Browsing by Subject "Reoperation"
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Item Open Access A cost-effectiveness comparisons of adult spinal deformity surgery in the United States and Japan.(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, 2018-03) Yagi, Mitsuru; Ames, Christopher P; Keefe, Malla; Hosogane, Naobumi; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank; Lafage, Virginie; Shay Bess, R; Matsumoto, Morio; Watanabe, Kota; International Spine Study Group (ISSG)Purpose
Information about the cost-effectiveness of surgical procedures for adult spinal deformity (ASD) is critical for providing appropriate treatments for these patients. The purposes of this study were to compare the direct cost and cost-effectiveness of surgery for ASD in the United States (US) and Japan (JP).Methods
Retrospective analysis of 76 US and 76 JP patients receiving surgery for ASD with ≥2-year follow-up was identified. Data analysis included preoperative and postoperative demographic, radiographic, health-related quality of life (HRQOL), and direct cost for surgery. An incremental cost-effectiveness ratio (ICER) was determined using cost/quality-adjusted life years (QALY). The cost/QALY was calculated from the 2-year cost and HRQOL data.Results
JP exhibited worse baseline spinopelvic alignment than the US (pelvic incidence and lumbar lordosis: 35.4° vs 22.7°, p < 0.01). The US had more three-column osteotomies (50 vs 16%), and shorter hospital stay (7.9 vs 22.7 days) (p < 0.05). The US demonstrated worse postoperative ODI (41.3 vs. 33.9%) and greater revision surgery rate (40 vs 10%) (p < 0.05). Due to the high initial cost and revision frequency, the US had greater total cost ($92,133 vs. $49,647) and cost/QALY ($511,840 vs. $225,668) at 2-year follow-up (p < 0.05).Conclusion
Retrospective analysis comparing the direct costs and cost-effectiveness of ASD surgery in the US vs JP demonstrated that the total direct costs and cost/QALY were substantially higher in the US than JP. Variations in patient cohort, healthcare costs, revision frequencies, and HRQOL improvement influenced the cost/QALY differential between these countries.Item Open Access Achievement and Maintenance of Optimal Alignment After Adult Spinal Deformity Corrective Surgery: A 5-Year Outcome Analysis.(World neurosurgery, 2023-12) Mir, Jamshaid M; Galetta, Matthew S; Tretiakov, Peter; Dave, Pooja; Lafage, Virginie; Lafage, Renaud; Schoenfeld, Andrew J; Passias, Peter GObjective
We sought to assess factors contributing to optimal radiographic outcomes.Methods
Operative adult spinal deformity (ASD) patients with baseline and 5-year (5Y) data were included. Optimal alignment (O) was defined as improving in at least 1 Scoliosis Research Society-Schwab modifier without worsening in any Scoliosis Research Society-Schwab modifier. A robust outcome was defined as having optimal alignment 2 years (2Y) post operation that was maintained at 5Y. Predictors of robust outcomes were identified using multivariate regression analysis, with a conditional inference tree for continuous variables.Results
Two-hundred and ninety-seven ASD patients met inclusion criteria. Most patients (77.4%) met O at 6W, which decreased to 54.2% at 2Y. The majority of patients (89.4%) that met O at 2Y went on to meet radiographic durability at 5Y (48.5% of total cohort). Rates of junctional failure were higher in O2+5- compared with O2+5- (P = 0.013), with reoperation rates of 17.2% due to loss of alignment. Multivariable regression identified the following independent predictors of optimal alignment at 5Y in those that had O at 2Y: inadequate correction of pelvic tilt and overcorrection of the difference between pelvic incidence and lumbar lordosis (P < 0.05). Increased age, body mass index, and invasiveness were the most significant nonradiographic predictors for not achieving 5Y durability (P < 0.05).Conclusions
The durability of optimal alignment after ASD corrective surgery was seen in about half of the patients at 5Y. While the majority of patients at 2Y maintained their radiographic outcomes at 5Y, major contributors to loss of alignment included junctional failure and adjacent region compensation, with only a minority of patients losing correction through the existing construct. The reoperation rate for loss of alignment was 17.2%. Loss of alignment requiring reoperation had a detrimental effect on 5Y clinical outcomes.Item Open Access Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation.(Clinical orthopaedics and related research, 2021-02) Kwan, Kenny Yat Hong; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Qiu, Yong; Schwab, Frank J; Cheung, Kenneth Man Chee; AO Spine Knowledge Forum DeformityBackground
The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset.Questions/purposes
After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires?Methods
A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test.Results
At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category.Conclusion
Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications.Level of evidence
Level III, diagnostic study.Item Open Access Assessment of Adult Spinal Deformity Complication Timing and Impact on 2-Year Outcomes Using a Comprehensive Adult Spinal Deformity Classification System.(Spine, 2022-03) Wick, Joseph B; Le, Hai V; Lafage, Renaud; Gupta, Munish C; Hart, Robert A; Mundis, Gregory M; Bess, Shay; Burton, Douglas C; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Virginie; Klineberg, Eric O; International Spine Study GroupStudy design
