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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., (© 2024 Wiley Periodicals LLC.)

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., Competing Interests: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Ischemia with non-obstructive coronary artery (INOCA) is a common cause of hospital admissions, leading to negative outcomes and reduced quality of life. Central to its pathophysiology is endothelial dysfunction, which contributes to myocardial ischemia despite the absence of significant coronary artery blockage. Addressing endothelial dysfunction is essential in managing INOCA to alleviate symptoms and prevent cardiovascular events. Recent studies have identified diabetes mellitus (DM) as a significant factor exacerbating INOCA complications by promoting endothelial impairment and coronary microvascular dysfunction. MicroRNAs (miRNAs) have emerged as potential biomarkers and therapeutic targets in various biological processes, including endothelial dysfunction and cardiovascular diseases. However, research on miRNA biomarkers in INOCA patients is sparse. In this study, we examined a panel of circulating miRNAs involved in the regulation of endothelial function in INOCA patients with and without DM. We analyzed miRNA expression using RT-qPCR in a cohort of consecutive INOCA patients undergoing percutaneous coronary intervention. We detected a significant dysregulation of miR-363-5p and miR-92a-3p in INOCA patients with DM compared to those without DM, indicating their role as biomarkers for predicting and monitoring endothelial dysfunction in INOCA patients with DM., (© 2024. The Author(s).)

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.

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., Competing Interests: Yu-Hui Chen reports receiving support from Dana-Farber Cancer Institute and is on the Hoosier Cancer Research Network Data Safety Monitoring Board. Tracy A. Balboni received grants from the National Institute of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and John Templeton Foundation and is the American Society for Radiation Oncology Bone Metastases Guidelines Chair. Mai Anh Huynh received research funding from the Jay Harris Early Career Research Award, Dana-Farber Early Career Innovation Fund, ViewRay, Inc, Immune-Sensor, Inc., and is the Dana-Farber Cancer Institute Bone Metastases Pathways Champion. No other disclosures were reported., (© 2024 The Author(s).)

Purpose: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease., Materials and Methods: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months., Results: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%., Conclusion: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials., Clinical Impact: In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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., (© 2023. Society of Surgical Oncology.)

Background: The primary patency rate of superficial femoral artery (SFA) after percutaneous transluminal angioplasty (PTA) has improved with the use of self-expanding stents. However, occurrence of in-stent restenosis (ISR) still represents a frequent problem. Despite different studies have assessed the role of atherectomy and drug coated balloons (DCBs), no long-term data exist about combined use. The aim of this study was to evaluate safety and efficacy of combined treatment with Jetstream (Boston Scientific Corp., Marlborough, MA, USA) atherectomy and DCB for SFA intrastent restenosis (ISR) at 2-year follow-up., Methods: 30 patients treated with PTA from November 2018 to September 2019 at Montevergine Clinic (Mercogliano, Avellino, Italy) were included in this analysis. All patients underwent PTA of SFA-ISR with Jetstream Atherectomy System followed by paclitaxel eluting balloon treatment. Patients were evaluated at 30 days, and every 3 months up to 24., Results: Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. No acute and sub-acute(in-hospital) procedure related complications occurred. During follow-up, 1 patient died due to stroke. Primary patency rate at 12 months was 93.4%. Primary patency rate at 24 months was 83.4%. Secondary patency rate at 24 months was 96.7%. One minor amputation, planned before treatment, was performed in the first 30 days., Conclusions: Our data suggest that combined therapy with Rotational Atherectomy and DCBs for SFA-ISR represents a safe and effective procedure with a high rate of primary patency at 2-year follow-up.

Hotter global temperatures and increasingly variable climate patterns negatively affect human health, with a wide recognition that climate change is a major global health threat. Human activities, including those conducted in the orthopaedic operating room (OR), contribute to climate change by generating greenhouse gases that trap infrared radiation from the earth's surface. This review provides an overview of the environmental effect of the orthopaedic OR and efforts to address environmental sustainability in the OR. These concepts are presented with a particular focus on patient safety and cost savings because roll-out of these efforts must be conducted with a pragmatic and patient-centered focus. Orthopaedic surgeons have an opportunity to lead efforts to improve environmental sustainability in the OR and thus contribute to efforts to curb climate change., (Copyright © 2022 by the American Academy of Orthopaedic Surgeons.)

