An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Temporary intravascular shunts and limb salvage in civilian vascular trauma.

Background: Temporary intravascular shunts (TIVS) may allow quick revascularization and distal reperfusion, reducing the ischemic time (IT) when an arterial injury occurs. Furthermore, TIVS temporarily restore peripheral perfusion during the treatment of concomitant life-threatening injuries or when patients require evacuation to a higher level of care. Notwithstanding, there are still disputes regarding the use of TIVS, in view of the paucity of evidence in terms of potential benefits and with regard to the anticoagulation during the procedure. The present study aimed to assess TIVS impact, safety, and timing on limb salvage in complex civilian vascular traumas. Patients and methods: Data were retrieved from the prospective database of our department, which included all patients hospitalized with a vascular injury of the extremities between January 2006 and December 2022. Patients undergoing TIVS during vascular injury management were included in group A, and those who could not postpone immediate care for TIVS insertion were included in group B (control group). Data concerning the times required for extremity revascularization or other surgical procedures such as orthopedic interventions and the time of limb ischemia were compared between the two groups. A comparison of the postoperative course between the two groups was also performed. Results: A total of 53 patients were included: group A (TIVS insertion, n = 31) and group B (control, n = 22). Revascularization time significantly differed (p = 0.002) between the two groups, which is lower in group A (4.17 ± 2.37 h vs. 5.81 ± 1.26 h). TIVS positively affected the probability of limb salvage (p = 0.02). At multivariate analysis, the factors independently associated with limb salvage were TIVS usage, the necessity of hyperbaric oxygen therapy, and the total IT. In group A, there were three deaths and one major amputation, and in group B, there were two deaths and four major amputations. Conclusions: The use of TIVS minimizes revascularization time and improves limb salvage probability. A multidisciplinary approach is recommended, and correct surgical timing is key to ensure the best outcome.

Elective Endovascular Aneurysm Repair (EVAR) for the Treatment of Infrarenal Abdominal Aortic Aneurysms of 5.0-5.5 cm: Differences between Men and Women.

BACKGROUND: There is significant debate regarding the existence of sex-related differences in the presentation, treatment, and outcomes of men versus women affected by abdominal aortic aneurysm (AAA). The purpose of this study is to compare endovascular aneurysm repair (EVAR) of infrarenal AAAs with the current sex-neutral 5.0-5.5 cm-diameter threshold for intervention between the two sexes. METHODS: Retrospective review of consecutive cases from a single teaching institution over a period of five years of patients who had undergone elective EVAR for AAAs between 5.0 and 5.5 cm in diameter. Outcomes of interest were compared according to sex. RESULTS: Ninety-four patients were included in the analysis, with a higher prevalence of men (53%). Females were older at the time of repair, 78 ± 5.1 years, versus 71.7 ± 7 years (p < 0.01), and had higher incidence of underlying comorbidities, namely, arrhythmia, chronic kidney disease, and previous carotid revascularization. Women had higher incidence of immediate systemic complications (p = 0.021), post-operative AMI (p = 0.001), arrhythmia (p = 0.006), pulmonary oedema (p < 0.001), and persistent renal dysfunction (p = 0.029). Multivariate analysis for post-operative factors associated to mortality and adjusted for sex confirmed that AMI (p = 0.015), arrhythmia (p = 0.049), pulmonary oedema (p = 0.015), persistent renal dysfunction (p < 0.001), cerebral ischemia (p < 0.001), arterial embolism of lower limbs (p < 0.001), and deep-vein thrombosis of lower limbs (p < 0.001) were associated to higher EVAR-related mortality; a higher incidence of post-operative AMI (p = 0.014), pulmonary edema (p = 0.034), and arterial embolism of lower limbs (p = 0.046) were associated to higher 30-days mortality. In females there was also a higher rate of suprarenal fixation (p = 0.026), insertion outside the instruction for use (p = 0.035), and a more hostile neck anatomy with different proximal aortic diameter (p < 0.001) and angle (p = 0.003). CONCLUSIONS: A similar threshold of size of AAA for elective surgery for both males and females might not be appropriate for surgical intervention, as females tend to have worse outcomes. Further population-based studies are needed to guide on sex-related differences and intervention on AAA.

