Circulation, Volume 146, Issue Suppl_1, Page A9613-A9613, November 8, 2022. Introduction:Arterial dissection or rupture during percutaneous angioplasty is rare but can be lethal. We invented a balloon-expandable stent with a very thin membrane typed biodegradable graft for the treatment of arterial dissection (BioGard).Hypothesis:The efficacy and safety of BioGard were evaluated in the rabbit iliac artery rupture model. The devices would be helpful to seal the emergent blood extravasation due to arterial perforation and reduce unfavorable vascular events in long-term follow-up.Method:Twenty iliac arterial dissections by balloon over-inflation were induced under the guidance of angiography. Twelve rabbits with huge contrast extravasation to retroperitoneal space (Ellis type 3) were treated using BioGards. Serial histologic examinations and micro-computed tomography (CT) were performed at 1, 2, and 8 weeks and 3, 6, 9, and 12 months. Final angiography at 1 year was performed to evaluate any vascular complication.Results:There are no significant adverse cardiovascular events after one year of BioGard implantation. Micro-CT and follow-up angiography at one year revealed no case of significant in-stent restenosis and thrombotic occlusion in vivo. Early-stage histologic examination demonstrated that disrupted vessels were completely sealed up by BioGard with mural hematoma, inflammatory cell infiltration, and red thrombi. Mid- and long-term histologic examination revealed patent stents and neointimal coverage over the stents with biodegraded graft material and mild peri-strut area inflammatory response.Conclusions:Twelve months post-BioGard implantation in rabbit iliac artery dissections demonstrated good efficacy and safety. BioGard at a severely dissected artery would be an option for preventing lethal vascular events. Further clinical evaluation of this novel technology would be warranted.
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Abstract 10434: Very Late Stent Thrombosis Caused by Rupture of In-Stent Neoatherosclerosis 15-Years After Bare Nitinol Stent Implantation in Superficial Femoral Artery Visualized With Multimodality Imaging
Circulation, Volume 146, Issue Suppl_1, Page A10434-A10434, November 8, 2022. A 77-year-old man complained of intractable rest pain in his left leg, which occurred one week before hospital admission. His past medical history included diabetes mellitus and history of smoking. He was prescribed cilostazol for treatment of peripheral vascular disease. He underwent endovascular therapy (EVT) 15-years earlier with a bare nitinol stent (BNS) implantation in his left superficial femoral artery (SFA), and no restenosis was detected by annual duplex ultrasound (DUS) follow-up until this session. DUS observed restenosis with 14.8 peak systolic velocity ratio, and initial angiography (Panel A, white arrow) revealed subtotal occlusion at the stented lesion. Intravascular angioscopy (Panel C) demonstrated disrupted cavity with red thrombus attached. Optical frequency domain imaging (OFDI) (Panel D) and intravascular ultrasound (IVUS) (Panel E) demonstrated fibrous cap disruption with a clear cavity formed inside the plaque (6 to 11 o’clock in Panel D and E), as well as thin sheet calcification. The other side (11 to 6 o’clock) shows a signal rich region with high attenuation that indicates fibroatheroma. The lesion was diagnosed as very late stent thrombosis (VLST) because multimodality images revealed rupture of in-stent neoatherosclerosis with red thrombus attached. After successful vessel preparation with a high-pressure 6mm balloon, 6 mm drug-coated balloons were used. The completion angiogram revealed an acceptable result with neither residual stenosis nor flow-limiting dissection (Panel B). Neoatherosclerosis has been reported as one of the major causes of VLST in the coronary arteries; however, it has rarely been reported in the peripheral arteries. This case illustrates valuable direct visualization with multimodality imaging of a case with VLST caused by rupture of in-stent neoatherosclerosis 15-years after BNS implantation, and the value of multimodality imaging for comprehensive evaluation to diagnose the mechanism of VLST in SFA.
