Browsing by Author "Kelly, Michael P"
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Item Open Access A Comprehensive Review of Complication Rates After Surgery for Adult Deformity: A Reference for Informed Consent.(Spine deformity, 2015-11) Sciubba, Daniel M; Yurter, Alp; Smith, Justin S; Kelly, Michael P; Scheer, Justin K; Goodwin, C Rory; Lafage, Virginie; Hart, Robert A; Bess, Shay; Kebaish, Khaled; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher P; International Spine Study Group (ISSG)Objective
An up-to-date review of recent literatures and a comprehensive reference for informed consent specific to ASD complications is lacking. The goal of the present study was to determine current complication rates after ASD surgery, in order to provide a reference for informed consent as well as to determine differences between three-column and non-three-column osteotomy procedures to aid in shared decision making.Methods
A review of the literature was conducted using the PubMed database. Randomized controlled trials, nonrandomized trials, cohort studies, case-control studies, and case series providing postoperative complications published in 2000 or later were included. Complication rates were recorded and calculated for perioperative (both major and minor) and long-term complication rates. Postoperative outcomes were all stratified by surgical procedure (ie, three-column osteotomy and non-three-column osteotomy).Results
Ninety-three articles were ultimately eligible for analysis. The data of 11,692 patients were extracted; there were 3,646 complications, mean age at surgery was 53.3 years (range: 25-77 years), mean follow-up was 3.49 years (range: 6 weeks-9.7 years), estimated blood loss was 2,161 mL (range: 717-7,034 mL), and the overall mean complication rate was 55%. Specifically, major perioperative complications occurred at a mean rate of 18.5%, minor perioperative complications occurred at a mean rate of 15.7%, and long-term complications occurred at a mean rate of 20.5%. Furthermore, three-column osteotomy resulted in a higher overall complication rate and estimated blood loss than non-three-column osteotomy.Conclusions
A review of recent literatures providing complication rates for ASD surgery was performed, providing the most up-to-date incidence of early and late complications. Providers may use such data in helping to counsel patients of the literature-supported complication rates of such procedures despite the planned benefits, thus obtaining a more thorough informed consent.Item Open Access Adult Cervical Deformity Patients Have Higher Baseline Frailty, Disability, and Comorbidities Compared With Complex Adult Thoracolumbar Deformity Patients: A Comparative Cohort Study of 616 Patients.(Global spine journal, 2023-11) Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Ben-Israel, David; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter; Gum, Jeffrey L; Kebaish, Khal; Mullin, Jeffrey P; Eastlack, Robert; Daniels, Alan; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Burton, Douglas; Ames, Christopher P; Bess, Shay; International Spine Study GroupStudy design
Multicenter comparative cohort.Objective
Studies have shown markedly higher rates of complications and all-cause mortality following surgery for adult cervical deformity (ACD) compared with adult thoracolumbar deformity (ATLD), though the reasons for these differences remain unclear. Our objectives were to compare baseline frailty, disability, and comorbidities between ACD and complex ATLD patients undergoing surgery.Methods
Two multicenter prospective adult spinal deformity registries were queried, one ATLD and one ACD. Baseline clinical and frailty measures were compared between the cohorts.Results
616 patients were identified (107 ACD and 509 ATLD). These groups had similar mean age (64.6 vs 60.8 years, respectively, P = .07). ACD patients were less likely to be women (51.9% vs 69.5%, P < .001) and had greater Charlson Comorbidity Index (1.5 vs .9, P < .001) and ASA grade (2.7 vs 2.4, P < .001). ACD patients had worse VR-12 Physical Component Score (PCS, 25.7 vs 29.9, P < .001) and PROMIS Physical Function Score (33.3 vs 35.3, P = .031). All frailty measures were significantly worse for ACD patients, including hand dynamometer (44.6 vs 55.6 lbs, P < .001), CSHA Clinical Frailty Score (CFS, 4.0 vs 3.2, P < .001), and Edmonton Frailty Scale (EFS, 5.15 vs 3.21, P < .001). Greater proportions of ACD patients were frail (22.9% vs 5.7%) or vulnerable (15.6% vs 10.9%) based on EFS (P < .001).Conclusions
