Factors associated with skeletal-related events in patients with bone metastatic melanoma: A retrospective study of 481 patients.

OBJECTIVES: Metastatic bone disease is estimated to develop in up to 17% of patients with melanoma, compromising skeleton integrity resulting in skeletal-related events (SREs), which impair quality of life and reduce survival. The objective of the study was to investigate (1) the proportion of melanoma patients developing SREs following diagnosis of bone metastasis and (2) the predictors for SREs in this patient cohort. METHODS: Four hundred and eighty-one patients with bone metastatic melanoma from two tertiary centers in the United States from 2008 to 2018 were included. The primary outcome was 90-day and 1-year occurrence of a SRE, including pathological fractures of bones, cord compression, hypercalcemia, radiotherapy, and surgery. Fine-Gray regression analysis was performed for overall SREs and pathological fracture, with death as a competing risk. RESULTS: By 1-year, 52% (258/481) of patients experienced SREs, and 28% (137/481) had a pathological fracture. At 90-day, lytic lesions, bone pain, elevated calcium and absolute lymphocyte, and decreased albumin and hemoglobin were associated with higher SRE risk. The same factors, except for decreased hemoglobin, were shown to predict development of SREs at 1-year. CONCLUSION: The high incidence of SREs and pathological fractures warrants vigilance using the identified factors in this study and preventative measures during clinical oncological care.

[Endovascular devices for severely calcified peripheral lesion preparation: state of the art]. / Dispositivi per la preparazione delle lesioni calcifiche del distretto periferico: stato dell'arte.

Over the last few decades, endovascular revascularization techniques have revolutionized the treatment of peripheral artery disease, offering a less invasive alternative to surgery. However, the successful treatment of heavily calcified lesions is often compromised by various vascular complications, including recoils, dissections, and the need for target vessel reinterventions. This has prompted the development of several tools for lesion preparation, with the aim of achieving better procedural outcomes. This review aims to summarize the main characteristics and current evidence related to the available devices for preparing severely calcified peripheral lesions.

Clinical Outcomes Among Patients Treated With Stereotactic Body Radiation Therapy to Femur Metastases for Oligometastatic Disease Control or Reirradiation: Results From a Large Single-Institution Experience.

Purpose: There are limited data regarding outcomes after stereotactic body radiation therapy (SBRT) for femur metastases, which was an exclusion criteria for the Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers (SABR-COMET) trial. We aimed to characterize clinical outcomes from a large single institution experience. Methods and Materials: Forty-eight patients with 53 lesions were consecutively treated with femur SBRT from May 2017 to June 2022. The Kaplan-Meier method and Cox proportional hazard models were used to characterize time-to-event endpoints and associations between baseline factors and clinical outcomes, respectively. Local control and locoregional control were defined as the absence of tumor progression within the radiation treatment field or within the treated femur, respectively. Results: Most patients had Eastern Cooperative Oncology Group performance status 0 to 1 (90%), prostate (52%) or breast/lung (17%) cancer, and 1 to 3 lesions (100%), including 29 proximal and 5 distal. Fifty-seven percent of the lesions were treated with concurrent systemic therapy. Median planning target volume was 49.1 cc (range, 6.6-387 cc). Planning target volume V100 (%) was 99% (range, 90-100). Fractionation included 18 to 20 Gy/1F, 27 to 30 Gy/3F, and 28.5-40 Gy/5F. Forty-two percent had Mirels score ≥7 and most (94%) did not have extraosseous extension. Acute toxicities included grade 1 fatigue (15%), pain flare (7.5%), nausea (3.8%), and decreased blood counts (1.9%). Late toxicities included fracture (1.9%) at 1.5 years and osteonecrosis (4%) from dose of 40 Gy in 5F and 30 Gy in 5F (after prior 30 Gy/10F). One patient (2%) required fixation postradiation for progressive pain. With median follow-up 19.4 months, 1- and 2-year rates of local control were 94% and 89%, locoregional control was 83% and 67%, progression-free survival were 56% and 25%, and overall survival were 91% and 73%. Fifty percent of local regional recurrence events occurred within 5 cm of gross tumor volume. Conclusions: Femur SBRT for oligometastatic disease control in well-selected patients was associated with good outcomes with minimal rates of acute and late toxicity. Patterns of local regional recurrence warrant consideration of larger elective volume coverage. Additional prospective study is needed.