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., (© 2021 Wiley Periodicals LLC.)

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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., Competing Interests: Ms. Crookall, and Drs. Schulz-Jander, Tunev, and Melder are full-time employees of Medtronic PLC, the manufacturer of the IN.PACT Admiral product evaluated in the study. Dr. Granada is the CEO, and Dr. Kaluza is an employee of the Cardiovascular Research Foundation which receives research and educational grant support from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2021 The Authors.)

Background Context: The New England Spinal Metastasis Score (NESMS) was proposed as an intuitive and accessible prognostic tool for predicting survival in patients with spinal metastases. We designed an appropriately powered, prospective, longitudinal investigation to validate the NESMS., Purpose: To prospectively validate the NESMS., Study Design: Prospective longitudinal observational cohort study., Patient Sample: Patients, aged 18 and older, presenting for treatment with spinal metastatic disease., Outcome Measures: One-year mortality (primary); 6-month mortality and mortality at any time point following enrollment (secondary)., Methods: The date of enrollment was set as time zero for all patients. The NESMS was assigned based on data collected at the time of enrollment. Patients were prospectively followed to one of two predetermined end-points: death, or survival at 365 days following enrollment. Survival was visually assessed with Kaplan-Meier curves and then analyzed using multivariable logistic regression, followed by Bayesian regression to assess for robustness of point estimates and 95% confidence intervals (CI)., Results: This study included 180 patients enrolled between 2017 and 2018. Mortality within 1-year occurred in 56% of the cohort. Using NESMS 3 as the referent, those with a score of 2 had significantly greater odds of mortality (odds ratio 7.04; 95% CI 2.47, 20.08), as did those with a score of 1 (odds ratio 31.30; 95% CI 8.82, 111.04). A NESMS score of 0 was associated with perfect prediction, as 100% of individuals with this score were deceased at 1-year. Similar determinations were encountered for mortality at 6-months and overall., Conclusions: This study validates the NESMS and demonstrates its utility in prognosticating survival for patients with spinal metastatic disease, irrespective of selected treatment strategy. This is the first study to prospectively validate a prognostic utility for patients with spinal metastases. The NESMS can be directly applied to patient care, hospital-based practice and health-care policy., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background and Objectives: Malignant tumors of the calcaneus are rare but pose a treatment challenge., Aims: (1) describe the demographics of calcaneal malignancies in a large cohort; (2) describe survival after amputation versus limb-salvage surgery for high-grade tumors., Methods: Study group: a "pooled" cohort of patients with primary calcaneal malignancies treated at two cancer centers (1984-2015) and systematic literature review. Kaplan-Meier analyses described survival across treatment and diagnostic groups; proportional hazards modeling assessed mortality after amputation versus limb salvage., Results: A total of 131 patients (11 treated at our centers and 120 patients from 53 published studies) with a median 36-month follow-up were included. Diagnoses included Ewing sarcoma (41%), osteosarcoma (30%), and chondrosarcoma (17%); 5-year survival rates were 43%, 73% (70%, high grade only), and 84% (60%, high grade only), respectively. Treatment involved amputation in 52%, limb salvage in 27%, and no surgery in 21%. There was no difference in mortality following limb salvage surgery (vs. amputation) for high-grade tumors (HR 0.38; 95% CI 0.14-1.05), after adjusting for Ewing sarcoma diagnosis (HR 5.15; 95% CI 1.55-17.14), metastatic disease at diagnosis (HR 3.88; 95% CI 1.29-11.64), and age (per-year HR 1.04; 95% CI 1.02-1.07)., Conclusions: Limb salvage is oncologically-feasible for calcaneal malignancies., (© 2020 Wiley Periodicals LLC.)