Compared with ATLD patients, ACD patients had worse baseline characteristics on all measures assessed (comorbidities/disability/frailty). These differences may help account for greater risk of complications and all-cause mortality previously observed in ACD patients and facilitate strategies for better preoperative optimization.Item Open Access Adult Spinal Deformity Knowledge in Orthopedic Spine Surgeons: Impact of Fellowship Training, Experience, and Practice Characteristics.(Spine deformity, 2018-01) Grabel, Zachary J; Hart, Robert A; Clark, Aaron J; Park, Sara Heejung; Shaffrey, Christopher I; Scheer, Justin K; Smith, Justin S; Kelly, Michael P; DePasse, J Mason; Gupta, Munish C; Ames, Christopher P; Daniels, Alan HSTUDY DESIGN:Survey study. OBJECTIVE:The purpose of this paper was to assess the level of adult spine deformity (ASD) knowledge among orthopedic spine surgeons and identify areas for improvement in spine surgery training. SUMMARY OF BACKGROUND DATA:ASD is increasingly encountered in spine surgery practice. While ASD knowledge among neurosurgeons has been evaluated, ASD knowledge among orthopedic spine surgeons has not previously been reported. METHODS:A survey of orthopedic spine surgeon members of North American Spine Society (NASS) was conducted to assess level of spine surgery training, practice experience, and spinal deformity knowledge base. The survey used was previously completed by a group of neurologic surgeons with published results. The survey used 11 questions developed and agreed upon by experienced spinal deformity surgeons. RESULTS:Complete responses were received from 413 orthopedic spine surgeons. The overall correct-answer rate was 69.0%. Surgeons in practice for less than 10 years had a higher correct-answer rate compared to those who have practiced for 10 years or more (74% vs. 67%; p = .000003). Surgeons with 75% or more of their practice dedicated to spine had a higher overall correct rate compared to surgeons whose practice is less than 75% spine (71% vs. 63%; p = .000029). Completion of spine fellowship was associated with a higher overall correct-answer rate compared to respondents who did not complete a spine fellowship (71% vs. 59%; p < .00001). CONCLUSIONS:Completion of spine fellowship and having a dedicated spine surgery practice were significantly associated with improved performance on this ASD knowledge survey. Unlike neurosurgeons, orthopedic spine surgeons who have practiced for less than 10 years performed better than those who have practiced for more than 10 years. Ongoing emphasis on spine deformity education should be emphasized to improve adult spinal deformity knowledge base.Item Open Access Adult Spinal Deformity Surgery Is Associated with Increased Productivity and Decreased Absenteeism From Work and School.(Spine, 2022-02) Durand, Wesley M; Babu, Jacob M; Hamilton, David K; Passias, Peter G; Kim, Han Jo; Protopsaltis, Themistocles; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Kelly, Michael P; Klineberg, Eric O; Schwab, Frank; Gum, Jeffrey L; Mundis, Gregory; Eastlack, Robert; Kebaish, Khaled; Soroceanu, Alex; Hostin, Richard A; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; Daniels, Alan H; International Spine Study Group (ISSG)Study design
Retrospective cohort study.Objective
We hypothesized that adult spinal deformity (ASD) surgery would be associated with improved work- and school-related productivity, as well as decreased rates of absenteeism.Summary of background data
ASD patients experience markedly decreased health-related quality of life along many dimensions.Methods
Only patients eligible for 2-year follow-up were included, and those with a history of previous spinal fusion were excluded. The primary outcome measures in this study were Scoliosis Research Society-22r score (SRS-22r) questions 9 and 17. A repeated measures mixed linear regression was used to analyze responses over time among patients managed operatively (OP) versus nonoperatively (NON-OP).Results
In total, 1188 patients were analyzed. 66.6% were managed operatively. At baseline, the mean percentage of activity at work/school was 56.4% (standard deviation [SD] 35.4%), and the mean days off from work/school over the past 90 days was 1.6 (SD 1.8). Patients undergoing ASD surgery exhibited an 18.1% absolute increase in work/school productivity at 2-year follow-up versus baseline (P < 0.0001), while no significant change was observed for the nonoperative cohort (P > 0.5). Similarly, the OP cohort experienced 1.1 fewer absent days over the past 90 days at 2 years versus baseline (P < 0.0001), while the NON-OP cohort showed no such difference (P > 0.3). These differences were largely preserved after stratifying by baseline employment status, age group, sagittal vertical axis (SVA), pelvic incidence minus lumbar lordosis (PI-LL), and deformity curve type.Conclusion
