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The aim of this study was to compare the 2-year outcomes of de novo versus postendovascular lesion treatment of femoropopliteal occlusions included in a national, multicenter, observational, prospective registry based on the treatment of critical Limb-threatening IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE) registry.From January 2018 to December 2019, 541 patients from 43 centers have been enrolled in the LIMBSAVE registry. Of these patients, 460 were included in the present study: 341 (74.1%) with de novo lesions (DN group) and 119 (25.9%) with postendovascular treatment lesions (PE group). Initial outcome measures were assessed at 30 days after treatment. Furthermore, at the 2-year follow-up, the estimated outcomes of primary patency, primary-assisted patency, secondary patency, and limb salvage were analyzed with Kaplan-Meier curves and compared between groups with the log-rank test.Both groups were homogeneous in terms of demographic data, preoperative risk factors, and clinical presentation. However, compared with DN group, more patients in PE group had a great saphenous vein diameter of less than 3 mm (11.1% vs 21%; P = .007). Intraoperatively, both groups showed similar distal anastomosis sites: below-the-knee popliteal artery (63% DN group, 66.4% PE group) and tibial vessel (37% DN group, 33.6% PE group) (P = .3). The overall mean duration of follow-up was 11.6 months (range, 1-24 months). At the 2-year follow-up, there were no differences between the two groups in terms of primary patency (66.3% DN group vs 74.1% PE group; P = .9), primary-assisted patency (78.2% DN group vs 79.5% PE group; P = .2), secondary patency (85.1% DN group vs 91.4% PE group; P = .2), and limb salvage (95.2% DN group vs 95.1% PE group; P = .9).The LIMBSAVE registry did not show a worsening of overall patency and limb salvages rates at the 2-year follow-up in patients undergoing in situ saphenous bypass after a failed endovascular approach for long femoropopliteal occlusive disease. This finding is in contrast with what has been published in literature.

The aim of this study is to evaluate early and long-term outcomes according to the timing to carotid endarterectomy (CEA) of symptomatic carotid stenosis.Consecutive CEAs with selective shunting for symptomatic carotid stenosis ≥50% performed between 2009 and 2020. Patients had acute neurological impairment on presentation, defined as5 points on the National Institutes of Health Stroke Scale (NIHSS). We grouped patients according to time between index event and CEA: the first group was operated between 0 and 2 days, the second group between 3 and 7 days, the third group between 8 and 14 days and the last group after 15 days. Thirty-day neurological status improvement was defined as a decrease (≥1) in the 30-day NIHSS score versus NIHSS score immediately before surgery.Five hundred CEAs were performed. The perioperative combined stroke and mortality rate was 3.6% (18/500), representing a perioperative mortality rate of 0.2 (n = 1) and stroke rate of 3.4% (n = 17). Overall freedom from stroke was 95% at 1 year, 89 % at 6 years, and 88% at 10 years. Annual stroke rate was 0.6% after the 30-day period. Thirty-day improvement in neurologic status occurred in 103 patients (20.6%), while in 380 (76%) neurologic status was unchanged, and 17 (3.4%) experienced worsening of their neurologic status. Patients treated within 7 days from the index event had significant benefit (OR = 2.6) in the 30-day neurological improvement versus those treated after 7 days from the index event. Timing to CEA2 days increased significantly the risk of late stroke (OR = 9.7).The ideal timing for performing CEA is between 3 and 7 days from the index event if NIHSS5 as it is associated with the best rates of improvement in neurological status and durability in the long term. Very early CEA (48 hrs) was associated with increased late stroke occurrence.

This position paper, written by members of International Union of Angiology (IUA) Youth Committee and senior experts, shows an overview of therapeutical approaches for patients with chronic limb-threatening ischemia (CLTI) and absence of 'standard' solutions for revascularization. The aim was to demonstrate the accurate management of the 'no-option' CLTI patient including the wound treatment and the rehabilitation, considering always the goal of the increase of quality of life of the patients.

This position paper, written by members of International Union of Angiology (IUA) Youth Committee, shows an overview of coagulation system and laboratory tests, analysis of medical therapies (older and newer), medication discontinuation/restart recommendations, bridging therapy recommendations, and an overview of hemostatic agents used in the operating room.

Sex-based differences in peripheral arterial disease are well-known. Aim of this study was to evaluate sex-related disparities in patients undergoing endovascular treatment of isolated popliteal artery lesions.Between 1th January 2004 and 1th January 2021 304 patients underwent endovascular treatment of an isolated popliteal artery lesion at three vascular centers. A retrospective analysis was performed comparing the outcomes in female versus male patients.The majority of the patients were female (51.3%). Male patients were younger (70.4 vs. 76.8 years, p 0.01). Hyperlipidemia (62.2% vs. 45.5%, p 0.01) and diabetes (62% vs. 40%, p 0.01) were more common in male group. There were more current and former smokers in the male group (p = 0.04 and p = 0.01). There were no differences regarding lesion length (mean 94.5 mm) nor location of the lesion. Technical success was comparable in both groups 94.6% vs. 97.4%), no differences in terms of in-hospital complications (9.5% vs. 7.7%) were found. At 3 years estimates did not demonstrate any difference in terms of clinically driven target lesion revascularization (23% vs. 34%), secondary patency (86% vs. 96%), and all-cause mortality (77% vs. 67%) between the two groups.In our experience the female sex showed clinical signs of popliteal artery lesion at higher age with less aggressive atherosclerotic risk factors. However, during the follow-up no sex-related significant differences were found in terms of morphological and clinical outcomes after endovascular revascularization.

Purpose To evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation. Methods The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention. Results Of the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2–89.9) and 90.4% (95% CI 86.5–93.3), and 92.3% (95% CI 89.9–94.1) and 92.9% (95% CI 89.7–95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4–15.3) in males and 11.9% (95% CI 8.6–16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9–11.9) in males and 4.0% (95% CI 2.3–7.0) in females. Conclusion Treatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation. Clinical Trial Registration NCT02276313. Level of Evidence Level 4.

Background Graft disruption is an unusual complication of the endovascular abdominal aortic aneurysm repair (EVAR). Case presentation A 71-year-old man underwent standard EVAR with Zenith Alpha Abdominal endograft. Follow-up examinations revealed an initial significant sac shrinkage. At 24 months, duplex ultrasound (DUS) scan and computed tomography showed increase of the sac diameter associated with complete disconnection of the suprarenal stent-graft from the main body without evidence of endoleak. A standard relining with a thoracic endograft was performed between the suprarenal stent and the main body of the previous graft. At 6 months DUS revealed sac shrinkage. Conclusions This report demonstrates an uncommon cause of endograft failure with suprarenal stent disconnection from main body and highlights the need for continuous follow-up in patients undergoing EVAR.

Vascular cadaver laboratory (CAD LAB) courses included vascular exposure techniques and simulations of open procedures. Aim of the study was to demonstrate the benefit of cadaver laboratory (CAD LAB) courses to improve trainees' experience in open surgical vascular procedures.Between 2014 and 2020, 162 vascular surgeons or medical trainees (mean age 28 years) participated in vascular CAD LAB courses in Italy and France. Outcomes were measured using the Linkert survey, performed pre- and postcourse to evaluate self-efficacy/confidence, surgical experience, and resident perception of the course with a range score from 0 to 5 for each point. Anatomical knowledge improvement was measured using a questionnaire with multiple answers pre- and postcourse. The course was considered to have yielded a positive result if the postcourse Linkert Survey Score increased by ≥2 points, or in the case of an increase of at least 30% above the baseline value of the multiple questionnaires.Postcourse questionnaires were positive for all outcomes evaluated. Participants' perception of the usefulness of the CAD LAB evaluation was 4.8 out of 5. For the vascular CAD LAB, participant anatomical knowledge improved overall from an average of 55% to 93% (P0.001), and self-efficacy/confidence improved from 2.3 to 4.5 out of 5 (P0.001). Regarding the different operative procedures, the greatest self-efficacy/confidence improvement was recorded in carotid endarterectomy and aortic procedures (+50% and +66% respectively; P0.001). The city location (Italy vs. France) did not affect the results.CAD LAB courses were shown to be effective in increasing participants' self-efficacy, confidence, and anatomical knowledge in open vascular surgical procedures.

