ST. LOUIS–On July 6, world-renowned neurosurgeon Richard Bucholz, MD, led a team at SSM Health Saint Louis University Hospital in St. Louis, Mo., to perform deep brain stimulation (DBS) to treat obsessive compulsive disorder (OCD) for the first time in the Centers for Medicare & Medicaid Services’ (CMS) Region VII.
“The outcome of this test case for the region has been extremely gratifying,” said Bucholz, vice chairman in the department of neurosurgery and K. R. Smith Endowed Chair in Neurosurgery at Saint Louis University (SLU), of the middle-age male patient, housebound by the disorder and unresponsive to medication. “This patient is rejoining society, not exhibiting previous compulsions, and seems to be doing extremely well.”
In a DBS procedure, mostly known for treating Parkinson’s patients, specially-trained neurosurgeons implant tiny electrodes through dime-sized incisions into areas of the brain that control movement. In a second procedure, the electrodes are attached to an implanted generator that dispatches signals to the electrodes in the brain. Later, a neurologist programs the generator to determine the optimal setting for normalizing brain activity to alleviate tremors, stiffness, slowness, involuntary movements and gait problems.
“A tremor from Parkinson’s is an excess motor activity in the brain,” explained Bucholz. “Similarly, compulsions from OCD are excess thoughts in the brain. Suppressing those thoughts through DBS is very similar to what we’ve done for years in treating movement disorders.”
In 2009, the U.S. Food and Drug Administration (FDA) approved DBS for treating OCD. Last year, a group of experts published a clinical guideline in Neurosurgery, recommending DBS for cases of OCD unresponsive to medication.
“I wasn’t really surprised the FDA approved DBS for treating OCD because the benefits of intervention in this area have been well known for a long time,” said Bucholz. “Also, results from pilot studies in the few (U.S.) centers that have done this for several years have been quite remarkable. I was a bit surprised that Medtronic, the research sponsor, decided to put this out as a humanitarian device exception, a special way of releasing a product that can only be placed under research protocol and in approved centers, as opposed to a more general release.”
As a result of the special designation, Saint Louis University Hospital remains one of few academic centers in the nation allowed to perform DBS for OCD.
“We’ve been enrolled in the study for some time and set up a committee to review potential candidates for this procedure,” he said. “It’s taken us a while to come up with individuals with all the appropriate indications for intervention.”
Appropriate candidates are determined by refractoriness and incapacitation, said Bucholz, who at press time had additional cases scheduled by the end of September.
Whether the newly FDA-approved procedure will be covered by insurers has been highly debatable, said Bucholz.
“There’s never been a test case in the regional group that covers St. Louis to determine reimbursement,” he explained. “That’s proven a challenge. Other Medicare review groups for other geographic areas of the U.S. have demonstrated reimbursement for this intervention, given the suitability based on criteria. We’ll see whether this test case gets reimbursed.”
CMS Region VII covers Missouri, Kansas, Iowa and Nebraska.
Bucholz became world known for his invention of StealthStation, an image-guided navigational device to improve surgeons’ abilities to access the brain and navigate complex neural and vascular anatomy. Developed in his St. Louis garage in 1990, the platform was FDA-approved in 1996, the same year Medtronic acquired it. StealthStation, now in its seventh revision as the S7 Surgical Navigation System, is commonplace in operating rooms around the globe that routinely house cranial surgery.
“StealthStation is the necessary infrastructure to perform DBS very accurately, precisely, and safely,” he said. “This common instrument allows neurosurgeons to intervene in the brain with stimulators, viruses, tissues, implants … you name it.”
Among other innovations for Bucholz, a National Academy of Inventors (NAI) Fellow: a special collar that holds the patient's head throughout the procedure in a way that makes patients who are awake during surgery feel more at ease. The collar replaced the cumbersome frame used by some neurosurgeons.
Positive outcomes of DBS cases for OCD have opened the door to treating a variety of conditions in the burgeoning field of neuromodulation. Bucholz is working closely with a group to develop an implantable device to treat rheumatoid arthritis and Crohn’s disease through the use of a stimulator placed on a nerve. But potential DBS treatments of some conditions remain sidelined.
“For example, there’s extreme interest in using DBS for patients with debilitating depression, but controversy remains about where to place the electrode for maximum effect,” said Bucholz. “Two centers have proposed two different areas of the brain to stimulate, but for now, studies don’t support either location.”
Regardless of ongoing debates in medical circles about which conditions to treat with DBS, Bucholz said it offers milestone relief for OCD sufferers.
“We know the target of the brain and it’s working quite well,” he said. “The more we learn about the brain, the more we can think about intervening to reverse debilitating conditions. It’s a rewarding time to see DBS transform the way people can lead their lives.”
Bucholz is the SLUCare functional neurosurgeon who leads DBS surgery at SLU Hospital; SLUCare neurosurgeon Pratap Chand, MD, who specializes in movement disorders, collaborated on the landmark surgery. The SLUCare Physician Group team also includes Lauren Schwarz, MD, a neuropsychologist who works with patients considering DBS.
LINKS:
CMS Regions: https://www.cms.gov/medicare-coverage-database/staticpages/region-descriptions.aspx
Medtronic’s StealthStation: http://www.medtronic.com/for-healthcare-professionals/products-therapies/spinal/surgical-navigation-imaging/surgical-navigation-systems/systems-software-instruments/index.htm
SSM Health Saint Louis University Hospital: www.ssmhealth.com/sluhospital
SLUCare Physician Group/Deep Brain Stimulation: http://www.slu.edu/neurology-and-psychiatry-home/neurology/deep-brain-stimulation
