Cardiac risk after elective endovascular repair for infrarenal abdominal aortic aneurysm: Results from the Italian Collaborators for EVAR multicenter registry.

OBJECTIVE: Major adverse cardiac events (MACEs) were common complications after endovascular aortic repair (EVAR) causing significant postoperative morbidity and mortality. The aim of the study was to evaluate the cardiac risk after elective EVAR for uncomplicated noninfected infrarenal abdominal aortic aneurysm in a large multicenter cohort. METHODS: This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study conducted by four academic tertiary referral hospitals from January 2018 to March 2021. Baseline, perioperative, and postoperative information of elective EVARs was evaluated. The primary outcome was the incidence of MACEs after EVAR, which was defined as acute coronary syndrome, non-ST-elevation myocardial infarction, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, and revascularization as well as cardiovascular death. Secondary outcomes were 1-year overall survival (all-cause mortality) and freedom from aorta-related mortality. Comparative analysis was conducted between MACE and overall population, and univariate and multivariate logistic regression analyses were used to analyze factors associated with the risk of the MACE occurrence and early 1-year mortality. RESULTS: The study has enrolled 497 patients (35 females, 7%) with a mean age of 75.3 ± 7.8 years. The MACE rate was 6.4% (32/497, events/patients), and the majority of the events were recorded in the postoperative period (24/32, 75%; overall 24/497, 4.8%). One-year survival from all-cause mortality was 94% (95% confidence interval [CI]: 91-96), and the MACE population showed a significantly lower survival estimation rate (Overall - MACEs, 95.8% [95% CI: 93-97] - 67.9% [95% CI: 47-82], log-rank 41.950, P = .0001). Freedom from aorta-related mortality was 99.3% (95% CI: 98-100). The perioperative need for red blood cell transfusions was strongly related to the MACE occurrence (odds ratio: 2.67, 95% CI: 1.52-4.68, P = .001) and 1-year mortality (hazard ratio: 2.14, 95% CI: 1.48-3.09, P = .0001). CONCLUSIONS: MACEs represent a common complication in the postoperative and early period after elective EVAR. Blood loss requiring red blood cell transfusions is associated with increased postoperative MACEs and early mortality, suggesting that all the efforts should be carried out to reduce the bleeding during and after elective interventions.

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.

Results of the Italian Collaborators for Evar Registry on Acute Kidney Injury After Elective Endovascular Aortic Repair of Infrarenal Abdominal Aortic Aneurysm.

OBJECTIVES: To analyze the incidence and predictive factors of postoperative acute kidney injury (AKI) after elective standard endovascular aortic repair (EVAR) in a large recent, multicenter cohort. MATERIALS AND METHODS: This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study. Between January 2018 and March 2021, only patients treated with elective standard EVAR for infrarenal non-infected abdominal aortic aneurysm were analyzed. Patients already on hemodialysis (HD) were excluded. AKI was defined as an increase in serum creatinine (sCr) ≥0.3 mg/dL within 48 hours or an increase in sCr to ≥1.5 times baseline known or presumed to have occurred within 7 days, or a urine volume of <0.5 mL/kg/h for 6 hours. Primary outcomes of interest were AKI incidence at 30 days and freedom from HD at 1-year follow-up. Secondary outcomes were freedom from severe postoperative complication, and freedom from aorta-related mortality (ARM) at 1 year. RESULTS: The final cohort analyzed 526 (29.8%). There were 489 (93%) males and 37 (7%) females: the median age was 76 years (interquartile range [IQR], 71-81). Chronic kidney disease (CKD) was present in 86 (16.3%) patients. Early mortality was observed in 8 (1.5%) patients, none was aorta-related. Complication rate was 17.1% (n=89). AKI was observed in 17 (3.2%). Renal replacement therapy was needed in 4 (0.8%). HD was transitory in 2 cases and definitive in 1. Binary logistic regression analysis identified CKD (odds ratio [OR]: 4.68, 95% confidence interval [CI]: 2.10-10.45, p<0.001), and the presence of renal artery stenosis (OR: 3.80, 95% CI: 1.35-10.66, p=0.011) to be associated with an increased risk of postoperative AKI. Estimated freedom from ARM was 94.9% at 1 year. Estimated freedom from HD rate at 1 year was 94%: This was significantly different between patients with preoperative CKD and those who did not have preoperative CKD (log-rank, p=0.042). CONCLUSION: AKI after elective standard EVAR still occurs but with an acceptably low incidence rate. Preoperative CKD is the most important predictor for postoperative AKI, which was not associated with the need for HD at 1-year follow-up but with a higher propensity of mortality. CLINICAL IMPACT: This "real world" experience confirm that EVAR performed with standard contrats agent protocol remains safe for acute kidney injury development. Therefore, only patients presenting with preoperative borderline or ascertained chronic kidney disease will take the most advantage from the use of carbon dioxide contrast.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Free-Cell Area Impact on Stroke Prevention in Asymptomatic Patients Undergoing Carotid Artery Stenting: The "Carotid Artery sTenting And CeLl-area Impact on Stroke and Major Adverse events" (CATACLISMA) Multicenter Registry.

