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Justin S. Smith, Christopher I. Shaffrey, Christopher P. Ames and Lawrence G. Lenke

Care of the patient with adult spinal deformity (ASD) has evolved from being primarily supportive to now having the ability to directly treat and correct the spinal pathology. The focus of this narrative literature review is to briefly summarize the history of ASD treatment, discuss the current state of the art of ASD care with focus on surgical treatment and current challenges, and conclude with a discussion of potential developments related to ASD surgery.

In the past, care for ASD was primarily based on supportive measures, including braces and assistive devices, with few options for surgical treatments that were often deemed high risk and reserved for rare situations. Advances in anesthetic and critical care, surgical techniques, and instrumentation now enable almost routine surgery for many patients with ASD. Despite the advances, there are many remaining challenges currently impacting the care of ASD patients, including increasing numbers of elderly patients with greater comorbidities, high complication and reoperation rates, and high procedure cost without clearly demonstrated cost-effectiveness based on standard criteria. In addition, there remains considerable variability across multiple aspects of ASD surgery. For example, there is currently very limited ability to provide preoperative individualized counseling regarding optimal treatment approaches (e.g., operative vs nonoperative), complication risks with surgery, durability of surgery, and likelihood of achieving individualized patient goals and satisfaction. Despite the challenges associated with the current state-of-the-art ASD treatment, surgery continues to be a primary option, as multiple reports have demonstrated the potential for surgery to significantly improve pain and disability. The future of ASD care will likely include techniques and technologies to markedly reduce complication rates, including greater use of navigation and robotics, and a shift toward individualized medicine that enables improved counseling, preoperative planning, procedure safety, and patient satisfaction.

Advances in the care of ASD patients have been remarkable over the past few decades. The current state of the art enables almost routine surgical treatment for many types of ASD that have the potential to significantly improve pain and disability. However, significant challenges remain, including high complication rates, lack of demonstrated cost-effectiveness, and limited ability to meaningfully counsel patients preoperatively on an individual basis. The future of ASD surgery will require continued improvement of predictability, safety, and sustainability.

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Thomas J. Buell, Davis G. Taylor, Ching-Jen Chen, Lauren K. Dunn, Jeffrey P. Mullin, Marcus D. Mazur, Chun-Po Yen, Mark E. Shaffrey, Christopher I. Shaffrey, Justin S. Smith and Bhiken I. Naik

OBJECTIVE

Significant blood loss and coagulopathy are often encountered during adult spinal deformity (ASD) surgery, and the optimal intraoperative transfusion algorithm is debatable. Rotational thromboelastometry (ROTEM), a functional viscoelastometric method for real-time hemostasis testing, may allow early identification of coagulopathy and improve transfusion practices. The objective of this study was to investigate the effect of ROTEM-guided blood product management on perioperative blood loss and transfusion requirements in ASD patients undergoing correction with pedicle subtraction osteotomy (PSO).

METHODS

The authors retrospectively reviewed patients with ASD who underwent single-level lumbar PSO at the University of Virginia Health System. All patients who received ROTEM-guided blood product transfusion between 2015 and 2017 were matched in a 1:1 ratio to a historical cohort treated using conventional laboratory testing (control group). Co-primary outcomes were intraoperative estimated blood loss (EBL) and total blood product transfusion volume. Secondary outcomes were perioperative transfusion requirements and postoperative subfascial drain output.

