Copenhagen Mesenteric stent study (COMESS)-a randomized trial of stent versus covered stent treatment for chronic mesenteric ischemia.

BACKGROUND: Current management of mesenteric ischemia is primarily endovascular stent treatment. Typical CMI symptoms are postprandial abdominal pain, food fear, weight loss, and diarrhea. Revascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated. This study aims to compare the outcome using bare metal stent (BMS) or covered stent (CS) in the endovascular treatment of chronic and acute on chronic mesenteric ischemia. METHODS: This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study at the Copenhagen University Hospital, Denmark. A total of 98 patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI) will be randomized to treatment with either BeSmooth BMS (Bentley Innomed GmbH) or BeGraft CS (Bentley Innomed GmbH). Randomization occurs intraoperatively after lesion crossing. DISCUSSION: There is currently no published data from prospective controlled trials regarding the preferred type of stent used for the treatment of chronic and acute-on-chronic mesenteric ischemia. This trial will evaluate the short- and long-term outcome of BMS versus CS when treating CMI and AoCMI, as well as the benefit of a more intense postoperative surveillance program. TRIAL REGISTRATION: ClinicalTrials.gov NCT05244629. Registered on February 8, 2022.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Certification of Basic Skills in Endovascular Aortic Repair Through a Modular Simulation Course With Real Time Performance Assessment.

OBJECTIVE: Endovascular aortic repair (EVAR) is being used increasingly for the treatment of infrarenal abdominal aortic aneurysms. Improvement in educational strategies is required to teach future vascular surgeons EVAR skills, but a comprehensive, pre-defined e-learning and simulation curriculum remains to be developed and tested. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), an assessment tool for simulation based education (SBE) in EVAR, has previously been designed to assess EVAR skills, and a pass limit defining mastery level has been set. However, EVARATE was developed for anonymous video ratings in a research setting, and its feasibility for real time ratings in a standardised SBE programme in EVAR is unproven. This study aimed to test the effect of a newly developed simulation based modular course in EVAR. In addition, the applicability of EVARATE for real time performance assessments was investigated. METHODS: The European Society of Vascular Surgery (ESVS) and Copenhagen Certification Programme in EVAR (ENHANCE-EVAR) was tested in a prospective cohort study. ENHANCE-EVAR is a modular SBE programme in EVAR consisting of e-learning and hands-on SBE. Participants were rated with the EVARATE tool by experienced EVAR surgeons. RESULTS: Twenty-four physicians completed the study. The mean improvement in EVARATE score during the course was +11.8 (95% confidence interval 9.8 - 13.7) points (p < .001). Twenty-two participants (92%) passed with a mean number of 2.8 ± 0.7 test attempts to reach the pass limit. Cronbach's alpha coefficient was 0.91, corresponding to excellent reliability of the EVARATE scale. Differences between instructors' EVARATE ratings were insignificant (p = .16), with a maximum variation between instructors of ± 1.3 points. CONCLUSION: ENHANCE-EVAR, a comprehensive certifying EVAR course, was proven to be effective. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE) is a trustworthy tool for assessing performance within an authentic educational setting, enabling real time feedback.

Danish Nationwide Study on Surgical Treatment of Infective Native Abdominal Aortic Aneurysms.

OBJECTIVE: This study aimed to describe surgical trends, survival, and infection related complications (IRC) in a Danish cohort of patients with infective native aortic aneurysms (INAAs). METHODS: A retrospective nationwide cohort study including all patients in Denmark who were surgically treated for abdominal INAA between 2000 and 2020 was conducted. Patients were identified through the Danish vascular registry, Karbase, which is a database registering all patients treated with vascular surgery in Denmark. Subsequent data on clinical presentation, treatment, all cause mortality, and complications were obtained from the electronic patient charts. RESULTS: Seventy-five patients were included in the study, of whom 60 (80%) were male, with a median age of 69 (IQR 64, 75) years. Open surgical repair (OSR) was performed in 54 (72%) patients and endovascular aortic repair (EVAR) in 21 (28%). Median follow up was 52 (IQR 32, 103) months. Open repair was consistently the most frequent treatment modality throughout the study period, but EVAR became more frequent over time. The 30 day survival of the total cohort was 97% (94 - 100%). Kaplan-Meier survival estimates for the cohort were 92% (95% CI 85 - 98%), 80% (95% CI 71 - 91%), 63% (95% CI 52 - 78%), and 48% (95% CI 35 - 66%) at one, three, five and 10 years, respectively. Patients treated by EVAR had comparable long term survival to patients treated by OSR, with a hazard ratio of 0.35 (95% CI 0.10 - 1.22), but was associated with better short term survival up to five years. The most common cause of death was sepsis. Five (9%) OSR patients had IRC compared with one (5%) EVAR patient. CONCLUSION: In this nationwide study of patients treated for abdominal INAA, an increasing number of patients were surgically treated during the study period. Patients treated by EVAR demonstrated long term survival comparable to OSR. The incidence of post-operative IRC was low. These results should be interpreted with caution and prospective registries are needed.

