Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

Regional Survey in Lombardy, Northern Italy, on Vascular Surgery Intervention Outcomes During The COVID-19 Pandemic.

OBJECTIVE: The characteristics and outcomes of patients undergoing vascular surgery hospitalised and managed in Lombardy are described with a comparison of patients tested positive for COVID-19 (CV19-pos) vs. those tested negative (CV19-neg). METHODS: This was a multicentre, retrospective, observational cohort study which involved all vascular surgery services in Lombardy, Northern Italy. Data were retrospectively merged into a combined dataset covering the nine weeks of the Italian COVID-19 pandemic phase 1 (8 March 2020 to 3 May 2020). The primary outcome was freedom from in hospital death, secondary outcomes were re-thrombosis rate after peripheral revascularisation, and freedom from post-operative complication. RESULTS: Among 674 patients managed during the outbreak, 659 (97.8%) were included in the final analysis: 121 (18.4%) were CV19-pos. CV19-pos status was associated with a higher rate of complications (OR 4.5; p < .001, 95% CI 2.64 - 7.84), and a higher rate of re-thrombosis after peripheral arterial revascularisation (OR 2.2; p = .004, 95% CI 1.29 - 3.88). In hospital mortality was higher in CV19-pos patients (24.8% vs. 5.6%; OR 5.4, p < .001;95% CI 2.86 - 8.92). Binary logistic regression analysis identified CV19-pos status (OR 7.6; p < .001, 95% CI 3.75 - 15.28) and age > 80 years (OR 3.2; p = .001, 95% CI 1.61 - 6.57) to be predictors of in hospital death. CONCLUSION: In this experience of the vascular surgery group of Lombardy, COVID-19 infection was a marker of poor outcomes in terms of mortality and post-operative complications for patients undergoing vascular surgery treatments.

Identification of dietary patterns in a general population of North Italian adults and their association with arterial stiffness. The RoCAV study.

BACKGROUND AND AIMS: The aims of this study were to identify dietary patterns in a general population of North Italian adults and to investigate the cross-sectional association between prevalent dietary patterns and arterial stiffness. METHODS AND RESULTS: Participants to the RoCAV study without chronic diseases at recruitment and with reliable dietary data were included. The food-frequency EPIC questionnaire was used to evaluate dietary habits. Dietary patterns were estimated using principal components analysis and Mediterranean diet adherence score (MedS). Carotid-femoral pulse wave velocity (cfPWV) was used as proxy of arterial stiffness. Basing on data from 2640 subjects (1608 men and 1032 women, mean ± SD 65.5 ± 6.7 years), four principal components (PC) were retained, explaining 24% of the overall variance. Considering 1284 subjects with cfPWV (mean ± SD 10.7 ± 2.5 m/s) data available, adherence to PC1 (Western-like dietary pattern) was associated with higher stiffness values (+0.29 m/s cfPWV for 1 SD increase of PC1, 95% CI:0.08,0.50; p = 0.007) in a multivariate model. Conversely, adherence to PC2 (Mediterranean-like) was not related to cfPWV values (-0.18, 95% CI: -0.36, 0.004; p = 0.06). Likewise, MedS and other PC patterns did not show any significant association with cfPWV. Mediation analysis showed that the association between Western-like dietary pattern and cfPWV is mediated by higher levels of leucocytes (9.2% of the effect, p = 0.047). CONCLUSIONS: Our study in a Southern European population identified a Western-like dietary pattern associated with an increased cfPWV, a proxy of arterial stiffness. The association with cfPWV was in part mediated by inflammatory status.

Differences in hub and spoke vascular units practice during the novel Coronavirus-19 (COVID-19) outbreak in Lombardy, Italy.

