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Background: The aim of this cohort study was to report the proportion of patients who develop periprocedural acute kidney injury (AKI) after endovascular repair (ER) and open surgery (OS) in patients with juxta/pararenal abdominal aortic aneurysm and to assess potential risk factors for AKI. The study also aimed to report the short- and long-term outcomes of patients with and without AKI., Methods: This was a multicenter cohort study of five European academic high-volume centers (>50 OS or 50 ER infrarenal AAA repairs, plus >15 complex AAA repairs per year). All consecutively treated patients were extracted from a prospective vascular surgical registry and the data were scrutinized retrospectively. The primary end point for this study was the development of AKI. AKI was diagnosed when there is a two-fold increase of serum creatinine or decrease of glomerular filtration rate of >50% within 1 week of AAA repair. Secondary end points included long-term mortality and end-stage renal disease (ESRD)., Results: AKI occurred in 16.6% of patients in the ER group vs 30.3% in the OS group (P < .001). The 30-day mortality rate was higher among patients with AKI in both ER (15.4% vs 3.1%; P = .006) and OS (13.2% vs 5.3%; P = .001) groups. Age, chronic kidney disease, presence of significant thrombus burden in the pararenal region, >1000 mL blood loss in ER group were associated with development of AKI. Age, diabetes mellitus, chronic kidney disease, presence of significant thrombus burden in the pararenal region, and a proximal clamping time of >30 minutes in the OS group were associated with the development of AKI, whereas renal perfusion during clamping was the protective factor against AKI development. After a median follow-up of 91 months, AKI was associated with higher mortality rates in both the ER group (58.9% vs 29.7%; P < .001) and the OS group (61.5% vs 27.3%; P < .001). After the same follow-up period, AKI was associated with a higher incidence of ESRD in both the ER group (12.8% vs 3.6%; P = .009) and the OS group (9.9% vs 2.9%; P < .001)., Conclusions: The current study identified important pre and postoperative factors associated with AKI after juxta/pararenal abdominal aortic aneurysm repair. Patients with postoperative AKI had significantly higher short- and long term mortality and higher incidence of ESRD than patients without AKI., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Abstract: CD19-negative relapse is a leading cause of treatment failure after chimeric antigen receptor (CAR) T-cell therapy for acute lymphoblastic leukemia. We investigated a CAR T-cell product targeting CD19 and CD22 generated by lentiviral cotransduction with vectors encoding our previously described fast-off rate CD19 CAR (AUTO1) combined with a novel CD22 CAR capable of effective signaling at low antigen density. Twelve patients with advanced B-cell acute lymphoblastic leukemia were treated (CARPALL [Immunotherapy with CD19/22 CAR Redirected T Cells for High Risk/Relapsed Paediatric CD19+ and/or CD22+ Acute Lymphoblastic Leukaemia] study, NCT02443831), a third of whom had failed prior licensed CAR therapy. Toxicity was similar to that of AUTO1 alone, with no cases of severe cytokine release syndrome. Of 12 patients, 10 (83%) achieved a measurable residual disease (MRD)-negative complete remission at 2 months after infusion. Of 10 responding patients, 5 had emergence of MRD (n = 2) or relapse (n = 3) with CD19- and CD22-expressing disease associated with loss of CAR T-cell persistence. With a median follow-up of 8.7 months, there were no cases of relapse due to antigen-negative escape. Overall survival was 75% (95% confidence interval [CI], 41%-91%) at 6 and 12 months. The 6- and 12-month event-free survival rates were 75% (95% CI, 41%-91%) and 60% (95% CI, 23%-84%), respectively. These data suggest dual targeting with cotransduction may prevent antigen-negative relapse after CAR T-cell therapy., (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Objective: In the majority of patients with chronic type B aortic dissection, there is persistent retrograde flow in the false lumen (FL) through distal re-entry tears. Among several endovascular techniques proposed for FL management, the "Candy Plug" (CP) technique has gained acceptance with good early results. The aim of this study is to report the types and outcomes of open and endovascular reinterventions and identify mechanisms of procedure failure as well as other causes for reinterventions., Methods: All patients with type B aortic dissection submitted to thoracic endovascular aneurysm repair and CP implantation for FL embolization from January 2016 to December 2022 at our institution were included in this study. The preoperative, intraoperative, and postoperative