Nellix Device Failure Mechanisms Analysis on Explanted Grafts.

OBJECTIVE: To understand possible reasons for poor durability of the Nellix (Endologix Inc., Irvine, USA) endovascular aneurysm sealing (EVAS) device. MATERIALS AND METHODS: 21 Nellix endoprostheses explanted for endoleaks and migration underwent visual examinations of stent structures and instrumental examinations of the polymer endobags on 4 devices. We harvested 2.0-gram polymer slices out of each of them and tested the samples in an in vitro implantation replication that included wet and dry exposures. During the wet phase, we placed samples in a beaker with saline, mimicking the filling of the endobags during implantation. An exposure to a 37°C environment with 60% humidity during the dry phase replicated the postimplantation conditions inside the aneurysmal sac. RESULTS: Iatrogenic defects affected 16 (76%) metal stents and 20 (95%) endobags. The polymer was disintegrated owing to degradation in 15 (71%) cases. The polymer could lose more than 70% of its initial weight when partially dehydrated and regain 80% when placed in saline. We observed volume decrease and polymer fragmentation during these study phases. CONCLUSIONS: The polymer can lose weight and volume while it dehydrates. This structural degradation of the polymer could lead to the development of endoleaks and/or migration of the device. CLINICAL IMPACT: Based on the results of previous investigations, due to possible endovascular device degradation, patients with endografts should be offered life-long surveillance, and the Nellix device is no exception. Herein we suggest polymer degradation as one of the possible reasons for the device failure. Although Nellix has been withdrawn from the market, there are numerous patients with this type of endograft. Due to its unpredictable performance in the medium and long term, these patients should be recommended enhanced life-long surveillance every 6 months. Any suspicious conditions during the follow-up must be taken seriously and explantation should be considered.

Editor's Choice -- Type IIIb Endoleaks: Fabric Perforations of Explanted New Generation Endoprostheses.

OBJECTIVE: To analyse explanted endografts (EGs) and describe fabric degradation responsible for type IIIb endoleaks. METHODS: As part of the European collaborative retrieval programme, 32 EGs with fabric defects on macroscopic evaluation were selected. The explanted EGs were processed and studied based on the ISO 9001 certified standard protocol. It includes instructions on the collection, transportation, cleaning, and examination of explanted material. The precise analysis was performed with a digital microscope of 20 - 200 times magnification. Possible perforation mechanisms were assessed in stress tests. RESULTS: The median time to explantation of the 32 EGs was 54 months. The explants included 65 separate EG modules, with 46 (70.8%) having a combined 388 fabric perforations. Each EG had a median of 4.79 mm2 (interquartile range [IQR] 9.86 mm2) of cumulated hole area (an average of 0.13% of an EG's area). There were 239 (61.6%) expanded polytetrafluoroethylene (ePTFE; 11 EGs) and 149 (38.4%) polyethylene terephthalate (PET; 21 EGs) fabric ruptures, with no difference in hole distribution between these types of material. Overall, 126 (32.5%) stent related and 262 (67.5%) non-stent related fabric perforations were identified. Perforations caused by fabric fatigue in ePTFE (151, 63.2%) and material kinking in PET (41, 27.5%) were the most common. The stent related perforations were larger in size (0.80 mm2) than non-stent related perforations (0.19 mm2); p < .001. Wider interstent spaces and prolonged implantation duration were associated with an increased risk of stent related perforation development; p < .001 and p = .004, respectively. Large stent related perforations were also detected in the short term, suggesting mechanical issues as underlying causes. CONCLUSION: The fabric of EGs may degrade and lead to the development of perforations. The largest perforations are stent related. Their occurrence and size depend on the implantation time and the EG shape affected by arterial tortuosity. The conclusions are limited to the samples from a select explant group.

Aortobifemoral Bypass in Kidney Transplant Candidates: A Ten-Year Experience.

