‘Bloodless’ Lung Transplants Offer Hint at Surgery’s Future

February 24, 2013

‘Bloodless’ Lung Transplants Offer Hint at Surgery’s Future


HOUSTON — Last April, after being told that only a transplant could save her from a fatal lung condition, Rebecca S. Tomczak began calling some of the top-ranked hospitals in the country.

She started with Emory University Hospital in Atlanta, just hours from her home near Augusta, Ga. Then she tried Duke and the University of Arkansas and Johns Hopkins. Each advised Ms. Tomczak, then 69, to look somewhere else.

The reason: Ms. Tomczak, who was baptized at age 12 as a Jehovah’s Witness, insisted for religious reasons that her transplant be performed without a blood transfusion. The Witnesses believe that Scripture prohibits the transfusion of blood, even one’s own, at the risk of forfeiting eternal life.

Given the complexities of lung transplantation, in which transfusions are routine, some doctors felt the procedure posed unacceptable dangers. Others could not get past the ethics of it all. With more than 1,600 desperately ill people waiting for a donated lung, was it appropriate to give one to a woman who might needlessly sacrifice her life and the organ along with it?

By the time Ms. Tomczak found Dr. Scott A. Scheinin at The Methodist Hospital in Houston last spring, he had long since made peace with such quandaries. Like a number of physicians, he had become persuaded by a growing body of research that transfusions often pose unnecessary risks and should be avoided when possible, even in complicated cases.

By cherry-picking patients with low odds of complications, Dr. Scheinin felt he could operate almost as safely without blood as with it. The way he saw it, patients declined lifesaving therapies all the time, for all manner of reasons, and it was not his place to deny care just because those reasons were sometimes religious or unconventional.

“At the end of the day,” he had resolved, “if you agree to take care of these patients, you agree to do it on their terms.”

Ms. Tomczak’s case — the 11th so-called bloodless lung transplant attempted at Methodist over three years — would become the latest test of an innovative approach that was developed to accommodate the unique beliefs of the world’s eight million Jehovah’s Witnesses but may soon become standard practice for all surgical patients.

Unlike other patients, Ms. Tomczak would have no backstop. Explicit in her understanding with Dr. Scheinin was that if something went terribly wrong, he would allow her to bleed to death. He had watched Witness patients die before, with a lifesaving elixir at hand.

Ms. Tomczak had dismissed the prospect of a transplant for most of the two years she had struggled with sarcoidosis, a progressive condition of unknown cause that leads to scarring in the lungs. The illness forced her to quit a part-time job with Nielsen, the market research firm.

Then in April, on a trip to the South Carolina coast, she found that she was too breathless to join her frolicking grandchildren on the beach. Tethered to an oxygen tank, she watched from the boardwalk, growing sad and angry and then determined to reclaim her health.

“I wanted to be around and be a part of their lives,” Ms. Tomczak recalled, dabbing at tears.

She knew there was danger in refusing to take blood. But she thought the greater peril would come from offending God.

“I know,” she said, “that if I did anything that violates Jehovah’s law, I would not make it into the new system, where he’s going to make earth into a paradise. I know there are risks. But I think I am covered.”

Cutting Risks, and Costs

The approach Dr. Scheinin would use — originally called “bloodless medicine” but later re-branded as “patient blood management” — has been around for decades. His mentor at Methodist, Dr. Denton A. Cooley, the renowned cardiac pioneer,performed heart surgery on hundreds of Witnesses starting in the late 1950s. The first bloodless lung transplant, at Johns Hopkins, was in 1996.

But nearly 17 years later, the degree of difficulty for such procedures remains so high that Dr. Scheinin and his team are among the very few willing to attempt them.

In 2009, after analyzing Methodist’s own data, Dr. Scheinin became convinced that if he selected patients carefully, he could perform lung transplants without transfusions. Hospital administrators resisted at first, knowing that even small numbers of deaths could bring scrutiny from federal regulators.

“My job is to push risk away,” said Dr. A. Osama Gaber, the hospital’s director of transplantation, “so I wasn’t really excited about it. But the numbers were very convincing.”

None of the 10 patients who preceded Ms. Tomczak, including two who had double-lung transplants, had problems related to surgical blood loss or postoperative anemia, Dr. Scheinin said. The first, a North Carolina man who received a lung in 2009, died in November after developing internal bleeding and an infection. Several others had various postoperative complications, but all were doing fine, Dr. Scheinin said.

Dr. Scheinin, 52, a native New Yorker, said he liked the tightrope walker’s rush of operating without a net. He said his focus was intensified by the knowledge that if a patient died for lack of blood, a second life might hang in the balance — the wait-listed patient who would otherwise have received the organ.

“If I agree to do an aortic bypass on a patient who refuses blood, and it’s a risk we’re both willing to take, that’s between me and him,” Dr. Scheinin said. “With a transplant, if the patient dies, you risk having people say you wasted a precious organ.”

