1
AGA Abstracts females (55 years) with ICD-9 codes specific for IDA. n=124,460 underwent both upper & lower endoscopy during the one year evaluated. If up to 30% may have unexpalined IDA after standard endoscopic evaluation, we would expect n=37,338 with a potential need for additional SB evaluation. We observed n=30,088 contrast radiography studies performed and while despite known better sensitivity for identifying SB mucosal lesions, only n=7,894 CE studies were performed (21% of expected). In addition, we further identified n=127,969 individuals with IDA and GI bleeding (using ICD-9 codes specific for GI bleeding) who had both upper & lower endoscopy within the one year studied, n=38,636 contrast radiography studies and n=16,513 CE studies were performed in this sub-cohort. Conclusions: Using a large US-based medical claims database, we found potential underutilization of CE in the evaluation of patients with unexplained IDA. Despite its known inferior sensitivity compared to CE in evaluating SB mucosa, we observed a high use of contrast radiography studies. These findings are despite current published data demonstrating the diagnostic value of CE in males and selected females with IDA who had a negative standard endoscopic evaluation. Additional research is required to elucidate possible reasons for this apparent underutilization. W1083 Interference Between Cardiac Pacemaker and Wireless Capsule Endoscopy Antonietta G. Gravina, Bozzi Rosamaria, Agnese Miranda, Cattaneo Domenico, Marco Romano, Angelo Pezzullo Background and Aim: Wireless capsule endoscopy is a new endoscopic tool for the diagnosis and management of small bowel diseases. The main indication at present is the evaluation of GI bleeding of obscure origin, Crohn's disease, coeliac disease and small bowel tumors. Studies suggest that capsule endoscopy is associated with few adverse events. Cardiac pacemaker is reported as a relative controindication to capsule endoscopy. However there is not much information available about the possibility of correctly performing a capsule endoscopy in patients with cardiac pacemaker. Case report: A 75 year old man with ischemic cardiopathy with dilatative evolution treated with aorto-coronaric bypass, complicated by cardiac cirrhosis and mild ascites and renal failure had an early history of melena (haemo- globin: 7.0 g/dl ). He carried a pacemaker that had been implanted following unsuccessful medical treatment for atrial fibrillation (pacemaker model Biotronik-Kalos 05 VVI n/s 36012460 with electrode Biotronik HL 150, n/s 56756B). Conventional diagnostic interven- tions, including upper and lower endoscopy, failed to identify the site of bleeding. A CT enteroclysis was performed and resulted normal. The patient underwent a small bowel study by capsule endoscopy (Endocapsule Olympus ®); the recorder was positioned next to external abdominal sites near the pulse generator while the electric cardiac activity was continuously recorded, to confirm the absence of pacing inhibition by the video transmission. During video capsule examination, we revealed an interference lasting 20 minutes, between the real time viewer and the pacemaker, confirmed after subsequent downloading on the workstation. In particular, we found this interference only when the recorder was positioned near pacemaker and the viewer was connected on it. This interference resulted in the absence of any image on the viewer and workstation screens. No interferences with recording images were found when the recorder was positioned at distance from pacemaker. Wireless capsule endoscopy revealed active arterial bleeding in the jejunum; a double balloon enteroscopy, performed on the same day, confirmed the presence of an angiodysplasia. Continuous cardiac monitoring by a central station was organized for the duration of the endoscopic procedures. Conclusion: This report dealing with video capsule endoscopy in a patient with cardiac pacemaker confirms the possibility of magnetic interference but does not exclude the correct functioning and diagnostic potential of the system on the basis of correct positioning between pacemaker and capsule endoscopy. W1084 Capsule Endoscopy (CE) in “Suspected” Small Bowel (SB) Crohn's Disease (CD): Economic Impact of Disease Diagnosis and Treatment Jonathan A. Leighton, Ian M. Gralnek, Randel E. Richner, Michael J. Lacey, Frank J. Papatheofanis PURPOSE: Diagnosing SB CD has been challenging due to limitations in endoscopic techno- logy. With the introduction of CE, there is the potential for diagnosing suspected CD earlier, thereby reducing costs of care. The aim of this economic analysis was to evaluate the clinical and economic benefits of CE compared to ileocolonoscopy and small bowel follow through (SBFT) for the evaluation of suspected small bowel CD. METHODS: Using a decision analytic model we evaluated a hypothetical cohort of 10,000 patients with suspected CD. We estimated the total expected global costs of the initial diagnostic work-up for suspected CD as well as expected follow-up costs of managing CD for one year after diagnosis including office visits, laboratory tests, medications, hospitalizations, and adverse events. To estimate key model variables we performed a systematic literature review to investigate the evidence concerning the use of ileocolonoscopy, SB radiography, and CE for evaluating suspected CD. The model