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.

Omniflow® II biosynthetic graft offers acceptable early and mid-term outcomes in redo surgery in patients with critical limb-threatening ischemia with no available autologous vein material.

BACKGROUND: In this study, the early and mid-term outcomes of Omniflow® II (LeMaitre Vascular, Inc., Burlington, MA, USA) biosynthetic graft in redo surgery in patients with critical limb-threatening ischemia (CLTI) with no available autologous vein material were investigated with the aim to compare the outcomes obtained in "de novo" surgery versus redo surgery. METHODS: From January 2018 until December 2022, data of CLTI patients from 18 centers in Italy with no autologous vein material underwent infrainguinal bypass with Omniflow® II biosynthetic graft were collected. Thirty-day outcome measures including intraoperative technical success, major morbidity, mortality, and graft patency were assessed and compared. At two-year follow-up, estimated outcomes of survival, primary patency, primary assisted patency, secondary patency, freedom from reintervention, and amputation-free survival were analyzed using Kaplan-Meier curves and compared between groups using the log-rank test. RESULTS: In the study period 119 CLTI patients had an infrainguinal bypass with Omniflow® II biosynthetic graft. Seventy-seven patients (64.7%) underwent bypass as "de novo" treatment (group de novo), whilst in the remaining 42 patients (35.3%) the procedure was performed as redo surgery due to occlusion and/or infection of a previous bypass graft (group redo). Two groups were homogeneous in terms of demographic, clinical, and morphological data. In group redo explantation of an infected prosthetic graft was needed in 4 cases (9.5%). Intraoperative technical success was achieved in all cases in both groups. At 30 days, the overall patency rate did not differ between the two groups (69/77, 89.6%, group de novo vs. 35/42, 83.3%, group redo; P=0.24), whilst in group redo limb loss was higher with a statistically significant different 30-day major amputation rate between the two groups (11.9% group redo vs. 1.3% group de novo; P<0.001). Overall median duration of follow-up was eight months (IQR 6-13). At two-year follow-up there were no differences between the two groups in terms of survival (67.7% group de novo vs. 55.8% group redo, P=0.53), primary patency (34.4% group de novo vs. 26.8% group redo, P=0.25), primary assisted patency (43.6% group de novo vs. 28.8% group redo, P=0.12), freedom from reintervention (64.1% group de novo vs. 68.8% group redo, P=0.98), and amputation-free survival (67.8% group de novo vs. 60% group redo, P=0.12). Secondary patency was significantly higher in group de novo (53.7% vs. 32.3%, P=0.05). During the follow-up, the overall rates of graft infection and aneurysmal degeneration were 3.4%, and 0.8%, respectively. CONCLUSIONS: Nevertheless, poorer early outcomes in terms of limb salvage, Omniflow® II biosynthetic graft offers acceptable ywo-year outcomes in redo surgery in CLTI patients with no available autologous vein material. Further studies with larger population sizes are needed to validate these outcomes.

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

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

Twenty-Five Year Multicentre Experience of Explantation of Infected Abdominal Aortic Endografts.

We report a multicenter experience of open conversions (OC) for aortic endograft infections (AEI). We retrospectively analyzed all patients who underwent OC for AEI after endovascular aneurysm repair (EVAR), from 1997 to 2021 in 12 Italian centers. The endpoints were as follows: mortality (30-days, in-hospital), major postoperative complications. Follow-up data included: survival, aortic-related complications, infection persistence or reoccurrence. Fifty-eight patients (mean age: 73.8 ± 6.6 years) were included. Median time from EVAR to OC was 14 months (interquartile range 7-45). Thirty-five patients (60.3%) were symptomatic at presentation. Aortic reconstruction was anatomic in 32 patients (55.2%), extra-anatomic in 26 (44.8%). Thirty-day mortality was 31% (18/58). Six additional patients died after 30 days during the same hospitalization (in-hospital mortality: 41.4%). Most common post-operative complications included respiratory failure (38.6%) and renal insufficiency (35.1%). During 28.1 ± 4 months follow-up, 4 aneurysm-related deaths were recorded. Infection re-occurred in 29.4% of the patients. Estimated survival was 50% at 1 year, and 30% at 5 years, and was significantly lower for patients who underwent extra-anatomic reconstructions (37 vs 61% at 1 year, 16 vs 45% at 5 years; log-rank P = .021). OC for AEI is associated with high early mortality. The poor mid-term survival is influenced by aortic complications and infection re-occurrence.

