Clinical features and outcome of vertebral osteomyelitis after spinal injection: is it worth the price?

PURPOSE: Spinal injections are increasingly used for back pain treatment. Vertebral osteomyelitis (VO) after spinal injection (SIVO) is rare, but patient characteristics and outcome have not been well characterized. The aim of this study was to assess patient characteristics of SIVO in comparison to patients with native vertebral osteomyelitis (NVO) and to determine predictors for 1-year survival. METHODS: This is a single-center cohort study from a tertiary referral hospital. This is a retrospective analysis of Patients with VO who were prospectively enrolled into a spine registry from 2008 to 2019. Student's t-test, Kruskal-Wallis test or Chi-square test were applied for group comparisons. Survival analysis was performed using a log-rank test and a multivariable Cox regression model. RESULTS: 283 VO patients were enrolled in the study, of whom 44 (15.5%) had SIVO and 239 (84.5%) NVO. Patients with SIVO were significantly younger, had a lower Charlson comorbidity index and a shorter hospital stay compared to NVO. They also showed a higher rate of psoas abscesses and spinal empyema (38.6% [SIVO] vs. 20.9% [NVO]). Staphylococcus aureus (27%) and coagulase-negative staphylococci (CNS) (25%) were equally often detected in SIVO while S. aureus was more frequently than CNS in NVO (38.1% vs. 7.9%).Patients with SIVO (P = 0.04) had a higher 1-year survival rate (Fig. 1). After multivariate analysis, ASA score was associated with a lower 1-year survival in VO. CONCLUSION: The results from this study emphasize unique clinical features of SIVO, which warrant that SIVO should be estimated as a separate entity of VO.

Assessment of Health Care Costs and Total Baclofen Use Associated With Targeted Drug Delivery for Spasticity.

BACKGROUND: Chronic spasticity causes significant impairment and financial burden. Oral baclofen, the first-line therapy, can have intolerable, dose-dependent side effects. Targeted drug delivery (TDD) through intrathecal baclofen delivers smaller amounts of baclofen into the thecal sac via an implanted infusion system. However, the health care resource utilization of patients with spasticity receiving TDD has not been studied extensively. MATERIALS AND METHODS: Adult patients who received TDD for spasticity between 2009 and 2017 were identified using the IBM MarketScan® data bases. Patients' use of oral baclofen and health care costs were examined at baseline (one year before implantation) and three years after implantation. A multivariable regression model using the generalized estimating equations method and a log link function was used to compare postimplantation costs with those at baseline. RESULTS: The study identified 771 patients with TDD for medication analysis and 576 for cost analysis. At baseline, the median costs were $39,326 (interquartile range [IQR]: $19,526-$80,679), which increased to $75,728 (IQR: $44,199-$122,676) in year 1, decreased to $27,160 (IQR: $11,896-$62,427) in year 2, and increased slightly to $28,008 (IQR: $11,771-$61,885) in year 3. In multivariable analysis, the cost was 47% higher than at baseline (cost ratio [CR] 1.47, 95% CI: 1.32-1.63) in year 1 but was 25% lower (CR 0.75, 95% CI: 0.66-0.86) in year 2 and 32% lower (CR 0.68, 95% CI: 0.59-0.79) in year 3. Before implant, 58% of patients took oral baclofen, which decreased to 24% by year 3. The median daily baclofen dose decreased from 61.8 mg (IQR: 40-86.4) before TDD to 32.8 mg (IQR: 30-65.7) three years later. CONCLUSIONS: Our findings indicate that patients who undergo TDD use less oral baclofen, potentially reducing the risk of side effects. Although total health care costs increased immediately after TDD, most likely owing to device and implantation costs, they decreased below baseline after one year. The costs of TDD reach cost neutrality approximately three years after implant, indicating its potential for long-term cost savings.

Ziconotide for the Management of Cancer Pain: A Budget Impact Analysis.

