Comparative outcomes of aortobifemoral bypass with or without previous endovascular kissing stenting of the aortoiliac bifurcation.

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Long-term Outcome Comparison of 2 Techniques for Embolization of Splenic Artery Aneurysms.

PURPOSE: The aim of the study is to analyze our single-center experience in endovascular treatment of splenic artery aneurysms (SAAs) with transcatheter coil embolization, comparing long-term outcomes of packing and sandwich techniques. MATERIALS AND METHODS: Between January 2010 and December 2021, 28 patients with certain diagnosis of non-ruptured asymptomatic SAA were treated with 2 different embolization techniques (packing, n=10, and sandwich, n=18). Early outcomes assessed were technical success, overall mortality, mean hospital stay, post-embolization syndrome rate, and freedom from splenectomy rate. Estimated 5-year outcomes in terms of freedom from sac reperfusion, and freedom from reintervention were evaluated and compared between the 2 different embolization techniques. RESULTS: The mean SAA diameter was 2.8±0.8 cm. Overall technical success rate was 100%. Intraoperative and 30-day mortality rates were 0 in both groups. One patient in the sandwich group required a postoperative splenectomy. The mean follow-up period was 58.3±44.5 months. Estimated overall 5-year survival was 86.7%. Five-year freedom from sac reperfusion was 100% in the sandwich group, and 85.7% in the packing group, with no difference between the 2 groups (p=0.131), whereas freedom from reintervention was 100% in the sandwich group, and 75% in the packing group with a statistically significant difference (p=0.049; log-rank=3.750). CONCLUSIONS: Embolization of SAAs seemed to be safe and effective with 100% of technical success rate and good perioperative results. Both sandwich and packing techniques yielded promising results also in the long-term period. CLINICAL IMPACT: Transcatheter coil embolization of splenic artery aneurysms seems to be a safe and effective procedure with a 100% technical success and satisfactory perioperative outcomes. Sandwich and packing techniques offer good results in the long-term period. Freedom from reintervention seems to be optimal and comparable between the 2 techniques.

Safety and effectiveness of the phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Protein-based tissue adhesive reduces time to haemostasis in peripheral vascular surgery.

OBJECTIVES: The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue®) in reducing time to haemostasis in patients undergoing peripheral vascular surgery. METHODS: From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions. Patients have been allocated in each centre into control with no use of Bioglue® (Group no-Bio, 50 patients) or use of Bioglue® (Group Bio, 50 patients) by a block randomization method 10:10 until the required sample size was reached. Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples tT -test and Gehan-Breslow-Wilcoxon test. RESULTS: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in Group Bio (52% vs. 24%, p = 0.004). Femoral endarterectomy was most common in Group Bio (44% vs. 24%, p = 0.03), whilst the percentage of lower limb vein bypasses was higher in Group no-Bio (50% vs. 36%, p = 0.03). Bovine pericardium was the preferred material in Group Bio (20 cases, 40%), whilst autologous vein is mostly used in Group no-Bio (26 cases, 52%) (p = 0.01). Time to haemostasis was faster in Group Bio (4.4 vs. 9.6 minutes, p < 0.001). The need for adjunctive stitches was higher in Group no-Bio (8 cases, 16%, Group Bio vs. 25 cases, 50%, Group no-Bio; p < 0.001). The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%, Group Bio vs. 7 cases, 14%, Group no-Bio; p = 0.39). CONCLUSIONS: The protein-based tissue adhesive Bioglue® reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery. However, it did not affect the overall rate of perioperative bleedings. Further studies with larger sample sizes are needed to validate these outcomes.

Different endovascular modalities of treatment for isolated atherosclerotic popliteal artery lesions (EMO-POP) registry.

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia.

OBJECTIVE: The aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). METHODS: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. RESULTS: At 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). CONCLUSIONS: Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry.

PURPOSE: Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. MATERIALS AND METHODS: Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan-Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. RESULTS: The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12-43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%-93.1%), 95.8% (95% CI: 92.7%-97.1%), 93.6% (95% CI: 90.2%-96.8%), 87% (95% CI: 83.3%-91.6%), and 97.7% (95% CI: 95.1%-98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%-95.5%] vs ZISL 94.3% [95% CI: 90.1%-95.9%], p=0.342; log-rank 0.903). CONCLUSION: Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. CLINICAL IMPACT: The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.