New Technologies in the Assessment of Carotid Stenosis: Beyond the Color-Doppler Ultrasound-High Frame Rate Vector-Flow and 3D Arterial Analysis Ultrasound.

Atherosclerotic plaque in the carotid artery is the main cause of ischemic stroke, with a high incidence rate among people over 65 years. A timely and precise diagnosis can help to prevent the ischemic event and decide patient management, such as follow up, medical, or surgical treatment. Presently, diagnostic imaging techniques available include color-Doppler ultrasound, as a first evaluation technique, computed tomography angiography, which, however, uses ionizing radiation, magnetic resonance angiography, still not in widespread use, and cerebral angiography, which is an invasively procedure reserved for therapeutically purposes. Contrast-enhanced ultrasound is carving out an important and emerging role which can significantly improve the diagnostic accuracy of an ultrasound. Modern ultrasound technologies, still not universally utilized, are opening new horizons in the arterial pathologies research field. In this paper, the technical development of various carotid artery stenosis diagnostic imaging modalities and their impact on clinical efficacy is thoroughly reviewed.

Early Experience with Ovation Alto Stent-Graft.

BACKGROUND: Alto is the latest generation of the Ovation stent-graft platform for endovascular aneurysm repair (EVAR). Its ultra-low profile and its proximal sealing zone close to the lowest renal artery (≥7 mm) increase standard EVAR eligibility. We report early clinical and technical outcomes with the Alto stent-graft in our University Hospital Center after CE Mark approval in August 2020. METHODS: Seven patients (all male, mean age 76.1 ± 6.2 years) underwent EVAR with Ovation Alto stent-graft between June 2021 and February 2022. All the EVAR procedures were performed by a team of vascular surgeons experienced on EVAR with previous generation of Ovation platform. Follow-up consisted of duplex ultrasound examination at 1, 3, and 6 months and of a 1-month control computed tomography angiography (CTA). Patients treated gave consent to participate in this case series and publication. A descriptive analysis of variables was performed. SPSS (version 25) and Excel were used for statistical analysis. RESULTS: Most of the patients had a fusiform abdominal aortic aneurysm (n = 5; 71.4%). The median maximal transversal aortic diameter was 5.06 cm (range, 3.98-6.99). Because of hostile aortic neck anatomy, on-label EVAR was considered feasible only with Ovation Alto stent-graft. Narrow iliac arteries (<6 mm) were also present in 2 cases. All procedures were performed according to the instruction for the use of the device. Technical success was achieved in all cases. No type IA/IB/III endoleak occurred at completion angiography. No distal migration (>10 mm) but 2 distal displacements (≥2 mm) were observed at control CTA. During follow-up, duplex ultrasound and CTA showed no type I/III endoleak, no stent-graft migration (>10 mm), and no proximal aortic neck variations (P = not statistically significant). Three patients (42.8%) are under strict surveillance because of low-flow type II endoleak not associated with sac variations. CONCLUSIONS: Our early experience shows promising technical and clinical success with Alto stent-graft. The proximal relocation of the proximal sealing rings and the ultra-low profile delivery system allow on-label EVAR in a wider range of aortic anatomies. Notwithstanding, further studies, meta-analysis, and prospective registries are mandatory to evaluate mid- and long-term efficacy and safety of this latest Ovation platform.

Natural Activators of Autophagy Increase Maximal Walking Distance and Reduce Oxidative Stress in Patients with Peripheral Artery Disease: A Pilot Study.

Trehalose, spermidine, nicotinamide, and polyphenols have been shown to display pro-autophagic and antioxidant properties, eventually reducing cardiovascular and ischemic complications. This study aimed to investigate whether a mixture of these components improves maximal walking distance (MWD) in peripheral artery disease (PAD) patients. Nitrite/nitrate (NOx), endothelin-1, sNOX2-dp, H2O2 production, H2O2 break-down activity (HBA), ATG5 and P62 levels, flow-mediated dilation (FMD), and MWD were evaluated in 20 PAD patients randomly allocated to 10.5 g of mixture or no-treatment in a single-blind study. The above variables were assessed at baseline and 60 days after mixture ingestion. Compared with baseline, mixture intake significantly increased MWD (+91%; p < 0.01) and serum NOx (+96%; p < 0.001), whereas it significantly reduced endothelin-1 levels (−30%, p < 0.01). Moreover, mixture intake led to a remarkable reduction in sNOX2dp (−31%, p < 0.05) and H2O2 (−40%, p < 0.001) and potentiated antioxidant power (+110%, p < 0.001). Finally, mixture ingestion restored autophagy by increasing ATG5 (+43%, p < 0.01) and decreasing P62 (−29%, p < 0.05). No changes in the above-mentioned variables were observed in the no-treatment group. The treatment with a mixture of trehalose, spermidine, nicotinamide, and polyphenols improves MWD in PAD patients, with a mechanism possibly related to NOX2-mediated oxidative stress downregulation and autophagic flux upregulation. Clinical Trial Registration unique identifier: NCT04061070.