OBJECTIVES: Recent recommendations on starting dose, smaller dose increments, and longer intervals between dose increase have the potential to increase the safety of ziconotide administration in addition to improving its value for money. Ziconotide is not routinely commissioned in England, with one of the concerns being whether it represents the best use of resources. The aim of this project is to conduct a budget impact analysis to estimate the costs or savings associated with the changes in ziconotide dosage in addition to its use in combination with morphine for the management of cancer pain. MATERIALS AND METHODS: An open, Markov-like cohort decision analytic model was developed to estimate the budget impact of ziconotide in combination with morphine (ziconotide combination therapy) vs morphine monotherapy through intrathecal drug delivery (ITDD) for the management of cancer pain. The perspective adopted was that of the UK National Health Service, with a five-year time horizon. Sensitivity analyses were conducted to evaluate different scenarios. RESULTS: Ziconotide combination therapy was more expensive than treatment with morphine monotherapy. The total costs of ziconotide combination therapy and morphine monotherapy for the first year were £395,748 and £136,628 respectively. The estimated five-year cumulative budget impact of treatment with ziconotide combination therapy for the five-year time horizon was £2,487,539, whereas that of morphine monotherapy was £913,804. The additional costs in any of the first five years are below the resource impact significance level of £1 million for medical technologies in England. CONCLUSIONS: The results of this budget impact analysis suggest that although a combination of intrathecal ziconotide in combination with morphine is associated with higher costs to the health care system in England, the incremental costs are not significant. Routine commissioning of ziconotide alone or in combination with morphine would provide an alternative for a population with limited ITDD treatment options.

Clinical application of intrathecal gadobutrol for assessment of cerebrospinal fluid tracer clearance to blood.

BACKGROUNDMethodology for estimation of cerebrospinal fluid (CSF) tracer clearance could have wide clinical application in predicting excretion of intrathecal drugs and metabolic solutes from brain metabolism and for diagnostic workup of CSF disturbances.METHODSThe MRI contrast agent gadobutrol (Gadovist) was used as a CSF tracer and injected into the lumbar CSF. Gadobutrol is contained outside blood vessels of the CNS and is eliminated along extravascular pathways, analogous to many CNS metabolites and intrathecal drugs. Tracer enrichment was verified and assessed in CSF by MRI at the level of the cisterna magna in parallel with obtaining blood samples through 48 hours.RESULTSIn a reference patient cohort (n = 29), both enrichment within CSF and blood coincided in time. Blood concentration profiles of gadobutrol through 48 hours varied between patients diagnosed with CSF leakage (n = 4), idiopathic normal pressure hydrocephalus dementia (n = 7), pineal cysts (n = 8), and idiopathic intracranial hypertension (n = 4).CONCLUSIONAssessment of CSF tracer clearance is clinically feasible and may provide a way to predict extravascular clearance of intrathecal drugs and endogenous metabolites from the CNS. The peak concentration in blood (at about 10 hours) was preceded by far peak tracer enhancement at MRI in extracranial lymphatic structures (at about 24 hours), as shown in previous studies, indicating a major role of the spinal canal in CSF clearance capacity.FUNDINGThe work was supported by the Department of Neurosurgery, Oslo University Hospital; the Norwegian Institute for Air Research; and the University of Oslo.

Pediatric SMA patients with complex spinal anatomy: Implementation and evaluation of a decision-tree algorithm for administration of nusinersen.

