Long-term Treatment Failure Research Articles

Tu1195 LONG-TERM OUTCOMES OF PER-ORAL ENODOSCOPIC MYOTOMY IN ACHALASIA PATIENTS WITH A MINIMUM FOLLOW-UP OF 4 YEARS: A MULTICENTER STUDY

Per-oral endoscopic myotomy (POEM) is associated with 82-100% short-term clinical response in patients with achalasia. However, durability of response is not well known as long-term data is limited. To study (1) clinical outcomes of patients with a minimum post-POEM follow-up of 4 years; and (2) factors associated with long−term clinical failure after POEM. We conducted a retrospective review of consecutive patients with achalasia who underwent POEM with a minimum follow-up of 4 years at 11 tertiary centers (2 US, 7 Europe, 2 Asia). Clinical response was defined by an Eckardt score of ≤3. A total of 146 patients (79 females (54%); mean age 49.8 yr.) with achalasia (41 type I, 70 type II, 9 type III and 26 with unspecified type) were included. Of these, 29 (19.9%) patients had prior pneumatic dilatation, 13 (8.9%) had botulinum toxin injection and 7 (4.8%) had a prior Heller myotomy. Anterior myotomy was performed in 77.8% and full-thickness LES myotomy was carried in 52.4% of patients. The mean length of esophageal myotomy was 8.5±2.5 cm and length of gastric myotomy was 3.2±1 cm. A total of 8 (5.5%) adverse events occured (6 mucosotomy, 2 pneumothorax). The median follow-up duration was 55 months (IQR 49.9-60.6). Clinical success was seen in 96.4% (136/141), 95.9% (118/123), 94.1% (127/135), 95.9% (118/123) and 95.2% (139/146) at 6 months, 12 months, 24 months, 36 months and ≥ 48 months, respectively. Of the 7 patients who experienced clinical failure at 4 years, 5 experienced initial response and then had a late (after 6 months) recurrence of symptoms. The mean Eckardt score decreased from 7.5±1.7 to 1.28±1.29 (p < 0.001) and 4sIRP pressure from 28.7 ± 11 to 10.1 ± 7.1 mmHg (P<0.001). On univariable analysis, male gender (OR 7.6, p 0.062), a sigmoid esophagus (OR 2.33, p 0.45), prior Heller myotomy (OR 3.7, p 0.26) and type III achalasia (OR 2.73, p 0.37) were associated with long-term treatment failure, although the association was not statistically significant. Four patients with clinical failure underwent re-treatment: 1 had a repeat POEM and 3 had a pneumatic balloon dilation. Clinical response was attained in 3 of the 4 patients. Symptomatic reflux was seen in 45/140 (32.1%) patients after POEM. Post-POEM pH monitoring testing was completed in 80 patients, of whom 38 (47.5%) had abnormal acid exposure. Reflux esophagitis was noted in 22 (16.8%) of the 131 patients who had an EGD after POEM. Regarding PPI use, 48 (35.3%) patients are currently using PPI on a daily basis and 15 (11%) occasionally, whereas 73 (53.7%) are not using the medication. POEM is a durable and safe procedure which provides high initial clinical success and excellent long-term outcomes. Less than 5% of patients who achieved clinical response at 6 months had recurrent symptoms at 4 years.Table 2. Univariable logistic regression analysis of factors associated with long-term clinical failure (≥ 4 years after POEM, n=7)View Large Image Figure ViewerDownload Hi-res image Download (PPT)

