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Elizabeth L. Yanik, Michael P. Kelly, Jon D. Lurie, Christine R. Baldus, Christopher I. Shaffrey, Frank J. Schwab, Shay Bess, Lawrence G. Lenke, Adam LaBore and Keith H. Bridwell

OBJECTIVE

Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.

METHODS

Patients 40–80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).

RESULTS

Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence−lumbar lordosis (PI–LL) match (≤ 11°). Male patients and patients with more (> 11°) PI–LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.

CONCLUSIONS

Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI–LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

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Praveen V. Mummaneni, Paul Park, Christopher I. Shaffrey, Michael Y. Wang, Juan S. Uribe, Richard G. Fessler, Dean Chou, Adam S. Kanter, David O. Okonkwo, Gregory M. Mundis Jr., Robert K. Eastlack, Pierce D. Nunley, Neel Anand, Michael S. Virk, Lawrence G. Lenke, Khoi D. Than, Leslie C. Robinson, Kai-Ming Fu and the International Spine Study Group (ISSG)

OBJECTIVE

Minimally invasive surgery (MIS) can be used as an alternative or adjunct to traditional open techniques for the treatment of patients with adult spinal deformity. Recent advances in MIS techniques, including advanced anterior approaches, have increased the range of candidates for MIS deformity surgery. The minimally invasive spinal deformity surgery (MISDEF2) algorithm was created to provide an updated framework for decision-making when considering MIS techniques in correction of adult spinal deformity.

METHODS

A modified algorithm was developed that incorporates a patient’s preoperative radiographic parameters and leads to one of 4 general plans ranging from basic to advanced MIS techniques to open deformity surgery with osteotomies. The authors surveyed 14 fellowship-trained spine surgeons experienced with spinal deformity surgery to validate the algorithm using a set of 24 cases to establish interobserver reliability. They then re-surveyed the same surgeons 2 months later with the same cases presented in a different sequence to establish intraobserver reliability. Responses were collected and analyzed. Correlation values were determined using SPSS software.

RESULTS

Over a 3-month period, 14 fellowship-trained deformity surgeons completed the surveys. Responses for MISDEF2 algorithm case review demonstrated an interobserver kappa of 0.85 for the first round of surveys and an interobserver kappa of 0.82 for the second round of surveys, consistent with substantial agreement. In at least 7 cases, there was perfect agreement between the reviewing surgeons. The mean intraobserver kappa for the 2 surveys was 0.8.

CONCLUSIONS

The MISDEF2 algorithm was found to have substantial inter- and intraobserver agreement. The MISDEF2 algorithm incorporates recent advances in MIS surgery. The use of the MISDEF2 algorithm provides reliable guidance for surgeons who are considering either an MIS or an open approach for the treatment of patients with adult spinal deformity.

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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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David B. Bumpass, Lawrence G. Lenke, Jeffrey L. Gum, Christopher I. Shaffrey, Justin S. Smith, Christopher P. Ames, Shay Bess, Brian J. Neuman, Eric Klineberg, Gregory M. Mundis Jr., Frank Schwab, Virginie Lafage, Han Jo Kim, Douglas C. Burton, Khaled M. Kebaish, Richard Hostin, Renaud Lafage, Michael P. Kelly and for the International Spine Study Group

OBJECTIVE

Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients.

METHODS

A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused.

RESULTS

Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused.

CONCLUSIONS

Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

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Michael P. Kelly, Lawrence G. Lenke, Jakub Godzik, Ferran Pellise, Christopher I. Shaffrey, Justin S. Smith, Stephen J. Lewis, Christopher P. Ames, Leah Y. Carreon, Michael G. Fehlings, Frank Schwab and Adam L. Shimer

OBJECTIVE

The authors conducted a study to compare neurological deficit rates associated with complex adult spinal deformity (ASD) surgery when recorded in retrospective and prospective studies. Retrospective studies may underreport neurological deficits due to selection, detection, and recall biases. Prospective studies are expensive and more difficult to perform, but they likely provide more accurate estimates of new neurological deficit rates.

METHODS

New neurological deficits were recorded in a prospective study of complex ASD surgeries (pSR1) with a defined outcomes measure (decrement in American Spinal Injury Association lower-extremity motor score) for neurological deficits. Using identical inclusion criteria and a subset of participating surgeons, a retrospective study was created (rSR1) and neurological deficit rates were collected. Continuous variables were compared with the Student t-test, with correction for multiple comparisons. Neurological deficit rates were compared using the Mantel-Haenszel method for standardized risks. Statistical significance for the primary outcome measure was p < 0.05.

RESULTS

Overall, 272 patients were enrolled in pSR1 and 207 patients were enrolled in rSR1. Inclusion criteria, defining complex spinal deformities, and exclusion criteria were identical. Sagittal Cobb measurements were higher in pSR1, although sagittal alignment was similar. Preoperative neurological deficit rates were similar in the groups. Three-column osteotomies were more common in pSR1, particularly vertebral column resection. New neurological deficits were more common in pSR1 (pSR1 17.3% [95% CI 12.6–22.2] and rSR1 9.0% [95% CI 5.0–13.0]; p = 0.01). The majority of deficits in both studies were at the nerve root level, and the distribution of level of injury was similar.

