Activation of GPBAR1 attenuates vascular inflammation and atherosclerosis in a mouse model of NAFLD-related cardiovascular disease.

While patients with nonalcoholic fatty liver disease (NAFLD) are at increased risk to develop clinically meaningful cardiovascular diseases (CVD), there are no approved drug designed to target the liver and CVD component of NAFLD. GPBAR1, also known as TGR5, is a G protein coupled receptor for secondary bile acids. In this study we have investigated the effect of GPBAR1 activation by BAR501, a selective GPBAR1 agonist, in Apolipoprotein E deficient (ApoE-/-) mice fed a high fat diet and fructose (Western diet), a validated model of NAFLD-associated atherosclerosis. Using aortic samples from patients who underwent surgery for abdominal aneurism, and ex vivo experiments with endothelial cells and human macrophages, we were able to co-localize the expression of GPBAR1 in CD14+ and PECAM1+ cells. Similar findings were observed in the aortic plaques from ApoE-/- mice. Treating ApoE-/- mice with BAR501, 30 mg/kg for 14 weeks, attenuated the body weight gain while ameliorated the insulin sensitivity by increasing the plasma concentrations of GLP-1 and FGF15. Activation of GPBAR1 reduced the aorta thickness and severity of atherosclerotic lesions and decreased the amount of plaques macrophages. Treating ApoE-/- mice reshaped the aortic transcriptome promoting the expression of anti-inflammatory genes, including IL-10, as also confirmed by tSNE analysis of spleen-derived macrophages. Feeding ApoE-/- mice with BAR501 redirected the bile acid synthesis and the composition of the intestinal microbiota. In conclusion, GPBAR1 agonism attenuates systemic inflammation and improve metabolic profile in a genetic/dietetic model of atherosclerosis. BAR501 might be of utility in the treatment for NAFLD-related CVD.

Defective Bile Acid Signaling Promotes Vascular Dysfunction, Supporting a Role for G-Protein Bile Acid Receptor 1/Farnesoid X Receptor Agonism and Statins in the Treatment of Nonalcoholic Fatty Liver Disease.

BACKGROUND: Patients with nonalcoholic fatty liver disease are at increased risk to develop atherosclerotic cardiovascular diseases. FXR and GPBAR1 are 2 bile acid-activated receptors exploited in the treatment of nonalcoholic fatty liver disease: whether dual GPBAR1/FXR agonists synergize with statins in the treatment of the liver and cardiovascular components of nonalcoholic fatty liver disease is unknown. METHODS AND RESULTS: Investigations of human aortic samples obtained from patients who underwent surgery for aortic aneurysms and Gpbar1-/-, Fxr-/-, and dual Gpbar1-/-Fxr-/- mice demonstrated that GPBAR1 and FXR are expressed in the aortic wall and regulate endothelial cell/macrophage interactions. The expression of GPBAR1 in the human endothelium correlated with the expression of inflammatory biomarkers. Mice lacking Fxr and Gpbar1-/-/Fxr-/- display hypotension and aortic inflammation, along with altered intestinal permeability that deteriorates with age, and severe dysbiosis, along with dysregulated bile acid synthesis. Vasomotor activities of aortic rings were altered by Gpbar1 and Fxr gene ablation. In apolipoprotein E-/- and wild-type mice, BAR502, a dual GPBAR1/FXR agonist, alone or in combination with atorvastatin, reduced cholesterol and low-density lipoprotein plasma levels, mitigated the development of liver steatosis and aortic plaque formation, and shifted the polarization of circulating leukocytes toward an anti-inflammatory phenotype. BAR502/atorvastatin reversed intestinal dysbiosis and dysregulated bile acid synthesis, promoting a shift of bile acid pool composition toward FXR antagonists and GPBAR1 agonists. CONCLUSIONS: FXR and GPBAR1 maintain intestinal, liver, and cardiovascular homeostasis, and their therapeutic targeting with a dual GPBAR1/FXR ligand and atorvastatin holds potential in the treatment of liver and cardiovascular components of nonalcoholic fatty liver disease.

Carotid stenting: Does stent design matter?

