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Bradley C. Lega, Shabbar F. Danish, Neil R. Malhotra, Seema S. Sonnad and Sherman C. Stein

Object

Chronic subdural hematoma (CSDH), a condition much more common in the elderly, presents an increasing challenge as the population ages. Treatment strategies for CSDH include bur-hole craniostomy (BHC), twist-drill craniostomy (TDC), and craniotomy. Decision analysis was used to organize existing data and develop recommendations for effective treatment.

Methods

A Medline search was used to identify articles about treatment of CSDH. Direct assessment by health care professionals of the relative health impact of common complications and recurrences was used to generate utility values for treatment outcomes. Monte Carlo simulation and sensitivity analyses allowed comparisons across treatment strategies. A second simulation examined whether intraoperative irrigation or postoperative drainage affect the outcomes following BHC.

Results

On a scale from 0 to 1, the utility of BHC was found to be 0.9608, compared with 0.9202 for TDC (p = 0.001) and 0.9169 for craniotomy (p = 0.006). Sensitivity analysis confirmed the robustness of these values. Craniotomy yielded fewer recurrences, but more frequent and more serious complications than did BHC. There were no significant differences for BHC with or without irrigation or postoperative drainage.

Conclusions

Bur-hole craniostomy is the most efficient choice for surgical drainage of uncomplicated CSDH. Bur-hole craniostomy balances a low recurrence rate with a low incidence of highly morbid complications. Decision analysis provides statistical and empirical guidance in the absence of well-controlled large trials and despite a confusing range of previously reported morbidity and recurrence.

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Matthew R. Sanborn, Jayesh P. Thawani, Robert G. Whitmore, Michael Shmulevich, Benjamin Hardy, Conrad Benedetto, Neil R. Malhotra, Paul Marcotte, William C. Welch, Stephen Dante and Sherman C. Stein

Object

There is considerable variation in the use of adjunctive technologies to confirm pedicle screw placement. Although there is literature to support the use of both neurophysiological monitoring and isocentric fluoroscopy to confirm pedicle screw positioning, there are no studies examining the cost-effectiveness of these technologies. This study compares the cost-effectiveness and efficacy of isocentric O-arm fluoroscopy, neurophysiological monitoring, and postoperative CT scanning after multilevel instrumented fusion for degenerative lumbar disease.

Methods

Retrospective data were collected from 4 spine surgeons who used 3 different strategies for monitoring of pedicle screw placement in multilevel lumbar degenerative disease. A decision analysis model was developed to analyze costs and outcomes of the 3 different monitoring strategies. A total of 448 surgeries performed between 2005 and 2010 were included, with 4 cases requiring repeat operation for malpositioned screws. A sample of 64 of these patients was chosen for structured interviews in which the EuroQol-5D questionnaire was used. Expected costs and quality-adjusted life years were calculated based on the incidence of repeat operation and its negative effect on quality of life and costs.

Results

The decision analysis model demonstrated that the O-arm monitoring strategy is significantly (p < 0.001) less costly than the strategy of postoperative CT scanning following intraoperative uniplanar fluoroscopy, which in turn is significantly (p < 0.001) less costly than neurophysiological monitoring. The differences in effectiveness of the different monitoring strategies are not significant (p = 0.92).

Conclusions

Use of the O-arm for confirming pedicle screw placement is the least costly and therefore most cost-effective strategy of the 3 techniques analyzed.

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R. Carter Clement, Brendan G. Carr, Michael J. Kallan, Catherine Wolff, Patrick M. Reilly and Neil R. Malhotra

Object

A positive correlation between outcomes and the volume of patients seen by a provider has been supported by numerous studies. Volume-outcome relationships (VORs) have been well documented in the setting of both neurosurgery and trauma care and have shaped regionalization policies to optimize patient outcomes. Several authors have also investigated the correlation between patient volume and cost of care, known as the volume-cost relationship (VCR), with mixed results. The purpose of the present study was to investigate VORs and VCRs in the treatment of common intracranial injuries by testing the hypotheses that outcomes suffer at small-volume centers and costs rise at large-volume centers.

Methods

The authors performed a cross-sectional cohort study of patients with neurological trauma using the 2006 Nationwide Inpatient Sample, the largest nationally representative all-payer data set. Patients were identified using ICD-9 codes for subdural, subarachnoid, and extradural hemorrhage following injury. Transfers were excluded from the study. In the primary analysis the association between a facility's neurotrauma patient volume and patient survival was tested. Secondary analyses focused on the relationships between patient volume and discharge status as well as between patient volume and cost. Analyses were performed using logistic regression.

Results

In-hospital mortality in the overall cohort was 9.9%. In-hospital mortality was 14.9% in the group with the smallest volume of patients, that is, fewer than 6 cases annually. At facilities treating 6–11, 12–23, 24–59, and 60+ patients annually, mortality was 8.0%, 8.3%, 9.5%, and 10.0%, respectively. For these groups there was a significantly reduced risk of in-hospital mortality as compared with the group with fewer than 6 annual patients; the adjusted ORs (and corresponding 95% CIs) were 0.45 (0.29–0.68), 0.56 (0.38–0.81), 0.63 (0.44–0.90), and 0.59 (0.41–0.87), respectively. For these same groups (once again using < 6 cases/year as the reference), there were no statistically significant differences in either estimated actual cost or duration of hospital stay.