PURPOSE: The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS). MATERIALS AND METHODS: This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period. RESULTS: A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years. CONCLUSION: In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention. CLINICAL IMPACT: The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention.

Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.

Advanced endovascular techniques, such as fenestrated stent grafts, are nowadays available that permit minimally invasive treatment of complex abdominal aortic aneurysms. However, thoracoabdominal aortic aneurysm patients have anatomic limitations to fenestrated stent-grafts given a large lumen, that is, the gap between the endograft and the inner aortic wall. This has led to the development of branched endovascular aneurysm repair as the ideal option for such patients. The Zenith t-Branch multibranched endograft (Cook Medical, Bloomington, IN), which has been commercially available in Europe to treat thoracoabdominal aortic aneurysm since June 2012, represents a feasible off-the-shelf alternative for treatment of such pathologies, especially in the urgent setting, for patients who cannot wait the time required for manufacturing and delivery of custom-made endografts. The device's anatomical suitability should be considered, especially for female patients with smaller iliofemoral vessels. Several tips may help deal with particularly complex scenarios (such as, for instance, in case of narrow inner aortic lumens or when treating patients with failure of prior endovascular aneurysm repair), and a broad array of techniques and devices must be available to ensure technical and clinical success. Despite promising early outcomes, concerns remain particularly regarding the risk for spinal cord ischemia and further assessment of long-term durability is needed, including the rate of target vessel instability and need for secondary interventions. As the published evidence mainly comes from retrospective registries, it is likely that reported outcomes may suffer from an intrinsic bias as most procedures reported to date have been carried out at high-volume aortic centers. Nonetheless, with the never-ceasing adoption of new and refined techniques, outcomes are expected to ameliorate.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

BACKGROUND: Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. METHODS: Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. RESULTS: Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. CONCLUSIONS: In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Long-Term Survival and Reintervention Following Thoracic Endovascular Aortic Repair in Blunt Traumatic Thoracic Aortic Injury: A Systematic Review and Meta-Analysis.

