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BACKGROUND: In eyes with diabetic macular edema, the relative efficacy of administering aflibercept monotherapy as compared with bevacizumab first with a switch to aflibercept if the eye condition does not improve sufficiently (a form of step therapy) is unclear. METHODS: At 54 clinical sites, we randomly assigned eyes in adults who had diabetic macular edema involving the macular center and a visual-acuity letter score of 24 to 69 (on a scale from 0 to 100, with higher scores indicating better visual acuity; Snellen equivalent, 20/320 to 20/50) to receive either 2.0 mg of intravitreous aflibercept or 1.25 mg of intravitreous bevacizumab. The drug was administered at randomization and thereafter according to the prespecified retreatment protocol. Beginning at 12 weeks, eyes in the bevacizumab-first group were switched to aflibercept therapy if protocol-specified criteria were met. The primary outcome was the mean change in visual acuity over the 2-year trial period. Retinal central subfield thickness and visual acuity at 2 years and safety were also assessed. RESULTS: A total of 312 eyes (in 270 adults) underwent randomization; 158 eyes were assigned to receive aflibercept monotherapy and 154 to receive bevacizumab first. Over the 2-year period, 70% of the eyes in the bevacizumab-first group were switched to aflibercept therapy. The mean improvement in visual acuity was 15.0 letters in the aflibercept-monotherapy group and 14.0 letters in the bevacizumab-first group (adjusted difference, 0.8 letters; 95% confidence interval, -0.9 to 2.5; P = 0.37). At 2 years, the mean changes in visual acuity and retinal central subfield thickness were similar in the two groups. Serious adverse events (in 52% of the patients in the aflibercept-monotherapy group and in 36% of those in the bevacizumab-first group) and hospitalizations for adverse events (in 48% and 32%, respectively) were more common in the aflibercept-monotherapy group. CONCLUSIONS: In this trial of treatment of moderate vision loss due to diabetic macular edema involving the center of the macula, we found no evidence of a significant difference in visual outcomes over a 2-year period between aflibercept monotherapy and treatment with bevacizumab first with a switch to aflibercept in the case of suboptimal response. (Funded by the National Institutes of Health; Protocol AC ClinicalTrials.gov number, NCT03321513.).
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Inibidores da Angiogênese , Bevacizumab , Retinopatia Diabética , Edema Macular , Receptores de Fatores de Crescimento do Endotélio Vascular , Proteínas Recombinantes de Fusão , Adulto , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/administração & dosagem , Bevacizumab/efeitos adversos , Bevacizumab/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/tratamento farmacológico , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Ranibizumab/efeitos adversos , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/administração & dosagem , Proteínas Recombinantes de Fusão/efeitos adversos , Proteínas Recombinantes de Fusão/uso terapêutico , Fator A de Crescimento do Endotélio VascularRESUMO
Poor bone quality is a risk factor for complications after spinal fusion surgery. This study investigated pre-operative bone quality in postmenopausal women undergoing spine fusion and found that those with small bones, thinner cortices and surgeries involving more vertebral levels were at highest risk for complications. PURPOSE: Spinal fusion is one of the most common surgeries performed worldwide. While skeletal complications are common, underlying skeletal deficits are often missed by pre-operative DXA due to artifact from spinal pathology. This prospective cohort study investigated pre-operative bone quality using high resolution peripheral CT (HRpQCT) and its relation to post-operative outcomes in postmenopausal women, a population that may be at particular risk for skeletal complications. We hypothesized that women with low volumetric BMD (vBMD) and abnormal microarchitecture would have higher rates of post-operative complications. METHODS: Pre-operative imaging included areal BMD (aBMD) by DXA, cortical and trabecular vBMD and microarchitecture of the radius and tibia by high resolution peripheral CT. Intra-operative bone quality was subjectively graded based on resistance to pedicle screw insertion. Post-operative complications were assessed by radiographs and CTs. RESULTS: Among 50 women enrolled (age 65 years), mean spine aBMD was normal and 35% had osteoporosis by DXA at any site. Low aBMD and vBMD were associated with "poor" subjective intra-operative quality. Skeletal complications occurred in 46% over a median follow-up of 15 months. In Cox proportional models, complications were associated with greater number of surgical levels (HR 1.19 95% CI 1.06-1.34), smaller tibia total area (HR 1.67 95% CI1.16-2.44) and lower tibial cortical thickness (HR 1.35 95% CI 1.05-1.75; model p < 0.01). CONCLUSION: Women with smaller bones, thinner cortices and procedures involving a greater number of vertebrae were at highest risk for post-operative complications, providing insights into surgical and skeletal risk factors for complications in this population.
