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Darryl Lau, Cecilia L. Dalle Ore, Patrick Reid, Michael M. Safaee, Vedat Deviren, Justin S. Smith, Christopher I. Shaffrey and Christopher P. Ames

OBJECTIVE

The benefits and utility of routine neuromonitoring with motor and somatosensory evoked potentials during lumbar spine surgery remain unclear. This study assesses measures of performance and utility of transcranial motor evoked potentials (MEPs) during lumbar pedicle subtraction osteotomy (PSO).

METHODS

This is a retrospective study of a single-surgeon cohort of consecutive adult spinal deformity (ASD) patients who underwent lumbar PSO from 2006 to 2016. A blinded neurophysiologist reviewed individual cases for MEP changes. Multivariate analysis was performed to determine whether changes correlated with neurological deficits. Measures of performance were calculated.

RESULTS

A total of 242 lumbar PSO cases were included. MEP changes occurred in 38 (15.7%) cases; the changes were transient in 21 cases (55.3%) and permanent in 17 (44.7%). Of the patients with permanent changes, 9 (52.9%) had no recovery and 8 (47.1%) had partial recovery of MEP signals. Changes occurred at a mean time of 8.8 minutes following PSO closure (range: during closure to 55 minutes after closure). The mean percentage of MEP signal loss was 72.9%. The overall complication rate was 25.2%, and the incidence of new neurological deficits was 4.1%. On multivariate analysis, MEP signal loss of at least 50% was not associated with complication (p = 0.495) or able to predict postoperative neurological deficits (p = 0.429). Of the 38 cases in which MEP changes were observed, the observation represented a true-positive finding in only 3 cases. Postoperative neurological deficits without MEP changes occurred in 7 cases. Calculated measures of performance were as follows: sensitivity 30.0%, specificity 84.9%, positive predictive value 7.9%, and negative predictive value 96.6%. Regarding the specific characteristics of the MEP changes, only a signal loss of 80% or greater was significantly associated with a higher rate of neurological deficit (23.0% vs 0.0% for loss of less than 80%, p = 0.021); changes of less than 80% were not associated with postoperative deficits.

CONCLUSIONS

Neuromonitoring has a low positive predictive value and low sensitivity for detecting new neurological deficits. Even when neuromonitoring is unchanged, patients can still have new neurological deficits. The utility of transcranial MEP monitoring for lumbar PSO remains unclear but there may be advantages to its use.

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Michael M. Safaee, Cecilia L. Dalle Ore, Corinna C. Zygourakis, Vedat Deviren and Christopher P. Ames

OBJECTIVE

Bone morphogenetic protein (BMP) is associated with reduced rates of pseudarthrosis and has the potential to decrease the need for revision surgery. There are limited data evaluating the cost-benefit of BMP for pseudarthrosis-related prevention surgery in adult spinal deformity.

METHODS

The authors performed a single-center retrospective review of 200 consecutive patients with adult spinal deformity. Demographic data and costs of BMP, primary surgery, and revision surgery for pseudarthrosis were collected. Patients with less than 12 months of follow-up or with infection, tumor, or neuromuscular disease were excluded.

RESULTS

One hundred fifty-one patients (107 [71%] women) with a mean age of 65 years met the inclusion criteria. The mean number of levels fused was 10; BMP was used in 98 cases (65%), and the mean follow-up was 23 months. Fifteen patients (10%) underwent surgical revision for pseudarthrosis; BMP use was associated with an 11% absolute risk reduction in the rate of reoperation (17% vs 6%, p = 0.033), with a number needed to treat of 9.2. There were no significant differences in age, sex, upper instrumented vertebra, or number of levels fused in patients who received BMP. In a multivariate model including age, sex, number of levels fused, and the upper instrumented vertebra, only BMP (OR 0.250, 95% CI 0.078–0.797; p = 0.019) was associated with revision surgery for pseudarthrosis. The mean direct cost of primary surgery was $87,653 ± $19,879, and the mean direct cost of BMP was $10,444 ± $4607. The mean direct cost of revision surgery was $52,153 ± $26,985. The authors independently varied the efficacy of BMP, cost of BMP, and cost of reoperation by ± 50%; only reductions in the cost of BMP resulted in a cost savings per 100 patients. Using these data, the authors estimated a price point of $5663 in order for BMP to be cost-neutral.