BACKGROUND: Carotid artery stenting (CAS) is considered an important tool in carotid revascularization. Carotid artery stenting is usually performed by using self-expandable stent with different designs. The stent design influences many physical characteristics. Also, it may affect the complication rate with special relevance to perioperative stroke, hemodynamic instability, and late restenosis. METHODS: This study comprised all consecutive patients who underwent carotid artery stenting for atherosclerotic carotid stenosis from March 2014 to May 2021. Both symptomatic patient and asymptomatic patients were included. Patients with a symptomatic carotid stenosis of ≥50% or asymptomatic carotid stenosis of ≥60% were selected for carotid artery stenting . Patients with fibromuscular dysplasia and acute or unstable plaque were not included. Variables of clinical relevance were tested in multivariable analysis using binary logistic regression model. RESULTS: A total of 728 patients were enrolled. The majority of this cohort was asymptomatic (578/728, 79.4%), while 150/728 (20.6%) were symptomatic. The mean degree of carotid stenosis was 77.82 ± 4.73%, with a mean plaque length of 1.76 ± 0.55 cm. A total of 277 (38%) patients were treated with Xact® Carotid Stent System. Successful carotid artery stenting was achieved in 698 (96%) of patients. Of these patients, stroke rate in symptomatic patients was nine (5.8%), while in asymptomatic patients was 20 (3.4%). In a multivariable analysis, the open-cell carotid stent was not associated with a differential risk for combined acute and sub-acute neurologic complications as compared with closed-cell stents. Patients treated with open cell stents had a significantly lower rate of procedural hypotension (P 0.0188) at bivariate analysis. CONCLUSION: Carotid artery stenting is considered a safe alternative to CEA that can be used in selected average surgical risk patient. Different stent designs can affect the rate of major adverse events in carotid artery stenting patients, but further studies are necessary with avoiding different bias to study the effect of different stent designs.

Editor's Choice - Multicentre Outcomes of Redo Fenestrated/Branched Endovascular Aneurysm Repair to Rescue Failed Fenestrated Endografts.

OBJECTIVE: To report the outcomes of redo fenestrated and/or branched endovascular aortic repair (F/BEVAR in FEVAR) to rescue previous failed FEVAR. METHODS: Retrospective review of all consecutive patients undergoing F/BEVAR in FEVAR at eight aortic centres including pre-, intra-, and post-operative data according to a pre-established protocol. Follow up consisted of at least yearly computed tomography angiography. Values are presented as median and interquartile range, and survival as estimate ± standard error in percentage. RESULTS: 18 male patients (76 years old; range 69 - 78 years) receiving FEVAR involving two (two or three) target vessels between 2006 and 2016 underwent F/BEVAR in FEVAR between 2012 and 2019 (aneurysm diameter of 63 mm; range 56 - 69 mm). Median interval between the procedures was 53 (29 - 103) months. The indication for F/BEVAR in FEVAR was type Ia endoleak in 16 cases (eight isolated and eight combined with graft migration), one graft migration without endoleak and one migration with significant proximal aortic expansion. F/BEVAR in FEVAR involved all patent renovisceral arteries and had an operating time of 260 (204 - 344) minutes. Technical success was achieved in 15 (83%) cases. There was a failure to bridge one renal artery, one renal capsular bleed with the subsequent need for renal artery embolisation within 24 hours and one persistent type Ib endoleak despite iliac extension. There was no peri- or in hospital death. Two patients developed spinal cord ischaemia, one transient paraparesis and one permanent paraplegia. The latter occurred in a non-staged procedure where spinal drainage was used. During a follow up of 27 (7 - 39) months, three (17%) patients underwent late re-interventions. Overall survival at 24 months was 70 ± 11% with no aneurysm related death and a secondary clinical success at 24 months of 84 ± 11%. CONCLUSION: F/BEVAR in FEVAR is a technically challenging but feasible solution to rescue failed FEVAR. The outcomes are promising in many aortic centres but need to be confirmed by further studies with longer follow up.

A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms.

