INTRAOPERATIVE TRANSIT-TIME FLOW AS A PREDICTOR OF FAILURE AFTER INFRAINGUINAL REVASCULARIZATION WITH HEPARIN-BONDED EXPANDED POLYTETRAFLUOROETHYLENE GRAFT.

INTRODUCTION: The Heparin-bonded expanded polytetrafluoroethylene (He-ePTFE) conduit is an option for patients requiring infrainguinal revascularization (iIR), but the risk of failure may be unpredictable, especially in cases with poor run-off. Intraoperative transit-time flow (TTF) provides an automated and quantitative analysis of flow and may serve as an adjunct evaluation during surgical revascularization. The aim of this study was to assess TTF in patients undergoing iIR with He-PTFE at three referral hospitals and to establish a predictive flow threshold for graft occlusion. METHODS: A prospective registry initiated in 2020 enrolled patients undergoing infrainguinal revascularization (iIR) using He-PTFE for critical limb ischemia or severe claudication, and TTF measurement was analyzed. Preoperative assessments of anatomical and clinical characteristics were available for all patients. The HT353 Optima Meter (Transonic Systems Inc., Ithaca, NY, USA) was used in all procedures according to a standardized protocol. The institutional ethics committee approved the study. A predictive model using receiver operating characteristic curve (ROC) analysis was utilized to establish the threshold of flow, and variables were compared. Anatomical and clinical evaluation were reported according to Rutherford grade, Global Limb Anatomic System (GLASS) and Wound, Ischemia and foot Infection (WIfI) classification. The main outcome considered was the correlation between TTF and graft occlusion. Secondary outcomes included survival, other predictors of graft occlusion, freedom from major adverse cardiovascular events (MACE), and freedom from major amputation. RESULTS: Among 68 patients, 55.8% had Rutherford 5-6, 45.6% had GLASS 3 and 73.5% had WIfI 3-4. Distal anastomosis was at tibial level in 23.5% and mean diameter of conduit was 6.4mm. Basal and post-operative TTF was 27.8 ± 15.6ml/min and 109.0 ± 53.0mil/min, respectively. After a mean follow up of 18 ± 13 months, 7 (10.9%) patients presented graft occlusion and 5 (7.8%) required major amputation. TTF threshold = 80 ml/min revealed a sensitivity and specificity of 81.8% (95%CI 48,2 - 97,7) and 80.7% (95% CI 68,1 - 90,0) respectively and it was selected as cut-off for graft occlusion. Freedom from graft occlusion in patients with TTF >80ml/min vs TTF ≤80ml/min at 6, 12, 24 months was 95.7% (SE=0.030) vs 65.5% (SE= 0.115), 95.7% (SE =0.030) vs 58.9% (SE=0.120) and 90.9% (SE=0.054) vs 51.6% (SE=0.126), p= 0.0003. No statistical difference in primary patency, secondary patency and limb salvage was observed. At multivariate analysis, distal anastomosis at tibial vessel (OR 8.50) and TTF ≤80ml/min (OR 9.39) were independent predictors of graft occlusion. CONCLUSIONS: These results suggest that TTF may serve as a valuable tool in the management of iIR. An TTF measurement of ≤80 ml/min should be regarded as a predictor of graft occlusion, prompting consideration of additional intraoperative maneuvers to enhance arterial flow. Caution should be exercised in patients requiring direct tibial artery revascularization, as it represents a predictor of failure independent of TTF levels. Larger cohorts of patients and longer follow-up periods are necessary to confirm these findings.

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.

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.

Clinical risk factors and features on computed tomography angiography in high-risk carotid artery plaque in patients with type 2 diabetes.

