Variation Between Hospitals in Outcomes and Costs of IBD Care: Results From the IBD Value Study.

BACKGROUND: Data on variation in outcomes and costs of the treatment of inflammatory bowel disease (IBD) can be used to identify areas for cost and quality improvement. It can also help healthcare providers learn from each other and strive for equity in care. We aimed to assess the variation in outcomes and costs of IBD care between hospitals. METHODS: We conducted a 12-month cohort study in 8 hospitals in the Netherlands. Patients with IBD who were treated with biologics and new small molecules were included. The percentage of variation in outcomes (following the International Consortium for Health Outcomes Measurement standard set) and costs attributable to the treating hospital were analyzed with intraclass correlation coefficients (ICCs) from case mix-adjusted (generalized) linear mixed models. RESULTS: We included 1010 patients (median age 45 years, 55% female). Clinicians reported high remission rates (83%), while patient-reported rates were lower (40%). During the 12-month follow-up, 5.2% of patients used prednisolone for more than 3 months. Hospital costs (outpatient, inpatient, and medication costs) were substantial (median: €8323 per 6 months), mainly attributed to advanced therapies (€6611). Most of the variation in outcomes and costs among patients could not be attributed to the treating hospitals, with ICCs typically between 0% and 2%. Instead, patient-level characteristics, often with ICCs above 50%, accounted for these variations. CONCLUSIONS: Variation in outcomes and costs cannot be used to differentiate between hospitals for quality of care. Future quality improvement initiatives should look at differences in structure and process measures of care and implement patient-level interventions to improve quality of IBD care. TRIAL REGISTRATION NUMBER: NL8276.

Variation in outcomes and costs cannot be used to differentiate between hospitals for quality of inflammatory bowel disease care. Future quality improvement initiatives should look at differences in structure and process measures and implement patient-level interventions to improve quality of inflammatory bowel disease care.

Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial.

BACKGROUND: Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. METHODS: We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. FINDINGS: Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). INTERPRETATION: The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. FUNDING: Atrium Maquet Getinge Group.

Validity of the self-administered comorbidity questionnaire in patients with inflammatory bowel disease.

Background: The International Consortium for Health Outcomes Measurement has selected the self-administered comorbidity questionnaire (SCQ) to adjust case-mix when comparing outcomes of inflammatory bowel disease (IBD) treatment between healthcare providers. However, the SCQ has not been validated for use in IBD patients. Objectives: We assessed the validity of the SCQ for measuring comorbidities in IBD patients. Design: Cohort study. Methods: We assessed the criterion validity of the SCQ for IBD patients by comparing patient-reported and clinician-reported comorbidities (as noted in the electronic health record) of the 13 diseases of the SCQ using Cohen's kappa. Construct validity was assessed using the Spearman correlation coefficient between the SCQ and the Charlson Comorbidity Index (CCI), clinician-reported SCQ, quality of life, IBD-related healthcare and productivity costs, prevalence of disability, and IBD disease activity. We assessed responsiveness by correlating changes in the SCQ with changes in healthcare costs, productivity costs, quality of life, and disease activity after 15 months. Results: We included 613 patients. At least fair agreement (κ > 0.20) was found for most comorbidities, but the agreement was slight (κ < 0.20) for stomach disease [κ = 0.19, 95% CI (-0.03; 0.41)], blood disease [κ = 0.02, 95% CI (-0.06; 0.11)], and back pain [κ = 0.18, 95% CI (0.11; 0.25)]. Correlations were found between the SCQ and the clinician-reported SCQ [ρ = 0.60, 95% CI (0.55; 0.66)], CCI [ρ = 0.39, 95% CI (0.31; 0.45)], the prevalence of disability [ρ = 0.23, 95% CI (0.15; 0.32)], and quality of life [ρ = -0.30, 95% CI (-0.37; -0.22)], but not between the SCQ and healthcare or productivity costs or disease activity (|ρ| ⩽ 0.2). A change in the SCQ after 15 months was not correlated with a change in any of the outcomes. Conclusion: The SCQ is a valid tool for measuring comorbidity in IBD patients, but face and content validity should be improved before being used to correct case-mix differences.

