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.

Kissing intravascular lithotripsy in iliac in-stent restenosis related to underexpanded stents.

Intravascular lithotripsy (IVL) has been used for the treatment of native highly calcified arterial lesions. No data are available in the literature about its use in the treatment of noncoronary in-stent restenosis (ISR). We report the case of kissing IVL in highly calcified iliac ISR related to underexpansion of stents previously deployed in the common iliac arteries. The procedures were performed with a combined percutaneous right femoral and surgical left axillary access. This case demonstrates the safety and effectiveness of IVL even for the treatment of iliac ISR when other "standard" techniques cannot be used to obtain a satisfactory outcome. This technique needs to be evaluated further with multicenter experiences and adequate population sizes.

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.

Early and midterm results of covered balloon-expandable stents (VBX-Gore) for endovascular treatment of chronic aorto-iliac occlusion.

BACKGROUND: Endovascular treatment is nowadays accepted as first-line treatment for most patients with aorto-iliac obstructive disease (AIOD), including those with Trans-Atlantic Inter-Society Consensus II (TASC-II) lesion types C and D. Aim of the study was to evaluate the role of Viabahn VBX (W. L. Gore and Associates, Flagstaff, AZ, USA), in patients with chronic occlusive aorto-iliac disease (ChO). METHODS: A retrospective review of patients undergone elective endovascular repair with VBX (W. L. Gore and Associates) for ChO at five referral vascular institutions in Italy from 2018 to 2022 was conducted. Primary endpoints were technical success and the incidence of any early and midterm procedure-related reintervention. Secondary endpoints were clinical success, primary and secondary patency. RESULTS: Among 89 included patients, technical success was obtained in 87 patients (97.8%). Postoperative complication requiring early surgical reintervention was necessary in 5 (6%), all but one for arterial bleeding. Clinical improvement of at least 3 classes was observed in 49 (55%). After a mean follow-up of 24.1 months ±14.1, primary patency and freedom from any procedure-related reintervention at 12, 24 and 36 months was 83.0% and 94.8%, 80.0% and 91.5%, 77.9% and 89.3%, respectively. Secondary patency was 100%. TASC-II D lesion (OR=3.67, 95% CI: 1.1289-11.9823, P=0.03) and Grade III iliac calcification (OR=3.41, 95% CI: 1.0944-10.6428, P=0.03) were identified as independent predictors for procedure-related reintervention. CONCLUSIONS: Use of VBX (W. L. Gore and Associates) in ChO was safe and effective with low rate of stenosis/occlusion in the early and mid-term follow-up. TASC-II D and Grade III calcifications resulted as independent predictors for procedure-related reintervention.

Intraoperative Predictors and Proposal for a Novel Prognostic Risk Score for In-Hospital Mortality after Open Repair of Ruptured Abdominal Aortic Aneurysms (SPARTAN Score).

(1) Background: Several mortality risk scores have been developed to predict mortality in ruptured abdominal aortic aneurysms (rAAAs), but none focused on intraoperative factors. The aim of this study is to identify intraoperative variables affecting in-hospital mortality after open repair and develop a novel prognostic risk score. (2) Methods: The analysis of a retrospectively maintained dataset identified patients who underwent open repair for rAAA from January 2007 to October 2023 in three Italian tertiary referral centers. Multinomial logistic regression was used to calculate the association between intraoperative variables and perioperative mortality. Independent intraoperative factors were used to create a prognostic score. (3) Results: In total, 316 patients with a mean age of 77.3 (SD ± 8.5) were included. In-hospital mortality rate was 30.7%. Hemoperitoneum (p < 0.001), suprarenal clamping (p = 0.001), and operation times of >240 min (p = 0.008) were negative predictors of perioperative mortality, while the patency of at least one hypogastric artery had a protective role (p = 0.008). Numerical values were assigned to each variable based on the respective odds ratio to create a risk stratification for in-hospital mortality. (4) Conclusions: rAAA represents a major cause of mortality. Intraoperative variables are essential to estimate patients' risk in surgically treated patients. A prognostic risk score based on these factors alone may be useful to predict in-hospital mortality after open repair.

