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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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Michael P. Kelly, Michael A. Kallen, Christopher I. Shaffrey, Justin S. Smith, Douglas C. Burton, Christopher P. Ames, Virginie Lafage, Frank J. Schwab, Han Jo Kim, Eric O. Klineberg, Shay Bess and the International Spine Study Group

OBJECTIVE

After using PROsetta Stone crosswalk tables to calculate Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores, the authors sought to examine 1) correlations with Scoliosis Research Society–22r (SRS-22r) scores, 2) responsiveness to change, and 3) the relationship between baseline scores and 2-year follow-up scores in adult spinal deformity (ASD).

METHODS

PROsetta Stone crosswalk tables were used to converted SF-36 scores to PROMIS scores for pain and physical function in a cohort of ASD patients with 2-year follow-up. Spearman correlations were used to evaluate the relationship of PROMIS scores with SRS-22r scores. Effect size (ES) and adjusted standardized response mean (aSRM) were used to assess responsiveness to change. Linear regression was used to evaluate the association between baseline scores and 2-year follow-up scores.

RESULTS

In total, 425 (425/625, 68%) patients met inclusion criteria. Strong correlations (all |r| > 0.7, p < 0.001) were found between baseline and 2-year PROMIS values and corresponding SRS-22r domain scores. PROMIS-PI showed a large ES (1.09) and aSRM (0.88), indicating good responsiveness to change. PROMIS-PF showed a moderate ES (0.52) and moderate aSRM (0.69), indicating a moderate responsiveness to change. Patients with greater baseline pain complaints were associated with greater pain improvement at 2 years for both SRS-22r Pain (B = 0.39, p < 0.001) and PROMIS-PI (B = 0.45, p < 0.001). Higher functional scores at baseline were associated with greater average improvements in both SRS-22r Activity (B = 0.62, p < 0.001) and PROMIS-PF (B = 0.40, p < 0.001).

CONCLUSIONS

The authors found strong correlations between the SRS-22r Pain and Activity domains with corresponding PROMIS-PI and -PF scores. Pain measurements showed similar and strong ES and aSRM while the function measurements showed similar, moderate ES and aSRM at 2-year follow-up. These data support further exploration of the use of PROMIS–computer adaptive test instruments in ASD.

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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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Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Steven D. Glassman, Kevin T. Foley, Eric A. Potts, Christopher I. Shaffrey, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Michael Y. Wang, Kai-Ming Fu, Jonathan R. Slotkin, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Silky Chotai, Anthony M. DiGiorgio, Regis W. Haid and Praveen V. Mummaneni

OBJECTIVE

The AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer “real-world” insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.

METHODS

Data from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol–5 Dimensions health survey (EQ-5D) results.

RESULTS

A total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β −4.79, 95% CI −9.28 to −0.31; p = 0.04).

CONCLUSIONS

Surgery for grade 1 lumbar spondylolisthesis—regardless of treatment strategy—was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.

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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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Paul Park, Kai-Ming Fu, Praveen V. Mummaneni, Juan S. Uribe, Michael Y. Wang, Stacie Tran, Adam S. Kanter, Pierce D. Nunley, David O. Okonkwo, Christopher I. Shaffrey, Gregory M. Mundis Jr., Dean Chou, Robert Eastlack, Neel Anand, Khoi D. Than, Joseph M. Zavatsky, Richard G. Fessler and the International Spine Study Group

OBJECTIVE

Achieving appropriate spinopelvic alignment in deformity surgery has been correlated with improvement in pain and disability. Minimally invasive surgery (MIS) techniques have been used to treat adult spinal deformity (ASD); however, there is concern for inadequate sagittal plane correction. Because age can influence the degree of sagittal correction required, the purpose of this study was to analyze whether obtaining optimal spinopelvic alignment is required in the elderly to obtain clinical improvement.

METHODS

A multicenter database of ASD patients was queried. Inclusion criteria were age ≥ 18 years; an MIS component as part of the index procedure; at least one of the following: pelvic tilt (PT) > 20°, sagittal vertical axis (SVA) > 50 mm, pelvic incidence to lumbar lordosis (PI-LL) mismatch > 10°, or coronal curve > 20°; and minimum follow-up of 2 years. Patients were stratified into younger (< 65 years) and older (≥ 65 years) cohorts. Within each cohort, patients were categorized into aligned (AL) or mal-aligned (MAL) subgroups based on postoperative radiographic measurements. Mal-alignment was defined as a PI-LL > 10° or SVA > 50 mm. Pre- and postoperative radiographic and clinical outcomes were compared.

RESULTS

Of the 185 patients, 107 were in the younger cohort and 78 in the older cohort. Based on postoperative radiographs, 36 (33.6%) of the younger patients were in the AL subgroup and 71 (66.4%) were in the MAL subgroup. The older patients were divided into 2 subgroups based on alignment; there were 26 (33.3%) patients in the AL and 52 (66.7%) in the MAL subgroups. Overall, patients within both younger and older cohorts significantly improved with regard to postoperative visual analog scale (VAS) scores for back and leg pain and Oswestry Disability Index (ODI) scores. In the younger cohort, there were no significant differences in postoperative VAS back and leg pain scores between the AL and MAL subgroups. However, the postoperative ODI score of 37.9 in the MAL subgroup was significantly worse than the ODI score of 28.5 in the AL subgroup (p = 0.019). In the older cohort, there were no significant differences in postoperative VAS back and leg pain score or ODI between the AL and MAL subgroups.

CONCLUSIONS

MIS techniques did not achieve optimal spinopelvic alignment in most cases. However, age appears to impact the degree of sagittal correction required. In older patients, optimal spinopelvic alignment thresholds did not need to be achieved to obtain similar symptomatic improvement. Conversely, in younger patients stricter adherence to optimal spinopelvic alignment thresholds may be needed.

https://thejns.org/doi/abs/10.3171/2018.4.SPINE171153

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