Lower rates of endoscopy and higher mortality in end-stage renal disease patients with gastrointestinal bleeding: A propensity matched national study.

BACKGROUND AND AIM: Patients with end-stage renal disease (ESRD) on hemodialysis are considered to be at higher risk of gastrointestinal bleeding (GIB) as compared with those without renal disease (NRD). We conducted a population-based study using the National Inpatient Sample (NIS) database to study the outcomes of GIB in ESRD. METHODS: Patients admitted with GIB (upper and lower) from 2005 to 2013 were extracted from the NIS database using ICD-9 codes. Patients were divided into NRD and ESRD groups, and a 1:1 propensity matched analysis was performed. Various outcomes were compared in both groups, and subgroup analysis based on the timing of endoscopy was also performed. RESULTS: A total of 218 032 patients were included in the study. There was an increase in inpatient admissions among ESRD patients with GIB with significant reduction in mortality (P < 0.001). In-hospital mortality, length of stay, and total costs were significantly higher in ESRD patients as compared with NRD. ESRD patients were less likely to undergo endoscopic evaluation compared with NRD (P < 0.001). Late endoscopy (> 48 h) was associated with increased need for transfusion and health-care utilization but without a significant difference in mortality as compared with early endoscopy. On multivariate analysis, endoscopy was associated with significantly lower rate of mortality in ESRD patients with GIB (odds ratio 0.28, P < 0.0001). CONCLUSION: End-stage renal disease patients with GIB had a significantly higher rate of mortality and a higher health-care utilization with a lower rate of endoscopic evaluation. Endoscopy was associated with a lower mortality rate on multivariate analysis.

Trends and risk factors for 30-day readmissions in patients with acute cholangitis: analysis from the national readmission database.

INTRODUCTION: Acute cholangitis (AC) can be associated with significant mortality and high risk of readmissions, if not managed promptly. We used national readmission database (NRD) to identify trends and risk factors associated with 30-day readmissions in patients with AC. METHODS: We conducted a retrospective cohort study of adult patients admitted with AC from 2010-2014 and Q1-Q3 of 2015 by extracting data from NRD. Initial admission with a primary diagnosis of acute cholangitis (ICD-9 code: 576.1) was considered as the index admission and any admission after index admission was considered a readmission regardless of the primary diagnosis. Multivariable regression analyses were performed to assess the association. RESULTS: From 52,906 AC index admissions, overall 30-day readmission rate was 21.48% without significant differences in the readmission rates across the study period. There was significant increase in the overall hospital charges for readmissions, while a significant reduction in the death rate was observed during the first readmission. Recurrent cholangitis (14%), septicemia (6.4%), and mechanical complication of bile duct prosthesis (3%) were the most common reasons for readmissions. The risk of readmission was significantly higher in patients with pancreatic neoplasm (OR 1.6, 95% CI 1.4-1.8), those who underwent percutaneous biliary procedures (OR 1.4, 95% CI 1.2-1.6), and who had an acute respiratory failure (OR 1.2, 95% CI 1.0-1.15). Other factors contributing to increased risk of readmissions included patients with Charleston comorbidity index > 3, diabetes, and length of stay > 3 days. Readmission risk was significantly lower in patients who underwent ERCP (OR 0.80, 95% CI 0.73-0.88) or cholecystectomy (OR 0.54, 95% CI 0.43-0.69). CONCLUSIONS: AC is associated with a high 30-day readmission rate of over 21%. Patients with malignant biliary obstruction, increased comorbidities, and those who undergo percutaneous drainage rather than ERCP seem to be at the highest risk.

Peroral Endoscopic Myotomy Is Safe and Highly Effective Treatment for Advanced Achalasia With Sigmoid Esophagus.

