Initial Experience of the Covered Endovascular Reconstruction of Iliac Bifurcation Technique.

INTRODUCTION: The distal landing zone in iliac arteries represents an important issue during endovascular repair of abdominal aortic aneurysms (EVAR). The aim of this study is to present a case series for landing in the external iliac artery (EIA) during EVAR while preserving blood flow in the internal iliac artery (IIA) with the covered endovascular reconstruction of the iliac bifurcation (CERIB) technique. METHODS: This is a single-center, retrospective analysis of prospectively collected data of patients that underwent EVAR either for intact abdominal aortic aneurysm (AAA) or previous failed EVAR from December 2022 up to September 2023. Indications for treatment were presence of common iliac artery aneurysm (CIAA), short CIA, or endoleak type Ib (ETIb). For the distal sealing zone, we used balloon-expandable covered stent (BXCS). Primary outcomes were technical success and first-month patency rate. Secondary outcomes were endoleak and re-intervention rate. RESULTS: Sixteen patients being treated with 20 CERIBs were included in the study. Four patients had a previous failed EVAR, while 3 patients were treated urgently for a symptomatic para-renal aneurysm. The indications for treatment were EIb (n=2), short CIA (n=4), CIAA with narrow lumen (n=3), and CIA aneurysm (n=11). Platforms that were used were the Cook Zenith Alpha (n=5), Gore C3 (n=2 and 3 limbs), Endurant IIs (n=2, and 3 limbs), and a t-branch device (n=3). Technical success rate was 100% with no adjunctive procedure. No death or re-intervention was recorded for all patients at postoperative 30-day period and at 6 months for 2 patients. At first-month CTA, patency rate was 100% (20/20), while in 2 patients that had 6-month CTA, the patency was also 100% (2/2). No kinking or stenosis was also noted. Two patients had ETIII after branched EVAR (BEVAR), 2 patients had ETII, and 1 patient had gutter ET in the area of the CERIB. CONCLUSION: The CERIB technique seems to be effective and safe in the early period. It is suitable with a variety of commercial endograft platforms. It may be a valuable alternative to iliac branch devices when there are anatomical considerations. Longer follow-up is needed to conclude for long-term patency and durability. CLINICAL IMPACT: The distal landing zone in iliac arteries represents an important issue during EVAR while it is important to preserve blood flow in the internal iliac artery. The covered endovascular reconstruction of the iliac bifurcation (CERIB) technique is a technique for the preservation of internal iliac arteries during EVAR, while it is suitable with a variety of commercial endograft platforms. The CERIB technique seems to be effective and safe in the early period. It may be valuable alternative to iliac branch devices when there are anatomical considerations.

Evaluation of Hemodynamic Properties After Chimney and Fenestrated Endovascular Aneurysm Repair.

BACKGROUND: Fenestrated (FEVAR) and chimney (ChEVAR) endovascular aortic repair have been applied in anatomically suitable complex aortic aneurysms. However, local hemodynamic changes may occur after repair. This study aimed to compare FEVAR's and ChEVAR's hemodynamic properties, focusing on visceral arteries. METHODS: Preoperative and postoperative computed tomography angiographies have been used to reconstruct patient-based models. Data of 3 patients, for each modality, were analyzed. Following geometric reconstruction, computational fluid dynamics simulations were used to extract near-wall and intravascular hemodynamic indicators, such as pressure drops, velocity, wall shear stress, time averaged wall shear stress, oscillatory shear index, relative residence time, and local normalized helicity. RESULTS: An overall improvement in hemodynamics was detected after repair, with either technique. Preoperatively, a disturbed prothrombotic wall shear stress profile was recorded in several zones of the sac. The local normalized helicity results showed a better organization of the helical structures at postoperative setting, decreasing thrombus formation, with both modalities. Similarly, time averaged wall shear stress increased and oscillatory shear index decreased postoperatively, signaling nondisturbed blood flow. The relative residence time was locally reduced. The flow in visceral arteries tended to be more streamlined in ChEVAR, compared to evident recirculation regions at renal and superior mesenteric artery fenestrations (P = 0.06). CONCLUSIONS: ChEVAR and FEVAR seem to improve hemodynamics toward normal values with a reduction of recirculation zones in the main graft and aortic branches. Visceral artery flow comparison revealed that ChEVAR tended to present lower recirculation regions at parallel grafts' entries while FEVAR showed less intense flow regurgitation in visceral stents.

Transition from Open Repair to Endovascular Aneurysm Repair for Rupture Aortic Aneurysms throughout a 16-Year Period of Time in a Single Tertiary Center.