BACKGROUND: High-risk carotid artery plaque (HPR) is associated with a markedly increased risk of ischemic stroke. The aims of this study were: 1) to examine the prevalence of HRP in a cohort of asymptomatic adults with type 2 diabetes (T2D); 2) to investigate the relationship between HRP, established cardiovascular risk factors and computed tomography angiography (CTA) profile; and 3) to assess whether the presence of HRP is associated with an increased risk of major adverse cardiovascular events (MACE). METHODS: This was a retrospective cohort study of T2D asymptomatic patients who underwent carotid endarterectomy (CEA) from January 2018 to July 2021. The carotid atherosclerotic plaque (CAP) was assessed for the presence of ulceration, the presence of lipids, fibrosis, thrombotic deposits, hemorrhage, neovascularization, and inflammation. A CAP presenting at least five of these histological features was defined as a HRP (Group A); in all other cases it was defined as a mild to moderate heterogeneous plaque and no-HRP (Group B). CTA features included the presence of rim sign consisting of thin peripheral adventitial calcification (<2 mm) and internal soft plaque (≥2 mm), NASCET percent diameter stenosis, maximum plaque thickness, ulceration, calcification, and intraluminal thrombus were recorded. Binary logistic regression with Uni- and Multivariate was used to evaluate possible predictors for HRP while multivariable Cox Proportional Hazards was used to assess independent predictors for MACE. RESULTS: One hundred eighty-five asymptomatic patients (mean age 73±8 years, 131 men), undergoing carotid endarterectomy, were included. Of these, 124 (67%) had HRP, and the 61 (33%) did not. Diabetic complications (OR 2.4, 95% CI: 1.1-5.1, P=0.01), NASCET stenosis ≥75% (OR 2.4, 95% CI: 1.2-3.7, P=0.02) and carotid RIM sign (OR 4.3, 95% CI: 3.9-7.3, P<0.001) were independently associated with HRP. However, HRP was not associated with a higher risk of MACE (freedom from MACE at 5 years: HRP 83.4% vs. non HRP 87.8%, P=0.72) or a reduction of survival (5-year survival estimates: HRP 96.4% vs. non HRP: 94.6%, P=0.76). CONCLUSIONS: A high prevalence of HRP (67%) was observed in asymptomatic and elderly T2D patients. Independent predictors of HRP were diabetic complications, NASCET stenosis ≥75% and carotid RIM sign (OR 4.3, 95% CI: 3.9-7.3, P<0.001). HRP was not associated with an increased risk of MACE during a mean follow-up of 39±24 years.

Mid-term Results of Endovascular Reconstruction of Aortic Bifurcation Using COVERA Stent Graft.

INTRODUCTION: This article aims to evaluate the short-term and mid-term performance of a self-expanding covered stent (COVERA Plus, Bard Tempe, Arizona) during the treatment of Trans-Atlantic Inter-Society Consensus (TASC) C/D aortoiliac obstructive lesions involving the aortic bifurcation. METHODS: A single-center retrospective review of all patients who underwent endovascular reconstruction of the aortoiliac bifurcation for obstructive disease, with the use of Covera, from January 2018 to March 2023. All patients received a postoperative CTA (computed tomography angiography) scan within 1 month from the intervention. Precision of deployment, stent conformation, and stent symmetry were evaluated at the arterial phase of the CTA. Early outcomes were technical success and freedom from open aortic reintervention and/or mortality. Late outcomes were primary and assisted primary patency rates and freedom from reintervention. RESULTS: During the study period, 35 patients underwent primary endovascular treatment of obstructive lesions involving the aortic bifurcation with parallel COVERA stents. Aortoiliac lesions were classified as TASC-IIC in 23 (65.7%) patients and TASC D in 12 (34.2%). Median follow-up was 49 months (interquartile [IQR]: 18-60). Overall survival was 97.1% (95% confidence interval [CI]=91-100) at 60 months. During follow-up, there were one early stent stenosis, treated with an angioplasty and stent relining with an estimated primary patency at 60 months of 97.1% (95% CI=94-100) and a primary-assisted patency of 100%. Estimated freedom from all types of reinterventions at 60 months was 94.3% (95% CI=89-99.3). CONCLUSIONS: The new self-expanding covered Bard COVERA Plus stent used for endovascular treatment of TASC C/D aorto iliac disease proved to be safe and feasible with high technical procedural success rates. Comparison with other types of stents is necessary to further assess the role of the COVERA Plus stent in aortic bifurcation repair. CLINICAL IMPACT: This study investigates the safety and feasibility of the new self-expanding covered Bard Covera Plus stent used for endovascular treatment of TASC C/D aorto iliac disease. The retrospective analysis of 35 patients highlights high technical success and primary patency rate at 60 months. The geometric analysis also helped to underline how this stent can be used precisely in particular conditions. These findings suggest the need for further research to compare COVERA with other types of stents in aortic bifurcation repair.

Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results. METHODS: This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated. RESULTS: A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%. CONCLUSIONS: The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.