OBJECTIVE: Patients in the Valiant Evo U.S. and international clinical trials had positive short-term outcomes; however, late structural failures, including type IIIb endoleaks have been recently discovered. Type IIIb endoleaks are serious adverse events because the repressurization of the aneurysm sac increases the risk of rupture. The purpose of the present study was to detail the imaging patterns associated with the structural failures with the aim of increasing awareness of failing graft presentation, early recognition, and prompt treatment. METHODS: The Valiant Evo clinical trial was a prospective, single-arm investigation of a thoracic stent graft system. With the recent late structural failures, sites were requested to submit all available imaging studies to date to allow the core laboratory to assess for structural failures such as type IIIb endoleaks, stent ring fractures, and stent ring enlargement. Of the 100 patients originally enrolled in the trial from 2016 to 2018, the core laboratory assessed the imaging studies performed at ≥1 year for 83 patients. RESULTS: No structural failures of the graft were reported through 1 year of follow-up. At 1 to 4 years, graft structural failures were detected in 11 patients with descending thoracic aortic aneurysms. Of the 11 patients, 5 had a type IIIb endoleak. Four of the five had imaging findings showing stent fractures consistent with the location of the graft seam and one had a type IIIb endoleak attributed to calcium erosion with no stent fracture or ring enlargement. Of the four patients with stent fracture in line with the graft seam, three underwent a relining procedure that successfully excluded the type IIIb endoleak. One of these three patients died 4 days later of suspected thoracic aortic rupture because the distal thoracic endovascular aortic repair extension had been landed in a previously dissected and fragile section of the aorta. The remaining six patients had had stent ring enlargement. One of the six patients had had persistent aneurysm expansion from the time of implantation onward and had died of unknown causes. The remaining five patients have continued to be monitored. CONCLUSIONS: In the present preliminary analysis, the imaging patterns associated with type IIIb endoleaks, stent fractures, and stent ring enlargement appear to be related to the loss of seam integrity or detachment of the stent rings from the surface of the graft material. The imaging patterns we have detailed should be closely monitored using computed tomography angiography surveillance to allow structural failures to be promptly identified and treated.

Predictors of Carotid Artery Stenting-Induced Hemodynamic Instability.

BACKGROUND: To address the predictors of hemodynamic instability (HI) related to carotid artery stenting (CAS) and evaluate the association between HI and periprocedural adverse outcomes. METHODS: This study comprised all consecutive patients who underwent CAS for atherosclerotic carotid artery stenosis from March 2014 to May 2018. A standardized dose of atropine (0.4 mg) was given prior to stent deployment. Changes in heart rate, blood pressure, and neurological status were monitored and recorded. Potential predictors of HI were tested in multivariate analysis using binary logistic regression model. RESULTS: A total of 728 patients were enrolled. Two hundred twenty seven patients (31.2%) developed periprocedural HI. The presence of hypertension (OR, 2.037; 95% CI, 1.292-3.211; P = 0.0022), symptomatic carotid lesions (OR, 1.704; 95% CI, 1.057-2.747; P = 0.0287), right sided lesions (OR, 3.090; 95% CI, 1.934-4.935; P ≤ 0.0001), hyperechoic/calcified plaques (OR, 2.195; 95% CI, 1.458-3.304; p P = 0.0002), and longer lesions (OR, 1.043; 95% CI, 1.012-1.076; P = 0.0072) were significant predictable factors for the occurrence of HI. On the other hand, smoking was significantly associated with a 48.1% decrease in risk of development of HI (OR, 0.519; 95% CI, 0.358-0.754; P = 0.0006). There were no statistically significant differences in periprocedural morbidity or mortality between patients with and without HI. CONCLUSION: HI occurs in a considerable percentage of patients undergoing CAS. Hypertension, right sided, symptomatic carotid lesions, calcified plaques, and longer lesions were shown to be independent risk factors for the development of periprocedural HI. Conversely, smoking demonstrated a protective effect. HI did not appear to predispose to periprocedural adverse events.

The Effect of Manufacturer's Instructions for Use Compliance on Cook ZBIS Iliac-Branched Endograft Long-Term Outcomes.

