bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multiple Stent Delivery System “Multi-LOC”: Focal self-expanding nitinol stenting of complex femoropopliteal lesions—A monocenter feasibility pilot study
Authors: Sigl Martin , Jung Johannes , Kölble Heinz , Amendt Klaus 
Published: January 2019

Aims The Multiple Stent Delivery System (VascuFlex® Multi-LOC) is a novel stent delivery system with six short stents (13 mm long each) mounted on one wire-guided catheter, designed for the treatment of femoropopliteal arteries. The aim of the present study is to evaluate the safety and the feasibility of the VascuFlex® “Multi-LOC” stent delivery system, which enables spot stenting without changing the delivery system. Methods and results After proof of concept in a porcine model and after European Conformity marking, first clinical experiences were gathered in 20 patients with severe intermittent claudication or critical limb ischemia. First-in-human data are presented. The study included 20 limbs that underwent femoropopliteal revascularization for claudication (n = 14) or critical limb ischemia (n = 6). “Multi-LOC” provisional spot stenting resulted in acute technical success in all lesions with resolution of flow-limiting dissection and elastic recoil after balloon dilatation of the femoropopliteal artery. There were no device-related complications. Follow-up examinations after 30 to 40 days revealed no major adverse events, and six months’ results were encouraging. Conclusions First clinical use of the novel Multiple Stent Delivery System (Multi-LOC) after balloon dilatation of the femoropopliteal artery was safe and feasible in this early study.
Current Strategies in Prevention of Postoperative Infections in Spine Surgery
Authors: Atesok Kivanc , Papavassiliou Efstathios , Heffernan Michael J. , Tunmire Danny , Sitnikov Irina , Tanaka Nobuhiro , Rajaram Sakthivel , Pittman Jason , Gokaslan Ziya L. , Vaccaro Alexander , Theiss Steven 
Published: January 2019

Study Design: Narrative review. Objectives: Postoperative surgical site infections (SSIs) are among the most common acute complications in spine surgery and have a devastating impact on outcomes. They can lead to increased morbidity and mortality as well as greater economic burden. Hence, preventive strategies to reduce the rate of SSIs after spine surgery have become vitally important. The purpose of this article was to summarize and critically analyze the available evidence related to current strategies in the prevention of SSIs after spine surgery. Methods: A literature search utilizing Medline database was performed. Relevant studies from all the evidence levels have been included. Recommendations to decrease the risk of SSIs have been provided based on the results from studies with the highest level of evidence. Results: SSI prevention occurs at each phase of care including the preoperative, intraoperative, and postoperative periods. Meticulous patient selection, tight glycemic control in diabetics, smoking cessation, and screening/eradication of Staphylococcus aureus are some of the main preoperative patient-related preventive strategies. Currently used intraoperative measures include alcohol-based skin preparation, topical vancomycin powder, and betadine irrigation of the surgical site before closure. Postoperative infection prophylaxis can be performed by administration of silver-impregnated or vacuum dressings, extended intravenous antibiotics, and supplemental oxygen therapy. Conclusions: Although preventive strategies are already in use alone or in combination, further high-level research is required to prove their efficacy in reducing the rate of SSIs in spine surgery before evidence-based standard infection prophylaxis guidelines can be built.
Establishing Clinically Significant Outcomes After Meniscal Allograft Transplantation
Authors: Liu Joseph N. , Gowd Anirudh K. , Redondo Michael L. , Christian David R. , Cabarcas Brandon C. , Yanke Adam B. , Cole Brian J. 
Published: January 2019

