An FDA-approved device used during heart procedures cut radiation exposure for cardiologists, nurses, and other medical staff in half, according to a study conducted by Southfield-based Beaumont Health.
The study results were announced Nov. 5 at the Cardiovascular Research Foundation’s TCT conference in Orlando, one of the largest educational gatherings of interventional cardiologists in the world.
The ControlRad device is one of two radiation-control mechanisms currently used at Beaumont Hospital, Royal Oak.
“For medical team members doing cath lab procedures, radiation exposure over days, weeks, and years is a serious health concern as they take care of patients,” says Dr. Simon Dixon, chairman of the Department of Cardiovascular Medicine at Beaumont Hospital, Royal Oak, and the Dorothy Susan Timmis, endowed chair of cardiology, who presented the study results at TCT. “Mitigating that exposure can help reduce health care workers’ higher incidence of cancer and cataracts over their lifetime.”
Radiation exposure in the cath lab can lead to a higher risk of head and neck cancers and cataracts. Heavy, lead-lined aprons worn in the cath lab to protect against radiation also can lead to chronic back issues for busy cardiologists and their staff.
As cardiologists and their teams unblock blood vessels, insert heart valves, and perform other cardiac procedures, the imaging x-ray equipment they use to peer into the body during the procedure emits radiation. The issue of radiation exposure is so critical that federal guidelines require cath lab workers to wear radiation-detecting badges to monitor their exposure — and stop doing procedures if they reach a certain threshold that puts them at higher risk for medical issues.
The ControlRad device, approved for commercial cath lab use by the FDA in December 2020, is retrofitted to x-ray equipment in the catheterization lab. It creates a type of aperture, much like the aperture that controls the viewing area of a camera. By using a touch pad, the cardiologist controls the aperture to narrow or widen the field of vision on the X-ray — and the amount of radiation used to produce it.
For the study, cath lab workers wore radiation-detecting badges near their thyroid and inside their lead apron during procedures. Another badge was placed on a wall inside the lab. The study detected a 55 percent to 57 percent decrease in radiation exposure at the thyroid position of the main cardiologist, or lead operator, and a 49 percent decrease in radiation exposure to the cardiologist assisting, or Operator 2. The badge on the wall detected a 38 percent decrease in radiation exposure.
“If a nurse or tech is standing at the wall, that’s a nearly 40 percent decrease in radiation exposure,” Dixon says. “Radiation exposure for the cardiologist is a real concern, but so is exposure for staff. Cath lab nurses, anesthesiologists, physician assistants, and others go into case after case as the doctors rotate. Protecting them is a real challenge.”
Staff at Beaumont Hospital, Royal Oak, also are studying another radiation protection device, the Protego barrier system. The Protego system places a barrier wall between the imaging equipment and the operator and staff. While it does not protect the patient from radiation during their singular procedure, it is designed to allow staff to work in the cath lab without wearing a heavy lead apron.
According to an abstract published in May 2021 in the peer-reviewed journal Cardiovascular Revascularization Medicine (CRM), a pre-clinical study of the system showed a 94 percent reduction in radiation throughout the cath lab, and a 97.8 percent to 99.8 percent reduction in radiation exposure for the main doctor, or primary operator.
“Years of working in the cath lab wearing a heavy lead apron has really affected my back, compressing it by more than an inch,” says Maher Rabah, director of the cardiac catheterization lab at Beaumont Hospital, Royal Oak. “He has been using the system as he unblocks vessels or stents blockages in percutaneous coronary interventions (PCI). Combined with the long-term effects of exposure to radiation, anything we can do to help limit issues for the medical staff is a step forward in providing compassionate, extraordinary care for all.”