MRI-based pre- and postprandial flow in the mesenteric vasculature of patients with suspected chronic mesenteric ischemia.

PURPOSE: The physiological increase of mesenteric blood flow after a meal is impaired in patients with occlusive chronic mesenteric ischemia (CMI). This principle could be used to develop a highly desired diagnostic test assessing the sufficiency of the collateral mesenteric circulation. This study assesses the potential to identify CMI patients using two-dimensional time-resolved phase-contrast magnetic resonance imaging (2D PC-MRI) flow measurements. METHOD: This prospective cohort study included patients with suspected CMI, based on: typical history, imaging, and functional testing. Cardiac gated 2D PC-MRI flow measurements (expressed as ml/min/kg) were performed in mesenteric arteries and veins during inspiration and expiration, after six hours of fasting and 20, 30, and 40 min after a meal challenge with a high caloric drink. RESULTS: Flow measurements were obtained in 19 patients: 8 CMI and 11 non-CMI. CMI patients showed a significantly smaller increase in postprandial blood flow in the superior mesenteric artery (SMA) at 30 and 40 min (30 min CMI 1.27(0.12-2.44) vs. non-CMI 7.82(6.28-10.90); 40 min CMI 0.30(-0.26-3.16) vs. non-CMI 7.94(6.32-10.90)) and a lower total arterial flow at 40 min (CMI 3.21(-0.72-5.05) vs. non-CMI 9.31(5.58-13.83)). Repeated flow measurements showed normalization of impaired postprandial venous flow after mesenteric artery stenting in one patient. CONCLUSIONS: The significantly lower increase in postprandial mesenteric blood flow in CMI patients confirms the promise of mesenteric blood flow measurements, before and 30-40 min after a meal, as a future diagnostic test to identify CMI patients among patients with a high clinical suspicion of CMI and mesenteric artery stenosis.

Gelatinous bone marrow transformation due to extensive weight loss in median arcuate ligament syndrome.

A 34-year-old man was referred to the outpatient clinic because of progressive abdominal pain, weight loss and pancytopenia. His body mass index (BMI) had fallen to 14.2 kg/m2 A CT angiography (CTA) showed narrowing of the truncus coeliacus with poststenotic dilation, and duodenal biopsy revealed ischaemia establishing a rare diagnosis: median arcuate ligament syndrome (MALS). This explained the postprandial pain and minimal intake. Further pancytopenia workup was performed. The bone marrow displayed gelatinous marrow transformation (GMT), a rare disorder of unknown pathogenesis, which has been associated with severe malnutrition. The final diagnosis was pancytopenia secondary to GMT due to severe malnutrition caused by MALS. The abnormalities in the bone marrow may be reversible by restoring nutritional status. This case emphasises the awareness of GMT in patients with weight loss, malnutrition and cytopenias. To our knowledge, this is the first report demonstrating an association between pancytopenia and MALS.

Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period.

INTRODUCTION: Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation. METHODS AND ANALYSIS: IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included. ETHICS AND DISSEMINATION: The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020-075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences. TRIAL REGISTRATION NUMBER: NL8276.

Systematic review: societal cost of illness of inflammatory bowel disease is increasing due to biologics and varies between continents.