Single branch arch stent graft combined with laser fenestration in the treatment of a zone two penetrating thoracic aortic ulcer.

We present the case of a 75-year-old man with a symptomatic penetrating aortic ulcer located in zone 2 on the arch inner curve between the left subclavian artery and left carotid artery treated using a single branch thoracic endovascular aortic repair combined with in situ laser fenestration. The patient underwent a successful procedure with no neurologic impairment and was discharged on the second postoperative day. The postoperative follow-up showed a well-excluded penetrating aortic ulcer.

Endovascular aneurysm repair for symptomatic abdominal aortic aneurysms has comparable results to elective repair in the long term.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has been extensively study regarding elective and ruptured abdominal aortic aneurysm (AAA) repair. However, much less is known about EVAR of symptomatic nonruptured AAA, especially concerning the long-term results. The aim of this study was to assess the outcomes of EVAR of symptomatic AAA compared with asymptomatic AAA at a tertiary center using a single graft. METHODS: All consecutive patients treated for symptomatic and asymptomatic AAAs from 1998 to 2012 at our institution, using the Cook Zenith stent graft (Cook Europe A/S, Bjaeverskov, Denmark), were included in the study. Ruptured AAAs were excluded. Patients' charts were reviewed to obtain preoperative, intraoperative, and postoperative data. All available imaging was reviewed. Life tables were constructed to assess for overall and late AAA-related survival, clinical success, and endoleak freedom. RESULTS: There were 680 patients included (137 symptomatic AAAs). No difference in technical success rate (96.1% for asymptomatic AAAs vs 94.9% for symptomatic AAAs) was present (P = .477). Thirty-day mortality was more common in symptomatic AAAs (6.6% vs 1.5% for asymptomatic AAAs; P = .002). Freedom from reinterventions was 72% ± 3% for asymptomatic AAAs vs 73% ± 5% for symptomatic AAAs (P = .785) at 10 years postoperatively. There was no difference in primary (P = .300) or secondary (P = .099) clinical success between groups, although there was higher assisted clinical success (P = .023) for asymptomatic AAAs compared with symptomatic AAAs. Persistent late clinical failure was similar in both groups (14.2% for asymptomatic AAAs vs 15.3% for symptomatic AAAs; P = .732). Freedom from late AAA-related death was higher (P = .016) for asymptomatic AAAs compared with symptomatic AAAs, but the differences disappeared when the first 30 days were disregarded. Overall survival (P = .687) was similar in both groups. An adequate aneurysm neck preoperatively conferred a better outcome in end points including overall survival. CONCLUSIONS: Symptomatic AAAs have an almost quadrupled 30-day mortality compared with asymptomatic AAAs, but the outcome differences fade in the long term. An adequate aneurysm neck was associated with better outcomes including overall survival independent of the initial presentation of the AAA. These results suggest the need of improving the identification of symptomatic patients requiring preoperative medical optimization. However, this is often limited by the acute need of the procedure, and more intensive postoperative monitoring may have greater potential. Independently, a strict anatomic selection for infrarenal EVAR is of paramount importance for the long-term outcome.

New Technique for Preconditioning of the Spinal Cord Before Endovascular Repair of Descending Thoracic and Thoracoabdominal Aortic Aneurysms.

Purpose: To propose a new simplified technique to occlude multiple segmental arteries for staging and preconditioning of the spinal cord to decrease the potential for spinal cord ischemia after thoracic and thoracoabdominal aortic aneurysm repair. Technique: A thoracic stent-graft that flares out to a maximum of 51 mm is deployed in a standard fashion covering all segmental arteries where graft-wall apposition occurs in the first ~20 cm of the aneurysm. The segmental arteries are always closed at their ostia in contrast to selective coil embolization, where there is a risk of more peripheral closure. Follow-up imaging shows thrombus lining the stent-graft-covered portion of the aneurysm and secondary proximal segmental artery occlusion. Conclusion: A new and fast way of staging and preconditioning the spinal cord using a modified stent-graft prior to definitive repair might be an alternative to segmental artery embolization.

