PICC management led by technicians: Establishment of a cooperation program with radiologists and evaluation of complications

PurposeThe purpose of this study was to evaluate a cooperation program in order to compare incidence of complications after peripherally inserted central catheter (PICC) placement between radiologists and technicians.Materials and methodsPICC placement technique was standardized with ultrasound-guided puncture and fluoroscopic guidance. Numbers of PICC delegated to technicians, and PICC placement difficulties, were prospectively recorded for the whole study population whereas complications such as PICC infection, deep venous thrombosis and catheter occlusion were prospectively recorded until PICC removal for a subgroup of patients included during one month.ResultsA total of 722 patients had PICC placement. There were 382 men and 340 women with a mean age of 66.8 ± 15.8 (SD) years (range: 18–94 years); of these, 442/722 patients (61.22%) were included in the cooperation program with 433/722 patients (59.97%) who effectively had PICC placement by technicians and 289/722 (40.03%) by radiologists. Technicians needed radiologists’ help for 23/442 patients (5.20%) including 6 failed PICC placement subsequently performed by radiologists. Twenty complications (20/77; 26%) were recorded in the subgroup of 77 patients studied for complications. No differences in complications rate were found between the 33 patients who underwent PICC placement by radiologists (6/33; 18%) and the 44 patients who underwent PICC placement by technicians (14/44; 32%) (P = 0.296). Complications included 8 PICC-related infections (8/77; 10.4%), 3 deep venous thromboses (3/77; 3.9%) and 9 catheter occlusions (9/77; 11.7%).ConclusionPICC placement led by technicians is feasible and safe without statistical difference in terms of complications compared to PICC placement made by radiologists.     

Sequential inferior vena cava filter insertion and peripherally inserted central catheter placement through upper extremity veins

PurposeTo report the sequential placement of inferior vena cava filter (IVCF) and peripherally inserted central catheter (PICC) using the same upper extremity venous access.Material and methodsThis is a retrospective study that reviewed the medical records of 379 consecutive patients who underwent IVCF insertion during a 39-month period at our center. Of these 379 patients, 28 patients had sequential insertion of an IVCF and a PICC through the same upper extremity venous access. The same vein entry site was used for placement of the IVCF followed by PICC insertion. Data collected included: indication and duration of IVCF and PICC placement, access site location, complications, and the type of IVCF.ResultsIVCFs were placed for prophylactic purposes in 15 patients (53.6%) and therapeutic purposes in 13 patients (46.4%). Right upper extremity veins were used for venous access in 27 patients (96.4%): brachial (n = 16), basilic (n = 9), and cephalic (n = 2). The left basilic vein was used in one patient (3.6%). IVCFs were temporary in 20 patients (71.4%) and permanent in 8 patients (28.6%). There were no procedural complications. The OptEase filter was used in 23 patients (82.1%) and the TrapEase filter was used in 5 patients (17.9%).ConclusionSimultaneous IVCF and PICC insertion using the same upper extremity venous access was feasible and safe in our series. This combined technique provides the patient with central venous access for repeated blood collections and intravenous therapy.     

Introduction of the use of a pediatric PICC line in a French University Hospital: Review of the first 91 procedures