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.

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.

A Pilot Study of Endovascular Repair for Ruptured Aortic Aneurysms With the Use of Carbon Dioxide Angiography Alone.

INTRODUCTION: Endovascular aortic repair (EVAR) of a ruptured abdominal aortic aneurysm (rAAA) has become a common approach. Hemorrhagic shock associated with the use of iodinated contrast medium (ICM) increases the risk of acute kidney injury (AKI). Theoretically, eliminating ICM from EVAR can decrease that risk. The aim of this pilot study was to analyze the feasibility and safety of emergent EVAR performed with the exclusive use of carbon dioxide (CO2) for a rAAA. METHODS: Since 2021, all consecutive rAAAs with hemorrhagic shock and suitable anatomical criteria for a standard endograft have been treated by EVAR with the exclusive use of CO2 using an automated CO2 injector (Angiodroid SpA, San Lazzaro di Savena, Italy). RESULTS: Eight percutaneous EVARs were performed under local anesthesia. Median age was 78 (interquartile range [IQR]=6) years, 5 patients were male. The technical success was 100%, the 30-day mortality was 25% (n=2), the median amount of administered CO2 was 400 (IQR=60) ml. The median change in serum creatinine level between admission, post-operative and 30-day values was an increase of 0.14 mg/dL and a decrease of 0.11 mg/dL, respectively. Post-operative AKI occurred in the two patients who died. All 6 surviving patients showed sac shrinkage >5 mm, and no reinterventions at a median follow-up of 10 months. CONCLUSIONS: Endovascular repair of rAAA with the exclusive use of CO2 as contrast agent is technically feasible and safe. Further studies are needed to determine whether CO2 increases survival rate and limits the progression of renal dysfunction after endovascular repair of rAAA. CLINICAL IMPACT: The recorded rate of post-operative AKI after endovascular repair of rAAA performed with the use of CO2 found in this pilot study was significantly lower than the one reported in the literature with the use of ICM. Our hyphotesis is that the use of CO2 during rEVAR might increase survival rate and limits the progression of renal dysfunction.

Duodenocaval fistula after bevacizumab therapy: case presentation and complete overview of the literature.

Duodenocaval fistula (DCF) is a very rare condition and is associated with a 41.1% of mortality rate. Although ingested foreign bodies, peptic ulcer disease and radiotherapy are often the etiologies described, only three patients have been described who developed DCF after bevacizumab therapy. We report a case of a 58-year-old woman with a history of ovarian neoplasia and subsequent surgical treatments, adjuvant radiotherapy and chemotherapy with bevacizumab with the appearance of a spontaneous DCF after 6 months at the end of this therapy. The multidisciplinary approach between oncologist and vascular surgeon together with the support of the anesthesiology team allowed the DFC to be treated surgically through the suture of the inferior vena cava and the duodenal breach. The patient was discharged on the 14th postoperative day and we found no postoperative morbidities both immediately and after 30 and 60 days.

Reintervention rate after infrarenal aortic aneurysm repair is lower for open than endovascular repair with aneurysm sac shrinkage: a fifteen-year study.

BACKGROUND: The aim of this study was to report long-term results of infrarenal abdominal aortic aneurysm (AAA) in a single tertiary Hospital. METHODS: One thousand seven hundred seventy-seven consecutive AAA repairs (2003-2018) were included. Primary outcomes were all-cause mortality, AAA-related mortality, reinterventions rate. Open repair (OSR) was offered in case the patient had a functional capacity ≥4 metabolic equivalents (MET), and a predicted >10 year life expectancy. Endovascular repair (EVAR) was offered in case of hostile abdomen, presence of anatomic feasibility for standard endovascular graft, and <4 MET. Sac shrinkage was defined as a reduction of both anterior-posterior and latero-lateral diameter of the sac of at least 5 mm at the last follow-up vs. the first post- operative follow-up imaging. RESULTS: Eight hundred twenty-eight (47%) OSRs and 949 (53%) EVARs were performed 90.6% (N.=1610) were male, mean age was 73.8 years. Mean follow-up was 79 (SD: 51) months. 30-day mortality was 0.7% (N.=6) and 0.6% (N.=6) for OSR and EVAR respectively (P=1). Long-term survival was better for OSR as expected by the selection criteria used (P<0.001), while AAA-related death was similar in the OSR vs. EVAR group (P=0.37); 664 (70%) sac shrinkages occurred at the last follow-up in the EVAR group. Freedom from reintervention was 97% and 96% at 1 year, 96.5% and 88.4% at 5 years, 95.8% vs. 81.7% at 10 years, and 94.6% vs.72.3% at 15 years for OSR and EVAR, respectively (P<0.001). The reintervention rate was significantly lower in the sac shrinkage vs. no-sac shrinkage subgroup and but higher than the OSR (P≤0.001). Any statistical difference was found for the survival outcome in case of sac shrinkage (P=0.1). CONCLUSIONS: Open repair of an infrarenal AAA had a lower reintervention rate than EVAR even in case of a shrinked sac at a long-term follow-up. Further studies with greater sample size are needed.