BACKGROUND: To highlight differences in clinical practice among referral (hub, HH) or satellite (spoke, SH) hospital vascular surgery units (VSUs) in Lombardy, during the COVID-19 pandemic "phase 1" period (March 8 - May 3, 2020). METHODS: The Vascular Surgery Group of Regione Lombardia Register, a real-word, multicenter, retrospective register was interrogated. All patients admitted with vascular disease were included. Patients' data on demographics, COVID-19 positivity, comorbidities and outcomes were extrapolated. Two cohorts were obtained: patients admitted to HH or SH. Primary endpoint was 30-day mortality rate. Secondary outcomes were 30-day complications and amputation (in case of peripheral artery disease [PAD]) rates. Univariate and multivariate analysis were used to compare HH and SH groups and predictors of poor outcomes. RESULTS: During the study period, 659 vascular patients in 4 HH and 27 SH were analyzed. Among these, 321 (48.7%) were admitted to a HH. No difference in COVID-19 positive patients was described (21.7% in HH vs. 15.9% in SH; P=0.058). After 30 days from intervention, HH and SH experienced similar mortality and no-intervention-related complication rate (12.1% vs. 10.0%; P=0.427 and 10.3% vs. 8.3%; P=0.377, respectively). Conversely, in HH postoperative complications were higher (23.4% vs. 16.9%, P=0.038) and amputations in patients treated for PAD were lower (10.8% vs. 26.8%; P<0.001) than in SH. Multivariate analysis demonstrated in both cohorts COVID-19-related pneumonia as independent predictor of death and postoperative complications, while age only for death. CONCLUSIONS: HH and SH ensured stackable results in patients with vascular disease during COVID-19 "phase 1." Despite this, poor outcomes were observed in both HH and SH cohorts, due to COVID-19 infection and its related pneumonia.

A Retrospective Comparison Between Hybrid Treatment and Prosthetic Above-the-Knee Femoro-Popliteal Bypass in the Management of the Obstructive Disease of the Superficial Femoral Artery.

OBJECTIVE: We assessed early and late outcomes following hybrid intervention (common femoral artery endarterectomy and superficial femoral artery (SFA) stenting) versus above-the-knee (AK) femoro-popliteal bypass performed for peripheral artery occlusive disease (PAOD) in a double-center retrospective comparative cohort study. MATERIALS AND METHODS: From January 2006 to December 2017, 82 hybrid revascularizations with femoral endarterectomy and SFA stenting (HY Group) and 98 AK femoro-popliteal bypasses with femoral endarterectomy (BP Group) were performed at two academic vascular centers. The two groups were compared in terms of preoperative and intraoperative details and of perioperative (<30 days) outcomes with χ2 test. Long-term results were compared using Kaplan-Meier curves and log-rank test. RESULTS: No differences were found in demographics variables, risk factors, comorbidities and clinical presentation between the two groups. Also perioperative outcomes were similar between the two groups. Median duration of follow-up was 38 months. At five years, the estimated survival rate was 60% in HY Group and 77.5% in BP Group (p = 0.002) Five-year primary patency rates were 46% in HY Group and 64% in BP Group (p = 0.005). Overall, 13 patients in HY Group required conversion to open surgery and 6 patients in BP Group underwent below-knee (n = 4) or distal (n = 2) bypass. The 5-year rate of limb maintenance was 85% in HY Group and 94% in BP Group (p = 0.1) and was not significantly different regardless of presentation, claudication or critical limb ischemia. CONCLUSIONS: In patients with PAOD due to complex long lesions of the infrainguinal arteries, open-surgical treatment with AK bypass provided better long-term survival and patency rates compared to a hybrid approach.

Prevalence and risk factors for heparin-bonded expanded polytetrafluoroethylene vascular graft infection after infrainguinal femoropopliteal bypasses.

