Counter-hemorrhaging medical device saves service members’ lives

Counter-hemorrhaging medical device saves service members’ lives

BETHESDA, Md., July 17, 2017 — Born out of necessity on the battlefield, a new medical device is buying vital time for critically wounded patients in combat and in emergency care environments worldwide.

The device, known as a resuscitative endovascular balloon occlusion of the aorta, or ER-REBOA, was developed by Air Force Col. (Dr.) Todd Rasmussen, the associate dean for clinical research at the Uniformed Services University of the Health Sciences here, and Dr. Jonathan Eliason, associate professor of Vascular Surgery at the University of Michigan. The “ER” stands for “Eliason” and “Rasmussen.”

From 2004-2007, the two surgeons were assigned together at Lackland Air Force Base in San Antonio and served tours at the military’s level III surgical hospital in Balad, Iraq. During their deployments, they both frequently saw combat trauma patients with critical injuries to the abdomen and pelvis — areas where it can be nearly impossible to control hemorrhaging to save a patient’s life.

While tourniquets helped prevent service members from bleeding to death from wounds to their arms and legs, nothing existed for this part of the body. There was an urgent need for a solution, Rasmussen said, and he was sure there had to be a better way to help these patients.

Rasmussen said he and Eliason put their heads together and came up with an approach that wasn’t particularly new. Their idea was similar to the concept of a common endovascular procedure, cardiac catheterization, which is used to help treat a blocked artery or an aneurysm by threading a catheter through a small incision in the groin and up through a vein or artery.

Controlling Bleeding

The two surgeons contrived a catheter with a small balloon at the end, which is inserted through a two- to three-millimeter incision near the groin and guided up through the femoral artery into the aorta. The balloon is then positioned at the desired level of the aorta and inflated with saline, blocking the aorta and cutting off circulation to the legs and pelvis, while still allowing blood to flow normally to the brain, heart, lungs and other vital organs.

This creates what could be described as an “internal tourniquet,” Rasmussen said and helps temporarily stop severe blood loss in the pelvic and abdominal area. This can allow a patient to stabilize as they begin to receive blood products and are transported to a higher level of trauma care — buying them critical time that they might not have had without the device.

“We had the vision for it, and we knew the elements of this approach worked very effectively for certain vascular disease conditions such as coronary artery disease and ruptured aortic aneurysms,” Rasmussen said.

In the following years, the surgeons were able to pair up with an entrepreneurial company that helped them create a more refined prototype. With the prototype, they conducted further research, producing data to demonstrate the device’s effectiveness, which led to it ultimately being patented jointly by the Defense Department and the University of Michigan.

Worldwide Use of Device

The device received Food and Drug Administration approval in November 2015. It’s become commercialized, and for the past year has not only been used in combat, but also in emergency and critical care environments worldwide. Bringing this to fruition has been a long and exciting journey but, Rasmussen said, their work is not yet complete.

The next steps are to continue researching the device’s effectiveness, explained Eliason, who retired from the military in 2007 and has since worked as a vascular surgeon at the University of Michigan. Today, the two doctors are conducting clinical studies to help determine which patients the device should be used on, which practitioners are best suited to administer it, when, and for how long. Like a regular tourniquet, Eliason said, the device cannot be left on permanently as that can cause damage, so it’s important to determine these factors.

Down the road, Rasmussen said he sees the device making an impact not only for trauma patients who are hemorrhaging but also in post-partum hemorrhaging, during complicated pregnancies, to potentially help save a mother’s life during delivery. The device could also help save lives from a heart attack or cardiac arrest, possibly if used in conjunction with CPR, he added.

“We’re very excited about the potential of this technology,” Rasmussen said.

He credits the efforts of the entire team that worked to help make this possible, including DoD, the University of Michigan and the entrepreneurial private sector.

Rasmussen said the project also has been rewarding in a different way.

Aiding Patients

“It allows us to develop a technology that can potentially help hundreds of patients,” said Rasmussen, noting he’s heard from doctors around the world who are interested in using the device.

“That’s very gratifying on a different level,” he said, adding it’s rewarding to be part of something that may give providers a tool they can use effectively. Trying to save a patient who is losing significant amounts of blood, while looking for ways to control the blood loss, is very difficult, he said.

“I know that personally,” Rasmussen added.

Air Force Maj. (Dr.) Justin Manley also knows first-hand what it’s like to be in such a situation. In July 2016, while deployed as a general surgeon in support of operations in the Middle East, he faced a similar situation receiving a patient in near cardiovascular collapse, which is almost always fatal. He quickly made the decision to use the device, becoming the first surgeon to use it while in a combat setting. As a result of his actions, the patient survived.

“We were very excited to have the opportunity to be able to use the device because we understood its potential,” said Manley, who is assigned to a Special Operations Surgical Team in the 720th Operations Support Squadron at Hurlburt Field, Florida. SOSTs deploy far forward into hostile or austere areas to perform life-saving surgeries with little to no support from medical facilities or systems.

During that 2016 deployment, Manley said he and his team used the device four times. All four patients faced cardiovascular collapse and with the device, all four successfully made it through the operation to the next level of care, he said. Since then, the device has been used three more times on subsequent deployments by SOSTs, with the same effect.

It’s remarkable to have an opportunity to give patients another chance at life, Manley said.

Eliason shared the same sentiments.

“If this can save one life, then it will be worth it,” he said.

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