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.

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.

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.

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.

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.

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.

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.

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.

A comparison between aortobifemoral bypass and aortoiliac kissing stents in patients with complex aortoiliac obstructive disease.

OBJECTIVE: The aim of this study was to retrospectively compare early and late results of aortobifemoral bypass and endovascular recanalization with the kissing stent technique in the management of TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions in the aortoiliac district in a multicenter study. METHODS: From January 2006 to December 2013, 210 open and endovascular interventions for TASC II class C and D aortoiliac obstructive lesions were performed at three Italian teaching hospitals. In all the cases, the intervention was performed for aortic and bilateral iliac involvement. An aortobifemoral bypass was performed in 82 patients (group 1); in the remaining 128, an endovascular recanalization with the kissing stent technique was carried out (group 2). Early results in the two groups were compared with the χ2 test. Follow-up results were analyzed with Kaplan-Meier curves and compared with log-rank test. Univariate and multivariate (forward Cox regression) analysis to identify potentially significant predictors of primary patency in the whole study group was performed. RESULTS: Patients in group 2 were more frequently female and more frequently had diabetes and arterial hypertension than patients in group 1. The indication for surgical intervention was the presence of critical limb ischemia in 29 cases in group 1 (35%) and in 31 cases in group 2 (24%; P = .07). Technical success in group 2 was 98.5%; two patients required immediate conversion to open surgery for iliac rupture. There was one perioperative death in group 1 (mortality rate, 1%; P = .2 in comparison with group 2). Four perioperative thromboses occurred, two in group 1 and two in group 2 (in one case requiring conversion to open surgical intervention), and no amputations at 30 days were recorded. Cumulative postoperative local and systemic complications occurred in 17 patients in group 1 (20.5%) and in 9 patients in group 2 (7%; P < .001). Mean duration of follow-up was 38 months (range, 1-96 months). Survival rates at 6 years were 65.5% (standard error [SE], 0.08) in group 1 and 83.5% (SE, 0.08) in group 2 (P = .08; log-rank, 2.2). At the same time interval, primary, assisted primary, and secondary patency rates were similar; reintervention rates were 6% in group 1 (SE, 0.05) and 11% in group 2 (SE, 0.04; P = .3; log-rank, 0.8). Univariate and multivariate analysis showed that only the presence of critical limb ischemia was independently associated with poorer primary patency during follow-up (hazard ratio, 2.4; 95% confidence interval, 0.9-6.4; P = .05). CONCLUSIONS: In this multicenter experience, endovascular repair of aortoiliac complex lesions with the kissing stent technique provided similar satisfactory early and late results to those obtained with open surgery.

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.

A Multicenter Predictive Score for Amputation-Free Survival for Patients Operated on with an Heparin-Bonded ePTFE Graft for Critical Limb Ischemia.

AIM OF THE STUDY: To retrospectively create a predictive score for estimating amputation-free survival (AFS) in patients with critical limb ischemia (CLI) operated on with the use of a heparin-bonded expanded polytetrafluoroethylene (ePTFE) bypass graft (Hb-ePTFE). METHODS: Over a 13-year period, ending in March 2015, a Hb-ePTFE graft was implanted in 683 patients undergoing below-knee revascularization for CLI in seven Italian vascular hospitals. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Univariate and multivariable analyses with Kaplan-Meier estimates were used to identify potential significant predictors of AFS at 5 years, and then a predictive risk score was constructed. A qualitative assessment of the Kaplan-Meier survival estimates for each integer score was performed, and subgroups of risk were stratified on the basis of the primary end point. RESULTS: Overall, estimated 5-year AFS rate was 48.3 % (SE 0.024). At multivariate analysis, older age, coronary artery disease, end-stage renal disease, tissue loss and poor runoff score were predictors of AFS. The integer score ranged from 0 to 11; Kaplan-Meier analysis for AFS in each score group identified three subgroups with significant differences at 5 years: low-risk subgroup (scores from 0 to 2, 67.7 %), medium-risk subgroup (scores 3 and 4, 49.2 %, p < 0.001 in comparison with low-risk subgroup) and high-risk subgroup (scores from 5 to 11, 25.2 %, p < 0.001 in comparison with either low-risk subgroup or medium-risk subgroup). CONCLUSIONS: A category of low-risk patients with CLI treated with the indexed graft does exist, thus suggesting a primary role for Hb-ePTFE in such patients. A prospective validation of such a score is necessary.

Thoracic Endovascular Aortic Repair for Embolizing Total Occlusion of the Descending Aorta due to Aortic Sarcoma.

