Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label

How future surgery will benefit from SARS-COV-2-related measures: a SPIGC survey conveying the perspective of Italian surgeons

COVID-19 negatively affected surgical activity, but the potential benefits resulting from adopted measures remain unclear. The aim of this study was to evaluate the change in surgical activity and potential benefit from COVID-19 measures in perspective of Italian surgeons on behalf of SPIGC. A nationwide online survey on surgical practice before, during, and after COVID-19 pandemic was conducted in March-April 2022 (NCT:05323851). Effects of COVID-19 hospital-related measures on surgical patients' management and personal professional development across surgical specialties were explored. Data on demographics, pre-operative/peri-operative/post-operative management, and professional development were collected. Outcomes were matched with the corresponding volume. Four hundred and seventy-three respondents were included in final analysis across 14 surgical specialties. Since SARS-CoV-2 pandemic, application of telematic consultations (4.1% vs. 21.6%; p < 0.0001) and diagnostic evaluations (16.4% vs. 42.2%; p < 0.0001) increased. Elective surgical activities significantly reduced and surgeons opted more frequently for conservative management with a possible indication for elective (26.3% vs. 35.7%; p < 0.0001) or urgent (20.4% vs. 38.5%; p < 0.0001) surgery. All new COVID-related measures are perceived to be maintained in the future. Surgeons' personal education online increased from 12.6% (pre-COVID) to 86.6% (post-COVID; p < 0.0001). Online educational activities are considered a beneficial effect from COVID pandemic (56.4%). COVID-19 had a great impact on surgical specialties, with significant reduction of operation volume. However, some forced changes turned out to be benefits. Isolation measures pushed the use of telemedicine and telemetric devices for outpatient practice and favored communication for educational purposes and surgeon-patient/family communication. From the Italian surgeons' perspective, COVID-related measures will continue to influence future surgical clinical practice

Image-Based Numerical Investigation in an Impending Abdominal Aneurysm Rupture

Blood flow dynamics plays a crucial role in the growth and rupture of abdominal aortic aneurysms. The aim of this study was to analyze the possibility of predicting aneurysmal rupture by numerical investigations based on diagnostic images. The blood flow dynamics was analyzed in a patient-specific abdominal aortic aneurysm, reconstructed from CT images of an aneurysm while it was rupturing. The patient-specific geometry was virtually repaired in order to obtain a non-ruptured model representative of the geometry immediately preceding the rupture. To reproduce physiological conditions, numerical simulations were performed under pulsatile flow conditions, and blood was modelled as a non-Newtonian fluid, using the Carreau rheological model. Hemodynamic parameters that influence the rupture of the aneurysm were investigated, and their possible association with vascular disease was discussed. The results of the numerical simulations indicated regions of slow recirculation and low values of Time Averaged Wall Shear Stress (TAWSS) in the region of rupture. Unlike literature results, a high Oscillatory Shear Index (OSI) was not clearly found in this region. Nevertheless, just in the region where the rupture will occur, high values of Endothelial Cell Activation Potential index (ECAP) were found. This index is therefore extremely significant for assessing the vulnerability of the aortic wall and locating the critical rupture region

High Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Associated with a Higher Risk of Hemodialysis Vascular Access Failure

Our aim was to determine the predictive role of the preoperative neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in vascular access malfunctioning in patients who had undergone their first native arterio-venous fistula (AVF) for hemodialysis. Methods: This was a single-center retrospective observational study. All patients who underwent the procedure of the creation of a first native AVF for hemodialysis from January 2019 to December 2020 were considered eligible to be part of this study. Reinterventions for AVF malfunctioning were registered and the population was subdivided into two groups with respect to AVF malfunctioning. ROC curves were obtained to find the appropriate cut-off values for the NLR and PLR. A multivariate analysis was used to identify the independent predictors for an AVF malfunction. Kaplan–Meier curves were used to evaluate the AVF patency rates. A total of 178 patients were enrolled in the study, of them 70% (n = 121) were male. The mean age was 67.5 ± 12 years. Reinterventions for AVF malfunctioning were performed on 102 patients (57.3%). An NLR > 4.21 and a PLR > 208.8 was selected as the cut-off for AVF malfunctioning. The study population was divided into two groups depending on the NLR and PLR values of the individual. For the NLR < 4.21 group, the AVF patency rates were 90.7%, 85.3%, and 84% at the 3-, 6-, and 12-month follow-up, respectively, and 77.5%, 65.8%, and 39.3% at 3, 6, and 12 months for the NLR > 4.21 group, respectively (p < 0.0001). For the PLR < 208.8 group, the patency rates were 85.6%, 76.7%, and 67.7% at the 3-, 6-, and 12-month follow-up. For the PLR > 208.28 group, the patency rates were 80.8%, 71.2%, and 50.7% for the 3-, 6-, and 12-month follow-up, respectively (p = 0.014). The multivariate analysis highlighted that diabetes mellitus, the neutrophil count, the lymphocyte count, and the NLR were independent risk factors for an AVF failure. In our experience, the NLR and PLR are useful markers for the stratification of vascular access failure in hemodialysis patients. The inexpensive nature and ready availability of the values of these biomarkers are two points of strength for everyday clinical practice