BACKGROUND: To analyze the prevalence and predictors of prosthetic vascular graft infection (PVGI) in a multicenter registry. METHODS: This registry-based, multicenter study retrospectively evaluated PVGI that developed after infrainguinal revascularization performed with a heparin-bonded expanded polytetrafluoroethylene graft that was used in 1400 interventions between 2002 and 2016. A prosthetic graft with infection was defined as direct involvement of the graft with positive bacterial cultures of graft or perigraft material, intraoperative gross purulence or failure of graft incorporation, or exposed graft in an infected wound. RESULTS: Critical limb ischemia (CLI) was the main indication for bypass (n = 915 [65%]). The median duration of follow-up was 29 months (range, 1-168 months; interquartile range, 12-60 months). A total of 33 heparin-bonded expanded polytetrafluoroethylene grafts (2.3%) became infected; the median time to occurrence was 5 months (range, 1-54 months; interquartile range; 2.00-13.25 months). Freedom from PVGI at 1 year was 98% (standard error, 0.4; 95% confidence interval [CI], 97.2-98.9), and 97% (standard error, 0.6; 95% CI, 95.6-98.0) at 5 years. The multivariate model identified CLI (P = .042; hazard ratio, 0.39; 95% CI, 0.164-0.969) to be independently associated with PVGI. In-hospital mortality of PVGI treatment was 12% (n = 4/33). Freedom from major amputation was significantly different between patients with PVGI and those who did not experience this complication (at 1 year, 67.0% vs 88.5%; Log-rank χ2 = 22.5; P = .001). CONCLUSIONS: In our "real-world" multicenter experience the prevalence of PVGI after infrainguinal femoropopliteal bypasses was relatively low at 2.3%, but still associated with significant mortality and limb loss. CLI was the only significant predictor of PVGI. This conclusion is reasonable; however, more comprehensive data are required to confirm these findings, because the presence of ischemic ulcers or gangrene was not predictive of PVGI.

Results of infrainguinal revascularization with bypass surgery using a heparin-bonded graft for disabling intermittent claudication due to femoropopliteal occlusive disease.

BACKGROUND: The purpose of this study was to analyze the results of infrainguinal revascularization for disabling intermittent claudication (IC) due to femoropopliteal occlusive disease using bypass graft (BPG) surgery with a heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft. METHODS: Between 2002 and 2016, we performed 1400 BPGs with HB-ePTFE interventions in patients with femoropopliteal occlusive disease, of which IC was an indication in 485 (34.6%) patients. Early major end points were in-hospital mortality and major complications; late major end points were primary patency, freedom from redo bypass, freedom from progression to critical limb ischemia, and freedom from above-knee amputation or prosthetic graft infection. RESULTS: We performed 200 (41.2%) above-knee BPGs and 231 (47.6%) below-knee BPGs; 54 (11.1%) BPGs targeted a tibial artery. In-hospital death occurred in two (0.4%) patients. Overall, the major complication rate was 4.3%. The median duration of follow-up was 33 months (range, 1-150 months; interquartile range [IQR], 14-62.8 months); the cumulative follow-up index for survival was 0.75 ± 0.25. During the follow-up, 56 (11.6%) patients died. Estimated primary patency of the BPG was 86.1% ± 1.6% (95% confidence interval [CI], 82.7-88.9) at 12 months, 68.4% ± 2.4% (95% CI, 63.5-72.9) at 36 months, and 57.7% ± 2.9% (95% CI, 52.0-63.2) at 60 months. On multivariate analysis, runoff status (no or one vessel), site of the distal anastomosis (below the knee), and postoperative medical treatment (oral anticoagulants) impaired primary patency. Estimated freedom from redo bypass was 96.1% ± 0.9% (95% CI, 93.9-97.5) at 12 months, 84.8% ± 1.9% (95% CI, 80.7-88.2) at 36 months, and 76.4% ± 2.6% (95% CI, 71.0-81.1) at 60 months. Both the runoff status (no or one vessel) and the diameter of the graft (6 mm) were significantly associated with the need for redo bypass. Freedom from progression to critical limb ischemia was 86.1% ± 2.2% (95% CI, 81.2-89.9) at 60 months. During the follow-up, there were 20 (4.1%) above-knee amputations, which occurred at a median of 33 months (range, 2-107 months; IQR, 14-63 months) after the indexed BPG intervention. Prosthetic graft infection occurred in seven (1.4%) patients, with a median delay from index procedure to presentation with graft infection of 33 months (range, 1-72 months; IQR, 14-62.5 months), resulting in a freedom from prosthetic graft infection rate of 98.2% ± 2% (95% CI, 95.8-99.2) at 60 months. CONCLUSIONS: In patients suffering from lifestyle-disabling IC with long or complex occlusive lesions of the femoropopliteal segment, open BPG surgery with Hb-ePTFE graft had an acceptably low mortality rate. A poor runoff status was a significant predictor of loss of graft patency, especially after a below-knee anastomosis, as was the need for redo bypass. Dual antiplatelet therapy had significantly better results against follow-up thrombosis, and 8-mm grafts showed better freedom from redo bypass compared with 6-mm grafts.