Background: Modern medical management of metastatic renal cell carcinoma (RCC) includes therapies targeting tyrosine kinases, growth pathways (mammalian target of rapamycin (mTOR)), and immune checkpoints., Objective: To test our hypothesis that patients with spinal metastases would benefit from postoperative systemic therapy despite presenting with disease that, in many cases, was resistant to prior systemic therapy., Methods: This is an Institutional Review Board-approved clinical retrospective cohort analysis. A sample of adult patients with RCC metastatic to the spine who underwent operative intervention between January 2010 and December 2017 at 2 large academic medical centers was used in this study., Results: We identified 78 patients with metastatic RCC in whom instrumented stabilization was performed in 79% and postoperative stereotactic radiosurgery was performed in 41% of patients. Of patients presenting with weakness or myelopathy, 93% noted postoperative improvement and 78% reported improvement in radicular and axial paraspinal pain severity. Increased overall survival (OS) (913 d (95% CI: 633-1975 d, n = 49) vs 222 d (95% CI: 143-1005 d, n = 29), P = .003) following surgery was noted in patients who received postoperative systemic therapy a median of 80 d (interquartile range 48-227 d) following the surgical intervention., Conclusion: Postoperative outcomes and palliation of symptoms for metastatic RCC without targeted therapies in this cohort are similar to those reported in earlier series prior to the adoption of these systemic therapies. We observed a significantly longer OS among patients who received modern systemic therapies postoperatively. These findings have implications for the preoperative evaluation of patients with systemic disease who may have been deemed poor surgical candidates prior to the availability of these systemic therapies., (Copyright © 2020 by the Congress of Neurological Surgeons.)

In patients with multivessel disease, complete revascularization (CR) is the most biologically plausible approach irrespective of definition or type or clinical setting (acute or chronic coronary syndrome [ACS or CCS]). It aims at minimizing residual ischemia, relieving symptoms and reducing the risk of future cardiovascular events. Large evidence supports CR benefits in ACS, predominantly ST-segment elevation myocardial infarction, except cardiogenic shock, although optimal assessment and timing remain debated. In patients with CCS, when revascularization is indicated, a functional CR should be attempted. Therefore, heart-team is crucial in selecting the ideal strategy for each patient to optimize decision-making., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aims: Chronic kidney disease (CKD) is associated with increased thrombotic events and seems to influence platelet reactivity. Conflicting results have been published on platelet response in CKD patients with stable coronary artery disease. The aim of our study was to investigate the impact of CKD on platelet aggregation in acute coronary syndrome (ACS) patients receiving dual antiplatelet therapy, included the more potent P2Y12 inhibitors., Methods: We enrolled 206 patients with ACS, divided in two groups, according to the presence or the absence of moderate/severe CKD. Platelet aggregation was performed with light transmission aggregometry and results are expressed as percentage of maximum platelet aggregation. High residual platelet reactivity (HRPR) was defined as maximum platelet aggregation more than 59%., Results: Patients with CKD [estimate glomerular filtration rate (eGFR) < 60 ml/min/1.73 m, n = 28] were prevalent older, diabetic, had previous coronary revascularization. In these patients, platelet aggregation was significantly higher than in those with eGFR ≥ 60 ml/min/1.73 m (ADP 10 μmol/l: 28.46 ± 26.19 vs. 16.64 ± 12.79, P < 0.001; ADP 20 μmol/l: 30.07 ± 25.89 vs. 17.46 ± 12.82, P < 0.001). HRPR was observed in 4.4% of patients, with higher prevalence in those with eGFR less than 60 ml/min/1.73 m [21.4 vs. 1.7%, P < 0.001, odds ratio (OR) [95% confidence interval (CI)] = 15.91 (3.71-68.17), P < 0.001]. At multivariate analysis, after correction for baseline confounders, eGFR [adjusted OR (95% CI) = 0.95 (0.91-0.98), P = 0.007], together with the use of clopidogrel [adjusted OR (95% CI) = 23.59 (4.01-138.82), P < 0.001], emerged as determinants of HRPR., Conclusion: In patients with ACS receiving dual antiplatelet therapy, CKD is associated with an increasing ADP-induced platelet aggregation and higher prevalence of HRPR, which is mainly correlated to clopidogrel use.

Purpose: The purpose of this study was to determine the prognostic value of serum alkaline phosphatase for treatment decision making in metastatic bone disease., Methods: 1090 patients who underwent surgery for extremity metastatic disease were retrospectively identified at two tertiary care centers. The association between alkaline phosphatase and mortality was assessed by bivariate and multivariate analyses., Results: Three-month and one-year mortality rates were 305 (29%) and 639 (62%), respectively. Alkaline phosphatase was associated with mortality at both three months and one year., Conclusion: Serum alkaline phosphatase may be a useful marker in prognostic algorithms for patients with extremity metastatic disease., Competing Interests: None., (© 2020 Professor P K Surendran Memorial Education Foundation. Published by Elsevier B.V. All rights reserved.)

