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.

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.

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.

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.

Reducing transmission of methicillin-resistant Staphylococcus aureus in a surgical ward of a resource-limited hospital in Indonesia: an intervention study.

BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in healthcare settings in Indonesia. AIM: To evaluate the effect of a bundle of preventive measures on the transmission and acquisition of MRSA in a surgical ward of a resource-limited hospital in Indonesia. METHODS: The study consisted of a pre-intervention (7 months), intervention (2 months), and post-intervention phase (5 months) and included screening for MRSA among eligible patients, healthcare workers (HCWs), and the hospital environment. In the intervention phase, a bundle of preventive actions was introduced, comprising: a hand hygiene educational program, cohorting of MRSA-positive patients, decolonization therapy for all MRSA-positive patients and HCWs, and cleaning and disinfection of the ward's innate environment. Hand hygiene compliance was assessed throughout the study period. The primary outcome was the acquisition rate of MRSA among patients per 1,000 patient-days at risk. Clonality of MRSA isolates was determined by Raman spectroscopy and multilocus sequence typing. FINDINGS: In total, 1,120 patients were included. Hand hygiene compliance rate rose from 15% pre-intervention to 65% post-intervention (P<0.001). The MRSA acquisition decreased from 9/1,000 patient-days at risk pre-intervention to 3/1,000 patient-days at risk post-intervention, but this difference did not reach statistical significance (P=0.08). Raman type 9 which belonged to ST239 was the single dominant MRSA clone. CONCLUSION: The introduction of a bundle of preventive measures may reduce MRSA transmission and acquisition among surgery patients in a resource-limited hospital in Indonesia, but additional efforts are needed.