In patients with severe aorto-iliac calcifications, vascular reconstructions can be performed in order to allow kidney transplantation. The aim of this study was to analyze the outcomes of kidney transplant candidates who underwent an aortobifemoral bypass (ABFB) for aorto-iliac calcifications. A retrospective study including all kidney transplant candidates who underwent an ABFB between 2012 and 2022 was performed. Primary outcome was 30-day morbidity-mortality after ABFB. Secondary outcome was accessibility to kidney transplant waiting list. Twenty-two ABFBs were performed: 10 ABFBs in asymptomatic patients presenting severe aorto-iliac circumferential calcifications without hemodynamic consequences, and 12 ABFBs in symptomatic patients in whom aorto-iliac calcifications were responsible for claudication or critical limb threatening ischemia. Overall 30-day mortality was 0%. Overall 30-day morbidity was 22.7%: 1 femoral hematoma and 1 retroperitoneal hematoma requiring surgical drainage in the asymptomatic group, and 2 digestive ischemia requiring bowel resection and 1 femoral hematoma requiring surgical drainage in the symptomatic group. Among the 22 patients, 20 patients could access to kidney waiting list and 8 patients underwent a kidney transplantation, including 3 living-donor transplantations. Aorto-iliac revascularization can be an option to overcome severe calcifications contraindicating kidney transplantation.

Intraoperative Staff Radiation Exposure During Aortic Endovascular Procedures.

BACKGROUND: The risk of radiation exposure in the surgical operating room (OR) and/or catheterization laboratory is now well established. Complex endovascular procedures often require multiple approaches and different positioning of the staff members around the patient, potentially increasing the levels of radiations exposure. Our goal was to evaluate the levels of radiation exposure of the members of the staff during endovascular aortic procedures in order to propose radioprotection optimization. METHODS: We included 41 aortic endovascular procedures out of 114 procedures performed between January 12, 2014, and August 31, 2015, including 24 standard endovascular aortic aneurysm repair (EVAR), 7 EVAR with iliac branch (EVARib), 8 complex fenestrated/branched EVAR (F/B EVAR), and 2 thoracic EVAR (TEVAR). Procedures were performed in an OR equipped with a carbon fiber table and a mobile fluoroscopy C-arm. We collected the usual dosimetry data given by the C-arm as well as the patient's peak skin dose (PSD). In all staff members, radiation exposure was measured with thermoluminescent chip dosimeters placed on both temples, on posterior sides of both hands, and on both lower legs. RESULTS: PSD levels were low for EVAR because 24 patients had values below the reading threshold. PSD significantly increased with more complex procedures. Main operator (MO) received the higher level of irradiation on whole body, hands, and ankles. Eye lenses irradiation was higher on both assistant operators (AOs). Other members received low levels of irradiation. We found a high ranges of radiation exposure with a high risk of exposure for the AO, mainly for F/B EVAR and EVARib. CONCLUSIONS: Even if all personal protections are used, staff positioning is a major point that must be considered. If MO is supposed to be the most exposed to X-rays, specific conditions of positioning of the AO may be at risk of exposure.

Fundamental Technical Skills of Endovascular Surgery: A Preliminary Study on Its Impact on Skills and Stress during Procedures.

BACKGROUND: Our objective is twofold: determining if simulation allows residents to reach proficient surgeons' performance concerning fundamental technical skills of endovascular surgery (FEVS) while investigating effects of the program on surgeons' stress. METHODS: Using a FEVS training simulator, 8 endovascular FEVS were performed by vascular surgery residents (simulator-naive or simulator-experienced residents [SER]) and seniors. Total time needed to complete the 8 tasks, called total completion time (TCT), was the main evaluation criterion. Analgesia Nociception Index (ANI) was monitored during simulation. Likert scale questionnaire was filled out after each simulation. RESULTS: For each task, TCT was significantly lower for SER and seniors than simulator-naive residents (P = 0.0163). After only 5 simulations, SER were able to reach and even exceed the seniors' level in terms of TCT, with a median time of 10.8 min for SER and 11.9 min for seniors, and wire's movements with a median distance during cannulation of 4.44 m for SER and 4.17 m for seniors. Seniors remained better than SER in terms of precise wire manipulation (wire movement after cannulation), 4.17 m against 4.44 m (3.72-5.96), respectively. Based on the Likert scale stress analysis, seniors felt less stressed than both residents' groups (P = 0.0618). Seniors' initial ANI and mean ANI over the session were significantly lower than those of the residents, P = 0.0358 and P = 0.0250, respectively. CONCLUSIONS: We showed that 5 simulation sessions allowed residents to reach experienced surgeons' capacities on FEVS concerning TCT. Subjectively, seniors felt less stressed than residents, contrary to the results of our objective measures of stress.

