Kane, Sunanda V.

LINKED CONTENTThis article is linked to Sebastian et al papers. To view these articles, visit https://doi.org/10.1111/apt.15456 and https://doi.org/10.1111/apt.15498.

Abstract Background: Anemia is an extremely prevalent disease and contributes to a substantial percentage of worldwide years lived with disability. Clinicians generally agree that investigation of the gastrointestinal (GI) tract with colonoscopy and/or endoscopy is warranted in the presence of either overt clinical evidence of GI bleeding or in the presence of documented iron deficiency. However, little is known about the appropriateness of these procedures in the evaluation of patients without either overt GI bleeding or iron deficiency. Additionally, while a large number of colonoscopies and endoscopies are performed each year, the proportion of such procedures performed in the absence of suspect history or findings has not been characterized. Methods: We performed a retrospective review of all patients at Mayo Clinic Rochester who underwent endoscopy, colonoscopy, or both procedures between July 1, 2014 and June 30, 2015 for an indication of either "anemia" or "iron deficiency anemia." Sources of data included provider notes, laboratory values, procedure notes, and pathology reports. Information including patient demographic characteristics, medical comorbidities, laboratory values related to anemia, findings at the time of gastrointestinal procedure, and procedure-related complications was collected. Data was entered into an electronic database and data analysis was performed using Microsoft Excel. Results: 999 procedures were included, including 224 colonoscopies, 306 endoscopies, and 469 combined colonoscopy/endoscopies. Of the 999 total procedures, 78 (8%) had no documented pre-procedure hemoglobin value, 666 (67%) were performed after documented anemia (defined as hemoglobin ≤12 g/dL), and 255 (26%) were performed after a documented hemoglobin of >12 g/dL. Of the 675 procedures performed for "iron deficiency anemia," 462 (68%) patients had documented anemia and documented ferritin prior to the procedure, including only 237 (35%) with both hemoglobin ≤12 and ferritin ≤ 20. 388 (39%) had a documented pre-procedure patient and/or provider report of blood in the stool, and 111 (11%) had a documented pre-procedure positive hemoccult test. 365 (37%) of the 999 procedures identified a probable benign source of bleeding, 54 (5.4%) identified a probable malignant source, and 580 (58%) had no findings consistent with a bleeding source. Patients with documented anemia were more likely to have a probable bleeding source identified than those without documented anemia [46% versus 34%, p<.001]. Of the 83 patients with hemoglobin >12 and ferritin >20, only 1 procedure in 83 demonstrated a malignant finding, and this patient did have blood in the stool at the time of the procedure. There were 46 patients who underwent a procedure without any "warning signs" (either anemia and/or blood in the stool and/or positive hemoccult). Of these patients, 0 had a malignant finding. Conclusions: A large number of procedures performed for either "anemia" or "iron deficiency anemia" were done without pre-procedure documentation of anemia and/or iron deficiency. Documentation of anemia is associated with an increased chance of finding a source of bleeding during the procedure. There were no missed diagnoses of malignancy among patients undergoing procedures without anemia, blood in the stool, and/or positive hemoccult. Careful attention to documentation should be encouraged, and quality improvement initiatives requiring appropriate documentation prior to performing these procedures may be helpful. Disclosures No relevant conflicts of interest to declare.

INTRODUCTION: Gastroparesis is defined as delayed gastric emptying in the absence of mechanical obstruction. Diabetes and medication side effects are common causes. AL amyloidosis is a systemic disease due to extracellular fibril deposition that can affect multiple organs. Gastro-intestinal (GI) involvement is less common than in other organ systems but can present in many different ways, including gastroparesis. CASE DESCRIPTION/METHODS: A 77 year old non-diabetic man from Mississippi presented with a one year history of intermittent abdominal distention, nausea and bloating. In addition, he had increasing dyspnea on exertion and lower extremity edema. Outside work-up consisted of multiple imaging studies demonstrating marked gastric distention as well as delayed gastric emptying (Figures 1 and 2). Outside colonoscopy was unrevealing and EGD was negative except for a distal esophageal ulcer and focal active duodenitis. He was started on a PPI and trialed on an alternating regimen of metoclopramide and erythromycin, without symptomatic relief. He was referred to our hospital for further diagnostic work-up. Repeat colonoscopy showed congested distal ileal mucosa and friable ascending colonic mucosa. Biopsies from both sites revealed amyloid deposits by Congo red stain (Figure 3). Serum protein electrophoresis noted a monoclonal IgG lambda peak with M-spike of 1.5 g/dL and bone marrow biopsy revealed approximately 70% of marrow cellularity consisting of plasma cells. Echocardiogram confirmed severely increased concentric left ventricular wall thickening consistent with cardiac amyloidosis. Interestingly, neither fat pad biopsy nor bone marrow biopsy showed presence of amyloid. The patient was diagnosed with myeloma and AL amyloidosis with gastro-intestinal and cardiac involvement. DISCUSSION: This case highlights the broad differential for gastric distention and dysmotility. When the ‘usual suspects’ such as diabetes, medication, post-surgery and neurological disease have been ruled out, rarer causes like an infiltrative process should be considered. Common manifestations of GI tract amyloidosis include GI bleeding, malabsorption, protein-losing enteropathy and chronic dysmotility. The diagnosis of amyloidosis is based on positive tissue diagnosis. While the combination of a fat pad and a bone marrow biopsy has a high sensitivity (89%) for diagnosing AL amyloidosis, negative results do not rule out amyloid elsewhere and tissue sampling from the affected organ site is essential, as demonstrated in this case.