PurposeIn order to assess the establishment of a pediatric PICC line service in a University Hospital after the first 91 consecutive procedures.Materials/Patients and methodsRetrospective study over a period of 24 months. The criteria analysed were success or failure of the procedure, indication, age when inserted, type of PICC line, mean length of use and development of complications such as accidental removal, venous thrombosis or infection.ResultsNinety-one PICC lines were inserted in 74 patients between 4 months and 25 years old (sex-ratio: 1.1 girls/boys). The procedure was performed under general anaesthesia in four cases (4.4%) and under EMLA and MEOPA in 87 cases (95.6%). The insertion was ultrasound guided through the basilic (n = 63, 70%), humeral (n = 18, 20%) or cephalic (n = 9, 10%) veins in the non-dominant arm (L in 62 cases, R in 28 cases). The insertion success rate was 99% (n = 90). The main indications were starting antibiotic therapy (n = 47, 52%), chemotherapy (n = 34, 38%) and parenteral nutrition (n = 5, 5%). The devices used were single lumen 3F (n = 4, 4%), single lumen 4F (n = 31, 34%), double lumen 4F (n = 2, 2.2%), single lumen 5F (n = 12, 13%), and double lumen 5F (n = 41, 45%). The PICC line was used for an average period of 45 days (14 to 300 days). The complications found were accidental removal (n = 2, 2.2%), catheter fracture (n = 2; 2.2%), obstruction (n = 5, 5.5%), suspected infection (n = 1, 1.1%), and venous thrombosis and pulmonary embolism (n = 3, 3.3%). The overall complication rate was 14.4% (n = 13) including 4.4% serious complications (n = 4).ConclusionPICC lines are a future solution in pediatrics. This technique is reliable and has a similar complication rate to studies carried out in adults, most of which can be prevented by careful catheter maintenance and informing the care staff.     

The incidence of coagulopathy in pregnant patients with intrahepatic cholestasis: should we delay or avoid neuraxial analgesia?

Study ObjectiveTo estimate the incidence of coagulopathy in patients with intrahepatic cholestasis inhepatic cholestasis of pregnancy (ICP).DesignRetrospective cohort investigation.SettingUniversity medical center.MeasurementsThe records of 319 parturients who met study inclusion criteria were reviewed for various laboratory values. The primary outcome was the incidence of abnormal hemostasis, defined as prothrombin time (PT) greater than 14.5 seconds (INR > 1.2). The incidence of postpartum hemorrhage was evaluated as a secondary outcome.Main ResultsThe incidence (95% CI) of abnormal PT was 0% (0 to 1.8). Other coagulation tests [partial thromboplastin time (PTT) and platelet count] were also normal, even in study subjects with significant (> 5 times) elevation of liver enzymes. The incidence of postpartum hemorrhage after vaginal delivery was 2.4% (4 of 208 pts) and 6.3% (7 of 111 pts) after Cesarean delivery.ConclusionsCoagulation abnormalities are rare in pregnant patients with ICP, even when a strict criterion is utilized (INR < 1.2). The use of neuraxial anesthesia and/or analgesia may not necessarily be delayed in parturients with isolated ICP.     

Regional citrate anticoagulation for continuous renal replacement therapy in severe burns—A retrospective analysis of a protocol-guided approach

IntroductionFor critically ill patients, the use of regional citrate anticoagulation as part of continuous renal replacement therapy (CRRT) has become increasingly common in recent years. However, there are scarce data on the use of this technique in patients with burns. The aim of this study was to examine the effectiveness, feasibility and complications of regional citrate anticoagulation for CRRT in burn patients, as well as the effects on coagulation and the electrolyte and acid–base balance.MethodsThis retrospective study included all patients who received renal replacement therapy with citrate anticoagulation to treat acute kidney injury (AKI) between January 1, 2004 and December 31, 2009 at the burn unit of St. Georg Hospital GmbH in Leipzig.ResultsDuring the examination period, 18 patients were treated using CRRT with regional citrate anticoagulation (CVVHDF in the pre-dilution mode). The median patient age was 64 years (49.5; 71), with a median TBSA of 42.5% (33.25; 52.5) and a median ABSI score of 10 (9; 10). The CRRT was initiated on a median of 6 days (4; 8.75) after admission to the hospital and continued for a median duration of 7 days (5; 8). The median dialysis dose was 38.2 ml kg BW⁻¹ h⁻¹ (31.8; 42.1). The median effective filter operation time was 67 h (46; 72). No relevant disorders associated with acid–base balance, electrolytes or coagulation occurred, and there were no bleeding complications.ConclusionIn terms of bleeding risk and electrolyte and acid–base balance, regional citrate anticoagulation may be considered to be an effective, safe and user-friendly procedure for patients with severe burns and AKI.     

