Primary vascular bone tumors in the spine: a challenge for pathologists and spine oncology surgeons

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Minimally Invasive Posterior Stabilization Improved Ambulation and Pain Scores in Patients with Plasmacytomas and/or Metastases of the Spine

Background. The incidence of spine metastasis is expected to increase as the population ages, and so is the number of palliative spinal procedures. Minimally invasive procedures are attractive options in that they offer the theoretical advantage of less morbidity. Purpose. The purpose of our study was to evaluate whether minimally invasive posterior spinal instrumentation provided significant pain relief and improved function. Study Design. We compared pre- and postoperative pain scores as well as ambulatory status in a population of patients suffering from oncologic conditions in the spine. Patient Sample. A consecutive series of patients with spine tumors treated minimally invasively with stabilization were reviewed. Outcome Measures. Visual analog pain scale as well as pre- and postoperative ambulatory status were used as outcome measures. Methods. Twenty-four patients who underwent minimally invasive posterior spinal instrumentation for metastasis were retrospectively reviewed. Results. Seven (29%) patients were unable to ambulate secondary to pain and instability prior to surgery. All patients were ambulating within 2 to 3 days after having surgery (P = 0.01). The mean visual analog scale value for the preoperative patients was 2.8, and the mean postoperative value was 1.0 (P = 0.001). Conclusion. Minimally invasive posterior spinal instrumentation significantly improved pain and ambulatory status in this series

Adverse Events Capture Systems, Checklists and Teamwork as Relevant Tools to Reduce Complications and Increase Patients’ Safety in Spinal Surgery

Adverse events in Hospitals are often related to surgery and they represent a relevant problem in healthcare. Different approaches have been introduced during the last decade to address the problem of patient safety, especially in the surgical environment. The teamwork is crucial in all these actions which aim to decrease adverse events and improve clinical outcomes. We analyze in particular the use of adverse events capture systems in spinal surgery and the use of checklist systems, starting from the Surgical Safety Checklist introduced by the World Health Organization (WHO) in 2008

Spinal surgery complications: an unsolved problem—Is the World Health Organization Safety Surgical Checklist an useful tool to reduce them?

Abstract Purpose To investigate whether the World Health Organization Safety Surgical Checklist (SSC) is an effective tool to reduce complications in spinal surgery. Methods We retrospectively evaluated the clinical and radiological charts prospectively collected from patients who underwent a spinal surgery procedure from January 2010 to December 2012. The aim of this study was to compare the incidence of complications between two periods, from January to December 2010 (without checklist) and from January 2011 and December 2012 (with checklist), in order to assess the checklist's effectiveness. Results The sample size was 917 patients with an average of 30-month follow-up. The mean age was 52.88 years. The majority of procedures were performed for oncological diseases (54.4%) and degenerative diseases (39.8%). In total, 159 complications were detected (17.3%). The overall incidence of complications for trauma, infectious pathology, oncology, and degenerative disease was 22.2%, 19.2%, 18.4%, and 15.3%, respectively. No correlation was observed between the type of pathology and the complication incidence. We observed a reduction in the overall incidence of complications following the introduction of the SSC: In 2010 without checklist, the incidence of complications was 24.2%, while in 2011 and 2012, following the checklist introduction, the incidence of complications was 16.7% and 11.7%, respectively (mean 14.2%). Conclusions The SSC seems to be an effective tool to reduce complications in spinal surgery. We propose to extend the use of checklist system also to the preoperative and postoperative phases in order to further reduce the incidence of complications. Graphic abstract These slides can be retrieved under Electronic Supplementary Material

Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma

BACKGROUND: Prognostic assessment in patients with hepatocellular carcinoma (HCC) remains controversial. Using the Italian Liver Cancer (ITA.LI.CA) database as a training set, we sought to develop and validate a new prognostic system for patients with HCC. METHODS AND FINDINGS: Prospective collected databases from Italy (training cohort, n = 3,628; internal validation cohort, n = 1,555) and Taiwan (external validation cohort, n = 2,651) were used to develop the ITA.LI.CA prognostic system. We first defined ITA.LI.CA stages (0, A, B1, B2, B3, C) using only tumor characteristics (largest tumor diameter, number of nodules, intra- and extrahepatic macroscopic vascular invasion, extrahepatic metastases). A parametric multivariable survival model was then used to calculate the relative prognostic value of ITA.LI.CA tumor stage, Eastern Cooperative Oncology Group (ECOG) performance status, Child-Pugh score (CPS), and alpha-fetoprotein (AFP) in predicting individual survival. Based on the model results, an ITA.LI.CA integrated prognostic score (from 0 to 13 points) was constructed, and its prognostic power compared with that of other integrated systems (BCLC, HKLC, MESIAH, CLIP, JIS). Median follow-up was 58 mo for Italian patients (interquartile range, 26-106 mo) and 39 mo for Taiwanese patients (interquartile range, 12-61 mo). The ITA.LI.CA integrated prognostic score showed optimal discrimination and calibration abilities in Italian patients. Observed median survival in the training and internal validation sets was 57 and 61 mo, respectively, in quartile 1 (ITA.LI.CA score 64 1), 43 and 38 mo in quartile 2 (ITA.LI.CA score 2-3), 23 and 23 mo in quartile 3 (ITA.LI.CA score 4-5), and 9 and 8 mo in quartile 4 (ITA.LI.CA score > 5). Observed and predicted median survival in the training and internal validation sets largely coincided. Although observed and predicted survival estimations were significantly lower (log-rank test, p < 0.001) in Italian than in Taiwanese patients, the ITA.LI.CA score maintained very high discrimination and calibration features also in the external validation cohort. The concordance index (C index) of the ITA.LI.CA score in the internal and external validation cohorts was 0.71 and 0.78, respectively. The ITA.LI.CA score's prognostic ability was significantly better (p < 0.001) than that of BCLC stage (respective C indexes of 0.64 and 0.73), CLIP score (0.68 and 0.75), JIS stage (0.67 and 0.70), MESIAH score (0.69 and 0.77), and HKLC stage (0.68 and 0.75). The main limitations of this study are its retrospective nature and the intrinsically significant differences between the Taiwanese and Italian groups. CONCLUSIONS: The ITA.LI.CA prognostic system includes both a tumor staging-stratifying patients with HCC into six main stages (0, A, B1, B2, B3, and C)-and a prognostic score-integrating ITA.LI.CA tumor staging, CPS, ECOG performance status, and AFP. The ITA.LI.CA prognostic system shows a strong ability to predict individual survival in European and Asian populations

How do we estimate survival? External validation of a tool for survival estimation in patients with metastatic bone disease-decision analysis and comparison of three international patient populations

How do we estimate survival? External validation of a tool for survival estimation in patients with metastatic bone disease-decision analysis and comparison of three international patient population

Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients

Background: Switching from IFX originator to CT-P13 is safe; however, little data on immunogenicity exists. Research design and methods: Consecutive IBD patients on IFX originator were switched to CT-P13 and followed-up for 12 months. Clinical activity, infliximab trough levels (ITLs), anti-drug antibodies (ATIs), and adverse events were recorded at predefined timepoints (baseline, second CT-P13 infusion, 6 and 12 months). The outcomes investigated were immunogenicity, pharmacokinetics, effectiveness and safety. Results: 119 patients were switched to CT-P13 after a median time with IFX of 5.8 years. No changes in mean ITLs were observed. ATIs were detected in 30 patients (25.2%): 14 before and 16 after switch. Mean persistent ATIs were significantly higher compared to mean transient ones (109.74 ng/mL ±84.70 vs 18.22 ng/mL ±11.37, p < 0.001), with significantly lower ITLs associated (mean 0.32 µg/mL ±0.6 vs 3.08 µg/mL ±3.22, p < 0.001). A significant decrease of patients in steroid-fee clinical remission was observed after the switch (p = 0.004), with subsequent improvement at 6 months (p = 0.005). Eighteen patients (15.1%) discontinued IFX, only 6 (5%) for loss of response. Conclusions: Switching from infliximab originator to CT-P13 seems safe and effective, without differences in immunogenicity. A temporary reduction of clinical benefit after switching could be potentially explained by a ‘nocebo-effect response’