Study Design: Retrospective cohort study., Objective: To develop a comprehensive understanding of the prognostic value of laboratory markers on morbidity and mortality following epidural abscess., Summary of Background Data: Spinal epidural abscess is a serious medical condition with high rates of morbidity. The value of laboratory data in forecasting morbidity and mortality after epidural abscess remains underexplored., Methods: We obtained clinical data on patients treated for epidural abscess at two academic centers from 2005 to 2017. Our primary outcome was the development of one or more complications within 90-days of presentation, with mortality a secondary measure. Primary predictors included serum albumin, serum creatinine, platelet-lymphocyte ratio, and ambulatory status at presentation. We used multivariable logistic regression techniques to adjust for confounders. The most parsimonious set of variables influencing both complications and mortality were considered to be clinically significant. These were then examined individually and in combination to assess for synergy along with model-discrimination and calibration. We performed internal validation with a bootstrap procedure using sampling with replacement., Results: We included 449 patients in this analysis. Complications were encountered in 164 cases (37%). Mortality within 1-year occurred in 39 patients (9%). Regression testing determined that serum albumin, serum creatinine, and ambulatory status at presentation were clinically important predictors of outcome, with albumin more than 3.5 g/dL, creatinine less than or equal to 1.2 mg/dL, and independent ambulatory function at presentation considered favorable characteristics. Patients with no favorable findings had increased likelihood of 90-day complications (odds ratio [OR] 5.43; 95% confidence intervals [CI] 1.98, 14.93) and 1-year mortality (OR 8.94; 95% CI 2.03, 39.37). Those with one favorable characteristic had greater odds of complications (OR 4.00; 95% CI 2.05, 7.81) and mortality (OR 5.71; 95% CI 1.60, 20.43)., Conclusion: We developed a nomogram incorporating clinical and laboratory values to prognosticate outcomes after treatment for epidural abscess. The results can be used in shared-decision making and counseling., Level of Evidence: 3.

Objective: We describe characteristics of patient and treatment recommendations from a spinal tumor board at one institution, including representation from palliative care. Background: The impact of prospective multidisciplinary input for patients with spinal tumors is poorly understood despite their increasing complexity. Methods: We retrospectively reviewed 622 cases sequentially discussed at a weekly spinal tumor board, and abstracted patient and treatment information from the medical record and meeting minutes. Results: From April 2017 to February 2019, 622 cases representing 438 unique patients were discussed. The median age was 62 years (range 21-92). Most patients had spinal tumors originating from metastases (91.78%), including breast (14.3%), nonsmall cell lung cancer (13.4%), prostate (10.9%), and renal cell cancer (8.8%), and the remainder had primary central nervous system (4.3%) or benign tumors (3.9%). Sixty-five percent of patients were alive at last follow-up. Conventional external beam radiotherapy was the most common treatment recommendation (33.8%) followed by surgery (26.2%), stereotactic body radiation therapy (17.8%), imaging follow-up (16.6%), and vertebroplasty (15.9%). Palliative care was the primary treatment recommended for 4.5%, and no therapy recommended for 4.0%. Treatment recommendation involved two modalities for 29% of cases, and three in 1.3% of cases. In four cases, biopsy to confirm pathology changed management due to unexpected findings of osteomyelitis, hematopoiesis, or new diagnosis of plasmacytoma. Conclusions: Multidisciplinary input is integral to the optimal care of spinal tumor patients. The high risk of death highlights the need to prioritize modalities that optimize quality of life in the context of a patient's individual prognosis., Competing Interests: No competing financial interests exist., (© Mai Anh Huynh et al., 2020; Published by Mary Ann Liebert, Inc.)

Aims: The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention., Methods and Results: The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up., Conclusions: In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.

The integration of the Absorb bioresorbable vascular scaffold (BVS) into the arterial wall has never been tested in an in vivo model of atherosclerosis. This study aimed to compare the long-term (up to 4 years) vascular healing responses of BVS to an everolimus-eluting metallic stent in the familial hypercholesterolemic swine model of atherosclerosis. The multimodality imaging and histology approaches indicate that the resorption and vascular integration profile of BVS is not affected by the presence of atherosclerosis. BVS demonstrated comparable long-term vascular healing and anti-restenotic efficacy to everolimus-eluting metallic stent but resulted in lower late lumen loss at 4 years., (© 2020 The Authors.)

