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The comprehensive anatomical spinal osteotomy and anterior column realignment classification

Presented at the 2018 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Juan S. Uribe, Frank Schwab, Gregory M. Mundis Jr., David S. Xu, Jacob Januszewski, Adam S. Kanter, David O. Okonkwo, Serena S. Hu, Deviren Vedat, Robert Eastlack, Pedro Berjano and Praveen V. Mummaneni

OBJECTIVE

Spinal osteotomies and anterior column realignment (ACR) are procedures that allow preservation or restoration of spine lordosis. Variations of these techniques enable different degrees of segmental, regional, and global sagittal realignment. The authors propose a comprehensive anatomical classification system for ACR and its variants based on the level of technical complexity and invasiveness. This serves as a common language and platform to standardize clinical and radiographic outcomes for the utilization of ACR.

METHODS

The proposed classification is based on 6 anatomical grades of ACR, including anterior longitudinal ligament (ALL) release, with varying degrees of posterior column release or osteotomies. Additionally, a surgical approach (anterior, lateral, or posterior) was added. Reliability of the classification was evaluated by an analysis of 16 clinical cases, rated twice by 14 different spine surgeons, and calculation of Fleiss kappa coefficients.

RESULTS

The 6 grades of ACR are as follows: grade A, ALL release with hyperlordotic cage, intact posterior elements; grade 1 (ACR + Schwab grade 1), additional resection of the inferior facet and joint capsule; grade 2 (ACR + Schwab grade 2), additional resection of both superior and inferior facets, interspinous ligament, ligamentum flavum, lamina, and spinous process; grade 3 (ACR + Schwab grade 3), additional adjacent-level 3-column osteotomy including pedicle subtraction osteotomy; grade 4 (ACR + Schwab grade 4), 2-level distal 3-column osteotomy including pedicle subtraction osteotomy and disc space resection; and grade 5 (ACR + Schwab grade 5), complete or partial removal of a vertebral body and both adjacent discs with or without posterior element resection. Intraobserver and interobserver reliability were 97% and 98%, respectively, across the 14-reviewer cohort.

CONCLUSIONS

The proposed anatomical realignment classification provides a consistent description of the various posterior and anterior column release/osteotomies. This reliability study confirmed that the classification is consistent and reproducible across a diverse group of spine surgeons.

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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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Blake N. Staub, Renaud Lafage, Han Jo Kim, Christopher I. Shaffrey, Gregory M. Mundis Jr., Richard Hostin, Douglas Burton, Lawrence Lenke, Munish C. Gupta, Christopher Ames, Eric Klineberg, Shay Bess, Frank Schwab, Virginie Lafage and the International Spine Study Group

OBJECTIVE

Numerous studies have attempted to delineate the normative value for T1S−CL (T1 slope minus cervical lordosis) as a marker for both cervical deformity and a goal for correction similar to how PI-LL (pelvic incidence–lumbar lordosis) mismatch informs decision making in thoracolumbar adult spinal deformity (ASD). The goal of this study was to define the relationship between T1 slope (T1S) and cervical lordosis (CL).

METHODS

This is a retrospective review of a prospective database. Surgical ASD cases were initially analyzed. Analysis across the sagittal parameters was performed. Linear regression analysis based on T1S was used to provide a clinically applicable equation to predict CL. Findings were validated using the postoperative alignment of the ASD patients. Further validation was then performed using a second, normative database. The range of normal alignment associated with horizontal gaze was derived from a multilinear regression on data from asymptomatic patients.

RESULTS

A total of 103 patients (mean age 54.7 years) were included. Analysis revealed a strong correlation between T1S and C0–7 lordosis (r = 0.886), C2–7 lordosis (r = 0.815), and C0–2 lordosis (r = 0.732). There was no significant correlation between T1S and T1S−CL. Linear regression analysis revealed that T1S−CL assumed a constant value of 16.5° (R2 = 0.664, standard error 2°). These findings were validated on the postoperative imaging (mean absolute error [MAE] 5.9°). The equation was then applied to the normative database (MAE 6.7° controlling for McGregor slope [MGS] between −5° and 15°). A multilinear regression between C2–7, T1S, and MGS demonstrated a range of T1S−CL between 14.5° and 26.5° was necessary to maintain horizontal gaze.

CONCLUSIONS

Normative CL can be predicted via the formula CL = T1S − 16.5° ± 2°. This implies a threshold of deformity and aids in providing a goal for surgical correction. Just as pelvic incidence (PI) can be used to determine the ideal LL, T1S can be used to predict ideal CL. This formula also implies that a kyphotic cervical alignment is to be expected for individuals with a T1S < 16.5°.

