Results of Iliac Branch Devices in Octogenarians Within the pELVIS Registry

Purpose:To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation.Materials and Methods:From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9 +/- 2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI).Results:Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1-127) and 29.3 months (range 1-127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%).Conclusion:IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation

Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE)

The objective of these Guidelines was to revise and update the previous 2016 Italian Guidelines on Abdominal Aortic Aneurysm Disease, in accordance with the National Guidelines System (SNLG), to guide every practitioner toward the most correct management pathway for this pathology. The methodology applied in this update was the GRADE-SIGN version methodology, following the instructions of the AGREE quality of reporting checklist as well. The first methodological step was the formulation of clinical questions structured according to the PICO (Population, Intervention, Comparison, Outcome) model according to which the Recommendations were issued. Then, systematic reviews of the Literature were carried out for each PICO question or for homogeneous groups of questions, followed by the selection of the articles and the assessment of the methodological quality for each of them using qualitative checklists. Finally, a Considered Judgment form was filled in for each clinical question, in which the features of the evidence as a whole are assessed to establish the transition from the level of evidence to the direction and strength of the recommendations. These guidelines outline the correct management of patients with abdominal aortic aneurysm in terms of screening and surveillance. Medical management and indication for surgery are discussed, as well as preoperative assessment regarding patients' background and surgical risk evaluation. Once the indication for surgery has been established, the options for traditional open and endovascular surgery are described and compared, focusing specifically on patients with ruptured abdominal aortic aneurysms as well. Finally, indications for early and late postoperative follow-up are explained. The most recent evidence in the Literature has been able to confirm and possibly modify the previous recommendations updating them, likewise to propose new recommendations on prospectively relevant topics

Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM)

: The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended

Results of the multicenter pELVIS Registry for isolated common iliac aneurysms treated by the iliac branch device

Objective: We evaluated the short-and long-term results of off-label use of iliac branch devices (IBDs) in isolated common iliac artery aneurysms compared with the manufacturer-recommended configuration with additional extension in the infrarenal aorta based on the pELVIS Registry (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation).Methods: Between January 2005 and April 2017, 804 patients underwent endovascular aneurysm repair with 910 IBDs owingto aneurysmal involvement of the iliac bifurcationinnine high-volumeEuropeanvascular centers. Amongthis cohort, 231 IBDs were implanted in 207 patients to treat an isolated common iliac aneurysm; 91 IBDs (group 1) were implanted without proximal aortic extension in the infrarenal aorta, and in the remaining cases (n = 140; group 2) an aortic bifurcated stent graft was deployed proximally as stated in the instructions for use. Primary outcomes were IBD and target hypogastric artery occlusions, type I and III endoleaks, procedure-related reinterventions, and aneurysm-related deaths.Results: Technical success was achieved in 90 cases (98.9%) in group 1 versus 137 cases (97.8%) in group 2 (P=.55). The overall aneurysm-related early reintervention rate for the two groups was 4.4% (4 of 91) and 2.1% (3 of 140), respectively (P=.33). The 30-day mortality was 1.1% in group 1 (n = 1), and 0% in group 2 (P=.21). The median postoperative follow-up in groups 1 and 2 were 34.1 months (range, 1-108 months) and 17.5 months (range, 1-90 months), respectively. The estimated rates of freedom from IBD occlusion at 60 months were 86% in group 1 and 83% in group 2 (P=.69). The estimated rates of freedom from target hypogastric artery occlusion at 60 months were 98.3% in group 1 and 91.3% in group 2 (P=.45). The estimated freedom from reintervention rates at 60 months for types I, types III, and IBD stenosis-occlusion were 78.2% in group 1 and 79.9% in group 2 (P=.79). The estimated freedom from all cause reintervention at 60 months was 64.5% in group 1 and 66.1% in group 2 (P=.44). The estimated freedom from aneurysm-related death at 60 months was 97.9% in group 1 and 100% in group 2 (P=.83).Conclusions: Single IBD placement for isolated common iliac artery aneurysms seems to be a safe and effective treatment option, when a proper anatomic patient selection is provided. Major benefits are represented by the decrease in X ray exposure, overall procedural time, and use of contrast medium, without affecting perioperative and long-term results in comparison with more extensive procedures

Outcomes Analysis of 677 Cases from the Multicenter Italian Registry on Primary Endovascular Treatment of Iliac and Aorto-Iliac Arteries Obstructive Disease (Iliacs Registry)