PD05-05 TRANSOBTURATOR TAPE: OVER 10 YEARS FOLLOW-UP

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I1 Apr 2018PD05-05 TRANSOBTURATOR TAPE: OVER 10 YEARS FOLLOW-UP Franca Natale, Ester Illiano, Chiara La Penna, Alessandro Zucchi, Francesca Parisi, Lorenzo Alunni, and Elisabetta Costantini Franca NataleFranca Natale More articles by this author , Ester IllianoEster Illiano More articles by this author , Chiara La PennaChiara La Penna More articles by this author , Alessandro ZucchiAlessandro Zucchi More articles by this author , Francesca ParisiFrancesca Parisi More articles by this author , Lorenzo AlunniLorenzo Alunni More articles by this author , and Elisabetta CostantiniElisabetta Costantini More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.413AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The growth of the elderly population in western countries highlights the importance of studying the long-term outcomes of the various treatments of chronic conditions, including urinary incontinence. The aim of this study is to assess the outcomes in incontinent patients who underwent TOT with a 10-year minimum follow-up. METHODS This is a single-center prospective study on women who underwent TOT for stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence. The pre-operative evaluation included: history; urogynaecological examination; cough stress test; urodymamics; UDI-6 and IIQ questionnaires for symptoms; the King′s Health Questionnaire (KHQ) for QoL. In Sept.-Oct. 2017 all patients who had undergone TOT before 2007 were recalled for follow-up. They completed the same pre-op questionnaires and the Patient Global Impression of Improvement (PGI-I): success was defined as ′very much better′ or ′much better′ on the PGI-I scale. The primary outcome was the SUI cure rate. Secondary outcomes included improvement in QoL, effect on urinary symptoms and late adverse events. Institutional Review Board Committees approved this study; participants gave informed consent. Statistical analysis: McNemar chi-square test; Fisher′s exact test. RESULTS From January 2003 to December 2007, 136 consecutive patients underwent TOT. Thirteen patients were lost to follow-up, so we report data on 123 patients. Mean age was 58.3±9.94; median parity was 2; mean BMI 27.22±2.76; 87 patients (70.2%) were menopausal. At a mean follow-up of 145 months, 77 patients (62.6%) were subjectively cured for SUI. Of the 46 failed patients only 10 underwent further SUI surgery: 8 underwent TVT and 2 underwent bulking agent therapy. Urgency reduced statistically significantly (from 67.5% to 38.3%), as did urgency urinary incontinence (from 56.9% to 31.7%). De novo urgency occurred in 7.3% of cases. Voiding symptoms increased from 8.9% to 18.7%. De novo voiding symptoms appeared in 14.6% of patients. All domains of the KHQ except general health and sleep saw statistically significant improvements. We had 5 cases of partial mesh extrusion, requiring tape revision; none became incontinent. CONCLUSIONS Our study demonstrates that in the period of ten or more years after TOT surgery, cure rates are lower than in shorter-term studies, however, at 62.6%, they may still be considered satisfactory. It is difficult to ascertain if a patient′s dissatisfaction 10 years or more after surgery is due to long-term treatment failure or to general factors like age or another pathology. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e146 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Franca Natale More articles by this author Ester Illiano More articles by this author Chiara La Penna More articles by this author Alessandro Zucchi More articles by this author Francesca Parisi More articles by this author Lorenzo Alunni More articles by this author Elisabetta Costantini More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

RETRACTED: Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study

Per-oral endoscopic myotomy (POEM) has shown promising safety and efficacy in short-term studies. However, long-term follow-up data are very limited. The aims of this study were to assess (1) clinical outcome of patients with a minimum post-POEM follow-up of 2 years and (2) factors associated with long-term clinical failure after POEM. A retrospective chart review was performed that included all consecutive patients with achalasia who underwent POEM with a minimum follow-up of 2 years at 10 tertiary-care centers. Clinical response was defined by a decrease in Eckardt score to 3 or lower. A total of 205 patients (45.8% men; mean age, 49 years) were followed for a median of 31 months (interquartile range, 26-38 months). Of these, 81 patients (39.5%) had received previous treatment for achalasia before POEM. Clinical success was achieved in 98% (185/189), 98% (142/144), and 91% (187/205) of patients with follow-up within 6 months, at 12 months, and≥24 months, respectively. Of 185 patients with clinical response at 6 months, 11 (6%) experienced recurrent symptoms at 2 years. History of previous pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23). Procedure-related adverse events occurred in 8.2% of patients and only 1 patient required surgical intervention. Abnormal esophageal acid exposure and reflux esophagitis were documented in 37.5% and 18% of patients, respectively. However, these rates are simply a reference number among a very selective group of patients. POEM is safe and provides high initial clinical success and excellent long-term outcomes. Among patients with confirmed clinical response within 6 months, 6% had recurrent symptoms by 2 years.