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Emmanuelle Ferrero, Barthelemy Liabaud, Jensen K. Henry, Christopher P. Ames, Khaled Kebaish, Gregory M. Mundis, Richard Hostin, Munish C. Gupta, Oheneba Boachie-Adjei, Justin S. Smith, Robert A. Hart, Ibrahim Obeid, Bassel G. Diebo, Frank J. Schwab and Virginie Lafage

OBJECTIVE

Three-column osteotomy (3CO) is a demanding technique that is performed to correct sagittal spinal malalignment. However, the impact of the 3CO level on pelvic or truncal sagittal correction remains unclear. In this study, the authors assessed the impact of 3CO level and postoperative apex of lumbar lordosis on sagittal alignment correction, complications, and revisions.

METHODS

In this retrospective study of a multicenter spinal deformity database, radiographic data were analyzed at baseline and at 1- and 2-year follow-up to quantify spinopelvic alignment, apex of lordosis, and resection angle. The impact of 3CO level and apex level of lumbar lordosis on the sagittal correction was assessed. Logistic regression analyses were performed, controlling for cofounders, to investigate the effects of 3CO level and apex level on intraoperative and postoperative complications as well as on the need for subsequent revision surgery.

RESULTS

A total of 468 patients were included (mean age 60.8 years, mean body mass index 28.1 kg/m2); 70% of patients were female. The average 3CO resection angle was 25.1° and did not significantly differ with regard to 3CO level. There were no significant correlations between the 3CO level and amount of sagittal vertical axis or pelvic tilt correction. The postoperative apex level significantly correlated with greater correction of pelvic tilt (2° per more caudal level, R = −0.2, p = 0.006). Lower-level 3CO significantly correlated with revisions for pseudarthrosis (OR = 3.88, p = 0.001) and postoperative motor deficits (OR = 2.02, p = 0.026).

CONCLUSIONS

In this study, a more caudal lumbar 3CO level did not lead to greater sagittal vertical axis correction. The postoperative apex of lumbar lordosis significantly impacted pelvic tilt. 3CO levels that were more caudal were associated with more postoperative motor deficits and revisions.

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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.

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Justin K. Scheer, Justin S. Smith, Frank Schwab, Virginie Lafage, Christopher I. Shaffrey, Shay Bess, Alan H. Daniels, Robert A. Hart, Themistocles S. Protopsaltis, Gregory M. Mundis Jr., Daniel M. Sciubba, Tamir Ailon, Douglas C. Burton, Eric Klineberg, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

The operative management of patients with adult spinal deformity (ASD) has a high complication rate and it remains unknown whether baseline patient characteristics and surgical variables can predict early complications (intraoperative and perioperative [within 6 weeks]). The development of an accurate preoperative predictive model can aid in patient counseling, shared decision making, and improved surgical planning. The purpose of this study was to develop a model based on baseline demographic, radiographic, and surgical factors that can predict if patients will sustain an intraoperative or perioperative major complication.

METHODS

This study was a retrospective analysis of a prospective, multicenter ASD database. The inclusion criteria were age ≥ 18 years and the presence of ASD. In total, 45 variables were used in the initial training of the model including demographic data, comorbidities, modifiable surgical variables, baseline health-related quality of life, and coronal and sagittal radiographic parameters. Patients were grouped as either having at least 1 major intraoperative or perioperative complication (COMP group) or not (NOCOMP group). An ensemble of decision trees was constructed utilizing the C5.0 algorithm with 5 different bootstrapped models. Internal validation was accomplished via a 70/30 data split for training and testing each model, respectively. Overall accuracy, the area under the receiver operating characteristic (AUROC) curve, and predictor importance were calculated.

RESULTS

Five hundred fifty-seven patients were included: 409 (73.4%) in the NOCOMP group, and 148 (26.6%) in the COMP group. The overall model accuracy was 87.6% correct with an AUROC curve of 0.89 indicating a very good model fit. Twenty variables were determined to be the top predictors (importance ≥ 0.90 as determined by the model) and included (in decreasing importance): age, leg pain, Oswestry Disability Index, number of decompression levels, number of interbody fusion levels, Physical Component Summary of the SF-36, Scoliosis Research Society (SRS)–Schwab coronal curve type, Charlson Comorbidity Index, SRS activity, T-1 pelvic angle, American Society of Anesthesiologists grade, presence of osteoporosis, pelvic tilt, sagittal vertical axis, primary versus revision surgery, SRS pain, SRS total, use of bone morphogenetic protein, use of iliac crest graft, and pelvic incidence–lumbar lordosis mismatch.

