Domenico Benevento

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.

Cerebrovascular Disease and Critical Limb Ischaemia

Old age can be defined as age approaching or surpassing the average life span of human beings and is thus at the end of the human life cycle. Older people have limited regeneration abilities and are more prone to disease, syndromes and sickness than other adults. Octogenarians are considered very fragile patients; they have a series of comorbidities presenting a high incidence of renal, pulmonary and cardiac diseases. Moreover, they often present some anatomical characteristics that may represent real contraindications for some types of procedure. Therefore, elderly patients are considered patients at high surgical risk. Cerebrovascular disease and critical limb ischaemia are two pathologies that affected elderly people and can represent a challenge for vascular surgeons.

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry (ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

INDIAN REGISTRY: The INDigo system In Acute lower limb malperfusioN (Preprint)

Background Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis. Objective The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. Methods This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month. Results The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints. Conclusions These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future. International Registered Report Identifier (IRRID) DERR1-10.2196/9972

Incidental extravascular findings in computed tomographic angiography for planning or monitoring endovascular aortic aneurysm repair: Smoker patients, increased lung cancer prevalence?

AIM To validate the feasibility of high resolution computed tomography (HRCT) of the lung prior to computed tomography angiography (CTA) in assessing incidental thoracic findings during endovascular aortic aneurysm repair (EVAR) planning or follow-up. METHODS We conducted a retrospective study among 181 patients (143 men, mean age 71 years, range 50-94) referred to our centre for CTA EVAR planning or follow-up. HRCT and CTA were performed before or after 1 or 12 mo respectively to EVAR in all patients. All HRCT examinations were reviewed by two radiologists with 15 and 8 years’ experience in thoracic imaging. The results were compared with histology, bronchoscopy or follow-up HRCT in 12, 8 and 82 nodules respectively. RESULTS There were a total of 102 suspected nodules in 92 HRCT examinations, with a mean of 1.79 nodules per patient and an average diameter of 9.2 mm (range 4-56 mm). Eighty-nine out of 181 HRCTs resulted negative for the presence of suspected nodules with a mean smoking history of 10 pack-years (p-y, range 5-18 p-y). Eighty-two out of 102 (76.4%) of the nodules met criteria for computed tomography follow-up, to exclude the malignant evolution. Of the remaining 20 nodules, 10 out of 20 (50%) nodules, suspected for malignancy, underwent biopsy and then surgical intervention that confirmed the neoplastic nature: 4 (20%) adenocarcinomas, 4 (20%) squamous cell carcinomas, 1 (5%) small cell lung cancer and 1 (5%) breast cancer metastasis); 8 out of 20 (40%) underwent bronchoscopy (8 pneumonia) and 2 out of 20 (10%) underwent biopsy with the diagnosis of sarcoidosis. CONCLUSION HRCT in EVAR planning and follow-up allows to correctly identify patients requiring additional treatments, especially in case of lung cancer.

Endovascular correction in acute bleeding after femoro-popliteal bypass: A single-center experience

BACKGROUND The endovascular correction (EC) has emerged in recent years as a possible alternative to surgical revision (SR) in case of bleeding complications after peripheral bypass (PB). The purpose of this study is to evaluate the efficacy and safety of EC compared to SR in case of bleeding complications of PB. METHODS From January 2004 to December 2014, we have submitted 32 patients to surgery for acute bleeding in previous PB (25 venous bypass, in situ or reversed, 6 PTFE bypass and 1 composite bypass). The cause of the bleeding was the dehiscence of proximal anastomosis in 14 patients, the dehiscence of distal anastomosis in 11 patients and the rupture of the graft in 7 patients. All patients postoperatively underwent anticoagulation or antiplatelet therapy, antibiotic therapy and close ultrasound follow-up. Patency rate, limb salvage rate and survival rate in the short term were assessed by Kaplan-Meier curves. RESULTS Of the 32 patients treated for acute bleeding in previous PB, 11 underwent endovascular correction with a technical success of 100% (no need for reintervention), while in 21 patients a surgical revision was performed. Among the latter, in 4 cases (19.1%) an early bleeding occurred, and endovascular correction was promptly performed solving the bleeding in the absence of sequelae (then a total of 15 patients were treated by endovascular correction). The 12-month patency, limb salvage and survival rates were respectively 71.4%, 88.2% and 88.2% in the SR group and 80%, 93.3% and 100% in the EC. CONCLUSIONS This topic underlines that endovascular correction after peripheral bypass bleeding is an attractive alternative to surgery, but there are still a few data to change the gold standard treatment. Randomized clinical trials comparing the two treatment options are warranted.

Endovascular Correction in Acute Bleeding after Femoropopliteal Bypass: A Single-Centre Experience

Introduction: The Endovascular Correction (EC) has emerged in recent years as a possible alternative to surgical revision (SR) in case of bleeding complications after Peripheral Bypass (PB). The purpose of this study is to evaluate the efficacy and safety of EC compared to SR in case of bleeding complications of PB. Methods: From January 2004 to December 2014, we have undergone surgery 32 patients for acute bleeding in previous PB (25 venous bypass, in situ or reversed, 6 PTFE bypass and 1 composite bypass). The cause of the bleeding was in 14 cases the dehiscence of proximal anastomosis, in 11 cases of distal anastomosis and in 7 cases the rupture of the graft. All patients postoperatively underwent anticoagulation or antiplatelet therapy, antibiotic therapy and close ultrasound follow-up. Patency rate, Limb Salvage rate and Survival rate in the short term were assessed by Kaplan-Meier curves. Results: Of the 32 patients treated for acute bleeding in previous PB, 11 underwent endovascular correction with a technical success of 100% (no need for reintervention), while in 21 patients was performed a surgical revision. Among the latter, in 4 cases (19.1%) an early bleeding occurred, and endovascular correction was promptly performed solving the bleeding in the absence of sequelae (then a total of 15 patients were treated by endovascular correction). The 12-months patency, limb salvage and survival rates were respectively 71.4%, 88.2% and 88.2% in the SR group and 80%, 93.3% and 100% in the EC. Conclusion: This topic underlines that endovascular correction after peripheral bypass bleeding is an attractive alternative to surgery, but there are still few data to change the gold standard treatment. Randomized Clinical Trials comparing the two treatment options are warranted.

Device selection for carotid stenting: reviewing the evidence

ABSTRACT Introduction: Carotid artery stenting (CAS) has recently changed the status in the treatment of the extracranial carotid atheromasic disease. In recent years, evolution in both stents and protection devices as well as in carotid stenting techniques, has resulted in an important reduction in the rate of stroke in patients undergoing CAS procedures. Areas covered: The purpose of this article is reviewing the literature and summarizing the current evidence of the new available materials to underline the importance of the correct choice of the devices during the procedure. Expert commentary: Certainly a key issue in order to limit the periprocedural events to the lowest possible, is to select the appropriate device for the appropriate patient anatomy and clinical syndrome, the so called ‘tailored approach’.