data of the primary intervention and secondary reinterventions, when performed, were prospectively collected and retrospectively analyzed. Preoperative and postoperative computed tomography angiography were also analyzed., Results: During the study period, 33 patients were submitted to thoracic endovascular aneurysm repair and CP implantation. Twenty-three patients (69.7%) showed thoracic FL complete thrombosis with aortic stability or positive remodeling at a mean follow-up of 45 ± 23.1 months. Ten patients (30.3%) underwent aortic reinterventions (male, n = 9; mean age, 60.5 ± 7.6 years). Of these 10 patients, in four patients, complete thrombosis of the FL was never achieved, leading to ongoing perfusion of the FL, defined as "primary failure." The other six patients underwent reinterventions for different causes: two patients, after initial sealing, showed a progressive enlargement of the abdominal FL leading to distal degeneration. One patient showed proximal degeneration, two patients showed a type II thoracoabdominal aortic aneurysm and CP implantation was used as a planned procedure to reduce the extent of the surgical procedure, and one patient had recurrent, intractable back pain despite complete thrombosis of the FL. Reinterventions were open in five cases and endovascular in five. One in-hospital death (postoperative day 27) after a type II thoracoabdominal aortic aneurysm open repair was recorded. In addition, two cases of delayed spinal cord ischemia after open reintervention were recorded: one resulting in permanent paraplegia and one transitory with complete recovery., Conclusions: The CP technique was safe and effective; however, a significant rate of aortic-related reintervention was observed. Several mechanisms led to reinterventions either in terms of "primary failure" of the CP or subsequent aneurysmal degeneration. Complex reinterventions were often necessary, with a high rate of major complications in case of open repair. Life-long and closer surveillance might be required in these patients., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters., Methods: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter., Results: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively., Conclusions: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To assess branch vessel outcomes after endovascular repair of complex aortic aneurysms analyzing possible factors influencing early and long-term results., Methods: The Italian Multicentre Fenestrated and Branched registry enrolled 596 consecutive patients treated with fenestrated and branched endografts for complex aortic disease from January 2008 to December 2019 by four Italian academic centers. The primary end points of the study were technical success (defined as target visceral vessel [TVV] patency and absence of bridging device-related endoleak at final intraoperative control), and freedom from TVV instability (defined as the combined results of type IC/IIIC endoleaks and patency loss) during follow-up. Secondary end points were overall survival and TVV-related reinterventions., Results: We excluded 591 patients (3 patients with a surgical debranching and 2 patients who died before completion from the study cohort) were treated for a total of 1991 visceral vessels targeted by either a directional branch or a fenestration. The overall technical success rate was 98.4%. Failure was related to the use of an off-the-shelf (OTS) device (custom-made device vs OTS, HR, 0.220; P = .007) and a preoperative TVV stenosis of >50% (HR, 12.460; P < .001). The mean follow-up time was 25.1 months (interquartile range, 3-39 months). The overall estimated survival rates were 87%, 77.4%, and 67.8% at 1, 3, and 5 years, respectively (standard error [SE], 0.015, 0.022, and 0.032). During follow-up, TVV branch instability was observed in 91 vessels (5%): 48 type IC/IIIC endoleaks (2.6%) and 43 stenoses-thromboses (2.4%). The extent of aneurysm disease (thoracoabdominal aortic aneurysm [TAAA] types I-III vs TAAA type IV/juxtarenal aortic aneurysm/pararenal aortic aneurysm) was the only independent predictor for developing a TVV-related type IC/IIIC endoleak (HR, 3.899; 95% confidence interval [CI]:, 1.924-7.900; P < .001). Risk of patency loss was independently associated with branch configuration (HR, 8.883; P < .001; 95% CI, 3.750-21.043) and renal arteries (HR, 2.848; P = .030; 95% CI, 1.108-7.319). Estimated rates at 1, 3, and 5 years of freedom from TVV instability and freedom from TVV-related reintervention were 96.6%, 93.8%, and 90% (SE, 0.005, 0.007, and 0.014) and 97.4%, 95.0%, and 91.6% (SE, 0.004, 0.007, and 0.013), respectively., Conclusions: Intraoperative failure to bridge a TVV was associated with a preoperative TVV stenosis of >50% and the use of OTS devices. Midterm outcomes were