First-in-human feasibility study of the aXess graft (aXess-FIH): 6-Month results.

OBJECTIVE: The creation of an arteriovenous fistula (AVF) is considered the most effective hemodialysis (HD) vascular access. For patients who are not suitable for AVF, arteriovenous grafts (AVGs) are the best access option for chronic HD. However, conventional AVGs are prone to intimal hyperplasia, stenosis, thrombosis, and infection. Xeltis has developed an AVG as a potential alternative to currently available AVGs based on the concept of endogenous tissue restoration. The results of the first 6-month follow-up are presented here. METHODS: The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites. RESULTS: At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported. CONCLUSION: The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.

The Correlation of Aortic Neck Angle and Length in Abdominal Aortic Aneurysm with Severe Neck Angulation for Prediction of Intraoperative Neck Complications and Postoperative Outcomes after Endovascular Aneurysm Repair.

OBJECTIVES: Endovascular aneurysm repair (EVAR) in a hostile neck has been associated with adverse outcomes. We aimed to determine the association of infrarenal aortic neck angle and length and establish an optimal cutoff value to predict intraoperative neck complications and postoperative outcomes. METHODS: This was a retrospective review of patients with an intact infrarenal abdominal aortic aneurysm (AAA) with severe neck angulation (>60 degrees) who underwent EVAR from October 2010 to October 2018. Demographic data, aneurysm morphology, and operative details were collected. The ratio of neck angle and length was calculated as the optimal cutoff value of the aortic neck angle-length index. The patients were categorized into two distinct groups using latent profile analysis, a statistical technique employed to identify concealed subgroups within a larger population by examining a predetermined set of variables. Intraoperative neck complications, adjunct neck procedures, and early and late outcomes were compared. RESULTS: 115 patients were included. Group 1 (G1) had 95 patients with an aortic neck angle-length index ≤ 4.8, and Group 2 (G2) had 20 patients with an aortic neck angle-length index > 4.8. Demographic data and aneurysm morphology were not significantly different between groups except for neck length (p < 0.001). G2 had more intraoperative neck complications than G1 (21.1% vs. 55%, p = 0.005). Adjunctive neck procedures were more common in G2 (18.9% vs. 60%, p < 0.001). The thirty-day mortality rate was not statistically different. G1 patients had a 5-year proximal neck re-intervention-free rate comparable to G2 patients (93.7% G1 vs. 87.5% G2, p = 0.785). The 5-year overall survival rate was not statistically different (59.9% G1 vs. 69.2% G2, p = 0.891). CONCLUSIONS: Patients with an aortic neck angle-length index > 4.8 are at greater risk of intraoperative neck complications and adjunctive neck procedures than patients with an aortic neck angle-length index ≤ 4.8. The 5-year proximal neck re-intervention-free rate and the 5-year survival rate were not statistically different. Based on our findings, this study suggests that the aortic neck angle-length index is a reliable predictor of intraoperative neck complications during EVAR in AAA with severe neck angulation.

Eversion technique versus traditional carotid endarterectomy with patch angioplasty: a systematic review with meta-analyses and trial sequential analysis.

Introduction: The use of an 'eversion' technique is not unequivocally proven to be superior to carotid endarterectomy with patch angioplasty. An up-to-date systematic review is needed for evaluation of benefits and harms of these two techniques. Methods: RCTs comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic and significant (≥50 %) stenosis of the internal carotid artery were enrolled. Primary outcomes were all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes included 30-day stroke and mortality rate, (a) symptomatic arterial occlusion or restenosis, and adverse events not critical for decision making. Results: Four RCTs were included with 1272 surgical procedures for carotid stenosis; eversion technique n = 643 and carotid endarterectomy with patch closure n = 629. Meta-analysis comparing both techniques showed, with a very low certainty of evidence, that eversion technique might decrease the number of patients with serious adverse events (RR 0.47; 95% CI 0.34 to 0.64; p ≤ 0.01). However, no difference was found on the other outcomes. TSA demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All patient-relevant outcomes were at low certainty of evidence according to GRADE. Conclusions: This systematic review showed no conclusive evidence of any difference between eversion technique and carotid endarterectomy with patch angioplasty in carotid surgery. These conclusions are based on data obtained in trials with very low certainty according to GRADE and should therefore be interpreted cautiously. Until conclusive evidence is obtained, the standard of care according to ESVS guidelines should not be abandoned.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Stroke Following Thoracic Endovascular Aortic Repair: Determinants, Short and Long Term Impact.