3D-Arterial analysis software and CEUS in the assessment of severity and vulnerability of carotid atherosclerotic plaque: a comparison with CTA and histopathology.

PURPOSE: Our purpose is to assess Multiparametric Ultrasound (MPUS) efficacy for evaluation of carotid plaque vulnerability and carotid stenosis degree in comparison with Computed Tomography angiography (CTA) and histology. MATERIAL AND METHODS: 3D-Arterial Analysis is a 3D ultrasound software that automatically provides the degree of carotid stenosis and a colorimetric map of carotid plaque vulnerability. We enrolled 106 patients who were candidates for carotid endarterectomy. Prior to undergoing surgery, all carotid artery plaques were evaluated with Color-Doppler-US (CDUS), Contrast-Enhanced Ultrasound (CEUS), and 3D Arterial analysis (3DAA) US along with Computerized Tomographic Angiography (CTA) to assess the carotid artery stenosis degree. Post-surgery, the carotid specimens were fixed with 10% neutral buffered formalin solution, embedded in paraffin and used for light microscopic examination to assess plaque vulnerability morphological features. RESULTS: The results of the CTA examinations revealed 91 patients with severe carotid stenoses with a resultant diagnostic accuracy of 82.3% for CDUS, 94.5% for CEUS, 98.4% for 3DAA, respectively. The histopathological examination showed 71 vulnerable plaques with diagnostic accuracy values of 85.8% for CDUS, 93.4% for CEUS, 90.3% for 3DAA, 92% for CTA, respectively. CONCLUSIONS: The combination of CEUS and 3D Arterial Analysis may provide a powerful new clinical tool to identify and stratify "at-risk" patients with atherosclerotic carotid artery disease, identifying vulnerable plaques. These applications may also help in the postoperative assessment of treatment options to manage cardiovascular risks.

Surgery for late type Ia/IIIb endoleak from a fabric tear and stent fracture of AFX2 stent graft.

Technical improvements and labeling updates of the AFX2 stent graft (Endologix Inc, Irvine, CA) seemed to have solved the known issues of its previous generation (AFX Strata). Although most endograft failures after endovascular abdominal aortic aneurysm repair will be managed endovascularly, a small subset of patients will still require secondary open conversion. Partial or complete endograft removal can be required, mainly dependent on the characteristics of the stent graft previously placed. We have report a case of secondary open conversion for late type Ia/IIIb endoleak due to stent fracture and fabric tear of the AFX2 stent graft 3 years after endovascular abdominal aortic aneurysm repair.

Duplex ultrasound as a reliable alternative to CT angiography for treatment planning of peripheral artery disease.

BACKGROUND: The aim of this work was to compare the diagnostic accuracy of Duplex ultrasound (DUS) and CT angiography (CTA) in the study of arterial vessels, in patients with chronic peripheral arterial disease (PAD) of the lower limbs to undergo endovascular revascularization with the use of intraprocedural digital angiography (DSA). METHODS: Ninety-four patients with obstructive pathology of the arterial axes of the lower limbs were enrolled in the study. In all patients, endovascular revascularization treatment was considered the most suitable therapeutic choice. For this reason, ultrasound and CTA was performed preoperatively in all and based on the data obtained it was decided to classify the arterial tree into five segments: iliac, common femoral, superficial femoral, popliteal and infra-geniculate. According to the degree of stenosis or occlusion, the arteries were scored in no stenotic, stenotic and occluded. The comparison of the data provided by the DUS and the CTA was carried out with reference to the parameters obtained by the DSA. RESULTS: The results of our experience have shown that in the iliac arterial district DUS proved to be less accurate than CT angiography when compared to DSA (Cohen's κ agreement of 0.91 and 1.0, respectively). Good diagnostic concordance was found in the femoro-popliteal district (Cohen's κ agreement 33 between 0.96 and 0.93). On the contrary, when the data of the infra-geniculate area were compared, CT angiography showed a net deficiency compared to DSA and DUS (Cohen's κ: 0.75). CONCLUSIONS: Due to its accuracy, high-quality DUS performed by well-trained operators may therefore represent a good alternative to CTA in patients undergoing endovascular revascularization, in order to reduce the use of contrast-enhanced radiological imaging especially when a condition of intolerance to the contrast medium and/or renal insufficiency coexists.