Ten-year experience with use of cryopreserved allografts for redo infrapopliteal bypass.

INTRODUCTION: The aim of this study is to report the early and late outcomes of cryopreserved saphenous vein (CSV) in redo infrainguinal bypass and to investigate possible predictors of primary patency loss. METHODS: All patients who underwent a redo bypass for critical limb ischemia from January 2010 to December 2020 were reviewed. Early and late complications were analyzed and included. The endpoints of the study were all cause mortality, major limb amputation, and primary patency (PP). RESULTS: Data were collected from 95 patients. Among the entire cohort, 16 (16.8%) patients received a cryopreserved vessel bypass with anastomosis in the popliteal artery and 79 (83.2%) patients had cryopreserved vessel bypasses with distal anastomosis in tibial vessels. Median duration of follow-up was 73 months; during this, period estimated survival at 5 years was 80.5 ± 4% (95% CI, 78.0-91.2) and estimates of freedom from limb amputation was 90.3 ± 3.2% (95% CI, 87.3-98.1). Overall, the estimated primary patency of the bypass was 43.7 ± 6.7% (95% CI, 30.2-51.4). On multivariable analysis, intraprocedural tibial vessel angioplasty (HR = 2.3, p = 0.01), distal anastomosis in tibial vessels (HR = 3.6, p = 0.36), and the use of a composite graft (HR = 2.4, p = 0.01) were independently associated with loss of PP. CONCLUSIONS: The use of CSV in redo bypass is an effective strategy in salvaging threatened lower extremities and in preventing or delaying limb amputation. Our results confirm that further attempts at revascularization are generally appropriate, even in technically changing patients.

Results of iliac branch devices for hypogastric salvage after previous aortic repair.

OBJECTIVE: The aim of this multicentric study was to assess the "REsults of iliac branch deviceS for hypogastriC salvage after previoUs aortic rEpair (RESCUE)." METHODS: All consecutive patients who underwent implantation of iliac branch devices (IBDs) after previous open aortic repair (OAR) or endovascular aortic repair (EVAR) at seven centers were captured. The study cohort was divided into two groups according to the type of repair originally performed. Early outcomes included immediate technical success and perioperative adverse events. Late outcomes included survival, side branch (SB) primary patency, SB instability, and new onset buttock claudication. RESULTS: A total of 94 patients (82 male) were included in the study, 10 of them received bilateral implantation of IBDs. This resulted in a total of 104 devices included in the final analysis. Indication for treatment were endoleak 1b or progressive iliac aneurysmal degeneration or distal para-anastomotic aortic aneurysms; 73 were implanted after previous EVAR and 31 after previous OAR. Technical success was 100% in both groups. The 3-year rate of freedom from SB instability was 90.1% after previous EVAR and 85.4% after previous OAR, respectively (P = .05). The 3-year estimates of SB primary patency were significantly lower in patients who had received OAR as compared with those that had received EVAR (89.8% vs 94.9%; P = .05). CONCLUSIONS: Endovascular treatment with IBDs following previous OAR or EVAR is safe and effective up to 3 years. Freedom from SB instability during follow-up was lower in patients who had previously undergone OAR than EVAR.

Acute perioperative complications after arterial and venous femoral access in major vascular and cardiac procedures: Ischemic or hemorrhagic patterns and how to solve them.

A direct percutaneous arterial and venous approach to the common femoral vessel has become the first option in most large-bore percutaneous vascular and cardiac procedures, making the issue of access site-related complications (ASCs) a pressing clinical concern. ASCs represent a potentially limb-threating and/or life-threatening scenario that alters the clinical success of the procedure and contributes to increased length of stay and resource utilization. Preoperative assessment of risk factors for ASCs should be well known before planning an endovascular percutaneous procedure and early diagnosis is necessary for prompt treatment. Several percutaneous and surgical approaches have been reported in case of ASCs, according to the different etiologies of these complications. The aim of this review was to report the incidence of ASCs in vascular and cardiac large-bore procedures, diagnosis, and available treatments according to the latest available literature.

A Scoping Review on the Incidence, Risk Factors, and Outcomes of Proximal Neck Dilatation after Standard and Complex Endovascular Repair for Abdominal Aortic Aneurysms.