The mid-term results after treatment of isolated popliteal lesions have been limited. The aim of the present study was to report the mid-term outcomes after endovascular treatment of isolated atherosclerotic popliteal artery lesions.A multicenter (15 hospitals in five countries) retrospective cohort study was performed. Between June 2016 and June 2021, 651 consecutive patients who had been treated for isolated popliteal lesions using endovascular methods exclusively were included in the present study. Six techniques were identified, including plain balloon angioplasty (PTA; n = 286; 43.9%), drug-coated balloon angioplasty (n = 98; 15.1%), stenting with low-chronic outward force (COF) stents (n = 84; 12.9%), stenting with high-COF stents (n = 76; 11.7%), atherectomy alone (n = 17; 2.6%), and directional atherectomy with drug-coated balloons (n = 90; 13.8%). The primary outcomes measures were primary and secondary patency and freedom from clinically driven target lesion revascularization (F-CDTLR).The mean patient age was 74.5 years. Most of the patients (n = 409; 62.9%) had had chronic limb-threatening ischemia. Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. The median follow-up was 26 months (range, 6-42 months). The actuarial rate for all patients at 26 months (per outcome measure) was as follows: primary patency, 73.9%; secondary patency, 88%; and F-CDTLR, 76.5%. When comparing PTA vs all other treatments in an adjusted regression analysis, the F-CDTLR was 75.2% for PTA vs 76.5% for all other treatment (hazard ratio, 1.06; 95% confidence interval, 0.75-1.48; P = .46, adjusted regression). The difference in secondary patency also was not statistically significant (85.7% for PTA vs 88%; P = .20). Adjusted Kaplan-Meier analysis revealed that the estimated primary patency was inferior for PTA in pairwise comparisons vs other treatments (P .001 vs atherectomy; P = .002 vs directional atherectomy with drug-coated balloons; and P = .002 vs low-COF stenting).The results from our study have shown that endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and F-CDTLR in the mid-term.

The aim was to demonstrate contemporary outcomes of in situ saphenous vein bypass using a valvulotome.Analysis of two year outcomes of a multicentre registry based on the treatment of critical Limb Ischaemia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE). Between January 2018 and December 2019, 541 patients in 43 centres were enrolled. In all patients an innovative valvulotome was used. Early outcomes were assessed. Two year outcomes according to Kaplan-Meier curves in terms of patency and limb salvage were evaluated. Associations between patient and procedure variables were analysed with univariable and multivariable analyses.In all cases, a valvulotome was able to lyse the valves. Vein injury due to the in situ technique was 3.5%. Thirty day mortality and major amputation rates were 3% and 0.9%, respectively. Mean follow up was 12.1 months. Two year estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 69.1%, 81.4%, 86.5%, and 94.5%, respectively. Multivariable analysis showed an association between pre-operative vein diameter3 mm and lower primary patency (hazard ration [HR] 14.3, p.001), primary assisted patency (HR 9.4, p = .002), secondary patency (HR 7.2, p = .007), and limb salvage (HR 7.8, p = .005) rates. Distal anastomosis to a tibial or foot vessel was also associated with lower primary patency (HR 4.8, p = .033), and primary assisted patency (HR 6, p = .011) rates. Use of a suprafascial tributary collateral as a graft was associated with lower primary patency (HR 6.7, p = .013), and primary assisted patency (HR 4.2, p = .042) rates.Vein diameter3 mm, distal anastomosis on a tibial or foot vessel, and use of a suprafascial tributary collateral as a graft were significantly associated with loss of patency and limb loss during follow up.

The aim of this study is to compare early and follow-up outcomes of late open conversions (LOC, with complete or partial endograft explantation) and semi-conversions (SC, with endograft preservation) after endovascular aneurysm repair in a multicenter experience.All LOC and SC performed from 1997 to 2020 in 11 vascular centers were compared. Endograft infections or thrombosis were excluded. Primary endpoints were early mortality and long-term survival estimates. Secondary endpoints were differences in postoperative complication rates and conversion-related complications during follow-up.In the considered period, 347 patients underwent surgery for endovascular aneurysm repair complications. Among these, 270 were operated on for endoleaks (222 LOC, 48 SC). The two groups were homogeneous in terms of American Society of Anesthesiologists score (LOC, 3.2 ± 0.7; SC, 3 ± 0.5; P = .128) and main endograft characteristics (suprarenal fixation, bifurcated/aorto-uni-iliac configuration). The mean age was 75 ± 8 years for LOC and 79 ± 7 years for SC (P = .009). Reasons for LOC were: 62.2% (138/222) type I endoleak, 21.6% (48/222) type II endoleak, 7.7% (17/222) type III endoleak, and 8.5% (19/222) endotension. Indications for SC were: 64.6% (31/48) type II endoleak, 33.3% (16/48) type I endoleak, and 2.1% (1/48) type III endoleak. Thirty-day mortality was 12.2% (27/222) in the LOC group, and 10.4% (5/48) in the SC group (P = .73). Postoperative complication rate was higher in the LOC group (45.5% vs 29.2%; P = .04). The estimated survival rate after LOC was 80% at 1 year and 64% at 5 years; after SC, it was 72% at 1 year and 37% at 5 years (log-rank P = .01). During the median follow-up of 21.5 months (interquartile range, 2.4-61 months), an endoleak after SC was found in the 38.3% of the cases; sac growth was recorded in the 27.7% of SC patients.SC has an early benefit over LOC in terms of reduced postoperative complications but has a significantly inferior mid-term survival. The high rates of persistent and/or recurrent endoleaks reduce SC durability.

Purpose: To report the benefits and the role of carbon dioxide (CO2) angiography in case of misalignment between fenestration and target vessel during fenestrated endovascular aneurysm repair (F-EVAR). Technique: During F-EVAR, misalignment between fenestration and target vessel is a potentially catastrophic complication. In 2 patients, we experienced that one of the target vessels were not visible during standard angiography in different projections after positioning a fenestrated graft and even after cannulation of the corresponding fenestration. In both cases, the graft was sealed to the aortic wall but not in the predictable position. Consequently, acute occlusion of the target vessel was hypothesized. However, CO2 angiography was useful to evaluate patency of the target vessel clarifying the relative position of the fenestration versus the target vessel. Rescue maneuvers were feasible under the guidance of CO2 angiography in order to obtain the cannulation of both renal arteries. In both cases, the procedure was successfully accomplished. Conclusion: In case of misalignment of a fenestration during F-EVAR and non-visualization of the target vessel with standard angiography, CO2 angiography could have the unique and complementary role of clarifying the patency and position of the target vessel. In addition, CO2 could guide the rescue maneuvers.