compared evaluation with CE vs SBFT following ileocolonoscopy. A secondary analysis compared CE to SBFT when used for initial evaluation. RESULTS: Aggregate global costs for newly diagnosed patients for the first year who are medically managed are approxim- ately $8,295. For those requiring aggressive medical management, including anti-TNF ther- apy, the cost is $29,508, and for patients requiring hospitalization $49,074. Compared to SBFT as a first- or second-line diagnostic test, a CE-based evaluation costs approximately $46 less. At a sensitivity >98.7%, CE becomes less costly than SBFT, at a specificity of >86.4%, CE is less costly than SBFT. W1085 A Standardized Data Sheet for Training Novice Capsule Reviewers Janice Freeman, Jason Roberts, Todd E. Dantzler, Brenda J. Hoffman Introduction: Wireless capsule endoscopy pre-readers may be used to facilitate physician interpretation. Training the pre-reader may be time consuming, is not standardized, and may not be feasible during regular business hours. A way to evaluate the progress and A-650 AGA Abstracts accuracy of the pre-reader is needed to assure competency. This measure should be readily adaptable in academic and private practices. Aim: To utilize a standard data sheet to provide feedback and progress assessment for novice wireless capsule endoscopy pre-readers. Methods: We developed a single sheet evaluation with listings of findings for each segment of the examination. Each of these could be designated by a simple circle. The trainee (JF) reviewed the capsule studies and filled out the data sheet on each of 55 patients. The physician reviewers (TD, BH) separately reviewed the capsule study and then assessed the data sheets provided. Feedback as to overcalls, missed lesions, and overall accuracy were given to the pre-reader. Results: 55 patients were evaluated with one data sheet per person. Agreement improved as the pre-reader gained experience with 37% for the first 30 studies and 72% for the last 25. The false negative rate (FN) was 27% for the first 30 studies compared to only 4% in the last 25. Conclusion: A simple one page standardized data sheet can be used to facilitate training of novice capsule pre-readers. This allows for assessment and training without a physician being physically present at the time of each review by the pre-reader. Pre-reader accuracy and FN rate improve with interpretation of at least 30 studies. Comparing Expert and Novice Wireless Capsule Readers Figure 1 W1086 Rectal Administration of D-Alpha Tocopherol for Active Ulcerative Colitis: Short Term Follow Up Results Seyed Amir Mirbagheri, Behtash G. Nezami, Solmaz Assa INTRODUCTION: Inflammatory bowel disease (IBD) is mainly characterized by upregulation of synthesis and release of different proinflammatory mediators. Recent studies suggest that anti-inflammatory properties for d-α tocopherol may reduce the development of tissue injury in IBD. We have previously reported the preliminary results of the study to investigate the anti-oxidant effects of rectal d-α tocopherol on patients with mild to moderate ulcerative colitis (UC). Herein we report the 12 months follow up results of the study. METHODS & PATIENTS: Fifteen patients (5 male, 10 female) with mild to moderately active UC were initially recruited in the open-label study of d-α tocopherol enema (8000 units/day). All patients were receiving concomitant therapy with 5-aminosalicylic acid derivatives (5-ASA) and/or immunomodulator medications. Disease activity was measured with Mayo disease activity index (DAI, including colonoscopy) and remission was defined as DAI of 2 out of 12 with no blood in stool. Clinical response was defined as a DAI reduction of 2. Modified DAI score (DAI without colonoscopy score) was used to assess the severity of the symptoms during follow up. Three patients have left the study since it beginning (1 on 3rd week, 2 after 12th week, due to personal reasons). RESULTS: At the end of 12th week, the average DAI score significantly decreased compared to the beginning of the study (2.3 ± 0.37 vs. 8 ± 0.48, P < 0.001). Disease activity remained stable during 12 months follow up, all 12 patients responded clinically to the therapy and remission was induced in 10 of them (83%). Follow up results show no case of recurrence among patients after 12 months. There have not been complications and patients tolerate the procedure with no major discomfort. Plasma level of vitamin E was normal in patients. CONCLUSION: The follow up results suggests that vitamin E not only reduces the development of colon inflammation, but also prevents the recurrence of UC in a 12 months survey. W1087 Does Therapy with Oral Mesalamine Have An Effect On Renal Function in Patients with Inflammatory Bowel Disease? Wojciech Blonski, Mark T. Osterman, Manuel Mendizabal, David Kotlyar, Ming V. Lin, Gary R. Lichtenstein Background: Mesalamine-based therapy is the mainstay of therapy for pts with inflammatory bowel disease (IBD). Long term use of mesalamine may be associated with worsening renal function. Our aim was to evaluate the renal function in patients with IBD treated with oral mesalamine. Based on daily mesalamine dose patients were divided into three cohorts: low dose (< 2.4 g), medium dose (> 2.4 g and 4.8 g) and high dose (> 4.8 g). Methods: A retrospective review of our electronic pt database was performed. Medical records were