RESULTS

The matched groups (ROTEM and control) comprised 17 patients each. Comparison of matched group baseline characteristics demonstrated differences in female sex and total intraoperative dose of intravenous tranexamic acid (TXA). Although EBL was comparable between ROTEM versus control (3200.00 ± 2106.24 ml vs 3874.12 ± 2224.22 ml, p = 0.36), there was a small to medium effect size (Cohen’s d = 0.31) on EBL reduction with ROTEM. The ROTEM group had less total blood product transfusion volume (1624.18 ± 1774.79 ml vs 2810.88 ± 1847.46 ml, p = 0.02), and the effect size was medium to large (Cohen’s d = 0.66). This difference was no longer significant after adjusting for TXA (β = −0.18, 95% confidence interval [CI] −1995.78 to 671.64, p = 0.32). More cryoprecipitate and less fresh frozen plasma (FFP) were transfused in the ROTEM group patients (cryoprecipitate units: 1.24 ± 1.20 vs 0.53 ± 1.01, p = 0.03; FFP volume: 119.76 ± 230.82 ml vs 673.06 ± 627.08 ml, p < 0.01), and this remained significant after adjusting for TXA (cryoprecipitate units: β = 0.39, 95% CI 0.05 to 1.73, p = 0.04; FFP volume: β = −0.41, 95% CI −772.55 to −76.30, p = 0.02). Drain output was lower in the ROTEM group and remained significant after adjusting for TXA.

CONCLUSIONS

For ASD patients treated using lumbar PSO, more cryoprecipitate and less FFP were transfused in the ROTEM group compared to the control group. These preliminary findings suggest ROTEM-guided therapy may allow early identification of hypofibrinogenemia, and aggressive management of this may reduce blood loss and total blood product transfusion volume. Additional prospective studies of larger cohorts are warranted to identify the appropriate subset of ASD patients who may benefit from intraoperative ROTEM analysis.

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Thomas J. Buell, Shay Bess, Ming Xu, Frank J. Schwab, Virginie Lafage, Christopher P. Ames, Christopher I. Shaffrey and Justin S. Smith

OBJECTIVE

Proximal junctional kyphosis (PJK) is, in part, due to altered segmental biomechanics at the junction of rigid instrumented spine and relatively hypermobile non-instrumented adjacent segments. Proper application of posteriorly anchored polyethylene tethers (i.e., optimal configuration and tension) may mitigate adjacent-segment stress and help prevent PJK. The purpose of this study was to investigate the impact of different tether configurations and tensioning (preloading) on junctional range-of-motion (ROM) and other biomechanical indices for PJK in long instrumented spine constructs.

METHODS

Using a validated finite element model of a T7–L5 spine segment, testing was performed on intact spine, a multilevel posterior screw-rod construct (PS construct; T11–L5) without tether, and 15 PS constructs with different tether configurations that varied according to 1) proximal tether fixation of upper instrumented vertebra +1 (UIV+1) and/or UIV+2; 2) distal tether fixation to UIV, to UIV−1, or to rods; and 3) use of a loop (single proximal fixation) or weave (UIV and/or UIV+1 fixation in addition to UIV+1 and/or UIV+2 proximal attachment) of the tether. Segmental ROM, intradiscal pressure (IDP), inter- and supraspinous ligament (ISL/SSL) forces, and screw loads were assessed under variable tether preload.

RESULTS

PS construct junctional ROM increased abruptly from 10% (T11–12) to 99% (T10–11) of baseline. After tethers were grouped by most cranial proximal fixation (UIV+1 vs UIV+2) and use of loop versus weave, UIV+2 Loop and/or Weave most effectively dampened junctional ROM and adjacent-segment stress. Different distal fixation and use of loop versus weave had minimal effect. The mean segmental ROM at T11–12, T10–11, and T9–10, respectively, was 6%, 40%, and 99% for UIV+1 Loop; 6%, 44%, and 99% for UIV+1 Weave; 5%, 23%, and 26% for UIV+2 Loop; and 5%, 24%, and 31% for UIV+2 Weave.

Tethers shared loads with posterior ligaments; consequently, increasing tether preload tension reduced ISL/SSL forces, but screw loads increased. Further attenuation of junctional ROM and IDP reversed above approximately 100 N tether preload, suggesting diminished benefit for biomechanical PJK prophylaxis at higher preload tensioning.