We performed a contemporary assessment of clinical and radiographic factors of stroke after thoracic endovascular aortic repair (TEVAR). Patients undergoing TEVAR from 2006 to 2017 were identified. We assessed clinical and radiographic data, including preoperative head and neck computed tomography, Doppler ultrasonography, and intraoperative angiography. Our primary outcome was stroke after TEVAR. Four hundred seventy-nine patients underwent TEVAR, mean age 68.1 ± 19.5 years, 52.6% male. Indications for TEVAR included aneurysms (n = 238, 49.7%) or dissections (n = 152, 31.7%). Ishimaru landing zones were Zone 2 (n = 225, 47.0%), Zone 3 (n = 151, 31.5%), or Zone 4 (n = 103, 21.5%). Stroke occurred in 3.8% (n = 18) of patients, with 1.9% (8) major events (modified Rankin Scale >3). Pathophysiology was predominantly embolic (n = 14), and occurred in posterior (n = 6), anterior (n = 6), or combined circulation (n = 4), and in the left hemisphere (n = 10) or bilateral (n = 6). Univariate analysis suggested use of lumbar drain (33.3% versus 57.2%, P = 0.04), inability to revascularize the left subclavian artery (16.7% vs 5.2%, P = 0.04) and number of implanted components (2.5 ± 1.2 vs 2.0 ± 0.97, P = 0.03) were associated with stroke. Multivariable analysis identified number of implanted components (OR 1.7, 95%CI 1.17-2.67 P = 0.00) and inability to revascularize the left subclavian artery as independent predictors of stroke. Stroke was associated with a higher perioperative mortality (27.8% vs 3.9%, P < 0.01). Stroke after TEVAR is primarily embolic in nature and related to both anatomic and procedural factors. This may have important implications for device development in the era of endovascular arch repair.

Patient-Specific Computational Modeling of Different Cannulation Strategies for Extracorporeal Membrane Oxygenation.

Institution of extracorporeal membrane oxygenation (ECMO) results in unique blood flow characteristics to the end-organ vascular beds. We studied the interplay between cardiac-driven and extracorporeal membrane oxygenation (ECMO)-driven flow to vascular beds in different ECMO configurations using a patient-specific computational fluid dynamics (CFD) analysis. A computational ECMO model (femoral artery cannulation [FAC]) was constructed using patient-specific imaging and hemodynamic data. Following model calibration, we augmented the 3D geometrical model to represent alternative ECMO configurations (ascending aorta cannulation [AAC] and subclavian artery cannulation [SAC]). We performed CFD analyses, including a novel virtual color-dye analysis to compare global and regional blood flow and pressure characteristics as well as contributions of cardiac and ECMO-derived flow to the various vascular beds. Flow waveforms at all the aortic branch vessels were pulsatile, despite low cardiac output and predominant nonpulsatile ECMO-driven hemodynamics. Virtual color-dye analysis revealed differential contribution of cardiac and ECMO-derived flow to the end-organ vascular beds in the FAC model, while this was more evenly distributed in the AAC and SAC models. While global hemodynamics were relatively similar between various ECMO configurations, several distinct hemodynamic indices, in particular wall shear stress and oscillatory shear patterns, as well as differential contribution of ECMO-derived flow to various vascular beds, showed remarkable differences. The clinical impact of this study highlighting the relevance of CFD modeling in assessment of complex hemodynamics in ECMO warrants further evaluation.

Left ventricular remodeling following aortic root and ascending aneurysm repair.