Update About the Management of Low-Density Lipoprotein Cholesterol and Hypertriglyceridemia in Lower Extremity Peripheral Artery Disease Patients: Consensus of the French Society of Vascular Medicine and the French Society for Vascular and Endovascular Surgery.

BACKGROUND: A French intersociety consensus on behalf the Société Française de Médecine Vasculaire and the Société de Chirurgie Vasculaire et Endovasculaire was proposed in 2021 for the management of patients with lower extremity peripheral artery disease (LEAD). Recent studies have been published and an update of this consensus about the management of low-density lipoprotein cholesterol (LDLc) and hypertriglyceridemia was required. METHODS: A steering committee of 12 vascular physicians and surgeons defined questions of interest about LDLc and hypertriglyceridemia management. A French expert panel voted the proposals. Consensus was considered to have been achieved if more than 80% of the responses corresponded to either "Agreement" or "Disagreement". RESULTS: Among the 56 experts who were asked to participate, 46 (82%) accepted. After the first round of the Delphi procedure, the 4 proposals reached consensus. The following suggestions and recommendations were approved: 1. For LEAD patients treated by the highest tolerated statin dose ± ezetimibe and who have an LDLc ≥0.70 g/L, we recommend adding a proprotein convertase subtilisin/kexin type 9 inhibitor. 2. For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram. CONCLUSIONS: This update will help clinicians to improve LEAD patient management.

Virtual reality simulation and real-life training programs for cataract surgery: a scoping review of the literature.

BACKGROUND: Cataract surgery requires a high level of dexterity and experience to avoid serious intra- and post-operative complications. Proper surgical training and evaluation during the learning phase are crucial to promote safety in the operating room (OR). This scoping review aims to report cataract surgery training efficacy for patient safety and trainee satisfaction in the OR when using virtual reality simulators (EyeSi [Haag-Streit, Heidelberg, Germany] or HelpMeSee [HelpMeSee foundation, Jersey city, New Jersey, United States]) or supervised surgical training on actual patients programs in residents. METHODS: An online article search in the PubMed database was performed to identify studies proposing OR performance assessment after virtual-reality simulation (EyeSi or HelpMeSee) or supervised surgical training on actual patients programs. Outcome assessment was primarily based on patient safety (i.e., intra- and post- operative complications, OR performance, operating time) and secondarily based on trainee satisfaction (i.e., subjective assessment). RESULTS: We reviewed 18 articles, involving 1515 participants. There were 13 using the EyeSi simulator, with 10 studies conducted in high-income countries (59%). One study used the HelpMeSee simulator and was conducted in India. The four remaining studies reported supervised surgical training on actual patients, mostly conducted in low- middle- income countries. Training programs greatly differed between studies and the level of certainty was considered low. Only four studies were randomized clinical trials. There were 17 studies (94%) proposing patient safety assessments, mainly through intraoperative complication reports (67%). Significant safety improvements were found in 80% of comparative virtual reality simulation studies. All three supervised surgery studies were observational and reported a high amount of cataract surgeries performed by trainees. However, intraoperative complication rates appeared to be higher than in virtual reality simulation studies. Trainee satisfaction was rarely assessed (17%) and did not correlate with training outcomes. CONCLUSIONS: Patient safety assessment in the OR remains a major concern when evaluating the efficacy of a training program. Virtual reality simulation appears to lead to safer outcomes compared to that of supervised surgical training on actual patients alone, which encourages its use prior to performing real cases. However, actual training programs need to be more consistent, while maintaining a balance between financial, cultural, geographical, and accessibility factors.

Case Report and Literature Review of Prosthetic Cardiovascular Mucormycosis.

We report a rare case of aorto-bi-iliac prosthetic allograft mucormycosis in a 57-year-old immunocompetent patient in France. Outcome was favorable after surgery and dual antifungal therapy with liposomal amphotericin B and isavuconazole. In a literature review, we identified 12 other cases of prosthetic vascular or heart valve mucormycosis; mortality rate was 38%.