Treatment and prognosis after progression in long-term responders to EGFR-tyrosine kinase inhibitor in advanced non-small cell lung cancer.

IntroductionThe aim of this study was to investigate the treatment and prognosis of advanced non-small cell lung cancer (NSCLC) patients after failure of long-term treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).Material and methodsWe retrospectively analyzed all NSCLC patients with EGFR-TKI (gefitinib or erlotinib) treatment at our institution between 2011 and 2013 who progressed after at least stable disease on erlotinib or gefitinib for more than 6 months. Survival curves were plotted using the Kaplan-Meier method. The Cox proportional hazard model was used for multivariate analysis.ResultsIn total, 521 patients were administered EGFR-TKI. Of these, 298 patients received EGFR-TKI with progression-free survival less than 6 months (group A), and the other 223 patients more than 6 months (group B). There was a significant difference in overall survival (OS) between group A and group B (7.2 months vs. 5.0 months, p < 0.0001). The median OS for group B patients was 5.0 months. Among the 223 patients in group B, 38 patients received chemotherapy with continued EGFR-TKI after failure of prior gefitinib or erlotinib treatment, 92 with chemotherapy alone and 93 with best supportive care. Patients who continued gefitinib or erlotinib had a significantly longer OS (median: 7.5 months), followed by chemotherapy (5.5 months) and best supportive care (4.0 months) (p < 0.001).ConclusionsThe prognosis of advanced NSCLC patients after failure of long-term treatment with EGFR-TKI was poor. Chemotherapy with continued EGFR-TKI beyond progression of long-term responders was feasible and led to prolonged OS in advanced NSCLC patients.

Rituximab as second-line treatment for adult immune thrombocytopenia (the RITP trial): a multicentre, randomised, double-blind, placebo-controlled trial

Immune thrombocytopenia is characterised by immune-mediated destruction and suboptimum production of platelets. Despite the absence of supporting evidence, rituximab is frequently used off-label in patients with immune thrombocytopenia. We aimed to assess the efficacy of rituximab as compared with placebo as a splenectomy-sparing treatment in patients who were previously treated with corticosteroids. In this multicentre, randomised, double-masked, placebo-controlled trial, we enrolled corticosteroid unresponsive adult patients (aged ≥18 years) with primary immune thrombocytopenia and a platelet count of less than 30 × 10(9) platelets per L. Patients were randomly assigned (1:1) to four weekly infusions of 375 mg/m(2) rituximab or placebo. Concurrent treatment with corticosteroids only was allowed during the study. The primary endpoint was rate of treatment failure within 78 weeks--a composite of splenectomy or meeting criteria for splenectomy after week 12 if splenectomy was not done, assessed in all patients who received at least one dose of study treatment. Secondary endpoints were response rates, relapse rates, and duration of response. Efficacy endpoints were assessed with the Kaplan-Meier method. Safety endpoints were assessed in all patients who received at least one dose. This trial is registered with ClinicalTrials.gov, number NCT00344149. Between Aug 17, 2006, and June 30, 2011, we enrolled 112 patients. 32 (58%) of 55 patients in the rituximab group and 37 (69%) of 54 patients in the placebo group had treatment failure within 78 weeks (Kaplan-Meier cumulative incidence 46% for rituximab vs 52% for placebo (hazard ratio [HR] 0·89, 95% CI 0·55-1·45; p=0·65). The cumulative incidence of overall response was 81% in the rituximab group versus 73% in the placebo group (p=0·15) and complete response was 58% in the rituximab group versus 50% in the placebo group (p=0·12). Of those achieving an overall response, 68% relapsed in the rituximab group and 78% relapsed in the placebo group, and of those achieving complete response, 50% relapsed in the rituximab group and 62% relapsed in the placebo group. Time to relapse in the rituximab group was longer in patients who achieved overall response (36 vs 7 weeks; p=0·01) but not complete response (76 vs 49 weeks; p=0·19). Rates of bleeding were similar in the two groups (21 [38%] in the rituximab group vs 27 [50%] in the placebo group; p=0·08) as were rates of infection (22 [40%] vs 13 [24%]; p=0·09). Despite no reduction in the rate of long-term treatment failure with rituximab, a small benefit cannot be ruled out, as suggested by an apparently longer duration of response and numerically higher response rates with rituximab. South-East Regional Health Authority and Østfold Hospital, Norway; Roche, France; and Roche, Norway.