CONCLUSIONS

In this study, finite element analysis demonstrated UIV+2 Loop and/or Weave tether configurations most effectively mitigated adjacent-segment stress in long instrumented spine constructs. Tether preload dampened ligament forces at the expense of screw loads, and an inflection point (approximately 100 N) was demonstrated above which junctional ROM and IDP worsened (i.e., avoid over-tightening tethers). Results suggest tether configuration and tension influence PJK biomechanics and further clinical research is warranted.

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James H. Nguyen, Thomas J. Buell, Tony R. Wang, Jeffrey P. Mullin, Marcus D. Mazur, Juanita Garces, Davis G. Taylor, Chun-Po Yen, Christopher I. Shaffrey and Justin S. Smith

OBJECTIVE

Recent literature describing complications associated with spinopelvic fixation with iliac screws in adult patients has been limited but has suggested high complication rates. The authors’ objective was to report their experience with iliac screw fixation in a large series of patients with a 2-year minimum follow-up.

METHODS

Of 327 adult patients undergoing spinopelvic fixation with iliac screws at the authors’ institution between 2010 and 2015, 260 met the study inclusion criteria (age ≥ 18 years, first-time iliac screw placement, and 2-year minimum follow-up). Patients with active spinal infection were excluded. All iliac screws were placed via a posterior midline approach using fluoroscopic guidance. Iliac screw heads were deeply recessed into the posterior superior iliac spine. Clinical and radiographic data were obtained and analyzed.

RESULTS

Twenty patients (7.7%) had iliac screw–related complication, which included fracture (12, 4.6%) and/or screw loosening (9, 3.5%). No patients had iliac screw head prominence that required revision surgery or resulted in pain, wound dehiscence, or poor cosmesis. Eleven patients (4.2%) had rod or connector fracture below S1. Overall, 23 patients (8.8%) had L5–S1 pseudarthrosis. Four patients (1.5%) had fracture of the S1 screw. Seven patients (2.7%) had wound dehiscence (unrelated to the iliac screw head) or infection. The rate of reoperation (excluding proximal junctional kyphosis) was 17.7%. On univariate analysis, an iliac screw–related complication rate was significantly associated with revision fusion (70.0% vs 41.2%, p = 0.013), a greater number of instrumented vertebrae (mean 12.6 vs 10.3, p = 0.014), and greater postoperative pelvic tilt (mean 27.7° vs 23.2°, p = 0.04). Lumbosacral junction–related complications were associated with a greater mean number of instrumented vertebrae (12.6 vs 10.3, p = 0.014). Reoperation was associated with a younger mean age at surgery (61.8 vs 65.8 years, p = 0.014), a greater mean number of instrumented vertebrae (12.2 vs 10.2, p = 0.001), and longer clinical and radiological mean follow-up duration (55.8 vs 44.5 months, p < 0.001; 55.8 vs 44.6 months, p < 0.001, respectively). On multivariate analysis, reoperation was associated with longer clinical follow-up (p < 0.001).

CONCLUSIONS

Previous studies on iliac screw fixation have reported very high rates of complications and reoperation (as high as 53.6%). In this large, single-center series of adult patients, iliac screws were an effective method of spinopelvic fixation that had high rates of lumbosacral fusion and far lower complication rates than previously reported. Collectively, these findings argue that iliac screw fixation should remain a favored technique for spinopelvic fixation.

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Bhargav D. Desai, Davis G. Taylor, Ching-Jen Chen, Thomas J. Buell, Jeffrey P. Mullin, Bhiken I. Naik, Justin S. Smith and Christopher I. Shaffrey

Tranexamic acid (TXA) is an antifibrinolytic agent with demonstrated efficacy in reducing blood loss when administered systemically. However, in patients with contraindications to systemic or intravenous TXA, topical TXA (tTXA) has been shown to reduce perioperative blood loss, with some studies suggesting equivalence compared to systemic TXA. However, these studies have been conducted in healthy cohorts without contraindications to systemic TXA. In the surgical management of adult spinal deformity (ASD), comorbid disease is commonly encountered and may preclude use of systemic TXA. In this subset of patients with ASD who have contraindications for systemic TXA, use of tTXA has not been reported.