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Introduction The aim of this study was to evaluate the influence of pedal arch quality on 5-year survival and limb salvage in diabetic patients with foot wounds undergoing peripheral angiography. Methods Between January 2014 and December 2014, 153 diabetic patients with foot wounds underwent peripheral angiography. Final foot angiograms were used to allocate patients according to pedal arch: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Five-year survival and limb salvage rates were analyzed with Kaplan–Meier curves and compared by means of Gehan–Breslow–Wilcoxon test. Associations of patient and procedure variables with overall survival and limb salvage outcomes were sought with univariate and multivariate analyses. Results A below-the-knee (BTK) artery was the target vessel in 80 cases (52.3%). Five-year Kaplan–Meier rates of survival were similar in all groups ( p = 0.1): CPA 30%, IPA 27.5%, and APA 26.4%. Five-year limb salvage rates were significantly better in patients with CPA/IPA ( p < 0.001): CPA 95.1%, IPA 94.3%, and APA 67.3%. In the whole population study, multivariate analysis showed significant association of smoking ( p = 0.01), chronic renal failure ( p = 0.02), and severity of foot wounds ( p < 0.001) with survival. Coronary artery disease ( p = 0.03), severity of foot wounds ( p = 0.001), and pedal arch status ( p = 0.05) showed strong association with limb salvage. Conclusions Pedal arch quality significantly affected limb salvage but not survival at 5 years in patients with diabetic foot ulcers. Smoking, chronic renal failure, and severity of foot wounds affected overall survival, whilst coronary artery disease, and severity of foot wounds limb salvage.

Modality of elective repair (open or endovascular) of popliteal artery aneurysms (PAAs) is still debated. About open repair no strict evidence exists about the best surgical technique. The aim of this study was to report a 20-year experience with ligation and in-situ saphenous vein bypass for the elective treatment of PAAs.A retrospective review of consecutive patients who underwent elective open surgical PAA repair in our center between January 2001 and April 2020 was performed. Ninety-two limbs in 84 patients underwent a PAA ligation and in-situ saphenous bypass. Early (30 day) outcomes were assessed. Estimated 5-year outcomes according to Kaplan-Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Associations of patient and procedure variables with patency and limb salvage outcomes were sought with multivariate analysis.Patients were predominantly male (80/84, 95.2%) with a mean age of 73.1 years (range 50-89). In all cases technical success was obtained. The mean hospital stay was 5.8 days (range 2-27). Thirty-day overall mortality (N.=1) and major amputation (N.=1) rates were both 1.2%. Mean duration of follow-up was 31.3 months (range: 1-168). At 5 years estimated rates of primary patency, primary assisted patency, secondary patency, and limb salvage were 76.3%, 81.5%, 89.9%, and 96.6%, respectively. On multivariate analysis the associations were: primary patency with PAA diameter30 mm (P=0.007), and poor run-off status (P0.001); primary assisted patency with poor run-off status (P0.001); secondary patency with poor run-off status (P=0.04). Major amputation had no independent predictors of poor outcomes.Elective surgical treatment of PAAs with ligation and in-situ saphenous vein bypass is safe, effective and durable with good 5-year outcomes in terms of overall patency and limb salvage. Poor run-off status seemed to be an independent predictor of worse patency rates. This surgical technique should be cautiously applied in patients with PAAs with a diameter30 mm.

To report long-term results of standard EVAR focusing on endoleak onset (ELo) and its evolution.880 EVARs using different stentgrafts (1999-2015) were included. Primary outcomes were all-cause mortality and AAA-related mortality. Timing of ELo after EVAR was categorized as follows: ELo1 = 0-2 years, ELo2 = 2-4 years, ELo3 = 4-6 years, ELo4 = 6-8 years, and ELo5 ≥ 8 years. The rate of sac shrinkage/sac expansion and the need to re-intervene were the variables considered to determine EL evolution.Median follow-up was 60 months (IQR: 36-84). Summary follow-up index was 0.99. Survival rate was 94.5% at 2 years, 57.7% at 10 years, 33.3% at 14 years. Freedom from AAA-related-death rate was 99.3% at 14 years. Freedom from endoleak was 86.4% at 2 years, 68.3% at 10 years, and 48.6% at 14 years. EL rate was 1.9% (n = 19),16.6% (n = 146), 0.8% (n = 7), and 0.4% (n = 4) for type I, II, III and IV, respectively. Only type II EL showed a significant difference in the ELo (Elo1 = 31%; ELo2 = 12.8%; ELo3 = 9.4%; Elo4 = 10.2%; Elo5 = 11.4%; P .001). Sac shrinkage occurred in 791 (90%) patients while 89 (10%) had a persistent sac expansion at the last follow-up. Freedom from reintervention was 95.6% at 2 years, 86.4% at 10 years, and 80% at 14 years. 48 out of 176 (27.2%) patients with EL underwent reintervention. The re-intervention rate was significantly higher within the first two years of follow-up if compared to the following years (17.6% vs.10%; P .001).An active lifelong surveillance follow-up can guarantee good long-term EVAR outcomes. Reinterventions and type II EL were more frequent in the first two-year of follow-up.

Summary: Background: Two-dimensional (2D) perfusion angiography is useful for the evaluation of foot perfusion in patients with critical limb-threatening ischemia (CLTI). Iloprost is a synthetic prostacyclin analogue presenting vasodilating properties. Aim of this study was to demonstrate the utility of 2D perfusion angiography as quantitative method to evaluate iloprost effect on foot circulation. Patients and methods: Between January 2020 and June 2020 25 patients with CLTI underwent below-the-knee (BTK) endovascular revascularization, intra-arterial administration of iloprost, and assessment of foot perfusion by 2D perfusion angiography. Iloprost was administered as an intra-arterial bolus of 3 μg over 1–3 minutes immediately after BTK revascularization. The 2D perfusion angiography was performed in a standardized manner with a 5-F catheter placed into the popliteal artery. A wide region of interest (ROI) was identified to assess the foot perfusion. Time–density curves were calculated by the perfusion software. Changes of the overall time-density curves before and after the administration of iloprost were evaluated. Results: Endovascular revascularization was successful in all cases. The mean reduction of systolic pressure value after iloprost administration was 23.1 mmHg. Eight patients (32%) experienced a minor complication (6 cutaneous rush, 2 symptomatic hypotension >40 mmHg). In 20 patients the time-density curves under ROI increased after the intra-arterial administration of iloprost (+31.6%, range from +4.9% to +78.7%). Five patients had no modification or a slight decrease of foot perfusion after iloprost administration (non-responders patients). Conclusions: Patients undergoing intra-arterial administration of iloprost accounted for a not negligible rate of minor complications. 2D perfusion angiography was valuable as quantitative method to evaluate the iloprost effect on foot circulation. This technique could be useful to classify the patients in responders or non-responders to iloprost therapy.

Background To report a novel staged hybrid technique to treat complex juxtarenal abdominal aortic aneurysm (JAAA) associated with at least one iliac artery aneurysm (IA) with no adequate distal fixation zone. Methods The novel technique herein described has two main "staged" steps. The first step consists in create an adequate distal fixation zone by endovascular means; after hypogastric embolization an iliac stent-graft has placed from 5 mm above the aortic bifurcation to the external iliac artery. The second step is the surgical resection of the JAAA and graft placement sutured distally to the stent-graft which was always performed the day after. Results The five cases included (mean age 74 years), were rejected for fenestrated or branched endovascular aortic repair or iliac branch devices. Four tube grafts and one aorto-bi-iliac graft were sutured to one stent-graft (n=3), two stent-grafts in iliac kissing configuration (n=1) and to a main body of a bifurcated stent-graft (n=1). Mean followup duration was 14 (4-27) months with no mortality. Technical success was obtained in all cases (2 suprarenal clamping). Postoperative complications included two pleural effusions, two transient gluteal intermittent claudications, and one renal failure. Conclusions The technique herein described seems to be a feasible and cost-effective alternative treatment for selected concomitant complex JAAAs and IAs unsuitable for totally endovascular treatment.