Retrospective review of prospectively collected multicenter registry data.Objective
To identify rates and timing of postoperative complications in adult spinal deformity (ASD) patients, the impact of complication type and timing on health related quality of life (HRQoL) outcomes, and the impact of complication timing on readmission and reoperation rates. Better understanding of complication timing and impact on HRQoL may improve patient selection, preoperative counseling, and postoperative complication surveillance.Summary of background data
ASD is common and associated with significant disability. Surgical correction is often pursued, but is associated with high complication rates. The International Spine Study Group, AO Spinal Deformity Forum, and European Spine Study Group have developed a new complication classification system for ASD (ISSG-AO spine complications classification system).Methods
The ISSG-AO spine complications classification system was utilized to assess complications occurring over the 2-year postoperative time period amongst a multicenter, prospectively enrolled cohort of patients who underwent surgery for ASD. Kaplan-Meier survival curves were established for each complication type. Propensity score matching was performed to adjust for baseline disability and comorbidities. Associations between each complication type and HRQoL, and reoperation/readmission and complication timing, were assessed.Results
Of 584 patients meeting inclusion criteria, cardiopulmonary, gastrointestinal, infection, early adverse events, and operative complications contributed to a rapid initial decrease in complication-free survival. Implant-related, radiographic, and neurologic complications substantially decreased long-term complication-free survival. Only radiographic and implant-related complications were significantly associated with worse 2-year HRQoL outcomes. Need for readmission and/or reoperation was most frequent among those experiencing complications after postoperative day 90.Conclusion
Surgeons should recognize that long-term complications have a substantial negative impact on HRQoL, and should carefully monitor for implant-related and radiographic complications over long-term follow-up.Level of Evidence: 4.Item Open Access Baseline Frailty Status Influences Recovery Patterns and Outcomes Following Alignment Correction of Cervical Deformity.(Neurosurgery, 2021-05) Pierce, Katherine E; Passias, Peter G; Daniels, Alan H; Lafage, Renaud; Ahmad, Waleed; Naessig, Sara; Lafage, Virginie; Protopsaltis, Themistocles; Eastlack, Robert; Hart, Robert; Burton, Douglas; Bess, Shay; Schwab, Frank; Shaffrey, Christopher; Smith, Justin S; Ames, ChristopherBackground
Frailty severity may be an important determinant for impaired recovery after cervical spine deformity (CD) corrective surgery.Objective
To evaluate postop clinical recovery among CD patients between frailty states undergoing primary procedures.Methods
Patients >18 yr old undergoing surgery for CD with health-related quality of life (HRQL) data at baseline, 3-mo, and 1-yr postoperative were identified. Patients were stratified by the modified CD frailty index scale from 0 to 1 (no frailty [NF] <0.3, mild/severe fraily [F] >0.3). Patients in NF and F groups were propensity score matched for TS-CL (T1 slope [TS] minus angle between the C2 inferior end plate and the C7 inferior end plate [CL]) to control for baseline deformity. Area under the curve was calculated for follow-up time intervals determining overall normalized, time-adjusted HRQL outcomes; Integrated Health State (IHS) was compared between NF and F groups.Results
A total of 106 CD patients were included (61.7 yr, 66% F, 27.7 kg/m2)-by frailty group: 52.8% NF, 47.2% F. After propensity score matching for TS-CL (mean: 38.1°), 38 patients remained in each of the NF and F groups. IHS-adjusted HRQL outcomes from baseline to 1 yr showed a significant difference in Euro-Qol 5 Dimension scores (NF: 1.02, F: 1.07, P = .016). No significant differences were found in the IHS Neck Disability Index (NDI) and modified Japanese Orthopedic Association between frailty groups (P > .05). F patients had more postop major complications (31.3%) compared to the NF (8.9%), P = .004, though DJK occurrence and reoperation between the groups was not significant.Conclusion
While all groups exhibited improved postop disability and pain scores, frail patients experienced greater amount of improvement in overall health state compared to baseline disability. This signifies that with frailty severity, patients have more room for improvement postop compared to baseline quality of life.Item Open Access Comparison of Complications and Clinical and Radiographic Outcomes Between Nonobese and Obese Patients with Adult Spinal Deformity Undergoing Minimally Invasive Surgery.(World neurosurgery, 2016-03) Park, Paul; Wang, Michael Y; Nguyen, Stacie; Mundis, Gregory M; La Marca, Frank; Uribe, Juan S; Anand, Neel; Okonkwo, David O; Kanter, Adam S; Fessler, Richard; Eastlack, Robert K; Chou, Dean; Deviren, Vedat; Nunley, Pierce D; Shaffrey, Christopher I; Mummaneni, Praveen V; International Spine Study GroupObjective
Obesity can be associated with increased complications and potentially worse outcomes. We aimed to evaluate the impact of obesity on complications and outcomes in patients with adult spinal deformity (ASD) who underwent minimally invasive surgery (MIS).Methods