satisfying, with an estimated 5-year freedom from TVV instability and reintervention of 90.0% and 91.6%, respectively. During follow-up, the larger extent of aneurysm disease was associated with an increased risk of TVV-related endoleaks, whereas a branch configuration and renal arteries were more prone to patency loss., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To compare costs and effectiveness of elective open (OR) vs fenestrated/branched endovascular (ER) repair of thoracoabdominal aneurysms (TAAAs) in a high-volume center., Methods: This single-center retrospective observational study (PRO-ENDO TAAA Study, NCT05266781) was designed as part of a larger health technology assessment analysis. All electively treated TAAAs between 2013 and 2021 were analyzed and propensity-matched. End points were clinical success, major adverse events (MAEs), hospital direct costs, and freedom from all causes and aneurysm-related mortality and reinterventions. Risk factors and outcomes were homogeneously classified according to the Society of Vascular Surgery reporting standards. Cost-effectiveness value and incremental cost-effectiveness ratio were calculated, considering the absence of MAEs as a measure of effectiveness., Results: Propensity matching identified 102 pairs of patients out of 789 TAAAs. Mortality, MAE, permanent spinal cord ischemia rates, respiratory complications, cardiac complications, and renal injury were higher for OR (13% vs 5%, P = .048; 60% vs 17%, P < .001; 10% vs 3%, P = .045; 91% vs 18%, P < .001; 16% vs 6%, P = .024; 27% vs 6%, P < .001, respectively). Access complication rate (6% vs 27%; P < .001) was higher in the ER group. Intensive care unit stay was longer (P < .001) for OR, and ER patients were discharged home more frequently (3% vs 94%; P < .001). No differences in midterm end points were observed at 2 years. Despite ER reducing all the hospital cost items (-42% to -88%, P < .001), the higher expenses (P < .001) of the endovascular devices increased the overall cost of ER by 80%. Cost-effectiveness value for ER was favorable to OR (56,365 vs 64,903 €/patient) with an incremental cost-effectiveness ratio of 48,409 € per MAE saved., Conclusions: ER of TAAA reduces perioperative mortality and morbidity compared with OR, with no differences in reinterventions and survival rates at midterm follow-up. Despite the expenses for endovascular grafts, ER was found to be more cost-effective in preventing MAEs., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs)., Methods: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality., Results: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach., Conclusions: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: In the field of thoracoabdominal aortic aneurysm (TAAA) open surgical repair (OSR), some preoperative characteristics are established risk factors for adverse outcomes, whereas others are supposed to be relevant, but their role still need to be defined; among them, the presence of "shaggy aorta" (SA), an extensive and irregular atheroma within the aorta. The aim of this study is to report the results of a single-center large cohort of patients treated with OSR for TAAA with SA, comparing the outcomes with patients affected by TAAA without SA, and analyzing the impact of the scores for SA on the outcomes., Methods: All consecutive patients receiving OSR for TAAA between 2012 and 2021 were retrospectively analyzed. Clinical data from patients with degenerative TAAA were included and analyzed for preoperative characteristics and postoperative outcomes; patients with ruptured TAAA, and patients with aortic dissection were excluded from the analysis. Patients with degenerative aortic aneurysm, thrombus measurement in non-aneurysmal aortic segments (≤40 mm), atheroma thickness ≥5 mm, and finger-like thrombus projection were included in the SA group, whereas the others were included in the non-shaggy aorta group (NSA group). The SA group and NSA group were compared using a propensity-matched comparison. Preoperative computed tomography scans of patients in the SA group were also stratified according to SA grading scores., Results: A total of 58 patients with SA were identified (male, n = 43 [74.1%], mean age 70.1 ± 7.8 years) among 497 patients with TAAA treated with open surgical repair. After propensity matching, there were 57 patients in the SA group and 57 in the NSA group with correction of all differences in baseline characteristics. Patients in the SA group presented significantly higher in-hospital mortality (SA group, 14.0% vs NSA group, 3.5%; P = .047), postoperative acute renal failure (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease [RIFLE], 3-5) (SA group, 21.1% vs NSA group, 5.3%; P = .013), and postoperative embolization (SA group, 28.1% vs NSA group, 8.8%; P = .008). Spinal cord ischemia and stroke rate were not significantly influenced by the presence of SA. In the SA group, 16 patients (27.6%) with end-organ embolization were compared with 42 patients (72.4%) without a documented embolization considering the grade of aortic "shagginess" and no significant difference was identified (P = .546)., Conclusions: Despite a better knowledge of the SA disease, new classifications, and intraoperative adjuncts, TAAA patients with SA treated with OSR have worse postoperative outcomes if compared with patients without SA. The presence of SA is a risk factor itself, whereas the grade of "shagginess" seems not to impact on postoperative outcomes., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Cerebral circulatory arrest times >40 minutes during aortic surgery have previously been shown to be associated with increased morbidity and mortality. The purpose of this study was to redefine what would constitute a safe period of circulatory arrest for patients who underwent elective proximal aortic operations requiring antegrade cerebral perfusion (ACP)., Methods: The ARCH International aortic database was queried, and 2008 patients undergoing elective arch operations with circulatory arrest using ACP were identified. Circulatory arrest time was categorized a priori in 10-minute intervals. To further determine the impact of this variable on outcomes, hierarchical multivariable regression analysis was performed., Results: Unadjusted mortality increased with increasing circulatory arrest time from 4.8% (<40 minutes) to 13.5% (>90 minutes; P < .001), but risk of stroke was not impacted (P = .4). When treated as a continuous variable, mortality increased significantly with increasing circulatory arrest time, whereas the risk of permanent stroke did not. Using <40 minutes as the reference, multivariable analysis showed no statistical increase in mortality for ranges up to 80 minutes of circulatory arrest. The risk of permanent stroke was not significantly higher for any time interval >40 minutes up to 90 minutes., Conclusions: In this series of patients who underwent elective proximal aortic surgery using ACP, periods of circulatory arrest up to at least 80 minutes were not associated with significant increases in mortality or permanent stroke. Modern perfusion strategies have allowed for increased safety during elective arch cases requiring prolonged periods of circulatory arrest., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Aberrant subclavian artery (AScA) with or without associated Kommerell's diverticulum (KD) is the most frequently encountered anomaly of the aortic arch, it may be life threatening, especially when associated with aneurysmal degeneration. The best management is still debated and depends on many clinical and anatomical factors. A systematic review was conducted to assess the current evidence on the treatment options and their efficacy and safety for AscA and KD repairs., Methods: A literature search in PubMed and Cochrane Library was performed, and articles that were published from January 1947 to August 2021 reporting on AscA and KD management were identified. Multicenter studies, single-center series, and case series with three or more patients were considered eligible in the present review. A comparison of outcomes of patients who underwent open surgery (OS), a hybrid approach (HA), and total endovascular repair (ER) (ie, 30-day mortality and stroke were analyzed when available and compared among the three groups (P < .05; Benjamini and Hochberg-adjusted P < .05; Bonferroni-adjusted P < .05). Titles, abstracts, and full texts were evaluated by two authors independently. Primary outcomes included survival rate, perioperative stroke, arm ischemia, and spinal cord ischemia. Endoleak, in the case of HA and ER, and reintervention rates were considered outcomes., Results: Three hundred thirty-one articles were initially evaluated and 30 studies, totaling 426 patients treated for AScA with 324 KD, were included. Of the 426 patients, 241 were male (56.5%), and the mean patient age was 57.9 ± 12.0 years. The approach was OS in 228 patients, HA in 147 patients, and ER in 51. Dysphagia was the most common presentation in 133 cases. Aortic rupture was observed in 16 of the 426 patients (3.8%), including 14 AScA/KD (3.3%) aneurysm rupture. KD maximum diameter varied widely from 12.6 to 63.6 mm. The overall 30-day mortality was 20 (4.7%) (OS group 8/228 [3.5%]; HA group 10/147 [6.8%]; ER 2/51 [3.9%]; P = NS). The overall stroke rate was 4.9% (21/426) (OS group 10/228 [4.4%]; HA group 6/147 [4.1%]; ER group 5/51 [9.8%]; P = NS), including nine transient and nondisabling neurological deficits. Overall secondary procedures for complications were reported in 36 of the 426 cases (8.4%), mostly owing to endoleak. Follow-up