St. Vincent’s East cath lab this month began using a potentially revolutionary device – developed and manufactured in Alabama – to shield doctors and technicians from the harmful effects of repeated radiation exposure.
And it could have a host of applications beyond helping vascular surgeons and their teams, which is what it was originally designed to do.
“This is about protecting the people who do this very important work,” said Tom Livingston, the president and COO of Rampart IC, based in Hardware Park.
The Rampart M1128, or Rampart for short, is a device using lead infused acrylic panels suspended above the patients to protect the medical team in the room during catheterization procedures.
The best way to describe the device is to illustrate how it was created.
Robert Foster is an interventional cardiologist who has been practicing at St. Vincent’s East since 1997. Over that time, he has performed thousands of interventional procedures on patients to find blockages around their hearts and in leg arteries. The procedures involve using X-rays to visualize where the blockages are. During some procedures, Foster then uses several means – lasers, scrapers, balloons, sanders, stents – to remove the blockages. The procedures can take anywhere from 20 minutes to several hours.
But because they involve radiation, doctors and technicians must wear heavy lead protective aprons to reduce repeated exposure to radiation. As Livingston explained, those engaged in interventional cardiology are typically exposed to three times the amount of radiation as a nuclear power plant worker over the course of their careers. Techs and physicians wear lead glasses but are about six times as likely to develop cataracts. Others are diagnosed with skin cancer lesions on their arms. Risks include hypertension and reproductive issues.
But outside of those risk, there are others.
“For my first 15 years, I was in the lab eight to 10 hours a day, three days a week, wearing about 20 to 30 pounds of lead,” Foster said.
That kind of long-term wear and tear on the body leads to cumulative back trauma. As many as 60 percent of those working in the cath lab experience back pain after 20 years, Foster said. Even though he stayed in shape, over the past five years he has ruptured two discs, on one occasion experiencing a temporarily paralyzed leg.
“But I got into this business to help people,” Foster said. That meant cutting down his schedule to about 500 to 600 of the procedures each year, with teaching sessions.
There are options beyond the heavy lead apron, but they have draw backs. There are lighter weight aprons that don’t offer as much protection. There is also a “zero gravity” device that is suspended from a large mobile platform, but it involves heavy equipment. Foster said it made his back hurt worse. And the arms and head of those wearing the aprons goes unprotected.
Foster and Livingston, however, thought there might be another way.
“How do we get this guy, who is extremely passionate about what he does, back to doing it at a very high level?” he said. “How do we get the weight off the physician? It literally started with a sketch on a napkin about five years ago.”
What resulted was the Rampart, which takes its name from the defensive fortifications around a city. But it can also mean to fortify, which was the motivating idea.
The solution was to transfer the weight of the protection from the physician to a support structure and the floor. The Rampart is made with see-thru lead infused acrylic, which can contain most of the radiation around the patient area. It uses a mobile base, which means there’s no need for any construction costs. The radiation is focused on the area being scanned, and the physicians and technicians are protected from the radiation “scatter” behind the Rampart. The patient experiences no change in radiation, Livingston said.
Rampart IC was aided in the development by Push Product Design and Fitz-Thors Engineering. It took about two-and-a-half years to develop a model, then another two years of testing before a production model was available.
The Rampart was tested over the last year-and-a-half with feedback provided by physicians, engineers and physicists. Livingston said. Over the course of a year, the Rampart exposes high volume medical staff in cath labs to less than a tenth of the maximum recommended radiation exposure they might ordinarily get using aprons.
Foster said there’s another benefit. A long day wearing an apron can tax not only the body, but a surgeon’s effectiveness.
“You need to be on your game,” he said. “And you can’t take a break during a procedure. Once you’re in, you’re in. This allows us to move around, allows you to stay sharp. And this can be great for teaching facilities. It’s easy to use.”
Livingston said deciding to use the Rampart is a significant commitment by St. Vincent’s and Ascension Healthcare, showing they are committed to the lab team’s safety and comfort.
“These are not cheap,” he said. “They are investing in their physicians and their teams in a very significant way. St. Vincent’s East and Ascension clearly want to lead the way. ”