But Dr. Scheinin and his team are also motivated by the broader agenda — of limiting transfusions for all surgical patients, not just those with religious objections.

The latest government data show that one of every 400 units transfused is associated with an adverse event like an allergic reaction, circulatory overload or sepsis. Even so, the share of hospital procedures that include a transfusion, usually of two or three units, has doubled in 12 years, to one in 10.

Yet at dozens of hospitals with programs that cater to Jehovah’s Witnesses, a million-patient market in the United States, researchers have found that surgical patients typically do just fine without transfusions.

“They are surviving things that on paper were not expected to go well at all,” said Sherri J. Ozawa, a nurse who directs the long-established bloodless medicine program at Englewood Hospital in New Jersey.

The economy is also helping the blood management movement. Processing and transfusing a single unit of blood can cost as much as $1,200, and many hospitals are trying to cut back. Administrators at Methodist said their bloodless lung transplants typically cost 30 percent less than other lung transplants, partly because careful management of hemoglobin levels before surgery has resulted in fewer complications and shorter stays.

Experts say they are beginning to see a measurable impact on blood usage, although the data to support it are not yet available. Dr. Richard J. Benjamin, the chief medical officer of the American Red Cross, predicted that the numbers would show the first decline in use since the AIDS scare began in the 1980s, perhaps by one million units.

“We’re changing this culture, this knee-jerk transfusion reaction,” Dr. Scheinin said. “And I think that’s been a good thing for all our patients.”

A Plan in Place

In October, the Tomczaks sent their poodle, Coco, to live with friends and moved temporarily to Houston. They stayed for the first month in a tidy suburban house with a Witness couple, Peter and Gerry Deichler, whom they had never met. The arrangements had been made by the church’s hospital liaison committee, a nationwide network that connects patients with doctors.

Two days after arriving, Ms. Tomczak walked Methodist’s long corridors as her husband, Gene, wheeled her oxygen tank behind her. Although wheezing and weary, she was characteristically cheerful as she endured numerous tests and met her doctors for the first time.

Ms. Tomczak, a nonsmoker who had been trim before falling ill, took mock offense when one doctor read from her chart that she had become obese. “He is supposed to say that I’m fluffy,” she objected.

Dr. Scheinin explained that the disease had shrunk her lung capacity by nearly half. The good news, he said, was that a CT scan showed that she did not have the kind of adhesions that might cause heavy bleeding during surgery.

The doctors reviewed the form Ms. Tomczak had signed to “knowingly refuse consent” for transfusions of whole blood and its four primary components — oxygen-carrying red cells, infection-fighting white cells, clot-forming platelets and plasma. The form released the doctors from any liability if she died for lack of blood.

Five days later, the hospital added Ms. Tomczak to its waiting list for a lung from a deceased donor. To determine her rank, the team’s pulmonologist, Dr. Harish Seethamraju, calculated a score based on how urgently she needed a transplant and how long she was likely to survive.

It placed her among the top half of candidates listed nationally, and Dr. Seethamraju predicted that it would take two to three months for her to rise up the list and be matched. Without a transplant, he gave her a 50 percent chance of surviving a year.

The hospital’s charges for a lung transplant, which would be paid by Medicare and a supplemental private policy, would most likely approach half a million dollars.

When Ms. Tomczak announced in a family conference call that she planned to have the transplant without a transfusion, her three daughters did not mount much of a challenge. They knew she was serious enough about her faith to carry a wallet card warning medics not to treat her with blood.

But they nonetheless found the prospects unsettling. Ms. Tomczak’s eldest daughter, Kim R. Davis, 49, who left the church as a teenager, struggled to make sense of the seeming inconsistencies, like how Witnesses could have transplants but not transfusions. “It’s hard for me to reconcile,” said Ms. Davis, who lives in Charlotte, N.C. “But she strongly believes in this.”

Founded in the late 19th century and best known for door-to-door evangelism, the Jehovah’s Witnesses first published a position on transfusions in 1945, as the blood donation system expanded after World War II. It grew out of edicts in both the Old and New Testaments that forbid the consumption of blood, which is revered as a life source. The church, based in Brooklyn, takes the position that there is no distinction between oral consumption and intravenous feeding.

The Witnesses’ hard line does have its soft spots. The church declared in 2000 that it was up to members to decide whether to accept blood fractions like clotting factors that are extracted from plasma. It has also left to individual conscience whether to accept synthetic proteins that stimulate red cell production or to use mechanical techniques that conserve and salvage blood.

Ms. Tomczak consented to allow all of those additional measures.

Waiting for an Organ

There were times during the nerve-fraying wait, as it stretched past Thanksgiving and Christmas and into the new year, that Ms. Tomczak felt ready to give up and go home.