Conclusions

A VOR exists in the treatment of neurotrauma, and a meaningful threshold for significantly improved mortality is 6 cases per year. Emergency and interfacility transport policies based on this threshold might improve national outcomes. Cost of care does not differ significantly with patient volume.

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Zoher Ghogawala, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Tanya Logvinenko, Neil R. Malhotra, Stephen J. Dante, R. John Hurlbert, Andrea F. Douglas, Subu N. Magge, Praveen V. Mummaneni, Joseph S. Cheng, Justin S. Smith, Michael G. Kaiser, Khalid M. Abbed, Daniel M. Sciubba and Daniel K. Resnick

Object

There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures.

Methods

An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform.

Results

Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work.

Conclusions

It is feasible to build a national spine registry for the collection of high-quality prospective data to demonstrate the effectiveness of spinal procedures in actual practice. Clinical trial registration no.: 01220921 (ClinicalTrials.gov).

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Peter Syre III, Leonardo Rodriguez-Cruz, Rajiv Desai, Karl A. Greene, Robert Hurst, James Schuster, Neil R. Malhotra and Paul Marcotte

Object

Gunshot wounds to the atlantoaxial spine are uncommon injuries and rarely require treatment, as a bullet traversing this segment often results in a fatal injury. Additionally, these injuries are typically biomechanically stable. The authors report a series of 10 patients with gunshot wounds involving the lateral mass and/or bodies of the atlantoaxial complex. Their care is discussed and conclusions are drawn from these cases to identify the optimal treatment for these injuries.

Methods

A retrospective review was conducted of patients presenting to the emergency rooms of 3 institutions with gunshot wounds involving the atlantoaxial spine. Mechanism of injury and neurological status were obtained, as was the extent of the osteoligamentous, vascular, and neurological injuries. Nonoperative and operative treatment, complications, and clinical and radiographic outcome were recorded. The data were then analyzed to determine the neurological and biomechanical prognosis of these injuries, the utility of the various diagnostic modalities in the acute management of the injuries, and the nature and effectiveness of the nonoperative and operative treatment modalities.

Results

Ten patients with gunshot wounds involving the lateral mass and/or bodies of the atlantoaxial complex were identified. All but 2 patients sustained a vertebral artery injury. Each patient was evaluated using cervical radiographs, CT scans, and vascular imaging, 8 in the form of digital subtraction angiography and 2 with high-resolution CT angiography. Uncomplicated patients were treated conservatively using cervical collar immobilization, local wound care, and antibiotics. One patient was treated using a halo for instability and 1 underwent posterior fusion following a posterolateral decompression for delayed myelopathy. One patient underwent transoral resection of a bullet fragment. One patient underwent embolization for a symptomatic arteriovenous fistula and a second patient underwent a neck exploration and a jugular vein ligation. None of the patients received anticoagulation therapy. The mean follow-up duration was 13 months. All but 2 patients regained their previous functional status and all ultimately attained a mechanically stable spine.

Conclusions

These 10 patients represent a rare form of cervical spine penetrating injury. Unilateral gunshot wounds to the atlantoaxial complex are usually stable and the need for acute surgical intervention is rare. Unilateral vertebral artery injury is well tolerated and any information provided by angiography does not alter the acute management of the patient. Vascular complications from gunshot wounds can be managed effectively by endovascular techniques.

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Sherman C. Stein, Neil R. Malhotra and Mark G. Burnett

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Praveen V. Mummaneni, Robert G. Whitmore, Jill N. Curran, John E. Ziewacz, Rishi Wadhwa, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Joseph S. Cheng, R. John Hurlbert, Andrea F. Douglas, Justin S. Smith, Neil R. Malhotra, Stephen J. Dante, Subu N. Magge, Michael G. Kaiser, Khalid M. Abbed, Daniel K. Resnick and Zoher Ghogawala

Object

There is significant practice variation and uncertainty as to the value of surgical treatments for lumbar spine disorders. The authors' aim was to establish a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures by using prospectively collected outcomes.

Methods

An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level fusion for spondylolisthesis or single-level lumbar discectomy were included. The 36-Item Short Form Health Survey (SF-36) and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: lumbar disc (125 patients) and lumbar listhesis (35 patients). The quality-adjusted life year (QALY) data were calculated using 6-dimension utility index scores. Direct costs and complication costs were estimated using Medicare reimbursement values from 2011, and indirect costs were estimated using the human capital approach with the 2011 US national wage index. Total costs equaled $14,980 for lumbar discectomy and $43,852 for surgery for lumbar spondylolisthesis.