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Densidade Óssea , Pós-Menopausa , Humanos , Feminino , Idoso , Estudos Prospectivos , Osso e Ossos , Absorciometria de Fóton/métodos , Rádio (Anatomia)/patologia , Tíbia/diagnóstico por imagem , Tíbia/cirurgia , Tíbia/patologiaRESUMO
OBJECTIVE: Severe spinal deformity results in restrictive pulmonary disease from thoracic distortions and lung-volume limitations. Though spirometry and body plethysmography are widely accepted tests for pulmonary function tests (PFTs), they are time-consuming and require patient compliance. This study investigates whether surface topographic [surface topography (ST)] measurements of body volume difference (BVD) and torso volume difference between maximum inhale and exhale correlate to values determined on PFTs. METHODS: This study included patients with idiopathic scoliosis and thoracic/thoracolumbar curves ≥40 degrees. Patients received ST scans, clinical examinations, and EOS biplanar radiographs on the same day. PFTs were performed within 3 months of ST/radiographic analysis. Univariate linear regression analysis was used to examine relationships between BVD, PFT values, and mean curves. RESULTS: Sixteen patients (14.6 ± 2.2 y, 69% females) with idiopathic scoliosis and mean thoracic/thoracolumbar curves of 62 degrees ± 15Ë degrees (45 degrees to 93 degrees) were assessed. BVD displayed statistically high-positive positive correlations with forced vital capacity ( R = 0.863, P < 0.0001), forced expiratory volume in 1 second ( R = 0.870, P < 0.001), vital capacity ( R = 0.802, P < 0.0001), and TLC ( R = 0.831, P < 0.0001. Torso volume difference showed similarly high positive correlations to forced vital capacity, forced expiratory volume in 1 second, vital capacity, and TLC, but not residual volume. No correlations emerged between the mean thoracic/thoracolumbar curve and BVD or PFT values. CONCLUSION: This study strongly endorses further investigation into ST scanning as an alternative to traditional PFTs for assessing pulmonary volumes. The noncontact and noninvasive nature of ST scanning presents a valuable alternative method for analyzing thoracic volume, particularly beneficial for patients unable to cooperate with standard PFTs. LEVEL OF EVIDENCE: Level II-prognostic.
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Medidas de Volume Pulmonar , Testes de Função Respiratória , Escoliose , Humanos , Escoliose/fisiopatologia , Escoliose/diagnóstico por imagem , Feminino , Masculino , Adolescente , Criança , Medidas de Volume Pulmonar/métodos , Pulmão/fisiopatologia , Pulmão/diagnóstico por imagem , Espirometria/métodosRESUMO
PURPOSE: This study aims to investigate the fusion rate and complications associated with trans-sacral interbody fusion (TSIF) in long fusions to the sacrum for adult spinal deformity (ASD) over a two year follow-up period. Potential predictor variables associated with pseudarthrosis were also examined. METHODS: A retrospective clinical review was conducted on a consecutive series of ASD patients who underwent long fusions to the sacrum, with TSIF performed as a same-day or staged procedure. Patient demographics, bone mineral density, operative details, perioperative and late complications, and fusion rates were reviewed. Univariate analysis was used to identify the risk factors associated with pseudarthrosis. RESULTS: The study included 43 patients with an average age of 55.3 ± 8.9 years. The perioperative complication rate was 28%, with 12% of the complications directly related to TSIF. The late complication rate was 33%, with 16% related to TSIF. The most common complications were pseudarthrosis (14%) and postoperative ileus (7%). The overall radiographic fusion rate at two years was 86%. Univariate analysis revealed that revision surgery was significantly associated with pseudarthrosis (p = 0.027). Over the follow-up period, patients who underwent TSIF during long posterior fusions to the sacrum showed improvement in overall SRS scores, ODI scores, and SF-36 physical health and mental health (p < 0.05). CONCLUSION: TSIF is a relatively safe and minimally invasive method for achieving interbody fusion at the lumbosacral junction in the treatment of ASD, with acceptable fusion rates and a low complication rate. However, TSIF is not recommended for revision reconstruction in ASD.
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Pseudoartrose , Fusão Vertebral , Adulto , Humanos , Pessoa de Meia-Idade , Sacro/cirurgia , Seguimentos , Estudos Retrospectivos , Pseudoartrose/epidemiologia , Pseudoartrose/etiologia , Pseudoartrose/cirurgia , Vértebras Lombares/cirurgia , Resultado do Tratamento , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Fusão Vertebral/efeitos adversos , Fusão Vertebral/métodosRESUMO
BACKGROUND: Life expectancy (LE) differences within and between states by race/ethnicity have not been examined. OBJECTIVE: To estimate LE for selected race/ethnicity groups in states from 1990 to 2019. DESIGN: Cross-sectional time-series analysis. SETTING: United States. PARTICIPANTS: Deidentified death records and Census data were used to construct regression models with smoothed time series of mortality from 1990 to 2019. MEASUREMENTS: LE at birth, by sex and year, for subgroups of people reporting Hispanic, non-Hispanic Black, or non-Hispanic White race/ethnicity. RESULTS: Disparities in LE across states were 8.0 years for females and 12.2 years for males in 1990 and 7.9 years for females and 7.8 years for males in 2019. When race/ethnicity groups were accounted for, disparities across states were 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019. Disparities across states increased within each race/ethnicity group between 1990 and 2019, with the largest increase for non-Hispanic White males and the smallest for Hispanic females. The disparity between race/ethnicity groups within states decreased for most of the 23 states with estimates for all 3 groups but increased for females in 7 states and males in 5 states. LIMITATION: Because of small sample size, LE was not estimated for 37 of 153 state-race/ethnicity groups. CONCLUSION: Disparity in LE across states was greater when race/ethnicity groups were considered. Disparities across all state-race/ethnicity groups in general have decreased over the past 3 decades. Within each race/ethnicity group, disparities across states have increased. Although racial/ethnic disparities decreased in most of the 23 states for which LE was estimated for all 3 groups, they increased for females in 7 states and males in 5 states. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.