Introduction - Endovascular revascularization has become the first-line strategy for iliac obstructive lesions (IOL), and also used increasingly as an alternative to conventional surgery for complex aorto-iliac obstructive disease (AIOD). Owing to the good results resembling those of open sur- gery, an endovascular-first strategy have been considered for complex AIOD even in the most recent guidelines if done by an experienced team and if it does not compromise subsequent surgical options. The aim of this study was to analyze the results of the endovascular treatment of IOL and AIOD in a multicenter Italian registry. Methods - Over a 3-year period, ending in December 2017, 677 treatments were performed for IOL and AIOD in eleven Italian hospitals and collected into a dedicated registry database. Intermittent claudication was an indication in 376 (55.5%) patients, whereas critical limb threatening ischemia in 298 (44.0%). Postoperative anti-thrombotic therapy was left at center’s discretion: follow-up evalua- tion was performed at 1, 6 and 12 months after the intervention. Early (<30 days) major end-points were mortality and major complications; late major end-point was freedom from reintervention. Early results were compared with the Chi-square test and the Wilcoxon’s signed rank test; follow-up results were analyzed with Kaplan-Meier survival estimates andcompared with log- rank test. Univariate and multivariate (forward Cox regression) analysis was used to identify potentially sig- nificantpredictors of need for reintervention. Results - We treated 511 (75.4%) males. Overall, mean age was 68 10 (range, 22-96; IQR, 62-76). Accordingly to the TASC II classification we treated 98 (14.5%) type A, 163 (24.1%) type B, 164 (24.2%) type C, and 248 (36.6%) type D lesions: stenoses were 370 (56.2%) and occlusions were 288 (43.8%). We used a totally percutaneous approach in 473 (69.9%): hybrid intervention was carried out in 204 (30.1%) patients, mostly with femoral endarterectomy plus patch plasty. A covered stent was implanted in 207 (30.6%) cases. Overall, a kissing-stent configuration was performed in 243 (36.1%) lesions. Primary technical success was ob- tained in 671 (99.3%) cases: earl mortality occurred in 3 (0.4%) cases, and postoperative complication was observed in 51 (7.5%) patients. Mean ankle-brachial index improved significantly from preoperative to postoperative period (0.5 0.2 vs. 0.9 0.1, P < 0.001). Median hos- pitalization was 5 days (IQR, 2-7). Early thrombosis, major amputation, and mortality was observed in 10 (1.5%), 3 (0.5%), and 4 (0.6%) cases, respectively. During the follow- up 21 (3.1%) died: the estimated survival was 96.3% at 12 months (95%CI: 93.8-97.8) and 90.2% at 36 months (95% CI: 82.7-94.7). Follow-up thrombosis occurred in 17 (2.5%) cases. Estimated primary patency and freedom from rein- tervention was 96% (IC95%: 93.3-97.7) and 97.2% (95%CI: 94.5-98.6) at 12 months, and 95% (95%CI: 89.0-97.6) for both outcomes at 36 months. At Cox regression analysis, no pre/intra/or-postoperative parameters independently predicted loss of primary patency and need for reintervention. Conclusion - In this “real world” registry experience, endovascular revascularization showed to be safe and effective. No independent predictors were found to be associated with the need of reintervention thus indicating that endovascular revascularization for IOL and AOID can be an effective and durable first-line alternative even for the treatment of complex AOI

Comparison of aortoiliac repair with iliac branch endoprosthesis versus hypogastric occlusion in aortoiliac aneurysms

BACKGROUND: The CARIBE Study aims to assess the outcome of endovascular repair (EVAR) with iliac branch endoprosthesis (IBE) in patients with aorto-iliac aneurysms extending to iliac bifurcation, comparing these results with those of EVAR with hypogastric occlusion pres¬ ent in the recent published literature. METHODS: Patients with aorto-iliac aneurysms anatomically suitable for EVAR with IBE, are included in the study. RESULTS: Primary safety outcome measure are total and aneurysm related death free survival. Efficacy endpoints include: iliac branch patency, aneurysmal sac exclusion and freedom from reinterventions or conversion to open repair. Patient reported outcomes are evaluated with Walking Impairment Questionnaire (WIQ), International Index of Erectile Function-5 (IIEF-5) and quality of life Euro-Qual EQ-5D Questionnaire. CONCLuSIONS: Comparison with recent hystorical literature obtained in patients with EVAR with HA occlusion will offer data useful for correct information of patients affected by aorto-iliac aneurysms

CD47-blocking immunotherapies stimulate macrophage-mediated destruction of small-cell lung cancer

Small-cell lung cancer (SCLC) is a highly aggressive subtype of lung cancer with limited treatment options. CD47 is a cell surface molecule that promotes immune evasion by engaging signal-regulatory protein alpha (SIRP alpha), which serves as an inhibitory receptor on macrophages. Here, we found that CD47 is highly expressed on the surface of human SCLC cells; therefore, we investigated CD47-blocking immunotherapies as a potential approach for SCLC treatment. Disruption of the interaction of CD47 with SIRPa using anti-CD47 antibodies induced macrophage-mediated phagocytosis of human SCLC patient cells in culture. In a murine model, administration of CD47-blocking antibodies or targeted inactivation of the Cd47 gene markedly inhibited SCLC tumor growth. Furthermore, using comprehensive antibody arrays, we identified several possible therapeutic targets on the surface of SCLC cells. Antibodies to these targets, including CD56/neural cell adhesion molecule (NCAM), promoted phagocytosis in human SCLC cell lines that was enhanced when combined with CD47-blocking therapies. In light of recent clinical trials for CD47-blocking therapies in cancer treatment, these findings identify disruption of the CD47/SIRP alpha axis as a potential immunotherapeutic strategy for SCLC. This approach could enable personalized immunotherapeutic regimens in patients with SCLC and other cancers