varied from 13 to 74 months., Conclusions: This systematic review assessed the current outcomes of the three types of therapeutic management for AScA and KD and demonstrated that they are all relatively safe and effective, providing satisfactory early and midterm outcomes. Long-term outcomes are warranted, especially for total ERs since the long-term durability of stent grafts remains unknown., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Fenestrated and branched endografting (F/B-EVAR) has been proposed as an endovascular solution for chronic post-dissection thoraco-abdominal aneurysms (PD-TAAAs). The aim of this study was to analyse the experience of four high volume centres nationwide and the current available literature., Methods: Data on patients undergoing F/B-EVAR in four Italian academic centres between 2008 and 2019 were collected, and those from patients with PD-TAAAs were analysed retrospectively. Peri-operative morbidity and mortality were assessed as early outcomes. Survival, freedom from re-intervention (FFR), target visceral vessel (TVV) patency, and aortic remodelling were assessed as follow up outcomes. A MEDLINE search was performed for studies published from 2008 to 2020 reporting on F/B-EVAR in PD-TAAAs., Results: Among 351 patients who underwent F/B-EVAR for TAAAs, 37 (11%) had PD-TAAAs (Crawford's extent I-III: 35% - 95%). Overall, 135 TVVs (from true lumen 120; false lumen seven; both true and false lumen eight) were accommodated by fenestrations (96% - 71%) and branches (39% - 29%). Technical success (TS) was achieved in 34 (92%) cases with three failures due to endoleaks (Ia: 1; Ic: 1; III: 1). There were no 30 day deaths. No cases of permanent spinal cord ischaemia (SCI) were recorded and six (16%) patients suffered from transient deficits. Renal function worsening (eGFR < 30% than baseline) and pulmonary complications were reported in two (5%) and four (11%) cases, respectively. From the Kaplan-Meier analysis, three year survival, FFR, and TVV patency were 81%, 66%, and 97%, respectively. Radiological imaging was available for 30 (81%) patients at 12 months with complete false lumen thrombosis in 26 (87%). Two hundred and fifty-six patients were reported in seven published papers with TS, 30 day mortality, and SCI ranging from 99% to 100%, 0 to 6%, and 0 to 16%, respectively. The mean follow up ranged from 12 to 26 months, with estimated two year survival between 81% and 90% and a re-intervention rate between 19% and 53%., Conclusion: F/B-EVAR is effective to treat PD-TAAAs. A high re-intervention rate is necessary to complete the aneurysm exclusion and promote aortic remodelling successfully., (Copyright © 2022. Published by Elsevier B.V.)

Objective: Although endovascular repair of thoraco-abdominal aortic aneurysm (TAAA) is the treatment of choice in the high risk population that is ineligible for an open surgical approach, little is known about the association between the type of anaesthesia and complications. This study compared the short term clinical outcomes of patients undergoing the visceral step of TAAA with fenestrated endograft aortic repair (FEVAR) and branched endograft aortic repair (BEVAR) under general anaesthesia (GA) with sedation with monitored care anaesthesia (MAC)., Methods: This single centre, retrospective, observational study recruited 124 consecutive patients undergoing elective F/BEVAR from 2014 - 2021. The primary endpoint was the short term complication rate according to the type of anaesthesia. Secondary endpoints included: need for inotropes or vasopressors for hypotension, time spent in the operating room, and admission to the intensive care unit. Propensity score matching was generated to account for the between group imbalance in the pre-operative covariables., Results: After propensity score matching, 42 patients under GA were matched with 42 under MAC. The two groups showed no difference in cardiac and non-cardiac complications. Among the secondary outcomes, a higher number of patients in the GA group required inotropes or vasopressors compared with MAC (33% vs. 9%; p = .031). Although GA and MAC showed the same 30 day technical success (81% vs. 83%; p = .078), non-significant lower rates of major adverse events (10% vs. 12%; p = .72), one year re-intervention (14% vs. 21%; p = .39), and one year target vessel instability (10% vs. 21%; p = .39) were observed in the GA group. Overall, the in hospital mortality rate was 4%, with no difference between GA and MAC (2% vs. 5%; p = 1.0)., Conclusion: The type of anaesthesia seemed to have no effect on procedure success, peri-operative morbidity, or mortality in patients undergoing F/BEVAR., (Copyright © 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: To report the outcomes of fenestrated-branched endovascular repair (FBEVAR) for thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk (TAR+FET)., Methods: Interrogation of prospectively maintained databases from four high-volume aortic centers identified consecutive patients treated with distal FBEVAR after prior TAR+FET between August 2013 and September 2020. The primary end point was 30-day/in-hospital mortality. Secondary end points were technical success, early clinical success, midterm survival, and freedom from reintervention. Data are presented as median (interquartile range)., Results: A total of 39 patients (21 men; median age, 73 years [67-75 years]) with degenerative (n = 22) and postdissection thoracoabdominal aortic aneurysms (n = 17) (median diameter, 71 mm [61-78 mm]) were identified. Distal FBEVAR was intended in 27 patients (median interval, 9.8 months [6.2-16.6 months]), anticipated in 7, and unexpected in 5. A total of 31 patients had a two- (n = 24) or three-stage (n = 7) distal FBEVAR. Renovisceral target vessel preservation was 99.3% (145 of 146). Early primary and secondary technical success was 92% and 97%, respectively. Thirty-day mortality was 2.6% (n = 1; respiratory failure and spinal cord ischemia [SCI]). Six survivors also developed SCI, which was associated with complete (n = 4) or partial recovery (n = 2) at hospital discharge. No patients required renal replacement therapy or suffered a stroke. Early clinical success was 95%. Median follow-up was 30.5 months (23.7-49.7 months). Eleven patients required 16 late reinterventions. Estimated 3-year survival and freedom from reintervention were 84% ± 6% and 63% ± 10%, respectively., Conclusions: Distal FBEVAR after prior TAR+FET is associated with high technical success and low early mortality. The risk of SCI is significant although the majority of patients demonstrate full or partial recovery before hospital discharge. Midterm patient survival is favorable, but there remains a high requirement for late reintervention. FBEVAR represents an acceptable alternative to distal open thoracoabdominal aortic aneurysm repair., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI., Methods: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed., Results: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02)., Conclusions: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Despite the introduction of several adjuncts to improve spinal perfusion, spinal cord ischemia (SCI) remains a devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair. Our aim was to assess the effects on clinical outcome of interventions triggered by motor evoked potentials (MEP) alerts. Furthermore, we want to assess whether a multimodal intraoperative neurophysiologic monitoring (IONM) protocol is helpful for stratifying patients according to the risk of SCI at the end of the vascular phase of surgery., Methods: We prospectively studied one-hundred consecutive patients who underwent TAAA repair. We applied a multimodal IONM including MEP, somatosensory evoked potentials (SEP) and peripheral nerve monitoring techniques. Signal deteriorations were classified as reversible/irreversible according to whether they recovered or not at the end of monitoring (EOM), set at the end of the vascular phase of surgery. Significant MEP changes drove a series of corrective measures aimed to improve spinal perfusion., Results: The rate of immediate postoperative motor deficits consistent with SCI was significantly higher with irreversible MEP deteriorations compared to reversible ones. The interpretation of MEP findings at the EOM led to the development of risk categories for SCI, based on the association between MEP results and motor outcome., Conclusions: Our data seem to justify interventions made to reverse MEP deterioration in order to improve the clinical outcome. A multimodal IONM protocol could improve MEP interpretation at the end of the vascular phase of surgery, supporting the surgeon in their decision-making, before concluding vascular maneuvers., Competing Interests: Declaration of Competing Interest The authors report no conflicts of interest relevant to this article., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Objective: Management of antithrombotic therapy in patients undergoing elective fenestrated branched endovascular aortic repair (F-BEVAR) is not standardised, nor are there any recommendations from current guidelines. By designing an international expert based Delphi consensus, the study aimed to create recommendations on the pre-, intra-, and post-operative management of antithrombotic therapy in patients scheduled for elective F-BEVAR in high volume centres., Methods: Eight facilitators created appropriate statements regarding the study topic that were voted on, using a four point Likert scale, by a selected panel of international experts using a three round modified