Background: To define proximal neck dilation (PND) after standard endovascular aneurysm repair (EVAR) and fenestrated EVAR (FEVAR), determining: incidence and risk factors; evidence base that links PND to outcomes of patients; recurring themes or gaps in the literature. Methods: We performed a scoping review and included only full-text English articles with follow-up focusing on PND in patients undergoing EVAR or FEVAR, published between 2000 and 2022. The following PICO question was used to build the search equation: in patients with abdominal-aortic-aneurysm (AAA) (Population) undergoing endovascular repair (Intervention), what are the incidence, risk factors and prognosis of radiologically defined PND (Comparison) on short-term and long-term outcomes (Outcomes)? Results: 15 articles were included after review. Measurement protocols for proximal aortic neck (PAN) varied among individual studies and the definition of PND resulted as heterogeneous. Rate of patients with a PND ranged between 0% and 41%. Large proximal neck (>28 mm) and excessive graft sizing (30%) were predictors for PND. New endografts with low outward radial forces and FEVAR seemed to be protective. Surgical conversion was the definitive option in the case of patients unfit for other endovascular treatments. Conclusions: PND is a frequent finding after EVAR and FEVAR. Excessive graft oversizing and large baseline PAN were predictors of neck enlargement, independently by the type of standard endograft used. FEVAR may be considered protective against complications, together with endografts using low outward radial forces. Lifelong radiological follow-up is mandatory.

Celiac Artery Coverage After Thoracic Endovascular Aortic Procedure: A Meta-Analysis of Early and Late Results.

BACKGROUND/AIM: Clinical outcomes of celiac artery (CA) coverage during aortic procedures are often contradicting and the fate of this additional maneuver is still unclear. This study summarizes the results of available literature and aims to clarify the impact of CA coverage during thoracic endovascular aneurysm repair (TEVAR) in patients with inadequate distal sealing zone. METHODS: Prospective and retrospective, observational original articles focused on CA coverage during elective/urgent TEVAR for descending thoracic aortic pathology (DTAP) were included. PubMed/MEDLINE, Embase, and Cochrane Central Register of Controlled Trials database were examined to identify articles published from January 2007 to December 2020, according to PRISMA guidelines. Early and late visceral (any sign or symptom reported) and neurological (both transient and permanent) complications were considered as primary outcomes. Onset of any endoleak, type IB endoleak, need of reintervention, and TEVAR-related mortality were considered as secondary outcomes. RESULTS: A total of 5618 articles were extracted for analysis and 13 studies were finally included in the synthesis. A total of 178 CAs were covered during 2653 TEVAR (7%). Spinal cord ischemia was 8% (95% CI, 5-14%, I2 0%) Any endoleak and type IB endoleak was observed in 12% (95% CI, 6-21%, I2 17%) and 5% (95% CI, 2-11%, I2 0%), respectively. Thoracic endovascular aneurysm repair-related reoperation was necessary in 8% (95% CI, 4-14%, I2 0%), the majority of which (14/18, 78%) performed for distal sealing failure; mortality rate was 9% (95% CI, 5-14%, I2 0%). Out of 178 patients, 168 (94%) were available for follow-up, ranged 12 to 42 months. Visceral complications, any endoleak, and type IB endoleak were identified in 15% (95% CI, 10-23%, I2 45%), 20% (95% CI, 13-29%, I2 8%), and 8% (95% CI, 4-15%, I2 0%), respectively. Thoracic endovascular aneurysm repair-related reintervention was required in 8% (95% CI, 4-14%, I2 0%). Mortality rate was 17% (95% CI, 12-25%, I2 4%). CONCLUSIONS: Celiac artery coverage in DTAP should be regarded as a "bailout" procedure especially in urgent/emergent settings but requires caution in elective cases. Even if transient visceral ischemia is frequent, life-threatening complications are rare. Early and late mortality rates are similar to standard TEVAR although the risk of type IB endoleak and reintervention may be an issue.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Association Between the Lockdown for SARS-CoV-2 (COVID-19) and Reduced Surgical Site Infections after Vascular Exposure in the Groin at Two Italian Academic Hospitals.