The approval of nusinersen for the treatment of spinal muscular atrophy (SMA) has significantly changed the natural history of the disease. Nevertheless, scoliosis secondary to axial muscle weakness occurs at some point in most of patients with SMA and a conventional posterior interlaminar approach for intrathecal administration of nusinersen can be particularly challenging to perform in patients with severe scoliosis and/or previous spine fusion surgeries. We developed a protocol for the administration of nusinersen in pediatric patients, which includes a decision-tree algorithm that categorizes patients according to the estimated technical difficulty for the intrathecal administration. Complex spine patients were defined as those with a Cobb angle greater than 50° and/or a history of spinal surgery, while the rest of patients were considered non-complex. Nusinersen was successfully administered through a conventional non-CT-guided lumbar puncture in all 14 non-complex spine patients (110 out of 110 procedures; 100%). The feasibility of the intrathecal injection in the 15 complex spine patients was assessed by 3D CT. Administration was considered unfeasible in 7 out of these 15 patients according to imaging. In the 8 complex spine patients in whom the administration was considered feasible, conventional non-CT-guided lumbar punctures were successful only in 19 out of 53 procedures (36%). The remaining 34 procedures (64%) were guided by CT scan, all successful. Our work demonstrates that a cut-off point of 50° in Cobb angle and history of spinal surgery can reliably be used to anticipate the need for CT guidance in nusinersen administration.

Early experiences of nusinersen for the treatment of spinal muscular atrophy: Results from a large survey of patients and caregivers.

BACKGROUND: This study aimed to examine the early experience of nusinersen for spinal muscular atrophy (SMA) from the patient and caregiver perspective. METHODS: A 54-item online survey was administered to adult patients and caregivers of pediatric patients diagnosed with SMA. RESULTS: Overall, respondents (56 patients and 45 caregivers) were satisfied with nusinersen. Satisfaction was highest on changes in energy, stamina, and motor function and lowest on treatment administration and overall time commitment. Differences were noted for treatment effect sustained over time as reported by adult patients vs caregivers reporting on behalf of pediatric patients. Respondents reported insurance approval as a key barrier to access, particularly among adult patients. CONCLUSIONS: Despite therapeutic advances, there remain significant unmet needs for SMA. Challenges with administration and barriers to access potentially limit the number of patients treated or delay treatment. Continued efforts are needed to develop more treatment options and to improve access to treatments.

The Unmet Need for Intrathecal Drug Delivery Pumps for the Treatment of Cancer Pain in England: An Assessment of the Hospital Episode Statistics Database.

OBJECTIVES: Intrathecal drug delivery (ITDD) devices have been shown to be a clinically effective and cost-effective option for the management of cancer pain and recommended for use in England. The aim of this study is to assess the impact of the 2015 NHS England Clinical Commissioning Policy on the uptake of ITDD pumps for the management of cancer pain or if there is an ongoing unmet need for this intervention in England. MATERIALS AND METHODS: Hospital Episode Statistics (HES) were obtained for all patients undergoing ITDD for the management of cancer pain between 2014 and January 2020. In addition, HES were utilized to estimate the number of patients with cancer potentially eligible for ITDD pump during the same period. RESULTS: The number of patients with cancer and those potentially suitable to receive an ITDD for the management of cancer pain have increased year on year since 2014. This increase has not been matched by an uptake in the provision of ITDD. Conservative estimates suggest that at least 8000 people with cancer pain would be eligible for ITDD; 458 patients received an intervention for pain management between April 2018 and March 2019 and only 30 ITDD pumps were implanted in that same period. CONCLUSIONS: We observed a substantial gap between the need and provision of ITDD for patients with refractory cancer pain in England despite the recommendation for the use of ITDD for this patient population. In addition, we present suggestions for improvement of access to and provision of ITDD in England.

Intrathecal hydromorphone as an analgesia option for gynecology patients.

Enhanced recovery after surgery (ERAS) is a multimodal perioperative strategy originally developed to attenuate the postsurgical stress response in patients after colorectal surgery. Patients undergoing gynecologic surgery who had ERAS had significantly shorter hospital length of stay, reduced hospital-related costs, and acceptable pain management with reduced opioid use, without compromising patient satisfaction. Intrathecal hydromorphone is an effective alternative ERAS protocol analgesia for these patients and will not compromise patient outcomes or healthcare costs.

Access to Intrathecal Baclofen Treatment for Children with Cerebral Palsy in European Countries: An SCPE Survey Reveals Important Differences.