CONCLUSIONS

Use of BMP was associated with a significant reduction in the rates of revision surgery for pseudarthrosis. At its current price, the direct in-hospital costs for BMP exceed the costs associated with revision surgery; however, this likely underestimates the true value of BMP when considering the savings associated with reductions in rehabilitation, therapy, medication, and additional outpatient costs.

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Cecilia L. Dalle Ore, Christopher P. Ames, Vedat Deviren and Darryl Lau

OBJECTIVE

Spinal deformity causing spinal imbalance is directly correlated to pain and disability. Prior studies suggest adult spinal deformity (ASD) patients with rheumatoid arthritis (RA) have more complex deformities and are at higher risk for complications. In this study the authors compared outcomes of ASD patients with RA following thoracolumbar 3-column osteotomies to outcomes of a matched control cohort.

METHODS

All patients with RA who underwent 3-column osteotomy for thoracolumbar deformity correction performed by the senior author from 2006 to 2016 were identified retrospectively. A cohort of patients without RA who underwent 3-column osteotomies for deformity correction was matched based on multiple clinical factors. Data regarding demographics and surgical approach, along with endpoints including perioperative outcomes, reoperations, and incidence of proximal junctional kyphosis (PJK) were reviewed. Univariate analyses were used to compare patients with RA to matched controls.

RESULTS

Eighteen ASD patients with RA were identified, and a matched cohort of 217 patients was generated. With regard to patients with RA, 11.1% were male and the mean age was 68.1 years. Vertebral column resection (VCR) was performed in 22.2% and pedicle subtraction osteotomy (PSO) in 77.8% of patients. Mean case length was 324.4 minutes and estimated blood loss (EBL) was 2053.6 ml. Complications were observed in 38.9% of patients with RA and 29.0% of patients without RA (p = 0.380), with a trend toward increased medical complications (38.9% vs 21.2%, p = 0.084). Patients with RA had a significantly higher incidence of deep vein thrombosis (DVT)/pulmonary embolism (PE) (11.1% vs 1.8%, p = 0.017) and wound infections (16.7% vs 5.1%, p = 0.046). PJK occurred in 16.7% of patients with RA, and 33.3% of RA patients underwent reoperation. Incidence rates of PJK and reoperation in matched controls were 12.9% and 25.3%, respectively (p = 0.373, p = 0.458). At follow-up, mean sagittal vertical axis (SVA) was 6.1 cm in patients with RA and 4.5 cm in matched controls (p = 0.206).

CONCLUSIONS

Findings from this study suggest that RA patients experience a higher incidence of medical complications, specifically DVT/PE. Preoperative lower-extremity ultrasounds, inferior vena cava (IVC) filter placement, and/or early initiation of DVT prophylaxis in RA patients may be indicated. Perioperative complications, morbidity, and long-term outcomes are otherwise similar to non-RA patients.

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Dominic Amara, Praveen V. Mummaneni, Christopher P. Ames, Bobby Tay, Vedat Deviren, Shane Burch, Sigurd H. Berven and Dean Chou

OBJECTIVE

Many options exist for the surgical management of adult spinal deformity. Radiculopathy and lumbosacral pain from the fractional curve (FC), typically from L4 to S1, is frequently a reason for scoliosis patients to pursue surgical intervention. The purpose of this study was to evaluate the outcomes of limited fusion of the FC only versus treatment of the entire deformity with long fusions.

METHODS

All adult scoliosis patients treated at the authors’ institution in the period from 2006 to 2016 were retrospectively analyzed. Patients with FCs from L4 to S1 > 10° and radiculopathy ipsilateral to the concavity of the FC were eligible for study inclusion and had undergone three categories of surgery: 1) FC only (FC group), 2) lower thoracic to sacrum (LT group), or 3) upper thoracic to sacrum (UT group). Primary outcomes were the rates of revision surgery and complications. Secondary outcomes were estimated blood loss, length of hospital stay, and discharge destination. Spinopelvic parameters were measured, and patients were stratified accordingly.