Efficacy of Ovarian Artery Embolization for Uterine Fibroids: Clinical and Magnetic Resonance Imaging Evaluations

PurposeThe objective of the study was to assess the efficacy of ovarian artery embolization (OAE) treatment for symptomatic uterine leiomyomas. MethodsA retrospective review of 17 patients who underwent OAE in conjunction with uterine artery embolization in a 6-year period (2006-2012) was performed. Ten patients had previous failed embolization, while 7 had not received any embolization therapy before. Percent uterine volume change, percent dominant fibroid volume change, and percent dominant fibroid infarction were assessed with magnetic resonance (MR) imaging. Resolution of menorrhagia, dysmenorrhea/pain, and bulk and/or pressure symptoms including urinary frequency were evaluated clinically. Change in menopausal state was also an outcome of interest. ResultsMean MR imaging follow-up was performed 3 months post-OAE. MR images showed complete infarction in the majority of cases (64.7%; n = 11), with infarction rates of 90%-100% in 3 cases, 1 case with 30%-50% infarction, and 2 cases with 0%-10% infarction. Average uterine size reduction on MR was 32.3% (95% confidence interval [CI]: 22.5%-42.2%; P < .001). The average size reduction for the dominant fibroid was 42.4% (95% CI: 27.7%-57.0%; P = .01). The mean time to final follow-up visit was 11 months. At this point complete symptom resolution (menorrhagia, dysmenorrhea and bulk-related) was achieved in 82.4% (n = 14) of cases. At the final follow-up 11.8% (n = 2) of cases reported menopause. ConclusionsWe observed OAE to be an effective and safe adjunct to uterine artery embolization when hypertrophic ovarian artery(ies) require intervention. However, incomplete fibroid infarction of 23% remains a concern with a potential for long-term treatment failure. In addition, long-term effect on ovarian function is uncertain.

Vacuum-assisted closure therapy in the management of lung abscess

BackgroundDespite significant advances in the treatment of thoracic infections, complex lung abscess remains a problem in modern thoracic surgery. We describe the novel application of vacuum-assisted closure for the treatment of a lung abscess. The technical details and preliminary results are reported.MethodsAfter the initial failed conservative treatment of an abscess, minimally invasive surgical intervention was performed with vacuum-assisted closure. The vacuum sponges were inserted in the abscess cavity at the most proximal point to the pleural surface. The intercostal space of the chest wall above the entering place was secured by a soft tissue retractor. The level of suction was initially set to 100 mm Hg, with a maximum suction of 125 mm Hg. The sponge was changed once on the 3rd postoperative day.ResultsThe abscess cavity was rapidly cleaned and decreased in size. The mini-thoracotomy could be closed on the 9th postoperative day. Closure of the cavity was simple, without any short- or long-term treatment failure. This technique reduced the trauma associated with the procedure. The patient was discharged on the 11th postoperative day.ConclusionsVacuum-assisted closure systems should be considered for widespread use as an alternative option for the treatment of complicated pulmonary abscess in elderly, debilitated, immunocompromised patients after failed conservative treatment.Electronic supplementary materialThe online version of this article (doi:10.1186/s13019-014-0157-x) contains supplementary material, which is available to authorized users.

