The last presentation I attended at the Napa Pain Conference was Dr. Michael Saulino’s Optimizing Outcomes with Intrathecal Baclofen Therapy. Dr. Saulino is widely known in the interventional pain and rehabilitation arenas. He is a very reputable individual, and he has a great personality … and I enjoy my interactions with fellow The Godfather movies aficionados.
During his discussion of intrathecal baclofen therapy, the doctor reviewed complex interactions between five factors: 1) the patient, 2) the clinician, 3) the device, 4) the agent, and 5) the disease (illness). Intrathecal baclofen (ITB) therapy is approved for severe spasticity of spinal and cerebral origin, and spasticity is defined as the velocity dependent resistance to the passive range of motion. Therefore, ITB is approved for spinal cord injuries, multiple sclerosis, cerebral palsy, strokes, and traumatic brain injury. Other potential opportunities for utilizing ITB are for hereditary spastic paresis conditions, transverse myelitis, and various dystonias.
One thing that can cause problems with increased muscle tone can be related to noxious stimuli, so Dr. Saulino examined areas where a previously stable patient begins to experience increased tone of an unknown origin. He expressed that searching for the driving force that is causing this increased tone can be a daunting task; but potential noxious stimuli in one area could be urinary in origin — whether that be an infection, stones, or distension. However, according to the doctor, there are also dermatological considerations (such as decubiti or surgical incisions or burns), neurological issues (such as hydrocephalus), pulmonary considerations (such as pneumonia or coughing), or some medications (such as Selective Serotonin Reuptake Inhibitors — SSRIs) that can affect, or can become, noxious stimuli. And, lastly, he indicated the usual sunburns, bee stings, or maybe the development of cancer that contribute as well.
Traditionally, there have been considerations that affect ITB therapy — including catheter tip location and dosing. Bernards, et al., demonstrated enhanced distribution of ITB away from the catheter tip in animal models; by using a lower concentration, you are administering a higher volume infused, thus achieving a greater clinical effect. I have discussed CSF flow, drug distribution, and volume infused in previous discussions; and I was happy to see Dr. Saulino reiterate these studies that illustrate the benefits of higher volume infusion.
Dr. Saulino presented another study by Chiodo, et al. that demonstrated improved spasticity control in a small case series with lower ITB concentrations — something I found to be of interest. He reviewed available ITB products; specifically Intrathecal Lioresal (an FDA-approved medication by Medtronic), Gablofen (an FDA-approved product by CNS Therapeutics), and compounded baclofen provided by compounding pharmacies. He indicated that these three agents may elicit different responses in patients; which needs to be taken into consideration while treating patients with ITB.
Dr. Saulino discussed device programming options; including: 1) Simple Continuous — a uniform delivery over a 24-hour period, 2) Complex Continuous (or Variable) — different doses within a 24-hour period, 3) Periodic Bolus — single bolus doses over a 24-hour period, and 4) Patient Directed Bolus — a patient-controlled management therapy. Complications with device delivery can sometimes arise due to battery failure or an empty reservoir. Other complications can come from catheter kinks, holes, or blockage. The doctor spoke of a very interesting concept that I had never heard of called “catheter microfractures.” He showed an electron microscopic image of a catheter and examined microfractures affecting the distribution of baclofen once in the intrathecal space.
Dr. Saulino delved into the methods for detecting catheter problems — specifically performing CT myelograms via the side port. He addressed the issue of removing two milliliters of fluid from the side port and then injecting 2-3 mLs of isotonic contrast to visually observe any disruptions or fractures within the catheter. He presented some great radiographs utilizing contrast showing catheter problems.
This presentation made it evident that there is a lot going on to optimize Baclofen therapy within patients. It was a great presentation, and I feel, again, that my knowledge has been enhanced upon viewing and listening to the doctor.
For more conference recaps, visit our Knowledge Center by clicking here.