Born on the battlefield

Trauma surgeons have a new way to stop internal bleeding

The high school senior was one of the 22 pedestrians injured May 18 by a man who drove his car through tourists in New York's Times Square, killing a teenager.

Jessica Williams of Dunellen, N.J., almost was a fatality, too. She was hemorrhaging internally, and transfusions could not keep up with her blood loss.

Doctors and nurses at NYC Health & Hospitals/Bellevue raced to save her, but she had severe injuries to her legs, abdomen and pelvis. Her pulse skyrocketed to 150. Her blood pressure dropped to 40/30.

"She was about to go into cardiac arrest," said Dr. Marko Bukur, a trauma surgeon.

He grabbed a device that neither he nor anyone else at the hospital had used, except in training sessions on mannequins. It had arrived at Bellevue just days before.

The device, called an ER-REBOA catheter, was born on the battlefields of Iraq and Afghanistan, the brainchild of two military doctors who saw soldiers die from internal bleeding that medical teams in small field hospitals could not stop.

Their invention, made by Prytime Medical and cleared by the Food and Drug Administration in 2015, is gradually being adopted in civilian trauma centers around the country. In Arkansas, surgeons at the University of Arkansas for Medical Sciences and UAMS Trauma Center expect to add it to their emergency room arsenal within a few months.

But medical teams need rigorous training first: Mishandled, it can be dangerous.

Bukur punctured Williams' thigh, threaded a slim tube into her femoral artery and eased it up about 12 inches into her aorta, the major artery that carries blood from the heart to most of the body. Then he injected salt water to inflate a balloon near the tip of the tube, blocking the aorta and cutting off circulation to Williams' pelvis and legs. Above the balloon, blood flowed normally to her brain, heart, lungs and other vital organs.

Almost instantly, her blood pressure rose and her racing heart slowed down. The balloon stopped the hemorrhaging inside her pelvis, almost as if he had turned off a faucet.

REBOA stands for resuscitative endovascular balloon occlusion of the aorta; some doctors describe it as an "internal tourniquet."

But it's really not a tourniquet, says Dr. Bill Beck, an assistant professor in the UAMS College of Medicine Department of Surgery. The first surgeon at UAMS to train on REBOA, Beck has used the technology -- on people as well as on mannequins -- during a fellowship at the University of Texas Health Sciences Center at Houston, in Memorial Hermann Hospital.

"When most people think of a 'tourniquet,' they're thinking of an extrinsic thing, something that you wrap around an arm or leg and then tighten," he says. Instead, REBOA is more like an inflatable plug.

"I think that folks can relate with the idea that if you put a balloon inside a tube and blow [the balloon] up, then things can't flow through that tube," he says.

STOP THE BLEEDING

The clock was ticking for Williams. Circulation could be safely cut off for only so long -- ideally, no more than about 30 minutes. Beyond that, the lack of blood flow could severely damage her legs and internal organs.

Blocking the aorta "removes the perfusion, or the blood flow, to all of the organs in the abdomen," Beck explains, "the small bowel, the large bowel, the stomach, the liver, the spleen, the kidneys as well as the lower extremities. And there's only a certain amount of time that those organs can go without perfusion before they will die."

The balloon had only bought the medical team a bit of time to find the source of the blood loss and fix it. If they failed, when they deflated the balloon they would be back where they started, with a teenager on the verge of bleeding to death.

Beck notes trauma surgeons do have an older technique to use in such dire circumstances -- resuscitative thoracotomy. It involves making a large incision in the left chest, reaching in and placing a clamp directly across

the descending aorta. While effective, "there's a significant amount of morbidity [disease] associated with that technique," Beck says.

The balloon device shuts off blood equally well, he says, but instead of giving the patient a chest wound, it requires "a very small skin nick. It's really just a needle stick in the groin" -- like the little puncture used for cardiac catheterization.

In New York, Dr. Sheldon H. Teperman, director of trauma and critical care services at NYC Health & Hospitals/Jacobi, and Dr. Aksim G. Rivera, a vascular surgeon there, have been teaching the procedure to trauma surgeons. The Bellevue surgeons who saved Williams trained with them.

"It's a lifesaving instrument, but it needs to be handled with respect because turning off the blood supply to half the body is dangerous," Teperman said, adding, "I lie awake at night worrying that maybe someone will use it improperly."

Several patients in Japan had to have legs amputated after being treated with a related device that was left inflated for too long.