Delphi consensus process. Based on the experts' responses, only those statements reaching Grade A (full agreement ≥ 75%) or B (overall agreement ≥ 80% and full disagreement < 5%) were included in the final document. The round answers' consistency was graded using Cohen's k, the intraclass correlation coefficient, and, in case of double re-submission, the Fleiss k., Results: Sixty-seven experts were included in the final analysis and voted the initial 43 statements related to pre- (n = 15), intra- (n = 10), and post-operative (n = 18) management of antithrombotic drugs. At the end of the process, six statements (13%) were rejected, 20 statements (44%) received a Grade B consensus, and 18 statements (40%) reached a Grade A consensus. Most statements (27; 71%) exhibited very high or high consistency grades, and 11 (29%) a fair or poor grading. The intra-operative statements mostly concentrated on threshold for and monitoring of proper heparinisation. The pre- and post-operative statements mainly focused on indications for dual antiplatelet therapy and its management, considering the possible need for cerebrospinal fluid drainage., Conclusion: Based on the elevated strength and high consistency of this international expert based Delphi consensus, most of the statements might guide current clinical management of antithrombotic therapy for elective F-BEVAR. Future studies are needed to clarify the debated issues., (Copyright © 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: Procedural staging is often performed to reduce the incidence of spinal cord ischemia (SCI) during endovascular treatment of extensive thoracoabdominal aortic aneurysms (TAAAs). However, its role in the case of previous thoracic or infrarenal aortic repair (historical staging) has been controversial. In the present study, we evaluated the SCI rates when procedural staging was routinely used and studied its potential benefits when previous aortic repairs had already been performed., Methods: The data from patients treated electively with fenestrated/branched endovascular aortic repair for extent I, II, III, and V TAAAs were retrieved from a multicenter registry (four high-volume national teaching hospitals) and analyzed. The primary endpoint was the rate of SCI and its association with preoperative and postoperative variables, including historical staging, procedural staging, and an impaired collateral network (subclavian or hypogastric stenosis >75% per occlusion). Variables were defined in accordance with the Society for Vascular Surgery reporting standards. A logistic regression model with stepwise selection was used to identify the predictors of SCI., Results: A total of 240 patients (76% male; median age, 73 years) were analyzed. Of the 240 patients, 43 (18%) had presented with an impaired collateral network, 136 (57%) had had historical staging, and 157 (65%) had received procedural staging. Preoperative spinal fluid cerebrospinal drainage was performed in 130 patients (54%). Permanent grade 3 SCI was observed in 13 patients (5%) and was negatively affected by both an impaired collateral network (odds ratio [OR], 17.3; 95% confidence interval [CI], 1.7-176; P = .016) and the presence of bilateral iliac occlusive disease (OR, 10.1; 95% CI, 1.1-98.3; P = .046). Both historical (OR, 0.02; 95% CI, 0.001-0.46; P = .014) and procedural (OR, 0.01; 95% CI, 0.02-0.7; P = .019) staging mitigated the permanent SCI rates. The need for postoperative transfusions (OR, 1.4; 95% CI, 1.1-1.8; P = .014) and the occurrence of postoperative renal complications (OR, 6.5; 95% CI, 1.2-35.0; P < .001) were associated with the development of SCI. Among the patients with historical staging, no further benefit from procedural staging was observed (SCI with procedural staging, 1%; vs no staging, 2%; P = NS)., Conclusions: For patients with extensive TAAAs treated with fenestrated/branched endovascular aortic repair, both historical and planned procedural staging were associated with reduced permanent SCI rates. However, no additional benefit was observed when procedural staging was performed in patients with historical staging and an intact collateral network. The protective role of preoperative cerebrospinal fluid drainage placement requires further investigation., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of the present study was to assess the early and mid-term outcomes of open surgical repair (OSR) for popliteal artery aneurysms (PAAs) with prosthetic grafts., Methods: The pre-, intra-, and postoperative data for all the patients who had undergone OSR for PAAs with prosthetic grafts at our Institution between January 2009 and July 2019 were included in a prospectively maintained database, which was retrospectively analyzed. Primary patency was defined as uninterrupted flow (<50% stenosis) in