Survival in Patients With Spinal Metastatic Disease Treated Nonoperatively With Radiotherapy: Are the SORG-ML Algorithms Relevant?

SUMMARY OF BACKGROUND DATA: The SORG-ML algorithms for survival in spinal metastatic disease were developed in patients who underwent surgery and were externally validated for patients managed operatively. OBJECTIVE: To externally validate the SORG-ML algorithms for survival in spinal metastatic disease in patients managed nonoperatively with radiation. STUDY DESIGN: Retrospective cohort. METHODS: The performance of the SORG-ML algorithms was assessed by discrimination [receiver operating curves and area under the receiver operating curve (AUC)], calibration (calibration plots), decision curve analysis, and overall performance (Brier score). The primary outcomes were 90-day and 1-year mortality. RESULTS: Overall, 2074 adult patients underwent radiation for spinal metastatic disease and 29% (n=521) and 59% (n=917) had 90-day and 1-year mortality, respectively. On complete case analysis (n=415), the AUC was 0.76 (95% CI: 0.71-0.80) and 0.78 (95% CI: 0.73-0.83) for 90-day and 1-year mortality with fair calibration and positive net benefit confirmed by the decision curve analysis. With multiple imputation (n=2074), the AUC was 0.85 (95% CI: 0.83-0.87) and 0.87 (95% CI: 0.85-0.89) for 90-day and 1-year mortality with fair calibration and positive net benefit confirmed by the decision curve analysis. CONCLUSION: The SORG-ML algorithms for survival in spinal metastatic disease generalize well to patients managed nonoperatively with radiation.

Distribution and Rate of Myxoid Liposarcoma Spine Metastases: Impact on Surveillance Imaging.

BACKGROUND: Myxoid liposarcoma (LPS) has a unique tendency to spread to extrapulmonary sites, including osseous sites such as the spine, and adjacent sites such as the paraspinous tissue. No clear consensus exists to guide the approach to imaging in these patients. OBJECTIVE: The aim of this study was to investigate the rate and distribution of spine metastases in patients with myxoid LPS and detection modality. METHODS: Records of all patients with myxoid LPS evaluated at our sarcoma center were retrospectively reviewed. Disease patterns and imaging modality utilization were analyzed. RESULTS: Between 2000 and 2020, 164 patients with myxoid LPS were identified. The majority (n = 148, 90%) presented with localized disease, with half (n = 82, 50%) of all patients developing metastases or recurrence during their disease course. With a median follow-up of 69.2 months, spine/paraspinous metastases developed in 38 patients (23%), of whom 35 (92%) already had synchronous, non-spine metastases. Spine disease was only visible on magnetic resonance imaging (MRI), as opposed to other imaging modalities, for over one-quarter of patients with spine metastases (n = 10). For patients with metastatic disease, spine metastases were associated with worse median overall survival (2.1 vs. 8.7 years, p < 0.001). CONCLUSION: Spine metastases occurred in nearly one-quarter of patients with myxoid LPS and represented an advanced disease state, as they primarily presented in the setting of synchronous, non-spine metastases, and were associated with worse overall survival. Routine surveillance with spine MRI in patients with localized disease likely provides no benefit but may be considered in those with known metastatic disease.

Does the SORG Machine-learning Algorithm for Extremity Metastases Generalize to a Contemporary Cohort of Patients? Temporal Validation From 2016 to 2020.

