he says. “These are big tubes that don’t require the skill of a coronary bypass, which is performed under magnification.”

The Odds of It Working

The real nail-biters come after surgery: the danger that the patient’s body will reject the donor organ and, further down the road, the increased risk of cancer, kidney failure and other side effects from the necessary immunosuppressant drugs.

There is, however, a period of suspense in the operating room after the sewing is complete and, little by little, Rosengard releases the clamp off the aorta and weans the patient from the heart-lung machine. The heart is supposed to start beating on its own once the blood flows. For the minute or two that the team waits for that to happen, the OR is silent.

In 10 to 15 percent of transplant cases, the heart doesn’t function well, and doctors make adjustments with drug therapy. On rare occasions, they implant a temporary ventricular device until the heart pumps normally. But in DeStefano’s case, the heart started up perfectly.

Not surprisingly, the new system costs more than a bag of ice and an Igloo cooler. In Europe, where it is commercially available, it runs close to $40,000—and it’s used only once. That expense would come on top of the $1 million cost of a typical U.S. heart transplant (including organ procurement, medications, physician fees and extended hospital stays before and after surgery).

Beswick predicts that if the system proves safe and effective, its price would be more than offset by the lower cost of maintaining patients with end-stage heart failure, who would receive transplants quicker, and with better outcomes. Besides, he says, “What is the value of a heart today that you couldn’t get yesterday?”

DeStefano doesn’t have to ask. After her surgery, during an echocardiogram, she dared herself to look. There it was, the new heart, pumping powerfully and beautifully. She realized two truths at that moment: that it wasn’t her heart inside of her, and that somebody had given her the ultimate gift.

Remembering the ultrasound image on the screen, she says, “I couldn’t keep my eyes off it.” And the surgeon—is he satisfied with his patient’s progress? “She’s doing extraordinarily well,” Rosengard says. “No problems whatsoever.”

Grace Talusan, J94, teaches writing at Tufts and is a widely published writer of fiction and nonfiction. She can be reached at grace.talusan@tufts.edu.