The PROTAGORAS 2.0 Study to Identify Sizing and Planning Predictors for Optimal Outcomes in Abdominal Chimney Endovascular Procedures.

OBJECTIVE: The aim was to identify predictors of adequate pre-operative sizing and planning for chimney endovascular aortic repair (ChEVAR) in order to reduce the incidence of persistent type Ia endoleaks (IaELs) without influencing chimney graft (CG) patency. METHODS: Consecutive patients who underwent ChEVAR between January 2009 and December 2017 at a single centre were evaluated retrospectively. Included were patients treated with one device combination (Medtronic Endurant mated with Getinge Advanta V12/iCast) and placement of single or double CG. The freedom from IaEL related re-interventions and primary CG patency was estimated by measuring aortic stent graft oversizing (OS), total neck length (TNL), and a composite parameter (L-OS: TNL [mm] + OS [%]). RESULTS: Seventy-three patients who underwent placement of 101 CGs (45 single, 28 double) met the inclusion criteria. The median radiological follow up was 25.5 (interquartile range [IQR] 12-48) months. Freedom from IaEL related re-intervention was achieved in 94.6% with a median OS of 38.5% (IQR 30%-44%, p = .004), TNL 19 mm (16-25 mm, p = .62), and L-OS 59 (51-65, p = .018). Primary CG patency was achieved in 95% of the cases with a median OS of 36% (29%-42%, p = .008), TNL 19 mm (15.5-26 mm, p = .91), and L-OS 57 (50-64, p = .005). By using the receiver operating characteristic curve, an optimal cut off to prevent IaEL related re-interventions was identified by an OS of 30% (p < .001; L-OS 55, p = .006) and to avoid CG stenosis/occlusions by OS 42% (p < .001; L-OS 65, p < .001). In multivariable analysis, aortic endograft OS was the only independent parameter preventive for IaEL related re-intervention (odds ratio, 0.78; 95% confidence interval, 0.61-0.99). CONCLUSION: With the Endurant-Advanta V12/iCast combination, an aortic stent graft OS of at least 30% (range 30%-42%) should be used to avoid type Ia endoleaks and likewise to ensure CG patency.

Beneficial effects of a combination of natural product activators of autophagy on endothelial cells and platelets.

BACKGROUND AND PURPOSE: Oxidative stress and insufficient autophagy activity are associated with inflammatory processes and are common features of many cardiovascular diseases (CVDs). We investigated if a combination of natural activators of autophagy could modulate oxidative stress, platelet aggregation and endothelial cell survival and function in response to stress. EXPERIMENTAL APPROACH: Ex vivo platelet aggregation and activation, H2 O2 production and autophagy were measured in platelets of subjects at high cardiovascular risk, including smokers, patients with metabolic syndrome (MetS) and patients with atrial fibrillation (AF). In vitro, the effects of a mixture of natural pro-autophagy molecules and antioxidants on platelets and human umbilical vein endothelial cells (HUVECs) were evaluated. KEY RESULT: Autophagy appeared to be inhibited, whereas aggregation was increased in platelets from AF and MetS patients and in smokers, as compared with healthy subjects. Treatment of platelets isolated from these patients with a mixture composed of trehalose, spermidine, catechin and epicatechin (Mix1) or with a mixture composed of trehalose, spermidine and nicotinamide (Mix2), significantly reduced platelet activation and oxidative stress, and increased autophagy, compared with the effect of each compound alone. Similarly, treatment of HUVECs with a combination of these compounds exhibited beneficial effects and increased endothelial cell survival, nitric oxide bioavailability and angiogenesis in response to stress in a potentiated manner. CONCLUSION AND IMPLICATIONS: A combination of natural activators of autophagy could inhibit platelet activity and oxidative stress and improve endothelial cell survival and function in a potentiated manner representing a useful strategy to reduce the effect of risk factors on CVD occurrence. LINKED ARTICLES: This article is part of a themed issue on Cellular metabolism and diseases. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v178.10/issuetoc.