Editor's Choice - RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study).

OBJECTIVE: The aim was to assess the proportion of patients undergoing endovascular therapy for femoropopliteal arterial disease (FP) who would be eligible to take part in seven major randomised controlled trials (RCTs) that investigated the efficacy of some of the currently available paclitaxel based (PTX) devices used in this clinical context. Various RCTs have shown a potential clinical benefit from the use of paclitaxel in FP endovascular therapy. Nonetheless, patients enrolled were highly selected and the generalisability of these findings in pragmatic cohorts is unclear. METHODS: Between 1 January and 31 December 2021, all consecutive patients who underwent endovascular procedures for symptomatic FP disease in 16 European centres were retrospectively screened and included in this analysis. The primary outcome measure was individual patient eligibility for inclusion into at least one of the seven RCTs. The reasons for exclusion (clinical and or radiological) as well as in hospital death and morbidity were also reported. RESULTS: A total of 1 567 consecutive patients (959 male, 61%), corresponding to 1 567 lower limbs, were included. Most patients (1 009 patients, 64.39%) were treated for chronic limb threatening ischaemia (CLTI). A total 1 280 patients (81.68%) were not eligible for inclusion in any of the evaluated RCTs. Of them, 741 (47.28%) were excluded for clinical and 1 125 (71.79%) for radiological reasons. CONCLUSION: The analysed RCTs assessing the efficacy or effectiveness of PTX based endovascular therapies do not seem representative of the patient population with FP disease receiving endovascular therapy in routine clinical practice.

A comparative analysis of anatomical variations of popliteal artery and its branches in concomitant aneurysmal disease.

OBJECTIVES: Open or endovascular treatment of popliteal artery aneurysms (PAAs) is still debated. Data about the popliteal artery anatomy and its branches are essential to plan a surgical approach. The aim of this study was to report the anatomical variations of the popliteal artery and its branches in a population with aneurysmal disease and compare them with a standard population with non-aneurysmal disease. METHODS: A retrospective review of consecutive patients who underwent surgical PAA repair in our center between January 2011 and December 2020 was performed. One-hundred-forty-six limbs in 128 patients underwent PAA treatment (Group 1). Computed tomography angiography images using a 128-section configuration were reviewed for anatomical variations of the popliteal artery and its branches. A control population of 178 limbs in 89 patients with non-aneurysmal disease was used to compare the outcomes (Group 2). All limbs were classified according to Kim's classification. The two groups were analyzed and compared by means of nonparametric Pearson chi-square test. RESULTS: Both groups were homogeneous in terms of demographics, risk factors, and clinical presentation. In Group 1, the limbs with PAA were classified as type IA, 133 (91.1%); type IB, 2 (1.4%); type IC, 0; type IIA1, 1 (0.7%); type IIA2, 1 (0.7%); type IIB, 4 (2.7%); type IIC, 0; type IIIA, 3 (2.1%); type IIIB, 0; and type IIIC, 2 (1.4%). In Group 2 the limbs with non-aneurysmal disease were classified as type IA, 163 (91.6%); type IB, 5 (2.8%); type IC, 1 (0.6%); type IIA1, 1 (0.6%); type IIA2, 3 (1.7%); type IIB, 2 (1.1%); type IIC, 0; type IIIA, 3 (1.7%); type IIIB, 0; and type IIIC, 0. No difference in terms of anatomy of the popliteal artery and its branches was found between the two groups (P = NS). CONCLUSIONS: Knowledge of anatomical variations of the popliteal artery and its branches is mandatory in case of the surgical approach. Anatomy in PAA patients is not different. Studies with larger population size are needed to validate these outcomes.

Comparison of long occlusive femoropopliteal de novo versus previous endovascularly treated lesions managed with in situ saphenous bypass.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Benefits and Role of Carbon Dioxide Angiography in Case of Misalignment Between Fenestration and Target Vessel During Fenestrated Endovascular Aneurysm Repair.

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.

Factors Affecting Patency of In Situ Saphenous Vein Bypass: Two Year Results from LIMBSAVE (Treatment of critical Limb Ischaemia with infragenicular Bypass adopting in situ SAphenous VEin technique) Registry.

OBJECTIVE: The aim was to demonstrate contemporary outcomes of in situ saphenous vein bypass using a valvulotome. METHODS: 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. RESULTS: 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 diameter < 3 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. CONCLUSION: Vein diameter < 3 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.

Timing to Carotid Endarterectomy Affects Early and Long Term Outcomes of Symptomatic Carotid Stenosis.

BACKGROUND: 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. METHODS: Consecutive CEAs with selective shunting for symptomatic carotid stenosis ≥50% performed between 2009 and 2020. Patients had acute neurological impairment on presentation, defined as <5 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. RESULTS: 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 CEA <2 days increased significantly the risk of late stroke (OR = 9.7). CONCLUSIONS: The ideal timing for performing CEA is between 3 and 7 days from the index event if NIHSS <5 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.

Influence of pedal arch quality on 5-year survival and limb salvage in patients with diabetic foot ulcers undergoing peripheral angiography.

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.

2D perfusion angiography as quantitative method to evaluate iloprost effect on foot circulation.

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.

Reallocation of Carotid Surgery Activity with the Support of Telemedicine in a COVID-Free Clinic during COVID-19 Pandemic.

The aim of this study is to report the reallocation of carotid surgery activity with the support of telemedicine in a COVID-free clinic during COVID-19 pandemic. Patients with symptomatic carotid stenosis or asymptomatic vulnerable plaques were reallocated to a COVID-free private clinic which began to cooperate with the National Health System during the emergency. Quick training of staff nurses was performed. Surgeons moved to the COVID-19 free clinic. Remote cerebral monitoring was performed with the support of telemedicine. Twenty-four patients underwent standard carotid endarterectomy with eversion technique. Five patients (20.8%) had recently symptomatic stenosis, and the remaining 19 patients (79.2%) had a risky asymptomatic carotid stenosis. No technical issue with remote cerebral monitoring was detected. In the early postoperative period, no neurological/systemic complication was observed. Three patients under dual antiplatelet therapy (12.5%) had neck hematoma. All patients were discharged the day after surgery. In our preliminary experience, reallocation in a COVID-free clinic allowed us to maintain a functioning carotid surgery activity during COVID-19 pandemic. A multidisciplinary approach and support of telemedicine were crucial. Training of unskilled nurse staff was necessary.

Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry.

OBJECTIVES: Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). METHODS: From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan-Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. RESULTS: Patients were predominantly male (n = 332, 77.6%) with a mean age of 73.3 years (range 39-95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1-5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1-60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. CONCLUSIONS: Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.

Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system - 12-month results from the LOCOMOTIVE EXTENDED study.

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.

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　- The SCELTA Trial.

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.

Midterm Results of Low-Profile Stents to Treat Atherosclerotic Iliac Artery Disease.

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 <30% residual stenosis. The overall access-related complication rate was 1.6% (brachial artery occlusion). Mean duration of follow-up was 24.1±22.3 months (range 1-72), during which 3 patients died and 1 major amputation occurred at 10 months. The 4-year Kaplan-Meier estimate of primary patency was 76.9% (95% CI 70.2% to 83.6%); the assisted primary and secondary patency estimates were 79.3% (95% CI 73% to 85.6%) and 91% (95% CI 84.5% to 97.5%). The 4-year freedom from TLR estimate was 73.8% (95% CI 67.4% to 80.2%). On multivariate analysis, the only associations confirmed involved Rutherford category 5/6 with primary patency (hazard ratio [HR] 5.7, 95% CI 4.4 to 7, p=0.02) and assisted primary patency (HR 6.1, 95% CI 4.9 to 7.3, p=0.01). CONCLUSION: Use of a low-profile 4-F stent in atherosclerotic iliac lesions was safe and effective. At 4 years, the overall patency and the absence of TLR were good. Midterm outcomes were poor in patients with Rutherford category 5/6 ischemia. Finally, the use of stents with a ≥6-mm diameter and postdeployment balloon dilation are recommended in all cases.