Background: Traditionally, the primary outcome in meniscal allograft transplantation (MAT) has been long-term survivorship; however, short-term clinically significant outcomes are necessary to fully evaluate patient improvement after surgery. Purpose: To (1) establish the minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) with respect to patient-reported outcome measures (PROMs) and (2) evaluate preoperative and intraoperative variables correlated with achieving these threshold values. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A prospectively maintained institutional registry was queried for all MATs performed between 1999 and 2017. The following PROM scores were collected: International Knee Documentation Committee (IKDC) score, Lysholm score, and Knee injury and Osteoarthritis Outcome Score (KOOS). Patients who completed preoperative and postoperative PROMs within a 1-month window were included to calculate the distribution-based MCID at this interval. An anchor question regarding satisfaction with surgery was asked at the same time point and was employed to determine the PASS using nonparametric receiver operating characteristic curve/area under the curve analysis. Multivariate regression analysis was performed to correlate patient demographics, medical history, and concomitant procedures to propensity in achieving the MCID and PASS. Results: A total of 98 patients who underwent MAT met the inclusion/exclusion criteria, of whom 10 underwent concomitant ligamentous procedures, 65 underwent concomitant cartilage procedures, and 7 underwent concomitant realignment procedures. The mean patient age was 29.4 ± 9.0 years, and the mean body mass index (BMI) was 26.8 ± 5.2 kg/m2. The distribution-based MCID and PASS were determined for the Lysholm score (12.3 and 66.5) and IKDC (9.9 and 36.0) as well as the KOOS Pain (9.9 and N/A ), Symptoms (9.7 and 73.0), Activities of Daily Living (9.5 and N/A), Sport (13.3 and N/A), and Quality of Life (14.6 and 53.0) subscales, respectively. A preoperative Short Form Physical Component Summary (SF PCS) score greater than 32.0 was predictive of postoperative satisfaction. Patients with work-related claims had a reduced likelihood of achieving the MCID for the IKDC and the PASS for the KOOS Symptoms. An increased BMI was also associated with failing to achieve the PASS for the KOOS Quality of Life (QOL). Conclusion: This study established the MCID and PASS for the Lysholm score, IKDC, and KOOS in patients undergoing MAT. Workers’ compensation and higher BMI were associated with failing to achieve clinically significant values. Lower preoperative Lysholm, IKDC, and KOOS scores were predictive of achieving the MCID, while higher preoperative SF PCS scores were associated with achieving satisfaction after MAT.
Effect of weft yarn twist level on mechanical and sensorial comfort of 100% woven cotton fabrics
Authors: Atalie Desalegn , Ferede Addisu , Rotich Gideon Kipchirchir 
Published: January 2019

AbstractFabric sensory properties are complex concepts which include dimensional changes at small forces such as tensile, shear, compression and bending, surface properties (friction and roughness) plus surface coolness or warmness. The aim of this study was to investigating the effect of weft yarn twist level on sensorial comfort of 100% woven cotton fabrics. Five cotton fabrics were woven with incremental weft yarn twist levels and their tensile and shear strength, pure bending, compression, surface friction and roughness were evaluated using Kawabata Evaluation System and compared. The other sample parameters such as count, thread density and fabric structure were kept constant. Fabric water permeability and its wicking ability were also evaluated. The results showed that as the twist level increased, the fabric tensile, shear and bending properties also increased. This was observed in both the warp and weft direction. At higher level of twist, lower surface friction, less compressibility, less slipperiness (0.264 warp and 0.199 weft direction), rougher surface (0.026 warp and 0.020 weft) and less even surface (2.643 warp and 1.998) were observed. The wicking ability also reduced with the increase in twist level while there was an improvement in water permeability.
Associations between childhood maltreatment and inflammatory markers
Authors: Palmos Alish B. , Watson Stuart , Hughes Tom , Finkelmeyer Andreas , McAllister-Williams R. Hamish , Ferrier Nicol , Anderson Ian M. , Nair Rajesh , Young Allan H. , Strawbridge Rebecca , Cleare Anthony J. , Chung Raymond , Frissa Souci , Goodwin Laura , Hotopf Matthew , Hatch Stephani L. , Wang Hong , Collier David A. , Thuret Sandrine , Breen Gerome , Powell Timothy R. 
Published: January 2019