Nellix endovascular aneurysm-sealing system: a single-center experience and review of current evidence.

Aims: We report the 6-year results of our use of the Nellix® endovascular aneurysm sealing system. Materials & methods: This is a retrospective review of patients we treated from 2013 to 2019. The outcomes described include technical success rate, mortality, all procedure-related complications, reinterventions, open surgical conversion and secondary sac rupture. Results & conclusions: A total of 68 patients were treated. Mortality was 2.9%. Secondary interventions were carried out for distal embolization (3), stent occlusion (1), pseudoaneurysm (1) and endoleak (5). Open surgical conversion was required in 6.4% of cases. Medium- and long-term complications of EVAS occurred more frequently than expected. Because the durability of endovascular aneurysm sealing is questionable, strict postoperative surveillance of Nellix is crucial to identify features of failure.

Duplex ultrasound versus CT angiography for the treatment planning of lower-limb arterial disease.

PURPOSE: This study aimed to assess the diagnostic accuracy of duplex sonography (DUS) compared with that of computed tomography angiography (CTA) in detecting occlusion and stenosis in peripheral arterial disease (PAD) in candidate patients for endovascular revascularization with intraprocedural digital subtraction angiography (DSA). METHODS: The study involved 94 patients suffering from PAD who were candidates for endovascular procedures requiring DSA. They were all submitted preoperatively to DUS and CTA. Based on image analysis, five segments of the arterial tree were assessed: iliac, common femoral, superficial femoral, popliteal, and infrageniculate. According to the stenosis or occlusion degree, the arteries were rated as nonstenotic, stenotic, and occluded. RESULTS: The agreement between DUS and CTA findings using DSA as a reference modality was expressed as a Cohen's kappa (κ) statistic agreement. Our results show that DUS has been less accurate than CTA in evaluating iliac arterial diseases (Cohen's κ agreement of 0.91 and 1.0, respectively) when measured against DSA. We found good diagnostic concordance between DUS and DSA in detecting hemodynamic stenosis and occlusion of the femoro-popliteal axis (Cohen's κ agreement between 0.96 and 0.93). Below the knee, CTA showed even less concordance with DSA (Cohen's κ 0.75). CONCLUSIONS: Because of its accuracy, high-quality DUS performed by well-trained operators may therefore represent a good alternative to CTA in patients undergoing endovascular revascularization to minimize the use of contrast-enhanced radiological imaging. Nevertheless, preoperative CTA imaging is required in cases of nondiagnostic DUS or when a more complete overview of the vascular tree is needed for complex invasive interventions.

A randomized trial comparing the acute coronary, systemic, and environmental effects of electronic vaping cigarettes versus heat-not-burn cigarettes in smokers of combustible cigarettes undergoing invasive coronary assessment: rationale and design of the SUR-VAPES 3 trial.

BACKGROUND: Traditional combustible cigarette (TCC) smoking remains a major cause of preventable cardiovascular morbidity and mortality. Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) may be safer than TCC but may still have detrimental oxidative, platelet and vascular effects of particular importance to people with symptomatic coronary artery disease (CAD). METHODS: We aimed to compare the acute coronary, systemic and environmental effects of two leading MRP in 20 TCC smokers admitted for invasive coronary assessment of CAD and willing to quit or after prior failed quitting attempts. After confirmation at angiography of an intermediate coronary stenosis, coronary flow reserve (CFR) will be appraised. Patients will then be randomized 1:1 to use a single EVC or a single HNBC in the catheterization laboratory, followed by repeat CFR measurement. The primary endpoint will be the change in CFR before and after product use. Quantitative coronary angiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) will also be measured. RESULTS: We expected to accrue results able to: 1) test whether MRP have in general a detrimental impact on coronary vascular function in TCC smokers; 2) test whether EVC have a different impact than HNBC on coronary function; 3) provide ancillary pathophysiologic and translational insights on the acute risk and safety profile of MRP in TCC smokers with established cardiovascular disease, including complex correlations between coronary, cardiac, systemic and environmental effects. In addition, by directly informing participants of their individual results, they will be further empowered to quit TCC. CONCLUSIONS: The Sapienza University of Rome-Vascular Assessment of Proatherosclerotic Effects of Smoking (SUR-VAPES) 3 trial will provide important insights into the pathophysiologic cardiovascular impact of EVC and HNBC, also suitable to inform patients and individualize their smoking cessation strategy.