ASD patients managed operatively exhibited an average increase in work/school productivity of 18.1% and decreased absenteeism of 1.1 per 90 days at 2-year follow-up, while patients managed nonoperatively did not exhibit change from baseline. Given the age distribution of patients in this study, these findings should be interpreted as pertaining primarily to obligations at work or within the home. Further study of the direct and indirect economic benefits of ASD surgery to patients is warranted.Level of Evidence: 3.Item Open Access Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?(JOURNAL OF NEUROSURGERY-SPINE, 2024) Mullin, Jeffrey P; Soliman, Mohamed AR; Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter G; Gum, Jeffrey L; Kebaish, Khaled; Eastlack, Robert K; Daniels, Alan H; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish C; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Burton, DouglasItem Open Access Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?(Journal of neurosurgery. Spine, 2024-03) Mullin, Jeffrey P; Soliman, Mohamed AR; Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter G; Gum, Jeffrey L; Kebaish, Khaled; Eastlack, Robert K; Daniels, Alan H; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish C; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Burton, DouglasObjective
Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors.Methods
Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA.Results
Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications.Conclusions
Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.Item Open Access Are Minimally Invasive Spine Surgeons or Classical Open Spine Surgeons More Consistent with Their Treatment of Adult Spinal Deformity?(World neurosurgery, 2022-09) Uribe, Juan S; Koffie, Robert M; Wang, Michael Y; Mundis, Gregory M; Kanter, Adam S; Eastlack, Robert K; Anand, Neel; Park, Paul; Smith, Justin S; Burton, Douglas C; Chou, Dean; Kelly, Michael P; Kim, Han Jo; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; Lenke, Lawrence G; Mummaneni, Praveen VObjective
Spine surgeons have a heuristic sense of how to surgically restore alignment and address adult spinal deformity (ASD) symptoms, but consensus on the extent of treatment remains unclear. We sought to determine the variability of surgical approaches in treating ASD.Methods
Sixteen spine surgeons were surveyed on treatment approaches in 10 select ASD cases. We repeated the survey with the same surgeons 4 weeks later, with cases ordered differently. We examined the variability in length of construct, use of interbody spacers, osteotomies, and pelvic fixation frequency.Results
Treatment approaches for each case varied by surgeon, with some surgeons opting for long fusion constructs in cases for which others offered no surgery. There was no consensus among surgeons on the number of levels fused, interbody spacer use, or anterior/posterior osteotomies. Intersurgeon and intrasurgeon variability was 48% (kappa = 0.31) and 59% (kappa = 0.44) for surgeons performing minimally invasive surgery (MIS) versus 37% (kappa = 0.21) and 47% (kappa = 0.30) for those performing open surgery. In the second-round survey, 8 of 15 (53%) surgeons substantially changed the construct length, number of interbody spacers, and osteotomies in at least half the cases they previously reviewed. Surgeons performing MIS versus open surgery were less likely to extend constructs to the pelvis (42.5% vs. 67.5%; P = 0.02), but construct length was not correlated with whether a surgeon performed MIS or open surgery.Conclusions
Spinal deformity surgeons lack consensus on the optimal surgical approach for treating ASD. Classifying surgeons as performing MIS or open surgery does not mitigate this variability.Item Open Access Artificial intelligence clustering of adult spinal deformity sagittal plane morphology predicts surgical characteristics, alignment, and outcomes.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2021-08) Durand, Wesley M; Lafage, Renaud; Hamilton, D Kojo; Passias, Peter G; Kim, Han Jo; Protopsaltis, Themistocles; Lafage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Kelly, Michael P; Klineberg, Eric O; Schwab, Frank; Gum, Jeffrey L; Mundis, Gregory; Eastlack, Robert; Kebaish, Khaled; Soroceanu, Alex; Hostin, Richard A; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; Daniels, Alan H; International Spine Study Group (ISSG)Purpose
AI algorithms have shown promise in medical image analysis. Previous studies of ASD clusters have analyzed alignment metrics-this study sought to complement these efforts by analyzing images of sagittal anatomical spinopelvic landmarks. We hypothesized that an AI algorithm would cluster preoperative lateral radiographs into groups with distinct morphology.Methods
This was a retrospective review of a multicenter, prospectively collected database of adult spinal deformity. A total of 915 patients with adult spinal deformity and preoperative lateral radiographs were included. A 2 × 3, self-organizing map-a form of artificial neural network frequently employed in unsupervised classification tasks-was developed. The mean spine shape was plotted for each of the six clusters. Alignment, surgical characteristics, and outcomes were compared.Results