W1086 Rectal Administration of D-Alpha Tocopherol for Active Ulcerative Colitis: Short Term Follow Up Results

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sfemales (≥55 years) with ICD-9 codes specific for IDA. n=124,460 underwent both upper& lower endoscopy during the one year evaluated. If up to 30% may have unexpalinedIDA after standard endoscopic evaluation, we would expect n=37,338 with a potential needfor additional SB evaluation. We observed n=30,088 contrast radiography studies performedand while despite known better sensitivity for identifying SB mucosal lesions, only n=7,894CE studies were performed (21% of expected). In addition, we further identified n=127,969individuals with IDA and GI bleeding (using ICD-9 codes specific for GI bleeding) who hadboth upper & lower endoscopy within the one year studied, n=38,636 contrast radiographystudies and n=16,513 CE studies were performed in this sub-cohort. Conclusions: Using alarge US-based medical claims database, we found potential underutilization of CE in theevaluation of patients with unexplained IDA. Despite its known inferior sensitivity comparedto CE in evaluating SB mucosa, we observed a high use of contrast radiography studies.These findings are despite current published data demonstrating the diagnostic value of CEin males and selected females with IDA who had a negative standard endoscopic evaluation.Additional research is required to elucidate possible reasons for this apparent underutilization.

W1083

Interference Between Cardiac Pacemaker and Wireless Capsule EndoscopyAntonietta G. Gravina, Bozzi Rosamaria, Agnese Miranda, Cattaneo Domenico, MarcoRomano, Angelo Pezzullo