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Negro ou Afro-Americano , Etnicidade , Estudos Transversais , Feminino , Hispânico ou Latino , Humanos , Recém-Nascido , Expectativa de Vida , Masculino , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Up to 75% of patients with idiopathic scoliosis (IS) report back pain, but the exact contributors are unclear. This study seeks to assess how pain correlates with demographics, radiographic and surface topographic (ST) measurements, and patient-reported outcome measures (PROMs) in patients with IS. METHODS: Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference (PI) and Scoliosis Research Society revised (SRS-22r) pain domain from an IRB approved prospectively collected registry containing patients 11 to 21 years old with IS were correlated (Spearman coefficients) with measurements from whole-body EOS radiography and ST scanning, PROMIS 1.0 PROMs, Trunk Appearance Perception Scale (TAPS), and SRS-22r domains. SRS-22r and PROMIS-PI were also compared between different sex, scoliosis severities, and primary curve locations with Mann-Whitney U or Kruskal-Wallis tests, and if significant differences were found, included with the 5 highest univariate correlated variables into stepwise multivariate linear regression models ( P <0.05 to enter, P >0.1 to remove) predicting SRS-22r pain and PROMIS-PI. RESULTS: One hundred and forty-nine patients (14.5 ± 2.0 y, body mass index 20.6 ± 4.1 kg/m 2 , 96 (64%) female, mean major coronal curve 40 ± 19 deg, range: 10 deg, 83 deg) reported mean PROMIS-PI of 42.2 ± 10.0 and SRS-22r pain of 4.4 ± 0.6. SRS-22r self-image was the most correlated variable with both SRS-22r pain (rho=0.519) and PROMIS-PI (rho=-0.594). Five variables, none of which were ST or radiographic measures, strongly predicted SRS pain domain (R=0.711, R2=0.505, N=138). Two variables (SRS-22r self-image and SRS-22r function) were utilized by a model correlated with PROMIS-PI (R=0.687, R2=0.463, N=124). CONCLUSIONS: SRS-22r function and self-image domains were more strongly correlated with SRS-22r pain and PROMIS-PI than any radiographic or ST measurements. LEVEL OF EVIDENCE: Level II-retrospective study.
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BACKGROUND: The proportion of reported causes of death (CoDs) that are not underlying causes can be relevant even in high-income countries and seriously affect health planning. The Global Burden of Disease (GBD) study identifies these 'garbage codes' (GCs) and redistributes them to underlying causes using evidence-based algorithms. Planners relying on vital registration data will find discrepancies with GBD estimates. We analyse these discrepancies, through the analysis of GCs and their redistribution. METHODS: We explored the case of Italy, at national and regional level, and compared it to nine other Western European countries with similar population sizes. We analysed differences between official data and GBD 2019 estimates, for the period 1990-2017 for which we had vital registration data for most select countries. RESULTS: In Italy, in 2017, 33 000 deaths were attributed to unspecified type of stroke and 15 000 to unspecified type of diabetes, these making a fourth of the overall garbage. Significant heterogeneity exists on the overall proportion of GCs, type (unspecified or impossible underlying causes), and size of specific GCs among regions in Italy, and among the select countries. We found no pattern between level of garbage and relevance of specific GCs. Even locations performing below average show interesting lower levels for certain GCs if compared to better performing countries. CONCLUSIONS: This systematic analysis suggests the heterogeneity in GC levels and causes, paired with a more detailed analysis of local practices, strengths and weaknesses, could be a positive element in a strategy for the reduction of GCs in Italy.