BACKGROUND: Knowledge of the cost of illness of inflammatory bowel disease (IBD) is essential for health policy makers worldwide. AIM: To assess the cost of illness of IBD from the societal perspective taking into account time trends and geographical differences. METHODS: A systematic review of all population-based studies on cost of illness of IBD published in Embase, Medline, Web of Science and Google Scholar. Methodology of included studies was assessed and costs were adjusted to 2018 US dollars. RESULTS: Study methodologies differed considerably, with large differences in perspective, valuation method and population. For prevalent Crohn's disease (CD) cases in the last ten years annual healthcare costs were in Asia $4417 (range $1230-$31 161); Europe $12 439 ($7694-$15 807) and North America $17 495 ($14 454-$20 535). For ulcerative colitis (UC), these were $1606 ($309-$14 572), $7224 ($3228-$9779) and $13 559 ($13 559-$13 559). The main cost driver was medication, the cost of which increased considerably between 1985 and 2018, while outpatient and inpatient costs remained stable. IBD had a negative impact on work productivity. Annual costs of absenteeism for CD and UC were in Asia (with presenteeism) $5638 ($5638-$5638) and $4828 ($4828-$4828); Europe $2660 ($641-$5277) and $2394 ($651-$5992); North America $752 ($307-$1303) and $1443 ($85-$2350). CONCLUSION: IBD societal cost of illness is increasing, driven by growing costs of medication, and varies considerably between continents. While biologic therapy was expected to decrease inpatient costs by reducing hospitalisations and surgery, these costs have not declined.

Early risk stratification of patients with suspected chronic mesenteric ischaemia using a symptom and mesenteric artery calcium score based score chart.

BACKGROUND: The mesenteric artery calcium score (MACS) identifies patients with possible chronic mesenteric ischaemia (CMI) using standard computed tomography (CT) imaging. The MACS does not necessitate a dedicated computed tomography angiography (CTA) which is required for evaluation of mesenteric artery patency. This study aimed to test the use of a symptom and MACS based score chart to facilitate the selection of patients with a low probability of CMI, in whom further diagnostic workup can be omitted, and to validate the CTA-based score chart proposed by van Dijk et al. which guides treatment decisions in patients with suspected CMI. METHODS: This retrospective study included consecutive patients with suspected CMI. The Agatston definition was used to calculate the MACS. Multivariable logistic regression analysis was used to create a MACS score chart, which was applied in all patients to determine its discriminative ability. The score chart by van Dijk et al. was validated in this independent external patient series. RESULTS: Hundred-ninety-two patients were included, of whom 49 had CMI. The MACS score chart composed of the variables weight loss, postprandial abdominal pain, history of cardiovascular disease, and MACS, showed an excellent discriminative ability (area under the curve [AUC] 0.87). CMI risks were 2.1% in the low-risk group (0-4 points) and 39.1% in the increased risk group (5-10 points); sensitivity (97.8%) and negative predictive value (NPV; 97.9%) were high. The CTA-based score chart by van Dijk et al. showed an excellent discriminative ability (AUC 0.89). CONCLUSION: The MACS score chart shows promise for early risk stratification of patients with suspected CMI based on a near-perfect NPV. It is complementary to the CTA-based score chart by van Dijk et al., which showed excellent external validity and is well suited to guide subsequent (invasive) treatment decisions in patients with suspected CMI.

Mesenteric artery calcium scoring: a potential screening method for chronic mesenteric ischemia.

