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Praveen V. Mummaneni, Erica F. Bisson, Panagiotis Kerezoudis, Steven Glassman, Kevin Foley, Jonathan R. Slotkin, Eric Potts, Mark Shaffrey, Christopher I. Shaffrey, Domagoj Coric, John Knightly, Paul Park, Kai-Ming Fu, Clinton J. Devin, Silky Chotai, Andrew K. Chan, Michael Virk, Anthony L. Asher and Mohamad Bydon

OBJECTIVE

Lumbar spondylolisthesis is a degenerative condition that can be surgically treated with either open or minimally invasive decompression and instrumented fusion. Minimally invasive surgery (MIS) approaches may shorten recovery, reduce blood loss, and minimize soft-tissue damage with resultant reduced postoperative pain and disability.

METHODS

The authors queried the national, multicenter Quality Outcomes Database (QOD) registry for patients undergoing posterior lumbar fusion between July 2014 and December 2015 for Grade I degenerative spondylolisthesis. The authors recorded baseline and 12-month patient-reported outcomes (PROs), including Oswestry Disability Index (ODI), EQ-5D, numeric rating scale (NRS)–back pain (NRS-BP), NRS–leg pain (NRS-LP), and satisfaction (North American Spine Society satisfaction questionnaire). Multivariable regression models were fitted for hospital length of stay (LOS), 12-month PROs, and 90-day return to work, after adjusting for an array of preoperative and surgical variables.

RESULTS

A total of 345 patients (open surgery, n = 254; MIS, n = 91) from 11 participating sites were identified in the QOD. The follow-up rate at 12 months was 84% (83.5% [open surgery]; 85% [MIS]). Overall, baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts. Two hundred fifty seven patients underwent 1-level fusion (open surgery, n = 181; MIS, n = 76), and 88 patients underwent 2-level fusion (open surgery, n = 73; MIS, n = 15). Patients in both groups reported significant improvement in all primary outcomes (all p < 0.001). MIS was associated with a significantly lower mean intraoperative estimated blood loss and slightly longer operative times in both 1- and 2-level fusion subgroups. Although the LOS was shorter for MIS 1-level cases, this was not significantly different. No difference was detected with regard to the 12-month PROs between the 1-level MIS versus the 1-level open surgical groups. However, change in functional outcome scores for patients undergoing 2-level fusion was notably larger in the MIS cohort for ODI (−27 vs −16, p = 0.1), EQ-5D (0.27 vs 0.15, p = 0.08), and NRS-BP (−3.5 vs −2.7, p = 0.41); statistical significance was shown only for changes in NRS-LP scores (−4.9 vs −2.8, p = 0.02). On risk-adjusted analysis for 1-level fusion, open versus minimally invasive approach was not significant for 12-month PROs, LOS, and 90-day return to work.

CONCLUSIONS

Significant improvement was found in terms of all functional outcomes in patients undergoing open or MIS fusion for lumbar spondylolisthesis. No difference was detected between the 2 techniques for 1-level fusion in terms of patient-reported outcomes, LOS, and 90-day return to work. However, patients undergoing 2-level MIS fusion reported significantly better improvement in NRS-LP at 12 months than patients undergoing 2-level open surgery. Longer follow-up is needed to provide further insight into the comparative effectiveness of the 2 procedures.

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Anthony L. Asher, Silky Chotai, Clinton J. Devin, Theodore Speroff, Frank E. Harrell Jr., Hui Nian, Robert S. Dittus, Praveen V. Mummaneni, John J. Knightly, Steven D. Glassman, Mohamad Bydon, Kristin R. Archer, Kevin T. Foley and Matthew J. McGirt

OBJECTIVE

Prospective longitudinal outcomes registries are at the center of evidence-driven health care reform. Obtaining real-world outcomes data at 12 months can be costly and challenging. In the present study, the authors analyzed whether 3-month outcome measurements sufficiently represent 12-month outcomes for patients with degenerative lumbar disease undergoing surgery.

METHODS

Data from 3073 patients undergoing elective spine surgery for degenerative lumbar disease were entered into a prospective multicenter registry (N2QOD). Baseline, 3-month, and 12-month follow-up Oswestry Disability Index (ODI) scores were recorded. The absolute differences between actual 12- and 3-month ODI scores was evaluated. Additionally, the authors analyzed the absolute difference between actual 12-month ODI scores and a model-predicted 12-month ODI score (the model used patients' baseline characteristics and actual 3-month scores). The minimal clinically important difference (MCID) for ODI of 12.8 points and the substantial clinical benefit (SCB) for ODI of 18.8 points were used based on the previously published values. The concordance rate of achieving MCID and SCB for ODI at 3-and 12-months was computed.