Outcomes Following Non-operative Management of Thoracic and Thoracoabdominal Aneurysms.

BACKGROUND: Surgical decision making remains difficult in several patients with aneurysmal disease of the descending thoracic (DT) or thoracoabdominal (TA) aorta. Despite previous studies that have investigated aneurysms treated non-operatively using a prospective growth analysis, completeness and accuracy of follow-up were inconsistent. We aim to describe the survival and freedom from adverse aortic events in patients with DT and TA who did not undergo operative repair. METHODS: This is a single-center retrospective analysis of all patients with either a descending degenerative atherosclerotic or dissection-related DT or TA aortic lesion who were treated non-operatively from April 2002 to December 2016. We studied patients who did not undergo operative repair of descending degenerative atherosclerotic or dissection-related DT or TA aortic lesion. Primary end points were overall survival and freedom from aortic-related mortality (ARM). RESULTS: Of the 315 patients diagnosed with DT or TA disease, 56 (18%) did not undergo surgical repair. Mean aneurysm diameter was 65 mm ± 15 (range 50-120; IQR 5.4-7.15). Extent of the aortic aneurysms was DT in 36 (11%) patients and TA in 20 (6%). Median duration of follow-up was 12 months (range 1-108; IQR 3-36). Over the course of the study, 41 (73%) patients died for an overall survival rate of 53% ± 7 at 1 year (95% CI 40-65) and 23% ± 7 at 3 year (95% CI 17-42.5). Aortic-related mortality was 27% (n = 15), significantly higher in patients with aneurysms ≥ 60 mm [n = 13, (39%) vs. n = 2, (9%); P = 0.025; OR = 5.04]. Overall, estimated freedom from ARM was 81% ± 5.5 at 1 year (95% CI 68-89) and 66.5% ± 9 at 3 year (95% CI 48-81). Only TA extent was independently associated with freedom from ARM during the follow-up (P = 0.005; HR: 5.74; 95% CI 1.711-19.729). CONCLUSIONS: Thoracoabdominal extent of the aneurysmal aortic disease is the most important predictor of ARM in unrepaired DT or TA aortic diseases. Mortality from aortic-related events was significantly more premature than mortality from non-aortic-related mortality.

Prevalence of Abdominal Aortic Aneurysms in the General Population and in Subgroups at High Cardiovascular Risk in Italy. Results of the RoCAV Population Based Study.

OBJECTIVES: Prevalence data on abdominal aortic aneurysm (AAA) in women, subjects younger than 65 years and in subgroups carrying specific risk factors are scarce. AAA prevalence was evaluated in an Italian population including women and younger subjects, stratifying for the presence of cardiovascular disease (CVD) risk factors and CVD risk score. MATERIALS AND METHODS: A population based cross-sectional study was conducted between 2013 and 2016. Men aged 50-75 and women aged 60-75 years, resident in the city of Varese (northern Italy), were randomly selected from the civil registry. A vascular surgeon performed an abdominal aortic ultrasound scan at four sites using the leading edge to leading edge method. CVD risk score was computed using the ESC-SCORE algorithm. The age and gender specific prevalence was estimated, stratifying by the presence of CVD and cardiovascular risk factors. RESULTS: Among the 3755 subjects with a valid ultrasound measurement, 63 subjects with an AAA were identified (5 referred for surgical intervention), among whom 34 were not previously known (30 men 1.3%, 95% CI 0.9-1.8; 4 women 0.3%, 95% CI 0.1-0.8). Considering age classes in men only, the highest prevalence of screen detected AAA was found in subjects aged 65-70 (1.2%; 95% CI 0.4-2.5) and 70-75 (2.5%; 95% CI 1.4-4.0) years. Among 65-75 year old men, the highest AAA prevalence was found in subjects with a previous myocardial infarction (MI 4.9%, 95% CI 2.0-9.9) and in ever-smokers reporting more than 15 pack years of smoking (4.1%, 95% CI 2.5-6.3). Among the younger subjects, those having an ESC-SCORE higher than 5% or a previous CVD (MI or stroke) showed a prevalence of 1.4% (95% CI 0.3-4.2; prevalence including subaneurysms 6.7%, 95% CI 3.7-11.0%). CONCLUSIONS: In the study population, both a general screening program in 65-75 year old men and an approach targeted to subgroups at higher risk merit evaluation in a cost-effectiveness study. In 50-64 year old men, strategies for population selection should consider CVD risk stratification tools.