A multicenter database of patients with ASD treated via MIS was queried. Of 190 patients in the database, 77 fit the inclusion criteria of 3 or more spinal levels treated minimally invasively. Patients were divided by body mass index (BMI) <30 (nonobese; n = 59) and BMI ≥ 30 (obese; n = 18).Results
Mean BMI was 24.6 nonobese and 35.0 obese (P < 0.001). There were mean 3.8 interbody fusions nonobese and 4.7 obese (P = 0.065). Levels treated posteriorly averaged 5.8 nonobese and 5.9 obese (P = 0.502). Mean follow-up was 34.4 months nonobese and 35.3 months obese (P = 0.976). Baseline radiographic parameters were similar between groups. Postoperatively, SVA averaged 83.9 mm obese and 20.4 mm nonobese (P = 0.002). Postoperative lumbar lordosis-pelvic incidence mismatch averaged 17.9° obese and 9.9° nonobese (P = 0.028). Both groups had improvement in Oswestry Disability Index (ODI) scores with no difference in postoperative ODI scores between groups (P = 0.090). Similarly, both groups had decreased VAS scores for back and leg pain with no difference between groups postoperatively. Twenty (33.9%) nonobese patients versus 7 (38.9%) obese patients had complications (P = 0.452).Conclusions
Our results suggest that obesity does not negatively impact complication rate or clinical outcomes in patients with ASD treated via MIS approaches.Item Open Access Complications, revision fusions, readmissions, and utilization over a 1-year period after bone morphogenetic protein use during primary cervical spine fusions.(The spine journal : official journal of the North American Spine Society, 2014-09) Goode, Adam P; Richardson, William J; Schectman, Robin M; Carey, Timothy SBackground context
Nationwide estimates examining bone morphogenetic protein (BMP) use with cervical spine fusions have been limited to perioperative outcomes.Purpose
To determine the 1-year risk of complications, cervical revision fusions, hospital readmissions, and health care services utilization.Study design
A retrospective cohort study from 2002 to 2009 using a nationwide claims database.Patient sample
There were 61,937 primary cervical spine fusions of which 1,677 received BMP.Outcome measures
Complications, revision fusions, 30-day hospital readmission, and health care utilization.Methods
Data for these analyses come from the Thomson Reuters MarketScan Commercial Claims and Encounters Database 2010. Patients were aged 18 to 64 years, receiving and not receiving BMP with a primary (C2-C7) cervical spine fusion. All outcomes were defined by International Classification of Diseases, 9th edition Clinical Modification and Current Procedural and Terminology, 4th edition codes. Complications were analyzed as any complication and stratified by nervous system, wound, and dysphagia or hoarseness. Cervical revision fusions were determined in the 1-year follow-up. Hospital readmission discharge records defined 30-day hospital readmission and reason for the readmission. The utilization of at least one health care service of cervical spine imaging, epidural usage or rehabilitation service was examined. Poisson regression models were used to estimate the relative risk and 95% confidence interval (CI). Linear regression was used to determine the time to hospital readmission. Results were stratified by anterior or posterior and circumferential approaches.Results
Patients receiving BMP were 29% more likely to have a complication (adjusted relative risk [aRR]=1.29 [95% CI, 1.14-1.46]) and a nervous system complication (aRR=1.42 [95% CI, 1.10-1.83]). Cervical revision fusions were more likely among patients receiving BMP (aRR=1.69 [95% CI, 1.35-2.13]). The risk of 30-day readmission was greater with BMP use (aRR=1.37 [95% CI, 1.07-1.73]) and readmission occurred 27.4% sooner on an average. Patients receiving BMP were more likely to receive computed tomography scans (aRR=1.34 [95% CI, 1.06-1.70]) and epidurals with anterior surgical approaches (aRR=1.29 [95% CI, 1.00-1.65]).Conclusions
These findings question both the safety and effectiveness of off-label BMP use in primary cervical spine fusions.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 Does MIS Surgery Allow for Shorter Constructs in the Surgical Treatment of Adult Spinal Deformity?(Neurosurgery, 2017-03) Uribe, Juan S; Beckman, Joshua; Mummaneni, Praveen V; Okonkwo, David; Nunley, Pierce; Wang, Michael Y; Mundis, Gregory M; Park, Paul; Eastlack, Robert; Anand, Neel; Kanter, Adam; Lamarca, Frank; Fessler, Richard; Shaffrey, Chris I; Lafage, Virginie; Chou, Dean; Deviren, Vedat; MIS-ISSG GroupBackground
The length of construct can potentially influence perioperative risks in adult spinal deformity (ASD) surgery. A head-to-head comparison between open and minimally invasive surgery (MIS) techniques for treatment of ASD has yet to be performed.Objective
To examine the impact of MIS approaches on construct length and clinical outcomes in comparison to traditional open approaches when treating similar ASD profiles.Methods
Two multicenter databases for ASD, 1 involving MIS procedures and the other open procedures, were propensity matched for clinical and radiographic parameters in this observational study. Inclusion criteria were ASD and minimum 2-year follow-up. Independent t -test and chi-square test were used to evaluate and compare outcomes.Results