BACKGROUND: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma. Different management strategies are available with varying clinical outcomes. However, thoracic endovascular aortic repair (TEVAR) has become the first-line option for most BTAI patients, mainly owing to its minimally invasive nature, yielding improved immediate results. This meta-analysis aims to investigate mortality, long-term survival, and reintervention following TEVAR in BTAI. MATERIAL AND METHODS: A systematic review conducted a comprehensive literature search on multiple electronic databases using strict search terms. Twenty-seven studies met the set inclusion/exclusion criteria. A proportional meta-analysis of extracted data was conducted using the Comprehensive Meta-Analysis Software, v.4. RESULTS: 1498 BTAI patients who underwent TEVAR were included. Using the SVS grading system, 2.6% of the population had Grade 1 injuries, 13.6% Grade 2, 62.2% Grade 3, 19.6% Grade 4, and 1.9% unspecific. All-cause mortality did not exceed 20% in all studies except one outlier with a 37% mortality rate. Using the random effects model, the pooled estimate of overall mortality was 12% (95% confidence interval [CI], 5.35-8.55%; I2 = 70.6%). This was 91% (95% CI, 88.6-93.2; I2 = 30.2%) at 6 months, 90.1% (95% CI, 86.7-92.3; I2 = 53.6%) at 1 year, 89.2% (95% CI, 85.2-91.8; I2 = 62.3%) at 2 years, and 88.1% (95% CI, 83.3-90.9; I2 = 69.6%) at 5 years. Moreover, the pooled estimate of reintervention was 6.4% (95% CI, 0.1-0.49%; I2 = 81.7%). CONCLUSIONS: Despite the high morbidity and mortality associated with BTAI, TEVAR has proven to be a safe and effective management strategy with favorable long-term survival and minimal need for reintervention. Nevertheless, diagnosis of BTAI requires a high index of suspicion with appropriate grading and prompt transfer to trauma centers with appropriate TEVAR facilities.

Current expert-based opinions on endovascular treatment of blunt thoracic aortic injury: A state-of-the-art narrative review on indications, techniques, results, and challenges.

INTRODUCTION: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma which warrants prompt recognition with expedited management. Clinical manifestations of BTAI may not be straightforward to detect and may be misdiagnosed. Therefore, diagnosis of BTAI requires a high index of suspicion based on the mechanism of injury along with urgent transfer to centers with appropriate expertise and facilities. METHODS: We provide an expert-based narrative review on endovascular treatment of BTAI highlighting indications, techniques, results, and challenges. RESULTS: Multiple imaging modalities can be used including computed tomography angiography, transesophageal echocardiography, magnetic resonance imaging, and intravascular ultrasound. Whilst conservative pharmacological management can be a safe option in low-grade BTAI, thoracic endovascular aortic repair has become the gold-standard strategy in most cases, replacing open surgical repair. Nevertheless, it is important to account for patient demographics particularly age, severity of injury, choice of endograft including its type and size, and endovascular technique including landing zone and left subclavian artery revascularization. CONCLUSIONS: Overall, TEVAR in BTAI has been shown to be an efficacious strategy with favorable early outcomes. In contrast, less is known on the long-term clinical outcomes of TEVAR in BTAI. Hence, despite the optimal early technical and clinical success rates, concerns remain about the need for long-term surveillance. The exact timing of follow-up and the integration of different modalities that can also investigate potential downstream cardiovascular effects remain hot topics for future research. Finally, industry should focus on developing more compliant endografts to improve the stiffness mismatch between the endograft and the aorta to optimize results.