Qualitatively, clusters C and D exhibited only mild sagittal plane deformity. Clusters B, E, and F, however, exhibited marked positive sagittal balance and loss of lumbar lordosis. Cluster A had mixed characteristics, likely representing compensated deformity. Patients in clusters B, E, and F disproportionately underwent 3-CO. PJK and PJF were particularly prevalent among clusters A and E. Among clusters B and F, patients who experienced PJK had significantly greater positive sagittal balance than those who did not.Conclusions
This study clustered preoperative lateral radiographs of ASD patients into groups with highly distinct overall spinal morphology and association with sagittal alignment parameters, baseline HRQOL, and surgical characteristics. The relationship between SVA and PJK differed by cluster. This study represents significant progress toward incorporation of computer vision into clinically relevant classification systems in adult spinal deformity.Level of evidence iv
Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.Item Open Access Assessment of Macular Microvasculature in Healthy Eyes of Infants and Children Using OCT Angiography.(Ophthalmology, 2019-12) Hsu, S Tammy; Ngo, Hoan T; Stinnett, Sandra S; Cheung, Nathan L; House, Robert J; Kelly, Michael P; Chen, Xi; Enyedi, Laura B; Prakalapakorn, S Grace; Materin, Miguel A; El-Dairi, Mays A; Jaffe, Glenn J; Freedman, Sharon F; Toth, Cynthia A; Vajzovic, LejlaPURPOSE:To assess macular vasculature in healthy infants and children using OCT angiography (OCTA). DESIGN:Prospective cross-sectional study. PARTICIPANTS:One hundred thirty-five normal maculae of 89 healthy infants and children (mean age, 8.5±5.3 years; range, 9 weeks-17 years) treated at the Duke University Eye Center. METHODS:We imaged 135 maculae of 89 pediatric patients using the standard Spectralis tabletop and investigational Spectralis with Flex module devices, both equipped with investigational OCTA software (Heidelberg Engineering, Heidelberg, Germany). OCT angiography images of the superficial vascular complex (SVC) and deep vascular complex (DVC) were analyzed for foveal avascular zone (FAZ) area and superficial and deep vessel density. We assessed effects of age, gender, race, axial length (AL), and central subfield thickness on FAZ and vessel density. Patients with both eyes imaged were assessed for agreement between the FAZ and vessel densities of the left and right eyes. MAIN OUTCOME MEASURES:The FAZ area, as well as vessel area density (VAD) and vessel length density (VLD) in the SVC and DVC. RESULTS:The FAZ varied significantly with race; white patients showed a significantly smaller FAZ than black patients (mean difference, 0.11 mm2; P = 0.004). The FAZ did not vary with age, gender, or AL (P > 0.05). In the SVC, VAD and VLD varied significantly with age (P < 0.001) and AL (R2 = 0.46; P < 0.001) but not gender (P > 0.05). The SVC VLD was significantly different between races and ethnicities (P = 0.037), but VAD was not (P < 0.05). In the DVC, VAD and VLD also varied significantly with age (P < 0.001) and AL (R2 = 0.46; P < 0.001) but not gender or race (P > 0.05). There was excellent agreement between the right and left eyes for FAZ (intraclass correlation [ICC], 0.97), SVC VLD (ICC, 1.00), and DVC VLD (ICC, 1.00). CONCLUSIONS:Quantitative studies of pediatric perifoveal vasculature should consider age, race, and AL. In eyes with unilateral disease, the perifoveal vasculature in the unaffected eye may be used as a control comparison because there is excellent agreement between eyes.Item Open Access Baseline Patient-Reported Outcomes Correlate Weakly With Radiographic Parameters: A Multicenter, Prospective NIH Adult Symptomatic Lumbar Scoliosis Study of 286 Patients.(Spine, 2016-11) Chapman, Todd M; Baldus, Christine R; Lurie, Jon D; Glassman, Steven D; Schwab, Frank J; Shaffrey, Christopher I; Lafage, Virginie; Boachie-Adjei, Oheneba; Kim, Han J; Smith, Justin S; Crawford, Charles H; Lenke, Lawrence G; Buchowski, Jacob M; Edwards, Charles; Koski, Tyler; Parent, Stefan; Lewis, Stephen; Kang, Daniel G; McClendon, Jamal; Metz, Lionel; Zebala, Lukas P; Kelly, Michael P; Spratt, Kevin F; Bridwell, Keith HStudy design
Prospective, cross-sectional study.Objective
The aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS).Summary of background data
Previous literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS.Methods
Prospective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014.Inclusion criteria
40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups.Results