Variability of [18F]FDG-PET/LDCT reporting in vascular graft and endograft infection.

PURPOSE: 18F-fluoro-D-deoxyglucose positron emission tomography with low dose and/or contrast enhanced computed tomography ([18F]FDG-PET/CT) scan reveals high sensitivity for the diagnosis of vascular graft and endograft infection (VGEI), but lower specificity. Reporting [18F]FDG-PET/CT scans of suspected VGEI is challenging, reader dependent, and reporting standards are lacking. The aim of this study was to evaluate variability of [18F]FDG-PET/low dose CT (LDCT) reporting of suspected VGEI using a proposed standard reporting format. METHODS: A retrospective cohort study was conducted including all patients with a suspected VGEI (according to the MAGIC criteria) without need for urgent surgical treatment who underwent an additional [18F]FDG-PET/LDCT scan between 2006 and 2022 at a tertiary referral centre. All [18F]FDG-PET/LDCT reports were scored following pre-selected criteria that were formulated based on literature and experts in the field. The aim was to investigate the completeness of [18F]FDG-PET/LDCT reports for diagnosing VGEI (proven according to the MAGIC criteria) and to evaluate if incompleteness of reports influenced the diagnostic accuracy. RESULTS: Hundred-fifty-two patients were included. Median diagnostic interval from the index vascular surgical procedure until [18F]FDG-PET/LDCT scan was 35.5 (7.3-73.3) months. Grafts were in 65.1% located centrally and 34.9% peripherally. Based on the pre-selected reporting criteria, 45.7% of the reports included all items. The least frequently assessed criterion was FDG-uptake pattern (40.6%). Overall, [18F]FDG-PET/LDCT showed a sensitivity of 91%, a specificity of 72%, and an accuracy of 88% when compared to the gold standard (diagnosed VGEI). Lower sensitivity and specificity in reports including ≤ 8 criteria compared to completely evaluated reports were found (83% and 50% vs. 92% and 77%, respectively). CONCLUSION: Less than half of the [18F]FDG-PET/LDCT reports of suspected VGEI met all pre-selected criteria. Incompleteness of reports led to lower sensitivity and specificity. Implementing a recommendation with specific criteria for VGEI reporting is needed in the VGEI-guideline update. This study provides a first recommendation for a concise and complete [18F]FDG-PET/LDCT report in patients with suspected VGEI.

Mechanical Performance Assessment of Physician Modified Aortic Stent Graft.

OBJECTIVE: This study aimed to compare various fenestration configurations of physician modified aortic stent grafts in order to identify which design parameters have a significant influence on the mechanical behaviour of the fenestration. METHODS: the fenestration configurations were considered according to different manufacturing parameters: cutting technique, fenestration reinforcement, suture material, reinforcement loop design, and number of suture points. The performance of the graft/bridging stent assembly was assessed at various levels: (1) branch pull out force; (2) fenestration enlargement and rupture strength; (3) balloon angioplasty resistance; and (4) behaviour under cyclic fatigue. RESULTS: Sixty manual fenestrations were created. The tests performed on the fenestrations had several main findings. First, reinforcement increased the radial force on the branch, which increased the pull out force; this may limit migration of the bridging stent in vivo. The phenomenon was amplified with a snare reinforced fenestration, which seemed to be the most efficient. Moreover, increasing the number of suture passes also appeared to increase the branch extraction force securing the assembly. The enlargement tests showed that non-reinforced fenestrations had the weakest radial strength. This was confirmed with the balloon angioplasty test, which showed that these latter specimens undergo the most significant textile degradation. After fatigue tests, all fenestrations were larger, showing that elastic recoil was incomplete in all samples. The largest recoil was observed in the non-reinforced ophthalmological cautery (OC) fenestrations (40%). Regarding the behaviour of the samples up to rupture, all samples behaved in a similar way; however, the double loop fenestration strength level was the highest. CONCLUSION: This study demonstrated that the snare double loop reinforcement has an advantage regarding durability of the graft branch assembly. Moreover, non-reinforced fenestrations show signs of weakness and lack of stability, which questions the in situ or laser fenestration procedures.

Assessment of Thoracic Endovascular Aortic Repair Using Relay Proximal Scallop: Results of a French Prospective Multicentre Study.