BACKGROUND: The ability to predict survival accurately in patients with osseous metastatic disease of the extremities is vital for patient counseling and guiding surgical intervention. We, the Skeletal Oncology Research Group (SORG), previously developed a machine-learning algorithm (MLA) based on data from 1999 to 2016 to predict 90-day and 1-year survival of surgically treated patients with extremity bone metastasis. As treatment regimens for oncology patients continue to evolve, this SORG MLA-driven probability calculator requires temporal reassessment of its accuracy. QUESTION/PURPOSE: Does the SORG-MLA accurately predict 90-day and 1-year survival in patients who receive surgical treatment for a metastatic long-bone lesion in a more recent cohort of patients treated between 2016 and 2020? METHODS: Between 2017 and 2021, we identified 674 patients 18 years and older through the ICD codes for secondary malignant neoplasm of bone and bone marrow and CPT codes for completed pathologic fractures or prophylactic treatment of an impending fracture. We excluded 40% (268 of 674) of patients, including 18% (118) who did not receive surgery; 11% (72) who had metastases in places other than the long bones of the extremities; 3% (23) who received treatment other than intramedullary nailing, endoprosthetic reconstruction, or dynamic hip screw; 3% (23) who underwent revision surgery, 3% (17) in whom there was no tumor, and 2% (15) who were lost to follow-up within 1 year. Temporal validation was performed using data on 406 patients treated surgically for bony metastatic disease of the extremities from 2016 to 2020 at the same two institutions where the MLA was developed. Variables used to predict survival in the SORG algorithm included perioperative laboratory values, tumor characteristics, and general demographics. To assess the models' discrimination, we computed the c-statistic, commonly referred to as the area under the receiver operating characteristic (AUC) curve for binary classification. This value ranged from 0.5 (representing chance-level performance) to 1.0 (indicating excellent discrimination) Generally, an AUC of 0.75 is considered high enough for use in clinical practice. To evaluate the agreement between predicted and observed outcomes, a calibration plot was used, and the calibration slope and intercept were calculated. Perfect calibration would result in a slope of 1 and intercept of 0. For overall performance, the Brier score and null-model Brier score were determined. The Brier score can range from 0 (representing perfect prediction) to 1 (indicating the poorest prediction). Proper interpretation of the Brier score necessitates a comparison with the null-model Brier score, which represents the score for an algorithm that predicts a probability equal to the population prevalence of the outcome for each patient. Finally, a decision curve analysis was conducted to compare the potential net benefit of the algorithm with other decision-support methods, such as treating all or none of the patients. Overall, 90-day and 1-year mortality were lower in the temporal validation cohort than in the development cohort (90 day: 23% versus 28%; p < 0.001, and 1 year: 51% versus 59%; p<0.001). RESULTS: Overall survival of the patients in the validation cohort improved from 28% mortality at the 90-day timepoint in the cohort on which the model was trained to 23%, and 59% mortality at the 1-year timepoint to 51%. The AUC was 0.78 (95% CI 0.72 to 0.82) for 90-day survival and 0.75 (95% CI 0.70 to 0.79) for 1-year survival, indicating the model could distinguish the two outcomes reasonably. For the 90-day model, the calibration slope was 0.71 (95% CI 0.53 to 0.89), and the intercept was -0.66 (95% CI -0.94 to -0.39), suggesting the predicted risks were overly extreme, and that in general, the risk of the observed outcome was overestimated. For the 1-year model, the calibration slope was 0.73 (95% CI 0.56 to 0.91) and the intercept was -0.67 (95% CI -0.90 to -0.43). With respect to overall performance, the model's Brier scores for the 90-day and 1-year models were 0.16 and 0.22. These scores were higher than the Brier scores of internal validation of the development study (0.13 and 0.14) models, indicating the models' performance has declined over time. CONCLUSION: The SORG MLA to predict survival after surgical treatment of extremity metastatic disease showed decreased performance on temporal validation. Moreover, in patients undergoing innovative immunotherapy, the possibility of mortality risk was overestimated in varying severity. Clinicians should be aware of this overestimation and discount the prediction of the SORG MLA according to their own experience with this patient population. Generally, these results show that temporal reassessment of these MLA-driven probability calculators is of paramount importance because the predictive performance may decline over time as treatment regimens evolve. The SORG-MLA is available as a freely accessible internet application at https://sorg-apps.shinyapps.io/extremitymetssurvival/ .Level of Evidence Level III, prognostic study.