BACKGROUND AND AIMS: In advanced achalasia patients with sigmoid esophagus, peroral endoscopic myotomy (POEM) might be technically challenging and its outcomes are not well known in western population. Hence, our study aims were to assess and compare the safety and efficacy of POEM in achalasia patients with and without sigmoid esophagus. MATERIALS AND METHODS: Medical records of achalasia patients who had POEM at our institution between April 2014 and December 2019 were reviewed. Patients who underwent work-up comprising timed barium esophagram (TBE) and high-resolution esophageal manometry (HREM) before POEM along with 2-month post-POEM esophageal pH study, TBE and HREM were included in the final analysis. Patients were categorized as either sigmoid or no sigmoid esophagus based on the morphology of esophagus on TBE as per Japan Esophageal Society guidelines. Treatment success was defined as reduction of post-POEM Eckardt score to ≤3. RESULTS: A total of 168 patients (sigmoid esophagus=20; no sigmoid esophagus=148) were included. Esophageal width on TBE at 1 minute was significantly higher in sigmoid esophagus group compared with no sigmoid esophagus group (4.9 vs. 3.0 cm, P<0.001). Procedural outcomes and complications were similar in both groups. At 2-month follow-up, both groups had significant improvement in Eckardt scores, TBE, and HREM parameters. Treatment success was high and similar in both sigmoid and no sigmoid groups (94.4% vs. 93.2%, P=0.84). The rates of gastroesophageal reflux disease were also similar in both groups. CONCLUSIONS: Our study findings suggest that POEM is safe and highly effective treatment for achalasia patients with sigmoid esophagus similar to those without sigmoid esophagus in western population. POEM should be considered as the treatment of choice in advanced achalasia with sigmoid esophagus.

Efficacy and safety of vedolizumab in elderly patients with inflammatory bowel disease: a matched case-control study.

BACKGROUND: Vedolizumab was demonstrated to be safe and effective in adults with moderately to severely active inflammatory bowel disease (IBD) in clinical trials. However, there are limited data regarding its efficacy and safety in elderly patients. METHODS: This was a case-control study comparing the efficacy (measured by rates of mucosal healing and need for IBD surgery) and safety of vedolizumab in IBD among patients ≥65 years of age (the elderly group) vs those <65 years (the control group). The two groups were matched individually on a 1:4 ratio based on gender and type of IBD. Conditional logistic regression was used for stratified analysis to calculate odds ratios and confidence intervals. RESULTS: We included 25 IBD patients in the elderly group and 100 matched patients in the comparison group. Eighty patients had Crohn's disease and 45 had ulcerative colitis. At baseline, the groups were comparable with regard to duration of IBD, prior anti-TNF therapy, and prior IBD surgery. The rate of mucosal healing on follow-up endoscopy was comparable between the elderly and control groups (50% vs 53%, P = 0.507). Although more patients in the elderly group required IBD-related surgery while on vedolizumab, the difference did not reach statistical significance (40% vs 19%, P = 0.282). Rates of vedolizumab-related adverse effects-rash, arthralgia, infections, infusion reactions, and dyspnea-were comparable between the two groups (all P > 0.05). CONCLUSIONS: In a real-world setting, vedolizumab was demonstrated to have an efficacy and safety profile among elderly IBD patients that were comparable to younger controls.

Weil's Disease: A Rare Cause of Jaundice.

Weil's disease is a complication of untreated leptospirosis and can be fatal. Awareness of leptospirosis and its hepatic manifestations are limited. We report the case of a 50-year-old man with gastrointestinal symptoms and a cholestatic pattern of liver injury diagnosed with Weil's disease. The patient showed remarkable improvement after treatment with appropriate antibiotics with normalization of liver function in one month. This case highlights the importance of recognizing leptospirosis and its myriad presentations.

Quality of Colonoscopy: A Comparison Between Gastroenterologists and Nongastroenterologists.