Post-implantation syndrome: the impact of different devices for endovascular abdominal aortic aneurysm repair and related etiopathogenetic implications.

BACKGROUND: Postimplantation syndrome (PIS) is a systemic inflammatory response occurring in early phase after abdominal aortic aneurysm (AAA) endovascular repair (EVAR). PIS can also occur after endovascular aneurysm sealing (EVAS) with Nellix system which prevent new onset of mural thrombus inside. Aim was to compare the incidence of PIS after EVAS and EVAR to evaluate the possible role of the new-onset thrombus inside the aneurysmal sac. Secondary aims were to assess the effect of AFX (Endologix) endoskeleton compared with other commercially available exoskeleton PTFE stent grafts on inflammatory response and its relationship with the clinical outcomes. METHODS: From 2013 to 2017, data on 60 elective EVAS with Nellix system (Endologix, Irvine, CA, USA) and 110 EVAR with ePTFE devices (56 AFX devices and 54 other stent grafts) for AAA patients were retrospectively collected. PIS was defined as composite of body temperature ≥38 °C coinciding with leukocyte count >12,000/mL and hs-CPR >10 mg/L. New-onset thrombus volume after EVAR was calculated by: endograft volume - preoperative luminal volume=volume of new-onset thrombus, whereas post-EVAS thrombus volume was calculated from difference between AAA volume and volume of Nellix endobags, including balloon expandable stents. Nonparametric χ2 distribution with corresponding P values were used to assess differences among categorical variables with regard to endograft type. Threshold of statistical significance was P<0.05. Subgroup analysis of outcomes by stent-graft design was performed using independent-samples t-test. RESULTS: EVAS with Nellix system was associated with lower incidence of PIS compared to EVAR using both AFX device and other endografts (8.3%, 30%, 35%, respectively, P=0.001). No significant new-onset of mural thrombus occurred following EVAS while an avarage new-onset thrombus of 21% and 14% was found in EVAR group A and group B, respectively. No statistically significant difference of PIS incidence was observed after endoskeleton AFX device deployment compared with other EVAR exoskeleton endografts. During follow-up, major complications were proportionally but not significantly (P=0.43) less frequent after EVAS (10.3%) than after EVAR and after EVAR using AFX device (8.9%) than after EVAR with other PTFE stent grafts (16.4%). CONCLUSIONS: The etiology and pathophysiology of PIS is not yet well understood. It is speculated that the type of the stent graft or the mural thrombus within the AAA may play a role in determing this inflammatory response. In this study, PIS was significantly less frequent after EVAS than EVAR. The lower inflammatory reaction observed after EVAS might be related to the endobags of Nellix system which completely seal the aneurysm sac reducing the new onset of mural thrombus. This could confirm the role of new-onset mural thrombus in the genesis of PIS. The systemic inflammatory response does not significantly differ after endoskeleton AFX device deployment compared with other EVAR exoskeleton stent grafts. PIS does not seem to have any significant prognostic implications in terms of major adverse events.

Open Conversion for Recurrent Endograft Occlusion after Endovascular Treatment of Blunt Traumatic Aortic Injury: A Peculiar Case Report.