BACKGROUND: Current guidelines indicate iliac-branched endografts (IBDs) as the ideal means to preserve pelvic perfusion during endovascular aortic repair. Because patient vascular anatomy represents the main limitation to extensive use of these devices, off-label application may be considered to expand the number of patients being treated. The aim of this study is to evaluate long-term outcomes obtained using the Cook ZBIS endograft in the treatment of aortoiliac aneurysms as per or outside manufacturer's instruction for use (IFU). METHODS: Data from all patients who underwent IBD implant in a single center were reviewed. Study population was divided into two subgroups: Group I treated as per manufacturer's IFU and group II treated outside IFU. RESULTS: During the study period (2008-2018), 119 patients were treated with 130 IBDs. Eighty-six patients were treated as per IFU (group I) and 44 outside IFU (group II). Overall technical success was 99.2%. Mean follow-up was of 63.5 ± 38.3 months for group I and 58.3 ± 35.9 months for group II (P = 0.45). Freedom from reintervention at ten years was 79.8% in group I and 69.6% in group II (P = 0.29). Freedom from IBD-related reintervention rate was 98.7% and 95.3% in groups I and II, respectively (P = 0.240). Iliac-branched module thrombosis occurred significantly more in patients treated outside IFU with 4 cases in group I (4.7%) and 10 cases in group II (22.7%), (P = 0.005). Cox regression analysis identified hypogastric artery aneurysm as the only independent predictor for both IBD thrombosis and hypogastric artery occlusion during follow-up. CONCLUSIONS: When used by an experienced team, Cook IBDs are safe and effective in the treatment of aortoiliac aneurysms both inside and outside IFU. Anyway a lower target hypogastric patency rate should be expected when treating patients with hypogastric aneurysms.

Branched Endograft Partial Deployment to Save Space for Vessel Cannulation When Treating Aneurysms with Narrow Aortic Lumen.

PURPOSE: To describe a novel technique developed for the treatment of patients with thoracoabdominal aortic aneurysms having narrow aortic lumens using branched endografts. TECHNIQUE: When treating patients with a narrow aortic inner diameter with branched endografts, we propose a partial graft deployment leaving the distal portion of the device inside the delivery system with the aim of spare space and facilitate target vessel cannulation. CONCLUSIONS: Partial endograft deployment could be considered in the case of expected difficulty associated with encumbrance deriving from the distal straight graft portion. This technique could be useful to avoid target vessel loss and therein save procedural and fluoroscopy time.

Long Term Outcomes of Endovascular Aortic Repair in Patients With Abdominal Aortic Aneurysm and Ectatic Common Iliac Arteries.

OBJECTIVE: The purpose of this study was to evaluate the long term results of endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysm (AAA) and ectatic common iliac arteries (CIAs). METHODS: In a retrospective analysis of a prospectively collected database in two high volume centres, patients with AAAs undergoing elective standard EVAR were divided into two groups: those with both CIA diameters <18 mm, and those with at least one ectatic iliac artery (CIA ≥ 18 mm). Patients with an intentional external iliac artery landing zone were excluded. Primary outcomes were survival and freedom from re-intervention. Secondary end points were EVAR failure and iliac related endoleak and iliac re-intervention. RESULTS: From 2000 to 2015, 648 patients were included in the study, 277 (43%) had at least one CIA ≥ 18 mm. Pre-operative risk factors were similar between the two groups, with the exception of chronic renal insufficiency (p = .010) and cerebrovascular events (p = .040), which were higher in the ectatic CIA group. At 30 days from primary procedure, there was a higher rate of type Ib endoleak in patients with ectatic iliacs (p = .020). A statistically significant increase in the incidence of late type Ib endoleak in patients with ectatic iliac arteries was confirmed at a mean follow up of 74.8 months (p = .01). The need for iliac related re-intervention was higher in patients with CIAs ≥18 mm (odds ratio 1.94; 95% confidence interval 1.1-3.2). CONCLUSION: Ectatic iliac arteries are considered suitable landing zones for EVAR, although there is an increased risk of secondary interventions in time mainly due to late CIA dilation and secondary type Ib endoleak. Patients receiving EVAR with flared iliac limbs may benefit a more intensive surveillance to avoid late failures.

Quadriplegia and quadriparesis after endovascular aortic procedures: a catastrophic and under-reported complication?

In this study are presented three cases of spinal cord ischemia (SCI) involving the cervical-dorsal level and leading to quadriplegia and quadriparesis, following thoraco-abdominal aortic aneurysm (TAAA) endovascular repair. A 79-year-old woman with an extent III TAAA was scheduled for a multi-step fenestrated/branched endovascular aortic repair. Immediately after the first step, consisting of standard proximal thoracic stent-graft implantation, she developed quadriplegia that did not resolve despite all therapeutic actions, and died therefore on postoperative day 32. A 72-year old male with an extent IV TAAA underwent endovascular repair, using a customized fenestrated aortic stent-graft. Five hours after the procedure, he developed an asymmetric quadriparesis, that progressively resolved after spinal fluid drainage and arterial pressure increase, even if signs of SCI were documented at magnetic resonance imaging (MRI). A 79-year old man, referred for a type II TAAA with rapid enlargement, underwent a one-stage endovascular repair, using a customized branched aortic stent-graft. As soon as the procedure was completed, the patient presented inferior limbs paralysis and upper limbs paresis. Although no signs of SCI were documented at MRI, the patient did not recover and died therefore three months after the procedure. Although rare, cervical-dorsal SCI may develop during TAAA endovascular aortic repair. This possibly catastrophic event should be considered in the decisional process of TAAA repair and considered to allow prompt recognition and treatment.