RESULTS

The 3-month ODI scores differed from 12-month scores by an absolute difference of 11.9 ± 10.8, and predictive modeling estimations of 12-month ODI scores differed from actual 12-month scores by a mean (± SD) of 10.7 ± 9.0 points (p = 0.001). Sixty-four percent of patients (n = 1982) achieved an MCID for ODI at 3 months in comparison with 67% of patients (n = 2088) by 12 months; 51% (n = 1731) and 61% (n = 1860) of patients achieved SCB for ODI at 3 months and 12 months, respectively. Almost 20% of patients had ODI scores that varied at least 20 points (the point span of an ODI functional category) between actual 3- and 12-month values. In the aggregate analysis of achieving MCID, 77% of patients were concordant and 23% were discordant in achieving or not achieving MCID at 3 and 12 months. The discordance rates of achieving or not achieving MCID for ODI were in the range of 19% to 27% for all diagnoses and treatments (decompression with and without fusion). The positive and negative predictive value of 3-months ODI to predict 12-month ODI was 86% and 60% for MCID and 82% and 67% for SCB.

CONCLUSIONS

Based on their findings, the authors conclude the following: 1) Predictive methods for functional outcome based on early patient experience (i.e., baseline and/or 3-month data) should be used to help evaluate the effectiveness of procedures in patient populations, rather than serving as a proxy for long-term individual patient experience. 2) Prospective longitudinal registries need to span at least 12 months to determine the effectiveness of spine care at the individual patient and practitioner level.

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Silky Chotai, Scott L. Parker, Ahilan Sivaganesan, J. Alex Sielatycki, Anthony L. Asher, Matthew J. McGirt and Clinton J. Devin

OBJECT

There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs.

METHODS

Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis).

RESULTS

Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1 ± 17.7 vs 25.3 ± 18.3, p = 0.02). However, there was no difference in the change scores in ODI and absolute scores across all other PROs between the 2 groups. In multivariable linear regression analysis, after controlling for an array of preoperative variables, the occurrence of a major complication was not associated with worsening ODI scores 12 months after surgery. There was no difference in the percentage of patients achieving the MCID for disability (66% vs 64%), back pain (55% vs 56%), leg pain (62% vs 59%), or quality of life (19% vs 14%) or in patient satisfaction rates (82% vs 80%) between those without and with major complications.

CONCLUSIONS

Major complications within 90 days following lumbar spine surgery have significant impact on the short-term PROs. Patients with complications, however, do eventually achieve clinically meaningful outcomes and report satisfaction equivalent to those without major complications. This information allows a physician to counsel patients on the fact that a complication creates frustration, cost, and inconvenience; however, it does not appear to adversely affect clinically meaningful long-term outcomes and satisfaction.

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Silky Chotai, Yi Liu, Jun Pan and Songtao Qi

OBJECT

Rathke's cleft cysts (RCCs) are benign lesions with a location that is entirely intrasellar, intrasellar with suprasellar extension (intrasuprasellar), or purely suprasellar. The recurrence of RCC is relatively uncommon. The present study was conducted to report clinical characteristics, histological features, and outcomes based on location of the cyst with a primary focus on analyzing the predictors of squamous metaplasia and recurrence in these 3 types of RCCs.

METHODS

A retrospective review of the medical records of patients with symptomatic RCCs who had undergone resection at the authors' institution was conducted. Data points, including clinical presentation, preoperative endocrine status, operative details, imaging findings, pathology, and clinical outcomes, were reviewed. A multivariable regression model was used to identify predictors of recurrence.