BACKGROUND: We report a rare case of delayed, symptomatic thoracic endograft thrombosis after the initial thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury which was successfully retreated with a redo TEVAR, followed by open conversion due to recurrent partial occlusion of the distal edge of the endografts. METHODS: Two years ago, a 22-year-old man had undergone an emergency TEVAR for blunt thoracic aortic injury. A Zenith Cook 22 × 100 mm (Cook Incorporated, Bloomington, IN) endograft was used. Six months later, he underwent an emergency endovascular relining of the endograft using the same type of device. The multiorgan perfusion was completely restored except for the spinal cord injury. After 8 months, a recurrent partial occlusion of the distal edge of the second graft was documented. The thoracic aorta was replaced with a 22-mm silver-coated graft (Maquet Spain, SLU). RESULTS: Histology examination showed a neointimal formation and thickening and fibrosis of the inner 1/3 of the media with loss of smooth muscle cells and increase of the elastic fibers. CONCLUSIONS: The need for secondary interventions or open conversion because of potential complications after TEVAR for traumatic aortic injury is an additional consideration when weighing the risks and benefits of endovascular repair and subsequent surveillance strategies.

Incidence of Post-Implantation Syndrome with Different Endovascular Aortic Aneurysm Repair Modalities and Devices and Related Etiopathogenetic Implications.

BACKGROUND: Postimplantation syndrome (PIS) is a systemic inflammatory response occurring in an early phase after abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR). The pathophysiology underlying PIS is still not well understood. It is speculated that the type of the stent graft or the mural thrombus within the AAA may play a role in determining this inflammatory response. At present, there is no consensus about the influence of PIS on clinical outcomes during follow-up. The endovascular aneurysm sealing (EVAS) with the Nellix sac-anchoring endoprosthesis (Nellix Endovascular, Palo Alto, CA) is a novel modality for AAA repair, which obliterates the sac, thus preventing the new onset of thrombus in the aneurysm sac. Our aim was to compare the incidence of postimplantation syndrome following EVAS and after EVAR. Secondary aims were to assess the effect of endoskeleton AFX (Endologix) device compared with other commercially available exoskeleton PTFE stent grafts on the inflammatory response. Finally, we analyzed the potential association of PIS with clinical outcomes. METHODS: From January 2013 to June 2018, 60 AAA patients underwent EVAS (mean age 72 ± 9 years), and 110 patients were submitted to EVAR: 56 AFX devices and 54 other PTFE stent grafts (mean age 74 ± 10 years) at a single center and were retrospectively reviewed. RESULTS: EVAS with the Nellix system was associated with a lower incidence of PIS compared to EVAR using both AFX device and other endografts (8.3, 30, 35%, respectively, P-value = 0.001). No statistically significant difference in PIS incidence was observed after endoskeleton AFX device deployment compared with other EVAR exoskeleton endografts. During follow up, the major complications were proportionally but not significantly (P = 0.43) less frequent after EVAS (10.3%) than after EVAR and after EVAR using AFX device (8.9%) than after EVAR with other PTFE stent grafts (16.4%). During follow up (mean 24 months), adverse outcome rates did not significantly differ in patients with and without PIS (8.0 vs. 13.4% P = 0.43). CONCLUSIONS: Our data confirm the lower risk of PIS following EVAS compared to EVAR. Most importantly, this study highlights the role of new-onset mural thrombus in the genesis of PIS. The lower inflammatory reaction observed after EVAS than after EVAR might be related to the endobags of the Nellix system, which completely seal the aneurysm sac, reducing the new onset of mural thrombus. The systemic inflammatory response does not significantly differ after endoskeleton AFX device deployment compared with other EVAR exoskeleton stent grafts. PIS does not seem to have any significant prognostic implications in terms of early major adverse events.

Infected chronic ischemic wound topically treated with a multi-strain probiotic formulation: a novel tailored treatment strategy.

BACKGROUND: A wide debate is ongoing regarding the role of cutaneous dysbiosis in the pathogenesis and evolution of difficult-to-treat chronic wounds. Nowadays, probiotic treatment considered as an useful tool to counteract dysbiosis but the evidence in regard to their therapeutic use in the setting of difficult-to-treat cutaneous ulcers is still poor. AIM: CLINICAL REPORT: An 83-year-old woman suffering a critical limb ischemia and an infected difficult-to-treat ulcerated cutaneous lesion of the right leg, was complementary treated with local application of a mixture of probiotic bacteria. METHODS: Microbiological and metabolomic analysis were conducted on wound swabs obtained before and after bacteriotherapy. RESULTS: During the treatment course, a progressive healing of the lesion was observed with microbiological resolution of the polymicrobial infection of the wound. Metabolomic analysis showed a significant difference in the local concentration of propionate, 2-hydroxyisovalerate, 2-oxoisocaproate, 2,3-butanediol, putrescine, thymine, and trimethylamine before and after bacteriotherapy. CONCLUSION: The microbiological and metabolomic results seem to confirm the usefulness of complementary probiotic treatment in difficult-to-treat infected wounds. Further investigations are needed to confirm these preliminary findings.

Nellix Endovascular Aortic Sealing Endoprosthesis Late Explantation for Concomitant Type I Endoleak and Stent Frames Proximal Caudal Migration.

Endovascular aneurysm sealing (EVAS) using the Nellix™ System was introduced in clinical practice with the aim of reducing the incidence of complications such as migration, endoleaks, and reinterventions after conventional endovascular aneurysm repair (EVAR). Although, initial efficacy data on this device have been encouraging, EVAS has also demonstrated to undergo adverse events. Herein, we report a case of Nellix graft explant due to endobags shrinkage after air bubble reabsorption leading to proximal type I A endoleak and stent migration. The focus of this article is on the importance of a more assiduous surveillance of this new device, in particular in those cases with air into the endobags immediately after the procedure; this surveillance should be aimed to timely identify complications which can otherwise lead to consequences that require open conversion.

Single-Center Experience in the Treatment of Visceral Artery Aneurysms.

BACKGROUND: Visceral artery aneurysms (VAAs), although rare, represent a life-threatening disease with high mortality rates. With the more frequent use of diagnostic tests, there has been an incidental detection of these lesions which are mostly asymptomatic. It follows that surgeons are increasingly called to decide on the most appropriate management of VAAs between an open surgical or endovascular approach and among the different endovascular options currently available. The aim of this retrospective study was to evaluate the results of open surgery and interventional endovascular strategies of visceral artery aneurysms with respect to technical success, therapy-associated complications, and postinterventional follow-up in the elective and emergency situation. METHODS: From January 1992 to January 2017, 125 open surgical or endovascular interventions for VAA were performed at our institution. Once the VAA was diagnosed and the indication for treatment was assessed, the preoperative diagnostic work-up consisted of contrast computed tomography (CT) or magnetic resonance imaging (MRI) and, in some patients, digital subtraction angiography. Follow-up included clinical and duplex ultrasound scan (DUS) and contrast-enhanced ultrasound to assess the treated vessel patency and organ perfusion after 1, 6, and 12 months, and yearly thereafter. CT or MRI controls were also performed at 1 year of follow-up and only when DUS was not diagnostic or showed a complication thereafter. After the first 5 years of follow-up, the status of the patient was obtained by a structured telephone survey. RESULTS: The treatment option was endovascular in 56 of 125 cases (44.8%). Technical success was 98.3%. In one case, the procedure was interrupted for the extensive dissection of the afferent vessel. Twenty-six patients were treated by coil embolization while 29 with covered stenting. The endovascular approach was in emergency in two cases (3.6%). In the endovascular group, mortality was nil. Complications occurred in 5 cases (8.9%): 1 subacute intestinal ischemia caused by superior mesenteric artery dissection, 2 aneurysm reperfusion, 1 stent thrombosis, and 1 massive splenic hematoma. In 69 (55.2%) cases, surgical treatment was preferred, with 24 VAA resections and 45 arterial reconstructions. In 20 cases (29%), open surgery was performed in emergency conditions. In the surgical group, 8 emergency patients (40%) died intraoperatively. The mortality after elective surgical interventions was nil. Complications after surgery were 4 graft late thrombosis (5.8%): asymptomatic in three cases and requiring splenectomy in one. CONCLUSIONS: There is no overall consensus regarding the indications for treatment of VAA. Currently in emergent setting, the endovascular approach should be considered as the first choice because of its reduced invasiveness, faster way to access and bleeding control; this accounts for the lower morality of the interventional therapy than open surgery. Endovascular approach is effective for elective repair of VAAs, but procedure-related complications may occur in a not negligible number of patients. Given comparable mortality rates and low procedure-related complication rate, surgical approach still has space in the elective management of VAAs, especially for aneurysms unsuitable or challenging for the endovascular option in patients with low surgical risk. The size, location, and morphology of VAAs, systemic or local comorbidities, and specific anatomical situations such as previous abdominal surgery should dictate treatment choice.