A total of 1215 patients were identified, with 84 patients matched in each group. Statistical significance was found for mean levels fused (4.8 for circumferential MIS [cMIS] and 10.1 for open), mean interbody fusion levels (3.6 cMIS and 2.4 open), blood loss (estimated blood loss 488 mL cMIS and 1762 mL open), and hospital length of stay (6.7 days cMIS and 9.7 days open). There was no significant difference in preoperative radiographic parameters or postoperative clinical outcomes (Owestry Disability Index and visual analog scale) between groups. There was a significant difference in postoperative lumbar lordosis (43.3° cMIS and 49.8° open) and pelvic incidence-lumbar lordosis correction (10.6° cMIS and 5.2° open) in the open group. There was no significant difference in reoperation rate between the 2 groups.Conclusion
MIS techniques for ASD may reduce construct length, reoperation rates, blood loss, and length of stay without affecting clinical and radiographic outcomes when compared to a similar group of patients treated with open techniques.Item Open Access Does vertebral level of pedicle subtraction osteotomy correlate with degree of spinopelvic parameter correction?(Journal of neurosurgery. Spine, 2011-02) Lafage, Virginie; Schwab, Frank; Vira, Shaleen; Hart, Robert; Burton, Douglas; Smith, Justin S; Boachie-Adjei, Oheneba; Shelokov, Alexis; Hostin, Richard; Shaffrey, Christopher I; Gupta, Munish; Akbarnia, Behrooz A; Bess, Shay; Farcy, Jean-PierreObject
Pedicle subtraction osteotomy (PSO) is a spinal realignment technique that may be used to correct sagittal spinal imbalance. Theoretically, the level and degree of resection via a PSO should impact the degree of sagittal plane correction in the setting of deformity. However, the quantitative effect of PSO level and focal angular change on postoperative spinopelvic parameters has not been well described. The purpose of this study is to analyze the relationship between the level/degree of PSO and changes in global sagittal balance and spinopelvic parameters.Methods
In this multicenter retrospective study, 70 patients (54 women and 16 men) underwent lumbar PSO surgery for spinal imbalance. Preoperative and postoperative free-standing sagittal radiographs were obtained and analyzed by regional curves (lumbar, thoracic, and thoracolumbar), pelvic parameters (pelvic incidence and pelvic tilt [PT]) and global balance (sagittal vertical axis [SVA] and T-1 spinopelvic inclination). Correlations between PSO parameters (level and degree of change in angle between the 2 adjacent vertebrae) and spinopelvic measurements were analyzed.Results
Pedicle subtraction osteotomy distribution by level and degree of correction was as follows: L-1 (6 patients, 24°), L-2 (15 patients, 24°), L-3 (29 patients, 25°), and L-4 (20 patients, 22°). There was no significant difference in the focal correction achieved by PSO by level. All patients demonstrated changes in preoperative to postoperative parameters including increased lumbar lordosis (from 20° to 49°, p < 0.001), increased thoracic kyphosis (from 30° to 38°, p < 0.001), decreased SVA and T-1 spinopelvic inclination (from 122 to 34 mm, p < 0.001 and from +3° to -4°, p < 0.001, respectively), and decreased PT (from 31° to 23°, p < 0.001). More caudal PSO was correlated with greater PT reduction (r = -0.410, p < 0.05). No correlation was found between SVA correction and PSO location. The PSO degree was correlated with change in thoracic kyphosis (r = -0.474, p < 0.001), lumbar lordosis (r = 0.667, p < 0.001), sacral slope (r = 0.426, p < 0.001), and PT (r = -0.358, p < 0.005).Conclusions
The degree of PSO resection correlates more with spinopelvic parameters (lumbar lordosis, thoracic kyphosis, PT, and sacral slope) than PSO level. More importantly, PSO level impacts postoperative PT correction but not SVA.Item Open Access Effect of Resident and Fellow Involvement in Adult Spinal Deformity Surgery.(World neurosurgery, 2019-02) Zuckerman, Scott L; Lim, Jaims; Lakomkin, Nikita; Than, Khoi D; Smith, Justin S; Shaffrey, Christopher I; Devin, Clinton JBackground
Adult spinal deformity (ASD) operations are complex and often require a multisurgeon team. Simultaneously, it is the responsibility of academic spine surgeons to train future complex spine surgeons. Our objective was to assess the effect of resident and fellow involvement (RFI) on ASD surgery in 4 areas: 1) perioperative outcomes, 2) length of stay (LOS), 3) discharge status, and 4) complications.Methods
Adults undergoing thoracolumbar spinal deformity correction from 2008 to 2014 were identified in the National Surgical Quality Improvement Program database. Cases were divided into those with RFI and those with attendings only. Outcomes were operative time, transfusions, LOS, discharge status, and complications. Univariate and multivariable regression modeling was used. Covariates included preoperative comorbidities, specialty, and levels undergoing instrumentation.Results
A total of 1471 patients underwent ASD surgery with RFI in 784 operations (53%). After multivariable regression modeling, RFI was independently associated with longer operations (β = 66.01 minutes; 95% confidence interval [CI], 35.82-96.19; P < 0.001), increased odds of transfusion (odds ratio, 2.80; 95% CI, 1.81-4.32; P < 0.001), longer hospital stay (β = 1.76 days; 95% CI, 0.18-3.34; P = 0.030), and discharge to an inpatient rehabilitation or a skilled nursing facility (odds ratio, 2.02; 95% CI, 1.34-3.05; P < 0.001). However, RFI was not associated with any increase in major or minor complications.Conclusion