Objective: Adverse left ventricular remodeling due to a mismatch between stiffness of native aortic tissue and current polyester grafts may be under-recognized. This study was conducted to evaluate the impact of proximal aortic replacement on adverse remodeling of the left ventricle. Materials and methods: All aortic root and ascending aortic aneurysm patients were identified (n = 2,001, 2006-2019). The study cohort consisted of a subset of patients (n = 98) with two or more electrocardiogram (ECG)-gated CT angiograms, but without concomitant aortic valve disease or bicuspid aortic valve, connective tissue disease, acute aortic syndrome or prior history of aortic repair or mitral valve surgery. LV myocardial mass was measured from CT data and indexed to body surface area (LVMI). The study cohort was divided into a surgery group (n = 47) and a control group; optimal medical therapy group (OMT, n = 51). Results: The mean age was 60 ± 11 years (80% male). Beta-blocker use was significantly more frequent in the surgery group (89 vs. 57%, p < 0.001), whereas, all other antihypertensive drugs were more frequent in the OMT group. The average follow-up was 9.1 ± 4.0 months for the surgery group and 13.7 ± 6.3 months for the OMT group. Average LVMI at baseline was similar in both groups (p = 0.934). LVMI increased significantly in the surgery group compared to the OMT group (3.7 ± 4.1 vs. 0.6 ± 4.4 g/m2, p = 0.001). Surgery, baseline LVMI, age, and sex were found to be independent predictors of LVMI increased on multivariable analysis. Conclusion: Proximal aortic repair with stiff polyester grafts was associated with increased LV mass in the first-year post-operative and may promote long-term adverse cardiac remodeling. Further studies should be considered to evaluate the competing effects of aortic aneurysm related mortality against risks of long-term graft induced aortic stiffening and the potential implications on current size thresholds for intervention.

Early and Late Outcomes of Endovascular Aneurysm Repair for Infected Abdominal Aortic and/or Iliac Aneurysms.

BACKGROUND: Infected abdominal aortic and/or iliac aneurysm (AAIA) is a rare condition with a high mortality rate when treated with open surgery. In the past decade, the condition has increasingly been treated with endovascular aneurysm repair (EVAR). However, early and late outcomes, including the continued need for antibiotic treatments and predictors of persistent infection, are poorly understood. METHODS: We evaluated the outcomes of patients who underwent EVAR for infected AAIA from January 2010 to October 2017. We collected data including patient age, gender, clinical presentation, aneurysm location, culture results, intraoperative details, postoperative complications, 30-day mortality, in-hospital mortality, persistent infection, reintervention, and survival. RESULTS: Among 792 patients diagnosed with AAIA, 64 were diagnosed with primary infected aneurysm, underwent EVAR, and were included in this study (81.3% male; median age, 72 years; range, 18-94 years). The most commonly isolated organisms were Salmonella species (34%), followed by Streptococcus (21%), and Staphylococcus species (21%). Aneurysms were intact in 48 patients (75%) and were ruptured in 16 (25%). The perioperative mortality was 4.7% (3 patients) of whom one was diagnosed with ruptured infected AAIA. Six (9.4%) patients died during hospitalization, 5 of severe sepsis with multiorgan failure and one of myocardial infarction. Among the 58 surviving patients, 34 (58.6%) had persistent infection, of whom 13 (22.4%) required early and late reintervention, including 2 with endograft infection, 8 with primary and secondary aortoenteric fistula, 2 with recurrent new aortic infection, and one with graft limb occlusion. The remaining 24 patients were able to discontinue antibiotics and had no recurrence or need for reintervention. Overall survival rates at 1, 3, and 5 years in the antibiotic-discontinuation group were 91.7%, 87.5%, and 68.0%, respectively, and 82.4%, 52.6%, and 32.9%, respectively, in the persistent-infection group (P = 0.009). In multivariable analysis, primary aortoenteric fistula (Adjusted OR [aOR], 20.469; 95% confidence interval (CI), 1.265-331.320; P = 0.034) and preoperative serum albumin level <3 g/dL (aOR, 7.399; 95% CI, 1.176-46.558; P = 0.033) were preoperative parameter that predicted persistent infection. A C-reactive protein level more than 5 mg/L (aOR, 34.378; 95% CI, 4.888-241.788; P < 0.001) was observed in patients with persistent infection. CONCLUSIONS: EVAR is a feasible treatment with acceptable perioperative mortality for infected AAIA. Patients able to discontinue antibiotics have better survival and lower reintervention rates than those with persistent infection. A preoperative albumin level below 3 g/dL and primary aortoenteric fistula predicted persistent infection in this population.

Arterio-ureteral fistula: a nationwide cross-sectional questionnaire analysis.