Objectives: The aim was to report indications, technical aspects, and outcomes of a multicentre experience of late open conversions (LOCs) after endovascular abdominal aneurysm repair (EVAR), in order to identify risk factors which may influence early morbidity and mortality rates, and long term survival. Methods: Ten vascular centres retrospectively reviewed all patients requiring LOC (≥30 days from initial EVAR, undergoing total or partial endograft explantation) from 1996 to 2017. Baseline characteristics, endograft data, indications, procedural details, post-operative outcomes, and follow up data were reviewed and analysed. Results: Included patients totalled 232 (90.1% males, mean age 74.3 ± 7.9 years). The number of LOC per year significantly increased during the study period, reaching 22 in 2017 (correlation r = 0.867, p

Summary: Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

Background The therapeutic efficacy of bone marrow mononuclear cells (BM-MNC) autotransplantation in critical limb ischemia (CLI) has been reported. Variable proportions of circulating monocytes express low levels of CD34 (CD14+CD34lowcells) and behave in vitro as endothelial progenitor cells (EPCs). The aim of the present randomized clinical trial was to compare the safety and therapeutic effects of enriched circulating EPCs (ECEPCs) with BM-MNC administration.Methods and Results:ECEPCs (obtained from non-mobilized peripheral blood by immunomagnetic selection of CD14+and CD34+cells) or BM-MNC were injected into the gastrocnemius of the affected limb in 23 and 17 patients, respectively. After a mean of 25.2±18.6-month follow-up, both groups showed significant and progressive improvement in muscle perfusion (primary endpoint), rest pain, consumption of analgesics, pain-free walking distance, wound healing, quality of life, ankle-brachial index, toe-brachial index, and transcutaneous PO2. In ECEPC-treated patients, there was a positive correlation between injected CD14+CD34lowcell counts and the increase in muscle perfusion. The safety profile was comparable between the ECEPC and BM-MNC treatment arms. In both groups, the number of deaths and major amputations was lower compared with eligible untreated patients and historical reference patients. Conclusions This study supports previous trials showing the efficacy of BM-MNC autotransplantation in CLI patients and demonstrates comparable therapeutic efficacy between BM-MNC and EPEPCs.

Background The aim of this study was to evaluate our preliminary experience with the use of the Endurant II short form (IIs) stent-graft in the treatment of abdominal aortic aneurysms (AAAs). Methods Between November 2014 and November 2015, 79 patients were consecutively treated with the Endurant IIs stent-graft at three European vascular centers. Early (30-day) results in terms of technical success, limb occlusion, major morbidity, and mortality were analyzed. Estimated 1-year outcomes in terms of survival, freedom from type I endoleak, freedom from limb occlusion, and freedom from any device-related reinterventions were assessed with Kaplan-Meyer method. Factors affecting 1-year freedom from type I endoleak were analyzed by log-rank test and by Cox regression test for multivariate analysis. Results Intraoperative technical success was achieved in all cases. Thirty-day mortality was 1.3% (one death due to cardiac failure). Early type I endoleak was detected in three patients (3.8%). During the follow-up (mean duration 6.7 months; range 1-14), two type I endoleaks resolved spontaneously. No limb occlusions or aneurysm-related reinterventions were recorded. Estimated survival, freedom from type I endoleak, freedom from limb occlusions, and freedom from any device-related reinterventions rates at 1 year were 96%, 96.6%, 100%, and 100%, respectively. Adoption of chimney technique significantly affected 1-year freedom from type I endoleak (P≤0.001). Conclusions Preliminary use of the new Endurant IIs stent-graft is safe and effective in endovascular repair of AAAs (EVAR) without early limb occlusions. Further studies with larger population sizes and longer follow-up are needed to evaluate mid- and long-term results.

Background In the endovascular era peripheral bypass surgery still plays a key role. In situ saphenous vein bypass is a standardized technique. The main limitation of this procedure is the vein diameter. A new hydrophylic valvulotome (HYDRO LeMaitre® Valvulotome; LeMaitre Vascular, Burlington, MA, USA) allows even to disrupt the valves in smaller veins. The aim of this study was to analyze the intraprocedural and technical successes of this new valvulotome. Methods In January 2018 in Italy a national, multicenter, observational, prospective registry based on the examination of treatment of critical limb ischemia with infragenicular bypass adopting in situ saphenous vein technique (LIMBSAVE registry) started the enrollment. Until December 2018 216 patients have been enrolled in the registry. All data concerning the procedures were prospectively collected in a dedicated database. The information included demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative features, and discharge outcomes, including the safety and effectiveness of the valvulotome during the surgical procedure. Results Patients were predominantly male (160, 74.1%) with a mean age of 74.1 years (range 49-95). The mean diameter of the great saphenous vein was 3.7 mm (range 1.7-10) in the proximal part of the thigh, 3.4 mm (range 1.6-7) in the distal part of the thigh, and 3.1 mm in the proximal part of the leg (range 1.6-5). The technical success was obtained in all cases (the bypass pulsed after the utilization of the valvulotome). The valvulotome was able to reach the proximal anastomosis in all cases. The mean number of utilizations was 2.6 (range 1-5). No vein perforation has been detected. In 6 cases (2.8%) a vein adventitial damage occurred. In one case with uncontrolled bleeding (0.5%) the substitution of the deleted vein segment was necessary. Conclusions Preliminary intraprocedural outcomes of LIMBSAVE registry showed that HYDRO LeMaitre® Valvulotome was safe and effective in disrupting the valves and obtaining the pulsatility of the saphenous vein. The rate of complications related to the utilization of the valvulotome was low. Further examinations are needed to evaluate the long-term outcomes of the bypass in terms of patency, reinterventions, and limb salvage.

Background Previous studies demonstrated that early recoil is frequently observed in patients undergoing balloon angioplasty. The aim of this study was to evaluate the impact of intra-arterial administration of iloprost (Endoprost®, Italfarmaco S.p.A., Milan, Italy) on early elastic recoil after balloon angioplasty of below-the-knee (BTK) vessels in patients with critical limb ischemia (CLI). Methods Between January 2015 and December 2015 32 patients with CLI underwent balloon angioplasty of at least one BTK vessel followed by intra-arterial administration of iloprost. Early elastic recoil was defined as residual lumen compromise >10%. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after BTK balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). Results Patients were predominantly female (18/32, 56.2%) with a mean age of 79.6 years (range 68-87). Most of the patients were diabetics (25/32, 78.1%). An occlusion was present in 24 cases (75%). Mean BTK lesion length was 144.1 mm (range 22-320). Mean MLD measurements were 0.1 mm (range 0-0.5; MLDbaseline), 2.5 mm (range 1.9-3; MLDpostdilation), and 1.9 mm (range 0.7-3; MLD15min). Early elastic recoil was recorded in 14 patients (43.8%). The mean percentage of elastic recoil after 15 minutes was 21.4%. Conclusions In our experience intra-arterial administration of iloprost reduces the risk of early elastic recoil after balloon angioplasty of BTK vessels in patients with CLI. Further analyses with larger population studies and randomized trials are needed to validate this therapeutic option.

The purpose of this study was to compare the outcomes obtained with Endurant stent graft in the early and midterm period in the treatment of patients with narrow aortic bifurcation vs patients with standard aortic bifurcation.Data were prospectively collected from 817 patients with abdominal aortic aneurysm treated between November 2007 and August 2014 with the Endurant stent graft at our center. There were 87 patients (10.6%) with a narrow aortic bifurcation (≤20 mm; NA group). The remaining 730 patients (89.4%) had a standard aortic bifurcation (SA group). Early and estimated 3-year outcomes were evaluated in these patients in terms of survival, freedom from any device-related reinterventions, and freedom from graft thrombosis. Univariate and multivariate analyses in the NA group were performed to detect possible predictors for poor outcomes.The two groups were similar in terms of demographics, preoperative diagnostic assessment, and intraoperative data. In 211 of 817 patients (25.8%), an adjunctive iliac limb stenting by balloon-expanding stents was performed. Overall, 41 patients in the NA group (47.1%) underwent iliac limb stenting, whereas an iliac stent was implanted in just 170 patients (23.3%) in the SA group (P .001). The mean follow-up was 16.3 months (range, 1-73 months). The estimated 3-year survival rate was similar between the two groups (87.2% in the NA group vs 80.8% in the SA group; P = .84). Furthermore, the estimated freedom from any device-related reinterventions was 92.9% in the NA group and 85.5% in the SA group (P = .1). Finally, the estimated 3-year freedom from graft thrombosis was 96.9% in the NA group and 94.8% in the SA group (P = .79). In the NA group at univariate and multivariate analyses, none of the examined preoperative or intraoperative factors were independent predictors of poor outcomes.Use of bifurcated Endurant stent graft, combined in almost half of the patients with narrow aortic bifurcation with additional aortoiliac stent placement, is feasible and safe. Early and midterm outcomes are similar to those obtained in non-narrow aortic bifurcation.