BACKGROUND: Colonoscopy performance by gastroenterologists has been shown to be associated with lower rates of developing interval colorectal cancer. However, it is unclear if this difference among specialists stems from a difference in meeting colonoscopy quality indicators. OBJECTIVE: The purpose of this study is to determine and compare the rates of colonoscopy quality indicators between different specialties. DESIGN: This is a cohort study of patients undergoing screening colonoscopy investigating quality metrics as compared by the proceduralist specialty. SETTING: All screening colonoscopies performed at the Cleveland Clinic between 2012 and 2014 were followed by manual chart review. PATIENTS: Average-risk patients, ≥50 years of age, who had a complete screening colonoscopy were included. MAIN OUTCOME MEASURES: Adenoma detection rate, cecal intubation rate, withdrawal time, and other nonestablished overall and segment-specific rates were calculated and compared using t tests. RESULTS: A total of 4151 patients were included in the analysis. Colonoscopies were performed by 54 (64.3%) gastroenterologists, 21 (25%) colorectal surgeons, and 9 (10.7%) general surgeons. Gastroenterologists had the highest overall adenoma detection rate (28.6 ± 1.2; p < 0.001), followed by colorectal surgeons (24.3 ± 1.5) and general surgeons (18.4 ± 2.3), as well as the highest adenoma detection rate in men (34.7 ± 1.3; p < 0.001), followed by colorectal surgeons (28.2 ± 1.6) and general surgeons (23.7 ± 2.6). Similarly, gastroenterologists had the highest adenoma detection rate in women (24.3 ± 1.1; p < 0.001), followed by colorectal surgeons (21.6 ± 1.4) and general surgeons (12.9 ± 2.0). Withdrawal time was the longest among general surgeons (11.1 ± 5.5; p = 0.041), followed by colorectal surgeons (10.94 ± 5.2) and gastroenterologists (10.16 ± 1.26). LIMITATIONS: We could not adjust for some procedure-related details such as retroflexion in the right colon and the use of end-of-scope devices. CONCLUSIONS: In this study, only gastroenterologists met the currently accepted overall and sex-specific adenoma detection rate benchmarks. They also outperformed nongastroenterologists in many other nonestablished quality metrics. See Video Abstract at http://links.lww.com/DCR/B232. CALIDAD DE LA COLONOSCOPIA: UNA COMPARACIÓN ENTRE GASTROENTERÓLOGOS Y NO GASTROENTERÓLOGOS: Se ha demostrado que el rendimiento de la colonoscopia por parte de los gastroenterólogos, se asocia con tasas más bajas de cáncer colorrectal en intervalos de desarrollo. Sin embargo, no está claro si esta diferencia entre especialistas, se deriva de una diferencia en el cumplimiento de los indicadores de calidad de la colonoscopia.El propósito del estudio, es determinar y comparar las tasas de indicadores de calidad de colonoscopia entre diferentes especialidades.Este es un estudio de cohorte de pacientes sometidos a una colonoscopia de detección, que investiga métricas de calidad en comparación con la especialidad de procesos.Todas las colonoscopias de detección realizadas en la Clínica Cleveland entre 2012 y 2014, fueron seguidas por una revisión manual del expediente.Pacientes de riesgo promedio, ≥50 años de edad que se sometieron a una colonoscopia de detección completa.La tasa de detección de adenomas, tasa de intubación cecal, tiempo de retirada y otras tasas generales y específicas de segmento no establecidas, se calcularon y compararon usando pruebas t.Un total de 4,151 pacientes fueron incluidos en el análisis. Las colonoscopias fueron realizadas por 54 (64.3%) gastroenterólogos, 21 (25%) cirujanos colorrectales y 9 (10.7%) cirujanos generales. Los gastroenterólogos tuvieron la tasa de detección más alta de adenomas en general (28.6 ± 1.2; p < 0.001), seguidos por los cirujanos colorrectales (24.3 ± 1.5) y los cirujanos generales (18.4 ± 2.3), así como la tasa de detección más alta de adenoma en hombres (34.7 ± 1.3; p < 0.001) seguido por cirujanos colorrectales (28.2 ± 1.6) y cirujanos generales (23.7 ± 2.6). Del mismo modo, los gastroenterólogos tuvieron la tasa más alta de detección de adenoma en mujeres (24.3 ± 1.1; p < 0.001), seguidos por los cirujanos colorrectales (21.6 ± 1.4) y los cirujanos generales (12.9 ± 2.0). El tiempo de extracción fue el más largo entre los cirujanos generales (11.1 ± 5.5; p = 0.041) seguido por los cirujanos colorrectales (10.94 ± 5.2) y los gastroenterólogos (10.16 ± 1.26).No pudimos ajustar algunos detalles relacionados con el procedimiento, tales como la retroflexión en el colon derecho y el uso de accesorios endoscópicos.En este estudio, solo los gastroenterólogos cumplieron con los índices de referencia actualmente aceptados, de detección de adenomas en general y específicas de género. También superaron a los no gastroenterólogos en muchas otras métricas no establecidas de calidad. Consulte Video Resumen en http://links.lww.com/DCR/B232. (Traducción-Dr. Fidel Ruiz Healy).

National trends in healthcare outcomes and utilization of endoscopic and surgical interventions in patients hospitalized with esophageal foreign body and food impaction.