Omitting pre-operative coagulation screening tests in hip fracture patients: Stopping the financial cascade?

BackgroundCoagulation screening continues as a standard of care in many hip fracture pathways despite the 2011 guidelines from the Association of Anaesthetists of Great Britain and Ireland (AAGBI) which recommend that such screening be performed only if clinically indicated. This study aims to evaluate the use of pre-operative coagulation screening and explore its financial impact.MethodsProspective data was collected in accordance with the “Standardised Audit of Hip Fractures in Europe” (SAHFE) protocol. All patients admitted to our hospital with hip fractures during a 12-month period from November 2011 to November 2012 were analysed. Data including coagulation results and the use of vitamin K or blood products were collected retrospectively from the hospital computer system. Patient subgroup analysis was performed for intraoperative blood loss, post-operative blood units transfused, haematoma formation and gastrointestinal haemorrhage.Results814 hip fractures were analysed. 91.4% (n = 744) had coagulation tests performed and 22.0% (n = 164) had an abnormal result. Of these, 55 patients were taking warfarin leaving 109 patients who had abnormal results and were not taking warfarin. When this group (n = 109) was compared to those who had normal test results (n = 580) and to all other patients (n = 705) there was no difference in intraoperative blood loss (p = 0.79, 0.78), postoperative transfusion (p = 0.38, 0.30), postoperative haematoma formation (p = 0.79, 1.00), or gastrointestinal haemorrhage (p = 0.45, 1.00), respectively. In those who were not taking warfarin, but had abnormal results, none had treatment to reverse their coagulopathy with either vitamin K or blood products. By omitting pre-operative coagulation tests in patients who are not taking warfarin, we estimate a financial saving of between £66,500 and £432,250 per annum.ConclusionsThis study supports the hypothesis that routine pre-operative coagulation screening is unnecessary in hip fracture patients unless they take warfarin or have a known coagulopathy. Moreover, its omission represents significant cost-saving potential.     

Fractura de cadera,antiagregantes plaquetarios y complicaciones postoperatorias

ObjectivesTo assess the incidence of postoperative complications, blood transfusions and survival at one month, in the old patients operated for hip fracture undergoing chronic treatment with antiplatelet drugs.Material and methodsTwo hundred twenty three patients operated for hip fracture were studied retrospectively, separated into 3 groups: patients who received acetylsalicylic acid (group I), patients who were given 100 mg/day of acetylsalicylic acid or 300 mg/day of triflusal (group II) and patients receiving > 100 mg/day of acetylsalicylic acid, or > 300 mg/day of triflusal or thienopyridines (group III). Surgery was delayed for 4 days in patients in group III. Demographic, biological, clinical and treatment characteristics, postoperative complications and survival at one month were recorded.ResultsPatients in group III were older and sustain worse general health status. Patients with a higher transfusion requirement were those of group II (73.8%) (P=0.192), who also showed a higher percentage of anaemia on admission. Severe cardiovascular complications were experienced by 5.4% of group III patients, 4.8% of group II patients and 2.1% of group I patients. Patients from group III presented a significant amount of respiratory complications (P=0.007).ConclusionsOur results suggest that delaying surgery for 4 days in patients treated with clopidogrel can be associated to an increase in postoperative respiratory complications and severe adverse cardiovascular events, without increasing the tranfusional index, hospital stay, mortality, and without complications related to neuraxial anaesthesia.     

Complications of long and intermediate term venous catheters in cystic fibrosis patients: A multicenter study

Background

Totally implantable venous access devices (TIVADs) or peripherally inserted central venous catheters (PICCs) are commonly used in the care of patients with cystic fibrosis (CF), but they are associated with various complications, including thrombosis, infection, and insertion site symptoms.