Sa1391 Utility of Endoscopic Treatment for Gastrojejunal Anastomotic Stenosis in Laparoscopic Roux-en-Y Gastric Bypass

Sa1389 Intragastric Balloon in the Treatment of Obese Population: Weight Loss and Complications Christian A. Sanchez*, Magdalena Ramos Mejia, Carolina Bolino, Luis E. Caro, Cecilio L. Cerisoli Gedyt, Buenos Aires, Argentina Introduction: Obesity, a new global epidemic, is associated with multiple metabolic diseases and high mortality. The failure of long-term conservative treatment led to the emergence of new therapies. The intragastric balloon (IGB) is an effective, well tolerated and minimally invasive procedure for loosing weight. Objectives: 1. Estimate the weight loss in patients who had IGB inserted for at least 6 months. 2. Describe immediate and mediate complications. Materials and Methods: We included patients R 18 years with BMI R 30 kg/m, R 35 kg/m with comorbidities or patients at high risk or non-conforming for surgery despite its indication. Contraindications for IGB were exclusion criteria. The study took place at a gastroenterology outpatient center between September, 2009 and September, 2013. Design: Interventionist, prospective, comparative, longitudinal study. Methods: Patients were selected by a multidisciplinary team and included consecutively. The IGB was placed according to its technique and the patient remained hospitalized for 12-24 hours for observation for eventual post placement symptoms. Diet, exercise plan and a schedule of monthly visits were prescribed at discharge. We evaluated the mean weight loss after 6 months and complications were recorded as immediate (!7days) and mediate (O 7days). Ethics: the protocol was approved by the local IRB. Statistical analysis: VCCstat 2.0. package; 95%CI were calculated; ANOVA test. Results: We evaluated 154 patients, 23 required IGB early removal. Finally 94 patients were analyzed. 72% (68/94) were women, mean age 42,25 11,5 years, with no difference between genders, mean BMI: 37.22 4.85 kg/m (range 29.03 to 58,11). The balloon was inserted for a median time of 208,50 30 days (range 162-333). Comorbidities were registered in 48% (45/94). 1. According to diet and exercise compliance the sample was stratified into five groups: Compliance to diet (G1), to exercise (G2), to both measures (G3), no compliance to both measures (G4), no nutritional monitoring at our institution (G5). The weight loss average in each group is detailed in the table 1. Immediate complications occurred in 44% patients (95%CI 34-55; 42/94), and were registered as follows: vomiting 53% (n:22), nausea 27% (n:11), epigastric pain 14% (n:6). Mediate complications were recorded in 2.1% patients (95%CI 0,3-7,5; 2/94). Conclusions: The weight loss varied according to treatment compliance. Patients who were compliant to diet and exercise lost more weight than the other groups. Early complications were more frequent.

Sa1389 Intragastric Balloon in the Treatment of Obese Population: Weight Loss and Complications

Obesity, a new global epidemic, is associated with multiple metabolic diseases and high mortality. The failure of long-term conservative treatment led to the emergence of new therapies. The intragastric balloon (IGB) is an effective, well tolerated and minimally invasive procedure for loosing weight.

Treatment failure in patients with chronic Blastocystis infection

This article reports long-term infection and treatment failure in 18 symptomatic individuals infected with Blastocystis spp. Patients were initially treated with either metronidazole, iodoquinol or triple combination therapy consisting of nitazoxanide, furazolidone and secnidazole. Following treatment, resolution of clinical symptoms did not occur and follow-up testing revealed ongoing infection with the same subtype. Patients then underwent secondary treatment with a variety of antimicrobial agents but remained symptomatic with Blastocystis spp. still present in faeces. Sequencing of the SSU rDNA was completed on all isolates and four subtypes were identified in this group: ST1, ST3, ST4 and ST5. This study highlights the lack of efficacy of several commonly used antimicrobial regimens in the treatment of Blastocystis and the chronic nature of some infections. It also demonstrates the need for further research into treatment options for Blastocystis infection.

