No Data to Support Asleep DBA is As Safe and Effective As Awake DBS
By Sierra Farris, MA, MPAS, PA-C
Reprinted with permission of the author
In an age when patients demand solid evidence for any conventional therapy, DBS performed while under general anesthesia (asleep) has escaped the critical appraisal of the evidence from the patient community, referring physicians and hospital systems. This post addresses a local movement in DBS that has gained momentum from intensive direct to patient marketing. Patients are provided a compelling one-sided view without the scientific evidence and the results have varied significantly when compared to standard DBS practices.
The questions which we do not have answers but need to be asked:
- If a proven technique is eliminated during DBS surgery, will results be compromised in the long-term?
- Should any surgeon adopt and perform asleep DBS without oversight?
- Will recovery from surgery be more difficult due to the use of general anesthesia?
- Do we have sufficient brain imaging to provide the accuracy needed for at least average results?
- Will insurance pay for correcting problems when a procedure is experimental (off-label)?
- Who will monitor the results, complications and unexpected problems when asleep DBS is not performed with regulatory oversight?
- Where can patients turn if suffering from a poor result after asleep DBS?
- What is the impact on the brain to undergo more brain surgery if the first attempt fails?
- If an unregulated procedure (asleep DBS) is being tested on patients, will confidence in the therapy be compromised for future patients, referring physicians or insurance payers?
- Who pays the ultimate price when signing up for an experimental technique when not in a research trial?
11. Should community hospitals allow a new surgical technique to be adopted and marketed that is off-label (not approved by the FDA)?
- Should surgeons gain access to devices that are to be used off-label?
The FDA has approved DBS to be implanted while awake when neurological testing confirms benefit without intolerable side effects. DBS is just like any medical therapy that must undergo extensive safety and efficacy testing before offering to patients. Without the research to gain FDA approval, asleep DBS is considered experimental. DBS is invasive brain surgery that can have serious complications. However, patients are signing up for this experimental brain surgery technique without the medical evidence or FDA oversight. The bottom line: asleep DBS has not met this basic standard of critical analysis by the medical community or the FDA to protect patients from false claims or required reporting of results and complications.
How is awake DBS different from asleep DBS?
The FDA has based approval for DBS on the extensive research performed while awake. The “awake part” involves waking the patient and testing the stimulation during the surgery. This provides the medical team and the patient with immediate indicators that the DBS probe is in a position to provide symptom improvement without intolerable side effects. When a person’s brain physiology is a little different, the probe placement can be customized to fit each individual during surgery. This gives the patient and the medical team the highest confidence that DBS should work when the stimulation is turned on in the clinic. Patients are only awake long enough to do the exam testing. There is little to no pain involved and the patient provides highly valuable feedback while stimulation is being tested in the operating room. Awake DBS requires expertise and collaboration from the neurology and surgical clinician that the DBS probe is in the best position in the brain to offer the greatest result without side effects. Awake DBS does not require general anesthesia as the patient is given an intravenous sedative.
Asleep DBS requires less time from the surgeon; eliminates the need for neurology expertise and collaboration during the surgery; requires high resolution MRI scanning services for the lowest error in targeting; eliminates the need for equipment to map the brain target. Asleep DBS requires the patient to be under general anesthesia.
Will asleep DBS be the way of the future?
Asleep DBS has been done for many years when patients cannot be awake due to safety (ie: severe dystonia). Fortunately, university DBS teams are in the process of studying the technique of placing the probe while the patient is under general anesthesia using high resolution MRI. These teams must prove that routinely using a new technique to place the DBS probe without testing is at least as good as our standard in DBS surgery. These teams are using MRI guided targeting by highly skilled neurosurgeons that have experienced teams to evaluate the immediate and long-term results.
Imaging may be the defining factor for great (or poor) results.
In DBS, millimeters matter substantially. For instance, a two millimeter deviation of the stimulation can mean the different between excellent, mediocre or poor results as well as intolerable side effects. DBS centers that strive for the greatest results will prefer high resolution MRI. Targeting using a CT scan has much more inherent error than using a MRI to guide probe placement and patients should be given this disclaimer that imaging techniques incur errors that may impact the actual probe placement. As of yet, there is no imaging technique that is without some degree of error with CT being the least accurate to visualize brain structures.
Does physiology matter with DBS?
The answer depends on who you ask. How the brain behaves is called physiology. When applying stimulation, we expect a specific behavior – improvement in certain symptoms. DBS success is founded on stimulating a specific area in the brain that is located while testing the brain. Assessing brain physiology requires expertise and experience and is a much more sophisticated task than identifying brain structures on MRI. Whether physiology (obtained during awake testing) is critical to results is unknown but does provide substantially more information about the uniqueness of a person’s brain and behavior during stimulation. We do not know if visualizing a spot within a brain structure is equal to that areas ultimate behavior when stimulated.
Why rush an unproven surgical technique before the research is done?
Novel techniques are generally spearheaded by highly respected researchers that have experience and teams to do the work necessary to prove a new technique is appropriate to use on patients. Promoting a new technique can increase the number of surgeries performed; produce enticing marketing claims; personal gain, beat the competition, satisfy quotas...
Why bother to speak up?
The emergent concern for asleep DBS is the unchecked impact on people with Parkinson’s and open yet blind acceptance for an experimental brain surgery. There may be testimonials that asleep DBS worked yet personal stories do not meet the evidence we should demand when sending patients to brain surgery. In my experience, patients that have poor results from DBS are less likely to seek help and become isolated or even embarrassed that DBS didn't work. People with Parkinson’s have a life-time of symptoms to deal with and deserve more than unproven marketing claims. The risk of mediocre DBS is not justified when there is an alternative proven technique that offers a long track record of success. Until the research is done and the long-term results are known, the procedure is experimental and there is presently no comparative data to debate. One area of clinic debate is whether to skip the research step and offer asleep DBS when the person down the street is intensely promoting it as the latest and greatest technique. From my perspective, the interest of the patient supersedes adopting an experimental technique that has a proven alternative. The debate should be whether asleep DBS brain surgery should be allowed to continue in the absence of the research and oversight that other medical procedures endure.
A patient's spouse asked recently why take the risk of speaking out. Although it is not without professional consequences to persist in speaking out against the funding support, marketing and adoption of a technique in my community, my perseverance is fueled by my alarming experience thus far with self-referred patients and the struggle to improve their poor and in some cases devastating results after asleep DBS - people with Parkinson's need to know.
About the Author:
Sierra Farris is a board certified physician assistant specialized in movement disorders and deep brain stimulation. Ms. Farris has significant experience with all aspects of DBS therapy including a special interest in DBS research and investigating DBS problems. Ms. Farris is co-owner and Director of DBS Services at the Movement & Neuroperformance Center located in Englewood Colorado. Sierra works alongside Dr. Monique Giroux and assists in neurosurgery during DBS surgery performed at Swedish Hospital in Englewood Colorado. (www.centerformovement.org) Ms. Farris is an author, researcher, bioethicist, physician assistant, teacher and mountaineer. Sierra's experience in DBS since 2000 puts her at the top of her field as an expert in deep brain stimulation therapy.