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Robert F. Heary, Paul A. Anderson and Paul M. Arnold

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Robert F. Heary, Paul A. Anderson and Paul M. Arnold

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Alan H. Daniels, Satoshi Kawaguchi, Alec G. Contag, Farbod Rastegar, Garrett Waagmeester, Paul A. Anderson, Melanie Arthur and Robert A. Hart

OBJECTIVE

Beginning in 2008, the Centers for Medicare and Medicaid Service (CMS) determined that certain hospital-acquired adverse events such as surgical site infection (SSI) following spine surgery should never occur. The following year, they expanded the ruling to include deep vein thrombosis (DVT) and pulmonary embolism (PE) following total joint arthroplasty. Due to their ruling that “never events” are not the payers' responsibility, CMS insists that the costs of managing these complications be borne by hospitals and health care providers, rather than billings to health care payers for additional care required in their management. Data comparing the expected costs of such adverse events in patients undergoing spine and orthopedic surgery have not previously been reported.

METHODS

The California State Inpatient Database (CA-SID) from 2008 to 2009 was used for the analysis. All patients with primary procedure codes indicating anterior cervical discectomy and fusion (ACDF), posterior lumbar interbody fusion (PLIF), lumbar laminectomy (LL), total knee replacement (TKR), and total hip replacement (THR) were analyzed. Patients with diagnostic and/or treatment codes for DVT, PE, and SSI were separated from patients without these complication codes. Patients with more than 1 primary procedure code or more than 1 complication code were excluded. Median charges for treatment from primary surgery through 3 months postoperatively were calculated.

RESULTS

The incidence of the examined adverse events was lowest for ACDF (0.6% DVT, 0.1% PE, and 0.03% SSI) and highest for TKA (1.3% DVT, 0.3% PE, 0.6% SSI). Median inpatient charges for uncomplicated LL was $51,817, compared with $73,432 for ACDF, $143,601 for PLIF, $74,459 for THR, and $70,116 for TKR. Charges for patients with DVT ranged from $108,387 for TKR (1.5 times greater than index) to $313,536 for ACDF (4.3 times greater than index). Charges for patients with PE ranged from $127,958 for TKR (1.8 times greater than index) to $246,637 for PLIF (1.7 times greater than index). Charges for patients with SSI ranged from $168,964 for TKR (2.4 times greater than index) to $385,753 for PLIF (2.7 times greater than index).

CONCLUSIONS

Although incidence rates are low, adverse events of spinal procedures substantially increase the cost of care. Charges for patients experiencing DVT, PE, and SSI increased in this study by factors ranging from 1.8 to 4.3 times those for patients without such complications across 5 common spinal and orthopedic procedures. Cost projections by health care providers will need to incorporate expected costs of added care for patients experiencing such complications, assuming that the cost burden of such events continues to shift from payers to providers.

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Y. Raja Rampersaud, Paul A. Anderson, John R. Dimar II, Charles G. Fisher and on behalf of the Spine Trauma Study Group and Degenerative Spine Study Group

OBJECTIVE

Reporting of adverse events (AEs) in spinal surgery uses inconsistent definitions and severity grading, making it difficult to compare results between studies. The Spinal Adverse Events Severity System, version 2 (SAVES-V2) aims to standardize the classification of spine surgery AEs; however, its inter- and intraobserver reliability are unknown. The objective of this study was to assess inter- and intraobserver reliability of the SAVES-V2 grading system for assessing AEs in spinal surgery.

METHODS

Two multinational, multicenter surgical study groups assessed surgical case vignettes (10 trauma and 12 degenerative cases) for AE occurrence by using SAVES-V2. Thirty-four members of the Spine Trauma Study Group (STSG) and 17 members of the Degenerative Spine Study Group (DSSG) participated in the first round of case vignettes. Six months later, the same case vignettes were randomly reorganized and presented in an otherwise identical manner. Inter- and intraobserver agreement on the presence, severity, number, and type of AE, as well as the impact of the AE on length of stay (LOS) were assessed using intraclass correlation (ICC), Cohen's kappa value, and the percentage of participants in agreement.

RESULTS

Agreement on the presence of AEs ranged from 97% to 100% in the 2 groups. Severity classification showed substantial interobserver (ICC = 0.75 for both groups) and intraobserver (ICC = 0.70 in DSSG, 0.71 in STSG) agreement. Judgments on the number of AEs showed high interobserver agreement and moderate intraobserver agreement in both groups. Both the STSG and DSSG had high intraobserver agreement on the type of AE; interobserver agreement for AE type was high in the STSG and fair in the DSSG. Agreement on impact of the AE on LOS was excellent in the DSSG and fair in the STSG.

CONCLUSIONS

There was good agreement on the presence, severity, and number of AEs in both trauma and degenerative cases in using the SAVES-V2. This grading system is a simple, reliable tool for identifying and capturing AEs in spinal surgery.

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Anthony L. Mikula, Seth K. Williams and Paul A. Anderson

OBJECT

Insertion of instruments or implants into the spine carries a risk for injury to neural tissue. Triggered electromyography (tEMG) is an intraoperative neuromonitoring technique that involves electrical stimulation of a tool or screw and subsequent measurement of muscle action potentials from myotomes innervated by nerve roots near the stimulated instrument. The authors of this study sought to determine the ability of tEMG to detect misplaced pedicle screws (PSs).

METHODS

The authors searched the US National Library of Medicine, the Web of Science Core Collection database, and the Cochrane Central Register of Controlled Trials for PS studies. A meta-analysis of these studies was performed on a per-screw basis to determine the ability of tEMG to detect misplaced PSs. Sensitivity, specificity, and receiver operating characteristic (ROC) area under the curve (AUC) were calculated overall and in subgroups.

RESULTS

Twenty-six studies were included in the systematic review. The authors analyzed 18 studies in which tEMG was used during PS placement in the meta-analysis, representing data from 2932 patients and 15,065 screws. The overall sensitivity of tEMG for detecting misplaced PSs was 0.78, and the specificity was 0.94. The overall ROC AUC was 0.96. A tEMG current threshold of 10–12 mA (ROC AUC 0.99) and a pulse duration of 300 µsec (ROC AUC 0.97) provided the most accurate testing parameters for detecting misplaced screws. Screws most accurately conducted EMG signals (ROC AUC 0.98).

CONCLUSIONS

Triggered electromyography has very high specificity but only fair sensitivity for detecting malpositioned PSs.

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Paul M. Arnold, Paul A. Anderson and Robert F. Heary

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Jason W. Savage, Mick P. Kelly, Scott A. Ellison and Paul A. Anderson

OBJECT

The authors compared the rates of postoperative adverse events and reoperation of patients who underwent lumbar spinal fusion with bone morphogenetic protein (BMP) to those of patients who underwent lumbar spinal fusion without BMP.

METHODS

The authors retrospectively analyzed the PearlDiver Technologies, Inc., database, which contains the Medicare Standard Analytical Files, the Medicare Carrier Files, the PearlDiver Private Payer Database (UnitedHealthcare), and select state all-payer data sets, from 2005 to 2010. They identified patients who underwent lumbar spinal fusion with and without BMP. The ICD-9-CM code 84.52 was used to identify patients who underwent spinal fusion with BMP. ICD-9-CM diagnosis codes identified complications that occurred during the initial hospital stay. ICD-9-CM procedural codes were used to identify reoperations within 90 days of the index procedure. The relative risks (and 95% CIs) of BMP use compared with no BMP use (control) were calculated for the association of any complication with BMP use compared with the control.

RESULTS

Between 2005 and 2010, 460,773 patients who underwent lumbar spinal fusion were identified. BMP was used in 30.7% of these patients. The overall complication rate in the BMP group was 18.2% compared with 18.7% in the control group. The relative risk of BMP use compared with no BMP use was 0.976 (95% CI 0.963–0.989), which indicates a significantly lower overall complication rate in the BMP group (p < 0.001). In both treatment groups, patients older than 65 years had a statistically significant higher rate of postoperative complications than younger patients (p < 0.001).

CONCLUSIONS

In this large-scale institutionalized database study, BMP use did not seem to increase the overall risk of developing a postoperative complication after lumbar spinal fusion surgery.

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Michael P. Kelly, Paul A. Anderson, Rick C. Sasso and K. Daniel Riew

OBJECT

The aim of this study is to evaluate the relationship between preoperative opioid strength and outcomes of anterior cervical decompressive surgery.

METHODS

A retrospective cohort of 1004 patients enrolled in 1 of 2 investigational device exemption studies comparing cervical total disc arthroplasty (TDA) and anterior cervical discectomy and fusion (ACDF) for single-level cervical disease causing radiculopathy or myelopathy was selected. At a preoperative visit, opioid use data, Neck Disability Index (NDI) scores, 36-Item Short-Form Health Survey (SF-36) scores, and numeric rating scale scores for neck and arm pain were collected. Patients were divided into strong (oxycodone/morphine/meperidine), weak (codeine/propoxyphene/hydrocodone), and opioid-naïve groups. Preoperative and postoperative (24 months) outcomes scores were compared within and between groups using the paired t-test and ANCOVA, respectively.

RESULTS

Patients were categorized as follows: 226 strong, 762 weak, and 16 opioid naïve. The strong and weak groups were similar with respect to age, sex, race, marital status, education level, Worker’s Compensation status, litigation status, and alcohol use. At 24-month follow-up, no differences in change in arm or neck pain scores (arm: strong −52.3, weak −50.6, naïve −54.0, p = 0.244; neck: strong −52.7, weak −50.8, naïve −44.6, p = 0.355); NDI scores (strong −36.0, weak −33.3, naïve −32.3, p = 0.181); or SF-36 Physical Component Summary scores (strong: 14.1, weak 13.3, naïve 21.7, p = 0.317) were present. Using a 15-point improvement in NDI to determine success, the authors found no between-groups difference in success rates (strong 80.6%, weak 82.7%, naïve 73.3%, p = 0.134). No difference existed between treatment arms (TDA vs ACDF) for any outcome at any time point.

CONCLUSIONS

Preoperative opioid strength did not adversely affect outcomes in this analysis. Careful patient selection can yield good results in this patient population.

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James T. Bernatz and Paul A. Anderson

OBJECT

The rate of 30-day readmissions is rapidly gaining significance as a quality metric and is increasingly used to evaluate performance. An analysis of the present 30-day readmission rate in the spine literature is needed to aid the development of policies to decrease the frequency of readmissions. The authors examine 2 questions: 1) What is the 30-day readmission rate as reported in the spine literature? 2) What study factors impact the rate of 30-day readmissions?

METHODS

This study was registered with Prospera (CRD42014015319), and 4 electronic databases (PubMed, Cochrane Library, Web of Science, and Google Scholar) were searched for articles. A systematic review and meta-analysis was performed to assess the current 30-day readmission rate in spine surgery. Thirteen studies met inclusion criteria. The readmission rate as well as data source, time from enrollment, sample size, demographics, procedure type and spine level, risk factors for readmission, and causes of readmission were extrapolated from each study.

RESULTS

The pooled 30-day readmission rate was 5.5% (95% CI 4.2%–7.4%). Studies from single institutions reported the highest 30-day readmission rate at 6.6% (95% CI 3.8%–11.1%), while multicenter studies reported the lowest at 4.7% (95% CI 2.3%–9.7%). Time from enrollment had no statistically significant effect on the 30-day readmission rate. Studies including all spinal levels had a higher 30-day readmission rate (6.1%, 95% CI 4.1%–8.9%) than exclusively lumbar studies (4.6%, 95% CI 2.5%–8.2%); however, the difference between the 2 rates was not statistically significant (p = 0.43). The most frequently reported risk factors associated with an increased odds of 30-day readmission on multivariate analysis were an American Society of Anesthesiology score of 4+, operative duration, and Medicare/Medicaid insurance. The most common cause of readmission was wound complication (39.3%).

CONCLUSIONS

The 30-day readmission rate following spinal surgery is between 4.2% and 7.4%. The range, rather than the exact result, should be considered given the significant heterogeneity among studies, which indicates that there are factors such as demographics, procedure types, and individual institutional factors that are important and affect this outcome variable. The pooled analysis of risk factors and causes of readmission is limited by the lack of reporting in most of the spine literature.