BACKGROUND Most of the studies on peripheral artery disease (PAD) focused on above-the-ankle artery disease, while less is known about foot artery disease. We hypothesize a scenario were two different diseases can be present in PAD patients, big artery disease (BAD) and small artery disease (SAD), overlapping at the foot level; the aim of this study is to evaluate their prevalence and their correlation with risk factors and critical limb ischemia (CLI) in a large cohort of patients with symptomatic PAD. METHODS We retrospectively reviewed 1915 limbs of 1613 patients (502 females, mean age 72.4±10.8 years) who underwent angiography between September 2009 and November 2013. Age, sex, diabetes, smoke history, high blood pressure, dialysis and BMI were considered as risk factors. Logistic regression was performed to test the association of arterial lesions patterns and CLI, and to evaluate the association between risk factors and lesion localization. RESULTS SAD was present in 414 patients (25.2%). Patients with disease of any of plantar, dorsalis pedis arteries and SAD faced higher risk of CLI (OR=13.25, 95% CI: 1.69-104.16). SAD was associated with diabetes and dialysis (both: OR=4.85; dialysis only: OR=3.60; diabetes only: OR=1.70; none: reference OR; P

Objective To retrospectively evaluate the impact of pedal arch quality on tissue loss and time to healing in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization. Materials and Methods Between January 2014 and June 2015, 137 consecutive diabetic patients with foot wounds underwent infrainguinal endovascular revascularization (femoro-popliteal or below-the-knee, arteries). Postprocedural angiography of the foot was used to divide the patients into the following three groups according to the pedal arch status: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Time to healing and estimated 1-year outcomes in terms of freedom from minor amputation, limb salvage, and survival were evaluated and compared among the three groups. Results Postprocedural angiography showed the presence of a CPA in 42 patients (30.7%), IPA in 60 patients (43.8%), and APA in 35 patients (25.5%). Healing within 3 months from the procedure was achieved in 21 patients with CPA (50%), 17 patients with IPA (28.3%), and in 7 patients with APA (20%) (p = 0.01). There was a significant difference in terms of 1-year freedom from minor amputation among the three groups (CPA 84.1% vs. IPA 82.4% vs. APA 48.9%, p = 0.001). Estimated 1-year limb salvage was significantly better in patients with CPA (CPA 100% vs. IPA 93.8% vs. APA 70.1%, p < 0.001). Estimated 1-year survival was significantly better in patients with CPA (CPA 90% vs. IPA 80.8% vs. APA 62.7%, p = 0.004). Conclusion Pedal arch status has a positive impact on time to healing, limb salvage, and survival in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization.

Background The aim of this study was to evaluate the safety and effectiveness of carbon-coated self-expandable stents in the revascularization of atherosclerotic iliac artery lesions. Methods Between January 2012 and June 2016 54 carbon-coated self-expandable stents (Easy HiFlype and Easy Flype; manufactured by CID S.p.A., a member of Alvimedica Group, Istanbul, Turkey) in 40 patients were implanted in our Center. Early and 2-year outcomes have been evaluated in terms of major morbidity, mortality, primary patency, primary assisted patency, secondary patency, absence of target lesion restenosis (TLR), healing of the lesions/relief of symptoms, and limb salvage. Results The patients were predominantly males (32/40, 80%) with a mean age of 71 years (range 46-94). One patient (2.5%) had a documented nickel allergy. Mean duration of follow-up was 13.9 months (range 1-48). At 30 days no patient died and 1 patient underwent surgical revision of percutaneous femoral access. The estimated 2-year primary patency, primary assisted patency, secondary patency, absence of TLR, and limb salvage were 92.8%, 93.1%, 95.7%, 79.5%, and 100%, respectively. At univariate analysis none of the pre- or intra-operative factors significantly affected the primary and primary assisted patency rates. Secondary patency was significantly affected by absence of post-stent balloon dilatation (P=0.003). Absence of TLR was significantly affected by age more than 80 years (P=0.01) and common iliac artery lesions (P=0.02). These significances were confirmed at Cox regression analysis. Conclusions Use of carbon-coated self-expandable stents in atherosclerotic iliac lesions was safe and effective. At 2 years, the patency rates and the absence of TLR were encouraging. Post-stent balloon dilatation should be recommended in all cases. Older patients and common iliac artery lesions were risk factors for restenosis in the mid-term period.

BACKGROUND Aim of this study was to evaluate the early and mid-term outcomes of drug-coated balloons (DCBs) in hemodialysis patients with recurrent stenosis of arteriovenous fistula and previously treated with plain balloon angioplasty (PBA). METHODS Between July 2013 and June 2016 38 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a DCB at our center. All patients were previously treated at the target lesion with a PBA. The intervals in months between the standard PBA and the procedure with DCB (time PBA-DCB) and between the procedure with DCB and the restenosis at the target lesion (time DCB-restenosis) were evaluated and compared with T-test. Estimated outcomes at 2 years in terms of patient survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis were assessed with Kaplan-Meier curves. RESULTS Intraprocedural technical success was obtained in 97.4% of the cases. During the follow-up (mean duration 14.3 months, range 2-33) 19 patients (50%) developed a restenotic lesion at the target lesion with an estimated 2-year freedom from target lesion restenosis of 32.8%. Mean time PBA-DCB was 6.4 months, and the mean time DCB-restenosis was 7.9 months with a statistically significant difference at T-test (P

BACKGROUND To evaluate early and mid-term outcomes of Freeway paclitaxel-releasing balloons (Eurocor GmbH, Bonn, Germany) in hemodialysis patients with recurrent stenosis of arteriovenous fistula. METHODS Between July 2013 and December 2016 27 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a Freeway balloon. About inclusion criteria, all patients were previously treated at the target lesion with a standard balloon angioplasty (BA). The intervals in months between standard BA and procedure with DCB (time BA-DCB) and between procedure with DCB and new restenosis (time DCB-restenosis) were evaluated and compared with T-test. 2-year estimated outcomes in terms of survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis (TLR) were assessed with Kaplan-Meier curves. RESULTS Technical success was obtained in 96.3% of the cases. During the follow-up (mean duration 13.6 months, range 1-33) 13 patients (48.1%) had a new restenosis. Mean time BA-DCB was 4.8 months, and the mean time DCB-restenosis was 7.6 months with a statistically significant difference at T-test (P

Purpose To compare the midterm results in patients treated with the Endurant stent-graft according to device-specific instructions for use (IFU) vs. those treated in an off-label (OL) situation. Methods Between November 2007 and March 2010, 177 patients (161 men; mean age 73.7 years) with abdominal aortic aneurysm were treated with the Endurant stent-graft at 2 European centers. Patients operated on according to the IFU (121, 68.4%) were compared with those who underwent endovascular aneurysm repair in OL circumstances (56, 31.6%) to evaluate estimated 5-year survival, freedom from any device-related reinterventions, freedom from graft thrombosis, and freedom from type I endoleak. Univariate and multivariate analyses were performed to identify independent predictors of poor outcomes in the OL group. Results Mean follow-up was 31.2 months (range 1-65). At 5 years, there were no differences in terms of survival (67.9% IFU vs. 54.1% OL, p=0.3), freedom from any device-related reintervention (91.2% IFU vs. 92.4% OL, p=0.8), or freedom from graft thrombosis (97.5% IFU vs. 92.7% OL, p=0.3). Estimated 5-year freedom from type I endoleak was significantly better in the IFU group than in OL (100% vs. 96.2%, respectively; p=0.03). In the OL group, multivariate analysis showed that female sex and coronary artery disease were independent predictors of poor survival. Conclusion Off-label use of the Endurant stent-graft was associated with a greater but acceptable risk of type I endoleak. Otherwise, there was no difference between the IFU and off-label groups as regards survival, graft thrombosis, or reintervention.