The incidence and number of emergency room visits for esophageal foreign body and food impaction (EFB) are on the rise. However, its impact on the rate of inpatient admissions, utilization of endoscopic and surgical interventions, and healthcare outcomes is poorly understood. We conducted a study to analyze these outcomes using the national inpatient sample (NIS) database. Data on all adult patients (≥18 years) admitted with EFB was extracted from the NIS database from 1998 to 2013. The temporal trends in discharge rates as well as in length of stay (LOS), hospital charges, and in-hospital mortality rates were assessed by linear and polynomial regression. Average age, gender, and race of inpatients with EFB were not significantly different between 1998 and 2013. The rate of EFB admissions increased significantly from 1998 to 2005 followed by a decline thereafter (p = 0.01). LOS and hospital charges significantly increased by 0.02 days/year (p = 0.015) and $1,547/year (p < 0.001), respectively. There was a trend towards less utilization of overall esophagogastroduodenoscopy (EGD) over the last decade with significant lower use of EGD within 24 hours in 2013 as compared to 1998 (p = 0.026). The rates of surgical intervention and inpatient mortality did not change significantly over the study period. The rate of inpatient admissions for EFB is on the decline in recent years, suggesting the modern-day practice of cost-effective medicine. Hospitalization costs for EFB have increased, whereas rates of surgical intervention and inpatient mortality have not changed significantly over the study period.

Obesity Does Not Impact Outcomes or Rates of Gastroesophageal Reflux After Peroral Endoscopic Myotomy in Achalasia.

BACKGROUND: Outcomes of laparoscopic Heller myotomy in obese patients with achalasia are suboptimal along with the increased risk of gastroesophageal reflux disease (GERD). The impact of obesity on treatment success and GERD after peroral endoscopic myotomy (POEM) are not well known. Hence, our study aims were to compare the clinical outcomes and rates of GERD after POEM in nonobese versus obese patients with achalasia. METHODS: Chart review of all achalasia patients who underwent POEM at our institution between April 2014 and June 2018. Patients with timed barium esophagram (TBE) and high-resolution esophageal manometry (HREM) before POEM along with post-POEM TBE, HREM, and esophageal pH study were included. Patients were categorized into 2 groups, nonobese (body mass index <30 kg/m) and obese (body mass index ≥30 kg/m). Patient demographics, TBE, HREM, pH study findings, and Eckardt scores were compared between the 2 groups. RESULTS: A total of 89 patients (46 nonobese; 43 obese) met the study criteria. There were no significant differences in age, gender, achalasia subtype, operative time, length of stay and complication rates between the 2 groups. Treatment success (Eckardt score ≤3) was similar in both groups (97.7% nonobese vs. 92.7% obese, P=0.35). Abnormal DeMeester scores on pH study (>14.72) were similar in nonobese and obese patients (58.7% vs. 46.5%, P=0.25). Symptomatic GERD was also similar in both groups (17.8% in nonobese vs. 20% in obese, P=0.79). CONCLUSIONS: POEM is an equally safe and effective treatment option for both nonobese and obese patients with achalasia in the short-term. Interestingly, POEM does not lead to higher rates of GERD in obese compared with nonobese patients.

The Colonic Single Stripe Sign: A Case of Ischemic Colitis.

Sudden, transient reduction in the blood flow especially in the "watershed" regions of the colon can lead to intestinal ischemia causing a decrease in the delivery of oxygen and nutrients to the intestinal wall. Patients with ischemic colitis often have elevated white blood cell counts, serum lactate, and serum amylase levels. Colonoscopy can confirm the diagnosis of ischemia and the findings include edematous, friable mucosa, erythema with interspersed pale areas, scattered hemorrhagic erosions or linear ulcerations. A single, linear ulcer running along the anti-mesenteric colonic wall, "single-stripe sign"- favors the diagnosis of ischemic colitis. Management of mild and moderate colonic ischemia includes supportive care with bowel rest, gastric suction for associated ileus, fluid-electrolyte balance, and broad-spectrum antibiotics. Patients with severe colonic ischemia may require abdominal exploration and colectomy.

Per oral endoscopic myotomy: Another tool in the toolbox.