RFI in ASD surgery was associated with increased operative time, the need for additional transfusions, longer LOS, and nonhome discharge. However, no increase in major, minor, or severe complications occurred. These data support the continued training of future deformity and complex spine surgeons without fear of worsening complications; however, areas of improvement exist.Item Open Access Effective Prevention of Proximal Junctional Failure in Adult Spinal Deformity Surgery Requires a Combination of Surgical Implant Prophylaxis and Avoidance of Sagittal Alignment Overcorrection.(Spine, 2020-02) Line, Breton G; Bess, Shay; Lafage, Renaud; Lafage, Virgine; Schwab, Frank; Ames, Christopher; Kim, Han Jo; Kelly, Michael; Gupta, Munish; Burton, Douglas; Hart, Robert; Klineberg, Eric; Kebaish, Khaled; Hostin, Richard; Mundis, Gregory; Eastlack, Robert; Shaffrey, Christopher; Smith, Justin S; International Spine Study GroupStudy design
Propensity score matched analysis of a multi-center prospective adult spinal deformity (ASD) database.Objective
Evaluate if surgical implant prophylaxis combined with avoidance of sagittal overcorrection more effectively prevents proximal junctional failure (PJF) than use of surgical implants alone.Summary of background data
PJF is a severe form of proximal junctional kyphosis (PJK). Efforts to prevent PJF have focused on use of surgical implants. Less information exists on avoidance of overcorrection of age-adjusted sagittal alignment to prevent PJF.Methods
Surgically treated ASD patients (age ≥18 yrs; ≥5 levels fused, ≥1 year follow-up) enrolled into a prospective multi-center ASD database were propensity score matched (PSM) to control for risk factors for PJF. Patients evaluated for use of surgical implants to prevent PJF (IMPLANT) versus no implant prophylaxis (NONE), and categorized by the type of implant used (CEMENT, HOOK, TETHER). Postoperative sagittal alignment was evaluated for overcorrection of age-adjusted sagittal alignment (OVER) versus within sagittal parameters (ALIGN). Incidence of PJF was evaluated at minimum 1 year postop.Results
Six hundred twenty five of 834 eligible for study inclusion were evaluated. Following PSM to control for confounding variables, analysis demonstrated the incidence of PJF was lower for IMPLANT (n = 235; 10.6%) versus NONE (n = 390: 20.3%; P < 0.05). Use of transverse process hooks at the upper instrumented vertebra (HOOK; n = 115) had the lowest rate of PJF (7.0%) versus NONE (20.3%; P < 0.05). ALIGN (n = 246) had lower incidence of PJF than OVER (n = 379; 12.0% vs. 19.2%, respectively; P < 0.05). The combination of ALIGN-IMPLANT further reduced PJF rates (n = 81; 9.9%), while OVER-NONE had the highest rate of PJF (n = 225; 24.2%; P < 0.05).Conclusion
Propensity score matched analysis of 625 ASD patients demonstrated use of surgical implants alone to prevent PJF was less effective than combining implants with avoidance of sagittal overcorrection. Patients that received no PJF implant prophylaxis and had sagittal overcorrection had the highest incidence of PJF.Level of evidence
3.Item Open Access Grading of Complications After Cervical Deformity-corrective Surgery: Are Existing Classification Systems Applicable?(Clinical spine surgery, 2019-07) Bortz, Cole A; Passias, Peter G; Segreto, Frank A; Horn, Samantha R; Lafage, Renaud; Smith, Justin S; Line, Breton G; Mundis, Gregory M; Kelly, Michael P; Park, Paul; Sciubba, Daniel M; Hamilton, D Kojo; Gum, Jeffrey L; Burton, Douglas C; Hart, Robert A; Schwab, Frank J; Bess, Shay; Shaffrey, Christopher; Klineberg, Eric O; International Spine Study GroupStudy design
This is a retrospective review of prospective multicenter cervical deformity (CD) database.Objective
Assess the impact of complication type and Clavien complication (Cc) grade on clinical outcomes of surgical CD patients BACKGROUND:: Validated for general surgery, the Clavien-Dindo complication classification system allows for broad comparison of postoperative complications; however, the applicability of this system is unclear in CD-specific populations.Methods
Surgical CD patients above 18 years with baseline and postoperative clinical data were included. Primary outcomes were complication type (renal, infection, cardiac, pulmonary, gastrointestinal, neurological, musculoskeletal, implant-related, radiographic, operative, wound) and Cc grade (I, II, III, IV, V). Secondary outcomes were estimated blood loss (EBL), length of stay (LOS), reoperation, and health-related quality of life (HRQL) score. The univariate analysis assessed the impact of complication type and Cc grade on improvement markers and 1-year postoperative HRQL outcomes.Results
In total, 153 patients (61±10 y, 61% female) underwent surgery for CD (8.1±4.6 levels fused; surgical approach included 48% posterior, 18% anterior, 34% combined). Overall, 63% of patients suffered at least 1 complication. Complication breakdown by type: renal (2.0%), infection (5.2%), cardiac (7.2%), pulmonary (3.9%), gastrointestinal (2.0%), neurological (26.1%), musculoskeletal (0.0%), implant-related (3.9%), radiographic (16.3%), operative (7.8%), and wound (5.2%). Of complication types, only operative complications were associated with increased EBL (P=0.004), whereas renal, cardiac, pulmonary, gastrointestinal, neurological, radiographic, and wound infections were associated with increased LOS (P<0.050). Patients were also assessed by Cc grade: I (28%), II (14.3%), III (16.3%), IV (6.5%), and V (0.7%). Grades I and V were associated with increased EBL (both P<0.050); Cc grade V was the only complication not associated with increased LOS (P=0.610). Increasing complication severity was correlated with increased risk of reoperation (r=0.512; P<0.001), but not inferior 1-year HRQL outcomes (all P>0.05).Conclusions