OBJECTIVE: A proximal scallop design allows aortic arch repair without complex endovascular manipulation in the aortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. METHODS: A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. RESULTS: Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. CONCLUSION: One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.

Editor's Choice - Infective Native Aortic Aneurysms: A Delphi Consensus Document on Terminology, Definition, Classification, Diagnosis, and Reporting Standards.

OBJECTIVE: There is no consensus regarding the terminology, definition, classification, diagnostic criteria, and algorithm, or reporting standards for the disease of infective native aortic aneurysm (INAA), previously known as mycotic aneurysm. The aim of this study was to establish this by performing a consensus study. METHODS: The Delphi methodology was used. Thirty-seven international experts were invited via mail to participate. Four two week Delphi rounds were performed, using an online questionnaire, initially with 22 statements and nine reporting items. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements revised, and results presented in iterative rounds. Consensus was defined as ≥ 75% of the panel selecting "strongly agree" or "agree" on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha coefficient > .80. RESULTS: All 38 panellists completed all four rounds, resulting in 100% participation and agreement that this study was necessary, and the term INAA was agreed to be optimal. Three more statements were added based on the results and comments of the panel, resulting in a final 25 statements and nine reporting items. All 25 statements reached an agreement of ≥ 87%, and all nine reporting items reached an agreement of 100%. The Cronbach's alpha increased for each consecutive round (round 1 = .84, round 2 = .87, round 3 = .90, and round 4 = .92). Thus, consensus was reached for all statements and reporting items. CONCLUSION: This Delphi study established the first consensus document on INAA regarding terminology, definition, classification, diagnostic criteria, and algorithm, as well as reporting standards. The results of this study create essential conditions for scientific research on this disease. The presented consensus will need future amendments in accordance with newly acquired knowledge.

Midterm Results of Physician-Modified Stent Grafts for Thoracoabdominal and Complex Abdominal Aortic Aneurysms Repair.

BACKGROUND: To assess midterm results of physician-modified stent grafts (PMSG) for the treatment of emergent complex abdominal and thoracoabdominal aortic aneurysms (TAAA) in high-risk patients. METHODS: All consecutive patients with emergent complex abdominal or TAAA undergoing PMSG technique between January 2012 and July 2019 were retrospectively included. Indications for PMSG were symptomatic aneurysms and rapidly growing aneurysms >70 mm. Ruptured aneurysms were excluded. RESULTS: Thirty-three patients (mean age: 74 +/- 11 years) were included. The mean aneurysm diameter was 76 +- 20 mm. Patients presented with TAAA (n = 20, 61%), complex abdominal aortic aneurysms (CAAA, n = 9, 27%), type I endoleak after previous endovascular aneurysm repair (n = 3, 9%) and intramural aortic hematoma (n = 1, 3%). Chimney technique was performed in addition to PMSG in seven cases (21%). Intraoperative adverse events were recorded in seven cases (35%) in the TAAA group and one case (11%) in the CAAA group. In-hospital mortality rate was 15% (n = 3) in the TAAA group and 11% (n = 1) in the CAAA group. Moderate to severe complications were recorded in 45% of cases (n = 15). Spinal cord ischemia occurred in two cases (6%, one case without residual deficit and one with minor motor deficit). One (3%) patient required transient hemodialysis. One patient presented with early aortic rupture and required an open conversion. The mean follow-up duration was 31 months (1-79). Overall survival estimates were 81.4% (95% confidence interval [CI]: 63.1.-91.2) at 1 year and 71.6% (95% CI: 52.6-84.1) at 2 years. Freedom from reintervention rates at 1 and 2 years were 61.2% (95% CI: 41.7-75.9) and 57.4% (95% CI: 37.9-72.8). Target vessel primary patency rates at 1 and 2 years were 99.2% (95% CI: 94.2-99.9) and 97.7% (95% CI: 90.7-99.4). CONCLUSIONS: PMSG for high-risk patients with complex aneurysms provided acceptable technical success and excellent target vessel patency rates but were associated with a 12% in-hospital mortality rate. Reinterventions were frequent. This technique should be limited to selected high-risk patients for whom the risk of rupture in the short-term is deemed too high to wait for graft manufacturing of custom-made device.