AIM: The aim is to study access to intrathecal baclofen (ITB) for children with cerebral palsy (CP) in Europe, as an indicator of access to advanced care. METHODS: Surveys were sent to CP registers, clinical networks, and pump manufacturers. Enquiries were made about ITB treatment in children born in 1990 to 2005 by sex, CP type, level of gross motor function classification system (GMFCS) and age at the start of treatment. Access to ITB was related to the country's gross domestic product (GDP) and % GDP spent on health. RESULTS: In 2011 population-based data from Sweden, Norway, England, Portugal, Slovenia, and Denmark showed that 114 (3.4%) of 3,398 children with CP were treated with ITB, varying from 0.4 to 4.7% between centers. The majority of the children were at GMFCS levels IV-V and had bilateral spastic CP. In Sweden, dyskinetic CP was the most commonly treated subtype. Boys were more often treated with ITB than girls (p = 0.014). ITB was reported to be available for children with CP in 25 of 43 countries. Access to ITB was associated with a higher GDP and %GDP spent on health (p < 0.01). Updated information from 2019 showed remaining differences between countries in ITB treatment and sex difference in treated children was maintained. CONCLUSION: There is a significant difference in access to ITB for children with CP across Europe. More boys than girls are treated. Access to ITB for children with CP is associated with GDP and percent of GDP spent on health in the country.

Treatments and Health Outcomes of Medicare Patients With Back Pain.

Back pain treatments are costly and frequently involve use of procedures that may have minimal benefit on improving patients' functional status. Two recent studies evaluated adverse outcomes (mortality and major medical complications) following receipt of spinal surgery but neither examined whether such treatments affected functional ability. Using a sample composed of Medicare patients with persistent back pain, we examined whether functional ability improved after treatment, comparing patients treated with back surgery or spinal injections to nonrecipients. We analyzed four binary variables that measure whether the ability to perform routine tasks improved. We used instrumental variables analysis to address the nonrandom selection of treatment received due to unobservable confounding. Contrary to the observational results, the instrumental variable estimates suggest that receipt of either back surgery or spinal injections does not improve back patients' functional ability. Failure to account for selection into treatment can lead to overestimating the benefits of specific treatments.

Health Care Utilization and Pain Outcomes Following Early Imaging for Low Back Pain in Older Adults.

BACKGROUND: Professional societies have provided inconsistent guidance regarding whether older patients should receive early imaging for low back pain, in the absence of clinical indications. The study assesses the implications of early imaging by evaluating its association with downstream utilization in an elderly population. METHODS: Patients were included if they had a Medicare Advantage plan, had claims-based evidence of low back pain in 2014, and lacked conditions justifying early imaging. The outcomes examined were short-term, nonchronic, and chronic opioid use, steroid injections, and spinal surgery in the following 730 days, and persistent low back pain at 180 to 365 days. Morphine dose equivalents of opioid use was used as a measure of intensity. Logistic and γ regressions were used to assess the association between imaging in the first 6 weeks and the outcomes. RESULTS: Among the 57,293 patients meeting inclusion criteria, the mean age was 71.2, and 26,606 (46.4%) received early imaging. Early imaging was associated with increased adjusted odds of short-term (odds ratio [OR], 1.21; 95% CI, 1.15 to 1.28), nonchronic (OR, 1.78; 95% CI, 1.69 to 1.88), and chronic (OR, 1.13; 95% CI, 1.07 to 1.18) opioid use, as well as steroid injections (OR, 2.55; 95% CI, 2.28 to 2.85) and spinal surgery (OR, 3.40; 95% CI, 2.97 to 3.90). Patients that received early imaging were more likely to experience persistent pain (OR, 1.09; 95% CI, 1.05 to 1.14) and used significantly more morphine dose equivalents if they had nonchronic opioid use. CONCLUSIONS: Early imaging for low back pain in older individuals was common, and was associated with greater utilization of downstream services and persistent pain.

Ex Vivo Assessment of an Ultrasound-Guided Injection Technique of the Lumbosacral Disc in the Horse.

