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Bagla S.,Vascular Institute of Virginia LLC | Sayed D.,University of Kansas Medical Center | Smirniotopoulos J.,New York Presbyterian Hospital Weill Cornell Medical Center | Brower J.,Providence Sacred Heart Medical Center And Childrens Hospital | And 5 more authors.
CardioVascular and Interventional Radiology | Year: 2016

Background: Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. Methods: Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. Results: Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported. Conclusion: RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases. © 2016, Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Source

Brott T.G.,Mayo Medical School | Howard G.,University of Alabama at Birmingham | Roubin G.S.,Cardiovascular Asso. of the Southeast | Meschia J.F.,Mayo Medical School | And 15 more authors.
New England Journal of Medicine | Year: 2016

BACKGROUND In the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. METHODS Among patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. RESULTS Among 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately. CONCLUSIONS Over 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.) © Copyright 2016 Massachusetts Medical Society. All rights reserved. Source

Murphy S.M.,Washington State University | Neven D.,Providence Sacred Heart Medical Center And Childrens Hospital
Journal of Emergency Medicine | Year: 2014

Background Frequent and unnecessary utilization of the emergency department (ED) is often a sign of serious latent patient issues, and the associated costs are shared by many. Helping these patients get the care they need in the appropriate setting is difficult given their complexity, and their tendency to visit multiple EDs. Study Objective We analyzed the cost-effectiveness of a multidisciplinary ED-care-coordination program with a regional hospital information system capable of sharing patients' individualized care plans with cooperating EDs. Methods ED visits, treatment costs, cost per visit, and net income were assessed pre- and postenrollment in the program using nonparametric bootstrapping techniques. Individuals were categorized as frequent (3-11 ED visits in the 365 days preceding enrollment) or extreme (≥ 12 ED visits) users. Regression to the mean was tested using an adjusted measure of change. Results Both frequent and extreme users experienced significant decreases in ED visits (5 and 15, respectively; 95% confidence intervals [CI] 2-5 and 13-17, respectively) and direct-treatment costs ($1285; 95% CI $492-$2364 and $6091; 95% CI $4298-$8998, respectively), leading to significant hospital cost savings and increased net income ($431; 95% CI $112-$878 and $1925; 95% CI $1093-$3159, respectively). The results further indicate that fewer resources were utilized per visit. Regression to the mean did not seem to be an issue. Conclusions When examined as a whole, research on the program suggests that expanding it would be an efficient allocation of hospital, and possibly societal, resources. © 2014 Elsevier Inc. Source

Day M.W.,Providence Sacred Heart Medical Center And Childrens Hospital
Critical Care Nurse | Year: 2011

Three intraosseous devices have been approved by the Food and Drug Administration for use in adult trauma patients when intravenous access cannot be obtained. Sites of insertion are the sternum (FAST1), proximal tibia and humerus (Big Injection Gun), and proximal and distal tibia and humerus (EZ-IO). Insertion generally requires less than 1 minute, and flow rates up to 125 mL/min can be achieved. The devices are used for emergency resuscitation and should be removed within 24 hours of insertion or as soon as practical after peripheral or central intravenous access has been achieved. Contraindications include fractures or other trauma at the insertion site, prosthetic joints near the site, previous attempts to insert an intra osseous device at the same site, osteoporosis or other bone abnormalities, infections at the proposed site, and inability to identify pertinent insertion landmarks. Primary complications are extravasation of medications and fluids into the soft tissue, fractures caused by the insertion, and osteomyelitis. © 2011 American Association of Critical-Care Nurses. Source

Felgenhauer J.L.,Providence Sacred Heart Medical Center And Childrens Hospital | Nieder M.L.,All Childrens Hospital | Krailo M.D.,University of Southern California | Bernstein M.L.,Health Center | And 8 more authors.
Pediatric Blood and Cancer | Year: 2013

Background: The aims of this study were to determine the feasibility of the combination of low dose, anti-angiogenic chemotherapy with standard therapy for patients with metastatic Ewing sarcoma (ES), and to obtain preliminary outcome data. Procedures: Patients with metastatic ES were eligible. Therapy consisted of alternating cycles of ifosfamide-etoposide, and vincristine, doxorubicin, cyclophosphamide. Vinblastine and celecoxib were concomitantly administered. Surgical, radiotherapeutic, or combination local control therapy was given per institutional preference. Results: Thirty-five eligible patients were enrolled. Ninety percent received at least 75% of planned vinblastine/celecoxib doses. There was no excess of neurologic, infectious, hemorrhagic, or cardiovascular toxicities. However, 7 of 21 patients who received pulmonary irradiation prior to experiencing pulmonary toxicity did develop grade 2 or greater pulmonary toxicity, including two deaths of apparent radiation pneumonitis. Fourteen of 16 patients with pelvic disease received local irradiation. Hemorrhagic cystitis developed in six patients, five of whom had received pelvic irradiation. The overall 24-month event free survival was 35% (19-51%); 71% (26-92%) for the seven with isolated pulmonary metastases, 26% (10-45%) for all others. Conclusion: The combination of vinblastine/celecoxib metronomic therapy with standard ES treatment was feasible according to the protocol definitions. However, excess toxicity in irradiated areas was noted and limits the usefulness of this protocol. The 24-month EFS for those with isolated pulmonary metastases is better than historical controls, although the number of patient number is small, follow up short and we are lacking contemporaneous controls. © 2012 Wiley Periodicals, Inc. Source

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