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.

The Management of Ruptured Abdominal Aortic Aneurysms: An Ongoing Challenge.

BACKGROUND: despite improvements in the diagnosis and treatment of elective AAAs, ruptured abdominal aortic aneurysms (RAAAs) continue to cause a substantial number of deaths. The choice between an open or endovascular approach remains a challenge, as does postoperative complications in survivors. The aim of this manuscript is to offer an overview of the contemporary management of RAAA patients, with a focus on preoperative and intraoperative factors that could help surgeons provide more appropriate treatment. METHODS: we performed a search on MEDLINE, Embase, and Scopus from 1 January 1985 to 1 May 2023 and reviewed SVS and ESVS guidelines. A total of 278 articles were screened, but only those with data available on ruptured aneurysms' incidence and prevalence, preoperative scores, and mortality rates after emergency endovascular or open repair for ruptured AAA were included in the narrative synthesis. Articles were not restricted due to the designs of the studies. RESULTS: the centralization of RAAAs has improved outcomes after both surgical and endovascular repair. Preoperative mortality risk scores and knowledge of intraoperative factors influencing mortality could help surgeons with decision-making, although there is still no consensus about the best treatment. Complications continue to be an issue in patients surviving intervention. CONCLUSIONS: RAAA still represents a life-threatening condition, with high mortality rates. Effective screening and centralization matched with adequate preoperative risk-benefit assessment may improve outcomes.

Peripheral Interventional Strategy Assessment (PISA) for Diabetic Foot Ulcer Revascularization: Preliminary Outcomes of a Multidisciplinary Pilot Study.

BACKGROUND: Digital subtraction angiography (DSA) still represents the gold standard for anatomical arterial mapping and revascularization decision-making in patients with chronic limb-threatening ischemia (CLTI), although DUS (Doppler Ultrasound) remains a primary non-invasive examination tool. The Global Vascular Guidelines established the importance of preoperative arterial mapping to guarantee an adequate in-line flow to the foot. The aim of this study was to evaluate the accuracy of DUS in guiding therapeutic vascular treatments on the basis of Global Vascular Guidelines without the need of a second-level examination. METHODS: Between January 2022 and June 2022, all consecutive patients with CLTI to be revascularized underwent clinical examination and DUS without further diagnostic examinations. Primary outcomes assessed were technical success, and 30-day mortality. Secondary outcomes were 1-year amputation free survival, and time between evaluation and revascularization. RESULTS: Sixty-eight patients with a mean age of 73.6 ± 8.5 years underwent lower limb revascularization. Technical success was 100%, and the 30-day mortality rate was 2.9%. Mean time between evaluation and revascularization was 29 ± 17 days. One-year amputation free survival was 97.1%. CONCLUSIONS: DUS without further diagnostic examinations can accurately assess the status of the vascular tree and foot runoff, providing enough information about target vessels to guide revascularization strategies.

Successful extreme foot revascularization with plaque cracking (percutaneous direct needle puncture of calcified plaque) technique of medial tarsal artery.

The percutaneous direct needle puncture of calcified plaque technique is a valuable method to allow for extreme revascularization of occluded below-the-ankle vessels. We report the case of an antegrade recanalization technique from the peroneal artery to medial plantar artery to achieve external "cracking" of a calcified plaque of the medial tarsal artery.

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.

Intraoperative predictors of in-hospital mortality after open repair of ruptured abdominal aortic aneurysms.