BACKGROUND: Endovascular aneurysm repair (EVAR) is recommended as the first option for both elective and ruptured abdominal aortic aneurysms (rAAAs) with suitable anatomy. The aim of this study was to evaluate the outcomes of the gradual adoption of ruptured EVAR (rEVAR) as first option in the management of rAAAs in a reference tertiary center over a 16 year-period. METHODS: A retrospective analysis of prospectively collected clinical data was undertaken, including all patients that were treated for rAAA infrarenal or juxtarenal either with open surgical repair (OSR) or EVAR from 2006-2023. Three periods were identified and analyzed: Initial (2006-2011); intermediate (2012-2017); and current (2018-2023). The primary outcomes were the 30-day mortality rate in relation to the changing pattern of treatment. Secondary outcomes were re-intervention and mortality during the follow up period. RESULTS: Two hundred patients were treated for rAAA; 52% by endovascular means [EVAR (94), Ch-EVAR (9), and branched endovascular aneurysm repair (1)] and 48% by OSR (96). In the initial period, 61 patients were treated for rAAA (21% EVAR vs. 79% OSR), 68 in intermediate patients (47% EVAR vs. 53% OSR), and 71 in current period (83% EVAR vs. 17% OSR). Only in the current period juxta -renal rAAAs were treated by endovascular means (14%). The 30-day mortality rate was 46% in initial period (31% for EVAR vs. 50% for OSR), 64% in second period (46% in EVAR vs. 80% for OSR), and 35% in third period (25% for EVAR vs. 83% for OSR). The mean follow up did not differ between the groups, (EVAR 28.3 ± 2 months, vs. OSR 33.1 ± 3 months, P = 0.56). The survival rate did not differ between the groups; in rEVAR was 82% (SE 5%), 74% (SE 6%), 68% (SE 6.5%), and 63% (SE 7.7%) at 12, 24, 36, and 48 months, respectively, and in OSR was 76% (SE 7%), 66% (SE 8%), and 56% (SE 9.5%) at 6, 24, and 48 months, respectively (P = 0.544). CONCLUSIONS: Through a 16-year period, the implementation of EVAR as treatment of choice for rAAAs over OSR resulted in a noticeable reduction in the 30-day mortality. rEVAR was feasible in over 80% of rAAA patients.

Postdischarge thromboembolic outcomes and mortality of hospitalized patients with COVID-19: the CORE-19 registry.

Thromboembolic events, including venous thromboembolism (VTE) and arterial thromboembolism (ATE), and mortality from subclinical thrombotic events occur frequently in coronavirus disease 2019 (COVID-19) inpatients. Whether the risk extends postdischarge has been controversial. Our prospective registry included consecutive patients with COVID-19 hospitalized within our multihospital system from 1 March to 31 May 2020. We captured demographics, comorbidities, laboratory parameters, medications, postdischarge thromboprophylaxis, and 90-day outcomes. Data from electronic health records, health informatics exchange, radiology database, and telephonic follow-up were merged. Primary outcome was a composite of adjudicated VTE, ATE, and all-cause mortality (ACM). Principal safety outcome was major bleeding (MB). Among 4906 patients (53.7% male), mean age was 61.7 years. Comorbidities included hypertension (38.6%), diabetes (25.1%), obesity (18.9%), and cancer history (13.1%). Postdischarge thromboprophylaxis was prescribed in 13.2%. VTE rate was 1.55%; ATE, 1.71%; ΑCM, 4.83%; and MB, 1.73%. Composite primary outcome rate was 7.13% and significantly associated with advanced age (odds ratio [OR], 3.66; 95% CI, 2.84-4.71), prior VTE (OR, 2.99; 95% CI, 2.00-4.47), intensive care unit (ICU) stay (OR, 2.22; 95% CI, 1.78-2.93), chronic kidney disease (CKD; OR, 2.10; 95% CI, 1.47-3.0), peripheral arterial disease (OR, 2.04; 95% CI, 1.10-3.80), carotid occlusive disease (OR, 2.02; 95% CI, 1.30-3.14), IMPROVE-DD VTE score ≥4 (OR, 1.51; 95% CI, 1.06-2.14), and coronary artery disease (OR, 1.50; 95% CI, 1.04-2.17). Postdischarge anticoagulation was significantly associated with reduction in primary outcome (OR, 0.54; 95% CI, 0.47-0.81). Postdischarge VTE, ATE, and ACM occurred frequently after COVID-19 hospitalization. Advanced age, cardiovascular risk factors, CKD, IMPROVE-DD VTE score ≥4, and ICU stay increased risk. Postdischarge anticoagulation reduced risk by 46%.

Conical Aortic Neck as a Predictor of Outcome after Endovascular Aneurysm Exclusion: Midterm Results.

BACKGROUND: Conical neck may affect endovascular aneurysm repair (EVAR) outcomes. The aim of this study was to present EVAR neck adverse events [endoleak type Ia (ET Ia) and graft migration], in patients with conical neck morphology compared to patients with non-conical necks. An additional analysis of the factors that may affect neck adverse events in patients with conical necks, during the first postoperative year, was executed. METHODS: A retrospective analysis of prospective data was conducted, including patients that underwent elective EVAR, between 2017 and 2019. All patients completed the clinical and imaging follow-up of the initial 12 months. Regarding imaging, all cases underwent computed tomography angiography (CTA), preoperatively, at the 1st and 12th month of follow-up. Preoperative and postoperative aneurysm anatomic characteristics (supra-renal and infra-renal aortic diameters, aneurysm diameter, neck angle, thrombus, and calcification) were recorded. Proximal neck was defined as the infrarenal aortic segment, with a diameter less than 30 mm. Conical neck was any neck with a diameter increase ≥2 mm per cm of length (from outer-to-outer aortic wall). The proximal 15 mm of the neck length were considered the zone of endograft sealing. Migration was any ≥10 mm caudal movement of the endograft, relative to its position detected at the CTA of the first month. Neck adverse events were defined as the composite event of ET Ia and migration. RESULTS: The cohort included 150 patients; 66 (44%) presented conical neck morphology. No significant difference was detected regarding the preoperative anatomic characteristics between the conical and non-conical groups. Only distal (15 mm) neck diameter was wider in the conical group (P < 0.001). Supra-renal active fixation was used in 63.3% of the total cohort; 59.5% in patients with non-conical necks and 68.2% in patients with conical morphology (P = 0.275). Graft oversizing was 18.2% and 18.7% in the non-conical and conical group, respectively (P = 0.248). Oversizing >20% was equal between groups [37.8% vs. 33.3%% (P = 0.608) while oversizing ≥30% was more common among patients with conical necks (3.5% vs. 10.6%, P < 0.001, 3.2 odds ratio, 95% confidence interval: 0.79, 12.91). Regarding ET Ia and migration, no difference was recorded between the groups. In a subanalysis among patients with conical necks, a lower graft migration rate was detected among patients with higher oversizing rate (P = 0.037). CONCLUSIONS: EVAR may offer similarly good midterm outcomes in patients with conical and non-conical neck anatomy. An oversizing to the higher suggested rate may be preventive of graft migration during the first postoperative year in necks with conical morphology. Aggressive oversizing (>20%) do not offer any benefit regarding the prevention of adverse events among patients with conical necks.