Increasing complication severity, assessed by the Clavien-Dindo classification system, was not associated with increased EBL, inpatient LOS, or inferior 1-year postoperative HRQL outcomes. Only operative complications were associated with increased EBL. These results suggest a need for modification of the Clavien system to increase applicability and utility in CD-specific populations.Item Open Access Highest Achievable Outcomes for Adult Spinal Deformity Corrective Surgery: Does Frailty Severity Exert a Ceiling Effect?(Spine, 2024-09) Passias, Peter G; Onafowokan, Oluwatobi O; Tretiakov, Peter; Williamson, Tyler; Kummer, Nicholas; Mir, Jamshaid; Das, Ankita; Krol, Oscar; Passfall, Lara; Joujon-Roche, Rachel; Imbo, Bailey; Yee, Timothy; Sciubba, Daniel; Paulino, Carl B; Schoenfeld, Andrew J; Smith, Justin S; Lafage, Renaud; Lafage, VirginieStudy design
Retrospective single-center study.Objective
To assess the influence of frailty on optimal outcome following ASD corrective surgery.Summary of background data
Frailty is a determining factor in outcomes after ASD surgery and may exert a ceiling effect on the best possible outcome.Methods
ASD patients with frailty measures, baseline, and 2-year ODI included. Frailty was classified as Not Frail (NF), Frail (F) and Severely Frail (SF) based on the modified Frailty Index, then stratified into quartiles based on two-year ODI improvement (most improved designated "Highest"). Logistic regression analyzed relationships between frailty and ODI score and improvement, maintenance, or deterioration. A Kaplan-Meier survival curve was used to analyze differences in time to complication or reoperation.Results
A total of 393 ASD patients were isolated (55.2% NF, 31.0% F, and 13.7% SF), then classified as 12.5% NF-Highest, 17.8% F-Highest, and 3.1% SF-Highest. The SF group had the highest rate of deterioration (16.7%, P =0.025) in the second postoperative year, but the groups were similar in improvement (NF: 10.1%, F: 11.5%, SF: 9.3%, P =0.886). Improvement of SF patients was greatest at six months (ΔODI of -22.6±18.0, P <0.001), but NF and F patients reached maximal ODI at 2 years (ΔODI of -15.7±17.9 and -20.5±18.4, respectively). SF patients initially showed the greatest improvement in ODI (NF: -4.8±19.0, F: -12.4±19.3, SF: -22.6±18.0 at six months, P <0.001). A Kaplan-Meier survival curve showed a trend of less time to major complication or reoperation by 2 years with increasing frailty (NF: 7.5±0.381 yr, F: 6.7±0.511 yr, SF: 5.8±0.757 yr; P =0.113).Conclusions
Increasing frailty had a negative effect on maximal improvement, where severely frail patients exhibited a parabolic effect with greater initial improvement due to higher baseline disability, but reached a ceiling effect with less overall maximal improvement. Severe frailty may exert a ceiling effect on improvement and impair maintenance of improvement following surgery.Level of evidence
Level III.Item Open Access Identification of decision criteria for revision surgery among patients with proximal junctional failure after surgical treatment of spinal deformity.(Spine, 2013-09) Hart, Robert; McCarthy, Ian; Oʼbrien, Michael; Bess, Shay; Line, Brett; Adjei, Oheneba Boachie; Burton, Doug; Gupta, Munish; Ames, Christopher; Deviren, Vedat; Kebaish, Khaled; Shaffrey, Christopher; Wood, Kirkham; Hostin, Richard; International Spine Study GroupStudy design
Multicenter, retrospective, consecutive case series.Objective
This study aims to identify demographic and radiographical characteristics that influence the decision to perform revision surgery among patients with proximal junctional failure (PJF).Summary of background data
Revision rates after PJF remain relatively high, yet the decision criteria for performing revision surgical procedures are not uniform and vary by surgeon. A better understanding of the factors that impact the decision to perform revision surgery is important in order to improve efficiency of surgical treatment of adult spinal deformity.Methods
A cohort of 57 patients with PJF was identified retrospectively from 1218 consecutive patients with adult spinal deformity. PJF was identified on the basis of 10° postoperative increase in kyphosis between upper instrumented vertebra (UIV) and UIV +2, along with 1 or more of the following: fracture of the vertebral body of UIV or UIV +1, posterior osseoligamentous disruption, or pullout of instrumentation at the UIV. Univariate statistical analysis was performed using t tests and Fisher exact tests. Multivariate analysis was performed using logistic regression.Results
Twenty-seven (47.4%) patients underwent revision surgery within 6 months of the index operation. Regression results revealed that patients with combined posterior/anterior approaches at index were significantly more likely to undergo revision (P = 0.001) as were patients with more extreme proximal junctional kyphosis angulation (P = 0.034). Patients sustaining trauma were also significantly more likely to undergo revision (P = 0.019). Variables approaching but not reaching significance as predictors of revision included female sex (P = 0.066) and higher sagittal vertical axis (SVA) (P = 0.090).Conclusion