OBJECTIVE: A practical screening tool for chronic mesenteric ischemia (CMI) could facilitate early recognition and reduce undertreatment and diagnostic delay. This study explored the ability to discriminate CMI from non-CMI patients with a mesenteric artery calcium score (MACS). METHODS: This retrospective study included CTAs of consecutive patients with suspected CMI in a tertiary referral center between April 2016 and October 2019. A custom-built software module, using the Agatston definition, was developed and used to calculate the MACS for the celiac artery (CA), superior mesenteric artery (SMA), and inferior mesenteric artery. Scoring was performed by two blinded observers. Interobserver agreement was determined using 39 CTAs scored independently by both observers. CMI was defined as sustained symptom improvement after treatment. Non-CMI patients were patients not diagnosed with CMI after a diagnostic workup and patients not responding to treatment. RESULTS: The MACS was obtained in 184 patients, 49 CMI and 135 non-CMI. Interobserver agreement was excellent (intraclass correlation coefficient 0.910). The MACS of all mesenteric arteries was significantly higher in CMI patients than in non-CMI patients. ROC analysis of the combined MACS of CA + SMA showed an acceptable AUC (0.767), high sensitivity (87.8%), and high NPV (92.1%), when using a ≥ 29.7 CA + SMA MACS cutoff. Comparison of two CTAs, obtained in the same patient at different points in time with different scan and reconstruction parameters, was performed in 29 patients and revealed significant differences in MACSs. CONCLUSION: MACS seems a promising screening method for CMI, but correction for scan and reconstruction parameters is warranted. KEY POINTS: • A mesenteric artery calcium score obtained in celiac artery and superior mesenteric artery has a high negative predictive value for chronic mesenteric ischemia and could serve as a screening tool. • Interobserver agreement of the mesenteric artery calcium score is excellent. • Scan and reconstruction parameters influence the mesenteric artery calcium score and warrant the development of a method to correct for these parameters.

The Incidence of Chronic Mesenteric Ischemia in the Well-Defined Region of a Dutch Mesenteric Ischemia Expert Center.

INTRODUCTION: This study aimed to determine the incidence of chronic mesenteric ischemia (CMI) and to examine the influence of the etiological cause, location, and severity of a mesenteric artery stenosis on the probability of having CMI. METHODS: A prospective database, containing the details of all patients with suspected CMI referred to a renowned CMI expert center, was used. Patients residing within the expert centers' well-defined region, between January 2014 and October 2019, were included. CMI was diagnosed when patients experienced sustained symptom improvement after treatment. RESULTS: This study included 358 patients, 75 had a ≥50% atherosclerotic stenosis of 1 vessel (CMI 16%), 96 of 2 or 3 vessels (CMI 81%), 81 celiac artery compression (CMI 25%), and 84 no stenosis (CMI 12%). In total, 138 patients were diagnosed with CMI, rendering a mean incidence of 9.2 (95% confidence interval [CI] 6.2-13.7) per 100,000 inhabitants. Atherosclerotic CMI was most common, with a mean incidence of 7.2 (95% CI 4.6-11.3), followed by median arcuate ligament syndrome 1.3 (95% CI 0.5-3.6) and chronic nonocclusive mesenteric ischemia 0.6 (95% CI 0.2-2.6). The incidence of CMI was highest in female patients (female patients 12.0 [95% CI 7.3-19.6] vs male patients 6.5 [95% CI 3.4-12.5]) and increased with age. CMI was more prevalent in the presence of a ≥70% atherosclerotic single-vessel stenosis of the superior mesenteric artery (40.6%) than the celiac artery (5.6%). DISCUSSION: The incidence of CMI is higher than previously believed and increases with age. Probability of CMI seems highest in suspected CMI patients with multivessel disease or a ≥70% atherosclerotic single-vessel superior mesenteric artery stenosis.

European guidelines on chronic mesenteric ischaemia - joint United European Gastroenterology, European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Gastrointestinal and Abdominal Radiology, Netherlands Association of Hepatogastroenterologists, Hellenic Society of Gastroenterology, Cardiovascular and Interventional Radiological Society of Europe, and Dutch Mesenteric Ischemia Study group clinical guidelines on the diagnosis and treatment of patients with chronic mesenteric ischaemia.

Chronic mesenteric ischaemia is a severe and incapacitating disease, causing complaints of post-prandial pain, fear of eating and weight loss. Even though chronic mesenteric ischaemia may progress to acute mesenteric ischaemia, chronic mesenteric ischaemia remains an underappreciated and undertreated disease entity. Probable explanations are the lack of knowledge and awareness among physicians and the lack of a gold standard diagnostic test. The underappreciation of this disease results in diagnostic delays, underdiagnosis and undertreating of patients with chronic mesenteric ischaemia, potentially resulting in fatal acute mesenteric ischaemia. This guideline provides a comprehensive overview and repository of the current evidence and multidisciplinary expert agreement on pertinent issues regarding diagnosis and treatment, and provides guidance in the multidisciplinary field of chronic mesenteric ischaemia.