Abstract 14285: Comparison of Percutaneous Coronary Intervention-Related Adverse Cardiac Outcomes in Patients With In-Stent versus De Novo Chronic Total Occlusion: A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A14285-A14285, November 8, 2022. Introduction:Contemporary literature reveals a range of cardiac complications in patients who receive the percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).Hypothesis:This study compared the adverse cardiac outcomes and procedural/technical success rates between the patients groups of in-stent (IS) CTO PCI and de novo CTO PCI.Methods:This systematic review and meta-analysis compared odds for primary (all-cause mortality, MACE, cardiac death post PCI, stroke) and secondary (bleeding requiring blood transfusion, ischemia-driven target-vessel revascularization, PCI procedural success, PCI technical success, and target-vessel MI) endpoints between 2,734 patients who received PCI for IS CTO and 17,808 for de novo CTO. Odds ratios for outcome variables were calculated within 95% confidence intervals (CIs) via the Mantel-Haenszel method. The pooled analysis was undertaken for observational (retrospective/prospective) single- and multi-centered studies published between January 2005 and December 2021.Results:We found 57% higher, 166% higher, 129% higher, and 57% lower odds for MACE (OR: 1.57, 95% CI 1.31, 1.89,p
Abstract 10491: Drug-Coated Balloon and Drug-Eluting Stent Safety in Patients With Femoropopliteal and Severe Chronic Kidney Disease
Circulation, Volume 146, Issue Suppl_1, Page A10491-A10491, November 8, 2022. Background:Severe-stage chronic kidney disease (CKD) patients were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCB) and drug-eluting stents (DES) vs. plain balloon angioplasty (POBA) and bare metal stents (BMS). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk.Methods:We studied patients undergoing femoropopliteal interventions (9/2016-12/2018) from Medicare-linked VQI registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4-5) CKD receiving DCB/DES, (4) severe-stage CKD receiving POBA/BMS.Results:We studied 8,799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% vs. 51% in early-stage vs. severe-stage CKD patients. Twenty-four-month mortality risk for early-stage CKD patients receiving DCB/DES (reference group) was 21% vs. 28% (HR=1.47, 95% CI, 1.31-1.65) for those receiving POBA/BMS; severe-stage CKD patients: those receiving DCB/DES had a 49% (HR=2.61,95% CI, 2.06-3.31) mortality risk vs. 52% (HR=3.64, 95% CI, 2.91-4.55) for those receiving POBA/BMS (interaction P
Abstract 15622: Hydro-Pneumopericardium Due to Esophageal-Pericardial Fistula: A Rare Complication of Esophageal Stent Migration
Circulation, Volume 146, Issue Suppl_1, Page A15622-A15622, November 8, 2022. Introduction:Esophageal-pericardial fistulas are rare complications of a variety of conditions ranging from benign esophageal disorders to iatrogenic etiologies such as radiofrequency catheter ablation. Here, we present a unique case of esophageal-pericardial fistula formation following esophageal stent migration in the setting of ulcerative esophagitis and benign esophageal stricture.Case Presentation:A 53-year-old woman with a history of ulcerative esophagitis and associated esophageal stricture was managed with esophageal stenting. Following stenting, her course was complicated by esophageal stent migration, resulting in severe dysphagia and multiple gastrointestinal bleeds requiring percutaneous endoscopic gastrostomy (PEG) tube placement. She presented with fatigue, melena, and dark output from her PEG tube and was hypotensive, tachycardic, and tachypneic. An echocardiogram (Figure 1A) showed hydro-pneumopericardium with cardiac tamponade physiology requiring emergent pericardiocentesis and aspirated fluid shown in Figure 1B. A subsequent computed tomography (CT) scan of the chest demonstrated a large complex pericardial effusion with air in the anterior pericardium, a large esophageal-pericardial fistula, and a moderate left hydropneumothorax (Figure 1C). Given the extent of her esophageal defect, the patient was taken for an esophagectomy with esophagostomy formation.Discussion:On review, we found only a few cases of hydro-pneumopericardium in the context of spontaneous pericardial herniation due to subcutaneous emphysema, radiofrequency ablation for atrial arrhythmias and esophagectomy for esophageal adenocarcinoma. However, there has been no report of esophageal-pericardial fistula due to esophageal stent migration.Conclusion:In an appropriate setting, clinicians should maintain a high index of suspicion for esophageal-pericardial fistulas, as delay in the management of these conditions could be fatal.