The decision to perform revision surgery is complicated and varies by surgeon. Factors that seem to influence this decision include traumatic etiology of PJF, severity of proximal junctional kyphosis angulation, higher SVA, and female sex. Factors that were expected to influence revision but had no statistical effect included soft tissue versus bony mode of failure, age, levels fused, and upper thoracic versus thoracolumbar proximal junction.Item Open Access Impact of Movement Disorders on Management of Spinal Deformity in the Elderly.(Neurosurgery, 2015-10) Ha, Yoon; Oh, Jae Keun; Smith, Justin S; Ailon, Tamir; Fehlings, Michael G; Shaffrey, Christopher I; Ames, Christopher PSpinal deformities are frequent and disabling complications of movement disorders such as Parkinson disease and multiple system atrophy. The most distinct spinal deformities include camptocormia, antecollis, Pisa syndrome, and scoliosis. Spinal surgery has become lower risk and more efficacious for complex spinal deformities, and thus more appealing to patients, particularly those for whom conservative treatment is inappropriate or ineffective. Recent innovations and advances in spinal surgery have revolutionized the management of spinal deformities in elderly patients. However, spinal deformity surgeries in patients with Parkinson disease remain challenging. High rates of mechanical complications can necessitate revision surgery. The success of spinal surgery in patients with Parkinson disease depends on an interdisciplinary approach, including both surgeons and movement disorder specialists, to select appropriate surgical patients and manage postoperative movement in order to decrease mechanical failures. Achieving appropriate correction of sagittal alignment with strong biomechanical instrumentation and bone fusion is the key determinant of satisfactory results.Item Open Access Improvement in SRS-22R Self-Image Correlate Most with Patient Satisfaction after 3-Column Osteotomy.(Spine, 2021-06) Gum, Jeffrey L; Shasti, Mark; Yeramaneni, Samrat; Carreon, Leah Y; Hostin, Richard A; Kelly, Michael P; Lafage, Virginie; Smith, Justin S; Passias, Peter G; Kebaish, Khaled; Shaffrey, Christopher I; Burton, Douglas L; Ames, Christopher P; Schwab, Frank J; Protopsaltis, Themistocles; Bess, R Shay; ISSGStudy design
Longitudinal cohort.Objectives
The aim of this study was to examine the relationship between patient satisfaction, patient-reported outcome measures (PROMs) and radiographic parameters in adult spine deformity (ASD) patients undergoing three-column osteotomies (3CO).Summary of background data
Identifying factors that influence patient satisfaction in ASD is important. Evidence suggests Scoliosis Research Society-22R (SRS-22R) Self-Image domain correlates with patient satisfaction in patients with ASD.Methods
This is a retrospective review of ASD patients enrolled in a prospective, multicenter database undergoing a 3CO with complete SRS-22R pre-op and minimum 2-years postop. Spearman correlations were used to evaluate associations between the 2-year SRS Satisfaction score and changes in SRS-22R domain scores, Oswestry Disability Index (ODI), and radiographic parameters.Results
Of 135 patients eligible for 2-year follow-up, 98 patients (73%) had complete pre- and 2-year postop data. The cohort was mostly female (69%) with mean BMI of 29.7 kg/m2 and age of 61.0 years. Mean levels fused was 12.9 with estimated blood loss of 2695 cc and OR time of 407 minutes; 27% were revision surgeries. There was a statistically significant improvement between pre- and 2-year post-op PROMs and all radiographic parameters except Coronal Vertical Axis. The majority of patients had an SRS Satisfaction score of ≥3.0 (90%) or ≥4.0 (68%), consistent with a moderate ceiling effect. Correlations of patient satisfaction was significant for Pain (0.43, P < 0.001), Activity (0.39, P < 0.001), Mental (0.38, P = 0.001) Self-Image (0.52, P < 0.001). ODI and Short-Form-36 Physical component summary had a moderate correlation as well, with mental component summary being weak. There was no statistically significant correlation between any radiographic or operative parameters and patient satisfaction.Conclusion
There was statistically significant improvement in all PROMs and radiographic parameters, except coronal vertical axis at 2 years in ASD patients undergoing 3CO. Improvement in SRS Self-Image domain has the strongest correlation with patient satisfaction.Level of Evidence: 3.Item Open Access Incidence, mode, and location of acute proximal junctional failures after surgical treatment of adult spinal deformity.(Spine, 2013-05) Hostin, Richard; McCarthy, Ian; OʼBrien, Michael; Bess, Shay; Line, Breton; Boachie-Adjei, Oheneba; Burton, Doug; Gupta, Munish; Ames, Christopher; Deviren, Vedat; Kebaish, Khaled; Shaffrey, Christopher; Wood, Kirkham; Hart, Robert; International Spine Study GroupStudy design
Multicenter, retrospective series.Objective
To analyze the incidence, mode, and location of acute proximal junctional failures (APJFs) after surgical treatment of adult spinal deformity.Summary of background data