RESULTS

Of the 99 patients eligible for inclusion in the study, 27 were in the FC group, 46 in the LT group, and 26 in the UT group. There were no significant preoperative differences in age, sex, smoking status, prior operation, FC magnitude, pelvic tilt (PT), sagittal vertical axis (SVA), coronal balance, pelvic incidence–lumbar lordosis (PI-LL) mismatch, or proportion of well-aligned spines (SVA < 5 cm, PI-LL mismatch < 10°, and PT < 20°) among the three treatment groups. Mean follow-up was 30 (range 12–112) months, with a minimum 1-year follow-up. The FC group had a lower medical complication rate (22% [FC] vs 57% [LT] vs 58% [UT], p = 0.009) but a higher rate of extension surgery (26% [FC] vs 13% [LT] vs 4% [UT], p = 0.068). The respective average estimated blood loss (592 vs 1950 vs 2634 ml, p < 0.001), length of hospital stay (5.5 vs 8.3 vs 8.3 days, p < 0.001), and rate of discharge to acute rehabilitation (30% vs 46% vs 85%, p < 0.001) were all lower for FC and highest for UT.

CONCLUSIONS

Treatment of the FC only is associated with a lower complication rate, shorter hospital stay, and less blood loss than complete scoliosis treatment. However, there is a higher associated rate of extension of the construct to the lower or upper thoracic levels, and patients should be counseled when considering their options.

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Darryl Lau, Joseph A. Osorio, Vedat Deviren and Christopher P. Ames

OBJECTIVE

Three-column osteotomies are increasingly being used in the elderly population to correct rigid spinal deformities. There is hesitation, however, in performing the technique in older patients because of the high risk for blood loss, longer operative times, and complications. This study assesses whether age alone is an independent risk factor for complications and length of stay.

METHODS

All patients with thoracolumbar adult spinal deformity (ASD) who underwent 3-column osteotomy (vertebral column resection or pedicle subtraction osteotomy) performed by the senior author from 2006 to 2016 were identified. Demographics, clinical baseline, and surgical details were collected. Outcomes of interest included perioperative complication, ICU stay, and hospital stay. Bivariate and multivariate analyses were used to assess the association of age with outcomes of interest.

RESULTS

A total of 300 patients were included, and 38.3% were male. The mean age was 63.7 years: 10.3% of patients were younger than 50 years, 36.0% were 50–64 years, 45.7% were 65–79 years, and 8.0% were 80 years or older. The overall mean EBL was 1999 ml. The overall perioperative complication rate was 24.7%: 18.0% had a medical complication and 7.0% had a surgical complication. There were no perioperative or 30-day deaths. Age was associated with overall complications (p = 0.002) and medical-specific complications (p < 0.001); there were higher rates of overall and medical complications with increased age: 9.7% and 6.5%, respectively, for patients younger than 50 years; 16.7% and 10.2%, respectively, for patients 50–64 years; 31.4% and 22.6%, respectively, for patients 65–79 years; and 41.7% and 41.7%, respectively, for patients 80 years or older. However, after adjusting for relevant covariates on multivariate analysis, age was not an independent factor for perioperative complications. Surgical complication rates were similar among the 4 age groups. Longer ICU and total hospital stays were observed in older age groups, and age was an independent factor associated with longer ICU stay (p = 0.028) and total hospital stay (p = 0.003). ICU stays among the 4 age groups were 1.6, 2.3, 2.0, and 3.2 days for patients younger than 50 years, 50–64 years, 65–79 years, and 80 years or older, respectively. The total hospital stays stratified by age were 7.3, 7.7, 8.2, and 11.0 days for patients younger than 50 years, 50–64 years, 65–79 years, and 80 years or older, respectively.

CONCLUSIONS

Older age was associated with higher perioperative complication rates, but age alone was not an independent risk factor for complications following the 3-column osteotomy for ASD. Comorbidities and other unknown variables that come with age are likely what put these patients at higher risk for complications. Older age, however, is independently associated with longer ICU and hospital stays.

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Michael M. Safaee, Vedat Deviren, Cecilia Dalle Ore, Justin K. Scheer, Darryl Lau, Joseph A. Osorio, Fred Nicholls and Christopher P. Ames

OBJECTIVE

Proximal junctional kyphosis (PJK) is a well-recognized, yet incompletely defined, complication of adult spinal deformity surgery. There is no standardized definition for PJK, but most studies describe PJK as an increase in the proximal junctional angle (PJA) of greater than 10°–20°. Ligament augmentation is a novel strategy for PJK reduction that provides strength to the upper instrumented vertebra (UIV) and adjacent segments while also reducing junctional stress at those levels.