External validation of a predictive algorithm for in-hospital and 90-day mortality after spinal epidural abscess.

BACKGROUND CONTEXT: Mortality in patients with spinal epidural abscess (SEA) remains high. Accurate prediction of patient-specific prognosis in SEA can improve patient counseling as well as guide management decisions. There are no externally validated studies predicting short-term mortality in patients with SEA. PURPOSE: The purpose of this study was to externally validate the Skeletal Oncology Research Group (SORG) stochastic gradient boosting algorithm for prediction of in-hospital and 90-day postdischarge mortality in SEA. STUDY DESIGN/SETTING: Retrospective, case-control study at a tertiary care academic medical center from 2003 to 2021. PATIENT SAMPLE: Adult patients admitted for radiologically confirmed diagnosis of SEA who did not initiate treatment at an outside institution. OUTCOME MEASURES: In-hospital and 90-day postdischarge mortality. METHODS: We tested the SORG stochastic gradient boosting algorithm on an independent validation cohort. We assessed its performance with discrimination, calibration, decision curve analysis, and overall performance. RESULTS: A total of 212 patients met inclusion criteria, with a short-term mortality rate of 10.4%. The area under the receiver operating characteristic curve (AUROC) of the SORG algorithm when tested on the full validation cohort was 0.82, the calibration intercept was -0.08, the calibration slope was 0.96, and the Brier score was 0.09. CONCLUSIONS: With a contemporaneous and geographically distinct independent cohort, we report successful external validation of a machine learning algorithm for prediction of in-hospital and 90-day postdischarge mortality in SEA.

Complete tumor necrosis after neoadjuvant chemotherapy defines good responders in patients with Ewing sarcoma.

BACKGROUND: Survival in patients who have Ewing sarcoma is correlated with postchemotherapy response (tumor necrosis). This treatment response has been categorized as the response rate, similar to what has been used in osteosarcoma. There is controversy regarding whether this is appropriate or whether it should be a dichotomy of complete versus incomplete response, given how important a complete response is for in overall survival of patients with Ewing sarcoma. The purpose of this study was to evaluate the impact that the amount of chemotherapy-induced necrosis has on (1) overall survival, (2) local recurrence-free survival, (3) metastasis-free survival, and (4) event-free survival in patients with Ewing sarcoma. METHODS: In total, 427 patients who had Ewing sarcoma or tumors in the Ewing sarcoma family and received treatment with preoperative chemotherapy and surgery at 10 international institutions were included. Multivariate Cox proportional-hazards analyses were used to assess the associations between tumor necrosis and all four outcomes while controlling for clinical factors identified in bivariate analysis, including age, tumor volume, location, surgical margins, metastatic disease at presentation, and preoperative radiotherapy. RESULTS: Patients who had a complete (100%) tumor response to chemotherapy had increased overall survival (hazard ratio [HR], 0.26; 95% CI, 0.14-0.48; p < .01), recurrence-free survival (HR, 0.40; 95% CI, 0.20-0.82; p = .01), metastasis-free survival (HR, 0.27; 95% CI, 0.15-0.46; p ≤ .01), and event-free survival (HR, 0.26; 95% CI, 0.16-0.41; p ≤ .01) compared with patients who had a partial (0%-99%) response. CONCLUSIONS: Complete tumor necrosis should be the index parameter to grade response to treatment as satisfactory in patients with Ewing sarcoma. Any viable tumor in these patients after neoadjuvant treatment should be of oncologic concern. These findings can affect the design of new clinical trials and the risk-stratified application of conventional or novel treatments.

Attitudes and trends in the use of radiolucent spinal implants: A survey of the North American Spine Society section of spinal oncology.