Management of Ascending Aorta and Aortic Arch: Similarities and Differences Among Cardiovascular Guidelines.

BACKGROUND: Ascending aorta and aortic arch diseases have an increasing interest among cardiovascular specialists regarding diagnosis and management. Innovations in endovascular surgery and evolution of open surgery have extended the indications for treatment in patients previously considered unfit for surgery. The aim of this systematic review of the literature was to present and analyze current cardiovascular guidelines for overlap and differences in their recommendations regarding ascending aorta and aortic arch diseases and the assessment of evidence. METHODS: The English medical literature was searched using the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from January 2009 to December 2020. Recommendations on selected topics were analyzed, including issues from definitions and diagnosis (imaging and biomarkers) and indications for treatment to management, including surgical techniques, of the most important ascending aorta and aortic arch diseases. RESULTS: The initial search identified 2414 articles. After exclusion of duplicate or inappropriate articles, the final analysis included 5 articles from multidisciplinary, cardiovascular societies published between 2010 and 2019. The definition of non-A-non-B aortic dissection is lacking from most of the guidelines. There is a disagreement regarding the class of recommendation and level of evidence for the diameter of ascending aorta as an indication. The indication for treatment of aortic disease may be individualized in specific cases while the growth rate may also affect the decision making. The role of endovascular techniques has not been established in current guidelines except by 1 society. Supportive evidence level in the management of aortic arch diseases remains limited. CONCLUSION: In current recommendations of cardiovascular societies, the ascending aorta and aortic arch remain a domain of open surgery despite the introduction of endovascular techniques. Recommendations of the included societies are mostly based on expert opinion, and the role of endovascular techniques has been highlighted only from 1 society. The chronological heterogeneity apparent among guidelines and the inconsistency in evidence level should be also acknowledged. More data are needed to develop more solid recommendations for the ascending aorta and aortic arch diseases.

Editor's Choice - Endovascular Aneurysm Repair in High Risk Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: To investigate outcomes of endovascular aneurysm repair (EVAR) in high risk patients. METHODS: Bibliographic sources (MEDLINE, EMBASE, CINAHL, and CENTRAL) were searched using combinations of thesaurus and free text terms. The review protocol was registered in PROSPERO (CRD42021287207) and reported according to PRISMA 2020. Pooled estimates were calculated using odds ratio (OR) or hazard ratio (HR) and 95% confidence interval (CI) applying the Mantel-Haenszel or inverse variance method. EVAR peri-operative mortality in high risk patients over time was examined with mixed effects meta-regression. The GRADE framework was used to rate the certainty of evidence. RESULTS: The pooled peri-operative mortality in 18 416 high risk patients who underwent EVAR was 3% (95% CI 2.3 - 4%) and has significantly reduced over time (year of publication p = .003; median study point p = .023). The peri-operative mortality was significantly lower in high risk patients treated with EVAR compared with open repair (OR 0.64; 95% CI 0.45 - 0.92), but no significant difference was found in overall (HR 1.06; 95% CI 0.76 - 1.49) or aneurysm related mortality (HR 0.57; 95% CI 0.21 - 1.55). No significant difference was found in overall mortality between high risk patients treated with EVAR vs. no intervention (HR 0.42; 95% CI 0.14 - 1.26), but the aneurysm related mortality was significantly lower in the former (HR 0.30; 95% CI 0.14 - 0.63). The peri-operative mortality was higher in high risk than normal risk patients treated with EVAR (OR 2.33; 95% CI 1.75 - 3.10), as was the overall mortality (HR 3.50; 95% CI 2.55 - 4.80). The certainty of evidence was very low for EVAR vs. open surgery or no intervention and low for high vs. normal risk patients. CONCLUSION: The EVAR peri-operative mortality in high risk patients has improved over time. Even though the aneurysm related mortality of EVAR is lower compared with no intervention, EVAR may confer no overall survival benefit.

COVID-19 related peripheral arterial thrombotic events in intensive care unit and non-intensive care unit patients: A retrospective case series.