The primary objective of this study was to conduct a systematic review on the use of tTXA in spine surgery and to present the authors’ initial experience with tTXA as a novel hemostatic technique for 2 patients with medically complex ASD. Both patients had contraindications to systemic TXA use and underwent high-risk, long-segment fusion operations for correction of ASD. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to obtain studies related to spine surgery and tTXA from the National Institutes of Health PubMed (www.pubmed.gov) database. Criteria for final selection included a demonstration of quantitative data regarding operative or postoperative blood loss with the use of tTXA, and selection criteria were met by 6 articles.

Topical TXA may offer a potential therapeutic role in reducing intra- and postoperative blood loss following long-segment spinal fusion surgeries, particularly for medically complex patients with contraindications to systemic TXA. It is reasonable to consider the use of tTXA as a salvage technique in complex high-risk patients with contraindications to systemic TXA, although further research is needed to delineate safety, magnitude of benefit, and optimization of dosing.

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Thomas J. Buell, James H. Nguyen, Marcus D. Mazur, Jeffrey P. Mullin, Juanita Garces, Davis G. Taylor, Chun-Po Yen, Mark E. Shaffrey, Christopher I. Shaffrey and Justin S. Smith

OBJECTIVE

Fixed sagittal spinal malalignment is a common problem in adult spinal deformity (ASD). Various three-column osteotomy techniques, including the extended pedicle subtraction osteotomy (ePSO), may correct global and regional malalignment in this patient population. In contrast to the number of reports on traditional PSO (Schwab grade 3 osteotomy), there is limited literature on the outcomes of ePSO (Schwab grade 4 osteotomy) in ASD surgery. The objective of this retrospective study was to provide focused investigation of radiographic outcomes and complications of single-level lumbar ePSO for ASD patients with fixed sagittal malalignment.

METHODS

Consecutive ASD patients in whom sagittal malalignment had been treated with single-level lumbar ePSO at the authors’ institution between 2010 and 2015 were analyzed, and those with a minimum 2-year follow-up were included in the study. Radiographic analyses included assessments of segmental lordosis through the ePSO site (sagittal Cobb angle measured from the superior endplate of the vertebra above and inferior endplate of the vertebra below the ePSO), lumbar lordosis (LL), pelvic tilt (PT), pelvic incidence and LL mismatch, thoracic kyphosis (TK), and sagittal vertical axis (SVA) on standing long-cassette radiographs. Complications were analyzed for the entire group.

RESULTS

Among 71 potentially eligible patients, 55 (77%) had a minimum 2-year follow-up and were included in the study. Overall, the average postoperative increases in ePSO segmental lordosis and overall LL were 41° ± 14° (range 7°–69°, p < 0.001) and 38° ± 11° (range 9°–58°, p < 0.001), respectively. The average SVA improvement was 13 ± 7 cm (range of correction: −33.6 to 3.4 cm, p < 0.001). These measurements were maintained when comparing early postoperative to last follow-up values, respectively (mean follow-up 52 months, range 26–97 months): ePSO segmental lordosis, 34° vs 33°, p = 0.270; LL, 47.3° vs 46.7°, p = 0.339; and SVA, 4 vs 5 cm, p = 0.330. Rod fracture (RF) at the ePSO site occurred in 18.2% (10/55) of patients, and pseudarthrosis (PA) at the ePSO site was confirmed by CT imaging or during rod revision surgery in 14.5% (8/55) of patients. Accessory supplemental rods across the ePSO site, a more recently employed technique, significantly reduced the occurrence of RF or PA on univariate (p = 0.004) and multivariable (OR 0.062, 95% CI 0.007–0.553, p = 0.013) analyses; this effect approached statistical significance on Kaplan-Meier analysis (p = 0.053, log-rank test). Interbody cage placement at the ePSO site resulted in greater ePSO segmental lordosis correction (45° vs 35°, p = 0.007) without significant change in RF or PA (p = 0.304). Transient and persistent motor deficits occurred in 14.5% (8/55) and 1.8% (1/55) of patients, respectively.