Abstract 11896: Spontaneous Heparin-Induced Thrombocytopenia Presenting as Acute Stent Thromboses Following an Acute St-Segment Elevation Myocardial Infarction
Circulation, Volume 146, Issue Suppl_1, Page A11896-A11896, November 8, 2022. Introduction:Spontaneous heparin-induced thrombocytopenia (HIT) is a rare clinical variant that develops without prior exposure to heparin. We present a 40-year-old man who was diagnosed with spontaneous HIT after an acute ST-segment elevation myocardial infarction complicated by multiple acute stent thromboses and left ventricular (LV) thrombus.Case:A 40-year-old previously healthy man with no known history of heparin exposure presented to our emergency department with an acute ST-segment elevation myocardial infarction. Emergent coronary angiography revealed a severely thrombotic 100% occlusion of his distal left anterior descending artery for which thrombectomy and percutaneous coronary intervention (PCI) were performed with placement of a drug eluting stent. Prior to angiography, the patient received 4000 units of unfractionated heparin and an additional 2000 units intra-arterially during the case. Labs prior to PCI revealed thrombocytopenia and HIT enzyme-linked immunoassay testing was sent. He underwent repeat angiography two additional times during his course for recurrent chest pain which both revealed acute stent thrombosis. HIT testing eventually returned positive for the presence of platelet factor 4 antibodies. A subsequent serotonin release assay returned positive, confirming the diagnosis of HIT. A transthoracic echocardiogram during his hospitalization also revealed an LV thrombus.Discussion:Heparin-induced thrombocytopenia (HIT) is traditionally diagnosed after thrombocytopenia develops 5 to 10 days after exposure to heparin. However, there have been rare reports of a spontaneous form of HIT that can occur without prior exposure to heparin. This case highlights a rare presentation of spontaneous HIT. Although infrequent, cardiologists should be aware of atypical presentations of HIT, since almost all patients will receive heparin prior to or during coronary angiography and coronary interventions. Spontaneous HIT should be considered in all patients who present with unexplained thrombocytopenia with arterial and/or venous thrombi. Failure to recognize this clinical entity could lead to potentially life-threatening thrombotic complications from further administration of heparin.
Abstract 15601: Optimal Virtual Monoenergetic Settings for Spectral Ct With a Dual-Layer Detector: A Breakthrough in Evaluating the Patency of the Coronary Arterial Lumen With a Metallic Stent in a Real-World Study
Circulation, Volume 146, Issue Suppl_1, Page A15601-A15601, November 8, 2022. Introduction:Evaluation of the patency of a metallic stent in coronary arteries using CT is difficult because the metallic stent causes a blooming artifact. The CT values of metallic stents are influenced by tube kilovoltage (kV). Recent spectral CT with a dual-layer detector can generate CT images at any kiloelectron voltage (keV) (range: 40-200) after ordinary acquisition using virtual monoenergetic settings (VMS).Hypothesis:Using a new spectral CT, we can determine the optimal VMS for evaluating the patency of stents in coronary arteries.Methods:We performed enhanced 128 slice Spectral CT 7500 scans with a dual-layer detector in 35 patients with CAC who underwent implantation of a metallic stent in coronary arteries (tube voltage: 120 kV). After scanning, VMS images at various keV values were created from the spectral-based images. We measured the mean CT values of the metallic stent, coronary artery calcification (CAC), lumen in the left coronary artery (LCA), and fat tissue around the coronary arteries in the axial images at each keV in the early phase with contrast.Results:Lower keV values were associated with markedly increased mean CT values of the metallic stent and CAC. The CT values of the lumen in the LCA were moderately increased. Conversely, the CT values of fat tissue were slightly decreased. The greatest differences in mean CT values between the metallic stent and lumen in the LCA were observed at 40-50 keV, however, those between the metallic stent and CAC were observed at 110-180 keV. The optimal keV for achieving the best contrast between the CT values of the metallic stent, CAC, and the lumen in the LMA at each patient was influenced by age, male sex.Conclusions:The metallic stent, CAC, lumen of the LCA, and fat tissue exhibit unique characteristics. When conventional rather than spectral CT is used to evaluate the patency of a metallic stent in coronary arteries, it is necessary to determine the optimal tube voltage based on the age and male sex of the patient.