Total aortic endovascular repair.

Endovascular repair has an established role in aortic treatment and has with evolving technologies expanded its applicability to the whole aorta. Whereas open repair is still the standard treatment for aortic arch and ascending aortic pathology, in high-risk patients, endovascular treatment has gained an increasing role. Endovascular options range from hybrid procedures to total endovascular repair using chimney grafts, branched and fenestrated stent grafts. Thoracic endovascular repair (TEVAR) for descending aortic pathologies including aneurysms, traumatic aortic transection, and complicated type B aortic dissection (TBAD) have also been firmly established and in many cases shown superior to open alternatives. For uncomplicated type B aortic dissection, TEVAR is controversial weighing the benefits of the long-term outcomes with increased short-term morbidity and mortality. Endovascular thoracoabdominal aortic aneurysm repair with fenestrated and branched stent grafts have also established its role with excellent short-term results and promising long-term durability. Staging of extensive repairs is widely adopted to prevent spinal cord ischemia. Off-the-shelf (OTS) devices have a complimentary role in emergency situations where custom-made device (CMD) are not available. Chimney and parallel graft techniques also still have a place in emergency situations. Fenestrated stent graft is a solid treatment for pararenal aneurysms with the trend toward more complex repair that aims for durability without compromising the operative outcomes. OTS fenestrated repair for juxtarenal aneurysms have shown its feasibility in the short-term but long-term results are yet to be published. Techniques for infrarenal aneurysm repair have reached a plateau. New devices have been developed to overcome the anatomical limitations of current stent grafts, especially for unfavorable neck anatomy. New polymer-based endovascular sealing (EVAS) technique has shown its feasibility and promising early outcomes, however long-term evidence is needed to define its role in the treatment armamentarium. Lastly, hypogastric artery preservation is now more feasible when iliac-branched devices have shown a good long-term patency and some new devices are available in clinical trial. This article gives an overview of available options and the results of endovascular solutions for the entire aorta from the ascending aorta to the iliac artery.

Aneurysm Shrinkage Is Compatible With Massive Endoleak in the Presence of an Aortocaval Fistula: Potential Therapeutic Implications for Endoleaks and Spinal Cord Ischemia.

PURPOSE: To present a patient with ruptured abdominal aortic aneurysm (AAA) and aortocaval fistula who was successfully treated with endovascular aneurysm repair in spite of developing a massive endoleak. CASE REPORT: A 70-year-old man with ruptured AAA and aortocaval fistula was treated with endovascular aneurysm repair (EVAR). During 8 years of follow-up, he had massive perfusion of the aneurysm sac by retrograde flow from the inferior mesenteric artery into the caval vein through the aortocaval fistula. The aneurysm diameter decreased continuously in spite of the type II endoleak. This observation illustrates the mechanisms of sac expansion and may have therapeutic implications for complicated type II endoleaks and prevention of spinal cord ischemia in thoracic stent-grafting. CONCLUSION: EVAR can be applied in this rare setting because the ensuing high-flow endoleak is associated with sac shrinkage owing to depressurization by the caval shunt.

Techniques to reduce radiation for patients and operators during aortic endografting.

Endovascular aortic repair of aortic pathologies has become widely spread among vascular surgeons. Much focus has been directed at perfecting and developing endovascular procedures to treat evermore complex issues. Much less focus has been directed at the radiation hazards to patients as well as operators and staff when such procedures are performed. Radiation exposure must be used according to the ALARA (As Low As Reasonably Achievable) principle to avoid short- and long-term negative side effects. Modern imaging technology offers many technological developments to reduce radiation such as low-dose programs, pulsed imaging, flat-panel technology and advanced intraoperative imaging techniques. But beside this, simple measures, based on the understanding of radiation exposure, can easily be implemented in everyday standard practice. Appropriate shielding of patients and staff, using adjuncts to be able to keep a safe distance to the radiation source and avoiding working with inappropriate C-arm angulations should be used routinely. Continued education of vascular surgeons is imperative to implement changes in practice to reduce radiation exposure.