Five-year sex-related outcomes of thoracic endovascular aortic repair in the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: The impact of sex on outcomes of thoracic endovascular aortic repair (TEVAR) represents an area of increased interest over the last decade, and long-term data are lacking. The aim of the present study was to investigate sex-related differences in long-term outcomes after TEVAR using real-world data from the Global Registry for Endovascular Aortic Treatment. METHODS: Data were obtained retrospectively after querying the multicenter, sponsored Global Registry for Endovascular Aortic Treatment. Patients treated with TEVAR between December 2010 and January 2021 were selected regardless of the type of thoracic aortic disease. The primary outcome was sex-specific all-cause mortality at 5 years and maximum follow-up. Secondary outcomes were sex-specific all-cause mortality at 30 days and 1 year, and aorta-related mortality, major adverse cardiac events, neurological complications, and device-related complications or reinterventions at 30 days, 1 year, 5 years, and maximum follow-up. RESULTS: A total of 805 patients were analyzed; 535 (66.5%) were males. Females were older (median, 66 years [interquartile range (IQR), 57-75 years] vs 69 years [IQR, 59-78 years], P < .001). Males had more frequently a history of coronary artery bypass grafting and renal insufficiency (8.7% vs 3.7% [P = .010] and 22.4% vs 11.6% [P < .001]). The median follow-up was 3.46 years (IQR, 1.49-4.99 years) for males and 3.18 years (IQR, 1.29-4.86 years) for females. Indications for TEVAR were mostly descending thoracic aortic aneurysms (n = 307 [38.1%]) type B aortic dissections (n = 250 [31.1%]) or others (n = 248 [30.8%]). Freedom from 5-year all-cause mortality was similar for males and females (67% [95% CI, 62.1-72.2] vs 65.9% [95% CI, 58.5-74.2]; P = .847), and there were no differences in secondary outcomes. Multivariable Cox regression showed females to have lower all-cause mortality rates; however, this difference did not reach statistical significance (hazard ratio, 0.97; 95% CI, 0.72-1.30; P = .834). Additional subgroup analyses based on the indication for TEVAR did not identify differences between both sexes for the primary and secondary outcomes except more endoleak type II in females with complicated type B aortic dissection (1.8% vs 12.1%; P = .023). CONCLUSIONS: The present analysis suggests that long-term outcomes of TEVAR performed irrespective of the type of aortic disease are similar for males and females. Further studies are needed to clarify existing controversies regarding the impact of sex on outcomes of TEVAR.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures.

OBJECTIVE: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. METHODS: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessel repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. RESULTS: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 - 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 - 12.1; p = .026), branched and fenestrated procedure (OR 3.4, 95% CI 1.2 - 9.6; p = .019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 - 20.7; p = .001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 - 9.0; p = .013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 - 13.8; p = .037), and aortic arch procedure (OR 7.3, 95% CI 1.7 - 31.1; p = .007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of adjunctive endovascular procedures was recorded in the percutaneous cohort (p < .001). CONCLUSION: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure.

Editor's Choice - Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED).

OBJECTIVE: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. METHODS: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. RESULTS: In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. CONCLUSION: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

Driving Technology for Thoracic Endovascular Aortic Repair: An International Analysis of Single-versus Double-Branch RELAY Outcomes.

BACKGROUND: The introduction of endovascular aortic arch repair (EAR) represents a paradigm shift in the management of complex arch pathologies usually treated with open surgical repair (OSR). This shift in treatment of aortic arch disease has also been accompanied with a rise in commercial interest in EAR resulting in the development of several endografts. However, the RELAY™ Branched by Terumo Aortic can be considered the prime endograft choice. In this international original study, a retrospective comparative analysis of international prospective outcomes data on the single- and double-branch RELAY stent grafts is provided. METHODS: International data on EAR procedures carried out from January 2019 to January 2022 using the single- and double-branch RELAY endograft configurations were collected prospectively. Follow-up data were collected at 30 days, 6 months, 12 months, and 24 months postoperatively. Retrospective descriptive analysis, logistic regression, and Kaplan-Meier analysis were performed. RESULTS: A total of 125 patients were included, out of which 17 (13.6%) received the single-branch RELAY and 108 the double-branch device. In the single-branch group, no mortalities, strokes, or reinterventions were recoded over 24 months of follow-up. The rates of these outcomes were higher in the other group; however, the differences did not reach significance. Target vessel patency was maintained at 100% throughout the study period with the single-branched RELAY. Overall, our Kaplan-Meier analyses proved that both configurations of RELAY Branched yield excellent short- and mid-term survival and freedom from reintervention. CONCLUSIONS: Our series has clearly demonstrated that EAR using RELAY Branched is a highly efficacious strategy that yields very favorable results which can be considered superior to other EAR devices as well as OSR. Nevertheless, it seems that clinical outcomes with the single-branch RELAY are more optimal than with the double-branch device.

Vascular Access Challenges in Thoracic Endovascular Aortic Repair: A Literature Review.