Background and Aim: Wireless capsule endoscopy is a new endoscopic tool for the diagnosisand management of small bowel diseases. The main indication at present is the evaluationof GI bleeding of obscure origin, Crohn's disease, coeliac disease and small bowel tumors.Studies suggest that capsule endoscopy is associated with few adverse events. Cardiacpacemaker is reported as a relative controindication to capsule endoscopy. However thereis not much information available about the possibility of correctly performing a capsuleendoscopy in patients with cardiac pacemaker. Case report: A 75 year old man with ischemiccardiopathy with dilatative evolution treated with aorto-coronaric bypass, complicated bycardiac cirrhosis and mild ascites and renal failure had an early history of melena (haemo-globin: 7.0 g/dl ). He carried a pacemaker that had been implanted following unsuccessfulmedical treatment for atrial fibrillation (pacemaker model Biotronik-Kalos 05 VVI n/s36012460 with electrode Biotronik HL 150, n/s 56756B). Conventional diagnostic interven-tions, including upper and lower endoscopy, failed to identify the site of bleeding. A CTenteroclysis was performed and resulted normal. The patient underwent a small bowel studyby capsule endoscopy (Endocapsule Olympus ®); the recorder was positioned next toexternal abdominal sites near the pulse generator while the electric cardiac activity wascontinuously recorded, to confirm the absence of pacing inhibition by the video transmission.During video capsule examination, we revealed an interference lasting 20 minutes, betweenthe real time viewer and the pacemaker, confirmed after subsequent downloading on theworkstation. In particular, we found this interference only when the recorder was positionednear pacemaker and the viewer was connected on it. This interference resulted in the absenceof any image on the viewer and workstation screens. No interferences with recording imageswere found when the recorder was positioned at distance from pacemaker. Wireless capsuleendoscopy revealed active arterial bleeding in the jejunum; a double balloon enteroscopy,performed on the same day, confirmed the presence of an angiodysplasia. Continuous cardiacmonitoring by a central station was organized for the duration of the endoscopic procedures.Conclusion: This report dealing with video capsule endoscopy in a patient with cardiacpacemaker confirms the possibility of magnetic interference but does not exclude the correctfunctioning and diagnostic potential of the system on the basis of correct positioning betweenpacemaker and capsule endoscopy.

W1084

Capsule Endoscopy (CE) in “Suspected” Small Bowel (SB) Crohn's Disease(CD): Economic Impact of Disease Diagnosis and TreatmentJonathan A. Leighton, Ian M. Gralnek, Randel E. Richner, Michael J. Lacey, Frank J.Papatheofanis

PURPOSE: Diagnosing SB CD has been challenging due to limitations in endoscopic techno-logy. With the introduction of CE, there is the potential for diagnosing suspected CD earlier,thereby reducing costs of care. The aim of this economic analysis was to evaluate the clinicaland economic benefits of CE compared to ileocolonoscopy and small bowel follow through(SBFT) for the evaluation of suspected small bowel CD. METHODS: Using a decision analyticmodel we evaluated a hypothetical cohort of 10,000 patients with suspected CD. Weestimated the total expected global costs of the initial diagnostic work-up for suspected CDas well as expected follow-up costs of managing CD for one year after diagnosis includingoffice visits, laboratory tests, medications, hospitalizations, and adverse events. To estimatekey model variables we performed a systematic literature review to investigate the evidenceconcerning the use of ileocolonoscopy, SB radiography, and CE for evaluating suspectedCD. Themodel compared evaluationwith CE vs SBFT following ileocolonoscopy. A secondaryanalysis compared CE to SBFT when used for initial evaluation. RESULTS: Aggregate globalcosts for newly diagnosed patients for the first year who are medically managed are approxim-ately $8,295. For those requiring aggressive medical management, including anti-TNF ther-apy, the cost is $29,508, and for patients requiring hospitalization $49,074. Compared toSBFT as a first- or second-line diagnostic test, a CE-based evaluation costs approximately$46 less. At a sensitivity >98.7%, CE becomes less costly than SBFT, at a specificity of>86.4%, CE is less costly than SBFT.