OBJECTIVE: Use of per oral endoscopic myotomy is increasing for the treatment of achalasia, with potential for rapid recovery and less invasiveness. We report our experience with per oral endoscopic myotomy to better understand how it fits into a modern paradigm of achalasia management. METHODS: A total of 152 patients with achalasia underwent per oral endoscopic myotomy from April 2014 to March 2018. Type II achalasia was the most prominent subtype in 69 patients (49%), and 33 patients (21.5%) had a prior Heller myotomy. Postoperative Eckardt scores, integrated relaxation pressure, and timed barium esophagram column height and width at 2 months were compared with preoperative measurements. RESULTS: Per oral endoscopic myotomy was completed in 149 patients (98%). Median operative time was 96 minutes (75 minutes for the last 30 cases), and length of stay was 1 day (interquartile range, 1-2). The most common morbidities were mucosal perforation in 2 patients (1.3%) and bleeding in 3 patients (2.0%), although no nonendoscopic intervention was required. Mortality was zero. Postoperatively, the median Eckardt score decreased from 6 to 0 (P < .001), residual lower esophageal sphincter pressure decreased from 22 mm Hg to 6 mm Hg (P < .001), and timed barium esophagram column height and width at 5 minutes decreased from 8 and 2.5 cm to 1.5 and 0.8 cm (P < .001), respectively. Median time to return to daily activity was 7 days; 49 patients (49.5%) had abnormal acid reflux on 24-hour pH testing postprocedure. CONCLUSIONS: Per oral endoscopic myotomy is a safe and effective intervention that provides clear subjective and objective improvement in patients with achalasia. High postprocedure acid reflux raises concern about future sequelae if used in a nonselective fashion.

Dedifferentiated Liposarcoma in a Giant Esophageal Polyp: A Case Report and Review of the Literature.

Soft tissue sarcomas represent an extremely rare cause of esophageal masses, and undifferentiated sarcomas are rarer. The proportion of dedifferentiated liposarcomas (DDL) is even lower. The case of a 58-year-old male who complained of dysphagia and was found to have an 18-centimeter long esophageal mass/polyp on esophagogastroduodenoscopy is presented. The lesion was resected endoscopically and a diagnosis of DDL was confirmed by fluorescence in situ hybridization. Due to its rarity, the treatment experience with esophageal DDLs is limited. However, based on our experience, endoscopic resection of the lesion can be considered as the treatment of choice when feasible. We performed a review of the literature to identify and analyze similar reported cases.

Obstructive Sleep Apnea and the Liver.

Nonalcoholic fatty liver disease (NAFLD), a disorder of altered metabolic pathways, is increasing worldwide. Recent studies established obstructive sleep apnea (OSA) and chronic intermittent hypoxia (CIH) as NAFLD risk factors. Studies have ascertained that CIH is independently related to NAFLD. Continuous positive airway pressure (CPAP) shows inconsistent results regarding its efficacy in improving NAFLD. Observational, longer duration CPAP therapy studies have shown positive outcomes, whereas shorter duration, randomized controlled trials have shown no benefit. A multifaceted approach to NAFLD management with sufficiently longer duration of CPAP therapy may be beneficial in patients with moderate to severe OSA.

Outcomes of endoscopic submucosal dissection in esophageal adenocarcinoma staged T1bN0 by endoscopic ultrasound in non-surgical patients.

Patients with esophageal adenocarcinoma (EAC) invading submucosa (T1b) are traditionally treated with esophagectomy and with chemoradiotherapy in poor surgical patients. Endoscopic submucosal dissection (ESD) has emerged as an alternative treatment in these patients. In this case series, we analyzed the outcomes of ESD in EAC staged T1bN0 by endoscopic ultrasound (EUS). Patients with EAC staged T1bN0M0 by EUS and PET scan who underwent ESD by a single operator (MS) between 2014 and 2017 at our institution were included. They were deemed as poor surgical candidates and ESD was considered as the most appropriate treatment option after a multi-disciplinary evaluation. There were 8 patients (male =5; female =3) with average age of 70.5 years old (range, 53-84 years old). ESD was completed in 7 and aborted in 1 patient due to tumor invasion into muscularis propria. En bloc, R0 and curative resection rates were 86% (6/7), 86% (6/7) and 71% (5/7) respectively. Final histology was intramucosal (T1a) in 4 and submucosal (T1b) in 3. One patient (14%) developed stricture requiring balloon dilation. Mean follow-up duration was 10 months (range, 3-15 months) and 71% (5/7) remain in clinical remission. Two patients required CRT, one with T1a who developed recurrence and another with T1b with lymphovascular invasion. In poor surgical candidates, ESD was associated with accurate staging and favorable outcomes in EAC staged T1bN0 by EUS. We suggest considering ESD in EAC staged T1bN0 for accurate histological staging, curative potential and also to help determine further course of treatment.

Esophageal Third Space Endoscopy: Recent Advances.