Background The aim of this study was to evaluate the impact of pedal arch status and direct-angiosome revascularization (DAR) on clinical outcomes in diabetic patients with foot wounds undergoing endovascular revascularization. Methods Between January 2014 and June 2015, 93 diabetic patients with foot wounds underwent endovascular revascularization of at least one below-the-knee vessel. Patients were divided into three groups according to the pedal arch status: complete pedal arch (CPA), incomplete pedal arch (IPA) and absent pedal arch (APA). Healing within 3 months and 1-year outcomes in terms of freedom from minor amputation, limb salvage, and survival were evaluated on the basis of DAR and pedal arch status. Results DAR did not affect healing within 3 months from the procedure (DAR, 13/55 cases, 23.6% vs. n-DAR, 9/38 cases, 23.7%; P=1), estimated 1-year freedom from minor amputation (DAR 74.4% vs. n-DAR 76.8%, P=0.80), limb salvage (DAR 88.2% vs. n-DAR 89.5%, P=0.44), and survival (DAR 83.3% vs. n-DAR 66.6%, P=0.15). Pedal arch had positive impact on wound healing within 3 months from the procedure (CPA 45.8% vs. IPA 12.5% vs. APA 20.7%, P=0.009), estimated 1-year limb salvage (CPA 100% vs. IPA 90.9% vs. APA 76.1%, P=0.02), and 1-year survival (CPA 100% vs. IPA 87.2% vs. APA 60.3%, P=0.02). Conclusions DAR is not a predictor of good outcomes in diabetic patients undergoing endovascular procedure. Pedal arch patency seems to be a key factor to obtain good outcomes in terms of wound healing, and limb salvage.

Purpose: To evaluate the safety and effectiveness of low-profile 4-F stents for the treatment of atherosclerotic iliac artery lesions. Methods: Between January 2009 and December 2015, 63 patients (mean age 69.3 years; 42 men) received low-profile stents (Astron Pulsar or Pulsar-18) at the discretion of the operator to treat iliac artery occlusive disease. The majority of patients (40, 63.5%) had critical limb ischemia; 36 of 82 lesions were total occlusions. All procedures were performed with 4-F equipment. Outcomes evaluated included mortality, patency (primary, assisted primary, and secondary), absence of target lesion revascularization (TLR), and limb salvage. Associations of patient and procedure variables with patency and TLR outcomes were sought with univariate and multivariate analysis. Results: Via a brachial (n=46/63) or femoral (n=17/63) access, 82 stents were successfully deployed to treat the 82 lesions, with

Objective To study the outcomes of three different types of native arteriovenous fistula (AVF), the distal (D: radial-cephalic), middle-arm (MA: radial-cephalic) and proximal (P: brachial-cephalic) AVF access creation for hemodialysis patients in a single center. Methods An 8-year retrospective review, from 2006 to 2014, was conducted at a single institution in which the surgical outcomes for three different types of native AVF creation were reviewed. Preoperative duplex vein mapping was obtained in all patients to choose the best vein and site for access. Results There were 317 patients identified with 41 D-AVFs, 120 MA-AVFs and 156 P-AVFs. Younger patients with a lower Charlson's Index were more frequent in the D-AVF group (p = 0.02). Mean operating room time was 15 minutes longer for the MA-AVF group than the two others (p = 0.018). Early failure (thrombosis at 30-day), one-year patency, one-year primary AVF functional patency for the D-AVF, MA-AVF, and P-AVF groups were 2.4% (n = 1), 8% (n = 1), 3.8% (n = 6), (p = 0.14); 97.6% (n = 39), 99% (n = 117), 89% (n = 129), (pConclusions D-AVF is still the gold-standard access for hemodialysis. If D-AVF is not possible, MA-AVF should be always investigated before committing to a P-AVF.

Purpose: To evaluate the safety and effectiveness of antegrade vs crossover femoral artery access in the endovascular treatment of isolated below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI). Methods: Between January 2014 and December 2015, 224 high-risk patients (mean age 75.8±9.8 years; 151 men) with CLI underwent infragenicular interventions on 292 crural vessels in 3 European vascular centers. All patients had isolated TransAtlantic Inter-Society Consensus (TASC) C (n=26) or D (n=198) BTK lesions. Primary endpoints were freedom from access-related complications and technical success comparing the antegrade vs crossover access groups. Results: Balloon angioplasty was the most used treatment modality (169 vessels, 75.4%). The technical success rate was 88.4% in the entire cohort and 88.0% in the antegrade group vs 90.4% in the crossover group (p>0.99). In all patients, the technical success rate was higher for stenotic lesions (100%) vs occlusions (85.5%, p=0.002) and in patients with TASC C BTK lesions (100%) vs TASC D (86.9%, p=0.033). The overall freedom from access-related complications was 97.8%: 99% in the antegrade group and 90.6% in the crossover group (p=0.022). Larger sheath size (5/6-F vs 4-F) was associated with a significantly higher risk for access-related complications (7.1% vs 1.1%, respectively; p=0.047). Conclusion: The present multicenter study showed high technical success and a low incidence of access-related complications in the treatment of isolated BTK lesions using either antegrade or crossover femoral access. The antegrade approach with the use of a 4-F system seems to have a significantly lower rate of access-related complications.

Purpose The aim of the study was to evaluate our experience in the hybrid simultaneous treatment (open and endovascular) of acute thrombosis of prosthetic grafts for hemodialysis. Methods Between January 2011 and June 2013, 23 patients with acute thrombosis of a prosthetic graft for hemodialysis were urgently treated with a hybrid simultaneous treatment in order to obtain a prompt restoration of the flow. A new puncture of the graft was scheduled after 24 hours. Results Intraoperative technical success was 100% with a completion angiography showing the restored patency of the graft. As adjunctive procedures, in 6 patients (26.1%) locoregional thrombolysis was necessary and in all cases further endovascular manoeuvres (angioplasty/stenting) were immediately performed to solve a significant stenosis of the venous anastomosis/first tract of the vein. At 24 hours when the first puncture was done, three grafts were occluded resulting in a primary patency of 87%. During the follow-up (mean duration 5.6 months) four reocclusions occurred. In-stent restenosis occurred in all patients undergone stenting. At 1 year the rates of primary patency, primary assisted patency and secondary patency were 58.7%, 78.3% and 87%, respectively. Conclusions In our series the combined simultaneous hybrid approach in urgency maximizes the use of different available techniques, which appeared to improve overall success rate to save a thrombosed graft for hemodialysis. The great difference showed between primary and primary assisted patency demonstrates the necessity of a close follow-up.

Background To describe a technique that connects an Anaconda stent graft (Vascutek, Terumo, Inchinnan, Scotland) to a target artery in a hybrid method. Case Report The patient was a 65-year-old man with a huge pluri-relapsing iliac and femoral pseudoaneurysm of a previous aortobifemoral bypass. An Anaconda stent graft was used to repair the lesion. After partial dissection of the femoral bifurcation, the Anaconda stent graft was partially introduced via a direct puncture in the anterior wall of the femoral artery over a guidewire. The end of the stent graft outside that artery was cut and adjusted to the exact length to be sutured in an end-to-end fashion to the profunda femoral artery. The proximal sutureless telescoping anastomosis avoided a challenging and risky iliac surgical access. The distal surgical anastomosis guaranteed a stable suture in such a dynamic region. Conclusions The hybrid technique using the Anaconda stent graft herein described is a safe alternative for challenging iliofemoral aneurysmatic disease treatment. Longer follow-up and more patients are needed before this technique could be recommended for use.