Surgical Treatment of Synchronous Type B Acute Aortic Dissection and Abdominal Aortic Aneurysm.

BACKGROUND: We report the results of the operative treatment of synchronous type B acute aortic dissection (TBAAD) and infrarenal abdominal aortic aneurysm (AAA). METHODS: It is an observational, descriptive multicenter case series. Inclusion criterion was patients with diagnosis of TBAAD and AAA detected synchronously for the first time at clinical onset of dissection. Follow-up imaging protocol included triple-phase spiral/computed tomography angiography performed at 1, 6, and 12 months after thoracic endovascular aortic repair (TEVAR), and annually thereafter. Major end points were perioperative mortality and long-term survival, freedom from aortic events, and freedom from reintervention. RESULTS: We identified and treated 15 cases. All TBAADs were treated by TEVAR in the acute phase: infrarenal aortic repair was performed with stent graft (SG) in 10 (66.7%) patients, with open repair in 5 (33.3%). Overall, staged repair was used in 11 (73.3%) patients. Mean descending aortic endovascular length coverage was 21 cm ± 7 (range, 10-35; interquartile range [IQR], 150-265). Overall, early perioperative mortality occurred in 1 (6.7%) patient. Median radiologic follow-up was 48 months (range, 6-120; IQR, 36-67). During the follow-up, TEVAR-related mortality was not observed. Aortic remodeling after TEVAR was obtained in 12 (85.7%) patients; abdominal sac shrinkage after SG was obtained in 8 (80.0%) patients. Freedom from aortic event rate was 79% ± 10 (95% confidence interval [CI]: 53.1-92.6) at 1 year and 64% ± 13 (95% CI: 38.1-83.5) at 5 year. Freedom from reintervention rate at 1 and 5 year was 85% ± 10 (95% CI: 57.8-95.7). CONCLUSIONS: In our experience, the association of TBAAD and AAA was a rare finding. Because of the lack of available evidence to opt for a single intervention or a staged approach, selective approach with TEVAR and endovascular/open conventional treatment of the abdominal aorta yielded satisfactory results at midterm follow-up.

Best Medical Treatment and Selective Stent-GraftRepair for Acute Type B Aortic Intramural Hematoma.

This study aimed to describe our experience with the management and the results of stent-graft (SG) repair of acute type B aortic intramural hematoma (B-IMH). Between January 2005 and July 2016, we identified 41 B-IMHs. Major end points were early and long-term survival, aortic remodeling, freedom from aortic-related mortality (ARM), and freedom from reintervention. Thirty-one (76%) patients eventually underwent SG repair: 16 (52%) cases in the acute phase, and 6 (19%) in the subacute (14-30 days) phase. Nine (29%) patients showed aortic lesion progression in the follow-up despite best medical treatment, and required SG repair in the chronic phase. The presence of ulcer-like projections at the admission computed tomography angiography was significantly higher in patients who eventually required SG repair (5% vs 36%, odds ratio: 4.08, P = .043). At 12 months, whereas ARM showed a trend in favor of SG (84% ± 10 vs 100%; log-rank: P = .075), the freedom from aortic progression was significantly lower in the SG group (64% ± 13 vs 94% ± 5; log-rank: P = .002). Median follow-up was 31 months (range, 2-96; interquartile range, 11-62.5). Freedom from ARM and freedom from aortic reintervention was 92% ± 5 (95% confidence interval: 75-98) at 12 months. Aortic remodeling was observed in 26 (84%) patients. No differences were noted between patients treated with SG in the acute and in the chronic phase. In our experience, B-IMH was associated with 47% aortic adverse event rate in the follow-up with best medical treatment alone. At mid-term, results of SG repair are encouraging.

Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass.

OBJECTIVE: The aim of the study was to retrospectively analyze early and follow-up results of above-the-knee femoropopliteal bypasses (AKb) performed with a bioactive heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft in patients with peripheral arterial obstructive disease in a multicentric retrospective registry involving seven Italian vascular centers. METHODS: During a 14-year period ending in March 2016, an HB-ePTFE graft was used in 1401 interventions performed for peripheral arterial obstructive disease. Comorbidities, risk factors, and follow-up outcomes were collected in a multicenter registry with a dedicated database. A post hoc analysis of the database was performed to identify 364 (25.9%) patients who underwent AKb. Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations, reinterventions, and the occurrence of major local and systemic complications. Follow-up results were analyzed by life-table analysis (Kaplan-Meier test) in terms of primary and secondary graft patency, assisted primary patency, limb preservation, and amputation-free survival. The analysis of follow-up results was stopped in December 2016. RESULTS: In 61 (16.7%) patients, AKb was performed after the failure of a previous ipsilateral revascularization. Critical limb ischemia was present in 164 (45%) cases; the remaining patients had life-limiting intermittent claudication. Perioperative mortality occurred in three (0.8%) patients: in the hospital (n = 2) due to acute myocardial infarction and after discharge (n = 1) due to fatal arrhythmia. Early thromboses occurred in six (1.6%) patients; all these patients had primary AKb for critical limb ischemia. The cumulative rate of perioperative amputations was 0.5% (2 cases), whereas the cumulative rate of early reinterventions was 3% (11 cases). Median duration of follow-up was 28 months (range, 1-168 months); the median cumulative follow-up index for survival was 0.75 (range, 0.05-1). Estimated survival at 5 years was 75.3% (standard error [SE], 0.03). Estimated 5-year primary patency was 64% (SE, 0.04); the corresponding figure in terms of assisted primary patency was 65% (SE, 0.035). Secondary patency rate at 5 years was 74.5% (SE, 0.03). The rate of limb preservation at 5 years was 95% (SE, 0.02); the corresponding figure in terms of amputation-free survival was 74% (SE, 0.04). CONCLUSIONS: In an era of endovascular enthusiasm, with conflicting results for the treatment of long or complex lesions of the superficial femoral artery, AKb with the use of HB-ePTFE graft remains an effective option, with low rate of perioperative complications and satisfactory long-term results.

Ten-year outcome analysis of the Italian Excluder Registry with the Gore Excluder endograft for infrarenal abdominal aortic aneurysms.

OBJECTIVE: The objective of this study was to report the 10-year outcomes of the multicenter Italian Excluder Registry for elective endovascular aneurysm repair (EVAR). METHODS: A retrospective analysis of all patients who underwent elective EVAR using the Gore Excluder (W. L. Gore & Associates, Flagstaff, Ariz) endograft (EG) at four Italian centers between 1998 and 2006 was carried out. Follow-up consisted of duplex ultrasound scan and computed tomography performed at 1 month, 6 months, and 12 months and yearly thereafter. Long-term outcomes were evaluated according to a life-table analysis. RESULTS: The Excluder EG was used in 461 patients (425 men; mean age, 72.9 ± 9.2 years) with abdominal aortic aneurysm (mean diameter, 52.2 ± 11.9 mm) who underwent elective EVAR. The 10-year cumulative survival was 62.5% ± 3.5% (95% confidence interval [CI], 55.5%-69.1%). During the follow-up, 14 (3.03%) patients were lost to follow-up. Estimated freedom from EG-related complication was 90.5% ± 1.5% (95% CI, 87.4%-92.9%) at 5 years, 89.2% ± 1.6% (95% CI, 85.6%-91.9%) at 7 years, and 88.4% ± 1.8% (95% CI, 84.4%-91.5%) at 10 years. Freedom from reintervention at 5, 7, and 10 years was 87.7% ± 1.8% (95% CI, 83.7%-90.8%), 82.4% ± 2.4% (95% CI, 77.2%-86.6%), and 80.6% ± 2.6% (95% CI, 75.5%-84.9%), respectively. On multivariable analysis, we did not find independent predictors of a higher rate of reintervention. There were 127 (27.5%) endoleaks detected during the follow-up. Only one type I endoleak was identified beyond 5-year follow-up. Cumulative freedom from endoleak rate was significantly different between the two different follow-up intervals (0-5 years, 2.6%; 6-10 years, 0.8%; P < .001). Estimated freedom from aorta-related mortality was 97.2% ± 0.8% (95% CI, 49.7%-99.9%) at 10 years. CONCLUSIONS: The Italian Excluder Registry outcomes confirmed sustained EVAR effectiveness at 10-year follow-up using the Gore Excluder EG. Freedom from EG-related complications, endoleaks, and reinterventions was satisfactory and remained acceptable beyond 5 years of follow-up, supporting a reasonable long-term durability of this device.