Early dropout predictive factors in obesity treatment

Diet attrition and failure of long term treatment are very frequent in obese patients. This study aimed to identify pre-treatment variables determining dropout and to customise the characteristics of those most likely to abandon the program before treatment, thus making it possible to modify the therapy to increase compliance. A total of 146 outpatients were consecutively enrolled; 73 patients followed a prescriptive diet while 73 followed a novel brief group Cognitive Behavioural Treatment (CBT) in addition to prescriptive diet. The two interventions lasted for six months. Anthropometric, demographic, psychological parameters and feeding behaviour were assessed, the last two with the Italian instrument VCAO Ansisa; than, a semi-structured interview was performed on motivation to lose weight. To identify the baseline dropout risk factors among these parameters, univariate and multivariate logistic models were used. Comparison of the results in the two different treatments showed a higher attrition rate in CBT group, despite no statistically significant difference between the two treatment arms (P = 0.127). Dropout patients did not differ significantly from those who did not dropout with regards to sex, age, Body Mass Index (BMI), history of cycling, education, work and marriage. Regardless of weight loss, the most important factor that determines the dropout appears to be a high level of stress revealed by General Health Questionnaire-28 items (GHQ-28) score within VCAO test. The identification of hindering factors during the assessment is fundamental to reduce the dropout risk. For subjects at risk, it would be useful to dedicate a stress management program before beginning a dietary restriction.

Pretreatment and on-treatment indicators of virologic breakthrough of lamivudine therapy in chronic hepatitis B patients: an Egyptian study.

The primary objectives of hepatitis B treatment include improved clinical and histological progression as well as virus eradication. For many years, lamivudine was a first-line therapy for treating hepatitis B virus (HBV) infection. However, its long-term use is associated with high resistance rates (up to 70% after 5 years) due to mutations in the viral YMDD motif. The purpose of this study was to outline factors responsible for the development of viral resistance during long-term lamivudine therapy. Initially, 230 patients receiving lamivudine therapy for chronic hepatitis B (CHB) infection were enrolled in the study. All subjects received follow-ups in the first year to assess viral and biochemical responses. Only 136 and 104 patients received follow-up assessments during the second and third years of treatment, respectively. Viral breakthrough (VBT) occurred in 49 of 230 patients (21.3%). Hepatitis B "e" antigen (HBeAg) status before treatment was significantly associated with VBT in the first 2 years of treatment; however, this effect was not significant in the third year. Pre-treatment HBV DNA levels were predictive of VBT in the HBeAg-positive subgroup after all years of treatment (P = 0.001, P = 0.002, and P = 0.002, respectively). These levels were also predictive in the HBeAg-negative subgroup after 1 year of treatment (P = 0.001). In resource-poor communities, financial concerns drive the selection of antiviral therapy to treat CHB. Lamivudine monotherapy is a relatively cheap and effective treatment to manage CHB. However, consistent follow-ups and treatment modifications appear essential to prevent long-term treatment failure.

Immediate antiretroviral therapy in young HIV-infected children

Purpose of reviewRecent WHO guidelines recommend immediate initiation of lifelong antiretroviral therapy (ART) in all children below 5 years, irrespective of immune/clinical status, to improve access to paediatric ART. Interim trial results provide strong evidence for immediate ART during infancy because of high short-term risk of mortality and disease progression, but there is wider debate regarding the potential risks and benefits of immediate ART in asymptomatic children aged above 1 year. Concerns include long-term toxicities and treatment failure, particularly in resource-constrained settings with limited paediatric treatment options.Recent findingsBenefits of immediate ART among infants appear to be maintained in the mid-term to long-term, with low risk of treatment failure, and better neurodevelopmental outcomes. In contrast, a trial reported no benefits of immediate versus deferred ART in asymptomatic children aged above 1 year. However, observational studies suggest that ART initiation at older ages and lower CD4 reduces the probability of immune reconstitution, with unclear implications on risk of clinical events or treatment change. A recent trial on treatment interruption following early intensive ART suggest that this may be a safe alternative approach.SummaryAlthough there are clear benefits of immediate ART among infants, there remains conflicting evidence on the benefits for older children.

FRI0092 Disease activity at three months is an excellent predictor of long-term treatment failure in actively treated rheumatoid arthritis patients, 5-year results of the neo-raco trial

BackgroundMost rheumatoid arthritis (RA) patients achieve remission, have marginal radiographic progression and sustain normal function when an initial aggressive combination treatment with three disease modifying antirheumatic drugs (DMARDs) and prednisolone...