Endovascular Pressure Measurements to Assess the Functional Severity of Mesenteric Arterial Stenoses.

PURPOSE: To assess the ability of pressure measurements to discriminate clinically significant celiac artery (CA) or superior mesenteric artery (SMA) stenosis in patients with suspected chronic mesenteric ischemia (CMI). MATERIALS AND METHODS: Single-center, retrospective cohort study of 41 intra-arterial pressure measurements during mesenteric angiography with intended revascularization, performed in 37 patients (mean age 67.7 ± 10.8 years, 62% female) between April 2015 and May 2017. Simultaneous prestenotic and poststenotic pressure measurements had been obtained before and after intra-arterial administration of nitroglycerin. Revascularization was performed in 38 of 41 procedures. Definitive diagnosis of CMI was defined as patient-reported symptom relief or improvement after successful revascularization. RESULTS: Pressure gradients obtained after vasodilator administration were significantly higher in CAs and SMAs with ≥50% stenosis. Pressure ratios (pressure distal [Pd]/pressure aorta [Pa]) obtained after vasodilator administration were significantly higher in CAs with ≥50% stenosis. Subgroup analysis of 22 patients with a ≥50% stenosis of either CA or SMA showed significantly higher pressure gradients and Pd/Pa ratios after vasodilator administration in CMI patients (median pressure gradient: CMI [interquartile ratio] 36 [21-40] mm Hg versus no-CMI 20 [9-21] mm Hg, P = 0.041; Pd/Pa: CMI 0.703 [0.598-0.769] versus no-CMI 0.827 [0.818-0.906], P = .009). A ≤0.8 Pd/Pa cutoff value after administration of a vasodilator best identified a clinically relevant stenosis, with 86% sensitivity and 83% specificity. Complications related to the pressure measurements were not observed. CONCLUSIONS: Intra-arterial pressure measurements are feasible and safe. Low Pd/Pa ratios were associated with clinically relevant CA or SMA stenosis.

No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis.

BACKGROUND & AIMS: Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP. METHODS: We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test. RESULTS: Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). Adverse event rates did not differ significantly between groups. CONCLUSIONS: In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. There were no significant differences in adverse events rates. Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416.

Single-Center Retrospective Comparative Analysis of Transradial, Transbrachial, and Transfemoral Approach for Mesenteric Arterial Procedures.

PURPOSE: To assess feasibility and safety of transradial access (TRA) compared with transfemoral access (TFA) and transbrachial access (TBA) for mesenteric arterial endovascular procedures. MATERIALS AND METHODS: A retrospective cohort analysis was performed including all consecutive patients who underwent a mesenteric arterial procedure in a tertiary referral center between May 2012 and February 2018. Exclusion criteria were absence of data and lost to follow-up within 24 hours after the procedure. During the study period, 103 patients underwent 148 mesenteric arterial procedures (TBA, n = 52; TFA, n = 39; TRA, n = 57). Mean patient age was 64.3 years ± 13.3, and 91 patients (62%) were women. Primary outcomes were vascular access specified technical success rate and access site complication rate, as reported in hospital records. RESULTS: Technical success rate specified for the vascular access technique did not differ between the 3 approaches (TBA 96%, TFA 87%, TRA 91%; TRA vs TBA, P = .295; TBA vs TFA, P = .112; TRA vs TFA, P = .524), and overall access site complication rate was not different between the 3 approaches (TBA 42%, TFA 23%, TRA 35%; TRA vs TBA, P = .439; TBA vs TFA, P = .055; TRA vs TFA, P = .208). However, more major access site complications were reported for TBA than for TRA or TFA (TBA 17%, TFA 3%, TRA 2%; TRA vs TBA, P = .005; TBA vs TFA, P = .026; TRA vs TFA, P = .785). CONCLUSIONS: TRA is a safe and feasible approach for mesenteric arterial procedures comparable to TFA, but with a significantly lower major access site complication rate than TBA.