METHODS

In this study, ligament augmentation was used in a consecutive series of adult spinal deformity patients at a single institution. Patient demographics, including age; sex; indication for surgery; revision surgery; surgical approach; and use of 3-column osteotomies, vertebroplasty, or hook fixation at the UIV, were collected. The PJA was measured preoperatively and at last follow-up using 36-inch radiographs. Data on change in PJA and need for revision surgery were collected. Univariate and multivariate analyses were performed to identify factors associated with change in PJA and proximal junctional failure (PJF), defined as PJK requiring surgical correction.

RESULTS

A total of 200 consecutive patients were included: 100 patients before implementation of ligament augmentation and 100 patients after implementation of this technique. The mean age of the ligament augmentation cohort was 66 years, and 67% of patients were women. Over half of these cases (51%) were revision surgeries, with 38% involving a combined anterior or lateral and posterior approach. The mean change in PJA was 6° in the ligament augmentation group compared with 14° in the control group (p < 0.001). Eighty-four patients had a change in PJA of less than 10°. In a multivariate linear regression model, age (p = 0.016), use of hook fixation at the UIV (p = 0.045), and use of ligament augmentation (p < 0.001) were associated with a change in PJA. In a separate model, only ligament augmentation (OR 0.193, p = 0.012) showed a significant association with PJF.

CONCLUSIONS

Ligament augmentation represents a novel technique for the prevention of PJK and PJF. Compared with a well-matched historical cohort, ligament augmentation is associated with a significant decrease in PJK and PJF. These data support the implementation of ligament augmentation in surgery for adult spinal deformity, particularly in patients with a high risk of developing PJK and PJF.

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Michael M. Safaee, Cecilia L. Dalle Ore, Corinna C. Zygourakis, Vedat Deviren and Christopher P. Ames

OBJECTIVE

Proximal junctional kyphosis (PJK) is a well-recognized complication of surgery for adult spinal deformity and is characterized by increased kyphosis at the upper instrumented vertebra (UIV). PJK prevention strategies have the potential to decrease morbidity and cost by reducing rates of proximal junctional failure (PJF), which the authors define as radiographic PJK plus clinical sequelae requiring revision surgery.

METHODS

The authors performed an analysis of 195 consecutive patients with adult spinal deformity. Age, sex, levels fused, upper instrumented vertebra (UIV), use of 3-column osteotomy, pelvic fixation, and mean time to follow-up were collected. The authors also reviewed operative reports to assess for the use of surgical adjuncts targeted toward PJK prevention, including ligament augmentation, hook fixation, and vertebroplasty. The cost of surgery, including direct and total costs, was also assessed at index surgery and revision surgery. Only revision surgery for PJF was included.

RESULTS

The mean age of the cohort was 64 years (range 25–84 years); 135 (69%) patients were female. The mean number of levels fused was 10 (range 2–18) with the UIV as follows: 2 cervical (1%), 73 upper thoracic (37%), 108 lower thoracic (55%), and 12 lumbar (6%). Ligament augmentation was used in 99 cases (51%), hook fixation in 60 cases (31%), and vertebroplasty in 71 cases (36%). PJF occurred in 18 cases (9%). Univariate analysis found that ligament augmentation and hook fixation were associated with decreased rates of PJF. However, in a multivariate model that also incorporated age, sex, and UIV, only ligament augmentation maintained a significant association with PJF reduction (OR 0.196, 95% CI 0.050–0.774; p = 0.020). Patients with ligament augmentation, compared with those without, had a higher cost of index surgery, but ligament augmentation was overall cost effective and produced significant cost savings. In sensitivity analyses in which we independently varied the reduction in PJF, cost of ligament augmentation, and cost of reoperation by ± 50%, ligament augmentation remained a cost-effective strategy for PJF prevention.

CONCLUSIONS

Prevention strategies for PJK/PJF are limited, and their cost-effectiveness has yet to be established. The authors present the results of 195 patients with adult spinal deformity and show that ligament augmentation is associated with significant reductions in PJF in both univariate and multivariate analyses, and that this intervention is cost-effective. Future studies will need to determine if these clinical results are reproducible, but for high-risk cases, these data suggest an important role of ligament augmentation for PJF prevention and cost savings.

