Training for the Intraspinal Drug Delivery System Reservoir Refill Procedure Highly Variable: A Nationwide Survey of Health Care Professionals.

OBJECTIVES: This study describes the training, experience with pocket fills, and life-long learning behaviors in a national sample of health care professionals who perform the reservoir refill procedure and compares results with intraspinal drug delivery morbidity and mortality clinical practice guidelines to demonstrate the need for standardized training. METHODS: Using a cross-sectional, descriptive design and a 23-item questionnaire administered via social media, 65 health care professionals who performed the reservoir refill procedure within the last year were surveyed. Descriptive and inferential statistics were used for analysis. RESULTS: Our results showed: 1) training varied widely and lacked supervision and mentoring for the inexperienced clinician, 2) the highest number of pocket fills was reported by the most experienced clinicians, and 3) there was limited participation in professional meetings where intraspinal therapy is discussed. The use of intraspinal drug delivery clinical practice guidelines significantly increased in current practice compared to use during training. CONCLUSION: Training for the reservoir refill procedure was highly variable, inconsistent with intraspinal drug delivery clinical practice guidelines' training recommendations with a high number of pocket fills, and low participation in national intraspinal drug delivery meetings. Standardized training is needed to reduce variability and minimize the risk for human error during the reservoir refill procedure.

Best practices for intrathecal drug delivery for pain.

OBJECTIVE: The objective of this study was to identify best practices and provide guidance to clinicians to ensure safety and optimize intrathecal drug delivery for chronic intractable pain. METHODS: Twelve experienced pain medicine practitioners-eight anesthesiologists, one neurosurgeon, one physiatrist, one clinical psychologist, and one advanced practice registered nurse-from the United States, Australia, and Europe gathered to identify and publish consensus on best practices in three areas related to safe intrathecal therapy for pain: safety and monitoring, patient and device management, and patient selection and trialing. CONCLUSIONS: Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain. While device-related complications (mostly with catheters) and surgical-site infections can occur, the main therapy-related safety issues associated with intrathecal drug delivery arise primarily with inadequate patient monitoring (e.g., respiratory depression), inflammatory mass (e.g., high doses and concentrations of opioids), wound healing, dosing errors (e.g., medication concentration and pump programming), pump fills or refills (e.g., pocket fills), and interaction with concomitant systemic medications (e.g., opioids and benzodiazepines). Many of the reported adverse events and complications of intrathecal drug delivery can be prevented by adequate clinician training, implementation of best practices, and experience. In adopting the therapy, patients must be apprised of its risks and benefits. Physicians and patients must partner to achieve both safety and effectiveness.

Epidural hematomas after removal of percutaneous spinal cord stimulator trial leads: two case reports.

OBJECTIVE: We report 2 cases of spinal epidural hematoma formation after the removal of percutaneous spinal cord stimulator trial leads and discuss the possible etiologies of these complications. CASE REPORT: Two patients developed spinal epidural hematomas shortly after removal of their percutaneous trial leads and required multilevel laminectomies for evacuation of the hematoma. Patient 1 reported taking aspirin the morning that his leads were pulled, whereas patient 2 had not taken aspirin in the 7 days before commencing his trial. There were 2 days between identification and evacuation of patient 1's hematoma, and he did not fully recover from the injury to his spinal cord. Patient 2 underwent surgery immediately with complete resolution of his symptoms. CONCLUSIONS: Currently, the neuromodulation community ascribes to the American Society of Regional Anesthesia and Pain Medicine guidelines, which state that nonsteroidal anti-inflammatory drugs do not significantly increase the risk for epidural hematoma with neuraxial anesthesia and, therefore, there is no need to discontinue these drugs before epidural or spinal anesthesia. We suggest that these guidelines may not be appropriate for neuromodulatory techniques that likely subject the surrounding vasculature to more trauma than neuraxial anesthesia. We recommend discontinuing nonsteroidal anti-inflammatory drugs, particularly aspirin, before neuromodulation procedures. Further investigation will establish a timeframe for holding these drugs to optimize patient safety.

Meningismus associated with malpositioned intraspinal catheter for drug delivery.

BACKGROUND: Implanted delivery systems for intrathecal drug administration have become more common in the management of nonmalignant pain. Many postprocedural complications have been described in the literature including infection and headache provoked by position changes. Determining the etiology of a postimplant headache is important particularly when considering the possibility of a life-threatening infection. CASE REPORT: We present a patient who underwent placement of an implantable drug delivery system (IDDS) for intractable abdominal pain that developed positional headaches, and significant neck and back pain. Attempted cerebrospinal fluid aspiration reproduced her symptoms and imaging revealed a malpositioned intraspinal catheter tip approximated to the meninges. Revision of the system completely relieved her symptoms. CONCLUSION: Meningismus from malpositioned catheters is a rare complication that can mimic meningitis but should be considered in the differential for postimplant headaches. Given the increased use of IDDS, it is important to recognize and evaluate postimplant complication and treat it appropriately. We discuss this case report and appropriate work-up and differential diagnosis for meningismus following implant.