PURPOSE: Arterio-ureteral fistula (AUF) is an uncommon diagnosis, but potentially lethal. Although the number of reports has increased over the past two decades, the true incidence and contemporary urologists' experience and approach in clinical practice remains unknown. This research is conducted to provide insight in the incidence of AUF in The Netherlands, and the applied diagnostic tests and therapeutic approaches in modern practice. METHODS: A nationwide cross-sectional questionnaire analysis was performed by sending a survey to all registered Dutch urologists. Data collection included information on experience with patients with AUF; and their medical history, diagnostics, treatment, and follow-up, and were captured in a standardized template by two independent reviewers. Descriptive statistics were used. RESULTS: Response rate was 62% and 56 AUFs in 53 patients were reported between 2003 and 2018. The estimated incidence of AUF in The Netherlands in this time period is 3.5 AUFs per year. Hematuria was observed in all patients; 9% intermittent microhematuria, and 91% presenting with, or building up to massive hematuria. For the final diagnosis, angiography was the most efficient modality, confirming diagnosis in 58%. Treatment comprised predominantly endovascular intervention. CONCLUSION: The diagnosis AUF should be considered in patients with persistent intermittent or massive hematuria.

Mid-Term Outcomes of Chimney Endovascular Aortic Aneurysm Repair: A Systematic Review and Meta-analysis.

BACKGROUND: To provide an overview of the literature on the mid-term outcomes of chimney EVAR (ChEVAR) for the treatment of juxtarenal abdominal aortic aneurysms (JAAA). METHODS: Different electronic databases were searched for published articles up to January 2020. The eligibility criteria were studies describing mid- or long-term outcomes of chimney EVAR (mean follow-up at least 1 year) for treatment of JAAA, including more than 10 cases, published in English, and with full text available. The outcomes measure were overall survival rate, target vessel patency, and freedom from reintervention at 3 years. Quality of the included studies was analyzed using the MINORS criteria. Pooled effect estimates were analyzed using random-effect models and heterogeneity was tested using I2 statistics. RESULTS: Thirteen articles met the inclusion criteria. The included studies described 1,019 patients. According to the quality assessment, methodological quality was moderate to poor. The pooled overall survival, freedom from reintervention, and target vessel patency at 3 year was 81.4 % (95%CI 73.8-87.9), 85.7% (95%CI 75.6-93.5), and 95.1% (95%CI 89.3-98.7) respectively. CONCLUSIONS: The results of this review show good to acceptable short and mid-term survival and good mid-term durability, which supports that ChEVAR as a suitable alternative in high-risk JAAA. However, proper patient selection for ChEVAR seems essential to attain good mid-term outcomes, and further large prospective and good quality studies are required to demonstrate its long-term results and enable conclusions on specific determinants for outcome.

Arterio-Ureteral Fistula: Systematic Review of 445 Patients.

PURPOSE: Arterio-ureteral fistula (AUF) is an uncommon diagnosis, but increasingly reported and potentially lethal. This systematic review comprehensively presents risk factors, pathophysiology, location and clinical presentation of AUF aiming to increase clinical awareness of this rare but life-threatening condition, and to put this entity into a contemporary perspective with modern diagnostic tools and treatment strategies. MATERIALS AND METHODS: This review was performed according to the PRISMA (Preferred Reporting Items for a Systematic Review and Meta-Analysis of Individual Participant Data) guidelines. A literature search in PubMed® and EMBASE™ was conducted. In addition, retrieved articles were cross-referenced. Data parameters included oncologic, vascular and urological history, diagnostics, treatment, and followup, and were collected using a standard template by 2 independent reviewers. RESULTS: A total of 245 articles with 445 patients and 470 AUFs were included. Most patients had chronic indwelling ureteral stents (80%) and history of pelvic oncology (70%). Hematuria was observed in 99% of the patients, of whom 76% presented with massive hematuria with or without previous episodes of (micro)hematuria. For diagnosis, angiography had a sensitivity of 62%. The most predominant location of AUF was at the common iliac artery ureteral crossing. AUF-specific mortality before 2000 vs after 2000 is 19% vs 7%, coinciding with increasing use of endovascular stents. CONCLUSIONS: AUF should be considered in patients with a medical history of vascular surgery, pelvic oncologic surgery, irradiation and/or chronic indwelling ureteral stents presenting with intermittent (micro)hematuria. A multidisciplinary consultation is necessary for diagnosis and treatment. The most sensitive test is angiography and the preferred initial treatment is endovascular.