Su1427 Predictors of Long-Term Endoscopic Treatment Failure Following ERCP With Biliary Stent Placement for Newly Diagnosed Pancreatic Malignancy

Placement of plastic rather than metal biliary endoprostheses has been preferred practice for relief of obstructive jaundice in patients with surgically resectable or “borderline” resectable pancreatic head malignancy. The aim of this study was to identify predictors of plastic stent failure in such patients, with stent failure defined broadly as need for any repeat ERCP for stent exchange, whether elective or due to clinical evidence of stent occlusion.

International collaborative systematic review of controlled clinical trials on pharmacologic treatments for acute pericarditis and its recurrences

Acute pericarditis is common, yet uncertainty persists on its treatment. We thus aimed to conduct a comprehensive systematic review on pharmacologic treatments for acute or recurrent pericarditis. Controlled clinical studies were searched in several databases and were included provided they focused on pharmacologic agents for acute pericarditis or its recurrences. Random-effect odds ratios (ORs) were computed for long-term treatment failure, pericarditis recurrence, rehospitalization, and adverse drug effects. From 2,078 citations, 7 studies were finally included (451 patients); but only 3 were randomized trials. Treatment comparisons were as follows: colchicine versus standard therapy (3 studies, 265 patients), steroids versus standard therapy (2 studies, 31 patients), low-dose versus high-dose steroids (1 study, 100 patients), and statins versus standard therapy (1 study, 55 patients). Colchicine was associated with a reduced risk of treatment failure (OR = 0.23 [0.11-0.49]) and recurrent pericarditis (OR = 0.39 [0.20-0.77]), but with a trend toward more adverse effects (OR = 5.27 [0.86-32.16]). Overall, steroids were associated with a trend toward increased risk of recurrent pericarditis (OR = 7.50 [0.62-90.65]). Conversely, low-dose steroids proved superior to high-dose steroids for treatment failure or recurrent pericarditis (OR = 0.29 [0.13-0.66]), rehospitalizations (OR = 0.19 [0.06-0.63]), and adverse effects (OR = 0.07 [0.01-0.54]). Data on statins were inconclusive. Clinical evidence informing decision-making for the management of acute pericarditis and its recurrences is still limited to few, small, and/or low-quality clinical studies. Notwithstanding such major caveats, available studies routinely using nonsteroidal anti-inflammatory agents in both experimental and control groups suggest a beneficial risk-benefit profile for colchicine and a detrimental one for steroids, especially when used at high dosages.

Long-term Outcomes and Patterns of Tumor Progression After Gamma Knife Radiosurgery for Benign Meningiomas

To characterize the timing and patterns of long-term treatment failure after Gamma Knife radiosurgery (GKRS) for benign meningiomas. Data were retrospectively reviewed in 116 patients who underwent 136 GKRS treatments for benign intracranial meningiomas from 1996 to 2004. Patients with atypical or malignant meningiomas were excluded. Surgical resection preceded GKRS in 72 patients (62%). The median tumor volume was 3.4 cm, and the median prescription dose to the 50% isodose line was 16 Gy. The median follow-up time was 75 months (range, 4-146 months). Overall tumor control was achieved in 128 of 136 lesions (94%), of which tumor size was stable in 68% and decreased in 26%. Seven patients experienced disease progression in 8 tumors, occurring at a mean time of 90 months. The overall 5-year and 10-year actuarial tumor control rate was 98.9% and 84%, respectively. Characteristics corresponding to tumor progression included insufficient tumor coverage (98% vs 93%, P = .007), cavernous sinus lesions, and meningiomatosis. Complications after GKRS developed in 8% of patients, in whom the mean tumor volume was nearly double that in patients with no adverse effects (11 vs 5.7 cm3, P = .003). GKRS demonstrates excellent long-term tumor control in the management of benign meningiomas. Tumor progression occurred at a mean time of 7.5 years after GKRS, reinforcing the need for long-term surveillance despite initial tumor control. Treatment failure was related to undercoverage of lesions in the majority of cases, with the remainder demonstrating evidence of abnormal tumor biology.