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Carga Global da Doença , Acidente Vascular Cerebral , Algoritmos , Causas de Morte , Saúde Global , HumanosRESUMO
BACKGROUND: Accurate, comprehensive, cause-specific mortality estimates are crucial for informing public health decision making worldwide. Incorrectly or vaguely assigned deaths, defined as garbage-coded deaths, mask the true cause distribution. The Global Burden of Disease (GBD) study has developed methods to create comparable, timely, cause-specific mortality estimates; an impactful data processing method is the reallocation of garbage-coded deaths to a plausible underlying cause of death. We identify the pattern of garbage-coded deaths in the world and present the methods used to determine their redistribution to generate more plausible cause of death assignments. METHODS: We describe the methods developed for the GBD 2019 study and subsequent iterations to redistribute garbage-coded deaths in vital registration data to plausible underlying causes. These methods include analysis of multiple cause data, negative correlation, impairment, and proportional redistribution. We classify garbage codes into classes according to the level of specificity of the reported cause of death (CoD) and capture trends in the global pattern of proportion of garbage-coded deaths, disaggregated by these classes, and the relationship between this proportion and the Socio-Demographic Index. We examine the relative importance of the top four garbage codes by age and sex and demonstrate the impact of redistribution on the annual GBD CoD rankings. RESULTS: The proportion of least-specific (class 1 and 2) garbage-coded deaths ranged from 3.7% of all vital registration deaths to 67.3% in 2015, and the age-standardized proportion had an overall negative association with the Socio-Demographic Index. When broken down by age and sex, the category for unspecified lower respiratory infections was responsible for nearly 30% of garbage-coded deaths in those under 1 year of age for both sexes, representing the largest proportion of garbage codes for that age group. We show how the cause distribution by number of deaths changes before and after redistribution for four countries: Brazil, the United States, Japan, and France, highlighting the necessity of accounting for garbage-coded deaths in the GBD. CONCLUSIONS: We provide a detailed description of redistribution methods developed for CoD data in the GBD; these methods represent an overall improvement in empiricism compared to past reliance on a priori knowledge.
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Confiabilidade dos Dados , Saúde Global , Algoritmos , Brasil , Causas de Morte , Feminino , França , Humanos , Japão , MasculinoRESUMO
BACKGROUND: Identifying early stages of hypersensitivity pneumonitis (HP) is hampered by variable presentation, heterogeneous or undetected causal antigens and lack of gold-standard biomarkers. Krebs von den Lungen (KL)-6 is pathophysiological biomarker of alveolar epithelial damage. Pigeon fanciers, susceptible to HP, provide a model to investigate early HP. OBJECTIVE: To test the hypothesis that plasma concentrations of KL-6 are increased in early-stage acute HP. METHODS: Clinical history, spirometry and blood samples were obtained from pigeon fanciers, 20 with intermittent acute symptoms indicative of developing HP, 27 with no symptoms and 10 healthy subjects with no avian exposure. Plasma KL-6 (units/mL) and pigeon antigen-specific IgG antibody were quantified by enzyme immunoassay. Blood lymphocytes were quantified by flow cytometry and antigen specificity by in vitro cytokine production. RESULTS: KL-6 was higher in fanciers than controls, median (IQR) 452 (244, 632) vs 274 (151, 377), P = .01. Although fanciers with symptoms had similar antigen exposure and lung function, they had higher KL-6 than those without, 632 (468, 1314) vs 320 (200, 480), P < .001. KL-6 correlated with IgG antibody titre in those with symptoms, r = .591, P = .006. High KL-6, irrespective of symptom category, was associated with higher antibody (P = .006) and lymphocyte proliferation (P = .041), and lower CD4+ T lymphocyte proportion (P = .032). CONCLUSION AND CLINICAL RELEVANCE: Raised KL-6 is associated with acute symptoms of early-stage HP, and its correlation with antibody may support therapeutic strategies when HP is suspected. KL-6 may act as a mechanistic biomarker of early pathogenesis by linking lung pathophysiological changes with an endotype of immune hypersensitivity.
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Pulmão do Criador de Aves/diagnóstico , Columbidae/imunologia , Mucina-1/sangue , Adulto , Animais , Biomarcadores/sangue , Pulmão do Criador de Aves/sangue , Pulmão do Criador de Aves/imunologia , Pulmão do Criador de Aves/fisiopatologia , Linfócitos T CD4-Positivos/imunologia , Estudos de Casos e Controles , Proliferação de Células , Células Cultivadas , Estudos Transversais , Diagnóstico Precoce , Humanos , Imunoglobulina G/sangue , Pulmão/imunologia , Pulmão/fisiopatologia , Ativação Linfocitária , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Regulação para CimaRESUMO
BACKGROUND: To date, the burden of injury in Mexico has not been comprehensively assessed using recent advances in population health research, including those in the Global Burden of Disease Study 2017 (GBD 2017). METHODS: We used GBD 2017 for burden of unintentional injury estimates, including transport injuries, for Mexico and each state in Mexico from 1990 to 2017. We examined subnational variation, age patterns, sex differences and time trends for all injury burden metrics. RESULTS: Unintentional injury deaths in Mexico decreased from 45 363 deaths (44 662 to 46 038) in 1990 to 42 702 (41 439 to 43 745) in 2017, while age-standardised mortality rates decreased from 65.2 (64.4 to 66.1) in 1990 to 35.1 (34.1 to 36.0) per 100 000 in 2017. In terms of non-fatal outcomes, there were 3 120 211 (2 879 993 to 3 377 945) new injury cases in 1990, which increased to 5 234 214 (4 812 615 to 5 701 669) new cases of injury in 2017. We estimated 2 761 957 (2 676 267 to 2 859 777) disability-adjusted life years (DALYs) due to injuries in Mexico in 1990 compared with 2 376 952 (2 224 588 to 2 551 004) DALYs in 2017. We found subnational variation in health loss across Mexico's states, including concentrated burden in Tabasco, Chihuahua and Zacatecas. CONCLUSIONS: In Mexico, from 1990 to 2017, mortality due to unintentional injuries has decreased, while non-fatal incident cases have increased. However, unintentional injuries continue to cause considerable mortality and morbidity, with patterns that vary by state, age, sex and year. Future research should focus on targeted interventions to decrease injury burden in high-risk populations.
