A coalition of neurovascular medical specialties has outlined a set of training and credentialing standards for performing carotid stenting that goes far beyond those released by interventional cardiologists and vascular surgeons.
The guidelines were developed by the American Academy of Neurology, the American Association of Neurological Surgeons, the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, the Congress of Neurological Surgeons, and others. They were simultaneously published in several medical journals.
These standards come at a critical time, said Anthony Furlan, M.D., a neurologist who helped develop the guidelines, since the Food and Drug Administration recently approved the Guidant Rx ACCULINK carotid stent and issued conditional approval to Cordis Corp.'s PRECISE OTW Nitinol Self-Expanding Stent.
And officials at the Centers for Medicare and Medicaid Services are poised to allow coverage for carotid stenting outside of clinical trials in patients who would be high-risk candidates for endarterectomy and who have symptomatic carotid artery stenosis of at least 70%.
“Our role here is to provide guidance to credentialing committees,” said Dr. Furlan, who serves on the American Academy of Neurology's Stroke Systems Task Force and heads the section of stroke and neurologic intensive care at the Cleveland Clinic Foundation.
The new standards are also an attempt to combine the broad knowledge of the neurological communities, said John J. Connors III, M.D., director of interventional neuroradiology at Baptist Hospital of Miami. “With the potential for so many different specialties to be performing carotid stenting, these standards are an opportunity to provide quality assurance based on the collective knowledge of experts in the fields of the neurological sciences,” Dr. Connors said in an interview.
“Many physicians may be experts in one area, but with carotid stenting they need to have a basic fund of knowledge in addition to being masters of a variety of skills,” he said. Importantly, a basic knowledge of the brain is required, he said. The neurovascular guidelines call for any physician performing carotid stenting to have had a minimum of 6 months of formal training approved by the Accreditation Council for Graduate Medical Education (ACGME) in at least one of the neurosciences.
In addition, before beginning postgraduate training in cervicocerebral interventional procedures, physicians must be appropriately trained in and must competently complete at least 100 diagnostic cervicocerebral angiograms.
Under these standards, many physicians would need to engage in additional training in order to achieve competency in these procedures, Dr. Connors said. But he noted that even these guidelines are a low bar considering that the potential adverse outcomes in carotid stenting are stroke and death.
The Neurovascular Coalition guidelines are aimed at creating a minimal standard for training in these procedures, Dr. Connors said, but they aren't aimed at locking any specialties out of the field.
However, Dr. Connors said he is concerned that guidelines developed jointly by the Society for Cardiovascular Angiography and Interventions, the Society for Vascular Medicine and Biology, and the Society for Vascular Surgery (SCAI/SVMB/SVS) do not require sufficient training.
For example, the SCAI/SVMB/SVS guidelines released call for physicians to perform a minimum of 30 diagnostic carotid angiograms and 25 carotid-stenting procedures in order to attain competence in carotid stenting. “This is exactly one-tenth of the training required for coronary artery stenting,” Dr. Connors said.
But Dr. William A. Gray, M.D., director of endovascular care at the Swedish Heart Institute in Seattle and one of the authors of the SCAI/SVMB/SVS guidelines, does not agree that performing 100 angiograms is necessary to show proficiency. In fact, he sees that requirement as a bit excessive.
“We look at this as a potential barrier to entry for otherwise qualified operators,” Dr. Gray said in an interview. Instead, the threshold of 30 diagnostic angiograms is consistent with the experience of many cardiologists who have been working in the field for years, and with the experience of operators in the recently completed carotid stent trials.
Dr. Gray said he respects the work that went into the neurovascular document, but believes the guidelines developed by the interventional cardiologists and vascular surgeons are a better reflection of the reality of performing carotid stenting and its program development.
Another concern is the requirement for physicians to complete 100 angiograms could lead to some unnecessary procedures, said Kenneth Rosenfield, M.D., of Massachusetts General Hospital in Boston and an author of the SCAI guidelines.
With the need for diagnostic angiograms declining, some physicians might be inclined to perform the procedure just to satisfy the requirements for performing carotid artery stenting, he said.