Clinical and Angiographic Follow-up of Spontaneous Isolated Superior Mesenteric Artery Dissection

ObjectivesTo observe the clinical features and angiographic findings in patients with a spontaneous isolated superior mesenteric artery dissection (SISMAD) and to identify any correlation between them.MethodsFrom a single institution, 32 patients (22 symptomatic patients at presentation; mean age 54 years; men 97%) with SISMAD were retrospectively reviewed. All patients were available for clinical follow-up after treatment (conservative, n = 28, 88%, open or endovascular superior mesenteric artery (SMA) reconstruction, n = 4, 12%), and follow-up CT scans were available in 28 patients (mean 22 months, range 1–80 months).ResultsWe found a positive correlation between pain severity and dissection length (p = 0.03, ρ = 0.50, Spearman's partial correlation analysis). After conservative treatment, only one patient (3%) required bowel resection, and there was no difference in outcome between patients who were treated with anticoagulation or anti-platelet therapy and those who were not (p = 1.00, Fisher's exact test). No patients had progression of their lesion on the follow-up CT angiography.ConclusionsIn SISMAD patients, dissection length is positively associated with more severe clinical symptoms. After conservative treatment, we observed a benign clinical course and no CT progression of the dissection, even without anticoagulation or anti-platelet therapy. Based on our observation, patients with SISMAD can be treated conservatively without anticoagulation therapy.     

The older they are the harder they fall: Injury patterns and outcomes by age after ground level falls

BackgroundTrauma centers are seeing an increasing number of geriatric patients that are more susceptible to injuries even from relatively minor insults such as a ground level fall (GLF). As life expectancy increases, people are living in the geriatric age bracket for decades and often use anticoagulation agents for various comorbidities. We hypothesize that this patient population is not homogenous and we investigated the injury patterns and outcomes after GLF as a function of age and anticoagulation use. We also sought to identify injury patterns and patient characteristics of GLF patients.MethodsA retrospective review of a Level I trauma center’s database identified all adult (age > 18) trauma patients admitted after GLFs between 1/2003 and 12/2013. Demographics, injury patterns, antiplatelet use, anticoagulation use (including warfarin, enoxaparin, and rivaroxaban) and outcomes were abstracted.ResultsThe cohort included 5088 patients. 3990 patients were >60 years and 38.2% were male. With each decade, although the mean ISS did not considerably change (range 7.0–8.6), mortality increased (0.9% at <60 years vs. 5.5% at >90 years), and the likelihood of home discharge decreased dramatically (73.7% at <60 years vs. 18.2% at >90 years). Abdominal solid organ injuries were rare (0.8%). Age was associated with an increased incidence of cervical spine (p = 0.002), rib (p = 0.009) and pelvic fractures (p < 0.001). Only aspirin use was significantly associated with intracranial bleed (p = 0.001). Aspirin (p = 0.049) or warfarin (p < 0.001) use was associated with increased overall mortality.ConclusionGLF patients are not homogenous as certain injury patterns change with increasing age. Aspirin use was associated with an increased incidence of intracranial bleeds, whereas other antiplatelet or anticoagulation agents were not. GLF is also associated with significant morbidity and mortality that increases dramatically with age. Both aspirin and warfarin are independently associated with increased mortality. These patient differences have implications for their evaluation and management.Level of evidenceEpidemiological/prognostic study level IV.     

Central venous occlusion in hemodialysis access: Comparison between percutaneous transluminal angioplasty alone and nitinol or stainless-steel stent placement