BACKGROUND: Several models and scores have been released to predict early mortality in patients undergoing surgery for a ruptured abdominal aortic aneurysm (rAAA). These scores included above all preoperative factors and they could be useful to deny surgical repair. The aim of the study was to evaluate intraoperative predictors of in-hospital mortality in patients undergoing open surgical repair (OSR) for a rAAA. METHODS: Between January 2007 and December 2020, 265 patients were admitted at our tertiary referral hospital for a rAAA. Two-hundred-twenty-two patients underwent OSR. Intra-operative factors were analyzed by means of univariate analysis (step 1). Associations of procedure variables with in-hospital mortality rates were sought based on a multivariate Cox regression analysis (step 2). RESULTS: Overall, in-hospital mortality rate was 28.8% (64 cases). Multivariate Cox regression analysis reported that operation time >240 minutes (P=0.032, OR 2.155, CI 95% 1.068-4.349), and hemoperitoneum (P<0.001, OR 3.582, CI 95% 1.749-7.335) were negative predictive factors for in-hospital mortality. Patency of at least one hypogastric artery (P=0.010; OR 0.128, CI 95% 0.271-0.609), and infrarenal clamping (P=0.001; OR 0.157, CI 95% 0.052-0.483) had a protective role in reducing in-hospital mortality rate. CONCLUSIONS: Operation time >240 minutes, and hemoperitoneum affected in-hospital mortality in patients undergoing OSR for rAAA. Patency of at least one hypogastric artery, and infrarenal clamping had a protective role. Further studies are needed to validate these outcomes. A validated predictive model could be useful to help the physicians in communication with patients' relatives.

Preoperative factors affecting long-term mortality in patients survived to ruptured abdominal aortic aneurysm repair.

BACKGROUND: Aim of this study was to retrospectively evaluate preoperative factors affecting long-term mortality in patients survived to surgical repair for ruptured abdominal aortic aneurysms (rAAAs). METHODS: From January 2007 to December 2021, 444 patients have been treated for symptomatic or ruptured aortoiliac aneurysms in two tertiary referral centers. Only 405 with diagnosis of rAAA at computed tomography were included in the present study. Initial outcome measures were assessed during at 30 and 90 days post-treatment. Estimated 10-year survival of patients survived after 90 days from the index procedure was evaluated with Kaplan-Meier Test. Uni- and multivariate analyses of the preoperative factors affecting 10-year survival in survivor patients was performed by means of log-rank and multivariate Cox regression analysis. RESULTS: Among included patients, 94 (23.3%) underwent endovascular aortic repair (EVAR) and 311 (76.8%) open surgical repair (OSR). Intraoperative death occurred in 29 patients (7.2%). At 30 days, overall death rate was 24.2% (98/405 cases). Hemorrhagic shock (HR 15.5, 95% CI 3.5 to 41.1, P<0.001) was an independent predictor for 30-day mortality. The overall rate of 90-day mortality was 32.6%. In survivors estimated survival rates at 1, 5, and 10 years were 84.2%, 58.2%, and 33.3%, respectively. Type of treatment (OSR vs. EVAR) did not affect long-term freedom from AAA-related death (HR 0.6, P=0.42). In survivor patients, multivariate analysis confirmed the association between late mortality and female sex (HR 4.7, 95% CI 3.8 to 5.9, P=0.03), age >80 years (HR 28.5, 95% CI 25.1 to 32.3, P<0.001), and chronic obstructive pulmonary disease (HR 5.2, 95% CI 4.3 to 6.3, P=0.02). CONCLUSIONS: Late freedom from AAA-related death was not affected by the type of treatment (EVAR vs. OSR) in patients undergoing urgent repair for rAAA. In survivors, female gender, elderly age, and chronic obstructive pulmonary disease negatively affected long-term survival.

Emergent management of diabetic foot problems in the modern era: Improving outcomes.

Limb amputation is a consequence, and the leading complication, of diabetic foot ulcers. Prevention depends on prompt diagnosis and management. Patients should be managed by multidisciplinary teams and efforts should be focused on limb salvage ("time is tissue"). The diabetic foot service should be organized in a way to meet the patient's clinical needs, with the diabetic foot centers at the highest level of this structure. Surgical management should be multimodal and include not only revascularization, but also surgical and biological debridement, minor amputations, and advanced wound therapy. Medical treatment, including an adequate antimicrobial therapy, has a key role in the eradication of infection and should be guided by microbiologists and infection disease physicians with special interest in bone infection. Input from diabetologists, radiologists, orthopedic teams (foot and ankle), orthotists, podiatrists, physiotherapists, and prosthetics, as well as psychological counseling, is required to make the service comprehensive. After the acute phase, a well-structured, pragmatic follow-up program is necessary to adequately manage the patients with the aim to detect earlier potential failures of the revascularization or antimicrobial therapy. Considering the cost and societal impact of diabetic foot problems, health care providers should provide resources to manage the burden of diabetic foot problems in the modern era.