Mean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups.Conclusion
In primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology.Level of evidence
2.Item Open Access Can unsupervised cluster analysis identify patterns of complex adult spinal deformity with distinct perioperative outcomes?(Journal of neurosurgery. Spine, 2023-05) Lafage, Renaud; Fourman, Mitchell S; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Kim, Han Jo; Kebaish, Khaled M; Burton, Douglas C; Hostin, Richard; Passias, Peter G; Protopsaltis, Themistocles S; Daniels, Alan H; Klineberg, Eric O; Gupta, Munish C; Kelly, Michael P; Lenke, Lawrence G; Schwab, Frank J; Lafage, Virginie; International Spine Study GroupObjective
The objective of this study was to use an unsupervised cluster approach to identify patterns of operative adult spinal deformity (ASD) and compare the perioperative outcomes of these groups.Methods
A multicenter data set included patients with complex surgical ASD, including those with severe deformities, significant surgical complexity, or advanced age who underwent a multilevel fusion. An unsupervised cluster analysis allowing for 10% outliers was used to identify different deformity patterns. The perioperative outcomes of these clusters were then compared using ANOVA, Kruskal-Wallis, and chi-square tests, with p values < 0.05 considered significant.Results
Two hundred eighty-six patients were classified into four clusters of deformity patterns: hyper-thoracic kyphosis (hyper-TK), severe coronal, severe sagittal, and moderate sagittal. Hyper-TK patients had the lowest disability (mean Oswestry Disability Index [ODI] 32.9 ± 17.1) and pain scores (median numeric rating scale [NRS] back score 6, leg score 1). The severe coronal cluster had moderate functional impairment (mean physical component score 34.4 ± 12.3) and pain (median NRS back score 7, leg score 4) scores. The severe sagittal cluster had the highest levels of disability (mean ODI 49.3 ± 15.6) and low appearance scores (mean 2.3 ± 0.7). The moderate cluster (mean 68.8 ± 7.8 years) had the highest pain interference subscores on the Patient-Reported Outcomes Measurement Information System (mean 65.2 ± 5.8). Overall 30-day adverse events were equivalent among the four groups. Fusion to the pelvis was most common in the moderate sagittal (89.4%) and severe sagittal (97.5%) clusters. The severe coronal cluster had more osteotomies per case (median 11, IQR 6.5-14) and a higher rate of 30-day implant-related complications (5.5%). The severe sagittal and hyper-TK clusters had more three-column osteotomies (43% and 32.3%, respectively). Hyper-TK patients had shorter hospital stays.Conclusions
This cohort of patients with complex ASD surgeries contained four natural clusters of deformity, each with distinct perioperative outcomes.Item Open Access Cell Saver for Adult Spinal Deformity Surgery Reduces Cost.(Spine deformity, 2017-07) Gum, Jeffrey L; Carreon, Leah Yacat; Kelly, Michael P; Hostin, Richard; Robinson, Chessie; Burton, Douglas C; Polly, David W; Shaffrey, Christopher I; LaFage, Virginie; Schwab, Frank J; Ames, Christopher P; Kim, Han Jo; Smith, Justin S; Bess, R Shay; International Spine Study GroupStudy design
Retrospective cohort.Objectives
To determine if the use of cell saver reduces overall blood costs in adult spinal deformity (ASD) surgery.Summary of background data
Recent studies have questioned the clinical value of cell saver during spine procedures.Methods
ASD patients enrolled in a prospective, multicenter surgical database who had complete preoperative and surgical data were identified. Patients were stratified into (1) cell saver available during surgery, but no intraoperative autologous infusion (No Infusion group), or (2) cell saver available and received autologous infusion (Infusion group).Results
There were 427 patients in the Infusion group and 153 in the No infusion group. Patients in both groups had similar demographics. Mean autologous infusion volume was 698 mL. The Infusion group had a higher percentage of EBL relative to the estimated blood volume (42.2%) than the No Infusion group (19.6%, p < .000). Allogeneic transfusion was more common in the Infusion group (255/427, 60%) than the No Infusion group (67/153, 44%, p = .001). The number of allogeneic blood units transfused was also higher in the Infusion group (2.4) than the No Infusion group (1.7, p = .009). Total blood costs ranged from $396 to $2,146 in the No Infusion group and from $1,262 to $5,088 in the Infusion group. If the cost of cell saver blood was transformed into costs of allogeneic blood, total blood costs for the Infusion group would range from $840 to $5,418. Thus, cell saver use yielded a mean cost savings ranging from $330 to $422 (allogeneic blood averted). Linear regression showed that after an EBL of 614 mL, cell saver becomes cost-efficient.Conclusion