PurposeThe purpose of this study was to compare the primary and secondary patency rates of percutaneous transluminal angioplasty (PTA) alone with those of metallic stent placement in patients with hemodialysis access and central venous occlusion (CVO) and to compare the respective effects of nitinol and stainless-steel stents on patency.Materıals and methodsA total of 150 consecutive patients with hemodialysis access who underwent endovascular treatment for symptomatic CVO with ipsilateral functioning hemodialysis access were evaluated. There were 67 men and 83 women with a mean age of 56.2 ± 15.2 (SD) years (range: 15–86 years). The primary endovascular treatment of CVO was PTA alone. Stent placement either with nitinol or stainless-steel stents was performed as a bailout procedure. The results were analyzed on a per patient basis.ResultsTechnical success was achieved in 141/150 patients (94%). Of the 141 patients, 109 (77%) underwent PTA alone and 32 (23%) underwent stent placement. The mean number of interventions in the stent group [4.3 ± 2.5 (SD)] was significantly higher than that in the PTA alone group [2.6 ± 2.8 (SD)] (P = 0.002). The primary patency rates at 12, 24, and 60 months for the stent group (58.7%, 41.9%, and 27.9%, respectively) were significantly higher than those in the PTA alone group (42.4%, 36.3%, and 20.2%, respectively) (P = 0.036). Secondary patency rates at 12, 24, and 60 months for the stent group (87.6%, 80.7%, and 50.3%, respectively) were significantly greater than those in the PTA alone group (68.4%, 56%, and 38.6%, respectively) (P = 0.046). Furthermore, the primary patency rates at 6 and 12 months in the nitinol stent group (89% and 80.9%, respectively) were significantly greater than those in the stainless-steel stent group (78.8% and 38.4%, respectively) (P = 0.007). The secondary patency rates at 6, 12 and 24 months for the nitinol stent group (92.8%, 87.7% and 65.8%, respectively) were significantly greater than those in the stainless-steel stent group (85.7%, 76.2% and 65.3%, respectively) (P = 0.011).ConclusıonAlthough PTA alone is an effective interventional treatment strategy of CVO in short term, stent placement yields greater primary and secondary patency rates in the long-term. But the mean number of interventions per vein after stenting is significantly higher. Close follow-up and multiple re-interventions are necessary to ensure long-term patency.     

Safety of rituximab in rheumatoid arthritis patients with a history of severe or recurrent bacterial infection: Observational study of 30 cases in everyday practice

ObjectivesTo report our experience with rituximab therapy in patients with rheumatoid arthritis (RA) and a history of severe or recurrent bacterial infections.Patients and methodsRetrospective observational study in five rheumatology departments experienced in the use of biotherapies. Patients were included if they had RA and a history of severe or recurrent bacterial infection (requiring admission and/or intravenous antimicrobial therapy) that contraindicated the introduction or continuation of TNFα antagonist therapy.ResultsOf 161 RA patients given rituximab in the five study centers, 30 met the inclusion criteria, 23 females and seven males with a mean age of 58.4 ± 11.8 years and a mean disease duration of 11.4 ± 13.9 years. Among them, 22 had rheumatoid factors and 21 had received TNFα antagonist therapy (one agent in 15 patients, two in five patients and three in one patient). Prior infections were as follows: septicemia, n = 2; lower respiratory tract infection or lung abscess, n = 12; prosthesis infection, n = 3; septic arthritis, n = 3; endocarditis, n = 1; pyelonephritis, n = 2; osteitis, n = 4; and various skin infections (erysipelas, cellulitis or skin abscess), n = 6. Of these 33 infections, 21 occurred during TNFα antagonist therapy. During rituximab therapy, all patients received concomitant glucocorticoid therapy (mean dosage, 12 ± 7.9 mg/day). The number of rituximab cycles was one in 13 patients, two in seven patients and three or more in 10 patients. Mean time from the single or last serious infection and the first rituximab infusion was 20.1 ± 18.7 months. Mean follow-up since the first rituximab infusion was 19.3 ± 7.4 months. During follow-up, six (20%) patients experienced one infection each. Immunoglobulin levels after rituximab therapy were within the normal range.ConclusionRituximab therapy was well tolerated in 24 (80%) of 30 patients with RA and a history of severe or recurrent bacterial infection. In everyday practice, rituximab therapy seems safe with regard to the recurrence of infectious episodes. However, longer follow-ups are needed.     