CONCLUSIONS

New neurological deficit rates were nearly twice as high in the prospective study than the retrospective study with identical inclusion criteria. These findings validate concerns regarding retrospective cohort studies and confirm the need for and value of carefully designed prospective, observational cohort studies in ASD.

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Michael P. Kelly, Lawrence G. Lenke, Christopher I. Shaffrey, Christopher P. Ames, Leah Y. Carreon, Virginie Lafage, Justin S. Smith and Adam L. Shimer

Object

The goal in this study was to evaluate the risk factors for complications, including new neurological deficits, in the largest cohort of patients with adult spinal deformity to date.

Methods

The Scoli-RISK-1 inclusion criteria were used to identify eligible patients from 5 centers who were treated between June 1, 2009, and June 1, 2011. Records were reviewed for patient demographic information, surgical data, and reports of perioperative complications. Neurological deficits were recorded as preexisting or as new deficits. Patients who underwent 3-column osteotomies (3COs) were compared with those who did not (posterior spinal fusion [PSF]). Between-group comparisons were performed using independent samples t-tests and chi-square analyses.

Results

Two hundred seven patients were identified—75 who underwent PSF and 132 treated with 3CO. In the latter group, patients were older (58.9 vs 49.4 years, p < 0.001), had a higher body mass index (29.0 vs 25.8, p = 0.029), smaller preoperative coronal Cobb measurements (33.8° vs 56.4°, p < 0.001), more preoperative sagittal malalignment (11.7 cm vs 5.4 cm, p < 0.001), and similar sagittal Cobb measurements (45.8° vs 57.7°, p = 0.113). Operating times were similar (393 vs 423 minutes, p = 0.130), although patients in the 3CO group sustained higher estimated blood loss (2120 vs 1700 ml, p = 0.066). Rates of new neurological deficits were similar (PSF: 6.7% vs 3CO: 9.9%, p = 0.389), and rates of any perioperative medical complication were similar (PSF: 46.7% vs 3CO: 50.8%, p = 0.571). Patients who underwent vertebral column resection (VCR) were more likely to sustain medical complications than those treated with pedicle subtraction osteotomy (73.7% vs 46.9%, p = 0.031), although new neurological deficits were similar (15.8% vs 8.8%, p = 0.348). Regression analysis did not reveal significant predictors of neurological injury or complication from collected data.

Conclusions

Despite higher estimated blood loss, rates of all complications (49.3%) and new neurological deficits (8.7%) did not vary for patients who underwent complex reconstruction, whether or not a 3CO was performed. Patients who underwent VCR sustained more medical complications without an increase in new neurological deficits. Prospective studies of patient factors, provider factors, and refined surgical data are needed to define and optimize risk factors for complication and neurological deficits.

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Praveen V. Mummaneni, Christopher I. Shaffrey, Lawrence G. Lenke, Paul Park, Michael Y. Wang, Frank La Marca, Justin S. Smith, Gregory M. Mundis Jr., David O. Okonkwo, Bertrand Moal, Richard G. Fessler, Neel Anand, Juan S. Uribe, Adam S. Kanter, Behrooz Akbarnia and Kai-Ming G. Fu

Object

Minimally invasive surgery (MIS) is an alternative to open deformity surgery for the treatment of patients with adult spinal deformity. However, at this time MIS techniques are not as versatile as open deformity techniques, and MIS techniques have been reported to result in suboptimal sagittal plane correction or pseudarthrosis when used for severe deformities. The minimally invasive spinal deformity surgery (MISDEF) algorithm was created to provide a framework for rational decision making for surgeons who are considering MIS versus open spine surgery.

Methods

A team of experienced spinal deformity surgeons developed the MISDEF algorithm that incorporates a patient's preoperative radiographic parameters and leads to one of 3 general plans ranging from MIS direct or indirect decompression to open deformity surgery with osteotomies. The authors surveyed fellowship-trained spine surgeons experienced with spinal deformity surgery to validate the algorithm using a set of 20 cases to establish interobserver reliability. They then resurveyed the same surgeons 2 months later with the same cases presented in a different sequence to establish intraobserver reliability. Responses were collected and tabulated. Fleiss' analysis was performed using MATLAB software.

Results

Over a 3-month period, 11 surgeons completed the surveys. Responses for MISDEF algorithm case review demonstrated an interobserver kappa of 0.58 for the first round of surveys and an interobserver kappa of 0.69 for the second round of surveys, consistent with substantial agreement. In at least 10 cases there was perfect agreement between the reviewing surgeons. The mean intraobserver kappa for the 2 surveys was 0.86 ± 0.15 (± SD) and ranged from 0.62 to 1.

Conclusions

The use of the MISDEF algorithm provides consistent and straightforward guidance for surgeons who are considering either an MIS or an open approach for the treatment of patients with adult spinal deformity. The MISDEF algorithm was found to have substantial inter- and intraobserver agreement. Although further studies are needed, the application of this algorithm could provide a platform for surgeons to achieve the desired goals of surgery.