OBJECTIVES: The aim of this study was to describe an ultrasound-guided injection technique of the lumbosacral disc in horses through the cranial vertebral notch of the sacrum and to evaluate both accuracy and potential complications of the technique on equine cadavers. MATERIALS AND METHODS: Twenty-four injections of the lumbosacral area were performed on 12 equine cadavers shortly after euthanasia under ultrasound guidance with the horse in recumbency using two different dyes (one colour for each side). The lumbosacral area was dissected in each horse and the accuracy of the technique, as well as its potential complications, was evaluated detecting the dyes and the structures that have been coloured. RESULTS: The lumbosacral area was correctly reached in only 11/24 injections. However, this technique allowed a lumbosacral peridiscal injection in 7/12 horses. The main difficulty was reaching the ventral opening of the L6-S1 intervertebral foramen that is partially hidden by the iliac wing on ultrasound. Puncture of the vertebral canal has been observed in 11/24 cases. The L6 spinal nerve roots emerging through the intervertebral foramen could potentially be damaged when inserting the needle. CLINICAL SIGNIFICANCE: The described ultrasound-guided technique allows peridiscal injection in the lumbosacral space in less than 60% of cases with potential sciatic nerve damage. Further investigations are warranted before using this technique in clinical practice in horses suffering from lumbosacral lesions.

Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

The cost impact of a quality-assured mechanical assessment in primary low back pain care.

Objectives: The escalating cost of low back pain (LBP) care has not improved outcomes. Our purpose: to compare costs between LBP care guided by a quality-assured mechanical assessment (MC) and usual community care (CC).Study Design: Administrative claims data analysis.Methods: Employees and dependents of a large self-insured manufacturer seeking care for LBP in 2013 chose between the company's primary care clinic (where MC was delivered) and community care.The claims of 5,036 were analyzed for one year following subjects' initial evaluation excluding only those with diagnostic codes for fractures, dislocations, or infections. MC included an advanced form of Mechanical Diagnosis & Therapy (MDT). CC varied based on each subjects' selection of providers. Primary outcome measure: one-year cost of each subject's care. Secondary: number of MRIs, spinal injections, and lumbar surgeries undertaken. The payer's proprietary risk-adjustment algorithm was utilized.Results: After risk adjustment, the average cost per MC subject was 51.48% lower than the CC average cost (p < .0279). The utilization of MRIs, injections, and surgeries was lower with MC by 49.75%, 39.44%, 78.38% with relative risks of 1.99, 1.64, and 4.73, respectively.Conclusions: This 51.5% cost-savings reflects the substantial reduction in downstream care-seeking with MC, including lower utilization of MRIs, injections, surgeries, and downstream care after six months from the initial visit. It is well documented that the MDT clinical examination typically elicit patterns of pain response that in turn identify how most can rapidly recover with self-care with no need for other intervention.Level of Evidence: 1b.

Intrathecal therapy for pain in cancer patients.

PURPOSE OF REVIEW: Intrathecal drug delivery systems (IDDS) for cancer pain remain little employed despite a high level of efficiency even though the technique is widely recommended. This review aims to summarize recent advances in IDDS for cancer patients. RECENT FINDINGS: The respective roles of catheter positioning, volume and flow rate in diffusion of intrathecal treatments, as well as the individual roles of blood pressure, heart rate, and amplitude of the respiratory movements in cerebrospinal fluid (CSF) treatment dispersion, are now well established. Models are available using MRI data. Morphine has long been the gold standard in first line treatment, but recent publications conclude that ziconotide has largely proven its efficiency and that adverse effects are controllable. Four recent publications have evaluated cohorts of cancer patients treated by IDDS in 315 patients. All found a great efficiency of intrathecal treatment for cancer pain. Technical innovations include new catheters and anchorage devices for easier placement and a lower rate of complication. Three-dimensional (3D) CT scan appears to be a noninvasive technique for the diagnosis of catheter complications. Ultrasound should be used to locate pump septum for refill. SUMMARY: All recent recommendations highlight the efficiency of IDDS and propose to use it sooner.