Validation of a score chart to predict the risk of chronic mesenteric ischemia and development of an updated score chart.

Background and objective: The objective of this article is to externally validate and update a recently published score chart for chronic mesenteric ischemia (CMI). Methods: A multicenter prospective cohort analysis was conducted of 666 CMI-suspected patients referred to two Dutch specialized CMI centers. Multidisciplinary consultation resulted in expert-based consensus diagnosis after which CMI consensus patients were treated. A definitive diagnosis of CMI was established if successful treatment resulted in durable symptom relief. The absolute CMI risk was calculated and discriminative ability of the original chart was assessed by the c-statistic in the validation cohort. Thereafter the original score chart was updated based on the performance in the combined original and validation cohort with inclusion of celiac artery (CA) stenosis cause. Results: In 8% of low-risk patients, 39% of intermediate-risk patients and 94% of high-risk patients of the validation cohort, CMI was diagnosed. Discriminative ability of the original model was acceptable (c-statistic 0.79). The total score of the updated chart ranged from 0 to 28 points (low risk 19% absolute CMI risk, intermediate risk 45%, and high risk 92%). The discriminative ability of the updated chart was slightly better (c-statistic 0.80). Conclusion: The CMI prediction model performs and discriminates well in the validation cohort. The updated score chart has excellent discriminative ability and is useful in clinical decision making.

Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial.

BACKGROUND: Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly higher patency rates for covered stents (CS). The Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI) trial is designed to prospectively assess the patency of CS versus BMS in patients with atherosclerotic CMI. METHODS/DESIGN: The CoBaGI trial is a randomized controlled, parallel-group, patient- and investigator-blinded, superiority, multicenter trial conducted in six centers of the Dutch Mesenteric Ischemia Study group (DMIS). Eighty-four patients with a consensus diagnosis of atherosclerotic CMI are 1:1 randomized to either a balloon-expandable BMS (Palmaz Blue with rapid-exchange delivery system, Cordis Corporation, Bridgewater, NJ, USA) or a balloon-expandable CS (Advanta V12 over-the-wire, Atrium Maquet Getinge Group, Hudson, NH, USA). The primary endpoint is the primary stent-patency rate at 24 months assessed with CT angiography. Secondary endpoints are primary stent patency at 6 and 12 months and secondary patency rates, freedom from restenosis, freedom from symptom recurrence, freedom from re-intervention, quality of life according the EQ-5D-5 L and SF-36 and cost-effectiveness at 6, 12 and 24 months. DISCUSSION: The CoBaGI trial is designed to assess the patency rates of CS versus BMS in patients treated for CMI caused by atherosclerotic mesenteric stenosis. Furthermore, the CoBaGI trial should provide insights in the quality of life of these patients before and after stenting and its cost-effectiveness. The CoBaGI trial is the first randomized controlled trial performed in CMI caused by atherosclerotic mesenteric artery stenosis. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02428582 . Registered on 29 April 2015.

Clinical management of chronic mesenteric ischemia.