OBJECTIVES: COVID-19 associated arterial thrombosis has been attributed to multiple inflammation and coagulation mechanisms. The aim of this study was to report the experience of a tertiary center on COVID-19 patients managed for acute peripheral arterial thrombosis. METHODS: A single-center case series was conducted, including retrospectively collected data from all COVID-19 patients presenting arterial thrombosis, from March 2020 to February 2022. Intensive care unit (ICU) and non-ICU cases were included. The primary outcomes were mortality, successful revascularization, and amputation at 30 days. RESULTS: Twenty patients presented peripheral arterial thrombosis (90% males, mean age 65 years (16-82 years)). Eighteen were diagnosed with the Delta variant and none was previously vaccinated. All cases presented acute lower limb ischemia; in 20% with bilateral involvement. Nine patients were hospitalized in the ward while 11 in the ICU. From the non-ICU cases, five presented Rutherford IIb and four cases, Rutherford's IIa ischemia. Six cases underwent revascularization (67%). Two of them were finally amputated (33%) and two died during hospitalization (33%). Two revascularizations were considered successful (33%). The ICU group presented mainly with Rutherford's III ischemia (54.5%). The mortality in the ICU cohort was 72.7%. Only one patient underwent successful revascularization and two were amputated in this subgroup. Early mortality was 50% for the total cohort while the type of management was not related to mortality. CONCLUSIONS: Covid-19 related arterial thrombosis in non-vaccinated population is associated with 50% early mortality; increased up to 72% in the ICU patients. The amputation rate was 20% while only 40% of the revascularizations were considered successful.

Clinical effect of accessory renal artery coverage after endovascular repair of aneurysms in abdominal and thoracoabdominal aorta.

BACKGROUND: The aim of our systematic review and meta-analysis was to assess the effect of accessory renal artery (ARA) coverage on renal function in terms of acute kidney injury (AKI), renal infarction, chronic renal failure (CRF), and mortality in patients undergoing standard endovascular aortic aneurysm repair (EVAR) or endovascular repair of complex aneurysms. METHODS: An electronic search of the English language medical literature from 2000 to September 2020 was conducted using the MEDLINE, EMBASE, and Cochrane databases with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method for studies reporting on ARA management in patients undergoing endovascular repair of aneurysms in the abdominal and thoracoabdominal aorta. The patients were divided into two groups: group 1, patients with ARA coverage; and group 2, patients without an ARA or without coverage of the ARA. Each group included two arms, one of patients who had undergone standard EVAR and one of patients who had undergone endovascular treatment of a complex aortic aneurysm. The GRADE (grading of recommendations assessment, development, evaluation) approach was used to evaluate the quality of evidence and summary of the findings. The primary outcomes included the incidence of AKI, renal infarction, CRF, and mortality. RESULTS: Ten retrospective, nonrandomized, control studies were included in the systematic review reporting on 1014 patients (302 with a covered ARA vs 712 without an ARA or without ARA coverage). In six studies, the mean diameter of the covered ARA was <4 mm (range, 2.7-3.4 mm). The mean follow-up was 22.74 months (range, 1-42 months). In the standard EVAR subgroup, the risk of AKI (odds ratio [OR], 0.72; 95% confidence interval [CI], 0.21-2.51; I2 = 0%] in the early period, and CRF (OR, 4.44; 95% CI, 0.46-42.61; I2 = 87%) and death (OR, 0.91; 95% CI, 0.36-2.31; I2 = 0%) during follow-up were similar between groups 1 and 2. Only the risk of renal infarction was greater in group 1 than in group 2 (OR, 93.3; 95% CI, 1.48-5869; I2 = 92%). In the complex aneurysm repair subgroup, the risk of AKI (OR, 1.85; 95% CI, 0.61-5.64; I2 = 42%) in early period and CRF (OR, 1.64; 95% CI, 0.88-3.07; I2 = not applicable) and death (OR, 3.63; 95% CI, 0.14-96.29; I2 = 56%) during follow-up were similar between groups 1 and 2. Only the risk of renal infarction was greater for group 1 compared with group 2 (OR, 8.58; 95% CI, 4.59-16.04; I2 = 0%). CONCLUSIONS: ARA (<4 mm) coverage in patients undergoing standard EVAR or endovascular repair of complex aneurysms is associated with an increased risk of renal infarction. However, we found no clinical effects of ARA coverage on renal function or mortality in early postoperative and follow-up period. Preservation of an ARA >4 mm should be considered.

Management of Descending Thoracic Aortic Diseases: Similarities and Differences Among Cardiovascular Guidelines.

Cardiovascular societies have developed recommendations regarding the management of thoracic aortic diseases. While improvements in treatment have been observed during the past decade in regard to patient selection, thoracic endovascular aortic repair (TEVAR) and associated techniques, and high-volume centralization, the broad expansion of TEVAR has raised considerations about its indications, appropriateness, limitations, and application. The aim of this systematic review was to assess the similarities and differences among current cardiovascular societies' guidelines for the management of thoracic aortic diseases. The MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from January 2009 to May 2020. The initial search identified 990 articles. After exclusion of duplicate or inappropriate articles, the final analysis included 5 articles from cardiovascular societies published between 2010 and 2020. Selected controversial topics were analyzed, including diagnosis, imaging, spinal cord ischemia prevention, and management of the most important thoracic aortic pathologies. The analysis included data concerning the therapeutic approach in acute and chronic type B aortic dissection, penetrating aortic ulcer, intramural hematoma, thoracic aortic aneurysm, and traumatic aortic injury, as well a discussion of inflammatory aneurysms, aortitis, and genetic syndromes. The review presents consistent and controversial recommendations, as well as "gray zone" issues that need further investigation. There was significant overlap and agreement among the 5 societies regarding the management of thoracic aortic diseases. Especially in dissection and aneurysm management, TEVAR has established its role as the treatment of choice. However, robust evidence is still needed in many aspects of the management of thoracic aortic pathologies.