Forced Complete Femoral Approach for Urgent Thoracoabdominal Aneurysm Repair Using an Inner Branched Endograft.

BACKGROUND: A successful case of urgent type II thoracoabdominal aneurysm repair with an inner branched endograft conducted entirely through femoral accesses without the bailout possibility to achieve an upper extremity approach for bridging stents delivery is described. CASE REPORT: A 70-year-old male patient underwent hybrid treatment for a thoracic aortic aneurysm on complicated type B dissection in 2 steps. First, arch debranching with carotid-carotid-subclavian bypass and then ascending aortic replacement with reimplantation of the anonymous trunk plus TEVAR were performed. The scheduled 1-month control computed tomography angiography (CTA) showed a rapid increase of the false lumen thoracoabdominal aneurysm, with axial diameter measuring more than 10 cm. The repair procedure was based on the use, as off-the-shelf graft, of a prosthesis customized for another patient with inner branches for visceral vessels that well suited the characteristics of the case. A steerable guiding sheath was essential to stabilize the system in the selective and sequential cannulation of 2 of the 4 inner branches (for celiac trunk and superior mesenteric artery) and to complete the bridging stents deployment. Procedure was carried out without complications. CONCLUSIONS: In an urgent setting, total endovascular correction of a thoracoabdominal aortic aneurysm exclusively through femoral accesses appears to be feasible when the appropriate tools are available.

Computed Tomography Postprocessing for Abdominal Aortic Aneurysm Lumen Recognition in Unenhanced Examinations.

INTRODUCTION: Contrast medium (CM) use in computed tomography (CT) is limited by nephrotoxicity and possible allergic reactions. The purpose of this study is to introduce a tool for the diagnosis of abdominal aortic aneurysms (AAAs) by avoiding the use of CM. METHODS: With and without CM CTs of patients with AAA were evaluated. A mathematical algorithm was implemented to allow visualization of the inner aortic lumen in the series without CM. The first step of the algorithm consisted in manually highlighting a squared region of interest (ROI) close to the target aortic area. The rest of the algorithm is completely automated and performs the following flow of operations: The "Kantorovich" algorithm is applied to the ROI for image enhancement. Then, a wavelet decomposition method is applied to identify the different frequency components of the image. Exploiting the wavelet decomposition, the system selects the low-frequency components of the image, corresponding to the major structures. Thresholding method, based on the analysis of the gray-level histogram, is then performed to extract the contours of the vessel. At this point, the extraction of the pervious area is completed. Final images were compared with the contrast enhanced scans, valued as gold standard. To validate the algorithm, an analysis of the results has been performed considering the following types of error: En = #m/#ROI ΔA = |1-(#CM/#CEX)| (#m = number of misclassified pixels; #ROI = number of pixels in the ROI; #CM = number of pixels belonging to the CM; #CEX = extracted areas). En provided a measure on the pixels wrongly classified, and ΔA the difference of extracted areas. RESULTS: The algorithm was applied to 233 CT images. Extracted images were compared with the ones with CM. Mean values of the numerical errors ranged from 0.12 to 0.17 for En and 0.11 to 0.35 for ΔA. For all the 233 CT images in the analyzed sequences, the mean error was 0.14 (En) and 0.28 (ΔA). CONCLUSIONS: The developed mathematical algorithm allows to detect the position of the vessel lumen and to extract its contours with a good accuracy. Our experience shows encouraging results and suggests a possible future clinical application to reduce CT CM use.

Achieving Consensus to Define Curricular Content for Simulation Based Education in Vascular Surgery: A Europe Wide Needs Assessment Initiative.