Compared to transfusing allogeneic blood, cell saver autologous infusion did not reduce the proportion or the volume of allogeneic transfusion for patients undergoing surgery for adult spinal deformity. The use of cell saver becomes cost-efficient above an EBL of 614 mL, producing a cost savings of $330 to $422.Level of evidence
Level III.Item Open Access Complication rates associated with 3-column osteotomy in 82 adult spinal deformity patients: retrospective review of a prospectively collected multicenter consecutive series with 2-year follow-up.(Journal of neurosurgery. Spine, 2017-10) Smith, Justin S; Shaffrey, Christopher I; Klineberg, Eric; Lafage, Virginie; Schwab, Frank; Lafage, Renaud; Kim, Han Jo; Hostin, Richard; Mundis, Gregory M; Gupta, Munish; Liabaud, Barthelemy; Scheer, Justin K; Diebo, Bassel G; Protopsaltis, Themistocles S; Kelly, Michael P; Deviren, Vedat; Hart, Robert; Burton, Doug; Bess, Shay; Ames, Christopher P; , on behalf of the International Spine Study GroupOBJECTIVE 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.Item Open Access Comprehensive study of back and leg pain improvements after adult spinal deformity surgery: analysis of 421 patients with 2-year follow-up and of the impact of the surgery on treatment satisfaction.(Journal of neurosurgery. Spine, 2015-05) Scheer, Justin K; Smith, Justin S; Clark, Aaron J; Lafage, Virginie; Kim, Han Jo; Rolston, John D; Eastlack, Robert; Hart, Robert A; Protopsaltis, Themistocles S; Kelly, Michael P; Kebaish, Khaled; Gupta, Munish; Klineberg, Eric; Hostin, Richard; Shaffrey, Christopher I; Schwab, Frank; Ames, Christopher P; International Spine Study GroupOBJECT Back and leg pain are the primary outcomes of adult spinal deformity (ASD) and predict patients' seeking of surgical management. The authors sought to characterize changes in back and leg pain after operative or nonoperative management of ASD. Outcomes were assessed according to pain severity, type of surgical procedure, Scoliosis Research Society (SRS)-Schwab spine deformity class, and patient satisfaction. METHODS This study retrospectively reviewed data in a prospective multicenter database of ASD patients. Inclusion criteria were the following: age > 18 years and presence of spinal deformity as defined by a scoliosis Cobb angle ≥ 20°, sagittal vertical axis length ≥ 5 cm, pelvic tilt angle ≥ 25°, or thoracic kyphosis angle ≥ 60°. Patients were grouped into nonoperated and operated subcohorts and by the type of surgical procedure, spine SRS-Schwab deformity class, preoperative pain severity, and patient satisfaction. Numerical rating scale (NRS) scores of back and leg pain, Oswestry Disability Index (ODI) scores, physical component summary (PCS) scores of the 36-Item Short Form Health Survey, minimum clinically important differences (MCIDs), and substantial clinical benefits (SCBs) were assessed. RESULTS Patients in whom ASD had been operatively managed were 6 times more likely to have an improvement in back pain and 3 times more likely to have an improvement in leg pain than patients in whom ASD had been nonoperatively managed. Patients whose ASD had been managed nonoperatively were more likely to have their back or leg pain remain the same or worsen. The incidence of postoperative leg pain was 37.0% at 6 weeks postoperatively and 33.3% at the 2-year follow-up (FU). At the 2-year FU, among patients with any preoperative back or leg pain, 24.3% and 37.8% were free of back and leg pain, respectively, and among patients with severe (NRS scores of 7-10) preoperative back or leg pain, 21.0% and 32.8% were free of back and leg pain, respectively. Decompression resulted in more patients having an improvement in leg pain and their pain scores reaching MCID. Although osteotomies improved back pain, they were associated with a higher incidence of leg pain. Patients whose spine had an SRS-Schwab coronal curve Type N deformity (sagittal malalignment only) were least likely to report improvements in back pain. Patients with a Type L deformity were most likely to report improved back or leg pain and to have reductions in pain severity scores reaching MCID and SCB. Patients with a Type D deformity were least likely to report improved leg pain and were more likely to experience a worsening of leg pain. Preoperative pain severity affected pain improvement over 2 years because patients who had higher preoperative pain severity experienced larger improvements, and their changes in pain severity were more likely to reach MCID/SCB than for those reporting lower preoperative pain. Reductions in back pain contributed to improvements in ODI and PCS scores and to patient satisfaction more than reductions in leg pain did. CONCLUSIONS The authors' results provide a valuable reference for counseling patients preoperatively about what improvements or worsening in back or leg pain they may experience after surgical intervention for ASD.Item Open Access Cost Benefit of Implementation of Risk Stratification Models for Adult Spinal Deformity Surgery.