BACKGROUND: The aim of this study was to evaluate whether the scrupulous hygiene rules and the restriction of contacts during the lockdown owing to the COVID-19 pandemic affected the rate and severity of surgical site infections (SSI) after vascular exposure in the groin at two Italian University Hospitals. METHODS: Starting from March 2020, strict hygiene measures for protection of health care workers (HCW) and patients from COVID-19 infection were implemented, and partly lifted in July 2020. The main exposure for analysis purposes was the period in which patients were operated. Accordingly, study subjects were divided into two groups for subsequent comparisons (preCOVID-19 era: March-June 2018-2019 versus COVID-19 era: March-June 2020). The primary endpoint was the occurrence of superficial and/or deep SSI within 30 days after surgery. The Centers for Disease Control and Prevention definitions were used to classify superficial and deep SSI. RESULTS: A total of 194 consecutive patients who underwent vascular exposure in the groin were retrospectively analyzed. Of those, 60 underwent surgery from April 1, 2018 to June 30 of the same year; 83 from April 1, 2019 to June 30 of the same year; and 51 from April 1, 2020 to June 30 of the same year. The mean age of the study cohort was 75 years and 140 (72%) were males. Patients who were operated in the COVID-19 era were less likely to develop SSI (10% vs. 28%; P = 0.008), including both deep SSI (4% vs. 13%; P = 0.04) and superficial SSI (6% vs. 15%; P = 0.05). After multivariate adjustments, being operated in the COVID-19 era was found to be a negative predictor for development of an SSI (odds ratio [OR] = 0.31; 95% confidence interval [CI] = 0.09-0.76; P < 0.001) or deep SSI (OR = 0.21; 95% CI = 0.03-0.98; P < 0.001). Operative time was also found as independent predictor for the development of deep SSI (OR = 1.21; 95%CI = 1.21-1.52; P = 0.02). Using binary logistic regression, there were no independent predictors of superficial SSI that could be identified. CONCLUSIONS: Vascular exposure in the groin carries a non-negligible risk of SSI. In this study, we provided important insights that are simple and easily viable precautions (such as the universal use of surgical masks both for patients and health care professionals during wound care, the widespread diffusion of hand sanitizers, and the reduction of the number of visitors in the surgical wards) could be promising and safe tools for SSI risk reduction.

Prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA): Derivation and validation of a novel risk score.

OBJECTIVE: The aim of the present study was to develop and validate a risk prediction model for the prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA). METHODS: Data were collected retrospectively from a dedicated database of consecutive patients who had undergone elective CEA for severe (>70% using the NASCET [North American Symptomatic Carotid Endarterectomy Trial] criteria) asymptomatic carotid stenosis at two Italian University Hospitals from 2008 through 2016. Internal validation of the score was performed after random sampling in a 3:1 fashion. The primary end point of the PREMY2SE-CEA risk score was the 5-year mortality. RESULTS: Of the 1214 patients, 901 were included in the derivation cohort and 313 in the validation cohort. Using multivariable logistic regression with backward elimination, a parsimonious model was derived. A risk score incorporating eight risk factors was generated and found to be highly predictive of long-term mortality in the derivation (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.28-1.41; P < .001) and validation (OR, 1.29; 95% CI, 1.21-1.37; P <.001) cohorts. The discrimination power in the receiver operating characteristic curve analysis was C = 0.775 (95% CI, 0.74-.80), and the optimism-corrected area under the curve in the bootstrapped samples was 0.761 (P < .001). A strong correlation was found between the predicted and actual mortality rates in the validation cohort (r = 0.71; P < .001). CONCLUSIONS: In the present study, we have described the development, evaluation, and validation of a risk prediction model (PREMY2SE-CEA) for long-term mortality after CEA in asymptomatic patients. Physicians could use the PREMY2SE-CEA risk scoring tool to complement their estimates of life expectancy and prompt selective consideration of prophylactic CEA to improve the long-term benefits of interventions.

Peri-Operative Management of Patients Undergoing Fenestrated-Branched Endovascular Repair for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms: Preventing, Recognizing and Treating Complications to Improve Clinical Outcomes.