Modeling and Computational Comparison of the Displacement Forces Exerted between the AFX Unibody Aortic Stent Graft and its Hybrid Combination with a Nitinol-based Proximal Aortic Cuff.

BACKGROUND: The bifurcated AFX (Endologix, Inc, Irvine, CA, USA) aortic stent-graft is the sole unibody endograft for the management of Abdominal Aortic Aneurysms (AAA). In order to improve the AFX central sealing and clinical efficacy in challenging cases, a replacement of the central chromium-cobaltium AFX extension with a Nitinol-based proximal aortic cuff has been suggested. Yet, comparative data regarding the hemodynamic performance of this design is missing. Aim of this study was to compare the displacement forces (DF) acting on the hybrid AFX-Endurant design, with the classic AFX and Endurant endografts, in angulated and non-angulated cases based on patient-specific Computational Fluid Dynamics (CFD) simulations. METHODS: 3D endograft models of 11 treated AAA cases were reconstructed from Computed Tomography Angiography (CTA) imaging data: 5 cases of AFX, 3 cases of the combination AFX-Endurant and 3 cases of the classic Endurant design. The DF on the main-body, the iliac limbs, and the entire stent-graft was calculated by processing the velocity and pressure fields generated by pulsatile CFD simulations. RESULTS: The range of total DF (acting on the whole endograft structure) in the AFX, hybrid AFX-Endurant and Endurant group was 2.5-5.2N, 2.0-5.9N and 1.9-2.9N respectively, with the maximum total DF being lower for Endurant. The DF on the main-body of the classic and hybrid AFX cases were higher than the right and left iliac limbs (2.5-4.9N vs. 0.6-5.3N and 0.7-3.6N respectively). Conversely, the DF on the main-body of the Endurant cases was comparable to the force exerted on the right and left limbs. When separating the cases with respect to their neck angulation, the DF on all endograft parts (main-body, limbs) and on the endograft as a whole were lower for the hybrid AFX-Endurant group compared to the classic AFX and Endurant groups, for cases with almost straight neck. CONCLUSION: The off-label use of the hybrid AFX-Endurant stent-graft does not seem superior to the conventional AFX or Endurant endografts in angulated cases but was associated with lower DF than AFX or Endurant in non-angulated cases. The clinical value and utility of these findings remain to be elucidated.

Multicenter Mid-term Results After Endovascular Aortic Aneurysm Repair with the Incraft® Device.

OBJECTIVES: Durability after endovascular aortic aneurysm repair (EVAR) is considered an ongoing topic of investigation and was always a point of concern with smaller profile devices. Recently released five-year clinical trial results using the Incraft® ultralow profile device are encouraging. However, additional real-life experience will need to assist these initial findings. Herein, we investigated the outcomes after EVAR, in real world practice using the Incraft® endograft (EG). MATERIAL AND METHODS: Seventy-seven patients with infrarenal abdominal aortic aneurysms (AAA) ≥50 mm in diameter treated with the Incraft® device in three vascular centers were enrolled from November 2015 to July 2018. Follow-up was completed in August 2020. Selection of EVAR using the Incraft® device was individualized according to aorto-iliac morphologic features, comorbidities, history of previous abdominal surgery and preference of the patient. At the early phase of the study, we specifically opted for preferential use of this low profile EG mainly in cases of small and tortuous iliac vessels (more challenging access routes). At later stages, it was used according to surgeon preference and not specifically in complex anatomies (real-world conditions). End-points included technical success, perioperative complications, 30-day survival, endoleg patency, presence of endoleaks, sac enlargement >5 mm and clinical success. RESULTS: The primary technical success rate was 97.4% before the addition of an aortic cuff and iliac extension for a type Ia and type Ib endoleak respectively, and the repair of a maldeployment iliac component (primary-assisted and secondary technical success, 100%). Intraoperative small type II endoleaks (visible in final angiogram) were noted in 19 patients (24.7%). There were no intraoperative deaths from AAA rupture, primary conversions or conversions to aortounilateral grafts. Two complications occurred, necessitating hybrid techniques for repair (replaced of a dislodged endoleg and distal external iliac artery hemostasis). No deaths were reported within 30 days. Occlusion of an endoleg, was observed in two patients, 6 and 14 months respectively after implantation (2.6%), and were treated by femoral-femoral PTFE bypass after unsuccessful endovascular recanalization. The latter required open conversion, 3 mo later, to repair compromised flow to the inflow iliac axis. Three patients (3.9%) experienced sac enlargement >5 mm in diameter compared with the 1-month CT scan. All of these had type II endoleaks and two received embolization procedures. Eleven patients died from causes unrelated to AAA repair. Clinical success was 97.3%, 92.8% and 89.4% through 1, 2 and 3 years respectively. CONCLUSIONS: EVAR with the Incraft® device might be considered a reliable option in real-world conditions and not specifically only in complex iliac anatomies.