The boredom had grown oppressive in the small apartment that she and her husband eventually rented, interrupted only by people-watching at Walmart and card games at a senior center. Two urgent calls from the hospital, both false alarms, had jangled her nerves.

In January came the news that Mr. Tomczak had cancer of the pancreas and liver. He had complained of abdominal pain for months, but it had been dismissed as a recurrence of his diverticulitis, an intestinal inflammation.

The diagnosis shocked the couple, and their attention had shifted to Mr. Tomczak’s care when Ms. Tomczak’s cellphone rang shortly before 9 p.m. on Jan. 30. It was the hospital. There was a lung, from a donor in New Mexico, and it was hers if she wanted it.

Before long, a surgeon from Methodist was taking off on a chartered jet for Albuquerque to recover the lung. Thirty minutes into the trip, the co-pilot announced that the plane’s flaps had malfunctioned, forcing a return to Houston. After a two-hour delay, another plane set off.

The donor, Raisa M. Montoya, 24, a single mother who had collapsed mysteriously, had been declared brain-dead three days earlier and was on life support as officials worked to place her organs. When the doctor from Methodist arrived, a team from another hospital had already started removing her liver.

After its flight back to Houston, the donor’s right lung arrived in the operating room at Methodist, iced in a blue cooler, at 9:35 a.m. Donated lungs remain viable on ice for only about six hours, so Dr. Scheinin had less than three hours to finish the transplant.

It had been a long night for the Tomczaks. While in the waiting room, Mr. Tomczak, 80, began having tremors and dizziness, wound up in the emergency room and was later admitted. The couple waved their goodbyes in a video chat on a pair of iPhones.

Before rolling into the operating room, Ms. Tomczak joined in a short prayer. Then she asked Dr. Scheinin if he had gotten plenty of rest. “I don’t want to hear any ‘oopses,’ ” she said.

Before surgery, doctors ordered doses of intravenous iron and Aranesp, a drug that stimulates red cell production. They also limited the number of blood draws for lab testing. Every milliliter might count.

As Dr. Scheinin opened the thoracic cavity and began cauterizing his way through tissue, another surgeon suctioned blood with a long tube. Rather than disposing of it as medical waste, he routed it through a hose into the cylinder of a cell salvage machine.

A centrifuge spun out the heavy red cells, which were washed with saline and later returned through a port in Ms. Tomczak’s jugular vein. The church does not view this as a transfusion because the blood ostensibly remains in a continuous circuit with the body.

The same was true of a process called hemodilution. At the outset of the operation, doctors ordered a unit of whole blood removed from Ms. Tomczak and replaced it with saline to maintain her blood pressure. The process diluted the hemoglobin concentration of her remaining blood, cushioning the impact of any blood loss. The drawn blood hung in a bag from a pole until shortly after the new lung was transplanted, when it was returned to the body.

Dr. Scheinin worked with cool and quiet focus as a soundtrack shuffled from ZZ Top to Bob Seger to Lynyrd Skynyrd. With Ms. Tomczak breathing on a ventilator, he clamped the pulmonary artery and vein, severed them and the bronchus and lifted her diseased lung into a bowl. It was riddled with BB-size nodules, hard to the touch.

After suturing in the new lung with methodical strokes, Dr. Scheinin unclamped the vessels and prodded the organ to inflate like a beach ball. The lung began to rise and fall in precise rhythm.

Ms. Tomczak’s recovery has not been without setbacks, albeit unrelated to her hemoglobin levels. Two weeks after the transplant, while building stamina in a rehabilitation unit, she contracted pneumonia in her new lung. Enough fluid accumulated that Dr. Scheinin had to surgically insert a tube and drain a liter. She is being treated with antibiotics.

Tests also detected the presence of unwelcome antibodies, which Dr. Seethamraju addressed with intravenous immunoglobulin, one of the blood proteins that Ms. Tomczak had consented to accept. But the doctors said scans and a biopsy otherwise showed that the lung was working properly, with no signs of major rejection. They expected Ms. Tomczak to be hospitalized for several more weeks, and to remain in Houston for monitoring for six months.

In a raspy telephone interview from her hospital room, Ms. Tomczak said that although sore from the trauma, she could feel a difference in the depth of her breathing. “I’m back from the dead,” she said, adding that she was eager to care for her husband, who had been discharged with a grim prognosis.

She expressed amazement — “Well, how about that?” — when told that the drop in her hemoglobin levels, measured before and immediately after surgery, had been barely perceptible. Jehovah, she said, must have been guiding Dr. Scheinin’s hand. Given what they had achieved together, that sat just fine with Dr. Scheinin, who is Jewish.

“Over the years, I’ve been blessed by Catholic priests, rabbis, Baptist ministers, even a Buddhist monk or two,” he said. “I wouldn’t trade in my surgical skills for a life of piety. But can anyone deny that a higher power doesn’t have some bearing on how this all plays out?”

About bambooinnovator
Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (www.heroinnovator.com), the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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