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Junseok Bae, Alexander A. Theologis, Russell Strom, Bobby Tay, Shane Burch, Sigurd Berven, Praveen V. Mummaneni, Dean Chou, Christopher P. Ames and Vedat Deviren

OBJECTIVE

Surgical treatment of adult spinal deformity (ASD) is an effective endeavor that can be accomplished using a variety of surgical strategies. Here, the authors assess and compare radiographic data, complications, and health-related quality-of-life (HRQoL) outcome scores among patients with ASD who underwent a posterior spinal fixation (PSF)–only approach, a posterior approach combined with lateral lumbar interbody fusion (LLIF+PSF), or a posterior approach combined with anterior lumbar interbody fusion (ALIF+PSF).

METHODS

The medical records of consecutive adults who underwent thoracolumbar fusion for ASD between 2003 and 2013 at a single institution were reviewed. Included were patients who underwent instrumentation from the pelvis to L-1 or above, had a sagittal vertical axis (SVA) of < 10 cm, and underwent a minimum of 2 years’ follow-up. Those who underwent a 3-column osteotomy were excluded. Three groups of patients were compared on the basis of the procedure performed, LLIF+PSF, ALIF+PSF, and PSF only. Perioperative spinal deformity parameters, complications, and HRQoL outcome scores (Oswestry Disability Index [ODI], Scoliosis Research Society 22-question Questionnaire [SRS-22], 36-Item Short Form Health Survey [SF-36], visual analog scale [VAS] for back/leg pain) from each group were assessed and compared with each other using ANOVA. The minimal clinically important differences used were −1.2 (VAS back pain), −1.6 (VAS leg pain), −15 (ODI), 0.587/0.375/0.8/0.42 (SRS-22 pain/function/self-image/mental health), and 5.2 (SF-36, physical component summary).

RESULTS

A total of 221 patients (58 LLIF, 91 ALIF, 72 PSF only) met the inclusion criteria. Average deformities consisted of a SVA of < 10 cm, a pelvic incidence–lumbar lordosis (LL) mismatch of > 10°, a pelvic tilt of > 20°, a lumbar Cobb angle of > 20°, and a thoracic Cobb angle of > 15°. Preoperative SVA, LL, pelvic incidence–LL mismatch, and lumbar and thoracic Cobb angles were similar among the groups. Patients in the PSF-only group had more comorbidities, those in the ALIF+PSF group were, on average, younger and had a lower body mass index than those in the LLIF+PSF group, and patients in the LLIF+PSF group had a significantly higher mean number of interbody fusion levels than those in the ALIF+PSF and PSF-only groups. At final follow-up, all radiographic parameters and the mean numbers of complications were similar among the groups. Patients in the LLIF+PSF group had proximal junctional kyphosis that required revision surgery significantly less often and fewer proximal junctional fractures and vertebral slips. All preoperative HRQoL scores were similar among the groups. After surgery, the LLIF+PSF group had a significantly lower ODI score, higher SRS-22 self-image/total scores, and greater achievement of the minimal clinically important difference for the SRS-22 pain score.

CONCLUSIONS

Satisfactory radiographic outcomes can be achieved similarly and adequately with these 3 surgical approaches for patients with ASD with mild to moderate sagittal deformity. Compared with patients treated with an ALIF+PSF or PSF-only surgical strategy, patients who underwent LLIF+PSF had lower rates of proximal junctional kyphosis and mechanical failure at the upper instrumented vertebra and less back pain, less disability, and better SRS-22 scores.

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Justin S. Smith, Christopher I. Shaffrey, Eric Klineberg, Virginie Lafage, Frank Schwab, Renaud Lafage, Han Jo Kim, Richard Hostin, Gregory M. Mundis Jr., Munish Gupta, Barthelemy Liabaud, Justin K. Scheer, Bassel G. Diebo, Themistocles S. Protopsaltis, Michael P. Kelly, Vedat Deviren, Robert Hart, Doug Burton, Shay Bess and Christopher P. Ames

OBJECTIVE

Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database.

METHODS

This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators.

RESULTS

Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1–11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up.

CONCLUSIONS

Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.