Evaluación de la higiene del sueño y la prevalencia de sus alteraciones en los pacientes con enuresis monosintomática. Utilidad del cuestionario BEARS

ObjectivesTo analyze if there is a higher prevalence of sleep disturbances and hygiene disorders in patients with monosymptomatic enuresis (MEN) with respect to general population and to patients with corrected MEN. Assess the usefulness of the BEARS sleep disorder screening tool for children with MEN.Material and methodsTransverse observational study (n = 341) classified as: MEN (n = 122), corrected MEN (≥ 1 one year without recurrence) (ANTENUR) (n = 47) and controls (n = 172). The BEARS childhood sleep disorder screening questionnaire was used. Clinical variables were collected, as well as variables related to sleep hygiene. Statistics: Chi-square, Student's t, ANOVA, Mann-Whitney U and Kruskal-Wallis. Significance p< .05.ResultsMean age 9.7 ± 3.0 years. There were no statistically significant differences in terms of age, sex, BMI, history of tonsillectomy, asthma and sleep time hours. With respect to sleep hygiene, patients with MEN presented a higher percentage of alterations than controls. As for the BEARS questionnaire, it showed a higher prevalence of sleep disorders in the group of patients with MEN, with respect to the other two groups: 60.7% (n = 74) versus 18.6% (n = 32) and 38.3% (n = 18) of controls and ANTENUR, respectively (p< .05).ConclusionsChildren with MEN had a higher prevalence of sleep disturbances and sleep disorders than controls. The BEARS questionnaire is a useful clinical tool in the detection of sleep disorders in children.     

Epidural hemostasis by autologous fat graft in minimally invasive surgery for lumbar spinal stenosis: In vivo experimental study

BackgroundEpidural hemostasis needs to use small, adapted material in minimally invasive surgery, including bilateral decompression via a unilateral approach for lumbar spinal stenosis. Most surgeons avoid external material for hemostasis because of possible neural tissue damage or complications. We compared epidural hemostasis in minimally invasive surgery by fat graft versus gelatin sponge.MethodsThe design was a prospective randomized controlled in-vivo human experimental study. The 24 levels operated on for lumbar spinal stenosis were evaluated in two groups: Group A (control group: gelatin sponge) and Group B (experimental group: fat graft). International Normalized Ratio and Prothrombin Time were assessed preoperatively. Number of cotton hemostats and systolic and diastolic blood pressure were assessed intraoperatively. Epidural hemorrhage area, spinal cord size and ratio of epidural hemorrhage area to spinal cord size were evaluated on early postoperative lumbar MRI.ResultsMean epidural hemorrhage area in groups A and B was respectively 1.3 ± 0.5 and 1.2 ± 0.6 cm², and mean spinal cord size 1.2 ± 0.6 and 1.8 ± 0.6 cm² on early postoperative axial lumbar MRI. The two groups did not significantly differ in ratio of epidural hemorrhage/spinal cord size or number of intraoperative hemostats (P = 0.36, and P = 0.71).ConclusionsThe autologous fat graft ensured sufficient and safe epidural hemostasis without serious adverse events in minimally invasive spinal surgery, and is preferable as autologous tissue is easily and quickly harvested. The surgeon feels safe with this technique and does not need external hemostatic agents.     

Preemptive therapy for cytomegalovirus based on real-time measurement of viral load in liver transplant recipients

BackgroundReal-time PCR has emerged as the preferred diagnostic assay for CMV. However, its utility as a preemptive therapy tool for CMV disease and related outcomes in liver transplant recipients has not been fully defined.MethodsPatients comprised 117 consecutive liver transplant recipients who underwent CMV surveillance monitoring using real-time PCR. Preemptive therapy with valganciclovir was employed upon detection of viremia. Baseline viral load was considered high based on log values (median).ResultsCMV viremia developed in 54% (63/117) of the patients, including 77% of R−/D+, 63% of R+/D+, 43% of R+/D−, and 10% of R−/D− patients. Overall, 23% (15/63) of the patients had recurrent viremia; R− serostatus (p = 0.065) but not initial viral load correlated with recurrent viremia (p = 0.80). At 12 months post-transplant, CMV disease occurred in 0.85% (1/117) of the patients (R+/D + recipient). None (0/30) of the R−/D + patients had CMV disease. Patients with CMV viremia treated preemptively did not differ significantly from those who never developed CMV viremia with regards to bacterial or fungal infections, rejection, graft loss, mortality rate, and probability of survival at 12 months (p > 0.05 for all variables). The above outcomes also did not differ for patients with high (> 1.9 logs) vs. low viral load (< 1.9 logs) (p > 0.05 for all outcomes).ConclusionsPreemptive therapy guided by real-time PCR based monitoring led to outcomes in all patients or in those with high viral loads that were comparable to outcomes in patients who never developed viremia or had low viral loads, respectively. Late-onset CMV disease at 12 months was observed in < 1% of all patients.     