A systematic review of the current status of interventions for type II endoleak after EVAR for abdominal aortic aneurysms.

OBJECTIVE: To study the mid- and long-term outcomes of type II endoleak treatment after EVAR and the technical aspects of different techniques to exclude endoleaks which different embolic agents. METHODS: A systematic review was performed using the approach recommended by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for meta-analyses of interventional studies. The comprehensive search was conducted using the following database: MEDLINE, EMBASE, and the Cochrane Library. Patient characteristic, intervention approaches, embolic agents, and results at mid and long term follow up were studied. RESULTS: A total of 6 studies corresponding to a total of 141 patients fulfilled the inclusion criteria with a mean age of 73-78.6 years and a mean duration of follow up varying from 25 to 42 months. There were different techniques for embolization used (translumbar, transarterial, and transcaval approach) with various types of embolic agents. In all studies, the indication for embolization of the type II endoleaks was sac enlargement of more than 5 mm. A wide range of technical success rate was reported regardless of the intervention strategy being used (17,6%-100%). The overall technical success rate of all studies was 62%. CONCLUSION: This systematic review shows that there is a wide variety of techniques to exclude a persistent type II endoleak. Different kinds of embolic agents have be used. Due to a lack of peer reviewed data on longterm follow-up, it was not possible to come to recommendations what treatment would be the best for a durable exclusion of a persistent type II endoleak after an initially successful EVAR. There remains an urgent need for proper executed studies, either randomized or with close observation in relation to longer follow-up.

Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials.

BACKGROUND: Patch angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques. METHODS: Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events. RESULTS: We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with patch angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation. CONCLUSIONS: This systematic review showed no conclusive evidence of a difference between carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials patch angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200-7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .

False lumen enhancement characteristics on computed tomography angiography predict risk of aneurysm formation in acute type B aortic dissection.

OBJECTIVES: Differential luminal enhancement [between true lumen (TL) and false lumen (FL)] results from differential flow patterns, most likely due to outflow restriction in the FL. We aimed to assess the impact of differential luminal enhancement at baseline computed tomography angiography on the risk of adverse events in patients with acute type B aortic dissection (TBAD). METHODS: Baseline computed tomography angiographies of patients with acute TBAD between 2007 and 2016 (n = 48) were analysed using three-dimensional software at multiple sites along the descending thoraco-abdominal aorta. At each location, we measured contrast density in TL and FL [Houndsfield unit (HU)], maximal diameter (cm) and circumferential FL extent (°). Outcome data were collected via retrospective chart review. Multivariable logistic regression models were employed to determine the independent risk of TL-FL differential luminal enhancement on aneurysm formation (maximal diameter ≥55 mm) and medical treatment failure. RESULTS: Patients were predominately male (75%) and 52.8±12.9 years at diagnosis. The mean follow-up was 5.9±2.6 years, and 42% (n = 20/48) patients were diagnosed with thoraco-abdominal aortic aneurysm. The baseline absolute difference between FL and TL contrast density measured at 2 cm distal to primary entry tear (TL-FLabs-Tear) was significantly higher among patients who developed aneurysm (26 HU, IQR: 15-53 vs 13 HU, IQR: 4-24, P = 0.001). Aneurysm development during follow-up was predicted by TL-FLabs-Tear (odds ratio 1.07, P = 0.012) and baseline maximal aortic diameter (odds ratio 1.90, P < 0.001). High (≥18 HU) differential luminal enhancement was associated with lower rates of aneurysm-free survival and higher rates of medical treatment failure. CONCLUSIONS: Differential luminal enhancement may be a novel predictor of aneurysm formation among patients with acute TBAD.

Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice.