Mortality and Delays of Management of Acute Mesenteric Ischemia: The Need of a Dedicated Program.

BACKGROUND: To study the mortality and delays of management of patients with acute mesenteric ischemia (AMI) admitted to the emergency department of a tertiary hospital and identify risk factors for 1-month mortality. METHODS: A single-center and retrospective study including all consecutive patients treated for AMI from January 2008 to December 2018 was conducted. Short- and medium-term survival was studied with a Kaplan-Meier analysis. Delays before diagnosis and surgical intervention were collected. To determine factors associated with mortality at 1 month postoperatively, univariate and multivariate analyzes were performed. RESULTS: The survival rate of the 67 included patients was 55.22% at 1 month and 37.31% at 1 year. In-hospital mortality was 50.74%. The average delay between admission and diagnosis was 4.83 ± 5.03 hr (95% confidence interval [CI], 3.60-6.05), and the delay between admission and surgical treatment was 10.64 ± 8.80 hr (95% CI, 8.49-12.79). The independent variables associated with an increased mortality at 1 month postoperatively in the univariate analysis were age >65 years old (odds ratio [OR] = 3.52; P = 0.046), lactate >3.31 mmol/l at admission (H0) (OR = 7.38; P < 0.001), lactate >3.32 mmol/l on day 1 (H24) (OR = 5.60; P = 0.002), creatinine >95.9 µmol/l at H0 (OR = 4.66; P = 0.004), aspartate aminotransferase (AST) >59 U/l at H0 (OR = 3.55; P = 0.017), and having hypertension as comorbidity (OR = 9.32; P = 0.040). Early curative anticoagulation (z = -2.4; P = 0.016) was an independent protective factor for mortality, and lactate >3.31 mmol/l at H0 (z = 2.62; P = 0.009) was an independent predictor factor of mortality at 1 month postoperatively in the multivariate analysis. CONCLUSION: AMI remains a serious and lethal condition with delays of surgical management remaining too long due to a lack of a dedicated therapeutic protocol allowing an early diagnosis.

Evidence-based guideline of the European Association of Nuclear Medicine (EANM) on imaging infection in vascular grafts.

PURPOSE: Consensus on optimal imaging procedure for vascular graft/endograft infection (VGEI) is still lacking and the choice of a diagnostic test is often based on the experience of single centres. This document provides evidence-based recommendations aiming at defining which imaging modality may be preferred in different clinical settings and post-surgical time window. METHODS: This working group includes 6 nuclear medicine physicians appointed by the European Association of Nuclear Medicine, 4 vascular surgeons, and 2 radiologists. Vascular surgeons formulated 5 clinical questions that were converted into 10 statements and addressed through a systematic analysis of available literature by using PICOs (Population/problem-Intervention/Indicator-Comparator-Outcome) strategy. Each consensus statement was scored for level of evidence and for recommendation grade, according to the Oxford Centre for Evidence-based Medicine criteria. RESULTS: Sixty-six articles, published from January 2000 up to December 2021, were analysed and used for evidence-based recommendations. CONCLUSION: Computed tomography angiography (CTA) is the first-line imaging modality in suspected VGEI but nuclear medicine modalities are often needed to confirm or exclude the infection. Positron emission tomography/computed tomography (PET/CT) with 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) has very high negative predictive value but it should be performed preferably at least 4 months after surgery to avoid false positive results. Radiolabelled white blood cell (WBC) scintigraphy, given its high diagnostic accuracy, can be performed at any time after surgery. PREAMBLE: The European Association of Nuclear Medicine (EANM) is a professional no-profit medical association that facilitates communication worldwide between individuals pursuing clinical and research excellence in nuclear medicine. The EANM was founded in 1985. EANM members are physicians, technologists, and scientists specializing in the research and practice of nuclear medicine. The EANM will periodically define new guidelines for nuclear medicine practice to help advance the science of nuclear medicine and to improve the quality of service to patients throughout the world. Existing practice guidelines will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated. Each practice guideline, representing a policy statement by the EANM, has undergone a thorough consensus process in which it has been subjected to extensive review. The EANM recognizes that the safe and effective use of diagnostic nuclear medicine imaging requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guideline by those entities not providing these services is not authorized. These guidelines are an educational tool designed to assist practitioners in providing appropriate care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, the EANM suggests caution against the use of the current consensus document in litigation in which the clinical decisions of a practitioner are called into question. The ultimate judgement regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in the light of all the circumstances presented. Thus, there is no implication that an approach differing from the consensus document, standing alone, is below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the consensus document when, in the reasonable judgement of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of the consensus document. The practice of medicine includes both the art and the science of the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to this consensus document will not ensure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient, to deliver effective and safe medical care. The sole purpose of this consensus document is to assist practitioners in achieving this objective.