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Carga Global da Doença , Saúde Global , Ferimentos e Lesões , Causas de Morte , Feminino , Humanos , Expectativa de Vida , Masculino , México , Anos de Vida Ajustados por Qualidade de Vida , Ferimentos e Lesões/epidemiologiaRESUMO
BACKGROUND: While there is a long history of measuring death and disability from injuries, modern research methods must account for the wide spectrum of disability that can occur in an injury, and must provide estimates with sufficient demographic, geographical and temporal detail to be useful for policy makers. The Global Burden of Disease (GBD) 2017 study used methods to provide highly detailed estimates of global injury burden that meet these criteria. METHODS: In this study, we report and discuss the methods used in GBD 2017 for injury morbidity and mortality burden estimation. In summary, these methods included estimating cause-specific mortality for every cause of injury, and then estimating incidence for every cause of injury. Non-fatal disability for each cause is then calculated based on the probabilities of suffering from different types of bodily injury experienced. RESULTS: GBD 2017 produced morbidity and mortality estimates for 38 causes of injury. Estimates were produced in terms of incidence, prevalence, years lived with disability, cause-specific mortality, years of life lost and disability-adjusted life-years for a 28-year period for 22 age groups, 195 countries and both sexes. CONCLUSIONS: GBD 2017 demonstrated a complex and sophisticated series of analytical steps using the largest known database of morbidity and mortality data on injuries. GBD 2017 results should be used to help inform injury prevention policy making and resource allocation. We also identify important avenues for improving injury burden estimation in the future.
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Carga Global da Doença , Saúde Global , Ferimentos e Lesões , Feminino , Humanos , Incidência , Expectativa de Vida , Masculino , Morbidade , Anos de Vida Ajustados por Qualidade de Vida , Ferimentos e Lesões/mortalidadeRESUMO
PURPOSE: The resection point of a lumbar three-column osteotomy (3CO) creates separation of the spino-pelvic complex. This study investigates the impact of patients' baseline deformity and level of 3CO resection on the distribution of correction between the trunk and the pelvis following osteotomy closure. METHODS: Patients who underwent single lumbar 3CO, upper instrumented vertebra (UIV) T1-T10, and 6 month follow-up were included. The truncal and pelvic closures were calculated based on the vertebrae adjacent to the osteotomy level and the impact of radiographic parameters and level of 3CO on the closures were analyzed. RESULTS: 113 patients were included. Patients who experienced more pelvic correction had significantly higher Pelvic Tilt and lower Sagittal Vertical Axis at baseline. Patients who underwent more caudal osteotomies with higher pelvic compensation with modest SVA sustained more pelvic correction. CONCLUSIONS: The osteotomy closure is driven by patient's specific deformity. More caudal osteotomy level leads to greater pelvic tilt improvement. LEVEL OF EVIDENCE: III.
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Vértebras Lombares/cirurgia , Osteotomia/métodos , Doenças da Coluna Vertebral/cirurgia , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Pelve , Estudos Retrospectivos , Doenças da Coluna Vertebral/fisiopatologia , Vértebras Torácicas/cirurgia , TroncoRESUMO
BACKGROUND CONTEXT: Left-digit bias is a behavioral heuristic or cognitive "shortcut" in which the leftmost digit of a number, such as patient age, disproportionately influences surgical decisions. PURPOSE: To determine if left-digit bias in patient age influences the decision to perform arthrodesis with instrumentation vs decompression in lumbar spinal stenosis (LSS). DESIGN: Retrospective cohort. PATIENT SAMPLE: Patients with an ICD-10 diagnosis of lumbar stenosis or spondylolisthesis identified in the 2017-2021 National Surgical Quality Improvement Program (NSQIP) database. OUTCOME MEASURES: The primary outcome was the percent of patients who underwent arthrodesis with instrumentation (AwI). Matched age group comparisons without left-digit differences (ie, 76/77 vs 78/79, 80/81 vs 82/83, etc.) were performed to isolate the effect of the heuristic. Secondary outcomes including peri-operative events and complications were also compared within AwI and decompression cohorts. METHODS: Using CPT codes, procedures were classified as either AwI or decompression. Patients were grouped into 6 cohorts based on 2-year age windows (74/75, 76/77, 78/79, 80/81, 82/83, 84/85). The cohorts were propensity matched with neighboring age groups based on the presence of spondylolisthesis, demographics, and comorbidities. The primary comparison was between those aged 78/79 vs 80/81. RESULTS: After matching, the primary cohort consisted of two groups of 1,550 patients (aged 78/79 and 80/81). Patients aged 80/81 were less likely to undergo AwI than patients aged 78/79 (23.5% vs 27.2%, p=.021). AwI procedures occurred at similar rates between age groups with the same left digit. Within the decompression and AwI cohorts, there were no differences in secondary outcomes between patients aged 78/79 and 80/81. CONCLUSIONS: LSS patients aged 80/81 are less likely to undergo AwI than patients aged 78/79, regardless of comorbidities. This was not seen when comparing patients with similar left digits in age. Until objective measures of physiologic capacity are established, left-digit bias may influence clinical decisions.