(Global Spine J, 2023-12-11) Passias, Peter G; Williamson, Tyler K; Kummer, Nicholas A; Pellisé, Ferran; Lafage, Virginie; Lafage, Renaud; Serra-Burriel, Miguel; Smith, Justin S; Line, Breton; Vira, Shaleen; Gum, Jeffrey L; Haddad, Sleiman; Sánchez Pérez-Grueso, Francisco Javier; Schoenfeld, Andrew J; Daniels, Alan H; Chou, Dean; Klineberg, Eric O; Gupta, Munish C; Kebaish, Khaled M; Kelly, Michael P; Hart, Robert A; Burton, Douglas C; Kleinstück, Frank; Obeid, Ibrahim; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher P; Schwab, Frank J; Hostin, Richard A; Bess, Shay; International Spine Study GroupSTUDY DESIGN/SETTING: Retrospective cohort study. OBJECTIVE: Assess the extent to which defined risk factors of adverse events are drivers of cost-utility in spinal deformity (ASD) surgery. METHODS: ASD patients with 2-year (2Y) data were included. Tertiles were used to define high degrees of frailty, sagittal deformity, blood loss, and surgical time. Cost was calculated using the Pearl Diver registry and cost-utility at 2Y was compared between cohorts based on the number of risk factors present. Statistically significant differences in cost-utility by number of baseline risk factors were determined using ANOVA, followed by a generalized linear model, adjusting for clinical site and surgeon, to assess the effects of increasing risk score on overall cost-utility. RESULTS: By 2 years, 31% experienced a major complication and 23% underwent reoperation. Patients with ≤2 risk factors had significantly less major complications. Patients with 2 risk factors improved the most from baseline to 2Y in ODI. Average cost increased by $8234 per risk factor (R2 = .981). Cost-per-QALY at 2Y increased by $122,650 per risk factor (R2 = .794). Adjusted generalized linear model demonstrated a significant trend between increasing risk score and increasing cost-utility (r2 = .408, P < .001). CONCLUSIONS: The number of defined patient-specific and surgical risk factors, especially those with greater than two, were associated with increased index surgical costs and diminished cost-utility. Efforts to optimize patient physiology and minimize surgical risk would likely reduce healthcare expenditures and improve the overall cost-utility profile for ASD interventions.Level of evidence: III.Item Open Access Cost-effectiveness Improves for Operative vs Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis at Eight-Year Follow-up.(Spine, 2024-10) Carreon, Leah Y; Glassman, Steven D; Smith, Justin S; Kelly, Michael P; Yanik, Elizabeth L; Baldus, Christine R; Lurie, Jon D; Edwards, Charles; Lenke, Lawrence G; Buchowski, Jacob M; Crawford, Charles H; Koski, Tyler; Lafage, Virginie; Gupta, Munish; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Shaffrey, Christopher I; Bridwell, Keith HStudy design
Secondary data analysis of the NIH sponsored study on Adult Symptomatic Lumbar Scoliosis (ASLS).Objectives
The purpose of this study is to perform a cost-effectiveness analysis comparing operative versus non-operative care for ASLS eight years after enrollment.Summary of background data
A prior cost-effectiveness analysis of the current cohort comparing operative to non-operative care at five years after enrollment showed and ICER of $44,033 in the As-Treated analysis and a ICER of $27,480 in the Intent-to-treat analysis.Methods
Data was collected every three months for the first two years, then every six months for the remainder of the study. Data included use of non-operative modalities, medications and employment status. Costs for index and revision surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Quality Adjusted Life Years (QALY) was determined using the SF6D.Results
There were 101 cases in the Operative (Op) and 103 in the Non-operative (Non-Op) group with complete eight year data. Thirty-eight patients (37%) in the Non-Op group had surgery from 3 to 72 months after enrollment. An As-Treated analysis including only cases who never had surgery (N=65) or cases with complete eight-year post-operative data (N=101) showed that operative treatment was favored with an ICER of $20,569 per QALY gained which is within Willingness-to-Pay (WTP) thresholds. An Intent-to-Treat analysis demonstrated greater QALY gains and lower cost in the Op group (ICER = $-13,911). However, Intent-to-Treat analysis is influenced by Non-Op patients who crossed over to operative treatment at variable times during follow-up.Conclusion