BackgroundChildhood maltreatment is one of the strongest predictors of adulthood depression and alterations to circulating levels of inflammatory markers is one putative mechanism mediating risk or resilience.AimsTo determine the effects of childhood maltreatment on circulating levels of 41 inflammatory markers in healthy individuals and those with a major depressive disorder (MDD) diagnosis.MethodWe investigated the association of childhood maltreatment with levels of 41 inflammatory markers in two groups, 164 patients with MDD and 301 controls, using multiplex electrochemiluminescence methods applied to blood serum.ResultsChildhood maltreatment was not associated with altered inflammatory markers in either group after multiple testing correction. Body mass index (BMI) exerted strong effects on interleukin-6 and C-reactive protein levels in those with MDD.ConclusionsChildhood maltreatment did not exert effects on inflammatory marker levels in either the participants with MDD or the control group in our study. Our results instead highlight the more pertinent influence of BMI.Declaration of interestD.A.C. and H.W. work for Eli Lilly Inc. R.N. has received speaker fees from Sunovion, Jansen and Lundbeck. G.B. has received consultancy fees and funding from Eli Lilly. R.H.M.-W. has received consultancy fees or has a financial relationship with AstraZeneca, Bristol-Myers Squibb, Cyberonics, Eli Lilly, Ferrer, Janssen-Cilag, Lundbeck, MyTomorrows, Otsuka, Pfizer, Pulse, Roche, Servier, SPIMACO and Sunovian. I.M.A. has received consultancy fees or has a financial relationship with Alkermes, Lundbeck, Lundbeck/Otsuka, and Servier. S.W. has sat on an advisory board for Sunovion, Allergan and has received speaker fees from Astra Zeneca. A.H.Y. has received honoraria for speaking from Astra Zeneca, Lundbeck, Eli Lilly, Sunovion; honoraria for consulting from Allergan, Livanova and Lundbeck, Sunovion, Janssen; and research grant support from Janssen. A.J.C. has received honoraria for speaking from Astra Zeneca, honoraria for consulting with Allergan, Livanova and Lundbeck and research grant support from Lundbeck.
Robotic versus laparoscopic gastrectomy for gastric adenocarcinoma: Propensity matched analysis of the National Cancer Database.
Authors: Ryan Sean , Murphy Amy , Tameron Ashley , Hussain Lala , Teng Annabelle , Dunki-Jacobs Erik M. , Lee David Y 
Published: January 2019

104 Background: The use of robotic technology in gastrointestinal surgical oncology is on the rise. We compared the outcomes of laparoscopic (LG) and robotic gastrectomies (RG) performed for gastric adenocarcinoma (GA) in the National Cancer Database (NCDB). Methods: The NCDB database was queried for patients ≥ 18 years old with stage I-III GA who underwent LG or RG. Propensity matching was performed between the two groups with regards to clinical staging, adjuvant treatment, demographics, and the extent of surgery. Results: A cohort of 1893 (1262-LG, 631-RG) patients was identified in a 2:1 propensity matching. Demographics and co-morbidities were similar between the groups. The clinical staging and the extent of the surgery were well matched. The rate of negative margin as well 30 and 90-day mortality was similar between the two cohorts. Outcomes with respect to readmission and length of stay were also similar (Table 1). Long-term survival was not significantly different between the two cohorts, with a median survival of 49 months for LG cohort and 56.1 months in the RG cohort (p=0.405). Also, lymph node (LN) positivity was similar between the two groups (40.1 % 42.8%, p= 0.278) However, the average number of LN sampled was significantly higher in the RA group compared to the LA group (19.6 vs 17.4, p<0.001). Similarly, the percentage of surgeries in which ≥ 15 LNs were sampled was also greater in the RG group compared to the LG group (63.9% vs 57.6%, p=0.010). Conclusions: Greater number of patients in the RG group achieved NCCN guideline of harvesting ≥ 15 lymph nodes for more accurate staging. RG may allow a greater harvest of lymph nodes without increasing short term adverse outcomes compared to LG. Long term outcomes in this well matched cohort appears comparable for both approaches.
Radiation dose to the thoracic vertebral bodies and impact on hematologic toxicity in patients receiving concurrent chemoradiation for esophageal cancer.
Authors: Fabian Denise , DiCostanzo Dominic J. , Barney Christian , Aljabban Jihad , Wuthrick Evan John , Williams Terence Marques , Bazan Jose G. 
Published: January 2019