Results

There were 198 patients enrolled over 1 year. The mean age was 46 years (49% female) for lumbar discectomy (n = 148) and 58.1 years (60% female) for lumbar spondylolisthesis (n = 50). Ten patients with disc herniation (6.8%) and 1 with listhesis (2%) required repeat operation at 1 year. The overall 1-year follow-up rate was 88%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, visual analog scale, and SF-36 scores (p = 0.0002), which persisted at the 1-year evaluation (p < 0.0001). By 1 year, more than 80% of patients in each cohort who were working preoperatively had returned to work. Lumbar discectomy was associated with a gain of 0.225 QALYs over the 1-year study period ($66,578/QALY gained). Lumbar spinal fusion for Grade I listhesis was associated with a gain of 0.195 QALYs over the 1-year study period ($224,420/QALY gained).

Conclusions

This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. These data are useful for demonstrating return to work and cost-effectiveness following surgical treatment of single-level lumbar disc herniation or spondylolisthesis. One-year cost per QALY was obtained, and this cost per QALY is expected to improve further by 2 years. This work sets the stage for real-world analysis of the value of health interventions.

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Robert G. Whitmore, Jill N. Curran, Zarina S. Ali, Praveen V. Mummaneni, Christopher I. Shaffrey, Robert F. Heary, Michael G. Kaiser, Anthony L. Asher, Neil R. Malhotra, Joseph S. Cheng, John Hurlbert, Justin S. Smith, Subu N. Magge, Michael P. Steinmetz, Daniel K. Resnick and Zoher Ghogawala

OBJECT

The authors have established a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures using prospectively collected outcomes. Collection of these data requires an extensive commitment of resources from each site. The aim of this study was to determine whether outcomes data from shorter-interval follow-up could be used to accurately estimate long-term outcome following lumbar discectomy.

METHODS

An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level lumbar discectomy for treatment of disc herniation were included. SF-36 and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Quality-adjusted life year (QALY) data were calculated using SF-6D utility scores. Correlations among outcomes at each follow-up time point were tested using the Spearman rank correlation test.

RESULTS

One hundred forty-eight patients were enrolled over 1 year. Their mean age was 46 years (49% female). Eleven patients (7.4%) required a reoperation by 1 year postoperatively. The overall 1-year follow-up rate was 80.4%. Lumbar discectomy was associated with significant improvements in ODI and SF-36 scores (p < 0.0001) and with a gain of 0.246 QALYs over the 1-year study period. The greatest gain occurred between baseline and 3-month follow-up and was significantly greater than improvements obtained between 3 and 6 months or 6 months and 1 year(p < 0.001). Correlations between 3-month, 6-month, and 1-year outcomes were similar, suggesting that 3-month data may be used to accurately estimate 1-year outcomes for patients who do not require a reoperation. Patients who underwent reoperation had worse outcomes scores and nonsignificant correlations at all time points.

CONCLUSIONS

This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. Three-month outcome data may be used to accurately estimate outcome at future time points and may lower costs associated with registry data collection. This registry effort provides a practical foundation for the acquisition of outcome data following lumbar discectomy.

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Luis Perez-Orribo, Laura A. Snyder, Samuel Kalb, Ali M. Elhadi, Forrest Hsu, Anna G. U. S. Newcomb, Devika Malhotra, Neil R. Crawford and Nicholas Theodore

OBJECTIVE

Craniovertebral junction (CVJ) injuries complicated by transverse atlantal ligament (TAL) disruption often require surgical stabilization. Measurements based on the atlantodental interval (ADI), atlas lateral diameter (ALD1), and axis lateral diameter (ALD2) may help clinicians identify TAL disruption. This study used CT scanning to evaluate the reliability of these measurements and other variants in the clinical setting.

METHODS

Patients with CVJ injuries treated at the authors' institution between 2004 and 2011 were evaluated retrospectively for demographics, mechanism and location of CVJ injury, classification of injury, treatment, and modified Japanese Orthopaedic Association score at the time of injury and follow-up. The integrity of the TAL was evaluated using MRI. The ADI, ALD1, and ALD2 were measured on CT to identify TAL disruption indirectly.

RESULTS

Among the 125 patients identified, 40 (32%) had atlas fractures, 59 (47.2%) odontoid fractures, 31 (24.8%) axis fractures, and 4 (3.2%) occipital condyle fractures. TAL disruption was documented on MRI in 11 cases (8.8%). The average ADI for TAL injury was 1.8 mm (range 0.9–3.9 mm). Nine (81.8%) of the 11 patients with TAL injury had an ADI of less than 3 mm. In 10 patients (90.9%) with TAL injury, overhang of the C-1 lateral masses on C-2 was less than 7 mm. ADI, ALD1, ALD2, ALD1 – ALD2, and ALD1/ALD2 did not correlate with the integrity of the TAL.

CONCLUSIONS

No current measurement method using CT, including the ADI, ALD1, and ALD2 or their differences or ratios, consistently indicates the integrity of the TAL. A more reliable CT-based criterion is needed to diagnose TAL disruption when MRI is unavailable.