BACKGROUND: This review aims to comprehensively summarize access challenges in thoracic endovascular aortic repair (TEVAR) by describing vascular access routes, associated risks, outcomes, and complications. METHODS: A literature search was conducted utilizing the PubMed (Medline), Scopus, and Web of Science databases. Qualitative and quantitative data from selected studies are extracted and discussed according to available standards for narrative reviews. RESULTS: In total, there were 109 eligible studies based on predefined inclusion- and exclusion criteria. There were 39 original articles or reviews and 57 case series or case reports. This article summarizes the evidence from these studies and discusses traditional retrograde access routes and techniques for TEVAR via a femoral or iliac route, with or without the use of conduits. Next, alternative antegrade access routes and techniques via a brachial, axillary, carotid, ascending aorta, transapical, transcaval, or another route are discussed. Vascular access complications are presented with specific attention to the importance of gender and alternative antegrade access routes. CONCLUSIONS: Multiple access routes and techniques are currently available to overcome access challenges associated with TEVAR, based on low grade evidence from heterogeneous studies. Future research that compares different access routes and techniques might help in the development of a tailored access protocol for specific patients with challenging TEVAR access.

Outcomes and Economic Impact of Hypogastric Artery Management During Elective Endovascular Aortic Repair for Aorto-Iliac Aneurysms.

BACKGROUND: To analyze clinical outcomes and perform a macro-costing evaluation of endovascular aortic repair (EVAR) for aorto-iliac aneurysms. METHODS: This is a retrospective, financially unsupported, physician-initiated observational cohort study. Patients with iliac artery involvement treated with EVAR between January 1st, 2014 and December 31st, 2021 were identified. Inclusion criteria were intact aneurysm, elective EVAR with at least 1 hypogastric artery (HA) treatment, use of bifurcated endograft (EG), and at least 6 months of follow-up. Primary outcomes of interest were overall survival, freedom from aneurysm-related mortality (ARM), freedom from EVAR-related reintervention, and overall EVAR(procedure)-related costs. RESULTS: We studied 122 (9.1%) patients: 119 (97.5%) were male and 3 (2.5%) females. Median age of patients was 76 years (range, 68.75-81). Overall, 107 (87.7%) patients had both HAs preserved according to following strategy: 45 (36.9%) with flared limbs, 13 (10.6%) with bilateral branched device, and 49 (40.2%) with a combination of flared limb on 1 side and branched device on the contralateral side. Bilateral overstenting was performed in 15 (12.3%) patients. Estimated overall survival was not different between groups of EVAR (Log-rank, P = 0.561). There was only 1 (0.8%) ARM ascertained during the follow-up. Estimated freedom from EVAR-related reintervention was not different among groups (Log-rank, P = 0.464). During the follow-up, 9 (7.4%) patients developed buttock claudication (Society for Vascular Surgery (SVS) grade 1, n = 4, SVS grade 2, n = 5), more frequently in HA overstenting (hazard ratio (HR): 3.6; 95% confidence intervals (CIs): 0.96-13.5, P = 0.058). When all cots were included, branched EVAR still carried the highest burden (P = 0.001) in comparison with the mixed subgroup, the overstenting subgroup, and the flared limbs subgroup. CONCLUSIONS: Early mortality and pelvic ischemic syndromes rate were acceptably low in all techniques. Hypogastric artery preservation showed lower complication rate in comparison with HA overstenting which, however, appears to be safe an effective for option with similar overall costs for patients who are not candidates for HA preservation based on aortic anatomy.

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.

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

BACKGROUND: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. METHODS: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. RESULTS: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (P-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; P=0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (P-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (P-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; P=0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (P=0.95) and postprocedural bleeding requiring intervention (P=0.93) was not significantly increased. CONCLUSIONS: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.

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.

Endovascular Reconstruction for Total Aorto-Iliac Occlusion.

OBJECTIVES: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto-iliac bifurcation in a multicenter Italian registry. METHODS: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto-iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto-iliac bifurcation were included. Early (<30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. RESULTS: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. CONCLUSIONS: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto-iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization.