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Sheeraz A. Qureshi, Steven McAnany, Vadim Goz, Steven M. Koehler, and Andrew C. Hecht

Object

In recent years, there has been increased interest in the use of cervical disc replacement (CDR) as an alternative to anterior cervical discectomy and fusion (ACDF). While ACDF is a proven intervention for patients with myelopathy or radiculopathy, it does have inherent limitations. Cervical disc replacement was designed to preserve motion, avoid the limitations of fusion, and theoretically allow for a quicker return to activity. A number of recently published systematic reviews and randomized controlled trials have demonstrated positive clinical results for CDR, but no studies have revealed which of the 2 treatment strategies is more cost-effective. The purpose of this study was to evaluate the cost-effectiveness of CDR and ACDF by using the power of decision analysis. Additionally, the authors aimed to identify the most critical factors affecting procedural cost and effectiveness and to define thresholds for durability and function to focus and guide future research.

Methods

The authors created a surgical decision model for the treatment of single-level cervical disc disease with associated radiculopathy. The literature was reviewed to identify possible outcomes and their likelihood following CDR and ACDF. Health state utility factors were determined from the literature and assigned to each possible outcome, and procedural effectiveness was expressed in units of quality-adjusted life years (QALYs). Using ICD-9 procedure codes and data from the Nationwide Inpatient Sample, the authors calculated the median cost of hospitalization by multiplying hospital charges by the hospital-specific cost-to-charge ratio. Gross physician costs were determined from the mean Medicare reimbursement for each current procedural terminology (CPT) code. Uncertainty as regards both cost and effectiveness numbers was assessed using sensitivity analysis.

Results

In the reference case, the model assumed a 20-year duration for the CDR prosthesis. Cervical disc replacement led to higher average QALYs gained at a lower cost to society if both strategies survived for 20 years ($3042/QALY for CDR vs $8760/QALY for ACDF). Sensitivity analysis revealed that CDR needed to survive at least 9.75 years to be considered a more cost-effective strategy than ACDF. Cervical disc replacement becomes an acceptable societal strategy as the prosthesis survival time approaches 11 years and the $50,000/QALY gained willingness-to-pay threshold is crossed. Sensitivity analysis also indicated that CDR must provide a utility state of at least 0.796 to be cost-effective.

Conclusions

Both CDR and ACDF were shown to be cost-effective procedures in the reference case. Results of the sensitivity analysis indicated that CDR must remain functional for at least 14 years to establish greater cost-effectiveness than ACDF. Since the current literature has yet to demonstrate with certainty the actual durability and long-term functionality of CDR, future long-term studies are required to validate the present analysis.

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Karim A. Shafi, Yuri A. Pompeu, Avani S. Vaishnav, Eric Mai, Ahilan Sivaganesan, Pratyush Shahi, and Sheeraz A. Qureshi

OBJECTIVE

The accuracy of percutaneous pedicle screw placement has increased with the advent of robotic and surgical navigation technologies. However, the effect of robotic intraoperative screw size and trajectory templating remains unclear. The purpose of this study was to compare pedicle screw sizes and accuracy of placement using robotic navigation (RN) versus skin-based intraoperative navigation (ION) alone in minimally invasive lumbar fusion procedures.

METHODS

A retrospective cohort study was conducted using a single-institution registry of spine procedures performed over a 4-year period. Patients who underwent 1- or 2-level primary or revision minimally invasive surgery (MIS)–transforaminal lumbar interbody fusion (TLIF) with pedicle screw placement, via either robotic assistance or surgical navigation alone, were included. Demographic, surgical, and radiographic data were collected. Pedicle screw type, quantity, length, diameter, and the presence of endplate breach or facet joint violation were assessed. Statistical analysis using the Student t-test and chi-square test was performed to evaluate the differences in pedicle screw sizes and the accuracy of placement between both groups.

RESULTS

Overall, 222 patients were included, of whom 92 underwent RN and 130 underwent ION MIS-TLIF. A total of 403 and 534 pedicle screws were placed with RN and ION, respectively. The mean screw diameters were 7.25 ± 0.81 mm and 6.72 ± 0.49 mm (p < 0.001) for the RN and ION groups, respectively. The mean screw length was 48.4 ± 4.48 mm in the RN group and 45.6 ± 3.46 mm in the ION group (p < 0.001). The rates of “ideal” pedicle screws in the RN and ION groups were comparable at 88.5% and 88.4% (p = 0.969), respectively. The overall screw placement was also similar. The RN cohort had 63.7% screws rated as good and 31.4% as acceptable, while 66.1% of ION-placed screws had good placement and 28.7% had acceptable placement (p = 0.661 and p = 0.595, respectively). There was a significant reduction in high-grade breaches in the RN group (0%, n = 0) compared with the ION group (1.2%, n = 17, p = 0.05).

CONCLUSIONS

The results of this study suggest that robotic assistance allows for placement of screws with greater screw diameter and length compared with surgical navigation alone, although with similarly high accuracy. These findings have implied that robotic platforms may allow for safe placement of the “optimal screw,” maximizing construct stability and, thus, the ability to obtain a successful fusion.

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Branko Skovrlj, Justin R. Mascitelli, Martin B. Camins, Amish H. Doshi, and Sheeraz A. Qureshi

A 65-year-old woman underwent an uneventful C3–4 anterior cervical discectomy and fusion for a large, symptomatic disc herniation. On postoperative Day 1 the patient suffered a sudden, acute respiratory compromise. Emergency fiberoptic intubation revealed significant anterior neck swelling with concern for physical obstruction of the airway. Computed tomography of the neck did not demonstrate an expanding hematoma. The patient was managed with surgical wound exploration and washout. Examination of the anterior neck after incision of the prior surgical site revealed a large volume of Surgifoam under high pressure, which was greater than the amount used during the initial surgery. Thorough washout of the surgical site did not reveal any swelling of the prevertebral soft tissues or hematoma, and the Hemovac drain did not appear to be occluded. The patient was extubated on the 2nd postoperative day and is symptom free 12 months after surgery. To the authors' knowledge, this report represents the first reported complication of acute respiratory failure from Surgifoam overexpansion after anterior cervical surgery.

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Sheeraz Qureshi, Vadim Goz, Steven McAnany, Samuel K. Cho, Andrew C. Hecht, Rick B. Delamarter, and Michael G. Fehlings

Object

Cost-effectiveness analysis (CEA) of medical interventions has become increasingly relevant to the discussion of optimization of care. The use of utility scales in CEA permits a quantitative assessment of effectiveness of a given intervention. There are no published utility values for degenerative disc disease (DDD) of the cervical spine, anterior cervical discectomy and fusion (ACDF), or cervical disc replacement (CDR). The purpose of this study was to define health utility values for those health states.

Methods

The 36-Item Short Form Health Survey data from the ProDisc-C investigational device exemption study were obtained for single-level DDD at baseline and 24 months postoperatively after ACDF or CDR procedures. Patients in the original study were randomized to either ACDF or CDR. Utilizing a commercially available Short Form–6 dimensions program, utility scores were calculated for each health state using a set of parametric preference weights obtained from a sample of the general population using the recognized valuation technique of standard gamble.

Results

The baseline health state utility (HSU) value for a patient with single-level DDD was 0.54 in both the ACDF and CDR groups. Postoperative changes in HSU values were seen in both intervention groups at 24 months. Cervical disc replacement had a HSU value of 0.72. Anterior cervical discectomy and fusion was found to have a postoperative utility state of 0.71. No statistically significant difference was found in the HSU for ACDF and CDR at 24 months of follow-up.

Conclusions

This study represents the first calculated HSU value for a patient with single-level cervical DDD. Additionally, 2 common treatment interventions for this disease state were assessed. Both treatments were found to have significant impact on the HSU values. These values are integral to future CEA of ACDF and CDR.

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Ellen M. Soffin, Douglas S. Wetmore, Lauren A. Barber, Avani S. Vaishnav, James D. Beckman, Todd J. Albert, Catherine H. Gang, and Sheeraz A. Qureshi

OBJECTIVE

Enhanced recovery after surgery (ERAS) pathways are associated with improved outcomes, lower morbidity and complications, and higher patient satisfaction in multiple surgical subspecialties. Despite these gains, there are few data to guide the application of ERAS concepts to spine surgery. The authors report the development and implementation of the first ERAS pathway for patients undergoing anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA).

METHODS

This was a retrospective cohort study of prospectively collected data. The authors created a multidisciplinary pathway based on best available evidence for interventions that positively influence outcomes after anterior cervical spine surgery. Patients were followed prospectively up to postoperative day 90. Patient data were collected via electronic medical record review and included demographics, comorbidities, baseline and perioperative opioid use, postoperative complications, and length of hospital stay (LOS). ERAS process measures and compliance with pathway elements were also tracked.

RESULTS

Thirty-three patients were cared for under the pathway (n = 25 ACDF; n = 8 CDA). The median LOS was 416 minutes (interquartile range [IQR] 210–1643 minutes). Eight patients required an extended stay—longer than 23 hours. Reasons for extended admission included pain (n = 4), dyspnea (n = 1), hypoxia (n = 1), hypertension (n = 1), and dysphagia (n = 1). The median LOS for the 8 patients who required extended monitoring prior to discharge was 1585 minutes (IQR 1423–1713 minutes). Overall pathway compliance with included process measures was 85.6%. The median number of ERAS process elements delivered to each patient was 18. There was no strong association between LOS and number of ERAS process elements provided (Pearson’s r = −0.20). Twelve percent of the cohort was opioid tolerant on the day of surgery. There were no significant differences between total intraoperatively or postanesthesia care unit–administered opioid, or LOS, between opioid-tolerant and opioid-naïve patients. There were no complications requiring readmission.

CONCLUSIONS

An ERAS pathway for anterior cervical spine surgery facilitates safe, prompt discharge. The ERAS pathway was associated with minimal complications, and no readmissions within 90 days of surgery. Pain and respiratory compromise were both linked with extended LOS in this cohort. Further prospective studies are needed to confirm the potential benefits of ERAS for anterior cervical spine surgery, including longer-term complications, cost, and functional outcomes.

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Francis C. Lovecchio, Avani S. Vaishnav, Michael E. Steinhaus, Yahya A. Othman, Catherine Himo Gang, Sravisht Iyer, Steven J. McAnany, Todd J. Albert, and Sheeraz A. Qureshi

OBJECTIVE

In an effort to prevent loss of segmental lordosis (SL) with minimally invasive interbody fusions, manufacturers have increased the amount of lordosis that is built into interbody cages. However, the relationship between cage lordotic angle and actual SL achieved intraoperatively remains unclear. The purpose of this study was to determine if the lordotic angle manufactured into an interbody cage impacts the change in SL during minimally invasive surgery (MIS) for lumbar interbody fusion (LIF) done for degenerative pathology.

METHODS

The authors performed a retrospective review of a single-surgeon database of adult patients who underwent primary LIF between April 2017 and December 2018. Procedures were performed for 1–2-level lumbar degenerative disease using contemporary MIS techniques, including transforaminal LIF (TLIF), lateral LIF (LLIF), and anterior LIF (ALIF). Surgical levels were classified on lateral radiographs based on the cage lordotic angle (6°–8°, 10°–12°, and 15°–20°) and the position of the cage in the disc space (anterior vs posterior). Change in SL was the primary outcome of interest. Subgroup analyses of the cage lordotic angle within each surgical approach were also conducted.

RESULTS

A total of 116 surgical levels in 98 patients were included. Surgical approaches included TLIF (56.1%), LLIF (32.7%), and ALIF (11.2%). There were no differences in SL gained by cage lordotic angle (2.7° SL gain with 6°–8° cages, 1.6° with 10°–12° cages, and 3.4° with 15°–20° cages, p = 0.581). Subgroup analysis of LLIF showed increased SL with 15° cages only (p = 0.002). The change in SL was highest after ALIF (average increase 9.8° in SL vs 1.8° in TLIF vs 1.8° in LLIF, p < 0.001). Anterior position of the cage in the disc space was also associated with a significantly greater gain in SL (4.2° vs −0.3°, p = 0.001), and was the only factor independently correlated with SL gain (p = 0.016).

CONCLUSIONS

Compared with cage lordotic angle, cage position and approach play larger roles in the generation of SL in 1–2-level MIS for lumbar degenerative disease.

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Ellen M. Soffin, Douglas S. Wetmore, James D. Beckman, Evan D. Sheha, Avani S. Vaishnav, Todd J. Albert, Catherine H. Gang, and Sheeraz A. Qureshi

OBJECTIVE

Enhanced recovery after surgery (ERAS) and multimodal analgesia are established care models that minimize perioperative opioid consumption and promote positive outcomes after spine surgery. Opioid-free anesthesia (OFA) is an emerging technique that may achieve similar goals. The purpose of this study was to evaluate an OFA regimen within an ERAS pathway for lumbar decompressive surgery and to compare perioperative opioid requirements in a matched cohort of patients managed with traditional opioid-containing anesthesia (OCA).

METHODS

The authors performed a retrospective analysis of prospectively collected data. They included 36 patients who underwent lumbar decompression under their ERAS pathway for spinal decompression between February and August 2018. Eighteen patients who received OFA were matched in a 1:1 ratio to a cohort managed with a traditional OCA regimen. The primary outcome was total perioperative opioid consumption. Postoperative pain scores (measured using the numerical rating scale [NRS]), opioid consumption (total morphine equivalents), and length of stay (time to readiness for discharge) were compared in the postanesthesia care unit (PACU). The authors also assessed compliance with ERAS process measures and compared compliance during 3 phases of care: pre-, intra-, and postoperative.

RESULTS

There was a significant reduction in total perioperative opioid consumption in patients who received OFA (2.43 ± 0.86 oral morphine equivalents [OMEs]; mean ± SEM), compared to patients who received OCA (38.125 ± 6.11 OMEs). There were no significant differences in worst postoperative pain scores (NRS scores 2.55 ± 0.70 vs 2.58 ± 0.73) or opioid consumption (5.28 ± 1.7 vs 4.86 ± 1.5 OMEs) in the PACU between OFA and OCA groups, respectively. There was a clinically significant decrease in time to readiness for discharge from the PACU associated with OFA (37 minutes), although this was not statistically significantly different. The authors found high overall compliance with ERAS process measures (91.4%) but variation in compliance according to phase of care. The highest compliance occurred during the preoperative phase (94.71% ± 2.88%), and the lowest compliance occurred during the postoperative phase of care (85.4% ± 5.7%).

CONCLUSIONS

OFA within an ERAS pathway for lumbar spinal decompression represents an opportunity to minimize perioperative opioid exposure without adversely affecting pain control or recovery. This study reveals opportunities for patient and provider education to reinforce ERAS and highlights the postoperative phase of care as a time when resources should be focused to increase ERAS adherence.

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Sohrab Virk, Avani S. Vaishnav, Jung Kee Mok, Steven McAnany, Sravisht Iyer, Todd J. Albert, Catherine Himo Gang, and Sheeraz A. Qureshi

OBJECTIVE

Preoperative pain assessment is often used to gauge the amount of disability in patients with lumbar disc herniation. How high preoperative pain scores impact the clinical course and outcomes of patients after lumbar microdiscectomy is not always clear. Here, the authors aimed to determine whether patients reporting higher preoperative pain scores have worse outcomes after lumbar microdiscectomy than those reporting lower preoperative scores.

METHODS

The authors performed a retrospective review of patients with symptomatic lumbar disc herniations that had failed to improve with nonsurgical methods and who had undergone tubular lumbar microdiscectomy. Health-related quality of life (HRQOL) scores had been collected in the preoperative and postoperative period. The anatomical severity of disease was graded based on lumbar disc health (Pfirrmann classification), facet degeneration, thecal sac cross-sectional area, and disc herniation grade. Data on each patient’s narcotic consumption and length of stay were collected. A Student t-test and chi-square test were used to compare patients with high preoperative pain scores (HP cohort) and those with lower preoperative scores (non-HP cohort).

RESULTS

One hundred thirty-eight patients were included in this analysis. The 47 patients in the HP cohort had taken more preoperative opioids (12.0 ± 21.2 vs 3.6 ± 11.1 morphine equivalent doses, p = 0.01). However, there was no statistically significant difference in Pfirrmann classification (p > 0.15), facet grade (p > 0.11), thecal sac cross-sectional area (p = 0.45), or disc herniation grade (p = 0.39) between the HP and non-HP cohorts. The latter cohort had statistically significant higher preoperative PROMIS scores (36.5 ± 7.0 vs 29.9 ± 6.4, p < 0.001), SF-12 mental component summary scores (48.7 ± 11.5 vs 38.9 ± 16.1, p < 0.001), and SF-12 physical component summary scores (PCS; 32.4 ± 8.6 vs 27.5 ± 10.0, p = 0.005), but a lower Oswestry Disability Index (56.4 ± 22.1 vs 35.4 ± 15.5, p < 0.001). There were only two time points after microdiscectomy when the HP cohort had worse HRQOL scores: at the 2-week follow-up for SF-12 PCS scores (32.4 ± 8.6 vs 29.3 ± 7.1, p = 0.03) and the 12-week follow-up for PROMIS scores (45.2 ± 9.5 vs 39.5 ± 7.1, p = 0.01). All other postoperative HRQOL measurements were similar between the two cohorts (p > 0.05).

CONCLUSIONS

A patient’s perceived severity of disease often does not correlate with the actual clinical pathology on imaging. Although patients who report high pain and have a symptomatic lumbar disc herniation may describe their pain as more extreme, they should be counseled that the outcomes of microdiscectomy are positive.

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Pratyush Shahi, Junho Song, Sidhant Dalal, Dimitra Melissaridou, Daniel J. Shinn, Kasra Araghi, Eric Mai, Evan Sheha, James Dowdell, Sheeraz A. Qureshi, and Sravisht Iyer

OBJECTIVE

The objective of this study was to assess the outcomes of minimally invasive lumbar decompression in patients ≥ 80 years of age and compare them with those of younger age groups.