The advent and refinement of complex endovascular techniques in the last two decades has revolutionized the field of vascular surgery. This has allowed an effective minimally invasive treatment of extensive disease involving the pararenal and the thoracoabdominal aorta. Fenestrated-branched EVAR (F/BEVAR) now represents a feasible technical solution to address these complex diseases, moving the proximal sealing zone above the renal-visceral vessels take-off and preserving their patency. The aim of this paper was to provide a narrative review on the peri-operative management of patients undergoing F/BEVAR procedures for juxtarenal abdominal aortic aneurysm (JAAA), pararenal abdominal aortic aneurysm (PRAA) or thoracoabdominal aortic aneurism (TAAA). It will focus on how to prevent, diagnose, and manage the complications ensuing from these complex interventions, in order to improve clinical outcomes. Indeed, F/BEVAR remains a technically, physiologically, and mentally demanding procedure. Intraoperative adverse events often require prolonged or additional procedures and complications may significantly impact a patient's quality of life, health status, and overall cost of care. The presence of standardized preoperative, perioperative, and postoperative pathways of care, together with surgeons and teams with significant experience in aortic surgery, should be considered as crucial points to improve clinical outcomes. Aggressive prevention, prompt diagnosis and timely rescue of any major adverse events following the procedure remain paramount clinical needs.

Scoping review of radiologic assessment and prognostic impact of skeletal muscle sarcopenia in patients undergoing endovascular repair for aortic disease.

OBJECTIVE: The primary objectives of our scoping review were to evaluate the methods used by research groups to assess the incidence of sarcopenia in patients with aortic disease and the extent of the evidence base that links sarcopenia to the survival of patients undergoing elective endovascular aortic repair and to identify the recurring themes or gaps in the literature to guide future research. METHODS: A scoping review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) protocols extension for scoping reviews was performed. The available studies included those fully reported in English (last query, April 30, 2022). The following PICO question was used to build the search equation: "in patients with aortic disease [population] undergoing endovascular repair [intervention], what was the prevalence and prognosis of radiologically defined sarcopenia [comparison] on the short- and long-term outcomes?" RESULTS: A total of 31 studies were considered relevant, and 18 were included in the present scoping review. In brief, 12 studies had focused on standard endovascular aneurysm repair (EVAR), 2 on thoracic EVAR, and 4 on complex EVAR. All but two studies were retrospective in design, and only one study had included patients from a multicenter database. Sarcopenia had generally been defined using the computed tomography angiography (CTA) findings of the cross-sectional area of the psoas muscle at L3 or L4, sometimes with normalization against the height. Overall, despite the heterogeneity in the methods used for its definition, sarcopenia was highly prevalent (range, 12.5%-67.6%). The patients with sarcopenia had had higher rates of mortality (ratio ranged from 2.28 [95% confidence interval, 1.35-3.84] to 6.34 [95% confidence interval, 3.37-10.0]) and adverse events (41% vs 16%; P = .020). CONCLUSIONS: Sarcopenia, as identified using computed tomography angiography-based measurements of the skeletal muscle mass, was prevalent among patients undergoing elective EVAR, thoracic EVAR, or complex EVAR. The presence of sarcopenia has been shown to have a negative prognostic impact, increasing the operative risk and has been linked to poorer long-term survival.

Clinical and Economic Impact of COVID-19 in Vascular Surgery at a Tertiary University "Hub" Hospital of Italy.

BACKGROUND: Since the first cases of a novel respiratory disease were reported in December 2019, coronavirus disease (COVID-19) Emergency State (Cov-ES) caused a worldwide outbreak requiring a complete reorganization of the healthcare system and new management of its personnel; aim of this study was to analyze the clinical and financial impact of Cov-ES in the Department of Vascular Surgery at a Tertiary University "Hub" Hospital in northeast Italy. METHODS: Differences in clinical practice according to Diagnostic Related Group (DRG) and International Statistical Classification of Diseases (ICD) and Related Health Problems and the financial impact of Cov-ES were considered. Vascular procedures performed between March 2019 and December 2019 (Prepandemic) were compared to those performed in the period March-December 2020 (Pandemic). Prepandemic and pandemic reimbursements of all vascular activities and the top 3 vascular diagnoses were evaluated. RESULTS: Prepandemic versus pandemic era documented a decrease of vascular consultations performed (2,882 vs. 2,270, -21.2%). The number of total vascular procedures decreased from 997 to 797 (-20.1%) with a higher reduction observed in outpatient surgical activities (247 to 136, -45.0%, P = 0.0005) rather than inpatient surgical activities (750 vs. 661, 11.9%, P = 0.02). Length of hospital stay (LOS) increased from 3.3 ± 2.7 days in prepandemic to 5.3 ± 3.9 in the pandemic era (P = 0.004). Among patients with limb-threatening ischemia, the rate of major limb amputation was higher in the pandemic (3.3% vs. 5.4%, respectively, P = 0.02), and a higher rate of elective hospitalization procedures was performed as urgent/emerging setting after clinical deterioration (2.8 % vs. 6.4%, P = 0.0002). According to DRG classification, an increase of "complicated" limb-threatening ischemia (DRG 554) and aortic aneurysm (DRG 110) was observed prepandemic to pandemic (+84.2% and +25.0%, respectively). Total reimbursement for vascular activities between pandemic versus prepandemic was 4,646,108€ vs. 5,054,398€, respectively (-8.0%). Management of "complicated" limb-threatening ischemia (DRG 554) and aortic aneurysm (DRG 110) required a higher clinical and financial support that was translated into higher economic reimbursement during the pandemic (273,035€ vs. 150,005€, +82.0% and 749,250€ vs. 603,680€, +24.1%, respectively). CONCLUSIONS: During the pandemic, the main resources were employed for the treatment of limb-threatening ischemia, aortic aneurysm, and carotid stenosis. Inpatient activities documented an increase in major limb amputation and LOS. An increased reimbursement for each vascular procedure and for all "complicated" diagnoses revealed that the more serious and resource-demanding pathology occurred in this period.