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Descompressão Cirúrgica , Vértebras Lombares , Estenose Espinal , Humanos , Estenose Espinal/cirurgia , Idoso , Masculino , Feminino , Descompressão Cirúrgica/métodos , Vértebras Lombares/cirurgia , Estudos Retrospectivos , Idoso de 80 Anos ou mais , Fusão Vertebral/métodos , Fatores Etários , Tomada de Decisão Clínica , Pessoa de Meia-Idade , Espondilolistese/cirurgiaRESUMO
PURPOSE: To assess the characteristics and risk factors for decisional regret following corrective adult spinal deformity (ASD) surgery at our hospital. METHODS: This is a retrospective cohort study of a single-surgeon ASD database. Adult patients (> 40 years) who underwent ASD surgery from May 2016 to December 2020 with minimum 2-year follow-up were included (posterior-only, ≥ 4 levels fused to the pelvis) (n = 120). Ottawa decision regret questionnaires, a validated and reliable 5-item Likert scale, were sent to patients postoperatively. Regret scores were defined as (1) low regret: 0-39 (2) medium to high regret: 40-100. Risk factors for medium or high decisional regret were identified using multivariate models. RESULTS: Ninety patients were successfully contacted and 77 patients consented to participate. Nonparticipants were older, had a higher incidence of anxiety, and higher ASA class. There were 7 patients that reported medium or high decisional regret (9%). Ninety percentage of patients believed that surgery was the right decision, 86% believed that surgery was a wise choice, and 87% would do it again. 8% of patients regretted the surgery and 14% believed that surgery did them harm. 88% of patients felt better after surgery. On multivariate analysis, revision fusion surgery was independently associated with an increased risk of medium or high decisional regret (adjusted odds ratio: 6.000, 95% confidence interval: 1.074-33.534, p = 0.041). CONCLUSIONS: At our institution, we found a 9% incidence of decisional regret. Revision fusion was associated with increased decisional regret. Estimates for decisional regret should be based on single-institution experiences given differences in patient populations.
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Tomada de Decisões , Emoções , Fusão Vertebral , Humanos , Masculino , Feminino , Estudos Retrospectivos , Fatores de Risco , Pessoa de Meia-Idade , Incidência , Adulto , Fusão Vertebral/psicologia , Fusão Vertebral/efeitos adversos , Idoso , Inquéritos e Questionários , Curvaturas da Coluna Vertebral/cirurgia , Curvaturas da Coluna Vertebral/psicologiaRESUMO
Historically, pedicle screw accuracy measurements have relied on CT and expert visual assessment of the position of pedicle screws relative to preoperative plans. Proper pedicle screw placement is necessary to avoid complications, cost and morbidity of revision procedures. The aim of this study was to determine accuracy and precision of pedicle screw insertion via a novel computer vision algorithm using preoperative and postoperative computed tomography (CT) scans. Three cadaveric specimens were utilized. Screw placement planning on preoperative CT was performed according to standard clinical practice. Two experienced surgeons performed bilateral T2-L4 instrumentation using robotic-assisted navigation. Postoperative CT scans of the instrumented levels were obtained. Automated segmentation and computer vision techniques were employed to align each preoperative vertebra with its postoperative counterpart and then compare screw positions along all three axes. Registration accuracy was assessed by preoperatively embedding spherical markers (tantalum beads) to measure discrepancies in landmark alignment. Eighty-eight pedicle screws were placed in 3 cadavers' spines. Automated registrations between pre- and postoperative CT achieved sub-voxel accuracy. For the screw tip and tail, the mean three-dimensional errors were 1.67 mm and 1.78 mm, respectively. Mean angular deviation of screw axes from plan was 1.58°. For screw mid-pedicular accuracy, mean absolute error in the medial-lateral and superior-inferior directions were 0.75 mm and 0.60 mm, respectively. This study introduces automated algorithms for determining accuracy and precision of planned pedicle screws. Our accuracy outcomes are comparable or superior to recent robotic-assisted in vivo and cadaver studies. This computerized workflow establishes a standardized protocol for assessing pedicle screw placement accuracy and precision and provides detailed 3D translational and angular accuracy and precision for baseline comparison.