105 Background: Concurrent chemotherapy and radiation (CRT) for the treatment of esophageal cancer (EC) is associated with acute hematologic toxicity (HT). There are few data evaluating the relationship between radiation dose (RT) to the thoracic vertebral bodies (TVB) and the development of HT in EC patients receiving CRT. We hypothesized that increasing RT to the TVB contributes to the development of HT in EC patients receiving CRT. Methods: We identified cases of EC treated with curative intent CRT from 2007-2016. We retrospectively contoured the thoracic vertebral bodies (TVB). The TVB-mean dose and the TVB V5-V50 were calculated from the dose volume histogram. HT was graded according to the Common Terminology Criteria for Adverse Events, v4 based on leukocyte, neutrophil, and platelet nadirs during CRT. Grade≥3 HT (HT3+) was the primary endpoint. Logistic regression was used to test associations between HT3+ and dosimetric/clinical parameters. Results: We included 137 cases: 115 males (84%); median age 61 years (Interquartile range [IQR], 55-67); predominantly stage III (54%). Most patients received concurrent carboplatin/paclitaxel (N = 83). Median RT dose was 50.4 (IQR = 50.4-50.4) Gy, and the majority underwent surgery (60.6%). The rate of HT3+ was 39.4% (N = 54) at a median of 28 (IQR = 21-32) days after CRT start. On univariate analysis, a 5% increase in TVB-V40 was associated with increased odds of HT3+ (OR = 1.13, 95% CI 1.04-1.23, p = 0.0004). TVB-mean and TVB V30-V50, age (OR = 1.04, p = 0.03), males (OR = 0.38, p = 0.04), and carboplatin/paclitaxel vs. other regimen (OR = 2.66, p = 0.01) were significantly associated with HT3+, while BMI was not (OR = 1.00, p = 0.94). On multivariate analysis, TVB-V40 (OR = 1.20, p = 0.0004), carboplatin/paclitaxel (OR = 4.84, p = 0.0007), and age (OR = 1.04, p = 0.03) were independently associated with HT3+ while male gender (OR = 0.48, p = 0.16) was not. The results were similar for TVB-mean and TVB V30-V50. Conclusions: We found that increasing TVB dose was associated with HT3+ in EC patients treated with CRT. This suggests that efforts to spare RT to the TVB may reduce rates of HT3+ and prospective evaluation of these results is needed.
Prognostic impact of splenic hilar lymph node metastasis in proximal gastric carcinoma: A retrospective analysis of 665 patients treated with D2 total gastrectomy.
Authors: Jeong Oh , Park Young-Kyu , Ryu Seong Yeob 
Published: January 2019

11 Background: Standard D2 lymph node (LN) dissection for proximal gastric carcinoma includes removing splenic hilar LNs. However, patients with splenic hilar LN metastasis often show a poor prognosis even after curative surgery. This study aimed to investigate the prognostic impact of splenic hilar LN metastasis in proximal gastric carcinoma. Methods: We reviewed prospectively constructed data of 665 patients who underwent total gastrectomy with D2 LN dissection for proximal gastric carcinoma. Clinicopathological features and survivals were compared between patients with and without splenic hilar LN metastasis. The prognostic value of splenic hilar LN metastasis was examined using a multivariate Cox prognostic model. Results: Of 665 patients, 63 (9.5%) with stage III or IV disease had splenic hilar LN metastasis. Splenic hilar LN metastasis was associated with a larger tumor size, B4 gross type, undifferentiated histology, and lymphovascular invasion. The 5-year survival of patients with splenic hilar LN metastasis was significantly worse at each tumor stage (stage III = 45% vs. 66%, p = 0.044, stage IV = 12% vs. 32%, p = 0.017). The 5-year survival of patients with splenic hilar LN metastasis did not significantly differ from that of the distant metastasis group (26% vs. 31%, p = 0.484). Multivariate analysis revealed that splenic hilar LN metastasis is an independent poor prognostic factor when adjusting for tumor node metastasis stage and other prognostic factors. Conclusions: Patients with splenic hilar LN metastasis show a poor prognosis after surgery. More intensive adjuvant treatment and postoperative surveillance will be required for patients with splenic hilar LN metastasis.
Randomized phase II study to compare docetaxel plus S-1 with cisplatin plus S-1 in advanced gastric cancer without measurable lesions (HERBIS-3).
Authors: Matsuyama Jin , Kurokawa Yukinori , Nishikawa Kazuhiro , Kimura Yutaka , Takeno Atsushi , Kawada Junji , Kawabata Ryohei , Makari Youichi , Tamura Shigeyuki , Doki Yuichiro , Sakai Daisuke , Shimokawa Toshio , Satoh Taroh 
Published: January 2019