OBJECTIVE: To gather consensus among European educators about technical procedures that should be included in a future simulation based curriculum in vascular surgery. METHODS: A three round modified Delphi survey was initiated among 189 key opinion leaders (KOL) from 34 countries across Europe who were identified according to their positions in the European Society for Vascular Surgery, the European Journal of Vascular and Endovascular Surgery, and Union Européenne des Médecins Spécialistes Section and Board of Vascular Surgery. The first round was a brainstorming phase to identify technical procedures that a newly qualified vascular surgeon should be able to perform. The answers were analysed qualitatively. The second round investigated how often the identified procedures are performed, the number of vascular surgeons that should be able to perform these procedures, whether the procedures pose a risk to the patients, and whether simulation based education (SBE) is feasible. In the third round, elimination and re-ranking of procedures were performed. Only procedures that gained more than 70% support were included. An international steering group consisting of open and endovascular surgeons and medical educators governed the process. RESULTS: Response rates in the three rounds were 75% (142/189), 89% (126/142), and 85% (107/126), respectively. In the final prioritised list of 30 technical procedures for SBE, the top five procedures focus on basic open vascular skills, basic endovascular skills, vascular imaging interpretation, femoral endarterectomy, and open peripheral bypass. Twenty-six procedures were eliminated, including peripheral pressure measurement, wound management, open management of complications, major amputations, and highly advanced endovascular skills. CONCLUSION: The prioritised list of technical procedures from this ESVS supported project could be used to guide planning and development of future SBE programs to meet the needs of vascular surgeons across Europe.

Polymer Embolization and Anaphylactic Reaction during Implantation of an Ovation Stent Graft for Abdominal Aortic Aneurysm Exclusion.

During implantation of an Ovation endograft for abdominal aortic aneurysm (AAA) correction, a patient experienced anaphylactic reaction after polymer leakage outside the device circuit. Procedure was completed after hemodynamic stabilization. Since postoperative day 2, patient complained of loss of legs strength. Medullar injury was excluded by electromyography test, and the clinical signs attributed to muscular necrosis and peripheral nerve involvement after arterial embolization. Furthermore, immediately after surgery, a wide erythematous area appeared in the lumbar region. During the next few days, the lesion developed from extensive blisters and necrosis to deep loss of substance. The wound needed to be medicated 2 or 3 times per week. One year after surgery, the patient still needs crutches for deambulation, and the back injury is currently under treatment. In conclusion, surgeons performing aortic endovascular repair with the Ovation endograft, as well as anesthesiologists participating in the procedure, should be aware of the possibility of embolization and ready to promptly treat possible complications.

Long-term Results of Tapered Stents in Endovascular Treatment of Carotid Stenosis.

BACKGROUND: Recent technological developments allowed significant improvements in interventional approach to carotid artery stenosis. Tapered stents were specifically designed for extracranial carotid artery stenting (CAS) to deal with vessels mismatch with the objective of decreasing the risk of thrombosis. Nevertheless, whether the stent geometry may affect the outcomes of CAS is uncertain. This study aims to investigate the impact of stent configuration on perioperative and long-term results of this procedure. METHODS: All CAS procedures performed between 2005 and 2012 at a single high-volume center were reviewed. Primary end points of the study were 30-day mortality and any ipsilateral neurological event. Secondary end points were any late (>30 days) neurological event and restenosis >50%. RESULTS: About 1,368 procedures were performed in the period 2005-2012. 9.1% of the patients were symptomatic for recent focal neurological event. 883 patients were treated with a cylindrical stent while the others underwent a tapered design device implantation. Technical success was achieved in 96% of the procedures. No perioperative mortality was recorded; perioperative stroke occurred in 1.2% vs. 1.6% (P = not significant) in tapered and straight stent group respectively. Stent design did not predict perioperative ipsilateral neurological events neither at bivariate nor at multivariate analysis. At a mean follow-up of 30 months, late neurological events occurred in 26 cases (1.9%); conic stents resulted protective at Kaplan-Meier analysis (P = 0.027). CONCLUSIONS: The use of conic stents appears to be associated with similar perioperative results when compared with straight stents. Late outcomes suggest a lower risk of restenosis and late neurological events in patients with conical shape stents.

Safety of Carotid Revascularization during the Acute Period of Neurological Symptom Onset in Women.