In Vitro Assessment of Fluorine Nanoemulsion-Labeled Hyaluronan-Based Hydrogels for Precise Intrathecal Transplantation of Glial-Restricted Precursors.

PURPOSE: We studied the feasibility of labeling hydrogel scaffolds with a fluorine nanoemulsion for 19F- magnetic resonance imaging (MRI) to enable non-invasive visualization of their precise placement and potential degradation. PROCEDURE: Hyaluronan-based hydrogels (activated hyaluronan, HA) with increasing concentrations of fluorine nanoemulsion (V-sense) were prepared to measure the gelation time and oscillatory stress at 1 h and 7 days after the beginning of gelation. All biomechanical measurements were conducted with an ARES 2 rheometer. Diffusion of fluorine from the hydrogel: Three hydrogels in various Vs to HA volumetric ratios (1:50, 1:10, and 1:5) were prepared in duplicate. Hydrogels were incubated at 37 °C. To induce diffusion, three hydrogels were agitated at 1000 rpm. 1H and 19F MRI scans were acquired at 1, 3, 7 days and 2 months after gel preparation on a Bruker Ascend 750 scanner. To quantify fluorine content, scans were analyzed using Voxel Tracker 2.0. Assessment of cell viability in vitro and in vivo: Luciferase-positive mouse glial-restricted progenitors (GRPs) were embedded in 0:1, 1:50, 1:10, and 1:5 Vs:HA mixtures (final cell concentration  =1 × 107/ml). For the in vitro assay, mixtures were placed in 96-wells plate in triplicate and bioluminescence was measured after 1, 3, 7, 14, 21, and 28 days. For in vivo experiments, Vs/HA mixtures containing GRPs were injected subcutaneously in SCID mice and BLI was acquired at 1, 3, 7, and 14 days post-injection. RESULTS: Mixing of V-sense at increasing ratios of 1:50, 1:10, and 1:5 v/v of fluorine/activated hyaluronan (HA) hydrogel gradually elongated the gelation time from 194 s for non-fluorinated controls to 304 s for 1:5 V-sense:HA hydrogels, while their elastic properties slightly decreased. There was no release of V-sense from hydrogels maintained in stationary conditions over 2 months. The addition of V-sense positively affected in vitro survival of scaffolded GRPs in a dose-dependent manner. CONCLUSIONS: These results show that hydrogel fluorination does not impair its beneficial properties for scaffolded cells, which may be used to visualize scaffolded GRP transplants with 19F MRI.

Radiation exposure of image-guided intrathecal administration of nusinersen to adult patients with spinal muscular atrophy.

PURPOSE: To examine diagnostic reference levels (DRL) and achievable doses (AD) of image-guided and size-specific dose estimates (SSDE) and organ and effective doses of CT-guided intrathecal nusinersen administration to adult patients with spinal muscular atrophy (SMA). METHODS: This study involved a total of 60 image-guided intrathecal nusinersen treatments between August 2017 and June 2018. Patient cohort comprised 14 adult patients with the following SMA types: type 2 (n = 9) and type 3 (n = 5) with a mean age of 33.6 years (age range 25-57 years). DRL, AD, SSDE, organ, and effective doses were assessed with a dose-monitoring program based on the Monte Carlo simulation techniques. RESULTS: DRL and AD for computed tomography are summarised as follows: in terms of CT-dose index (CTDIvol), DRL 56.4 mGy and AD 36.7 mGy; in terms of dose-length product (DLP), DRL 233.1 mGy cm and AD 120.1 mGy cm. DRL and AD for fluoroscopic guidance were distributed as follows: in terms of dose-area product (DAP), DRL 239.1 µGy m2 and AD 135.2 mGy cm2. Mean SSDE was 9.2 mGy. Mean effective dose of the CT-guided injections was 2.5 mSv (median 2.0 mSv, IQR 1.3-3.2 mSv). Highest organ doses in the primary beam of radiation were the small intestine 12.9 mSv, large intestine 9.5 mSv, and ovaries 3.6 mSv. CONCLUSION: Radiation exposure of SMA patients measured as DRLs is generally not higher compared with patients without SMA despite severe anatomical hazards. Dose monitoring data may allow clinicians to stratify radiation risk, identify organs at risk, and adopt measures for specific radiation dose reduction.