CONCLUSIONS

Extended PSO is an effective technique to correct fixed sagittal malalignment for ASD. In comparison to traditional PSO techniques, ePSO may allow greater focal correction with comparable complication rates, especially with interbody cage placement at the ePSO site and the use of accessory supplemental rods.

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Justin K. Scheer, Taemin Oh, Justin S. Smith, Christopher I. Shaffrey, Alan H. Daniels, Daniel M. Sciubba, D. Kojo Hamilton, Themistocles S. Protopsaltis, Peter G. Passias, Robert A. Hart, Douglas C. Burton, Shay Bess, Renaud Lafage, Virginie Lafage, Frank Schwab, Eric O. Klineberg, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Pseudarthrosis can occur following adult spinal deformity (ASD) surgery and can lead to instrumentation failure, recurrent pain, and ultimately revision surgery. In addition, it is one of the most expensive complications of ASD surgery. Risk factors contributing to pseudarthrosis in ASD have been described; however, a preoperative model predicting the development of pseudarthrosis does not exist. The goal of this study was to create a preoperative predictive model for pseudarthrosis based on demographic, radiographic, and surgical factors.

METHODS

A retrospective review of a prospectively maintained, multicenter ASD database was conducted. Study inclusion criteria consisted of adult patients (age ≥ 18 years) with spinal deformity and surgery for the ASD. From among 82 variables assessed, 21 were used for model building after applying collinearity testing, redundancy, and univariable predictor importance ≥ 0.90. Variables included demographic data along with comorbidities, modifiable surgical variables, baseline coronal and sagittal radiographic parameters, and baseline scores for health-related quality of life measures. Patients groups were determined according to their Lenke radiographic fusion type at the 2-year follow-up: bilateral or unilateral fusion (union) or pseudarthrosis (nonunion). A decision tree was constructed, and internal validation was accomplished via bootstrapped training and testing data sets. Accuracy and the area under the receiver operating characteristic curve (AUC) were calculated to evaluate the model.

RESULTS

A total of 336 patients were included in the study (nonunion: 105, union: 231). The model was 91.3% accurate with an AUC of 0.94. From 82 initial variables, the top 21 covered a wide range of areas including preoperative alignment, comorbidities, patient demographics, and surgical use of graft material.

CONCLUSIONS

A model for predicting the development of pseudarthrosis at the 2-year follow-up was successfully created. This model is the first of its kind for complex predictive analytics in the development of pseudarthrosis for patients with ASD undergoing surgical correction and can aid in clinical decision-making for potential preventative strategies.

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Thomas J. Buell, Davis G. Taylor, Ching-Jen Chen, Christopher I. Shaffrey, Justin S. Smith and Shay Bess

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Renaud Lafage, Ibrahim Obeid, Barthelemy Liabaud, Shay Bess, Douglas Burton, Justin S. Smith, Cyrus Jalai, Richard Hostin, Christopher I. Shaffrey, Christopher Ames, Han Jo Kim, Eric Klineberg, Frank Schwab, Virginie Lafage and the International Spine Study Group

OBJECTIVE

The surgical correction of adult spinal deformity (ASD) often involves modifying lumbar lordosis (LL) to restore ideal sagittal alignment. However, corrections that include large changes in LL increase the risk for development of proximal junctional kyphosis (PJK). Little is known about the impact of cranial versus caudal correction in the lumbar spine on the occurrence of PJK. The goal of this study was to investigate the impact of the location of the correction on acute PJK development.

METHODS

This study was a retrospective review of a prospective multicenter database. Surgically treated ASD patients with early follow-up evaluations (6 weeks) and fusions of the full lumbosacral spine were included. Radiographic parameters analyzed included the classic spinopelvic parameters (pelvic incidence [PI], pelvic tilt [PT], PI−LL, and sagittal vertical axis [SVA]) and segmental correction. Using Glattes’ criteria, patients were stratified into PJK and noPJK groups and propensity matched by age and regional lumbar correction (ΔPI−LL). Radiographic parameters and segmental correction were compared between PJK and noPJK patients using independent t-tests.