Factors associated with elimination of type II endoleak during the first year after endovascular aneurysm repair.

OBJECTIVE: The natural history of endoleak type II (ET II) after endovascular aneurysm repair (EVAR) is still debatable. The aim of this study was to examine the presence of preoperative and postoperative factors associated with persistence of ET II during the initial 12-month follow-up period. METHODS: A two-center retrospective study including patients subjected to EVAR from 2006 to 2017 was undertaken. Patients with ET II at 1-month computed tomography angiography (CTA) were categorized into two groups, resolution (group 1) vs persistence (group 2) of ET II at 12-month CTA. Preoperative demographics, comorbidities, aneurysm anatomic details, and pelvic artery index were assessed. Intraoperative details were also recorded. RESULTS: Of 825 patients, 140 (17%) patients (mean age, 71.7 ± 8.5 years; 94% male) presented with ET II at 1-month CTA. Group 1 included 58 patients (41%) and group 2, 82 patients (59%). The anatomic characteristics of the inferior mesenteric artery and lumbar arteries and the pelvic artery indices were not associated with ET II persistence. All patients in group 1 had presence of intraluminal thrombus (ILT) on preoperative CTA (group 1, 100%; group 2, 67%; P = .001), and the circular pattern of ILT was more common in group 1 (group 1, 44%; group 2, 24%; P = .01). At 12-month CTA, the mean sac regression was higher in group 1 (group 1, -3 ± 4 mm; group 2, 0.55 ± 3 mm; P = .000). After multivariate analysis, persistence of ET II was directly associated only with intraoperative internal iliac occlusion (odds ratio [OR], 0.232; 95% confidence interval [CI], 0.06-0.86; P = .03) and inversely with statin therapy (OR, 2.6; 95% CI, 1.01- 6.8; P = .047) and sac regression (OR, 1.24; 95% CI, 1.11-1.39; P = .001). CONCLUSIONS: Induced occlusion of the internal iliac artery during EVAR was the only factor associated with persistence of ET II during the first year after EVAR. The presence and pattern of ILT may play a role in ET II persistence, whereas the number of patent infrarenal aortic branches and their diameter as well as the pelvic artery indices were not associated with ET II. The use of statins may have a positive effect on ET II resolution during the first postoperative year. Sac diameter is more likely to regress in patients with ET II resolution.

The TAXINOMISIS Project: A multidisciplinary approach for the development of a new risk stratification model for patients with asymptomatic carotid artery stenosis.

INTRODUCTION: Asymptomatic carotid artery stenosis (ACAS) may cause future stroke and therefore patients with ACAS require best medical treatment. Patients at high risk for stroke may opt for additional revascularization (either surgery or stenting) but the future stroke risk should outweigh the risk for peri/post-operative stroke/death. Current risk stratification for patients with ACAS is largely based on outdated randomized-controlled trials that lack the integration of improved medical therapies and risk factor control. Furthermore, recent circulating and imaging biomarkers for stroke have never been included in a risk stratification model. The TAXINOMISIS Project aims to develop a new risk stratification model for cerebrovascular complications in patients with ACAS and this will be tested through a prospective observational multicentre clinical trial performed in six major European vascular surgery centres. METHODS AND ANALYSIS: The risk stratification model will compromise clinical, circulating, plaque and imaging biomarkers. The prospective multicentre observational study will include 300 patients with 50%-99% ACAS. The primary endpoint is the three-year incidence of cerebrovascular complications. Biomarkers will be retrieved from plasma samples, brain MRI, carotid MRA and duplex ultrasound. The TAXINOMISIS Project will serve as a platform for the development of new computer tools that assess plaque progression based on radiology images and a lab-on-chip with genetic variants that could predict medication response in individual patients. CONCLUSION: Results from the TAXINOMISIS study could potentially improve future risk stratification in patients with ACAS to assist personalized evidence-based treatment decision-making.

Anatomical Differences Between Intact and Ruptured Large Abdominal Aortic Aneurysms.

Purpose: To compare different anatomical characteristics between intact and ruptured large abdominal aortic aneurysms (rAAA >80 mm) with the goal of refining the process of estimating rupture risk. Materials and Methods: A retrospective study involving 62 male patients with large (>80 mm) aneurysms matched for age and smoking produced a 31-patient elective group with a mean maximum aneurysm diameter of 92±9.7 mm and a 31-patient rAAA group (mean maximum aneurysm diameter 95.7±12 mm). Preoperative computed tomography angiography scans were analyzed with a dedicated workstation, and anatomical characteristics of the aortic neck, iliac arteries, and aneurysm were compared in multivariable regression analyses; the outcomes are given as the odds ratio (OR) with 95% confidence interval (CI). The prognostic utility of several characteristics as predictors of rupture occurrence was examined with receiver operating characteristic (ROC) curves. Results: Anatomical characteristics differing significantly between elective and ruptured aneurysms were the infrarenal aortic neck diameters at 5 mm, 10 mm and 15 mm; the neck length and calcification; the common iliac artery (CIA) lengths; the iliac artery indexes; the left CIA and external iliac artery diameters; and the total and true lumen aneurysm volumes. Intraluminal thrombus (ILT) volume did not differ (p=0.76), although its distribution in elective vs ruptured cases did [absent: 0% vs 19%, respectively (p=0.025); circumferential: 61% vs 35%, respectively (p=0.04)]. Total aneurysm volume was higher in rAAA (442±140 mL) vs intact AAA (331±143 mL, p=0.014), while the ILT/total aneurysm volume rate was lower in rAAA (55%) vs intact AAA (70%, p=0.02). Multivariate analysis determined that a shorter left CIA (OR 1.07, 95% CI 1.01 to 1.1, p=0.016) and a smaller total aneurysm volume (OR 1.007, CI. 1.001 to 1.014, p=0.016) were associated with intact AAA. After a ROC curve analysis, left CIA length <50 mm demonstrated a lower incidence of rupture (sensitivity 60% and specificity 78%), while total aneurysm volume <380 mL had 60% sensitivity and specificity. Conclusion: Large rAAAs seem to have different anatomical characteristics than similarly sized intact AAAs. Large intact AAAs have lower total aneurysm volumes and shorter left CIAs, with higher ILT/aneurysm volume rates.