Practice Variation Among Surgeons Treating Lumbar Spinal Stenosis in a Single Institution.

STUDY DESIGN: A retrospective study. OBJECTIVE: The aim of this study was to examine practice variation in the treatment of lumbar spinal stenosis and identify targets for reducing variation. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is a degenerative condition susceptible to practice variation. Reducing variation aims to improve quality, increase safety, and lower costs. Establishing differences in surgeons' practices from a single institution can help identify personalized variation. METHODS: We identified adult patients first diagnosed with lumbar spinal stenosis between 2003 and 2015 in three hospitals of the same institution with ICD-9 codes.We extracted number of office visits, imaging procedures, injections, electromyographies (EMGs), and surgery within the first year after diagnosis; physical therapy within the first 3 months after diagnosis. Multivariable logistic regression was used to identify factors associated with surgery. The coefficient of variation (CV) was calculated to compare the variation in practice. RESULTS: The 10,858 patients we included had an average of 2.5 visits (±1.9), 1.5 imaging procedures (±2.0), 0.03 EMGs (±0.22), and 0.16 injections (±0.53); 36% had at least one surgical procedure and 32% had physical therapy as part of their care. The CV was smallest for number of visits (19%) and largest for EMG (140%).Male sex [odds ratio (OR): 1.23, P < 0.001], seeing an additional surgeon (OR: 2.82, P < 0.001), and having an additional spine diagnosis (OR: 3.71, P < 0.001) were independently associated with surgery. Visiting an orthopedic clinic (OR: 0.46, P < 0.001) was independently associated with less surgical interventions than visiting a neurosurgical clinic. CONCLUSION: There is widespread variation in the entire spectrum of diagnosis and therapy for lumbar spinal stenosis among surgeons in the same institution. Male gender, seeing an additional surgeon, having an additional spine diagnosis, and visiting a neurosurgery clinic were independently associated with increased surgical intervention. The main target we identified for decreasing variability was the use of diagnostic EMG. LEVEL OF EVIDENCE: 3.

Assessment of Neurological Toxicity of Hydroxyethyl Starch 130/0.4 Injected in the Intrathecal Space in Rats.

Objective: Epidural blood patch is the procedure of choice to relieve postdural puncture headache. Hydroxyethyl-starch (HES) has been proposed as a patch in some circumstances such as in the case of hematological disease due to the theoretical risk of neoplastic seeding to the central nervous system. Acute neurological HES toxicity has been excluded by a previous animal study, but the long-term neurological toxicity has not been evaluated. Methods: Rats were randomly assigned to one of three groups: no intrathecal injection, 20 µL of intrathecal saline, or a 20-µL intrathecal HES (6% hydroxyethyl starch 130/0.4) administered via a cervical puncture. Clinical daily rat activity was measured before and after dural puncture by actinometry. The rats were killed at day 28, and the spinal cord was surgically removed and stained with hematoxylin-phloxine-saffron for gross and microscopic examination. Results: Eleven rats underwent dural puncture without injection, 11 were injected with normal saline, and 12 received intrathecal HES. No clinical or actimetric changes (total distance traveled, number of direction changes, and number of rearings) were observed up to one month after injection. Nonspecific histopathological changes were equally observed in all groups. Conclusions: The results of the current study indicate that intrathecal injection of HES in rats does not induce any clinical or histopathological evidence of long-term neuronal toxicity. Further safety studies in animals are warranted before HES might be considered a safe alternative to the classic epidural blood patch.