Mills valvulotome reduces distal vein injuries and improves follow-up freedom from restenosis in patients undergoing infrainguinal in-situ saphenous vein bypass.

BACKGROUND: In this study, the early and mid-term outcomes of the use of the Mills valvulotome in patients with chronic limb-threatening ischemia (CLTI) undergoing infrainguinal in-situ saphenous vein bypass were investigated. METHODS: From January 2018 until December 2019, 153 consecutive CLTI patients from 7 centers have been treated with infrainguinal in-situ saphenous vein bypass. In all patients the devalvulation of the great saphenous vein (GSV) was obtained with the use of the HYDRO LeMaitre® valvulotome (LeMaitre Vascular, Burlington, MA, USA). Eighty-six patients (56.2%) received the additional treatment of the LeMills valvulotome (LeMaitre Vascular) to disrupt the distal valves of the GSV (Group MV), whilst in the remaining 67 patients (43.8%) this adjunctive device was not used (Group no-MV). Initial outcome measures including intraoperative vein injuries were assessed and compared. At 2-year follow-up, estimated outcomes of primary patency, primary assisted patency, secondary patency, freedom from distal vein restenosis, and limb salvage were analyzed using Kaplan-Meier curves and compared between groups using the log-rank test. RESULTS: Intraoperatively, the overall rate of vein injuries related to the devalvulation was 5.2% (8 cases) with four cases in both groups (4/86, 4.6%, Group MV vs. 4/67, 6%, Group no-MV; P=0.49). Overall, 4 lesions occurred in the distal portion of the GSV and were all reported in Group no-MV (0/86, 0%, Group MV vs. 4/67, 6%, Group no-MV; P=0.03). Median duration of follow-up was 12 months (IQR: 6-24). At 2-year follow-up there were no differences between the two groups in terms of primary patency (69.9% Group MV vs. 79.8% Group no-MV, P=0.08), primary assisted patency (85.4% Group MV vs. 90.5% Group no-MV, P=0.37), secondary patency (94.2% Group MV vs. 92.1% Group no-MV, P=0.61), and limb salvage (97.4% Group MV vs. 98.2% Group no-MV, P=0.74). Patients in Group MV had a higher rate of freedom from distal vein restenosis (92.2% Group MV vs. 76% Group no-MV, P=0.03). CONCLUSIONS: Adjunctive use of the Mills valvulotome (LeMaitre Vascular) reduces intraoperative distal vein injuries and improves the 2-year freedom from distal vein restenosis in patients undergoing infrainguinal in-situ saphenous vein bypass.

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.

Association of 2D Perfusion Angiography and Wound Healing Rate in Combined Femoro-popliteal and Below-the-Knee Lesions in Ischemic Patients Undergoing Isolated Femoro-popliteal Endovascular Revascularization.

The aim of this study was to demonstrate the association between 2-dimensional (2D) perfusion angiography and wound healing rate in patients with combined femoro-popliteal and below-the-knee lesions in critical limb-threatening ischemia (CLTI) and foot wounds undergoing isolated femoro-popliteal endovascular revascularization. Between January and June 2019, 24 patients with multilevel CLTI and foot wounds underwent isolated femoro-popliteal endovascular revascularization. In all of them, an assessment of foot perfusion by 2D perfusion angiography was performed. To evaluate the foot perfusion, a region of interest was identified, and time-density curves were calculated. Changes of the overall time-density curves were evaluated together with transcutaneous oximetry (TcPO2) using bivariate correlation (Pearson correlation coefficient) and associated with 6-month wound healing. The mean increase of time-density curves was 212.2% (range from +9.8% to +1984.9%) and the mean increase of TcPO2 was 116.4% (range from -4.7% to 485.7%). No significant association between time-density curves and TcPO2 values (Pearson correlation coefficient: -0.24) was observed (P = .3). At 6 months, wound healing occurred in 15 of 24 (62.5%) patients. In conclusion, this preliminary experience confirmed that 2D perfusion angiography associates with wound healing rate in CLTI patients with ischemic foot wounds and combined femoro-popliteal and below-the-knee lesions who are undergoing isolated femoro-popliteal endovascular revascularization. No association between time-density curves and TcPO2 values was observed.