Aims: Peripheral arteries are constantly exposed to deformation (elongation, twisting, shortening, compression) making bioresorbable scaffolds (BRS) a potentially attractive therapeutic alternative to metallic stents. We conducted a long-term pilot preclinical study of a novel sirolimus-eluting BRS in peripheral arteries., Methods and Results: Fourteen BRS were deployed in iliofemoral arteries of seven healthy Yucatan miniswine and examined with imaging, pharmacokinetic, histopathologic, and polymer degradation techniques at 0, 30, 90, 180 days, 1, 2, and 3.3 years. Angiographic late luminal loss remained unchanged at 30 and 180 days but significantly decreased from 1 to 3.3 years. optical coherence tomography (OCT) showed late increase in lumen area (1 year: 14.70 ± 3.58 mm 2 , 2 years 22.04 ± 3.81 mm 2 , and 3.3 years 23.45 ± 7.07 mm 2 ; p < .05) primarily due to scaffold area enlargement between 1 and 3.3 years, while there was no difference in the percent area stenosis at all time points. Histologic evidence of scaffold degradation was observed starting at 2 years, with minimal inflammatory reaction. At 3.3 years, BRS struts were rarely discernible by OCT, confirmed by a nearly complete polymer degradation by molecular weight analysis., Conclusions: In this pilot study, novel sirolimus-eluting BRS showed promising acute and chronic performance in the iliofemoral arteries of Yucatan miniswine., (© 2020 Wiley Periodicals, Inc.)

Objectives: To describe patient-specific characteristics associated with non-operative failure leading to surgery., Patients and Methods: We conducted a retrospective review of patients treated for spinal metastases from 2005 to 2017. We deemed patients as failures if they were treated non-operatively and then received a surgical intervention within one year of starting a non-operative regimen. We used multivariable Poisson regression to identify factors associated with non-operative failure. We conducted internal validation using bootstrapping with 1000 replications., Results: We identified 1205 patients with spinal metastases, of whom 834 were initially treated non-operatively and constituted the analytic sample. Of these 77 (9%) went on to have surgery within 1-year of presentation and were deemed non-operative treatment failures. We identified vertebral body collapse and/or pathologic fracture (adjusted Risk Ratio [RR] 1.75; 95% Confidence Interval [CI] 1.11, 2.76) and neurologic signs or symptoms at presentation (RR 1.90; 95% CI 1.19, 3.03) as factors independently associated with an increased risk of non-operative failure. Platelet-lymphocyte ratio >155, a marker for inflammatory state, was also associated with an increased risk of failure (RR 2.32; 95% CI 1.15, 4.69). Failure rates among those with 0, 1, 2 or all three of these risk factors were 5%, 7%, 12% and 20%, respectively (p = 0.004)., Conclusion: We found that 9% of patients with spinal metastases initially treated non-operatively received surgery within 1-year of commencing care. The likelihood of surgery increased with the number of risk factors. These results can be used in counseling and shared decision making at the time of initial presentation., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background Context: Laboratory values have been found to be useful predictive measures of survival following surgery. The utility of laboratory values for prognosticating outcomes among patients with spinal metastases has not been studied., Purpose: To determine the prognostic capacity of laboratory values at presentation including white blood cell count, serum albumin and platelet-lymphocyte ratio (PLR) in patients with spinal metastases., Study Design: Retrospective review of records from two tertiary care centers (2005-2017)., Patient Sample: Patients, aged 40 to 80, who received operative or nonoperative management for spinal metastases., Outcome Measures: Survival, complications, or hospital readmissions within 90 days of treatment and a composite measure for treatment failure accounting for changes in ambulatory function and mortality at 6 months following presentation., Methods: Multivariable Cox proportional hazard regression analysis was used to analyze the relationship between laboratory values and length of survival, adjusting for confounders. Multivariable logistic regression was used in analyses related to 6-month and 1-year mortality, complications, readmissions, and treatment failure. A scoring rubric was developed based on the performance of laboratory values in the multivariable tests. Internal validation was performed using a bootstrap simulation that consisted of sampling with replacement and 1,000 replications., Results: We included 1,216 patients. Thirty-seven percent of patients received a surgical intervention and 63% were treated nonoperatively. Median survival for the cohort as a whole was 255 days (interquartile range 93-642 days). The PLR (hazard ratio [HR] 1.53; 95% confidence interval [CI] 1.29, 1.80; p<.001) and albumin (HR 0.54; 95% CI 0.45, 0.64; p<.001) were significantly associated with survival, whereas WBC count (HR 1.08; 95% CI 0.86, 1.36; p=.50) was not associated with this outcome. Similar findings were encountered for 6-month and 1-year mortality as well as the composite measure for treatment failure. The PLR and albumin performed well in our scoring rubric and findings were preserved in the bootstrapping validation., Conclusions: Individuals with low serum albumin and elevated PLR should be advised regarding the impact of these laboratory markers on outcomes including survival, irrespective of treatments received. An effort should also be made to optimize nutrition and PLR, if practicable, before treatment to minimize the potential for development of adverse events., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: To assess the impact of surgical intervention on survival, ambulatory capacity, complications and readmissions following treatment for lumbar metastases., Patients and Methods: We identified all adult patients treated for lumbar metastases between 2005-2017. To limit the potential for inherent bias to influence determinations, we used principal component analysis to identify confounders to be included in multivariable testing. Multivariable logistic regression was performed, followed by Bayesian analysis to generate conservative estimates of effect size and 95% confidence intervals (CI). In a sensitivity test, analyses were repeated in a population where patients who died before they could initiate treatment were excluded., Results: In the period under study, we identified 571 patients who met inclusion criteria. Twenty-one percent of the cohort received a surgical intervention. Bayes regression indicated surgical intervention was independently associated with decreased mortality at 6-months (odds ratio [OR] 0.49; 95% CI 0.34, 0.68) and 1-year (OR 0.63; 95% CI 0.51, 0.76), along with lower odds of being non-ambulatory at 6-months following presentation (OR 0.29; 95% CI 0.18, 0.45). Surgery was also associated with increased odds of complications (OR 1.60; 95% CI 1.24, 2.06) and readmissions (OR 1.37; 95% CI 1.09, 1.72). Numerous clinical characteristics were found to be associated with the outcomes of interest including serum albumin, lung metastases and vertebral body collapse., Conclusions: Given the favorable outcomes associated with the incorporation of surgery as a component of treatment, we believe that such interventions may be considered part of the treatment approach in patients with lumbar metastases., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Surgery for spinal metastases is challenging and carries a high risk of perioperative morbidity and mortality. Procedures with such characteristics often exhibit a volume-outcome relationship. This has not been previously characterized for spinal metastasis surgery to our knowledge., Methods: The Florida State Inpatient Database (2011 through 2014) was queried to identify patients who had undergone surgery for spinal metastases. Surgeon and hospital surgical volumes were compared with 90-day complication and readmission rates to develop procedural cut-points used to define high and low-volume providers. These were included in a multivariable logistic regression analysis that was adjusted for confounders. A separate analysis was performed to evaluate the effect of race/ethnicity and insurance status on the likelihood of receiving care from a high-volume surgeon or hospital., Results: This study included 3,135 patients treated by 1,488 surgeons at 162 hospitals. Patients treated at low-volume hospitals had significantly higher odds of having postoperative complications (odds ratio [OR] = 1.47; 95% confidence interval [CI] = 1.13, 1.91) and readmissions (OR = 1.36; 95% CI = 1.06, 1.75). Those treated by low-volume surgeons also demonstrated a higher likelihood of complications (OR = 1.40; 95% CI = 1.16, 1.69) and readmissions (OR = 1.38; 95% CI = 1.17, 1.62). The likelihood of receiving intervention from a high-volume surgeon was significantly lower for African Americans (OR = 0.55; 95% CI = 0.41, 0.75) and Hispanics (OR = 0.60; 95% CI = 0.44, 0.83). The odds of being treated at a high-volume hospital were also significantly lower for African Americans (OR = 0.58; 95% CI = 0.40, 0.84) and Hispanics (OR = 0.28; 95% CI = 0.20, 0.38)., Conclusions: There is a clear relationship between the volume and outcomes of surgical treatment of spinal metastases, with high-volume providers demonstrating reduced complication and readmission rates. Racial and ethnic minorities appear to experience health-care segregation when it comes to surgical care for spinal metastases. Regionalization of care for these conditions may help improve access to high-volume providers and mitigate disparities in care., Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.