Early and midterm outcomes of hybrid first line treatment in patients with chronic limb threatening ischemia.

OBJECTIVE: The aim of the study was to evaluate the outcome of first line hybrid treatment in patients with chronic limb threatening ischemia (CLTI) and to evaluate possible predictors of primary patency (PP) loss and limb clinical improvement (LCI). METHODS: This was a retrospective non-randomized study. All patients underwent one-stage hybrid common femoral artery (CFA) endarterectomy combined with an inflow and/or outflow endovascular revascularization procedure. Demographic, clinical, and lesion characteristics for each patient were reported. Primary patency analysis was performed using Kaplan-Meier life tables, and univariate and multivariate analysis was used to assess possible predictors of PP loss and clinical improvement. RESULTS: Complete data were obtained from 132 patients. Patients were divided into two groups according to their Rutherford's category (RC), group 1 (Rutherford 4) and group 2 (Rutherford 5 and 6). Technical success was 98%. The overall surgical peri-operative complication rate was 8%. At a mean follow-up of 32 ± 23 months, the rate of major adverse limb events (MALE) was 30%; only the rate of major amputation between two groups was significant statistically different (p = .006). Group 1 had significantly lower amputation rate at 36 months (p = .01). The presence of high iliac peripheral artery calcium scoring system (PACCS) grade (HR 9.43, 95% CI 2.40-36.9, p = .001), the poor run-off of leg vessels (HR 0.15, 95% CI 0.02-0.92, p = .04), and undergoing CFA endarterectomy combined with outflow endovascular revascularization procedure (HR 4.25, 95% CI 1.07-16.89, p = .04) were independent predictors of PP loss, while severe iliac artery stenosis (OR 0.09, 95% CI 0.02-0.32, p = <.001) and the presence of pre-operative patent leg vessels (OR 8.03, 95% CI 2015-29.95, p = .002) were the significant independent predictors of LCI. CONCLUSION: The use of hybrid first line approach in patients with CLTI is a safe and feasible technique. From the analysis of the current study, it is clear that any effort should be made to achieve as many patency leg vessels as possible in order to obtain better and longer lasting clinical outcomes.

Sheath-Anchoring for Rail Guidewire Technique to Advance and Deploy Thoracic Endograft in Hostile Anatomy.

BACKGROUND: To describe a bailout technique to advance and precisely deploy thoracic endograft in the ascending aorta in case of difficulty crossing the aortic arch. CASE REPORTS: A 73-year-old man presented with a large ruptured aneurysms in the descending aorta. During the TEVAR, stent-graft passage through the aortic arch was impossible due to the severe tortuosity of the aorta. The problem has been resolved using the sheath-anchoring rail guidewire (SARG) technique. RESULTS: Through an axillary access, a snare was used to capture the stiff wire from the femoral access. A sheath was advanced over the stiff wire to the ascending aorta and placed there. By exploiting the grip of the sheath on the stiff in the ascending aorta, it was possible to handle the tension, move the delivery system through the arch and carefully deploy the graft. CONCLUSION: The SARG is a simple and quick learning technique which can be useful for Physicians dealing with complex aortic arch anatomy.