Secondary endovascular procedures improve overall patency and limb salvage in patients undergoing in situ saphenous vein infragenicular bypass.

BACKGROUND: Secondary interventions strongly improves patency and limb salvage rates in patients undergoing infrainguinal vein bypass. The aim of this study was to evaluate the influence of secondary endovascular procedures performed during the follow-up on patency and limb salvage in patients with critical limb-threatening ischemia (CLTI) undergoing in situ saphenous vein infragenicular bypass. METHODS: From January 2018 to December 2019 541 patients in 43 centers have been enrolled into the LIMBSAVE registry (treatment of critical Limb IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique). In all patients a strict surveillance program with Duplex scan was established (1, 3, 6, 9, 12, 18, 24 months). During the follow-up indications for endovascular procedures were anastomotic stenoses, improvement of run-in (iliac stenosis) or run-off (tibial vessels' stenoses or occlusions). Two-year estimated outcomes in terms of overall patency, and limb salvage were analyzed by life-table analysis (Kaplan-Meier test). Outcomes obtained in patients undergoing endovascular procedure (Group-endo) were compared by means of Gehan-Breslow-Wilcoxon Test with those obtained in patients with no secondary endovascular procedure during the follow-up (Group-no endo). RESULTS: Two groups were homogeneous in terms of demographics and intraprocedural details. Overall mean duration of follow-up was 12.1 months (range 1-24). During the follow-up period (>30 days) 55 endovascular procedures were performed in 49 patients (9.1%) (Group-endo). Most of endovascular procedures (37/55, 67.3%) was performed to treat stenoses at proximal or distal anastomosis. Secondary endovascular procedures (40/55, 72.7%) were predominantly performed within 6 months from the index procedure. Estimated 2-year overall patency (97.9% vs. 85.2%, P=0.05), and limb salvage (100% vs. 93.9%, P=0.05) rates were significantly better in Group-endo. CONCLUSIONS: Secondary endovascular procedures in patients with CLTI undergoing in situ saphenous infragenicular bypass significantly improve the rates of overall patency and limb salvage in the mid-term period.

Occult endoleaks revealed during open conversions after endovascular aortic aneurysm repair in a multicenter experience.

BACKGROUND: An occult endoleak (OE) may be the underlying cause of aneurysm sac expansion after endovascular aneurysm repair (EVAR). The aim of this study is to describe intraoperative findings of OE during surgical endograft explantations. METHODS: This is a retrospective, multicenter analysis of all open conversions (OC) after EVAR from 1997 to 2020 in 12 vascular centers. We excluded patients with a preoperative diagnosis of endograft infection, endograft thrombosis, and thoracic-EVAR. An OE was defined as an endoleak revealed during OC not shown on preoperative imaging, which was likely the real cause for sac enlargement. We reported the number of OE, and we described the type of OE in relation to the initial alleged or associated endoleak. A separate analysis of patients with an initial diagnosis of endotension was also performed. RESULTS: An OE was found in 32/255 patients (12.5%). In the 78.1% of the cases (25/32) a type II endoleak hid a type I or III endoleak. Endotension was the initial diagnosis of 26/255 patients (10.2%). In 4/26 cases (15.4%), a type I or II OE was revealed. In 5/26 cases (19.2%) an endograft infection was found intraoperatively. In 2/26 cases we found an angiosarcoma. Fifteen cases of endotension (57.7%) remained unexplained. CONCLUSIONS: OE represent a not negligible cause of EVAR failure. A type II endoleak associated with sac enlargement may actually conceal a higher-flow endoleak. In most of the cases, the initial diagnosis of endotension remains unexplained. However, endotension sometimes conceals severe underlying pathologies such as infections.

The new educational project Televascular Games during the Coronavirus Disease 2019 pandemic.