Switching to Second-Line Therapies in Interferon-Beta-Treated Relapsing-Remitting Multiple Sclerosis Patients

Background:Interferon-β (IFNB) therapies are the most widely used as first-line intervention in the treatment of relapsing-remitting (RR) multiple sclerosis (MS). Despite long-term experience, however, the definition and prediction of response remain controversial. Aim:The objective of this study was to assess the long-term validity of the main clinical definitions of response applied after 1 and 2 years of IFNB therapy in a cohort of RRMS patients followed up for at least 5 years. Methods:We tested these different definitions against a ‘hard’ parameter of treatment failure, represented by the need to suspend IFNB and switch to an intravenous immunosuppressive (IVIS) treatment, using Kaplan-Meier and Cox survival analyses. Results:Out of 147 RRMS patients treated with IFNB therapy and followed up for 7.8 ± 2.1 years, 26 (18%) were switched to an IVIS therapy. On the whole, disability progression as indicated using the Expanded Disability Status Scale (EDSS) and a higher number of relapses in the first 2 years of therapy were related to long-term treatment failure. Conclusion:Our study highlights the role of disability and high relapse rate in the first 2 years of treatment in predicting long-term response and the switching to second-line therapies.

Endoscopic Therapies for the Treatment of Reflux Disease

Endoscopic techniques for the treatment of reflux disease were first introduced in 2000 as an alternative to laparoscopic antireflux operations. Because of reports of long-term treatment failure with laparoscopic fundoplication and the fact that surgery is increasingly being reserved for the relatively small proportion of patients with complicated reflux disease, attempts to develop safe, effective, and durable endoscopic approaches to antireflux surgery continue. Techniques include radiofrequency ablation, injection therapy, and suturing/stapling techniques. Of these, the suturing/stapling techniques are most similar to the anatomic restructuring of the gastroesophageal junction provided by fundoplication. While early attempts at endoscopic suturing have been disappointing, significant advances in endoscopic instrumentation, a more complete understanding of the gastroesophageal junction anatomy, and improvements in the technical skills of the endoscopic surgeon have been realized. As a result, techniques now being tested, such as the endoluminal fundoplication, may prove more effective and durable than previous endoscopic antireflux procedures.

The Effect of Opioid Dose and Treatment Duration on the Perception of a Painful Standardized Clinical Stimulus

The concept of opioid-induced hyperalgesia has recently gained prominence as a contributing factor for opioid tolerance and long-term treatment failure. But whereas the preclinical data for this phenomenon are strong, the mixed clinical data derive primarily from experimental pain models conducted in volunteers and heroin addicts, and nonstandardized clinical stimuli, e.g., surgery. The primary objective of this study is to delineate the effect of opioid dose and treatment duration on pain intensity and unpleasantness ratings following a standardized clinical pain stimulus. Three hundred and fifty-five patients, on a steady regimen of analgesic medications and scheduled for an interventional procedure, received a standardized subcutaneous injection of lidocaine prior to a full dose of local anesthetic. Before and immediately following the injection, subjects were asked to rate pain and unpleasantness intensity on a 0 to 10 numerical rating scale. Subjects were stratified into 6 groups based on opioid dosage. A control group of 27 volunteers who had no pain and were taking no analgesics were also injected. Both opioid dose and duration of treatment directly correlated with pain intensity and unpleasantness scores. Baseline pain intensity was also positively associated with both outcome variables. Gender was found to be associated with pain intensity and unpleasantness, with females scoring higher in both categories than males. Compared with patients not receiving opioid treatment, patients receiving opioid therapy were more likely to rate the standardized pain stimulus as being more unpleasant than painful. The results of this study bolster preclinical and experimental pain models demonstrating enhanced pain perception in subjects receiving opioid therapy. This simple clinical model may provide a useful tool in examining opioid-induced hyperalgesia.