RESULTS

The mean age of the 87 eligible patients, 64 females and 23 males, was 41 ± 14 years (range 10–73 years). Sixteen patients (18%) had an entirely intrasellar RCC, 21 (24%) had a purely suprasellar cyst, and 50 (58%) had an intrasuprasellar RCC. The mean cyst volume was 2.4 ± 0.9 cm3 (range 0.36–4.9 cm3). Headache was the most frequent initial symptom (76%) followed by visual disturbance (45%). The transsphenoidal approach was performed for all intrasellar RCCs (16 cysts) and 33 of 50 intrasuprasellar RCCs. The transcranial route was used for all suprasellar cysts (21 cysts) and 17 of 50 intrasuprasellar RCCs. Squamous metaplasia was present in 27 (31%) of 87 RCCs. The occurrence of squamous metaplasia was associated with cyst location (p = 0.027), T1 signal intensity (p = 0.004) and ring enhancement on Gd-enhanced MRI (p = 0.017), and cyst volume (p = 0.045). A suprasellar location (p = 0.048, OR 3.89, 95% CI 1.010–15.020), ring enhancement on Gd-enhanced MRI (p = 0.028, OR 3.922, 95% CI 1.158–13.288), hypointensity on T1-weighted MRI (p = 0.002, OR 6.86, 95% CI 1.972–23.909), and cyst volume (p = 0.01, OR 0.367, 95% CI 0.170–0.789) were independent predictors of squamous metaplasia. The mean time to reaccumulation (11 [12.6%] of 87 cases) and recurrence (7 [8%] of 87 cases) was 14 ± 6 months. Recurrence-free survival was 84.5% at a mean of 98.2 ± 4.6 months after treatment. A suprasellar cyst location (p = 0.007, OR 7.7, 95% CI 1.75–34.54), the occurrence of squamous metaplasia (p = 0.007, OR 19.3, 95% CI 2.25–165.18), and isointensity on T2-weighted MRI (p = 0.041, OR 10.29, 95% CI 1.094–96.872) were the independent predictors of RCC recurrence.

CONCLUSIONS

A suprasellar cyst location, the occurrence of squamous metaplasia, and isointensity on T2-weighted MRI were independent predictors of RCC recurrence. The extent of resection and type of surgical approach used were not associated with recurrence. A tailored extent of resection based on cyst location and predictive factors is recommended.

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Song-tao Qi, Yi Liu, Jun Pan, Silky Chotai and Lu-xiong Fang

Object

The completeness of meningioma resection depends on the resection of dura mater invaded by the tumor. The pathological changes of the dura around the tumor can be interpreted by evaluating the dural tail sign (DTS) on MRI studies. The goal of this study was to clarify the pathological characteristics of the DTSs, propose a classification based on the histopathological and radiological correlation, and identify the invasive range of tumor cells in different types of DTS.

Methods

The authors retrospectively reviewed 179 patients with convexity meningiomas who underwent Simpson Grade I resection. All patients underwent an enhanced MRI examination preoperatively. The convexity meningiomas were dichotomized into various subtypes in accordance with the 2007 WHO classification of tumors of the CNS, and the DTS was identified based on the Goldsher criteria. The range of resection of the involved dura was 3 cm from the base of the tumor, which corresponded with the length of DTS on MRI studies. Histopathological examination of dura at 0.5, 1.0, 1.5, 2.0, 2.5, and 3.0 cm from the base of the tumor was conducted, and the findings were correlated with the preoperative MRI appearance of the DTS.

Results

A total of 154 (86%) of 179 convexity meningiomas were classified into WHO Grade I subtype, including transitional (44 [28.6%] of 154), meningothelial (36 [23.4%] of 154), fibrous (23 [14.9%] of 154), psammomatous (22 [14.3%] of 154), secretory (10 [6.5%] of 154), and angiomatous (19 [12.3%] of 154). The other 25 (14%) were non–Grade I (WHO) tumors, including atypical (12 [48%] of 25), anaplastic (5 [20%] of 25), and papillary (8 [32%] of 25). The DTS was classified into 5 types: smooth (16 [8.9%] of 179), nodular (36 [20.1%] of 179), mixed (57 [31.8%] of 179), symmetrical multipolar (15 [8.4%] of 179), and asymmetrical multipolar (55 [30.7%] of 179). There was a significant difference in distribution of DTS type between Grade I and non–Grade I tumors (p = 0.004), whereas the difference was not significant among Grade I tumors (0.841) or among non–Grade I tumors (p = 0.818). All smooth-type DTSs were encountered in Grade I tumors, and the mixed DTS (52 [33.8%] of 154) was the most common type in these tumors. Nodular-type DTS was more commonly seen in non–Grade I tumors (12 [48%] of 25). Tumor invasion was found in 88.3% (158 of 179) of convexity meningiomas, of which the range of invasion in 82.3% (130 of 158) was within 2 cm and that in 94.9% (150 of 158) was within 2.5 cm. The incidence of invasion and the range invaded by tumor cells varied in different types of DTS, and differences were statistically significant (p < 0.001).

Conclusions

Nodular-type DTS on MRI studies might be associated with non–Grade I tumors. The range of dural resection for convexity meningiomas should be 2.5 cm from the tumor base, and if this extent of resection is not feasible, the type of DTS should be considered. However, for skull base meningiomas, in which mostly Simpson Grade II resection is achieved, the use of this classification should be further validated. The classification of DTS enables the surgeon to predict preoperatively and then to achieve the optimal range of dural resection that might significantly reduce the recurrence rate of meningiomas.