METHODS

This was a retrospective cohort study. Patients who underwent primary unilateral laminotomy for bilateral decompression (ULBD) (any number of levels) and had a minimum of 1 year of follow-up were included and divided into three groups by age: < 60 years, 60–79 years, and ≥ 80 years. The outcome measures were 1) patient-reported outcome measures (PROMs) (visual analog scale [VAS] back and leg, Oswestry Disability Index [ODI], 12-Item Short-Form Health Survey [SF-12] Physical Component Summary [PCS] and Mental Component Summary [MCS] scores, and Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS PF]); 2) percentage of patients achieving the minimal clinically important difference (MCID) and the time taken to do so; and 3) complications and reoperations. Two postoperative time points were defined: early (< 6 months) and late (≥ 6 months).

RESULTS

A total of 345 patients (< 60 years: n = 94; 60–79 years: n = 208; ≥ 80 years: n = 43) were included in this study. The groups had significantly different average BMIs (least in patients aged ≥ 80 years), age-adjusted Charlson Comorbidity Indices (greatest in the ≥ 80-year age group), and operative times (greatest in 60- to 79-year age group). There was no difference in sex, number of operated levels, and estimated blood loss between groups.

Compared with the preoperative values, the < 60-year and 60- to 79-year age groups showed a significant improvement in most PROMs at both the early and late time points. In contrast, the ≥ 80-year age group only showed significant improvement in PROMs at the late time point. Although there were significant differences between the groups in the magnitude of improvement (least improvement in ≥ 80-year age group) at the early time point in VAS back and leg, ODI, and SF-12 MCS, no significant difference was seen at the late time point except in ODI (least improvement in ≥ 80-year group). The overall MCID achievement rate decreased, moving from the < 60-year age group toward the ≥ 80-year age group at both the early (64% vs 51% vs 41% ) and late (72% vs 58% vs 52%) time points. The average time needed to achieve the MCID in pain and disability increased, moving from the < 60-year age group toward the ≥ 80-year age group (2 vs 3 vs 4 months). There was no significant difference seen between the groups in terms of complications and reoperations except in immediate postoperative complications (5.3% vs 4.8% vs 14%).

CONCLUSIONS

Although in this study minimally invasive decompression led to less and slower improvement in patients ≥ 80 years of age compared with their younger counterparts, there was significant improvement compared with the preoperative baseline.

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Philip K. Louie, Basel Sheikh Alshabab, Michael H. McCarthy, Sohrab Virk, James E. Dowdell, Michael E. Steinhaus, Francis Lovecchio, Andre M. Samuel, Kyle W. Morse, Frank J. Schwab, Todd J. Albert, Sheeraz A. Qureshi, Sravisht Iyer, Yoshihiro Katsuura, Russel C. Huang, Matthew E. Cunningham, Yu-Cheng Yao, Karen Weissmann, Renaud Lafage, Virginie Lafage, and Han Jo Kim

OBJECTIVE

The objective of this study was to initially validate a recent morphological classification of cervical spine deformity pathology.

METHODS

The records of 10 patients for each of the 3 classification subgroups (flat neck, focal deformity, and cervicothoracic), as well as for 8 patients with coronal deformity only, were extracted from a prospective multicenter database of patients with cervical deformity (CD). A panel of 15 physicians of various training and professional levels (i.e., residents, fellows, and surgeons) categorized each patient into one of the 4 groups. The Fleiss kappa coefficient was utilized to evaluate intra- and interrater reliability. Accuracy, defined as properly selecting the main driver of deformity, was reported overall, by morphotype, and by reviewer experience.

RESULTS

The overall classification demonstrated a moderate to substantial agreement (round 1: interrater Fleiss kappa = 0.563, 95% CI 0.559–0.568; round 2: interrater Fleiss kappa = 0.612, 95% CI 0.606–0.619). Stratification by level of training demonstrated similar mean interrater coefficients (residents 0.547, fellows 0.600, surgeons 0.524). The mean intrarater score was 0.686 (range 0.531–0.823). A substantial agreement between rounds 1 and 2 was demonstrated in 81.8% of the raters, with a kappa score > 0.61. Stratification by level of training demonstrated similar mean intrarater coefficients (residents 0.715, fellows 0.640, surgeons 0.682). Of 570 possible questions, reviewers provided 419 correct answers (73.5%). When considering the true answer as being selected by at least one of the two main drivers of deformity, the overall accuracy increased to 86.0%.

CONCLUSIONS

This initial validation of a CD morphological classification system reiterates the importance of dynamic plain radiographs for the evaluation of patients with CD. The overall reliability of this CD morphological classification has been demonstrated. The overall accuracy of the classification system was not impacted by rater experience, demonstrating its simplicity.