CONCLUSIONS

A successful model (87% accuracy, 0.89 AUROC curve) was built predicting major intraoperative or perioperative complications following ASD surgery. This model can provide the foundation toward improved education and point-of-care decision making for patients undergoing ASD surgery.

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Alexander A. Theologis, Gregory M. Mundis Jr., Stacie Nguyen, David O. Okonkwo, Praveen V. Mummaneni, Justin S. Smith, Christopher I. Shaffrey, Richard Fessler, Shay Bess, Frank Schwab, Bassel G. Diebo, Douglas Burton, Robert Hart, Vedat Deviren and Christopher Ames

OBJECTIVE

The aim of this study was to evaluate the utility of supplementing long thoracolumbar posterior instrumented fusion (posterior spinal fusion, PSF) with lateral interbody fusion (LIF) of the lumbar/thoracolumbar coronal curve apex in adult spinal deformity (ASD).

METHODS

Two multicenter databases were evaluated. Adults who had undergone multilevel LIF of the coronal curve apex in addition to PSF with L5–S1 interbody fusion (LS+Apex group) were matched by number of posterior levels fused with patients who had undergone PSF with L5–S1 interbody fusion without LIF (LS-Only group). All patients had at least 2 years of follow-up. Percutaneous PSF and 3-column osteotomy (3CO) were excluded. Demographics, perioperative details, radiographic spinal deformity measurements, and HRQoL data were analyzed.

RESULTS

Thirty-two patients were matched (LS+Apex: 16; LS: 16) (6 men, 26 women; mean age 63 ± 10 years). Overall, the average values for measures of deformity were as follows: Cobb angle > 40°, sagittal vertical axis (SVA) > 6 cm, pelvic tilt (PT) > 25°, and mismatch between pelvic incidence (PI) and lumbar lordosis (LL) > 15°. There were no significant intergroup differences in preoperative radiographic parameters, although patients in the LS+Apex group had greater Cobb angles and less LL. Patients in the LS+Apex group had significantly more anterior levels fused (4.6 vs 1), longer operative times (859 vs 379 minutes), and longer length of stay (12 vs 7.5 days) (all p < 0.01). For patients in the LS+Apex group, Cobb angle, pelvic tilt (PT), lumbar lordosis (LL), PI-LL (lumbopelvic mismatch), Oswestry Disability Index (ODI) scores, and visual analog scale (VAS) scores for back and leg pain improved significantly (p < 0.05). For patients in the LS-Only group, there were significant improvements in Cobb angle, ODI score, and VAS scores for back and leg pain. The LS+Apex group had better correction of Cobb angles (56% vs 33%, p = 0.02), SVA (43% vs 5%, p = 0.46), LL (62% vs 13%, p = 0.35), and PI-LL (68% vs 33%, p = 0.32). Despite more LS+Apex patients having major complications (56% vs 13%; p = 0.02) and postoperative leg weakness (31% vs 6%, p = 0.07), there were no intergroup differences in 2-year outcomes.

CONCLUSIONS

Long open posterior instrumented fusion with or without multilevel LIF is used to treat a variety of coronal and sagittal adult thoracolumbar deformities. The addition of multilevel LIF to open PSF with L5–S1 interbody support in this small cohort was often used in more severe coronal and/or lumbopelvic sagittal deformities and offered better correction of major Cobb angles, lumbopelvic parameters, and SVA than posterior-only operations. As these advantages came at the expense of more major complications, more leg weakness, greater blood loss, and longer operative times and hospital stays without an improvement in 2-year outcomes, future investigations should aim to more clearly define deformities that warrant the addition of multilevel LIF to open PSF and L5–S1 interbody fusion.

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Joshua Bakhsheshian, Justin K. Scheer, Jeffrey L. Gum, Richard Hostin, Virginie Lafage, Shay Bess, Themistocles S. Protopsaltis, Douglas C. Burton, Malla Kate Keefe, Robert A. Hart, Gregory M. Mundis Jr., Christopher I. Shaffrey, Frank Schwab, Justin S. Smith, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

Mental disease burden can have a significant impact on levels of disability and health-related quality of life (HRQOL) measures. Therefore, the authors investigated the significance of mental health status in adults with spinal deformity and poor physical function.

METHODS

A retrospective analysis of a prospective multicenter database of 365 adult spinal deformity (ASD) patients who had undergone surgical treatment was performed. Health-related QOL variables were examined preoperatively and at the 2-year postoperative follow-up. Patients were grouped by their 36-Item Short Form Health Survey mental component summary (MCS) and physical component summary (PCS) scores. Both groups had PCS scores ≤ 25th percentile for matched norms; however, the low mental health (LMH) group consisted of patients with an MCS score ≤ 25th percentile, and the high mental health (HMH) group included patients with an MCS score ≥ 75th percentile.

