Techniques and Technology in Medicine

"[It -- a balloon catheter -- was] really designed to be used in nice surgery centers, with well-staffed, fancy operating rooms."
"[The] golden hour [following an injury is the time when doctors and medics must react]. That's where the margin to save lives is greatest."
Dr. Todd E. Rasmussen, former surgeon deployed in Iraq

"None of that [conventional hospital procedure where the balloon catheter is used by vascular surgeons] translates well into when all hell is breaking loose [in a war zone] and your patient is going to die in seven minutes."
David Spencer, president, Prytime Medical, ER-Reboa manufacturer

ER-REBOA Catheter for Emergency Occlusion of Aorta

Necessity, those steeped in the wisdom of the ages intone, is the mother of invention. And when Drs. Todd E. Rasmussen and Jonathan L. Eliason were desperate to save the lives of U.S. military members fighting in Iraq in 2006, they had the use of improved tourniquets and transfusion techniques to prevent their military patients from bleeding to death from catastrophic limb wounds as byproducts of battlefield action.

However, those advanced techniques did nothing whatever to help in emergencies like extreme bleeding in the abdomen or the pelvic area. They were vascular surgeons, and began work on the development of a new device to fill that obvious gap. Using the old device of a surgical-room balloon catheter as a guide, one whose design was specific to bleeding prevention in patients undergoing surgery on the aorta, they perfected their own device which they named the ER-Reboa.

It is now being used in some hospitals, gaining ground as its reputation is on the rise as a more reliable medical tool  than the older, larger, device requiring to be guided by X-rays. At NYC Health & Hospitals/Jacobi in New York City, director of Trauma and Critical Care Services Dr. Sheldon H. Teperman and vascular surgeon Dr. Aksim G. Rivera have been tutoring trauma surgeons in the use of this new device.

A woman, 60 years of age, had been hit and run over by a pickup truck, sustaining internal injuries so dire she almost died from internal hemorrhaging resulting from severe pelvic injuries. She was the first patient in the city that the new device was used for, by a Jacobi team. And her life was spared. In May, a high school student suffering internal hemorrhaging as a victim of a deliberate vehicle mow-down by a terrorist in Times Square, recovered thanks to the device, when transfusions failed to restore the equilibrium of blood loss.

The student had emerged from the attack with severe injuries to her legs, abdomen and pelvis. Her pulse skyrocketed, her blood pressure plunged. "She was about to go into cardiac arrest", noted trauma surgeon Dr. Marko Bukur. He immediately reached for an ER-Reboa catheter, punctured the student's thigh to thread a slim tube through her femoral artery then on to her aorta, the major artery carrying blood from heart to body. Injecting salt water, a balloon was inflated to block the aorta, cutting off circulation to pelvis and legs.

While above the balloon, blood flowed as it normally would to her brain, her heart, lungs and other organs. Reactively, her blood pressure rose, her heart showed down as the balloon halted the internal pelvic hemorrhaging. The resuscitative endovascular balloon occlusion of the aorta (Reboa) had done its work as it was meant to, as an "internal tourniquet". Dr. Bukur packed the damage area with gauze once the balloon was deflated, while another surgeon removed the student's ruptured spleen, her life saved.

The two former military surgeons had succeeded in creating a smaller, stripped-down version of the complex, large and awkward-to-use outside a well-equipped hospital operating theatre, one that could be manoeuvred swiftly into the aorta without the use of guiding X-rays, by general surgeons, emergency room doctors and even medics, since the last two represent those who are generally the first responders reaching people who are bleeding to death.

Engineer, Heal Thyself

"I'm just a curious individual. Since I could walk, I've had a screwdriver and a spanner in my hand I'm an engineer. My whole life has been spent asking the question, 'How do we improve this?' Is there a better way?"
"My example is pretty extreme, but it makes the point that pretty much every patient can make a contribution to the health-care system. Even the least intellectually competent of us can say, 'I don't like how that doctor treated me' or 'I found that form difficult to fill in'. If you get that feedback, you can improve things."
"I thought to myself, 'This is an engineering problem'. I asked [the surgeon], 'Why aren't we scanning the aorta. CAD-modelling it, then rapid-prototyping a model and using that to make a support? He just said, 'What?'!"
"I'd love to say I did this for philanthropic reasons, but that would be total crap. I was terrified. For me, it was about self-preservation."
"It was incredible to meet a surgeon who was actually prepared to admit there were things about his job that he didn't know."
"I didn't think I did have the solution. I don't think I have the arrogance and the ego. I just thought, 'Holy s---, I've got to do something'."
Tal Golesworthy, British Chemical Engineer

Tal Goldsworthy invented the device that saved his own life.  Darren Brown / Postmedia

He was terrified and he was desperate to 'do something' with his chemical engineering background, to come up with a solution that would negate the necessity for him to have open-heart surgery to correct a condition he was born with. Tal Golesworthy was born with Marfan syndrome, an inherited disorder of the body's connective tissue. That disorder had the potential to stretch and rupture his aorta. He knew, throughout his life, that sooner or later he would be faced with his condition turned desperate.

He had become accustomed to submitting to regular scans of his heart for the purpose of measuring the amount his aorta was stretching as a result of Marfan syndrome. Scans indicated in 2004 that the situation was reaching a level clearly dangerous to his longevity. A cardiologist was consulted to find out what could be done about his condition. Open-heart surgery was the response, a radical procedure once rare, now commonplace for heart bypasses and valve replacement, for example.

The details of the procedure caused his heart to literally palpitate with fear. His body temperature would be drastically lowered to 18C while he would be connected to a cardiopulmonary bypass machine and his heart stopped. Breathing tubes would be plunged down his throat. A surgery that would take hours would ensue. Recovery would take months. And afterward, he would need to take blood thinners to ensure that a blood clot wouldn't develop to cause a stroke.

(This is simplified, of course. And it's just as well to remember that aspirin is a blood-thinner and millions take aspirin in small doses daily as a heart attack and stroke preventive.)

So Mr. Golesworthy's brain went into overdrive, and he spoke to the surgeon of potential alternatives, a treatment that would bypass the need for that open-heart surgery. Private investors such as friends helped to fund his research and he underwent 30 hours of MRI scans to fine-tune mapping techniques. A computer-aided design professional helped to create a "bespoke" computer model, used to create a plastic copy of his aorta. That copy was used as a platform to tailor a woven, lightweight synthetic mesh that doctors could secure his aorta with, by wrapping it with the mesh.

The result was his invention, ExoVase, to reinforce the aortic artery. It has, to date, been used in six countries; the United Kingdom, Belgium, Poland and New Zealand. The U.S. Food and Drug Administration has placed the device on its study list which could eventually result in its acceptance for use in North America. So far, 80 patients have received his invention. One of them a boy of eleven. Unfortunately, one patient died post-surgery as a result of the surgeon inadvertently cutting an artery during the operation.

As for Mr. Golesworthy, his own aorta now is stable enough that he's been able to put a halt to the annual scan meant to measure its diameter. And he was a guest speaker at a conference called Strategy for Patient-Oriented Research, hosted by the Canadian Institutes of Health Research, meant to examine how doctors and the health-care system, by listening to ideas and responses from the patients they serve, can improve their protocols and outcomes.