Risk factors analysis of thromboembolectomy for acute thromboembolic lower extremity ischemia in native arteries.

BACKGROUND: Aim of this study is to report the results of thromboembolectomy (ThEmb) for acute thromboembolic lower limb ischemia (ATLI) in native arteries and to create a predictive score for amputation-free survival (AFS) at 30 days. METHODS: It is a single center, retrospective analysis of a four years period. All patients had ThEmb: adjunctive procedures included femoral and/or popliteal endarterectomy in 30 (18.3%) cases, PTA-stent in 24 (14.6%), and femoral endarterectomy plus PTA-stent in 12 (7.3%). Fasciotomies were performed in 6 (3.6%) patients. Predictors of AFS identified on univariate screen (inclusion threshold, P<.20) were included in a multivariable model. The resulting significant predictors were assigned an integer score to stratify patients into risk groups. RESULTS: Authors analyzed 164 limbs in 164 patients. Mean age was 80±10 years (range, 40-99). In-hospital mortality was 9.8% (N.=16); AFS at 30 days was 84.7% (N.=139). The anatomic level (iliac vs. femoropopliteal vs. infrapopliteal) of the occlusion did not affect AFS (P=.326). Multivariable analysis identified six significant predictors of AFS at 30 days: age >85 (P=0.050), chronic obstructive pulmonary disease (P=0.008), chronic renal insufficiency (P=0.019), late (>6 hours) onset (P=0.004), the presence of major neurologic deficit (P=0.023), and an increased (>800IU/L) level of creatine phosphokinase (P=0.001). An integer score generated two risk groups (low-risk 0-2 [70.1% of cohort], and high-risk ≥3 [29.9% of cohort]): stratification of the patients according to risk category yielded significantly different AFS at 30 days (low-risk 5.2% vs. high-risk 38.8%, P<0.0001). CONCLUSIONS: Among patients selected to undergo ThEmb for ATLI in native arteries, this risk score identified a group of patients with a 40% chance of death or major amputation at 30 days. The score can help to optimize the operative strategy, but further prospective validation is needed.

Total endovascular treatment for extent type 1 and 5 thoracoabdominal aortic aneurysms.

OBJECTIVE: The study objective was to describe the results of thoracic endovascular aortic repair with the intentional coverage of the celiac artery and distal supramesenteric landing zone for extent type 1 and type 5 thoracoabdominal aortic aneurysms. METHODS: Inclusion criteria were thoracic endovascular aortic repair with celiac artery coverage to treat elective or urgent extent type 1 and 5 thoracoabdominal aortic aneurysms. Primary end points were in-hospital and follow-up survival, freedom from aortic-related mortality, and freedom from reintervention. RESULTS: Thoracoabdominal disease extent was type 1 in 12 patients (71%) and type 5 in 5 patients (29%). Urgent repair was performed in 4 patients (23.5%). Primary technical success was 100%. Early mortality and visceral ischemia did not occur. Permanent spinal cord ischemia rate was 6% (n = 1). Follow-up ranged from 3 to 120 months (interquartile range, 12-36.5). Survival estimate was 85% ± 9% (95% confidence interval, 67-94) at 1 year and 49% ± 17% (95% confidence interval, 21-78) at 5 years. Cumulative freedom from aortic-related mortality was 94%, and estimated freedom from reintervention at 1 and 5 years was 93% ± 7% (95% confidence interval, 68-99). Neither type 1 endoleaks nor distal stent-graft migration causing superior mesenteric artery occlusion was detected. CONCLUSIONS: Thoracic endovascular aortic repair with intentional coverage of celiac artery for extent 1 and 5 thoracoabdominal aortic aneurysms had satisfactory results in selected patients at high risk for open repair. Visceral ischemia did not occur, but spinal cord ischemia is still high at 6%. At midterm follow-up, neither endoleak development nor aortic reintervention was related to the inadequate distal landing zone. Follow-up survival is satisfactory and comparable to open repair.