RESULTS

After propensity matching, 312 of 483 patients were included in the analysis (mean age 64 years, 76% women, 40% with PJK). There were no significant differences between PJK and noPJK patients at baseline or postoperatively, or between changes in alignment, with the exception of thoracic kyphosis (TK) and ΔTK. PJK patients had a decrease in segmental lordosis at L4-L5-S1 (−0.6° vs 1.6°, p = 0.025), and larger increases in segmental correction at cranial levels L1-L2-L3 (9.9° vs 7.1°), T12-L1-L2 (7.3° vs 5.4°), and T11-T12-L1 (2.9° vs 0.7°) (all p < 0.05).

CONCLUSIONS

Although achievement of an optimal sagittal alignment is the goal of realignment surgery, dramatic lumbar corrections appear to increase the risk of PJK. This study was the first to demonstrate that patients who developed PJK underwent kyphotic changes in the L4–S1 segments while restoring LL at more cranial levels (T12–L3). These findings suggest that restoring lordosis at lower lumbar levels may result in a decreased risk of developing PJK.

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Micheal Raad, Brian J. Neuman, Amit Jain, Hamid Hassanzadeh, Peter G. Passias, Eric Klineberg, Gregory M. Mundis Jr., Themistocles S. Protopsaltis, Emily K. Miller, Justin S. Smith, Virginie Lafage, D. Kojo Hamilton, Shay Bess, Khaled M. Kebaish, Daniel M. Sciubba and the International Spine Study Group

OBJECTIVE

Given the recent shift in health care toward quality reporting requirements and a greater emphasis on a cost-quality approach, patient stratification with respect to long-term outcomes and the use of health care resources is of increasing value. Stratification tools may be effective if they are simple and evidence based. The authors hypothesize that preoperative patient-reported activity levels might independently predict postoperative outcomes in patients with adult spinal deformity.

METHODS

This is a retrospective cohort. A total of 575 patients in a prospective adult spinal deformity surgical database were identified with complete data regarding the preoperative level of activity. Answers to question 5 of the Scoliosis Research Society-22r Patient Questionnaire (SRS-22r) were used to stratify patients into active and inactive groups. Outcomes were length of hospital stay (LOS), level of activity, and reaching the minimum clinically important difference (MCID) for SRS-22r domains and the Physical Component Summary (PCS) of the SF-36 at 2 years postoperatively. The 2 groups were compared with respect to several potential confounders. Covariates with p < 0.1 were controlled for. The impact of activity on LOS was assessed using multivariate negative binomial regression analysis. Multivariate logistic regression models additionally controlling for the respective baseline health-related quality of life (HRQOL) scores were used to assess the association between preoperative activity levels and reaching the MCID at 2 years postoperatively.

RESULTS

A total of 420 (73%) of the 575 patients who met the inclusion criteria had complete data at 2 years postoperatively. The inactive group was more likely to be significantly older, have a higher Charlson Comorbidity Index, worse baseline radiographic deformity, and greater correction of most radiographic parameters. After controlling for possible confounders, the active group had a significantly shorter LOS (incidence risk ratio 0.91, p = 0.043). After adding respective baseline HRQOL scores to the models, active patients were significantly more likely to reach the MCID for the SRS-22r pain domain (OR 1.72, p = 0.026) and PCS (OR 1.94, p = 0.013). Active patients were also significantly more likely to be active at 2 years postoperatively on multivariate analysis (OR 8.94, p < 0.001).

CONCLUSIONS

The authors’ results show that patients who belong to the inactive group are likely to have a longer LOS and lower odds of reaching the MCID in HRQOL or being active at 2 years postoperatively. Inquiring about patients’ preoperative activity levels might be a reliable and simple stratification tool in terms of long- and short-term outcomes in ASD patients.