Background: In spinal oncology, titanium implants pose several challenges including artifact on advanced imaging and therapeutic radiation perturbation. To mitigate these effects, there has been increased interest in radiolucent carbon fiber (CF) and CF-reinforced polyetheretherketone (CFR-PEEK) implants as an alternative for spinal reconstruction. This study surveyed the members of the North American Spine Society (NASS) section of Spinal Oncology to query their perspectives regarding the clinical utility, current practice patterns, and recommended future directions of radiolucent spinal implants. Methods: In February 2021, an anonymous survey was administered to the physicians of the NASS section of Spinal Oncology. Participation in the survey was optional. The survey contained 38 items including demographic questions as well as multiple-choice, yes/no questions, Likert rating scales, and short free-text responses pertaining to the "clinical concept", "efficacy", "problems/complications", "practice pattern", and "future directions" of radiolucent spinal implants. Results: Fifteen responses were received (71.4% response rate). Six of the participants (40%) were neurosurgeons, eight (53.3%) were orthopedic surgeons, and one was a spinal radiation oncologist. Overall, there were mixed opinions among the specialists. While several believed that radiolucent spinal implants provide substantial benefits for the detection of disease recurrence and radiation therapy options, others remained less convinced. Ongoing concerns included high costs, low availability, limited cervical and percutaneous options, and suboptimal screw and rod designs. As such, participants estimated that they currently utilize these implants for 27.3% of anterior and 14.7% of all posterior reconstructions after tumor resection. Conclusion: A survey of the NASS section of Spinal Oncology found a lack of consensus with regards to the imaging and radiation benefits, and several ongoing concerns about currently available options. Therefore, routine utilization of these implants for anterior and posterior spinal reconstructions remains low. Future investigations are warranted to practically validate these devices' theoretical risks and benefits.

A Natural History of Patients Treated Operatively and Nonoperatively for Spinal Metastases Over 2 Years Following Treatment: Survival and Functional Outcomes.

STUDY DESIGN: Prospective observational study. OBJECTIVE: We present the natural history, including survival and function, among participants in the prospective observational study of spinal metastases treatment investigation. SUMMARY OF BACKGROUND DATA: Surgical treatment has been touted as a means to preserve functional independence, quality of life, and survival. Nearly all prior investigations have been limited by retrospective design and relatively short-periods of post-treatment surveillance. METHODS: This natural history study was conducted using the records of patients who were enrolled in the prospective observational study of spinal metastases treatment study (2017-2019). Eligible participants were 18 or older and presenting for treatment of spinal metastatic disease. Patients were followed at predetermined intervals (1, 3, 6, 12, and 24-mo) following treatment. We conducted cox proportional hazard regression analysis adjusting for confounders including age, biologic sex, number of comorbidities, type of metastatic lesion, neurologic symptoms at presentation, number of metastases involving the vertebral body, vertebral body collapse, New England Spinal Metastasis Score (NESMS) at presentation, and treatment strategy. RESULTS: We included 202 patients. Twenty-three percent of the population had died by 3 months following treatment initiation, 51% by 1 year, and 70% at 2 years. There was no significant difference in survival between patients treated operatively and nonoperatively (P = 0.16). No significant difference in HRQL between groups was appreciated beyond 3 months following treatment initiation. NESMS at presentation (scores of 0 [HR 5.61; 95% CI 2.83, 11.13] and 1 [HR 3.00; 95% CI 1.60, 5.63]) was significantly associated with mortality. CONCLUSION: We found that patients treated operatively and nonoperatively for spinal metastases benefitted from treatment in terms of HRQL. Two-year mortality for the cohort as a whole was 70%. When prognosticating survival, the NESMS appears to be an effective utility, particularly among patients with scores of 0 or 1.Level of Evidence: 2.

Albumin and Survival in Extremity Metastatic Bone Disease: An Analysis of Two Independent Datasets.