The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms

An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta that progressively grows until it ruptures. Treatment is typically recommended when the diameter is more than 5 cm. The EVAR (Endovascular aneurysm repair) is a minimally invasive procedure that involves the placement of an expandable stent graft within the aorta to treat aortic disease without operating directly on the aorta. For years, stent grafts’ essential design was based on metallic stent frames to support the fabric. More recently, a polymer-based technology has been proposed as an alternative method to seal AAA. This review underlines the two platforms that are based on a polymer technology: (1) the polymer-filled endobags, also known as Endovascular Aneurysm Sealing (EVAS) with Nellix stent graft; and (2) the O-ring EVAR polymer-based proximal neck sealing device, also known as an Ovation stent graft. Polymer characteristics for this particular aim, clinical applications, and durability results are hereby summarized and commented critically. The technique of inflating endobags filled with polymer to exclude the aneurysmal sac was not successful due to the lack of an adequate proximal fixation. The platform that used polymer to create a circumferential sealing of the aneurysmal neck has proven safe and effective

Early carotid artery stenting after onset neurologic symptoms

Multicenter clinical trials level 1 evidence favors the application of carotid endarterectomy in symptomatic patients, especially the in the elderly cohort. Carotid artery stenting has been proposed as a possible early alternative in selected patients after onset of ipsilateral neurologic symptoms. It is well known that treatment of acute stroke is time-dependent in patients with acute ischemic stroke caused by high-grade stenosis of the internal carotid artery, but intensive medical treatment in conjunction with intervention to improve stroke severity and clinical outcomes has not been established. Two major clinical concerns exist: (1) the risk of hemorrhagic infarction after cerebral revascularization in the acute stage and (2) application of carotid stenting in the acute embolic stage, which may be associated with continued embolic risk after carotid artery stenting compared to carotid endarterectomy, which removes the symptomatic plaque. This review summarizes the indications and results of early carotid artery stenting after onset of neurologic symptoms, considering the new carotid stents and cerebral protection systems available for clinical use and enhanced stenting techniques

Acute on chronic limb ischemia. From surgical embolectomy and thrombolysis to endovascular options

After the invention of the balloon catheter by Fogarty in 1963, surgical thromboembolectomy was considered the gold standard treatment for many years in patients with acute lower limb ischemia (ALLI). ALLI is a dramatic event, carrying a high risk of amputation and perioperative morbidity and mortality. The evolution of endovascular technologies has resulted in a variety of therapeutic options to establish arterial patency. In the 1970s, Dotter first introduced the idea of clot lysis in the treatment of ALLI, which was modified to catheter-directed thrombolysis, and now clot aspiration techniques. Currently, the majority of ALLI (about 70%) is arterial thrombosis, which generally occurs in the setting of preexisting vascular lesion. This condition is very common in patients with diabetes. Clinical presentation in case of thrombosis on atherosclerotic stenosis (so called "acute on chronic ischemia") may be less severe, but treatment is generally more challenging than ALLI due to embolism, considering the complexity in device trackability through the diseased vessels, potential vessel injury, incomplete revascularization, and need of correction of underlying vascular lesions. Although surgery is still a treatment option, especially for ALLI, endovascular interventions have assumed a prominent role in restoring limb perfusion. In this review, the treatment options for ALLI are detailed from surgical thromboembolectomy to thrombolysis and current endovascular techniques, including mechanical fragmentation, rheolytic thrombectomy, and aspiration thrombectomy. The evolution to endovascular therapies has resulted in improved clinical outcomes and lower rates of morbidity. (C) 2018 Elsevier Inc. All rights reserved

Acute on chronic limb ischemia: From surgical embolectomy and thrombolysis to endovascular options

After the invention of the balloon catheter by Fogarty in 1963, surgical thromboembolectomy was considered the gold standard treatment for many years in patients with acute lower limb ischemia (ALLI). ALLI is a dramatic event, carrying a high risk of amputation and perioperative morbidity and mortality. The evolution of endovascular technologies has resulted in a variety of therapeutic options to establish arterial patency. In the 1970s, Dotter first introduced the idea of clot lysis in the treatment of ALLI, which was modified to catheter-directed thrombolysis, and now clot aspiration techniques. Currently, the majority of ALLI (about 70%) is arterial thrombosis, which generally occurs in the setting of preexisting vascular lesion. This condition is very common in patients with diabetes. Clinical presentation in case of thrombosis on atherosclerotic stenosis (so called "acute on chronic ischemia") may be less severe, but treatment is generally more challenging than ALLI due to embolism, considering the complexity in device trackability through the diseased vessels, potential vessel injury, incomplete revascularization, and need of correction of underlying vascular lesions. Although surgery is still a treatment option, especially for ALLI, endovascular interventions have assumed a prominent role in restoring limb perfusion. In this review, the treatment options for ALLI are detailed from surgical thromboembolectomy to thrombolysis and current endovascular techniques, including mechanical fragmentation, rheolytic thrombectomy, and aspiration thrombectomy. The evolution to endovascular therapies has resulted in improved clinical outcomes and lower rates of morbidity