This This Dutch Mesenteric Ischemia Study group consists of: Ron Balm, Academic Medical Center, Amsterdam Gert Jan de Borst, University Medical Center Utrecht, Utrecht Juliette T Blauw, Medisch Spectrum Twente, Enschede Marco J Bruno, Erasmus MC University Medical Center, Rotterdam Olaf J Bakker, St Antonius Hospital, Nieuwegein Louisa JD van Dijk, Erasmus MC University Medical Center, Rotterdam Hessel CJL Buscher, Gelre Hospitals, Apeldoorn Bram Fioole, Maasstad Hospital, Rotterdam Robert H Geelkerken, Medisch Spectrum Twente, Enschede Jaap F Hamming, Leiden University Medical Center, Leiden Jihan Harki, Erasmus MC University Medical Center, Rotterdam Daniel AF van den Heuvel, St Antonius Hospital, Nieuwegein Eline S van Hattum, University Medical Center Utrecht, Utrecht Jan Willem Hinnen, Jeroen Bosch Hospital, 's-Hertogenbosch Jeroen J Kolkman, Medisch Spectrum Twente, Enschede Maarten J van der Laan, University Medical Center Groningen, Groningen Kaatje Lenaerts, Maastricht University Medical Center, Maastricht Adriaan Moelker, Erasmus MC University Medical Center, Rotterdam Desirée van Noord, Franciscus Gasthuis & Vlietland, Rotterdam Maikel P Peppelenbosch, Erasmus MC University Medical Center, Rotterdam André S van Petersen, Bernhoven Hospital, Uden Pepijn Rijnja, Medisch Spectrum Twente, Enschede Peter J van der Schaar, St Antonius Hospital, Nieuwegein Luke G Terlouw, Erasmus MC University Medical Center, Rotterdam Hence JM Verhagen, Erasmus MC University Medical Center, Rotterdam Jean Paul PM de Vries, University Medical Center Groningen, Groningen Dammis Vroegindeweij, Maasstad Hospital, Rotterdam review provides an overview on the clinical management of chronic mesenteric ischemia (CMI). CMI is defined as insufficient blood supply to the gastrointestinal tract, most often caused by atherosclerotic stenosis of one or more mesenteric arteries. Patients classically present with postprandial abdominal pain and weight loss. However, patients may present with, atypically, symptoms such as abdominal discomfort, nausea, vomiting, diarrhea or constipation. Early consideration and diagnosis of CMI is important to timely treat, to improve quality of life and to prevent acute-on-chronic mesenteric ischemia. The diagnosis of CMI is based on the triad of clinical symptoms, radiological evaluation of the mesenteric vasculature and if available, functional assessment of mucosal ischemia. Multidisciplinary consensus on the diagnosis of CMI is of paramount importance to adequately select patients for treatment. Patients with a consensus diagnosis of single-vessel or multi-vessel atherosclerotic CMI are preferably treated with endovascular revascularization.

Oxygen-dependent delayed fluorescence of protoporphyrin IX measured in the stomach and duodenum during upper gastrointestinal endoscopy.

Protoporphyrin IX-triplet state lifetime technique (PpIX-TSLT) is a method used to measure oxygen (PO2 ) in human cells. The aim of this study was to assess the technical feasibility and safety of measuring oxygen-dependent delayed fluorescence of 5-aminolevulinic acid (ALA)-induced PpIX during upper gastrointestinal (GI) endoscopy. Endoscopic delayed fluorescence measurements were performed 4 hours after oral administration of ALA in healthy volunteers. The ALA dose administered was 0, 1, 5 or 20 mg/kg. Measurements were performed at three mucosal spots in the gastric antrum, duodenal bulb and descending duodenum with the catheter above the mucosa and while applying pressure to induce local ischemia and monitor mitochondrial respiration. During two endoscopies, measurements were performed both before and after intravenous administration of butylscopolamine. Delayed fluorescence measurements were successfully performed during all 10 upper GI endoscopies. ALA dose of 5 mg/kg showed adequate signal-to-noise ratio (SNR) values >20 without side effects. All pressure measurements showed significant prolongation of delayed fluorescence lifetime compared to measurements performed without pressure (P < .001). Measurements before and after administration of butylscopolamine did not differ significantly in the duodenal bulb and descending duodenum. Measurements of oxygen-dependent delayed fluorescence of ALA-induced PpIX in the GI tract during upper GI endoscopy are technically feasible and safe.