119 Background: Cisplatin and S-1 (CS) regimen is one of the standard chemotherapy as first-line for advanced gastric cancer. Docetaxel is a well-known agent with high anti-tumor effect for peritoneal metastasis from gastric cancer. A previous phase III study showed docetaxel plus S-1 (DS) regimen was recommended especially for advanced gastric cancer without measurable lesions. However, there was no study comparing the efficacy and safety of these two regimens. Methods: Eligibility criteria included HER2-negative unresectable or recurrent gastric adenocarcinoma, no measurable lesion according to RECIST v1.1, no massive peritoneal metastasis, no prior chemotherapy or radiotherapy, age ≤75, PS 0-2, adequate oral intake, and preserved organ functions. Patients were randomized to receive CS (cisplatin 60 mg/m² on day 8, S-1 40–60 mg twice a day for 3 weeks, every 5 weeks) or DS (docetaxel 40 mg/m² on day 1, S-1 40–60 mg twice a day for 2 weeks, every 3 weeks). Primary endpoint was overall survival (OS), and secondary endpoints were progression-free survival (PFS) and adverse events. Results: Sixty-one patients were randomly allocated the CS group (n = 31) or the DS group (n = 30) between Aug 2011 and Sep 2015. All were unresectable primary cases, and baseline characteristics were well balanced between the two groups. One patient was ineligible due to HER2-positive. There was no treatment-related death. The main grade 3 or worse adverse events were neutropenia (27% in CS vs. 40% in DS), anemia (10% in CS vs. 10% in DS), fatigue (13% in CS vs. 7% in DS), anorexia (10% in CS vs. 3% in DS), and diarrhea (10% in CS vs. 3% in DS). The median OS time were 15.8 months in CS and 20.0 months in DS, respectively (log-rank P = 0.113). Hazard ratio for OS was 0.617 (95%CI, 0.337 – 1.128). The median PFS time were 9.6 months in CS and 11.2 months in DS, respectively (log-rank P = 0.196). Hazard ratio for PFS was 0.698 (95%CI, 0.404 – 1.208). Conclusions: DS showed less toxic and more active profiles than CS for treatment of advanced gastric cancer without measurable lesions. The clinical benefit of DS regimen should be demonstrated in a phase III study. Clinical trial information: UMIN000006179.
Retrospective observational study of salvage line ramucirumab monotherapy (RAM) for patients (pts) with unresectable advanced gastric cancer (AGC) which was refractory to fluoropyrimidine and taxanes.
Authors: Fukuda Naoki , Kawai Sadayuki , Omae Katsuhiro , Mitani Seiichiro , Wakatsuki Takeru , Kato Ken , Kadowaki Shigenori , Takahari Daisuke , Boku Narikazu , Muro Kei , Machida Nozomu 
Published: January 2019

129 Background: RAM showed a survival benefit over best supportive care in second-line treatment after failure of fluoropyrimidine-containing chemotherapy for pts with advanced gastric or gastro-esophageal junction adenocarcinoma (AGC). In clinical practice, RAM is used for some pts who have disease refractory to fluoropyrimidine and taxanes in salvage line setting. Methods: We retrospectively evaluated efficacy and safety of RAM in salvage lines between June 2015 and April 2017 for AGC at four Japanese institutions. All pts received 2 or more prior regimens containing fluoropyrimidine and taxanes, but not ramucirumab. We also explored prognostic factors for progression free survival (PFS) and overall survival (OS). Results: Fifty-one pts were collected. Pts' characteristics were as follows; median age: 67 (range 39-84) years; ECOG performance status ≤ 1: 43 (84%) pts; HER2 positive: 17 (33%) pts; number of metastatic sites ≥ 2: 29 (57%); number of prior therapies 2/3/4/5: 7(14%)/25(49%)/12(24%)/7(14%) pts. Median PFS and OS were 1.9 (95% confidence interval [CI]: 1.6-2.2) and 5.1 (95% CI: 4.1-6.8) months, respectively. Twelve-week PFS rate was 25.5%. Objective response rate in 43 pts who had measurable disease was 2%. Disease control rate was 35%. Grade 3 adverse events (AEs) occurred in 7 (13%) pts such as anemia in 2 (4%), fatigue in 1 (2%), hypertension in 2 (4%), proteinuria in 2 (4%), intestinal bleeding in 1 (2%), and others in 2 (4%) pts. No grade 4 AEs and treatment related deaths were observed. Although multivariate analyses suggested that absence of primary tumor and neutrophil lymphocyte ratio < 2.5 at baseline were associated with better PFS, while statistically significant prognostic factors for OS were not identified in this study. Conclusions: Salvage line RAM showed acceptable toxicities and comparable efficacy with those reported in previous studies of second-line setting. It is suggested that RAM could be considered for salvage line treatment after fluoropyrimidine and taxanes containing regimens.