Stapled Porcine Pericardium Displays Lower Infectivity In Vitro Than Native and Sutured Porcine Pericardium.

BACKGROUND: Biological xenografts using tubulized porcine pericardium are an alternative to replace infected prosthetic graft. We recently reported an innovative technique using a stapled porcine pericardial bioconduit for immediate vascular reconstruction in emergency. The objective of this study is to compare the growth and adherence to grafts of bacteria and yeast incubated with stapled porcine pericardium, sutured or naked pericardium. MATERIAL AND METHODS: One square centimeter of porcine pericardial patches, with or without staples or sutures, was incubated with 105 colony forming units of Escherichia coli, Staphylococcus aureus, Staphylococcus epidermidis, and Candida albicans for 1, 6, and 24 h. The medium was collected to quantify planktonic microorganisms, while grafts were sonicated to quantify adherent microorganisms. Dacron and Dacron Silver were analyzed in parallel as synthetic reference prostheses. RESULTS: Stapled porcine pericardium reduced the growth and the adherence of E coli (2- to 30-fold; P < 0.0005), S aureus (11- to 1000-fold; P < 0.0006), S epidermidis (>500-fold; P < 0.0001), and C albicans (12- to 50-fold; P < 0.0001) when compared to medium alone (growth) and pericardium or Dacron (adherence). Native and sutured porcine pericardium interfered with the growth and the adherence of E coli and C albicans, and Dacron with that of S epidermidis. As expected, Dacron Silver was robustly bactericidal. CONCLUSIONS: Stapled porcine pericardium exhibited a lower susceptibility to infection by bacteria and yeasts in vitro when compared to the native and sutured porcine pericardium. Stapled porcine pericardium might be a good option for rapid vascular grafting without increasing infectivity.

Arterial Embolization of Polycystic Kidneys for Heterotopic Transplantation.

INTRODUCTION: The purpose of this study was to evaluate the efficacy of polycystic kidney embolization, performed to reduce kidney volume before heterotopic kidney transplantation, as this technique could be an alternative to pretransplant nephrectomy. MATERIALS AND METHODS: All patients who underwent pretransplant embolization of polycystic kidneys were included in a prospective register from June 2014 to February 2020. All patients underwent computed tomography (CT) scan with volumetric reconstruction (OsiriX, Bernex, Switzerland) before embolization and were then followed up at 3 and 6 months after embolization. Primary outcome was percentage of kidney volume reduction. Secondary outcomes were 30 day mortality and morbidity. RESULTS: Thirty-one embolizations performed on 29 patients (medium age = 55.6; 62.1% male) were included between June 2014 and February 2020. All patients were under dialysis before embolization (9 peritoneal dialysis and 20 hemodialysis). Technical success was observed in 96.8% of cases. Mean procedural time was 65 minutes (range = 35-106 minutes) and mean length of in-hospital stay was 3.8 days (range = 3-6 days). A volume reduction allowing a kidney transplant was obtained for 28 patients (96.5%). The mean volume reduction was 39.9% (range = 6.01-68.2). The main observed complication was postembolization pain in 10 cases (32.2%). One patient needed complementary nephrectomy due to insufficient volume reduction. Twenty-three patients (79.3%) received renal transplant during follow-up with a mean delay of 19.5 month (range = 4-54). CONCLUSION: Polycystic kidney embolization is an effective and safe minimally invasive technique. It can be proposed as the first-choice technique for kidney transplant recipients as an alternative to pretransplantation nephrectomy.

Endovascular Porcine Model of Iliocaval Venous Thrombosis.