Background To demonstrate that a fast-track program consisting in early endovascular revascularization and local surgical treatment saves tissue in patients with diabetic foot infection (DFI). Methods Between January and December 2014, 48 patients with DFI underwent early endovascular revascularization and local surgical treatment at our Diabetic Foot Center. In all cases, endovascular revascularization and local surgical treatment were performed within 1 week from the diagnosis of infection and during the same hospital stay. One-year outcomes were evaluated in terms of survival, primary patency, primary-assisted patency, secondary patency, absence of target lesion restenosis (TLR), and limb salvage. Results The patients were predominantly males (34 of 48, 70.8%) with a mean age of 72.4 years (range, 51–91). The target vessel was a tibial artery in 34 cases (70.8%). Surgical treatment consisted of debridement without bone resection in 27 cases (56.2%), toe and/or ray amputation in 15 cases (31.2%), Lisfranc amputation in 2 cases (4.2%), transmetatarsal amputation in 2 cases (4.2%). In the remaining 2 cases, a leg amputation was necessary with an overall 30-day major amputation rate of 4.2%. During the follow-up (mean duration 6.9 months, range 1–12) healing of the lesions was obtained in 30 cases (62.5%). Estimated 12-month survival, primary patency, primary-assisted patency, secondary patency, absence of TLR, and limb salvage rates were 83.5%, 53.4%, 65%, 65%, 60.7%, and 86.6%, respectively. Conclusions A fast-track program consisting in early endovascular revascularization and local surgical treatment contributes to our experience in limiting amputation levels in patients with DFI. A multidisciplinary approach and adoption of diabetic foot triage are essential to achieve these outcomes.

Intravenous iloprost is an important option in the treatment of ischemic disease of the lower limbs; however, the administration of therapy is frequently compromised because of the need for long cycles of infusion in a hospital setting. The aim of the study is to evaluate the efficacy, safety, feasibility, and the economic impact of infusion therapy in the outpatient setting.Twenty-four consecutive patients were treated with iloprost at their homes where they were administered a slow rate of infusion for 24 hours a day, during 9.9 ± 2.3 days, with a portable syringe pump (Infonde®).The clinical condition of patients evaluated with the modified SVS/ISCVS scale significantly improved after treatment (+1.29 ± 1.04 points vs. baseline, p0.001). The drug was well tolerated; neither significant adverse events associated with medication nor problems related to venous access were recorded at home. Ninety-six percent of patients successfully completed the entire treatment cycle, and the evaluation questionnaire showed a high acceptance of the therapy. From the perspective of the hospital authority, lower direct medical costs were estimated for the domiciliary infusion process compared with the inpatient infusion setting.Treatment with iloprost in the outpatient setting is effective, safe, feasible, and more acceptable to patients than infusion at the hospital. In addition, it has a favorable economic and organizational impact on the medical ward.

Background Percutaneous angioplasty for atherosclerotic iliac disease is commonly performed via the femoral and/or brachial route. In the coronary field a transradial approach has been shown to reduce both major and minor access site bleedings, in experienced hands. However, this route has not yet been well studied for the majority of peripheral interventions, like those involving the iliac arteries. Methods We investigated the feasibility and safety of a transradial approach in a consecutive series of patients undergoing percutaneous iliac intervention at our center, comparing it to a similar series of patients treated with a transfemoral approach in the same period. Endpoints of the study were procedural success, duration of procedure and event free survival at one month. Results From our database we enrolled 42 patients undergone iliac percutaneous interventions (21 with a transradial and 21 with a transfemoral approach); the 2 populations had similar baseline characteristics. Procedural success was achieved in all of our patient population. Among the secondary study endpoints analyzed we observed similar duration of the procedure and one-month clinical follow up. Technical aspects of the transradial approach are discussed. Conclusions A transradial approach is feasible for the treatment of atherosclerotic iliac disease and does not increase procedural time in experienced hands. Further studies are needed to confirm if this approach is as safe as the transfemoral one.

To investigate the secondary procedures in patients with previous endovascular aortic repair by fenestrated or branched stent-grafts for aneurysms involving the renal and visceral vessels.Between January 2001 and May 2010, 107 consecutive high-risk patients (97 men; mean age 73 years, range 50-86) with aortic aneurysms involving the renal and visceral arteries were treated with endovascular techniques. A custom-made Zenith graft was used in all patients. All secondary graft-related procedures performed in the perioperative period and during follow-up were analyzed. Estimates of survival, freedom from migration/type I endoleak, and freedom from any device-related secondary procedures were assessed with Kaplan-Meier analyses.The 30-day mortality rate was 1.9%. During follow-up (mean 25 months, range 1-94), 34 secondary procedures were performed in 28 (26.2%) patients for 6 (17.6%) limb graft stenoses/thromboses (5.6% of 107 cases), 8 (23.5%) in-stent visceral vessel stenoses/occlusions (7.5% of 107 cases), 8 (23.5%) migrations/type I endoleaks with/without visceral stent fractures (7.5% of 107 cases), and 12 (35.3%) type III endoleaks (9.3% of 107 cases). The mean interval between the primary and secondary procedures was 12.9 months (range 1-68). In 26 (76.5%) of 34 cases, a secondary endovascular procedure was performed; in the remaining 8 (23.5%) cases, the complication was treated surgically. The secondary procedure was unsuccessful in 9 cases of visceral vessel compromise (failure to cannulation, stent fracture/migration, in-stent stenosis/occlusion). Estimated 3-year survival was 77%, while the 3-year rate for freedom from any device-related secondary procedure was 75.5%.The incidence of early and late complications requiring a secondary procedure after treatment with fenestrated or branched devices was not negligible. Endoleak type III represented the most common cause for reintervention during follow-up. Secondary procedures performed for visceral vessel compromise had high rates of treatment failure. Accurate preoperative planning, the advent of new materials/techniques, and strict follow-up could be the key factors to improving the results of fenestrated or branched stent-graft interventions and to reduce the rate of secondary procedures.

To present our initial experience with the use of chimney grafts in endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with challenging anatomy.Among 390 EVAR cases performed at our institution between November 2008 and February 2010, 15 patients (all men; mean age 81.8 years) underwent EVAR with synchronous placement of chimney grafts. The chimney technique involved placing covered stents parallel to the main aortic stent-graft to preserve or rescue flow to aortic branch vessels while extending the proximal fixation zone. All patients presented with pararenal aortic aneurysms with short necks (between 0 and 10 mm long) that required either suprarenal clamping to tailor a proximal anastomosis in open repair or suprarenal fixation to anchor an endoprosthesis. Chimney grafts were implanted into 10 left renal and 5 right renal arteries.The immediate technical success was 100%. One early type II endoleak due to retrograde flow from the inferior mesenteric artery was detected and is under surveillance. Mean follow-up was 6.8 months (range 1-13). One chimney graft occluded 45 days postoperatively; the patient underwent open thrombectomy of the left renal artery and iliorenal bypass. The creatinine value at discharge was 1.6 mg/dL, and resting renal scintigraphy showed 36% perfusion for the left kidney and 64% for the right kidney. During follow-up, no patient required hemodialysis; no aneurysm-related deaths were noted.This limited experience demonstrates that the use of abdominal chimney grafts is feasible and safe. Long-term results in larger patient cohorts are needed evaluate the utility of this alternative endovascular technique.