INTRODUCTION: Numerous prognostication models have been developed to estimate survival in patients with extremity metastatic bone disease, but few include albumin despite albumin's role in malnutrition and inflammation. The purpose of this study was to examine two independent datasets to determine the value for albumin in prognosticating survival in this population. MATERIALS AND METHODS: Extremity metastatic bone disease patients undergoing surgical management were identified from two independent populations. Population 1: Retrospective chart review at two tertiary care centers. Population 2: A large, national, North American multicenter surgical registry with 30-day follow-up. Bivariate and multivariate analyses were used to examine albumin's value for prognostication at 1-, 3-, and 12-month after surgery. RESULTS: In Population 1, 1,090 patients were identified with 1-, 3-, and 12-month mortality rates of 95 (8.8%), 305 (28.9%), and 639 (62.0%), respectively. In Population 2, 1,675 patients were identified with one-month postoperative mortality rates of 148 (8.8%). In both populations, hypoalbuminemia was an independent prognostic factor for mortality at 30 days. In the institutional set, hypoalbuminemia was additionally associated with 3- and 12-month mortality. CONCLUSIONS: Hypoalbuminemia is a marker for mortality in extremity metastatic bone disease. Further consideration of this marker could improve existing prognostication models in this population. LEVEL OF EVIDENCE: III.

Characterizing Health-Related Quality of Life by Ambulatory Status in Patients with Spinal Metastases.

STUDY DESIGN: Retrospective review of prospective longitudinal data. OBJECTIVE: To determine health-related quality of life (HRQL) utilities associated with specific ambulatory states in patients with spinal metastases: independent, ambulatory with assistance, and nonambulatory. SUMMARY OF BACKGROUND DATA: It is assumed that HRQL is aligned with ambulatory ability in patients with spinal metastases. Few studies have effectively considered these parameters while also accounting for clinical confounders. METHODS: We used prospective longitudinal data from patients treated at one of three tertiary medical centers (2017-2019). HRQL was characterized using the Euroquol-5-dimension (EQ5D) inventory. We performed standardized estimations of HRQL stratified by ambulatory state using generalized linear modeling that accounted for patient age at presentation, biologic sex, follow-up duration, operative or nonoperative management, and repeated measures within the same participant. RESULTS: We evaluated 675 completed EQ5D assessments, with 430 for independent ambulators, 205 for ambulators with assistance, and 40 for nonambulators. The average age of the cohort was 61.5. The most common primary cancer was lung (20%), followed by breast (18%). Forty-one percent of assessments were performed for participants treated surgically. Mortality occurred in 51% of the cohort. The standardized EQ5D utility for patients with spinal metastases and independent ambulatory function was 0.76 (95% confidence interval [CI] 0.74, 0.78). Among those ambulatory with assistance, the standardized EQ5D utility was 0.59 (95% CI 0.57, 0.61). For nonambulators, the standardized EQ5D utility was 0.14 (95% CI 0.09, 0.19). CONCLUSION: Patients with spinal metastases and independent ambulatory function have an HRQL similar to patients with primary cancers and no spinal involvement. Loss of ambulatory ability leads to a 22% decrease in HRQL for ambulation with assistance and an 82% reduction among nonambulators. Given prior studies demonstrate superior maintenance of ambulatory function with surgery for spinal metastases, our results support surgical consideration to the extent that it is clinically warranted.Level of Evidence: 3.

Three-year outcome of directional atherectomy and drug coated balloon for the treatment of common femoral artery steno-occlusive lesions.

BACKGROUND: Endarterectomy is considered the gold standard therapy for common femoral artery (CFA) steno-occlusive lesions, but a significant risk of perioperative mortality and complications has been reported. OBJECTIVE: Aim of this study is to evaluate the efficacy at a long-term follow-up of patients with CFA steno-occlusive lesions treated with directional atherectomy and drug coated balloon (DCB). MATERIAL AND METHODS: In this single-center registry, 78 patients (male: 80.7%; age: 71 ± 15 years; occlusions: 25%) with 80 CFA lesions were included, with 39.7% of them undergoing directional atherectomy and drug coated balloon due to critical limb ischemia and 60.3% due to lower-limb intermittent claudication. The long-term follow-up was completed by 75 patients (3 years). The 31 patients with critical ischemia (39.7%) were further subdivided into 20 (25.6%) patients with pain at rest and 11 (14.1%) with trophic changes, ulcers and/or tissue loss. We considered the primary and the secondary outcome, referring, respectively to peak systolic velocity ratio (PSVR) ≥ 2.4 on duplex or > 50% stenosis on digital subtraction angiography at 36 months and to clinically driven target lesion revascularization at 36 months. RESULTS: The primary and secondary outcome was obtained in 84% and 86.7% of patients, at 36 months of follow up. Bailout stenting was necessary in 6/80 cases (7.5%) for suboptimal result. Freedom from MALE was obtained in 98.6% of patients. CONCLUSIONS: These results confirm that directional atherectomy and drug coated balloon strategy for the treatment of CFA lesions is effective at a long-term follow-up and could be considered as a good alternative to surgery.

Prospective comparison of the accuracy of the New England Spinal Metastasis Score (NESMS) to legacy scoring systems in prognosticating outcomes following treatment of spinal metastases.

BACKGROUND CONTEXT: We developed the New England Spinal Metastasis Score (NESMS) as a simple, informative, scoring scheme that could be applied to both operative and non-operative patients. The performance of the NESMS to other legacy scoring systems has not previously been compared using appropriately powered, prospectively collected, longitudinal data. PURPOSE: To compare the predictive capacity of the NESMS to the Tokuhashi, Tomita and Spinal Instability Neoplastic Score (SINS) in a prospective cohort, where all scores were assigned at the time of baseline enrollment. PATIENT SAMPLE: We enrolled 202 patients with spinal metastases who met inclusion criteria between 2017-2019. OUTCOME MEASURES: One-year survival (primary); 3-month mortality and ambulatory function at 3- and 6-months were considered secondarily. METHODS: All prognostic scores were assigned based on enrollment data, which was also assigned as time-zero. Patients were followed until death or survival at 365 days after enrollment. Survival was assessed using Kaplan-Meier curves and score performance was determined via logistic regression testing and observed to expected plots. The discriminative capacity (c-statistic) of the scoring measures were compared via the z-score. RESULTS: When comparing the discriminative capacity of the predictive scores, the NESMS had the highest c-statistic (0.79), followed by the Tomita (0.69), the Tokuhashi (0.67) and the SINS (0.54). The discriminative capacity of the NESMS was significantly greater (p-value range: 0.02 to <0.001) than any of the other predictive tools. The NESMS was also able to inform independent ambulatory function at 3- and 6-months, a function that was only uniformly replicated by the Tokuhashi score. CONCLUSIONS: The results of this prospective validation study indicate that the NESMS was able to differentiate survival to a significantly higher degree than the Tokuhashi, Tomita and SINS. We believe that these findings endorse the utilization of the NESMS as a prognostic tool capable of informing care for patients with spinal metastases.

The Cost-Effectiveness of Surgical Intervention for Spinal Metastases: A Model-Based Evaluation.