Operative treatment was more cost-effective than non-operative treatment for ASLS at eight-year follow-up. The ICER continued to improve as compared to the five-year values ($20,569 vs. $44,033).Item Open Access Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.(Spine deformity, 2020-12) Glassman, Steven D; Carreon, Leah Y; Shaffrey, Christopher I; Kelly, Michael P; Crawford, Charles H; Yanik, Elizabeth L; Lurie, Jon D; Bess, R Shay; Baldus, Christine R; Bridwell, Keith HStudy design
Longitudinal comparative cohort.Objective
The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis.Methods
Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D.Results
Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment.Conclusion
This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis.Level of evidence
II.Item Open Access Cost-effectiveness of Operative versus Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis an Intent-to-treat Analysis at 5-year Follow-up.(Spine, 2019-11) Carreon, Leah Y; Glassman, Steven D; Lurie, Jon; Shaffrey, Christopher I; Kelly, Michael P; Baldus, Christine R; Bratcher, Kelly R; Crawford, Charles H; Yanik, Elizabeth L; Bridwell, Keith HSTUDY DESIGN:Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms. OBJECTIVE:The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS. SUMMARY OF BACKGROUND DATA:The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates. METHODS:Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D. RESULTS:There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain. CONCLUSION:In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years. LEVEL OF EVIDENCE:2.Item Open Access Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.(Spine, 2020-07) Jain, Amit; Yeramaneni, Samrat; Kebaish, Khaled M; Raad, Micheal; Gum, Jeffrey L; Klineberg, Eric O; Hassanzadeh, Hamid; Kelly, Michael P; Passias, Peter G; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Bess, Shay; Lafage, Virginie; Glassman, Steve; Carreon, Leah Y; Hostin, Richard A; International Spine Study GroupStudy design
Economic modeling of data from a multicenter, prospective registry.Objective
The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery.Summary of background data
ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis.Methods
Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05).Results
BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients.Conclusion
BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research.Level of evidence
2.Item Open Access Defining a Surgical Invasiveness Threshold for Increased Risk of a Major Complication Following Adult Spinal Deformity Surgery.(Spine, 2021-07) Neuman, Brian J; Harris, Andrew B; Klineberg, Eric O; Hostin, Richard A; Protopsaltis, Themistocles S; Passias, Peter G; Gum, Jeffrey L; Hart, Robert A; Kelly, Michael P; Daniels, Alan H; Ames, Christopher P; Shaffrey, Christopher I; Kebaish, Khaled M; and the International Spine Study GroupStudy design
Retrospective review.Objectives
The aim of this study was to define a surgical invasiveness threshold that predicts major complications after adult spinal deformity (ASD) surgery; use this threshold to categorize patients into quartiles by invasiveness; and determine the odds of major complications by quartile.Summary of background data
Understanding the relationship between surgical invasiveness and major complications is important for estimating the likelihood of major complications after ASD surgery.Methods
Using a multicenter database, we identified 574 ASD patients (more than 5 levels fused; mean age, 60 ± 15 years) with minimum 2-year follow-up. Invasiveness was calculated as the ASD Surgical and Radiographic (ASD-SR) score. Youden index was used to identify the invasiveness score cut-off associated with optimal sensitivity and specificity for predicting major complications. Resulting high- and low-invasiveness groups were divided in half to create quartiles. Odds of developing a major complication were analyzed for each quartile using logistic regression (alpha = 0.05).Results
The ASD-SR cutoff score that maximally predicted major complications was 90 points. ASD-SR quartiles were 0 to 65 (Q1), 66 to 89 (Q2), 90 to 119 (Q3), and ≥120 (Q4). Risk of a major complication was 17% in Q1, 21% in Q2, 35% in Q3, and 33% in Q4 (P < 0.001). Comparisons of adjacent quartiles showed an increase in the odds of a major complication from Q2 to Q3 (odds ratio [OR] 1.8; 95% confidence interval [CI]: 1.0-3.0), but not from Q1 to Q2 or from Q3 to Q4. Patients with ASD-SR scores ≥90 were 1.9 times as likely to have a major complication than patients with scores <90 (OR 1.9, 95% CI 1.3-2.9). Mean ASD-SR scores above and below 90 points were 121 ± 25 and 63 ± 17, respectively.Conclusion
The odds of major complications after ASD surgery are significantly greater when the procedure has an ASD-SR score ≥90. ASD-SR score can be used to counsel patients regarding these increased odds.Level of Evidence: 3.