Primary malignant tumors of the aorta are extremely rare, and the diagnosis is difficult from the clinical onset. Accordingly to the principles of cancer surgery, "en bloc" resection of the tumor-involved aorta and graft interposition is the gold standard, but it is still technically challenging and comorbidities may rule out some patients from an operative treatment. Thoracic endovascular aortic repair has been reported anecdotally, but it is an ease and rapid alternative in urgent circumstances and proved to be effective to relieve symptoms caused by these lesions. Unfortunately, no matter what is the type of histology or immunohistochemistry, or the type of treatment, the prognosis of aortic malignancies is very poor. Nevertheless, an operative treatment strategy which includes surgical resection and chemotherapy or radiation had long survival than patients treated with a single modality. We report a case of acute mesenteric syndrome caused by an occlusive and embolizing thrombus of the descending thoracic aorta caused by primary aortic sarcoma treated with thoracic endovascular aortic repair.

Operative Treatment of Type 2 Endoleaks Involving the Inferior Mesenteric Artery.

BACKGROUND: We report the results of the operative treatment for type 2 endoleak (T2E) involving the inferior mesenteric artery (IMA) using the transarterial embolization (TAE) or the video laparoscopic ligation (VLS). METHODS: Between January 2005 and December 2015, we retrospectively analyzed 901 patients treated with endovascular aortic repair (EVAR): 883 (98%) had 1 valid postoperative radiologic evaluation, at least. All patients with operative repair for IMA-related T2E entered the final analysis. Indication of their operative repair was sac enlargement (>5 mm within 6 months or >1 cm from the preoperative diameter, irrespectively of the postoperational time) and/or its persistence >12 months. RESULTS: We detected 192 (21.7%) T2Es, overall. We identified 37 (4.2%) IMA-related T2Es, and treated 21 cases (VLS n = 11, TAE n = 10). Aneurysm-related mortality and major or minor morbidity was never observed. Time of intervention did not differ significantly (minutes, VLS = 97 ± 46 vs. TAE = 95 ± 21, P = 0.901). Hospitalization was significantly lower in the TAE group (days, 4 ± 2 vs. 1 ± 0.4, P < 0.001). No patient was lost at a mean follow-up of 46 ± 32 months (range, 1-110; median, 48). At last follow-up, sac diameter was significantly more stable in the VLS (mm, 60 ± 10 vs. 55 ± 7, P = 0.593) than that in the TAE group (mm, 57 ± 9 vs. 63 ± 10, P = 0.050). The IMA-related T2E reintervention rate was not significantly different between the groups (VLS, n = 0 [0%] vs. TAE, n = 2 [20.0%], P = 0.213). Secondary aortic reintervention rate was 28.6% (n = 6), and secondary open conversion rate was 9.5% (VLS, n = 1 [9.1%] vs. TAE, n = 1 [10.0%], P = 1). CONCLUSIONS: In authors' experience, operative treatment of IMA-related T2E was safe; VLS proved to be effective and durable in sealing this type of T2E. Patients receiving correction of IMA-related T2E after EVAR remained at risk for development of any type of endoleaks, as well as at risk of reintervention.

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.

Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft.

OBJECTIVE: Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. METHODS: This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. RESULTS: Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P = .05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). CONCLUSIONS: No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

Stent-graft Repair of a True Internal Thoracic Artery Aneurysm.

We present the case of a 49-year-old woman diagnosed with Sneddon's syndrome and previous endovascular embolization for cerebral and left renal artery aneurysms. The aneurysm was asymptomatic and incidentally detected as coin opacity at a preoperative X-ray performed for breast surgery. The 13-mm saccular left internal thoracic artery aneurysm engaged through a percutaneous left brachial artery access was successfully excluded with a stent graft. A 6-month follow-up computed tomography angiography confirmed the exclusion of the aneurysm, the patency of the internal thoracic artery, and the absence of endoleak or edge stenoses. True aneurysm of the internal thoracic artery is a rare entity. Stent-graft repair is a viable end effective alternative treatment for the exclusion of this lesion.

Thoracic endovascular aortic repair for blunt thoracic aortic injuries in complex aortic arch vessels anatomies.

The aim of this study is to report the use of thoracic endovascular aortic repair (TEVAR) in blunt thoracic aortic injuries (BTAIs) presenting with complex anatomies of the aortic arch vessels. Two patients were admitted to our hospital for the management of BTAI. Anomalies were as follow: aberrant right subclavian artery (n = 1) and right-sided aortic arch with 5 vessels anatomy variant (n = 1). TEVAR was accomplished using parallel graft with periscope configuration in the patient with the aberrant right subclavian artery. At 12-month follow-up, computed tomography angiographies confirmed the exclusion of the BTAI, the stability of the endograft, the resolution of the pseudoaneurysm, and the patency of the parallel endograft. Aortic arch vessels variants and anomalies are not rare, and should be recognized and studied precisely to plan the most appropriate operative treatment. TEVAR proved to be effective even in complex anatomies.