W1085

A Standardized Data Sheet for Training Novice Capsule ReviewersJanice Freeman, Jason Roberts, Todd E. Dantzler, Brenda J. Hoffman

Introduction: Wireless capsule endoscopy pre-readers may be used to facilitate physicianinterpretation. Training the pre-reader may be time consuming, is not standardized, andmay not be feasible during regular business hours. A way to evaluate the progress and

A-650AGA Abstracts

accuracy of the pre-reader is needed to assure competency. This measure should be readilyadaptable in academic and private practices. Aim: To utilize a standard data sheet to providefeedback and progress assessment for novice wireless capsule endoscopy pre-readers.Methods: We developed a single sheet evaluation with listings of findings for each segmentof the examination. Each of these could be designated by a simple circle. The trainee (JF)reviewed the capsule studies and filled out the data sheet on each of 55 patients. Thephysician reviewers (TD, BH) separately reviewed the capsule study and then assessed thedata sheets provided. Feedback as to overcalls, missed lesions, and overall accuracy weregiven to the pre-reader. Results: 55 patients were evaluated with one data sheet per person.Agreement improved as the pre-reader gained experience with 37% for the first 30 studiesand 72% for the last 25. The false negative rate (FN) was 27% for the first 30 studiescompared to only 4% in the last 25. Conclusion: A simple one page standardized data sheetcan be used to facilitate training of novice capsule pre-readers. This allows for assessmentand training without a physician being physically present at the time of each review by thepre-reader. Pre-reader accuracy and FN rate improve with interpretation of at least 30 studies.Comparing Expert and Novice Wireless Capsule Readers

Figure 1

W1086

Rectal Administration of D-Alpha Tocopherol for Active Ulcerative Colitis:Short Term Follow Up ResultsSeyed Amir Mirbagheri, Behtash G. Nezami, Solmaz Assa

INTRODUCTION: Inflammatory bowel disease (IBD) is mainly characterized by upregulationof synthesis and release of different proinflammatory mediators. Recent studies suggest thatanti-inflammatory properties for d-α tocopherol may reduce the development of tissue injuryin IBD. We have previously reported the preliminary results of the study to investigate theanti-oxidant effects of rectal d-α tocopherol on patients with mild to moderate ulcerativecolitis (UC). Herein we report the 12 months follow up results of the study. METHODS &PATIENTS: Fifteen patients (5 male, 10 female) with mild to moderately active UC wereinitially recruited in the open-label study of d-α tocopherol enema (8000 units/day). Allpatients were receiving concomitant therapy with 5-aminosalicylic acid derivatives (5-ASA)and/or immunomodulator medications. Disease activity was measured with Mayo diseaseactivity index (DAI, including colonoscopy) and remission was defined as DAI of ≤ 2 outof 12 with no blood in stool. Clinical response was defined as a DAI reduction of ≥ 2.Modified DAI score (DAI without colonoscopy score) was used to assess the severity of thesymptoms during follow up. Three patients have left the study since it beginning (1 on 3rdweek, 2 after 12th week, due to personal reasons). RESULTS: At the end of 12th week, theaverage DAI score significantly decreased compared to the beginning of the study (2.3 ±0.37 vs. 8 ± 0.48, P < 0.001). Disease activity remained stable during 12 months followup, all 12 patients responded clinically to the therapy and remission was induced in 10 ofthem (83%). Follow up results show no case of recurrence among patients after 12 months.There have not been complications and patients tolerate the procedure with no majordiscomfort. Plasma level of vitamin E was normal in patients. CONCLUSION: The followup results suggests that vitamin E not only reduces the development of colon inflammation,but also prevents the recurrence of UC in a 12 months survey.

W1087

Does Therapy with Oral Mesalamine Have An Effect On Renal Function inPatients with Inflammatory Bowel Disease?Wojciech Blonski, Mark T. Osterman, Manuel Mendizabal, David Kotlyar, Ming V. Lin,Gary R. Lichtenstein

Background: Mesalamine-based therapy is the mainstay of therapy for pts with inflammatorybowel disease (IBD). Long term use of mesalamine may be associated with worsening renalfunction. Our aim was to evaluate the renal function in patients with IBD treated with oralmesalamine. Based on daily mesalamine dose patients were divided into three cohorts: lowdose (< 2.4 g), medium dose (> 2.4 g and ≤ 4.8 g) and high dose (> 4.8 g). Methods: Aretrospective review of our electronic pt database was performed. Medical records were