Predictors of disease flare after discontinuation of concomitant methotrexate in Japanese patients with rheumatoid arthritis treated with tocilizumab

ObjectiveTo investigate predictors of disease flare after methotrexate discontinuation in Japanese rheumatoid arthritis (RA) patients with sustained low disease activity undergoing tocilizumab plus methotrexate combination therapy.MethodsParticipants of this multicenter, open-label, uncontrolled, prospective study were RA patients maintaining low disease activity (Clinical Disease Activity Index [CDAI] ≤ 10) for ≥ 12 weeks with tocilizumab plus methotrexate. Methotrexate was discontinued after 12 weeks of biweekly administration while continuing tocilizumab therapy. Disease flare was defined as either a CDAI score > 10 or intervention with rescue treatments for any reason even if the CDAI score was ≤ 10. The impact of baseline characteristics on disease flare at week 64 (52 weeks after methotrexate discontinuation) was assessed with logistic regression models.ResultsEfficacy analyses were performed in 49 patients, of whom 15 had a disease flare by week 64. The proportion (95% confidence interval [CI]) of patients who maintained low disease activity without a flare at week 64 was 69.4% (54.6–81.8%). The dosing interval of tocilizumab was longer than that described on the drug label in Japan (i.e., intravenously every 4 weeks, or subcutaneously every 2 weeks) in 27% and 6% of patients with and without a flare, respectively. Multivariate analysis revealed that male sex (odds ratio [OR]: 18.00, 95% CI: 2.80–115.56) and extended dosing interval of tocilizumab (OR: 12.00, 95% CI: 1.72–83.80) were independent predictors of disease flare.ConclusionMale patients and those receiving tocilizumab at an extended dosing interval are at high risk of disease flare after discontinuation of concomitant methotrexate.Trial registration numberjRCTs041180071, UMIN000021247.     

Acetic acid versus radiofrequency ablation for the treatment of hepatocellular carcinoma: A randomized controlled trial

PurposeThe purpose of this prospective study was to compare the efficacy of percutaneous acetic acid (PAAI) to that of radiofrequency ablation (RFA) in the treatment of small (≤ 5 cm) hepatocellular carcinoma (HCC) using a randomized trial.Material and methodsConsecutive patients with small HCC underwent clinical, biochemical, and imaging evaluation. Those fulfilling the inclusion criteria (Child's A/B cirrhosis, less than 5 HCC nodules, HCC nodules ≤ 5 cm diameter, no extrahepatic disease, patent portal vein, normal coagulation profile with informed consent) were randomly assigned to receive RFA or PAAI. Tumor response and survival rate were estimated. Non-inferiority margin of 10% difference was taken for effectivity of PAAI compared to RFA.ResultsOf the 86 patients screened, 55 patients with 67 HCC nodules were included. There were 40 men and 15 women with a mean age of 54.3 ± 10.5 (SD) years (range: 28–71 years). Of these, 26 patients had PAAI and 29 had RFA. The clinical, demographic and imaging profiles of the two groups were similar. Complete response was non-inferior to RFA [PAAI 75% and RFA 83.3%, difference 8.3% CI (−12.5% to 29.2%)]. Lower limit of this 95% CI (−12.5%) was lower than the 10% non-inferiority margin difference (8.3%). Survival rates were similar at 12 months (PAAI, 81.6% vs. RFA, 71.9%; P = 0.68) and at 30 months (PAAI, 54.4% vs. RFA, 52%; P = 0.50).ConclusionPAAI and RFA have similar efficacy in treating small HCC. PAAI could thus be a cost-effective alternative in situations where RFA is either unavailable or unaffordable.     

