Inspired by War Zones, Balloon Device May Save Civilians From Fatal Blood Loss

A high school senior mowed down by a car with other pedestrians in last month’s Times Square attack was hemorrhaging internally and transfusions could not keep up with the blood loss.

Doctors and nurses at NYC Health & Hospitals/Bellevue raced to save the student, Jessica Williams of Dunellen, N.J., who suffered severe injuries to her legs, abdomen and pelvis. But 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 ever 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 and has recently been used by the military. But medical teams need rigorous training to use it: Mishandled, it can be dangerous.

Dr. Bukur punctured Ms. Williams’s 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 Ms. Williams’s pelvis and legs. Above the balloon, blood still 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 like turning off a faucet. Reboa stands for resuscitative endovascular balloon occlusion of the aorta, but some doctors describe it simply as an “internal tourniquet.”

The clock was ticking. 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 Ms. Williams’s legs and internal organs. 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 Ms. Williams on the verge of bleeding to death.

In New York City, 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 at city hospitals and other medical centers in the area. Bellevue surgeons trained with them.

A Jacobi team led by the trauma surgeon Dr. Edward Chao was the first in the city to use the ER-Reboa, in February. Their patient, Nanetta Hall, 60, a manager in the city’s Human Resources Administration, had been run over by a pickup truck. Like Ms. Williams, she nearly died from internal hemorrhaging caused by pelvic injuries.

“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,” Dr. 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.

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 Dr. 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.

Dr. Rasmussen and Dr. 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, Dr. Rasmussen said, adding, “That’s where the margin to save lives is greatest.”

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

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

After a talk Dr. Rasmussen gave in 2009 that mentioned the lack of commercial interest in military medical research, Mr. 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, Mr. 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, Dr. Rasmussen said, and he makes no money from it.

People with pelvic injuries, like Ms. Williams and Ms. Hall, are ideal candidates for Reboa, surgeons say. Those injuries are a notorious cause of life-threatening hemorrhage. 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. Bleeding in the pelvis can be difficult or impossible to stop, because the area often cannot be compressed enough.

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

The balloon almost certainly saved Ms. Williams’s life, Dr. 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 Ms. Williams’s spleen, which had ruptured and was also bleeding copiously.

Nearly a month later, Ms. 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 one of the city’s rehabilitation hospitals. It will be months before she can walk again. She has no memory of being hit by the car that killed another person and injured 22 on May 18.

“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.”

She missed her high school prom, but was planning to watch her classmates graduate remotely.

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

“We’re conservative on claiming it saved someone,” he said.

The device may prevent accident victims from bleeding to death, but they may have head injuries or organ damage that turn out to be fatal.

“Reboa is not the second coming of Jesus Christ,” Mr. Spencer said. “It is not going to miraculously save someone on a motorcycle who hit a car going 80 miles an hour. But it gives the surgeons a chance where maybe there wasn’t a chance before.”

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 both her and the baby.

At a Reboa training course last week for about 50 trauma surgeons from the New York region, Dr. Teperman introduced a surprise guest: Nanetta Hall. Injured in February, she was just about to be released from a rehabilitation hospital. With a walker, she made her way slowly to the front of the auditorium to address the doctors. Without the Reboa procedure, she said, she almost certainly would not have survived.

Mr. Spencer, from Prytime, had just described a soldier’s death that had driven the military surgeons to create ER-Reboa. Gesturing to Ms. Hall, he said, “Because that man died, this lady is alive.”

Addressing the doctors, Ms. Hall said: “Please, please, take this seriously. And let the word be spread to everybody that this is a vital procedure that should be taught.”

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