BACKGROUND: Operative and nonoperative treatments for spinal metastases are expensive interventions with a high rate of complications. We sought to determine the cost-effectiveness of a surgical procedure compared with nonoperative management as treatment for spinal metastases. METHODS: We constructed a Markov state-transition model with health states defined by ambulatory status and estimated the quality-adjusted life-years (QALYs) and costs for operative and nonoperative management of spine metastases. We considered 2 populations: 1 in which patients presented with independent ambulatory status and 1 in which patients presented with nonambulatory status due to acute (e.g., <48 hours) metastatic epidural compression. We defined the efficacy of each treatment as a likelihood of maintaining, or returning to, independent ambulation. Transition probabilities for the model, including the risks of mortality and becoming dependent or nonambulatory, were obtained from secondary data analysis and published literature. Costs were determined from Medicare reimbursement schedules. We conducted analyses over patients' remaining life expectancy from a health system perspective and discounted outcomes at 3% per year. We conducted sensitivity analyses to account for uncertainty in data inputs. RESULTS: Among patients presenting as independently ambulatory, QALYs were 0.823 for operative treatment and 0.800 for nonoperative treatment. The incremental cost-effectiveness ratio (ICER) for a surgical procedure was $899,700 per QALY. Among patients presenting with nonambulatory status, those undergoing surgical intervention accumulated 0.813 lifetime QALY, and those treated nonoperatively accumulated 0.089 lifetime QALY. The incremental cost-effectiveness ratio for a surgical procedure was $48,600 per QALY. The cost-effectiveness of a surgical procedure was most sensitive to the variability of its efficacy. CONCLUSIONS: Our data suggest that the value to society of a surgical procedure for spinal metastases varies according to the features of the patient population. In patients presenting as nonambulatory due to acute neurologic compromise, surgical intervention provides good value (ICER, $48,600 per QALY). There is a low value for a surgical procedure performed for patients who are ambulatory at presentation (ICER, $899,700 per QALY). LEVEL OF EVIDENCE: Economic and Decision Analysis Level III. See Instructions for Authors for a complete description of levels of evidence.

Downstream Paclitaxel Released Following Drug-Coated Balloon Inflation and Distal Limb Wound Healing in Swine.

The authors evaluated the presence of paclitaxel and healing of distal hind limb wounds created in 27 swine using biopsy punches followed by paclitaxel-coated balloon (PCB) use in the iliofemoral arteries of healthy swine. After 14 and 28 days, no differences were seen in time course, appearance, and histopathology of wound healing between the single or triple PCB and uncoated balloon treatment despite clinically relevant paclitaxel concentrations in the skin adjacent to the healing wounds. Presence of paclitaxel downstream from the PCB treatment site does not impair the wound healing response of preexisting distal cutaneous lesions in healthy swine.

Evaluating ambulatory function as an outcome following treatment for spinal metastases: a systematic review.

BACKGROUND CONTEXT: Studies regarding treatment of spinal metastases are critical to evidence-based decision-making. However, variation exists in how a key outcome, ambulatory function, is assessed. PURPOSE: To characterize the sources and tools investigators have used to evaluate ambulatory function as an outcome following treatment of spinal metastases. We also sought to understand the ways ambulatory function has been conceptualized in prior studies. STUDY DESIGN: Systematic review of the literature. PATIENT SAMPLE: We identified 44 published studies for inclusion. Samples within these investigations ranged from 20 to 2,096 subjects. OUTCOME MEASURES: We describe the methods investigators have used to evaluate ambulatory function following treatment for spinal metastases. METHODS: We conducted a systematic review through PubMed, Scopus and Web of Science following PRISMA guidelines. We included studies that consisted of adult patients receiving operative or non-operative treatment for spinal metastases. We also required that study investigators specified post-treatment ambulatory function as an outcome. We recorded year of publication, study design, types of spinal metastases included in the study, treatments employed, and sample size. We also described the source (medical record, study-specific observer and/or provider, patient and/or participant), tool (standardized measure, quantitative, qualitative) and concept (eg, ambulatory vs. non-ambulatory; independent ambulation vs. ambulatory with assistance vs. non-ambulatory) used to assess ambulatory function. RESULTS: We found the plurality of studies relied on medical record documentation as their source. Amongst prospective studies, only a minority used a quantitative measure (eg, prespecified degree of walking ability) to assess ambulatory function. Most studies conceptualized ambulatory function as a dichotomized outcome, typically ambulatory versus non-ambulatory or a similar equivalent. CONCLUSIONS: Wide variation exists in how ambulatory function is defined in studies involving patients with spinal metastases. We suggest several improvements that will allow a more robust assessment of the quality and quantity of ambulatory function among patients treated for spinal metastases.