OBJECTIVE: To develop a large animal model of iliocaval deep venous thrombosis (DVT), which enables development and evaluation of interventional management and existing imaging modalities. METHODS: The experimental protocol consisted of a total endovascular approach. Pigs were percutaneously accessed through the right internal jugular and bilateral femoral veins. Three balloon catheters were inflated to induce venous stasis in the infrarenal inferior vena cava (IVC) and bilateral common iliac veins (CIVs). Hypercoagulability was induced by injecting 10 000 IU of thrombin. After 2.5 hours, the balloon catheters were removed before animal recovery. After seven, 14, 21, 28, or 35 days, animals were euthanised; the IVC and CIV were harvested en bloc, cross sectioned and prepared for histological examination. Multimodal imaging was performed before and after thrombus creation, and before animal euthanasia. RESULTS: Thirteen female domestic pigs with a mean weight of 59.3 kilograms were used. The mean maximum IVC diameter and area were 16.4 mm and 1.2 cm2, respectively. The procedure was successful in 12 animals with occlusive venous thrombosis in the region of interest on immediate post-operative magnetic resonance venography and a mean thrombus volume of 19.8 cm3. Clinical pathology results showed platelet consumption, D dimer increase, and inflammatory response. Histological evaluation demonstrated a red cell, fibrin, and platelet rich thrombus on day 1, with progressive inflammatory cell infiltration from day 7. Collagen deposition appeared in week 2 and neovascularisation in week 3. CONCLUSION: Endovascular occlusion combined with thrombin infusion is a reliable minimally invasive approach to produce acute and subacute DVT in a large animal model.

Editor's Choice - European Society for Vascular Surgery Clinical Practice Guideline Development Scheme: An Overview of Evidence Quality Assessment Methods, Evidence to Decision Frameworks, and Reporting Standards in Guideline Development.

OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.

Risk Factors of Long-Term Incisional Hernia after Open Surgery for Abdominal Aortic Aneurysm: A Bicentric Study.

BACKGROUND: Conventional open surgery is still important beside endovascular surgery in the management of abdominal aortic aneurysms, with less reinterventions in the long-term follow-up. Incisional hernias are the major complication open surgery in the mid- and long term. The occurrence of this late complication could be due to the choice of the incision, median or transverse. The objectives of our retrospective and bicentric study were to characterize the long-term risk factors for incisional hernias after open surgery for abdominal aortic aneurysms, in particular by comparing the 2 types of laparotomy, and to determine the prevalence of the operated and not operated incisional hernias. MATERIALS AND METHODS: Between January 2009 and December 2011, all the patients having elective open surgery for abdominal aortic aneurysm (AAA) by midline laparotomy at the University hospital of Besancon or by transversal laparotomy at the University Hospital of Strasbourg were included retrospectively. The demographic data, the time of diagnosis of the incisional hernia and the parietal reinterventions were collected during a 5-year postoperative follow-up. A univariate and multivariate Cox model was used for the statistical analysis to determine the long-term risk factors for the appearance of an incisional hernia. RESULTS: During the study period, 223 patients presenting with AAA were included, 112 of them were operated by a midline laparotomy and 111 by a transverse laparotomy. The mean age of the patients was 69 ± 8,4years and 208 (93.3%) were men. The 5-year prevalence of incisional hernias was 14.3% (32), and 20 of these hernias (9%) had to be operated. Eighteen hernias (16.1%) occurred after a midline laparotomy and 14 (12.6%) after a transverse incision (P = 0.30). In univariate analysis, obstructive chronic pulmonary disease was the only significant risk factor for incisional hernia (P = 0.01) and an age over 65 years appeared to protect against this risk (P = 0.049). These results were confirmed by multivariate analysis, which showed that obstructive chronic pulmonary disease was an independent risk factor for incisional hernia (HR = 2.35, 95% CI 1.16-4.75), and that an age over 65 years was a protective factor (HR = 0.49 95% IC 0.00-0.99). CONCLUSIONS: The type of laparotomy did not modify the rate of incisional hernias. We showed that only 9% of the patients had to be operated to treat an incisional hernia during the first 5 years after surgery for AAA in our bicentric study. Chronic obstructive pulmonary disease was the only independent risk factor for the occurrence of an incisional hernia.