Correction: Production of IL-8, VEGF and Elastase by Circulating and Intraplaque Neutrophils in Patients with Carotid Atherosclerosis.

[This corrects the article DOI: 10.1371/journal.pone.0124565.].

An update of the Italian Stroke Organization-Stroke Prevention Awareness Diffusion Group guidelines on carotid endarterectomy and stenting: A personalized medicine approach.

Although proof-based medicine has generated much valid evidence for the drawing up of guidelines and recommendations for best clinical practice in symptomatic and asymptomatic carotid stenosis, whether and when it is better to employ endarterectomy or stenting as the intervention of choice still remain matters of debate. Moreover, guidelines have been targeted up to now to the 'representative' patient, as resulting from the statistical analyses of the studies conducted on the safety and efficacy of both interventions as well as on medical therapy alone. The Italian Stroke Organization (ISO) and Stroke Prevention and Awareness Diffusion (SPREAD) group has thus decided to update its statements for an 8th edition. To this end, a multidisciplinary team of authors representing Italian scientific societies in the neurology, neuroradiology, vascular and endovascular surgery, interventional cardiology, and general medicine fields re-examined the literature available on stroke. Analyses and considerations on patient subgroups have allowed to model the risks/benefits of endarterectomy and stenting in the individual. Accordingly, the guideline's original methodology has been revised to follow the new SIGN (Scottish Intercollegiate Guideline Network) Grade-like approach, integrating it with new considerations on Precision, or Personalized Medicine. Therefore, this guideline offers recommendations on precision medicine for the single patient, and can be followed in addition to the more standard guidelines.

Outcome Analysis of Carotid Cross-Clamp Intolerance during Carotid Endarterectomy under Locoregional Anesthesia.

BACKGROUND: To analyze the predictors and describe the outcomes of cross-clamp intolerance (CCI) and the results of the use of carotid endarterectomy (CEA) with shunting or a shift strategy to immediate carotid artery stenting (CAS) in this setting. METHODS: Between January 2008 and December 2015, 385 patients were elected for single-sided, isolated CEA under locoregional anesthesia. In case of CCI, CEA with shunt was used selectively, whereas indication to immediate conversion to CAS was the immediate onset and severe persistent deterioration of the neurologic status, and/or local technical difficulties to perform endarterectomy. Primary outcome was prevention of death and all early (<30 days) perioperative cerebrovascular events. RESULTS: We treated 169 (43.9%) symptomatic lesions; urgent (≤48 hours) intervention was performed in 85 (22.1%) cases. Carotid CCI occurred in 45 (11.7%) patients. CEA with shunt was used in 16, whereas CAS in 27 (7.0%, 2 refused further treatment). Multivariable analysis identified hypertension (odds ratio [OR]: 2.93, 95% confidence interval [CI]: 1.01-8.52; P = 0.049) and symptomatic lesions (OR: 2.34, 95% CI: 1.11-4.93; P = 0.025) as significant predictors of CCI. In-hospital mortality rate was 0.5%; none occurred in CCI group. Postoperative cerebrovascular event rate was 2.3% (n = 9). At multivariable analyses, only CCI (OR: 6.60, 95% CI: 1.65-26.36; P = 0.008) was significantly associated with postoperative cerebrovascular events, with no significant different clinical outcomes between CEA and CAS. CONCLUSIONS: Hypertension and symptomatic carotid stenosis were significant predictors of CCI, which was found to be predictive for postoperative cerebrovascular events. In selected patients with CCI, CAS had satisfactory, similar results of CEA.

Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use.

PURPOSE: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. METHODS: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). RESULTS: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. CONCLUSION: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.