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Algoritmos , Cadáver , Parafusos Pediculares , Procedimentos Cirúrgicos Robóticos , Tomografia Computadorizada por Raios X , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Procedimentos Cirúrgicos Robóticos/instrumentação , Vértebras Lombares/cirurgia , Vértebras Lombares/diagnóstico por imagem , Fusão Vertebral/métodos , Fusão Vertebral/instrumentação , Cirurgia Assistida por Computador/métodosRESUMO
STUDY DESIGN: Retrospective case series. OBJECTIVE: To characterize the change in angle of trunk rotation (ATR), axial vertebral rotation (AVR), and body surface rotation (BSR) in patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion (PSF) with en-bloc derotation across multiple postoperative visits. SUMMARY OF BACKGROUND DATA: Previous research has documented ATR, AVR, and BSR correction for AIS patients after surgery. However, there is a lack of evidence on the sustainability of this correction over time. METHODS: This was a retrospective study from a single-center prospective surface topographic registry of patients with AIS, age 11-20 at time of surgery, who underwent PSF with en-bloc derotation. Patients with previous spine surgery were excluded. ATR was measured with a scoliometer, AVR through EOS radiographic imaging, and BSR via surface topographic scanning, Data collection occurred at: preoperative, six-week, three-month, six-month, one-year, and two-year postoperative visits. BSR and AVR were tracked at the preoperative apical vertebral level, and the level with maximum deformity, at each respective timepoint. Generalized estimating equations models were used for statistical analysis. Covariates included age, sex, and body mass index. RESULTS: 49 patients (73.4% female, mean age 14.6±2.2 years, mean preoperative coronal curve angle 57.9°±8.5, and 67% major thoracic) were evaluated. ATR correction was significantly improved at all postoperative timepoints and there was no significant loss of correction. AVR Max and AVR Apex were significantly improved at all timepoints but there was a significant loss of correction for AVR Apex between the six-week and one-year visit (P=0.032). BSR Max achieved significant improvement at the three-month visit. BSR Apex was significantly improved at the three-month and one-year visit. CONCLUSION: ATR and AVR demonstrated significant axial plane correction at two-years postoperative in patients undergoing PSF for AIS. BSR did not maintain significant improvement by the two-year visit.
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STUDY DESIGN: Systematic review. OBJECTIVE: To describe the various definitions of PJK and PJF used in spinal deformity literature and their utility over time. SUMMARY OF BACKGROUND DATA: Proximal junctional kyphosis or failure (PJK/PJF) is among the most common complication after long-segment fusions, but there is no consensus on their definitions. This presents challenges in understanding risk factors, management, and prevention strategies. METHODS: A systematic literature review was performed on studies specifying a definition of PJK and/or PJF. PJK definitions were categorized as radiographic vs non-radiographic and data was collected on PJK criteria including threshold for proximal junctional angle (PJA), change in PJA, vertebra selection for PJA measurement, and follow-up timepoints. PJF definitions were categorized as structural failure, need for revision, symptomatic failure, and radiographic (angular). RESULTS: 359 studies defining PJK and/or PJF were identified. While 56% of studies used the definition PJA>10° and PJA change from baseline>10°, the remainder expressed significant heterogeneity with respect to criteria for magnitude of PJA and degree of PJA change. The most common vertebrae assessed were UIV/UIV+2 (74%) and most common minimum follow-up (mFU) listed was 2 years (60%). Mean FUs for studies varied considerably even in studies with the same mFU, from 2.1-8.9 years (2-year mFU) and 1.1-4.0 years (1-year mFU). PJF definitions were most commonly structural (58%) or defined as a need for revision (48%), with a much less common use of PJA thresholds (23%). CONCLUSIONS: The challenges faced in preventing proximal junctional complications are mired in the heterogenous groundwork by which PJK and PJF are defined. Most definitions of PJK use radiographic thresholds without consideration of clinical relevance and variations in individual alignment. Conversely, definitions of PJF are based on clinical criteria, which are often subjective. Future research should focus on understanding the mechanisms of PJK/PJF, as only then will we be able to accurately define and prevent these complications.