BACKGROUND: Benefit from carotid revascularization is supposed to be lower in women due to increased periprocedural risks. The aim of this study was to investigate the risk of stroke/death after carotid intervention in women treated within 15 days from last neurological event. METHODS: Data from 282 consecutive patients treated during 2009-2015 by carotid endarterectomy or carotid stenting within 15 days from neurological symptoms were analyzed by sex and stratified according to treatment delay toward symptoms onset. RESULTS: Eighty women (28.4%) underwent carotid stenosis correction: in 37 treatment was performed within 7 days from symptoms (in 12 within 48 hr); the remaining underwent carotid disease correction between day 8 and day 15 after the index event. Baseline comorbidity profile, presenting symptoms (stroke, transient ischemic attack, and recurrent symptoms) and treatment delay were comparable between sexes. The 30-day stroke/death rate was 2.5% in women (2/80) and 3.5% (7/202) in men (P = 1.00). There was no 30-day death or cerebral hemorrhage in women and in patients treated within the first 48 hours. In adjusted analyses, female sex was not associated with increased stroke/death risk. At 4 years, for women and men survival was 93.9% vs. 79.2% (P = 0.047) and freedom from stroke 92.6% vs. 92.2% (P = 0.76). CONCLUSIONS: Women with symptomatic carotid stenosis may benefit as men from intervention when performed within the acute (15 days) or hyperacute (48 hr) period after neurological event. Thirty-day stroke/death rate in this experience is lower or comparable to men's and treatment appears to be effective in preventing new strokes at midterm.

Mortality Risk for Ruptured Abdominal Aortic Aneurysm in Women.

BACKGROUND: Sex differences in presentation and outcomes of abdominal aortic aneurysms (AAA) with increased mortality rates in women are suggested. This study aimed to assess mortality risk after repair of ruptured AAA (rAAA) in women in the endovascular abdominal aortic repair (EVAR) era. METHODS: Patients treated between 2006 and 2015 for rAAA were included in a prospective database. Characteristics at presentation and outcomes were compared between women and men. Multivariable logistic regression and Cox proportional analyses were performed to identify the effect of sex adjusted for other predictors on mortality. RESULTS: One hundred thirteen patients were identified; of these, 17.7% (20/113) of the patients were women. Forty-four procedures (38.9%) were by EVAR, with comparable rates in women (45%) and men (37.6%, P = 0.62). On admission, women and men shared similar comorbidities and presentation (shock 45% vs. 43.0%, P = 0.81; free rupture 65.0% vs. 67.7%, P = 0.80) and comparable mean aneurysm diameter (76.5 vs. 78.8 mm, P = 0.68), but women were older (mean age 86.4 + 5.5 vs. 75.2 ± 10.6 years, P < 0.0001) and octogenarian women were twice as likely as men (90% vs. 40%, P < 0.0001). Perioperative mortality was comparable between women and men (40.0% vs. 38.7%) either after EVAR (22.2% vs. 40.0% in women and men respectively; odds ratio [OR] 0.45, 95% confidence interval [CI] 0.77-2.37) or after open surgery (54.5% vs. 37.9%; OR 2.0, 95% CI 0.54-7.21), even though there was a trend for lower mortality in women with EVAR. In adjusted analyses, female sex was not associated with perioperative mortality as it was for older age (octogenarians: OR 6.6, 95% CI 2.08-20.82, P = 0.001) and free rupture (OR 4.2, 95% CI 1.29-13.73, P = 0.02). Mean follow-up was 34.32 months. After controlling for age, surgical repair, free rupture, cardiac disease, and shock at presentation, female sex was not a predictor of late mortality. CONCLUSIONS: AAA repair is often delayed in women and applied at older age; nevertheless, currently women do not show increased perioperative mortality risks from rAAA treatment after the introduction of EVAR.

Impact of age and urgency on survival after thoracic endovascular aortic repair.