Abstract 14141: A Novel Endothelial Function Test in Predicting Late Coronary In-Stent Restenosis
Circulation, Volume 146, Issue Suppl_1, Page A14141-A14141, November 8, 2022. Introduction:Endothelial dysfunction is related with in-stent restenosis (ISR) of prior drug-eluting stents (DES) implanted more than 1 year ago (late ISR). EndoPAT is a novel non-invasive test quantifying endothelial function as reactive hyperemia peripheral arterial tonometry index (RHI).Hypothesis:EndoPAT is a potential predicting test for late ISR.Methods:We conducted a case control study on 186 patients with coronary DES implanted more than 1 year ago in a single medical center. Those who had contraindications to EndoPAT test, acute myocardial infarction, coronary artery bypass graft (CABG), chronic kidney disease (CKD) stage III and above, active infection and rheumatologic disease or acute decompensated heart failure were excluded. Patients were divided into ISR and non-ISR group based on coronary angiography. EndoPAT test was done at 24 to 48 hours prior to catherization. LnRHI is an index after natural log transformation of RHI. A receiver operative characteristic (ROC) curve analysis was used to determine the sensitivity and specificity of LnRHI for predicting late ISR.Results:ISR group had significantly more patients with history of ISR or triple-vessel disease, longer stent length and fewer totally occlusive lesions than non-ISR group. LnRHI was significantly lower in ISR group than in non-ISR group (0.66 vs 0.50, p
Abstract 11248: The Impact of Acute Coronary Syndrome on Early In-Stent Neoatherosclerosis Using Optical Coherence Tomography
Circulation, Volume 146, Issue Suppl_1, Page A11248-A11248, November 8, 2022. Introduction:Patients with acute coronary syndromes (ACS) are known to have a higher risk of target vessel revascularization after percutaneous coronary intervention (PCI) and worse long-term prognosis than patients with stable angina. Neoatherosclerosis is one of the significant factors at very late stent thrombosis. And the presence of in-stent neoatherosclerosis is independently associated with major adverse cardiac event. Although many studies have been reported on neoatherosclerosis, few have been reported on short-term in-stent neoatherosclerosis. Moreover, none have evaluated the impact of ACS. We investigated the impact of ACS on in-stent neoatheroscrelosis using Optical Coherence Tomography (OCT) in the present study.Methods:From March 2017 to November 2020, we investigated 102 patients (122 lesions) who had undergone PCI using drug eluting stent during that period and were followed up for OCT within one year. Subjects were categorized as ACS or non-ACS according to clinical findings at the time of target lesion intervention. We used OCT to investigate the presence of early in-stent neoatherosclerosis.Result:ACS group consisted of 21 (20.6%). In patients with ACS, women tended to be more common (38% vs 19%,P=0.0777). There were no differences in age or presence of diabetes or dyslipidemia during treatment. There were also no significant differences in LDL-C levels at the time of PCI (88 (73-114) mg/dL vs 100 (85-124) mg/dL,P=0.319) and when observed by OCT (67 (55-81) mg/dL vs 68 (57-89) mg/dL,P=0.622). The ACS group was significantly more likely to have a previous history of ACS (38% vs 12%,P=0.0104). Stent length was significantly shorter in ACS patients (24 (18-28) mm vs 32 (23-38) mm,P=0.0365). The mean dulation from PCI was 292 days. In-stent neoatherosclerosis was more frequent in the ACS group (31.8 % vs 9.9 %,P=0.014).Conclusion:This observational study using OCT indicates that stenting for ACS lesion is associated with early in-stent neoatherosclerosis.
Abstract 12383: Large Field-of-View Intravascular Ultrasound for Peri-Procedural Assessment of Stent Frame Expansion After Transcatheter Heart Valve-in-Valve
Circulation, Volume 146, Issue Suppl_1, Page A12383-A12383, November 8, 2022. Introduction.It is unknown whether large field-of-view intravascular ultrasound (IVUS) can be a valid peri-procedural imaging tool to assess actual expansion of transcatheter heart valve (THV) during valve-in-valve procedures.Hypothesis.To compare % expansion of SAPIEN 3 THV measured with peri-procedural IVUS versus post-procedural cardiac gated contrast multi-slice computer tomography (MSCT). Expansion was defined as actual outer frame area/nominal area x 100%.Methods.Studied were patients with successful valve-in-valve for failed surgical mitral and tricuspid bioprosthetic valves. All underwent peri-procedural IVUS using 10MHz Vision PV035 (Philips North America Corporation, Andover, USA) and post-procedural MSCT (SOMATOM Definition Flash, Dual Source, SIEMENS). IVUS and MSCT (Syngo Via, Siemens, Germany) measurements wereoff-line and done at 1-mm step along the entire height of SAPIEN 3 THV (height 18, 20 and 22 mm for the Sapien THV 23, 26 and 29 mm, respectively).Results.Five patients (68.8±11.2 years, 3 female) were treated for failed surgical mitral (n=3) and tricuspid (2) bioprosthetic valves using SAPIEN 3 THV size 23mm (n=1), 26mm (n=1), and 29mm (n=3). Mean peri-procedural and pre-discharge residual transvalvular gradient differed substantially (1.9±0.9 vs 7.9±1.1mmHg, p=0.001). In total, 104 corresponding cross-sections of the THVs were measured with both IVUS and MSCT. Actual outer-frame SAPIEN 3 expansion was smaller within the lengths of inflow and mid segment (overlapping the ring) than in the outflow, being substantially smaller than nominal (Fig 1). Overall, there was very good agreement between % expansion of THV stent frame assessed in IVUS and MSCT (93.5%±13.3% vs 96.3%±11.3%;r=0.976 and p
Abstract 14105: Stent Ahoy: Ventricular Tachycardia Due to Stent Migration Into the Right Ventricle