RESULTS

Of the 264 patients (72.3%) with a 2-year follow-up, 104 (28.5%) met the inclusion criteria for LMH and 40 patients (11.0%) met those for HMH. The LMH group had a significantly higher overall rate of comorbidities, specifically leg weakness, depression, hypertension, and self-reported neurological and psychiatric disease processes, and were more likely to be unemployed as compared with the HMH group (p < 0.05 for all). The 2 groups had similar 2-year postoperative improvements in HRQOL (p > 0.05) except for the greater improvements in the MCS and the Scoliosis Research Society-22r questionnaire (SRS-22r) mental domain (p < 0.05) in the LMH group and greater improvements in PCS and SRS-22r satisfaction and back pain domains (p < 0.05) in the HMH group. The LMH group had a higher rate of reaching a minimal clinically important difference (MCID) on the SRS-22r mental domain (p < 0.01), and the HMH group had a higher rate of reaching an MCID on the PCS and SRS-22r activity domain (p < 0.05). On multivariable logistic regression, having LMH was a significant independent predictor of failure to reach an MCID on the PCS (p < 0.05). At the 2-year postoperative follow-up, 14 LMH patients (15.1%) were categorized as HMH. Two LMH patients (2.2%), and 3 HMH patients (7.7%) transitioned to a PCS score ≥ 75th percentile for age- and sex-matched US norms (p < 0.01).

CONCLUSIONS

While patients with poor mental and physical health, according to their MCS and PCS scores, have higher medical comorbidity and unemployment rates, they still demonstrate significant improvements in HRQOL measurements postoperatively. Both LMH and HMH patient groups demonstrated similar improvements in most HRQOL domains, except that the LMH patients had difficulties in obtaining improvements in the PCS domain.

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Khoi D. Than, Paul Park, Kai-Ming Fu, Stacie Nguyen, Michael Y. Wang, Dean Chou, Pierce D. Nunley, Neel Anand, Richard G. Fessler, Christopher I. Shaffrey, Shay Bess, Behrooz A. Akbarnia, Vedat Deviren, Juan S. Uribe, Frank La Marca, Adam S. Kanter, David O. Okonkwo, Gregory M. Mundis Jr., Praveen V. Mummaneni and the International Spine Study Group

OBJECTIVE

Minimally invasive surgery (MIS) techniques are increasingly used to treat adult spinal deformity. However, standard minimally invasive spinal deformity techniques have a more limited ability to restore sagittal balance and match the pelvic incidence–lumbar lordosis (PI-LL) than traditional open surgery. This study sought to compare “best” versus “worst” outcomes of MIS to identify variables that may predispose patients to postoperative success.

METHODS

A retrospective review of minimally invasive spinal deformity surgery cases was performed to identify parameters in the 20% of patients who had the greatest improvement in Oswestry Disability Index (ODI) scores versus those in the 20% of patients who had the least improvement in ODI scores at 2 years' follow-up.

RESULTS

One hundred four patients met the inclusion criteria, and the top 20% of patients in terms of ODI improvement at 2 years (best group, 22 patients) were compared with the bottom 20% (worst group, 21 patients). There were no statistically significant differences in age, body mass index, pre- and postoperative Cobb angles, pelvic tilt, pelvic incidence, levels fused, operating room time, and blood loss between the best and worst groups. However, the mean preoperative ODI score was significantly higher (worse disability) at baseline in the group that had the greatest improvement in ODI score (58.2 vs 39.7, p < 0.001). There was no difference in preoperative PI-LL mismatch (12.8° best vs 19.5° worst, p = 0.298). The best group had significantly less postoperative sagittal vertical axis (SVA; 3.4 vs 6.9 cm, p = 0.043) and postoperative PI-LL mismatch (10.4° vs 19.4°, p = 0.027) than the worst group. The best group also had better postoperative visual analog scale back and leg pain scores (p = 0.001 and p = 0.046, respectively).

CONCLUSIONS

The authors recommend that spinal deformity surgeons using MIS techniques focus on correcting a patient's PI-LL mismatch to within 10° and restoring SVA to < 5 cm. Restoration of these parameters seems to impact which patients will attain the greatest degree of improvement in ODI outcomes, while the spines of patients who do the worst are not appropriately corrected and may be fused into a fixed sagittal plane deformity.

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Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.