Aim of this study was to analyze our experience in the last 5 years of combined carotid and cardiac surgery.During a 5-year period (January 2002-December 2006), 111 patients underwent combined carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG) (group 1), while 1,446 patients underwent isolated CEA (group 2). Perioperative outcomes in the two groups were compared using chi(2) and Fisher's exact tests to analyze neurological deficits, cardiac events, and death at 30 days. Results during follow-up were analyzed using Kaplan-Meier survival curves, and both groups were compared using the log-rank test.Immediate postoperative neurological deficits occurred more frequently in group 1 patients (2.5 vs. 0.4%, p = 0.002), with a higher incidence of transient ischemic attacks in group 1; however, there was no difference in the incidence of stroke (1% group 1 vs. 0.6% group 2, p = n.s.). Mortality rate was increased in the combined surgery group (3.5 vs. 0.5%, p0.001). Combined stroke/myocardial infarction/death rate at 30 days was 6.3% in group 1 compared with 1.4% in group 2, p = 0.001. Perioperative stroke/myocardial infarction/death rate was much improved in the 55% (61/111) of patients undergoing CABG off-pump (3.3 vs. 10%, p = 0.001). Mean follow-up was 18.7 months (range, 1-60). Survival at 24 months was significantly higher in patients of group 2 compared with group 1 (99.4 vs. 91.3% respectively, p0.001). At 24 months, there was no significant difference between the two groups in the risk of developing ipsilateral or contralateral neurologic events (3.1% group 1 vs. 1.7% group 2).In our experience, combined CEA and cardiac surgery carries a higher risk of perioperative mortality than patients undergoing isolated CEA. Whenever possible, CEA combined with off-pump CABG seems to be the therapeutic strategy of choice.

Purpose To assess preliminary results of the Endurant stent-graft, which was developed to treat patients with abdominal aortic aneurysms (AAAs) and challenging aortoiliac anatomy. Materials and Methods From November 2007 to October 2008, 45 patients with AAAs were treated with the Endurant stent-graft in three European vascular centers. Thirty-eight of the 45 patients (84%) had a hostile anatomy of the proximal neck. Early (30 days), early midterm (6 months), and late midterm (1 year) results were analyzed in terms of technical success, clinical success, morbidity, and mortality. Results Intraoperative immediate technical and clinical success was achieved in all cases. At completion angiography, a type II endoleak was detected in seven of the 45 patients (16%) and an iliac limb stenosis was diagnosed and successfully treated in five (11%). At discharge, computed tomography demonstrated a type I endoleak in one of the 45 patients (2.2%). At 30 days, a graft limb thrombosis was diagnosed (2.2%) and successfully treated. The 30-day overall technical and clinical success rates were 97.8% (44/45 cases) and 95.6% (43/45 cases), respectively. During follow-up (mean duration, 8 months; range, 5–16 months), the type I endoleak was successfully treated with an aortic extension. Estimated freedom from type I or III endoleak and repeat intervention at 1 year was 97.8% (44/45 cases) and 93.3% (42/45 cases), respectively. Conclusions The initial experience shows that the Endurant stent-graft appears to be effective in endovascular repair of AAAs in patients with hostile aortoiliac anatomy. This graft permits a broader group of patients to be treated with endovascular aneurysm repair; however, further studies are needed to evaluate the long-term results.

The aim of the study was to evaluate the immediate and long-term results of femoropopliteal bypasses performed with a new bioactive heparin-treated expanded polytetrafluoroethylene (ePTFE) graft in a single-center experience. From March 2002 to April 2006, 51 patients underwent lower limb revascularization with a new bioactive ePTFE prosthetic graft with covalent end-point attachment of heparin to the graft surface. Data concerning preoperative assessment, intraoperative strategy, drug administration, and follow-up surveillance program were prospectively collected in a dedicated database; early results were analyzed in terms of graft patency, amputation rate, and deaths. Follow-up consisted of clinical and duplex scan examination at 1, 6, and 12 months and yearly thereafter. Midterm results in terms of primary and secondary patency, limb salvage, and survival were analyzed. Patients were predominantly male (35 patients, 71%), with a mean age of 71 years (SD = 9.05). Indications for surgical revascularization were critical limb ischemia in 36 patients and severe intermittent claudication in 15 patients. Interventions were performed for occlusion of a native vessel in 35 cases, whereas 12 patients had late thrombosis of a femoropopliteal bypass; the remaining four patients were operated on for an occluded popliteal artery aneurysm. Intervention consisted of below-knee bypass in 34 patients, while the other 17 had an above-knee revascularization. No perioperative deaths occurred. Cumulative 30-day graft patency was 88%, with an amputation rate of 4% (two cases). Results were similar in above- and below-knee revascularizatons. Mean duration of follow-up was 18 months (SD = 7). Cumulative estimated 24-month survival and primary patency rates were 97% and 80.2%, respectively; the corresponding limb salvage rate was 85.7%. Long-term results did not significantly differ in above- and below-knee revascularizatons. In our experience, the use of a modified ePTFE graft with covalent end-point linkage of heparin molecules on the graft surface provides good early and midterm results, with low rates of graft thrombosis and amputation.

To describe the hydrodynamic boost (HB) technique and report our preliminary results with this technique in the subintimal angioplasty of below-the-knee vessels. HB was used in 23 cases (14 males, mean age 73 ± 12 years) of critical limb ischemia, with long chronic total occlusion of tibial arteries extended to the ankle level. The operator performs a manual injection of diluted contrast dye through a 4 F catheter into the subintimal space, close to the patent true distal lumen, in order to achieve a tear in the intimal flap and a connection with the true lumen. In 19/23 (83 %) cases, the HB was effective in creating a connection between the subintimal space and the true distal lumen and it was possible to advance a wire and to conclude the procedure. In 4/23 (17 %) lesions, the HB failed and the procedure was successfully completed by retrograde approach. No major complications occurred. Mean length between catheter tip and re-entry point was 8 ± 5 mm. HB seems to be a feasible, safe and effective re-entry technique in distal below-the-knee vessels. This method represents an easy option for re-entry that extends the possibility of antegrade approach to obtain a successful revascularization. • In subintimal angioplasty of below-the-knee vessel re-entry can represent a challenge. • Inability to re-enter may determine the failure of the revascularization procedure. • HB is a novel re-entry technique feasible in distal below-the-knee vessels. • HB may increase the success rate of antegrade approach. • In case of failure, retrograde approach remains feasible.

The aim of this study was to evaluate the outcome of tapered balloon use in recanalization of long occlusions of below-the-knee (BTK) arteries in diabetic patients with critical limb ischemia (CLI).Forty-nine occluded BTK arteries in 35 diabetic patients with CLI were revascularized in our Diabetic Foot Center between January and September 2014 using tapered balloons. Twelve-month outcomes were evaluated in terms of healing of the lesions, survival, limb salvage, primary patency, primary assisted patency, and secondary patency.The patients were predominantly male (27/35, 77.1%) with a mean age of 70.9 years (±10.3 standard deviation [SD]). During the follow-up (mean duration 12.4 months ± 4 SD), healing of the lesions was obtained in 27 of the 35 cases (77.1%). Estimated 12-month survival and limb salvage were 85.7% and 91.1%, respectively. Estimated 12-month primary patency, primary assisted patency, and secondary patency were 78.3%, 79%, and 88.9%, respectively. Univariate analysis demonstrated that the presence of chronic renal failure affected survival (P = 0.005), and assignment to Rutherford class 6 affected limb salvage (P = 0.005), primary patency (P 0.001), and primary assisted patency (P 0.001). Furthermore, the presence of coronary artery disease affected primary patency (P = 0.001) and primary assisted patency (P = 0.05).Tapered balloons are a safe and effective means to recanalize long occlusions of BTK arteries in diabetic patients with CLI. Outcomes are poorer in patients with major tissue loss and with a history of coronary artery disease. Further experience with larger groups is needed to validate these outcomes.