PURPOSE OF THE REVIEW: The novel concept of third space endoscopy was first applied to humans in 2008 for the management of achalasia through peroral endoscopic myotomy (POEM) procedure. Over the ensuing 10 years, this revolutionary procedure, which started in Japan, has been adopted and mastered by surgeons and gastroenterologists across the globe. In this article, we review the recent innovations and applications of third space endoscopy in the management of esophageal disorders. RECENT FINDINGS: With experience and innovation, the application of third-space endoscopy has extended beyond achalasia, and currently, it is used in the management of other esophageal disorders including, spastic esophageal disorders, subepithelial tumors, complete esophageal obstruction, and esophageal diverticula. The recent advances in third space endoscopic procedures have not only permitted endoscopic access to places, previously thought impossible, but also enabled the precision of surgery along with reduced peri-operative morbidity due to its minimally invasive nature. While short- and mid-term outcome studies have shown excellent results, we eagerly await the long-term outcome studies before these procedures could be established as the procedures of choice.

Peroral Endoscopic Myotomy Is Effective for Patients With Achalasia and Normal Lower-Esophageal Sphincter Relaxation Pressures.

Increased lower esophageal sphincter integrated relaxation pressure (LES-IRP) is a cardinal feature of achalasia. However, some patients with characteristic features of achalasia have normal LES-IRP.1,2 The efficacy of peroral endoscopic myotomy (POEM) in achalasia patients with normal LES-IRP is not well known. Hence, we aimed to compare POEM outcomes in achalasia patients with normal (<15 mm Hg) and increased (≥15 mm Hg) LES-IRP.

Peroral endoscopic myotomy leads to higher rates of abnormal esophageal acid exposure than laparoscopic Heller myotomy in achalasia.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) may be associated with higher rates of gastroesophageal reflux disease (GERD) than laparoscopic Heller's myotomy with fundoplication (LHM), since POEM is not combined with a fundoplication. However, peri-esophageal anti-reflux barriers are preserved in POEM, which might prevent GERD. Hence, we sought to compare the objective esophageal pH study findings in achalasia patients after POEM and LHM. METHODS: Achalasia patients undergoing POEM from 2014 to 2015 at our institution were matched 1:3 with LHM patients using propensity score matching. Demographics, prior interventions, pre-treatment and 2-month post-treatment timed barium esophagram (TBE), high-resolution esophageal manometry (HREM) and 24-h esophageal pH study findings were compared between the two groups. RESULTS: Thirty-one patients in the POEM group and 88 patients in the LHM group were included. Larger proportion of POEM patients had prior interventions for achalasia as compared to LHM patients (overall: 71% vs. 44.3%; p = 0.012). Esophageal acid exposure was significantly higher in POEM as compared to LHM patients (abnormal total acid exposure: 48.4% vs. 13.6%; p < 0.001, abnormal DeMeester score 54.8% vs. 17.4%; p = 0.005 respectively). In sub-group analysis, similar results were noted on 24-h pH study after exclusion of the POEM patients with prior LHM and corresponding matches. There was no significant difference in the rate of GERD symptoms between POEM and LHM. There was no significant correlation between the post-treatment basal lower esophageal sphincter pressure and integrated relaxation pressure with abnormal acid exposure in either POEM or LHM. CONCLUSIONS: In patients with achalasia, POEM leads to significantly higher rates of abnormal esophageal acid exposure, without an increase in the rate of GERD symptoms, when compared to LHM with fundoplication. Interestingly, prior LHM has no impact on post-POEM pH study findings. Potential of increased esophageal acid exposure and possible consequences should be discussed with all patients prior to POEM. Further studies are needed to determine the long-term effects of increased acid exposure after POEM.

Erratum: Radiation therapy-induced aortoesophageal fistula: a case report and review of literature.

[This corrects the article DOI: 10.1093/gastro/gou081.].

Correction: Vedolizumab for Ulcerative Colitis: Treatment Outcomes from the VICTORY Consortium.

This Article was originally published under Nature Research's License to Publish, but has now been made available under a CC BY-NC-ND license. The PDF and HTML versions of the Article have been modified accordingly.

Vedolizumab for Ulcerative Colitis: Treatment Outcomes from the VICTORY Consortium.

OBJECTIVES: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. METHODS: Retrospective review (May 2014-December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. RESULTS: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38-0.75) and endoscopic remission (HR 0.51, 95% CI 0.29-0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). CONCLUSION: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.