BATTLEFIELD INSPIRATION

The idea for the ER-REBOA catheter came to Dr. Todd E. Rasmussen and Dr. Jonathan L. Eliason in 2006, while they were deployed as surgeons in Iraq. Improved tourniquets and transfusion techniques did prevent soldiers from bleeding to death from wounds in their arms and legs. But there was no similar solution for bleeding in the abdomen or pelvis, or what doctors call "noncompressible hemorrhage."

The two doctors, both vascular surgeons, started to develop a new device based on an older balloon catheter designed to prevent bleeding in people having surgery on the aorta.

The older device can be used on trauma victims, but not easily. It is large and complex, and meant for use by vascular surgeons with X-rays to guide it. It was "really designed to be used in nice surgery centers, with well-staffed, fancy operating rooms," said Rasmussen, an Air Force colonel, who is associate dean for research and an attending surgeon at the military medical school and medical center at the Uniformed Services University in Bethesda, Md.

"None of that translates well into when all hell is breaking loose and your patient is going to die in seven minutes," said David Spencer, the president of Prytime Medical.

Rasmussen and Eliason set out to create a smaller, stripped-down version that could be placed quickly inside the aorta without X-rays by trauma surgeons and, eventually, by general surgeons, emergency room doctors and maybe medics.

Those doctors and medics are usually the first to reach people who are bleeding, in what trauma experts call the "golden hour" after an injury, Rasmussen said, adding, "That's where the margin to save lives is greatest."

By 2009, he and Eliason made a prototype, nicknamed their "Home Depot version" of the device.

"It was pretty clunky," Rasmussen said. But it was good enough to start testing in the lab. The results were promising, but big medical device companies showed no interest in developing it.

TAKING A CHANCE

After a talk Rasmussen gave in 2009 that mentioned the lack of commercial interest in military medical research, Spencer, a technology entrepreneur and venture capitalist from San Antonio, offered to start a company to make and market the device. A self-described Army brat, Spencer said he liked the idea that something inspired by a military need could also save civilian lives.

The catheters, used once and then thrown away, cost about $2,000, which is relatively cheap compared with other devices used in vascular surgery. The ER in the product name stands for the last names of the two inventors, Eliason and Rasmussen.

The Defense Department and the University of Michigan hold the patent, Rasmussen said, and he makes no money from it.

Beck notes that the new device would not be used in every trauma case. "People are always finding new and inventive ways to injure themselves, but this balloon is useful in victims of car accidents who may suffer massive ... internal vascular injuries or pelvic injuries and then the other group of folks that we might sometimes use this on would be victims of violent crime" -- shootings and stabbings.

Bleeding in the pelvis can be difficult or impossible to stop, because the area often cannot be compressed enough.

People with massive pelvic injuries, like Williams, are ideal candidates for REBOA, surgeons say. When the body is hit hard enough to break the pelvis, the impact almost always shears or severs hundreds of tiny veins and arteries that bleed profusely.

Abdominal bleeding can also be stopped with the device, if it is pushed higher into the aorta.

The balloon almost certainly saved Williams' life, Bukur said. With her circulation cut off, he was able to pack the damaged area with gauze to prevent more bleeding after the balloon was deflated. Another surgeon removed Williams' spleen, which had ruptured and was also bleeding copiously.

126 SAVES IN 1,000 USES

Nearly a month later, Williams and her mother, Elaine, were stunned to learn that a plastic tube with a balloon on it had played a crucial role in saving her. She is recovering in a rehabilitation hospital. It will be months before she can walk again, and she has missed her prom. She has no memory of being hit by the car.

"I'm kind of happy I don't remember," she said. "I can focus on getting better and taking it one day at a time."

Spencer said that the device had been used more than 1,000 times, and that 126 of those patients were known to have survived.

One case, at the University of California, Davis Medical Center, involved a pregnant woman at high risk of bleeding to death from a placental abnormality. A Jehovah's Witness, she could not accept blood transfusions. Using the balloon helped doctors perform a cesarean section that saved her and the baby.

At a REBOA training course in June for about 50 trauma surgeons from the New York area, Teperman introduced a surprise guest: Nanetta Hall. Hall, 60, a manager in the city's Human Resources Administration, was run over by a pickup truck in February. As with Williams, she nearly died from internal hemorrhaging caused by pelvic injuries.

A Jacobi team led by trauma surgeon Dr. Edward Chao used the ER-REBOA to save her -- the first time the device was used on a person in New York.

With a walker, she made her way slowly to the front of the auditorium to address the doctors. "Please, please, take this seriously," she said. "And let the word be spread to everybody that this is a vital procedure that should be taught."

Without it, she said, she would have died. Instead, she was looking forward to going home.

Celia Storey added information to this report.

ActiveStyle on 06/26/2017

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