Objective: To report methodology and first-year results of a new educational project called Televascular Games," which took place during coronavirus disease 2019 pandemic. Methods: Complex aneurysmal aortic disease was discussed during a 2-hour competition webinar, according to three modalities. (1) Planning case competition (PCC): Two to four preoperative computed tomography angiography (CTA) scans of an already performed selected case were submitted for the competition. CTA scans were uploaded anonymously, without any reference to the center or the surgeon who performed the case. The competitor had to prepare a presentation of how he or she would have diagnosed, sized, planned, treated, and followed up the case, of the medical therapy and of the bail-out maneuvers. (2) Challenging case competition (CCC): The competitor elaborates a presentation of an already treated case concerning an aortic topic and discusses sizing, planning, treatment, possible bail-out maneuvers and obtained results. For the CCC and PCC, the competitors with the best score were preselected to present and discuss their plan during the webinars. (3) Quiz competition: Two to six CTA scans of already performed selected aortic cases were submitted for the competition. A quiz with multiple choice questions was answered by the competitors. The top four competitors were selected for the webinars and then they discussed the cases during the webinar. Finally, at the end of the case discussion, the effective case resolution and follow-up were shown. A final winner was voted via televoting, based on six preestablished criteria. The project was endorsed by different national and international societies. Results: Between October 2020 and December 2021, there were 12 Italian and 1 international webinars with 1695 participants overall (mean, 130; range, 86-177). Competitors were 54 years of age (mean, 27 years; range, 22-38 years). Two editions were CCCs, two quiz competitions, and nine PCCs. The reliability of the interobserver sizing of competitors was κ = 0.43 and κ = 0.62 for the proximal and distal sealing measurements respectively and very good (κ = 0.88-0.95) in the evaluation of orientation of the vessels, presence of angulations, calcifications, and thrombus. The sizing discrepancy resulted in a significant variability of the planning (κ = 0.45). The project ranked 9.6 on a 10-point rating scale by all the participants and competitors. Conclusions: The formula of gaming and collegial discussion of aortic cases herein reported has proved valid and attractive during coronavirus disease 2019 pandemic period. The variability of the results on sizing and planning suggested to confer with a second opinion, especially for less experienced surgeons.

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.

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.

Editor's Choice - Peri-Operative Outcomes of Carotid Endarterectomy are Not Improved on Dual Antiplatelet Therapy vs. Aspirin Monotherapy: A Systematic Review and Meta-Analysis.

OBJECTIVE: A systematic review and meta-analysis of the peri-operative outcomes of carotid endarterectomy (CEA) on dual antiplatelet therapy (DAPT) vs. aspirin monotherapy was carried out, to determine optimal peri-operative management with these antiplatelet agents. DATA SOURCES: The Web of Science, Pubmed, and Embase databases were searched from inception to July 2021. The corresponding authors of excluded articles were contacted to obtain additional data for possible inclusion. REVIEW METHODS: The main outcomes included ischaemic complications (stroke, transient ischaemic attack [TIA], and transcranial Doppler [TCD] measured micro-emboli), haemorrhagic complications (haemorrhagic stroke, neck haematoma, and re-operation for bleeding), and composite outcomes. Pooled estimates using odds ratios (ORs) were combined using a random or fixed effects model based on the results of the chi square test and calculation of I2. RESULTS: In total, 47 411 patients were included in 11 studies, with 14 345 (30.2%) receiving DAPT and 33 066 (69.7%) receiving aspirin only. There was no significant difference in the rates of peri-operative stroke (OR 0.87, 95% confidence interval [CI] 0.72 - 1.05) and TIA (OR 0.78, 95% CI 0.52 - 1.17) despite a significant reduction in TCD measured micro-emboli (OR 0.19, 95% CI 0.10 - 0.35) in the DAPT compared with the aspirin monotherapy group. Subgroup analysis did not reveal any significant difference in ischaemic stroke risk between patients with asymptomatic and symptomatic carotid artery stenosis. DAPT was associated with an increased risk of neck haematoma (OR 2.79, 95% CI 1.87 - 4.18) and re-operation for bleeding (OR 1.98, 95% CI 1.77 - 2.23) vs. aspirin. Haemorrhagic stroke was an under reported outcome in the literature. CONCLUSION: This meta-analysis found that CEA while on DAPT increased the risk of haemorrhagic complications, with similar rates of ischaemic complications, vs. aspirin monotherapy. This suggests that the risks of performing CEA on DAPT outweigh the benefits, even in patients with symptomatic carotid stenosis. The overall quality of studies was low, and improved reporting of CEA outcomes in the literature is necessary.

Multicenter comparison between open conversions and semi-conversions for late endoleaks after endovascular aneurysm repair.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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.