Circulation, Volume 146, Issue Suppl_1, Page A14105-A14105, November 8, 2022. Case:A 46-year-old female with PMHx of ESRD on dialysis and prothrombin gene mutation presented with acute onset of left breast swelling, redness and pain for nearly 24 hours. She was found to have SVC occlusion and underwent successful SVC recanalization and stent placement with an uncovered 14×40 mm nitinol stent. She presented 4 days later with complaints of chest pain and shortness of breath. Initial vitals were notable for tachypnea with oxygen saturations of nearly 70%, and a blood pressure of 114/71 mmHg. Physical exam demonstrated an obese female in distress. Shortly after arrival in the emergency department, she developed a non-sustained episode of ventricular tachycardia (NSVT). Amiodarone and lidocaine were started, however, she continued to have runs of NSVT. Initial CXR found no acute process but failed to demonstrate the previously placed SVC stent. ECG demonstrated normal sinus rhythm with frequent PVCs and runs of NSVT. A limited echo demonstrated a free edge of an endovascular stent within the right ventricle. TEE demonstrated the stent appeared to be tethered to the septal leaflet of the tricuspid valve with the leading edge free within the right ventricle. Endovascular retrieval was proposed but given the degree of entanglement within the tricuspid leaflets, large stent size, and recurrent NSVT, was deemed an unsuitable therapeutic strategy. Urgent open-heart surgery was performed for removal. The patient tolerated the procedure well and had no further recurrence of NSVT.Discussion:Stent migration is a rare but feared complication of venous stent deployment, with only 32 reported cases over the past 30 years. While NSVT is often attributed to the RVOT, the etiology being the result of migrated stents has been rarely reported. This is the first case to our knowledge of SVC stent migration leading to runs of NSVT.Conclusion:Clinicians must remain cognizant of the risk for venous stent migration and unusual clinical presentations resulting from migration.
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Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial
Circulation, Ahead of Print. BACKGROUND:A clear patency benefit of a drug-eluting stent (DES) over a bare metal stent (BMS) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMS for the treatment of femoropopliteal artery lesions.METHODS:EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory–assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization. Health-related quality of life and walking function were assessed.RESULTS:A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMS (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222];P
Protocol for Guos aortIc Arch recoNstrucTion: a prospective, multicentre and single-arm study to evaluate the safety and efficacy of the WeFlow-Arch modular inner branch stent-graft system for aortic arch lesions (GIANT study)
Introduction
Endovascular repair of the entire aortic arch provides treatment opportunities for patients with aortic arch lesions who are intolerant to open surgery. However, the complex anatomical configuration, high-speed blood flow and long access from the femoral artery increase the difficulty of endovascular aortic arch repair. On the basis of our earlier studies, a new modular inner branch stent-graft system was developed specifically for lesions located in the aortic arch and part of the ascending aorta. This study aims to evaluate the safety and efficacy of the novel modular branch stent-graft system in patients with aortic arch lesions who are unsuitable for open aortic arch replacement.
Methods and analysis
This prospective, multicentre, single-arm, clinical trial will enrol 80 patients with aortic arch lesions requiring intervention, namely, true aortic arch aneurysms, pseudo-aortic arch aneurysms and penetrating ulcers involving the aortic arch. Clinical information and CT angiography (CTA) images will be collected and analysed to investigate the safety and efficacy of the novel modular branch stent-graft system. Patients will be followed up for 5 years. The primary outcome will be all-cause mortality and severe stroke within 12 months after the procedure. In addition, this trial will evaluate mid-term to long-term clinical and imaging outcomes through the annual clinical and CTA follow-up for 2–5 years postoperatively.
Ethics and dissemination
We have registered the study on a registry website (https://clinicaltrials.gov/ct2/home). The study findings will be disseminated through peer-reviewed journals, physician newsletters, conferences and the mass media.
Trial registration number
NCT04765592.
Correction:Real-life multicentre study of lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections
Amato A, Tarantino I, Facciorusso A On behalf of i-EUS Group, et al. Real-life multicentre study of lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections. Gut 2022;71:1050-2. doi:10.1136/gutjnl-2022-326880.
There are errors in two of the affiliations.
The affiliations 6 and 13 should be as follows:
(6) Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
(13) Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Correction: Real-life multicentre study of lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections
Amato A, Tarantino I, Facciorusso A On behalf of i-EUS Group, et al. Real-life multicentre study of lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections. Gut 2022;71:1050-2. doi:10.1136/gutjnl-2022-326880.
There are errors in two of the affiliations.
The affiliations 6 and 13 should be as follows:
(6) Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
(13) Department of Biomedical Sciences, Humanitas University, Milan, Italy.