Chronic Limb-Threatening Ischemia and the Need for Revascularization.

BACKGROUND: Patients presenting with critical limb-threatening ischemia (CLTI) have been increasing in number over the years. They represent a high-risk population, especially in terms of major amputation and mortality. Despite multiple guidelines concerning their management, it continues to be challenging. Decision-making between surgical and endovascular procedures should be well established, but there is still a lack of consensus concerning the best treatment strategy. The aim of this manuscript is to offer an overview of the contemporary management of CLTI patients, with a focus on the concept that evidence-based revascularization (EBR) could help surgeons to provide more appropriate treatment, avoiding improper procedures, as well as too-high-risk ones. METHODS: We performed a search on MEDLINE, Embase, and Scopus from 1 January 1995 to 31 December 2022 and reviewed Global and ESVS Guidelines. A total of 150 articles were screened, but only those of high quality were considered and included in a narrative synthesis. RESULTS: Global Vascular Guidelines have improved and standardized the way to classify and manage CLTI patients with evidence-based revascularization (EBR). Nevertheless, considering that not all patients are suitable for revascularization, a key strategy could be to stratify unfit patients by considering both clinical and non-clinical risk factors, in accordance with the concept of individual residual risk for every patient. The recent BEST-CLI trial established the superiority of autologous vein bypass graft over endovascular therapy for the revascularization of CLTI patients. However, no-option CLTI patients still represent a critical issue. CONCLUSIONS: The surgeon's experience and skillfulness are the cornerstones of treatment and of a multidisciplinary approach. The recent BEST-CLI trial established that open surgical peripheral vascular surgery could guarantee better outcomes than the less invasive endovascular approach.

A technical review of bail-out procedures to place Najuta stent-graft into the ascending aorta.

BACKGROUND: The Najuta stent-graft (Kawasumi Laboratories Inc., Tokyo, Japan) is usually easily advanced to the correct deployment position in the ascending aorta thanks to the pre-curved delivery J-sheath with all fenestrations automatically oriented towards the supra-aortic vessels. Aortic arch anatomy and delivery system stiffness could however represent limitations for proper endograft advancement, especially when the aortic arch bends sharply. The aim of this technical note is to report a series of bail-out procedures that could be useful to overcome the difficulties encountered during the Najuta stent-graft advancement up to the ascending aorta. MAIN BODY: The insertion, positioning and deployment of a Najuta stent-graft requires a through-and-through guidewire technique using a .035″ 400 cm hydrophilic nitinol guidewire (Radifocus™ Guidewire M Non-Vascular, Terumo Corporation, Tokyo, Japan) with right brachial and both femoral accesses. When standard maneuver to put the endograft tip into the aortic arch, some bail-out procedures can be applied to obtain proper positioning. Five techniques are described into the text: positioning of a coaxial extra-stiff guidewire; positioning of a long introducer sheath down to the aortic root from the right brachial access; inflation of a balloon inside the ostia of the supra-aortic vessels; inflation of a balloon inside the aortic arch (coaxial to the device); and transapical access technique. This is a troubleshooting guide for allowing physicians to overcome various difficulties with the Najuta endograft as well as for other similar devices. SHORT CONCLUSION: Technical issues in advancing the delivery system of Najuta stent-graft could occur. Therefore, the rescue procedures described in this technical note could be useful to guarantee the correct positioning and deployment of the stent-graft.

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.

Transaxillary Tri-Branch Aortic Endovascular Graft Repair of Recurrent Thoracoabdominal Aneurysm With Pararenal Aortic Occlusion.

The absence of an adequate ileo-femoral access is usually considered an absolute contraindication to fenestrated and branched aortic repairs. Alternative routes and dedicated stent-graft designs have been advocated. Hereby, we describe the case of a 73-year-old man with a recurrent type IV thoracoabdominal aortic aneurysm and complete thrombotic pararenal aortic occlusion treated successfully with a tri-branch custom-made endograft deployed via a transaxillary access.

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.