INTRODUCTION: While the operator radiation dose rates are correlated to patient radiation dose rates, discrepancies may exist in the effect size of each individual radiation dose predictors. An operator dose rate prediction model was developed, compared with the patient dose rate prediction model, and converted to an instant operator risk chart. MATERIALS AND METHODS: The radiation dose rates (DRoperator for the operator and DRpatient for the patient) from 12,865 abdomen X-ray acquisitions were selected from 50 unique patients undergoing standard or complex endovascular aortic repair (EVAR) in the hybrid operating room with a fixed C-arm. The radiation dose rates were analyzed using a log-linear multivariable mixed model (with the patient as the random effect) and incorporated varying (patient and C-arm) radiation dose predictors combined with the vascular access site. The operator dose rate models were used to predict the expected radiation exposure duration until an operator may be at risk to reach the 20 mSv year dose limit. The dose rate prediction models were translated into an instant operator radiation risk chart. RESULTS: In the multivariate patient and operator fluoroscopy dose rate models, lower DRoperator than DRpatient effect size was found for radiation protocol (2.06 for patient vs 1.4 for operator changing from low to medium protocol) and C-arm angulation. Comparable effect sizes for both DRoperator and DRpatient were found for body mass index (1.25 for patient and 1.27 for the operator) and irradiated field. A higher effect size for the DRoperator than DRpatient was found for C-arm rotation (1.24 for the patient vs 1.69 for the operator) and exchanging from femoral access site to brachial access (1.05 for patient vs 2.5 for the operator). Operators may reach their yearly 20 mSv year dose limit after 941 minutes from the femoral access vs 358 minutes of digital subtraction angiography radiation from the brachial access. CONCLUSION: The operator dose rates were correlated to patient dose rate; however, C-arm angulation and changing from femoral to brachial vascular access site may disproportionally increase the operator radiation risk compared with the patient radiation risk. An instant risk chart may improve operator dose awareness during EVAR.

Imaging surveillance after open aortic repair: a feasibility study of three-dimensional growth mapping.

OBJECTIVES: Confident growth assessment during imaging follow-up is often limited by substantial variability of diameter measurements and the fact that growth does not always occur at standard measurement locations. There is a need for imaging-based techniques to more accurately assess growth. In this study, we investigated the feasibility of a three-dimensional aortic growth assessment technique to quantify aortic growth in patients following open aortic repair. METHODS: Three-dimensional aortic growth was measured using vascular deformation mapping (VDM), a technique which quantifies the localized rate of volumetric growth at the aortic wall, expressed in units of Jacobian (J) per year. We included 16 patients and analysed 6 aortic segments per patient (96 total segments). Growth was assessed by 3 metrics: clinically reported diameters, Jacobian determinant and targeted diameter re-measurements. RESULTS: VDM was able to clearly depict the presence or absence of localized aortic growth and allows for an assessment of the distribution of growth and its relation to anatomic landmarks (e.g. anastomoses, branch arteries). Targeted diameter change showed a stronger and significant correlation with J (r = 0.20, P = 0.047) compared to clinical diameter change (r = 0.15, P = 0.141). Among 20/96 (21%) segments with growth identified by VDM, growth was confirmed by clinical measurements in 7 and targeted re-measurements in 11. Agreement of growth assessments between VDM and diameter measurements was slightly higher for targeted re-measurements (kappa = 0.38) compared to clinical measurements (kappa = 0.25). CONCLUSIONS: Aortic growth is often uncertain and underappreciated when assessed via standard diameter measurements. Three-dimensional growth assessment with VDM offers a more comprehensive assessment of growth, allows for targeted diameter measurements and could be an additional tool to determine which post-surgical patients at high and low risk for future complications.

Endovascular ascending aortic repair in type A dissection: A systematic review.

PURPOSE: Up to 10% of acute type A aortic dissection (TAAD) patients are deemed unfit for open surgical repair, exposing these patients to high mortality rates. In recent years, thoracic endovascular aortic repair has proven to be a promising alternative treatment modality in specific cases. This study presents a comprehensive overview of the current state of catheter-based interventions in the setting of primary TAAD. METHODS: A literature search was conducted, using MEDLINE and PubMed databases according to PRISMA guidelines, updated until January 2020. Articles were selected if they reported on the endovascular repair of DeBakey Type I and II aortic dissections. The exclusion criteria were retrograde type A dissection, hybrid procedures, and combined outcome reporting of mixed aortic pathologies (e.g., pseudoaneurysm and intramural hematoma). RESULTS: A total of 31 articles, out of which 19 were case reports and 12 case series, describing a total of 92 patients, were included. The median follow-up was 6 months for case reports and the average follow-up was 14 months for case series. Overall technical success was 95.6% and 30-day mortality of 9%. Stroke and early endoleak rates were 6% and 18%, respectively. Reintervention was required in 14 patients (15%). CONCLUSION: This review not only demonstrates that endovascular repair in the setting of isolated TAAD is feasible with acceptable outcomes at short-term follow-up, but also underlines a lack of mid-late outcomes and reporting consistency. Studies with longer follow-up and careful consideration of patient selection are required before endovascular interventions can be widely introduced.