Management of Abdominal Aortic Aneurysm Disease: Similarities and Differences Among Cardiovascular Guidelines and NICE Guidance.

The development of endovascular techniques has improved abdominal aortic aneurysm (AAA) management over the past 2 decades. Different cardiovascular societies worldwide have recommended the endovascular approach as the standard of care in their currently available guidelines. While endovascular treatment has established its role in daily clinical practice, a new debate has arisen regarding the indications, appropriateness, limitations, and role of open surgery. To inform this debate, the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched from 2010 to May 2020; the systematic search identified 5 articles published between 2011 and 2020 by 4 cardiovascular societies and the National Institute of Health and Care Excellence (NICE). Four debatable domains were assessed and analyzed: diagnostic methods and screening, preoperative management, indications and treatment modalities, and postoperative follow-up and endoleak management. The review addresses controversial proposals as well as widely accepted recommendations and "gray zone" issues that need to be further investigated and analyzed, such as screening in women, medical management, and follow-up imaging. While the recommendations for AAA management have significant overlap and agreement among international cardiovascular societies, the NICE guidelines diverge regarding the role of open repair in aortic disease, recommending conventional surgery in most elective cases.

Completion imaging techniques and their clinical role after carotid endarterectomy: Systematic review of the literature.

BACKGROUND: Completion imaging has been suggested for the intraoperative quality control assessment of the carotid endarterectomy technical success, in order to immediately resolve pathologic findings and accordingly improve patients' outcome. The aim of this study was to present existing evidence of different completion imaging techniques after carotid endarterectomy and their role on clinical outcome. MATERIAL AND METHODS: A systematic review was performed searching in MEDLINE, CENTRAL, and Cochrane databases including studies reporting on completion imaging techniques after carotid endarterectomy. RESULTS: A total of 12,378 patients in 35 studies (20 retrospective and 15 prospective) underwent a completion imaging technique after carotid endarterectomy: in 19 studies, 5340 patients underwent arteriography; in 5 studies, 2095 angioscopy; in 21 studies, 5722 DUS; and in 2 studies, 150 patients underwent transcranial Doppler. Ten studies assessed > 1 imaging technique. The mean age was 67 ± 7 years old (69% males) with common co-morbidities to be hypertension (74%), smoking (64%), and hyperlipidemia (54%). Almost half of the patients (4949; 44%) were treated for symptomatic disease. In 1104 (9.7%) patients, a major defect was identified intra-operatively, while in 329 patients (2.9%), a minor defect. Common pathological findings were the presence of mural thrombus, carotid dissection, residual stenosis, and intimal flaps. An immediate re-intervention was undertaken in 75% (790/1053) of the patients to treat a major intra-operative imaging finding. In patients with re-intervention, only 2.3% (14/609) had an intra-operative stroke and 0.8% (5/609), a transient ischemic attack, while only 1.4% (8/575) had a stroke and 0.2% a transient ischemic attack (1/575) during 30-day post-operative period. No intra-operative death was reported. In the same period, the restenosis rate of internal and common carotid artery was 0.5% (3/575) and 0.2% (1/575), respectively. CONCLUSION: Completion imaging techniques can detect defects in almost 10% of patients that may lead to immediate intra-operative surgical revision with low intra-operative stroke/transient ischemic attack rate and low early carotid restenosis. During the 30-day follow-up period, in those patients, the incidence of stroke/transient ischemic attack may be low but present. This review cannot provide any evidence on which completion imaging technique is better, and the clinical impact conferred by each technique in the absence of a randomized control studies.

Endograft Specific Haemodynamics After Endovascular Aneurysm Repair: Flow Characteristics of Four Stent Graft Systems.