The effect of the acute inflammatory response of burns and its treatment on clot characteristics and quality: A prospective case controlled study

IntroductionBurns are known to have an effect on coagulation in the early period after burn. Current coagulation tests have been criticised in acute burns due to their inherent limitations. This study aims to investigate the potential for a new quantitative functional biomarker of clot quality, fractal dimension, to identify changes in clot microstructure as a result of the burn inflammatory response and its treatment.MethodsA total of fifty-eight burn patients were included in this prospective case-controlled study. The control group (29 patients mean TBSA 1%), and case group (29 patients mean TBSA 30%) were compared at baseline and the case group investigated further over four time points (baseline, 12 h, 24 h and 5–7 days). Fractal analysis was performed, as well as current markers of coagulation, inflammatory markers and point-of-care tests, Thromboelastography and Multiplate analysis.ResultsFractal dimension did not differ between groups at admission (1.73 ± 0.06 and 1.72 ± 0.1), and fell within the healthy index normal range (1.74 ± 0.7), suggesting a normal clot microstructure in the early period after burn. Fractal dimension significantly reduced from baseline over the first 24 h following injury (1.59 ± 0.03 p < 0.005), indicating a significant reduction in mechanical clot strength and functionality consistent with a hypocoagulable state, not identified with other markers.ConclusionsThis is the first study to quantify the changes in clot microstructure following burn injury. This study confirms clot microstructure is significantly altered during the first 24 h after burn, with the production of a weaker, more porous fibrin clot, consistent with a hypocoagulable state.     

TBS and BMD at the end of AI-therapy: A prospective study of the B-ABLE cohort

IntroductionPatients with breast cancer under aromatase inhibitor (AI) treatment often develop osteoporosis and their average bone loss rate is twice that of natural reduction during menopause, increasing fracture risk. As the current diagnostic technique based on bone mineral density (BMD) provides no information on bone quality, the Trabecular Bone Score (TBS) has been proposed to reflect bone microarchitecture status. The present study was designed to assess prospective changes in TBS and lumbar spine (LS) BMD in postmenopausal women with breast cancer at completion of AI treatment.MethodsB-ABLE is a prospective cohort of 735 women with breast cancer treated with AIs according to American Society of Clinical Oncology recommendations: 5 years of AI starting within 6 weeks post-surgery or 1 month after the last cycle of chemotherapy (5y-AI group), or switching to an AI to complete 5-year therapy after 2–3 years of tamoxifen (pTMX-AI group). Patients with osteoporosis were treated with oral bisphosphonates (BP). TBS and LS-BMD changes at completion of AI therapy were evaluated by Student t-test for paired samples. Pearson correlation coefficients were computed for correlations between LS-BMD and TBS.ResultsAI treatment was completed by 277 women. Of these, 70 (25.3%) were allocated to BP therapy. The non-BP-treated patients (74.7%) showed significant decreases in TBS (− 2.94% in pTMX-AI and − 2.93% in 5y-AI groups) and in LS-BMD (− 4.14% in pTMX-AI and − 2.28% in 5y-AI groups) at the end of AI treatment. In BP-treated patients, TBS remained stable at the end of AI treatment, whereas LS-BMD showed significant increases (+ 2.30% in pTMX-AI and + 5.33% in 5y-AI groups). Moderate associations between TBS and LS-BMD values at baseline and at the end of AI treatment (r = 0.4; P < 0.001) were observed. At the end of treatment, changes in spine BMD and TBS were weakly correlated (r = 0.1, P < 0.01).ConclusionsAI therapy induces significant decreases in TBS, comparable to BMD loss. BP-treated patients maintained TBS values, whereas BMD increased. AI treatment leads to deterioration of bone microarchitecture, which seems to be attenuated by BP therapy.