Important longitudinal and circumferential pulsatile changes in zone 0 of the aorta during the cardiac cycle.

OBJECTIVES: Correct stent-graft sizing is important when planning for thoracic endovascular repair in zone 0. As the movements of the aorta are constantly evolving in longitudinal and circumferential directions during the cardiac cycle, the diameter may not be the only important measurement. The aim of this study is to measure the circumferential and longitudinal pulsatile changes throughout the cardiac cycle. METHODS: Ninety-two patients, who were evaluated for transcatheter aortic valve replacement, were selected for this retrospective study. Their electrocardiogram-gated cardiac computed tomography was analysed. We identified the area, perimeter and diameter of the thoracic aorta in zone 0 and calculated the differences between these parameters at 3 locations in zone 0. The measurements were made in multiplanar views perpendicular to the semi-automatically created centreline in both systolic and diastolic phases. RESULTS: The mean age of our study cohort was 77 ± 11 years. The mean change between systole and diastole of the area (mm2), perimeter (mm) and diameter (mm) were compared at 3 different locations in the ascending aorta: at the sinotubular junction (0.78 mm2 vs 0.89 mm vs 1.41 mm), mid-ascending (0.72 mm2 vs 0.68 vs 0.81 mm) and proximal edge of the brachiocephalic artery (0.76 mm2 vs 0.73 mm vs 0.73 mm). The change in percentage is the smallest in the area at the sinotubular junction compared to the perimeter and diameter (2.6% vs 3.1% vs 4.7%). CONCLUSIONS: Changes in measurement of ascending aortic diameter with cardiac cycle are larger than measurement change in the area. This is especially more pronounced in zone 0A. For more accurate information on the morphometric changes, it may be necessary to measure the area when planning for thoracic endovascular repair to maximize results. A prospective study comparing these different measurements regarding the outcomes is advised by the authors to understand the clinical implications.

Early and late outcomes of endovascular aneurysm repair to treat abdominal aortic aneurysm compared between severe and non-severe infrarenal neck angulation.

BACKGROUND: Abdominal aortic aneurysm with severe infrarenal neck angle (>60°) has long been thought to be an obstacle to endovascular aneurysm repair. However, some previous studies reported endovascular aneurysm repair to be safe and efficacious for treating abdominal aortic aneurysm in patients with severe neck angulation. The aim of this study was to investigate the early and late outcomes of endovascular aneurysm repair to treat abdominal aortic aneurysm compared between patients with severe and non-severe infrarenal neck angulation. METHODS: Fifty-four severe and 144 non-severe neck angulation patients who were treated at Siriraj Hospital (Bangkok, Thailand) during January 2010-October 2013 were recruited. The primary endpoints were intraoperative neck complications (e.g., type 1A endoleak or proximal graft migration) and immediate adjunct aortic neck procedures. The secondary endpoints included perioperative mortality, overall survival, and the proportion of patients that were reintervention-free at five years compared between the severe and non-severe groups. RESULTS: Severe angulation patients were significantly older than non-severe angulation patients (77 ± 6.3 vs. 74 ± 7.9 years; p = 0.021). The median proximal angle was significantly greater in the severe group (82° vs. 13.5°; p < 0.001). Intraoperative proximal neck complications developed in 29.6% of patients in the severe angulation group compared with 9.0% in the non-severe group (p < 0.001). Significantly more patients in the severe group required intraoperative adjunct procedures (29.6% vs. 7.6%; p < 0.001). There was no significant difference in perioperative mortality between groups. At the five-year follow-up, there was no significant difference between groups for overall survival or the proportion of patients that remained reintervention-free. CONCLUSIONS: Endovascular aneurysm repair to treat abdominal aortic aneurysm in patients with severe proximal neck angulation is technically feasible and safe Although the severe angulation group had a higher rate of intraoperative neck complications and immediate adjunct neck procedures than the non-severe group, there was no significant difference between groups for 30-day mortality, overall survival or the proportion of patients who remained reintervention-free at five years.