OBJECTIVE: Elderly patients are often turned down from receiving treatment for descending thoracic aortic diseases (DTADs) because of the uncertain benefits, especially in acute settings. This study investigated the impact of old age and timing of thoracic endovascular aortic repair (TEVAR) on outcomes of DTAD in patients older than 75 years of age. METHODS: Patients from a prospective TEVAR database were dichotomized by age (75 and 80 years of age). Older and young patients were compared in three timing scenarios: (1) elective procedures, (2) any emergency (within 15 days from onset), and (3) acute ruptures (any emergency subgroup). Primary outcome was perioperative mortality assessed at 30 and 90 days. RESULTS: Between 2003 and 2015, 141 consecutive TEVARs (71.6% men) were performed. Fifty-seven patients (40.4%) were older than 75 years of age; 28 were octogenarians. Eighty-three TEVARs were performed electively and 58 emergently. Among overall emergencies, 42 TEVARs were for acute ruptures. In the elective scenario, the 30-day mortality rate was 5.0% vs 0 (odds ratio [OR], 1.1; 95% confidence interval [CI], 0.98-1.1; P = .23), and 90-day mortality was 7.5% vs 0, for patients older than 75 years of age vs those who were younger than 75, respectively (P = .11). No octogenarian died. In the emergency scenario, 30-day mortality was 41.2% vs 9.8%, for patients older than 75 years of age vs those who were younger than 75, respectively (OR, 6.5; 95% CI, 1.6-26.6; P = .01) with unchanged rates at 90 days. The mortality rate was 50% for octogenarians. In the acute rupture scenario, 30-day mortality was 40% vs 11.1% (OR, 5.3; 95% CI, 1.10-25.99; P = .05) for patients older than 75 years of age vs those younger than 75 years of age and 46% vs 10% (OR, 7.5; 95% CI, 1.47-37.46; P = .016) for octogenarians vs younger patients. Rates remained unchanged at 90 days. Patients older than age 75 survived for a mean of 53.98 ± 7.7 months after TEVAR. CONCLUSIONS: In the elderly patient population with DTAD, mortality risks from TEVAR are strongly related to timing and age. When compared to younger patients, those older than 75 years of age have three to five times the risk of mortality after urgent or emergent TEVAR. However, older patients should still be considered for emergent life-saving treatment, given that the majority survives.

Safety of Carotid Revascularization in Symptomatic Patients with less than 70 Years.

BACKGROUND: Age is a main risk factor for stroke and perioperative risk. This study aims to analyze the effect of age by symptomatic status in young patients receiving carotid revascularization. METHODS: Consecutive carotid revascularization procedures performed during the period 2001-2009 were reviewed. Patients were analyzed by age using the 70-year threshold as suggested by trials. Primary end point was perioperative stroke or death rate. Secondary end points included survival and late stroke incidence at 6 years. RESULTS: A total of 2,196 procedures (1,080 by carotid artery stenting [CAS] and 1,116 by carotid endarterectomy [CEA]) were analyzed. Symptomatic patients (n = 684) showed higher perioperative stroke or death risks (24 of 684 [3.5%] versus 29 of 1,512 [1.9%], odds ratio [OR] 1.8; 95% confidence interval [CI] 1.07-3.22; P = 0.034) and lower 6-year survival (74% vs. 82%, P < 0.0001) or freedom from late stroke (93% vs. 97%, P = 0.001) when compared with asymptomatic patients with similar differences detected within CEA or CAS procedure. Overall 949 procedures were in patients with 70 years or less at the time of intervention (500 CEA and 449 CAS); 282 were in patients symptomatic for minor stroke or transient ischemic attack within 6 months before revascularization. For young symptomatic patients, primary end point rates were <2.5% after both CEA and CAS procedure. Perioperative stroke or death rates were 2.4% in symptomatic versus 1.5% in asymptomatic (4 of 170 vs. 5 of 330; OR 1.57; 95% CI 0.42-5.91; P = 0.50) within the CEA group and 1.8% in symptomatic versus 1.2% in asymptomatic (2 of 112 vs. 4 of 337; OR 1.51; 95% CI 0.27-8.38; P = 0.64) within the CAS group. At 6 years, symptomatic young patients showed survival (89.5% vs. 89%, P = 0.76) and freedom from late stroke (97% vs. 98%, P = 0.56) rates comparable to those found in asymptomatic patients, with similar incidences after CAS or CEA procedure. CONCLUSIONS: Outcomes after carotid revascularization are related to patients' age. At younger ages (<70 years), after carotid revascularization, symptomatic patients show low perioperative risks of stroke or death, comparable with those in asymptomatic patients. The same, 2.5% or lower, threshold for perioperative stroke or death risk related to asymptomatic carotid procedures must be applied today to symptomatic patients when younger than age of 70 years.