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Background/Objectives: While the economic cost of adult spinal deformity (ASD) surgery has been studied extensively, its environmental impact is unknown. The aim of this study is to determine the carbon footprint (CF) associated with ASD surgery. Methods: ASD patients who underwent > four levels of corrective surgery between 2017 and 2021 were included. The open group included a posterior-only, single-stage technique, while the minimally invasive surgery (MIS) group was defined as the use of lateral interbody fusion and percutaneous posterior screw fixation. The two groups were propensity-score matched to adjust for baseline demographic, surgical, and radiographic characteristics. Data on all disposables and reusable instruments, anesthetic gas, and non-gas medications used during surgery were collected from medical records. The CF of transporting, using, and disposing of each product and the footprint of energy use in operating rooms were calculated. The CF produced was evaluated using the carbon dioxide equivalent (CO2e), which is relative to the amount of CO2 with an equivalent global warming potential. Results: Of the 175 eligible patients, 15 pairs (65 ± 9 years, 47% female) were properly matched and analyzed for all variables. The average CF generated per case was 147.7 ± 37.3 kg-CO2e, of which 54% was attributable to energy used to sterilize reusable instruments, followed by anesthetic gas released into the environment (17%) and operating room air conditioning (15%). Conclusions: The CF generated during ASD surgery should be reduced using a multidisciplinary approach, taking into account that different surgical procedures have different impacts on carbon emission sources.
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STUDY DESIGN: A randomized, double-blinded, placebo-controlled trial. OBJECTIVE: To examine the effect of intravenous ketorolac (IV-K) on hospital opioid use compared with IV-placebo (IV-P) and IV acetaminophen (IV-A). SUMMARY OF BACKGROUND DATA: Controlling postoperative pain while minimizing opioid use after lumbar spinal fusion is an important area of study. PATIENTS AND METHODS: Patients aged 18 to 75 years undergoing 1 to 2 level lumbar fusions between April 2016 and December 2019 were included. Patients with chronic opioid use, smokers, and those on systemic glucocorticoids or contraindications to study medications were excluded. A block randomization scheme was used, and study personnel, hospital staff, and subjects were blinded to the assignment. Patients were randomized postoperatively. The IV-K group received 15 mg (age > 65) or 30 mg (age < 65) every six hours (q6h) for 48 hours, IV-A received 1000 mg q6h, and IV-P received normal saline q6h for 48 hours. Demographic and surgical details, opioid use in morphine milliequivalents, opioid-related adverse events, and length of stay (LOS) were recorded. The primary outcome was in-hospital opioid use up to 72 hours. RESULTS: A total of 171 patients were included (58 IV-K, 55 IV-A, and 58 IV-P) in the intent-to-treat (ITT) analysis, with a mean age of 57.1 years. The IV-K group had lower opioid use at 72 hours (173 ± 157 mg) versus IV-A (255 ± 179 mg) and IV-P (299 ± 179 mg; P = 0.000). In terms of opiate use, IV-K was superior to IV-A ( P = 0.025) and IV-P ( P = 0.000) on ITT analysis, although on per-protocol analysis, the difference with IV-A did not reach significance ( P = 0.063). When compared with IV-P, IV-K patients reported significantly lower worst ( P = 0.004), best ( P = 0.001), average ( P = 0.001), and current pain ( P = 0.002) on postoperative day 1, and significantly shorter LOS ( P = 0.009) on ITT analysis. There were no differences in opioid-related adverse events, drain output, clinical outcomes, transfusion rates, or fusion rates. CONCLUSIONS: By reducing opioid use, improving pain control on postoperative day 1, and decreasing LOS without increases in complications or pseudarthrosis, IV-K may be an important component of "enhanced recovery after surgery" protocols.
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Cetorolaco , Transtornos Relacionados ao Uso de Opioides , Humanos , Pessoa de Meia-Idade , Cetorolaco/uso terapêutico , Analgésicos Opioides/uso terapêutico , Tempo de Internação , Método Duplo-Cego , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologiaRESUMO
OBJECTIVE: To review the incidence and closure rate of full-thickness macular holes (MH) in cases associated with concomitant rhegmatogenous retinal detachment (RRD). METHODS: A retrospective consecutive case series was performed from patients undergoing surgical repair of RRD and simultaneous closure of MH. The presence of proliferative vitreoretinopathy (PVR), rates of hole closure and reattachment, and visual acuity outcomes were evaluated. RESULTS: There were a total of 607 RRDs during the study period. The incidence of concomitant MH in RRD cases was 2.3% (14 of 607), and the overall incidence of PVR was 15.8% (96 of 607). All eyes with a MH had a primary break that was distinct from the MH. Five patients did not meet the inclusion criteria for review of the postoperative outcomes. In the remaining 9 patients, the retinal reattachment rate was 100%, and MH closure was achieved in 8 of 9 (89%) eyes after a single surgery. At the time of primary repair, PVR was present in 6 of these 9 cases (66.7%). There was a significant association between the presence of PVR and a concomitant MH (P = 0.0027). The mean preoperative visual acuity was 2.59 ± 0.649 logarithm of the minimum angle of resolution units and significantly improved to 1.23 ± 1.01 logarithm of the minimum angle of resolution units (P = 0.00124). Overall, 88.8% of patients showed an improvement in visual acuity at the final postoperative visit, and a visual acuity of 20/125 or better was achieved in 66.7% of cases. CONCLUSION: Macular holes combined with a RRD are infrequent, and good anatomical results can be achieved after a simultaneous repair. Also, PVR may be more frequently encountered in this particular subset of RRDs.