Early proximal junctional failures above adult deformity constructs are a serious clinical problem; however, the incidence and nature of early APJFs remain unclear.Methods
A total of 1218 consecutive adult spinal deformity surgeries across 10 deformity centers were retrospectively reviewed to evaluate the incidence and nature of APJF, defined as any of the following within 28 weeks of index procedure: minimum 15° post-operative increase in proximal junctional kyphosis, vertebral fracture of upper instrumented vertebrae (UIV) or UIV + 1, failure of UIV fixation, or need for proximal extension of fusion within 6 months of surgery.Results
Sixty-eight APJF cases were identified out of 1218 consecutive surgeries (5.6%). Patients had a mean age of 63 years (range, 26-82 yr), mean fusion levels of 9.8 (range, 4-18), and mean time to APJF of 11.4 weeks (range, 1.5-28 wk). Fracture was the most common failure mode (47%), followed by soft-tissue failure (44%). Failures most often occurred in the thoracolumbar region (TL-APJF) compared with the upper thoracic region (UT-APJF), with 66% of patients experiencing TL-APJF compared with 34% experiencing UT-APJF. Fracture was significantly more common for TL-APJF relative to UT-APJF (P = 0.00), whereas soft-tissue failure was more common for UT-APJF (P < 0.02). Patients experiencing TL-APJF were also older (P = 0.00), had fewer fusion levels (P = 0.00), and had worse postoperative sagittal vertical axis (P < 0.01).Conclusion
APJFs were identified in 5.6% of patients undergoing surgical treatment of adult spinal deformity, with failures occurring primarily in the TL region of the spine. There is evidence that the mode of failure differs depending on the location of UIV, with TL failures more likely due to fracture and UT failures more likely due to soft-tissue failures.Item Open Access Inefficient dystrophin expression after cord blood transplantation in Duchenne muscular dystrophy.(Muscle & nerve, 2010-06) Kang, Peter B; Lidov, Hart GW; White, Alexander J; Mitchell, Matthew; Balasubramanian, Anuradha; Estrella, Elicia; Bennett, Richard R; Darras, Basil T; Shapiro, Frederic D; Bambach, Barbara J; Kurtzberg, Joanne; Gussoni, Emanuela; Kunkel, Louis MWe report a boy who received two allogeneic stem cell transplantations from umbilical cord donors to treat chronic granulomatous disease (CGD). The CGD was cured after the second transplantation, but 2.5 years later he was diagnosed with Duchenne muscular dystrophy (DMD). Examinations of his DNA, muscle tissue, and myoblast cultures derived from muscle tissue were performed to determine whether any donor dystrophin was being expressed. The boy was found to have a large-scale deletion on the X chromosome that spanned the loci for CYBB and DMD. The absence of dystrophin led to muscle histology characteristic of DMD. Analysis of myofibers demonstrated no definite donor cell engraftment. This case suggests that umbilical cord-derived hematopoietic stem cell transplantation will not be efficacious in the therapy of DMD without additional interventions that induce engraftment of donor cells in skeletal muscle.Item Open Access Maintenance of radiographic correction at 2 years following lumbar pedicle subtraction osteotomy is superior with upper thoracic compared with thoracolumbar junction upper instrumented vertebra.(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, 2015-01) Scheer, Justin K; Lafage, Virginie; Smith, Justin S; Deviren, Vedat; Hostin, Richard; McCarthy, Ian M; Mundis, Gregory M; Burton, Douglas C; Klineberg, Eric; Gupta, Munish; Kebaish, Khaled; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P; International Spine Study Group (ISSG)Purpose
The goal of this study was to characterize the spino-pelvic realignment and the maintenance of that realignment by the upper-most instrumented vertebra (UIV) for adult deformity spinal (ASD) patients treated with lumbar pedicle subtraction osteotomy (PSO).Methods
ASD patients were divided by UIV, classified as upper thoracic (UT: T1-T6) or Thoracolumbar (TL: T9-L1). Complications were recorded and radiographic parameters included thoracic kyphosis (TK, T2-T12), lumbar lordosis (LL, L1-S1), sagittal vertical axis (SVA), pelvic tilt, and the mismatch between pelvic incidence and LL. Patients were also classified by the Scoliosis Research Society (SRS)-Schwab modifier grades. Changes in radiographic parameters and SRS-Schwab grades were evaluated between the two groups. Additional analyses were performed on patients with pre-operative SVA ≥ 15 cm.Results
165 patients were included (UT: 81 and TL: 84); 124 women, 41 men, with average age 59.9 ± 11.1 years (range 25-81). UT had a lower percentage of patients above the radiographic thresholds for disability than TL. UT had a significantly higher percentage of patients that improved in SRS-Schwab global alignment grade than the TL group at 2 years. Within the patients with pre-operative SVA ≥ 15 cm, TL developed significantly increased SVA and had a significantly higher percentage of patients above the SVA threshold at 3 months, and 1 and 2 years than UT.Conclusions
Patients undergoing a single-level PSO for ASD who have fixation extending to the UT region (T1-T6) are more likely to maintain sagittal spino-pelvic alignment, lower overall revision rates and revision rate for proximal junctional kyphosis than those with fixation terminating in the TL region (T9-L1).
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