INTRODUCTION: Double balloon enteroscopy (DBE) is an important tool for evaluation of obscure GI bleeding but is a limited resource given time and expertise required. Patient selection is important to help optimize diagnostic yield and subsequent successful management of small bowel bleeding. To maximize the efficiency of DBE performed, our endoscopy group established a screening protocol (Figure) prior to approval of any procedure. We developed a quality improvement project to assess the efficacy of this screening protocol and to evaluate which components of screening were most predictive for procedural success. METHODS: A retrospective chart review was performed on all patients who underwent anterograde or retrograde double balloon enteroscopy for suspected GI bleeding from January 2016 to December 2017. Our screening protocol was implemented on February 1 st , 2017. Data was obtained on patient demographics, clinical presentation, laboratory evaluation, and prior investigation for bleeding evaluation. Endoscopy outcomes were separated into procedural success, defined as lesion identified, and clinical success, defined as resolution of bleeding. Success rates were compared pre and post intervention. Regression analysis was performed to evaluate which components best predicted a successful procedure. RESULTS: We reviewed 114 DBE procedures in 89 patients, 53.5% male (n = 61) with a mean age of 62.8 + 13.3 years. Of these, 86% (n = 98) were performed prior to initiation of the screening protocol. Overall, there was no significant difference in procedural success pre and post intervention as defined by presence of recurrent bleeding, persistent anemia, or transfusion need (Table 1). On univariate analysis of clinical success, defined as lack of recurrent bleeding, gender, anticoagulation use, and presence of lesion on CE were significant (Table 2). Identification and intervention on a lesion during the balloon endoscopy did not impact future anemia, bleeding, or transfusion requirements. CONCLUSION: The patient screening protocol was successful in decreasing the number of procedures performed but did not improve our lesion detection rate on endoscopy and did not improve clinical outcomes as measured by rebleeding. Patients on anticoagulation and those who had prior lesions identified on capsule endoscopy had higher odds of rebleeding, indicating clinical failure. This data may help modify patient selection to maximize success of DBE procedures in the future.

Background and aims: Patient-reported outcomes (PROs) will become increasingly important as primary endpoints in future clinical trials. We aimed to evaluate the relationship between health-related quality of life (HRQoL) and the combination of patient-reported clinical symptoms (ClinPRO2) and Mayo endoscopic subscore (MES) in patients with ulcerative colitis (UC). Methods: We conducted a prospective cross-sectional study of 90 consecutive UC patients who were scheduled for sigmoidoscopy or colonoscopy. All patients completed the following questionnaires: (1) self-rated rectal bleeding and stool frequency (ClinPRO2); (2) Short Inflammatory Bowel Disease Questionnaire (SIBDQ); (3) European Quality of Life 5-Dimensions 3-Level (EQ5D3L); (4) Work Productivity and Activity Impairment questionnaire (WPAI); (5) Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and (6) Hospital Anxiety and Depression Scale (HADS). The endoscopic images were graded according to the MES. “No symptoms” was defined as a symptom score of 0, and “mucosal healing” was defined as MES score of 0–1. Correlations between the combined ClinPRO2 and MES with HRQoL were assessed using Spearman’s correlation coefficients. Results: The combination of the ClinPRO2 and MES was well correlated to SIBDQ (r = −0.70), EQ5D3L (r = −0.51), WPAI (r = 0.62), FACIT-F (r = −0.58), and HADS-depression (r = 0.45). SIBDQ scores had strong correlations with FACIT-F (r = 0.86), WPAI (r = −0.80), and HADS-depression (r = −0.75) (p < 0.05 for all correlations). Patients with no symptoms reported the greatest all HRQoL scores. Conclusions: In patients with ulcerative colitis, the combination of a ClinPRO2 and the MES had good correlation with the SIBDQ. In addition, SIBDQ was well correlated to the various HRQoL.

Abstract Background Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. Methods We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014–June 2015 (Era 1) and July 2015–June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. Results A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease–related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. Conclusion Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later.