OBJECTIVES: The implication of haemodynamics in the occurrence of complications after endovascular aneurysm repair (EVAR) has been raised in the literature. Different aortic stent graft configurations may lead to different haemodynamic properties. The current study deals with the post-operative haemodynamic variability between four stent graft systems with different structure, material, and type of fixation. METHODS: Computed tomography data of 32 patients were used, equally distributed among the four endograft groups, namely the AFX, Endurant, Excluder, and Nellix. Velocity, wall shear stress (WSS), and helicity statistics were calculated, in regions around the flow division where disturbances are expected. The haemodynamic data were compared between and within the groups. RESULTS: The morphology of AAAs pre-operatively did not vary significantly among the four groups. Before the flow division, lowest velocity was observed in Endurant cases and highest in Nellix cases. Endurant induced the lowest peak WSS and Nellix the highest (p = .03). The helicity levels were low in AFX and Nellix cases and high in Endurant and Excluder cases. After the flow division, the trend in the results was preserved. Nellix induced the highest velocity and WSS, followed closely by Excluder and AFX. There was a significant increase of helicity before and after flow division in AFX (p <0.001, R2 = 0.09) and Nellix (p <0.001) cases. CONCLUSIONS: It has been shown that different types of endografts induce variable haemodynamic conditions around the flow division. The parallel limb structure, featured by Nellix, seems to induce favourable flow conditions in terms of velocity and WSS, while helical flow before the flow division is suppressed. High WSS is generally considered to be a desirable flow characteristic in endovascular devices, whereas helicity extremes (very low or high) are potentially a negative sign. Endurant, with the stiffer material and the short neck structure, was associated with the lowest blood velocity and WSS values but preserved high helicity levels. The AFX and Excluder, which include the same material, induced similar haemodynamic conditions.

Large Diameter (≥29 mm) Proximal Aortic Necks Are Associated with Increased Complication Rates after Endovascular Repair for Abdominal Aortic Aneurysm.

BACKGROUND: The aim of this study is to investigate the impact of proximal aortic diameter on outcome after endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs). METHODS: This is a case-control (1:1) retrospective analysis of prospectively collected data on 732 AAA patients treated with EVAR in 2 university centers. Patients with an infrarenal neck diameter of 29-32 mm (wide neck, WN group) were compared with patients with a neck diameter of 26-28.9 mm (control group) matched for age, gender, and maximum aneurysmal sac diameter. Any patients treated outside the instructions for use of each endograft or with no adequate follow-up were excluded. The primary end point was any neck-related adverse event (a composite of type Ia endoleak, neck-related secondary intervention, and endograft migration) during follow-up. RESULTS: Sixty-four patients with a proximal neck diameter of 29-32 mm (WN group) were compared with a matched control group of 64 patients with a neck diameter of 26-28.9 mm (control group). Oversizing was significantly higher in the study group (17.9% vs. 15.5%, P = 0.001). Overall median available follow-up was 24 months (range 12-84) (WN group 24 months vs. control group 18.5 months, P = 0.943). Primary end point was recorded in 8 patients (12.5%) of the WN group and in 1 patient (1.6%) of the control group. Freedom from the primary end point at 36 months (standard error <10%) was 87.3% for the study versus 98.4% for the control group (log rank = 4.66, P = 0.03). On multiple regression analysis, the presence of a proximal aortic neck >29 mm was the only independent risk factor for neck-related adverse events (odds ratio 7.4, 95% confidence interval 1.2-47.1). CONCLUSIONS: EVAR in the presence of a wide proximal aortic neck is likely to be associated with higher adverse neck-related event rates and thus, in such cases closer follow-up may be required.

Suprarenal Aortic Remodeling after Endovascular Aortic Aneurysm Repair among Three Endografts with Different Types of Proximal Fixation System.

BACKGROUND: Remodeling of suprarenal aorta after endovascular aortic aneurysm repair (EVAR) in relation to different endograft designs has not been thoroughly investigated. The aim of this study is to assess the anatomical configuration of the suprarenal aorta after using endografts with different proximal fixation during the first post-EVAR year. METHODS: A retrospective study including EVAR patients using 3 types of endografts with different proximal fixation systems according to Instructions for Use was undertaken (50: Ovation, Endologix, Irvin, CA; 25: Endurant IIs, Medtronic, Santa Rosa, CA; 25: Excluder C3, W. L. Gore & Associates, Flagstaff, AZ). Comorbidities were recorded. Anatomic variables of the supra-aortic anatomy, abdominal aortic aneurysm (AAA) maximum diameter, and neck angulation were analyzed. Computed tomography angiography was obtained preoperatively at 1 and 12 months post-EVAR, while a duplex scan was undertaken at 6 months. RESULTS: Comorbidities were not different across the 3 groups. Presence and amount of neck calcification (P = 0.139) and thrombus (P = 0.116) was similar among groups. Maximum aortic diameter showed significant reduction from preoperative measurements to 12-month postoperative ones, for all groups. (Ovation: 56.5 to 53 mm, P < 0.001; Endurant: 57 to 51 mm, P < 0.001; Excluder: 55 to 50 mm, P < 0.001). Suprarenal angulation was decreased significantly in the Ovation (P < 0.001) and Excluder groups (P = 0.05), while the infrarenal angulation was decreased in all groups. Among endografts, the decrease in AAA maximum diameter was similar (P = 0.99), while the suprarenal aortic diameter was significantly increased in Ovation patients in comparison to the other 2 endografts at the level of 5 mm (P = 0.02) and 25 mm (P = 0.01). Suprarenal angulation reduction was similar (P = 0.7), while infrarenal angulation was significantly more decreased in Ovation endograft than the other 2 systems (P < 0.001). CONCLUSIONS: Proximal endograft configuration appears to have different impact on supra-aortic anatomy. Longer follow-up is needed to clarify future remodeling and clinical impact of these observations.