the graft with no additional procedures performed. Secondary patency was defined as the restoration of graft patency., Results: A total of 82 patients had undergone OSR for 104 PAAs (median age, 71 years; interquartile range [IQR], 67-78 years; 82 men) with prosthetic grafts. Of the 104 PAAs, 72 (68%) had been asymptomatic. The median diameter was 30 mm (IQR, 24-37 mm). A medial approach was used for 35 PAAs (34%) and a posterior approach for 69 (65%). The repairs consisted of aneurysmectomy or aneurysm ligation without removal with an interposition graft placed and end-to-end anastomoses. The median operative time was 120 minutes (IQR, 103-142 minutes). The estimated blood loss was 281 mL (IQR, 150-281 mL). Only one patient treated with a posterior approach sustained a permanent peroneal nerve lesion. A second patient also treated via the posterior approach had required surgical revision for bleeding on postoperative day 2. No temporary lesions were recorded. No early amputations were required, and no perioperative deaths occurred. The median length of stay was 3 days (IQR, 3-4 days). An expanded polytetrafluoroethylene graft was used in 92 cases (88%) and a Dacron graft in 12 cases (12%). An 8-mm graft was used in 64 cases (62%). The median follow-up was 34.6 months (IQR, 8.5-62.7 months). No related mortality occurred. Of the 104 PAAs, 19 had required reintervention, with primary and secondary patency of 78% and 88% at 3 years, respectively. The median interval to reintervention was 28.3 months., Conclusions: OSR of PAAs with prosthetic grafts is safe and feasible, with good mid-term results and satisfactory primary and secondary patency at 3 years., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the technique and outcomes of intentional occlusion of directional branches (DBs) using endovascular plugs during branched endovascular aortic repair using off-the-shelf Zenith t-Branch thoracoabdominal (TAAA) stent grafts., Methods: We reviewed the clinical data and outcomes of all consecutive patients treated by branched endovascular aortic repair using off-the-shelf Zenith t-Branch TAAA stent-graft (Cook Medical, Bloomington, Ind) in seven academic centers from 2013 to 2019. All patients had at least one DB intentionally occluded using extension of the branch with balloon or self-expandable covered stent, followed by placement of endovascular plugs. Intentional occlusion was indicated in patients with variations in the normal four-vessel renal-mesenteric anatomy, pre-existing dialysis, or in those who failed catheterization of a target vessel. End points were 30-day/in-hospital mortality, major adverse events, secondary interventions, target artery (TA) patency, TA instability, and patient survival., Results: There were 100 patients, 65 male and 35 female, with median age of 71 years (interquartile range [IQR], 66-75 years). Of these, 31 patients (31%) had urgent/emergent operations for symptomatic/contained ruptured aneurysms. The median aneurysm diameter was 72 mm (IQR, 61-85 mm). A total of 290 renal-mesenteric arteries were incorporated with a median of three (IQR, 3-3) vessels/patient. Indications for DB occlusion were less than four suitable renal-mesenteric targets in 84 patients or pre-existing dialysis and inability to catheterize a target vessel in eight patients each. There were 110 DBs occluded by vascular plugs, including 48 celiac axis, one superior mesenteric artery, and 61 renal DBs. Thirty-day/in-hospital mortality was 10%, including 9% for elective and 13% for urgent/emergent procedures. Major adverse events occurred in 44 patients (44%), including acute kidney injury in 19 patients (19%), estimated blood loss >1 L in 12 patients (12%), respiratory failure and new onset dialysis in six patients (6%) each, bowel ischemia in five patients (5%), and myocardial infarction and paraplegia in two patients (2%) each. The median follow-up was 5 months (range, 1-13 months). Eighteen patients (18%) required secondary interventions, none for problems related to the occluded DB. There were no endoleaks related to the occluded DB. At 2 years, primary and secondary patency and freedom from TA instability were 93% ± 3%, 97% ± 2%, and 91% ± 4%, respectively. Freedom from secondary interventions and patient survival were 75% ± 6% and 63% ± 7%, respectively., Conclusions: Intentional occlusion of DBs using endovascular plugs allows versatile use of a four-vessel off-the-shelf multi-branched TAAA stent graft in patients with variations in the normal renal and mesenteric anatomy or when technical difficulties prevent successful target vessel stenting. There were no endoleaks or secondary interventions associated with the occluded DB., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Allogeneic hematopoietic stem cell transplantation (HSCT) is a potentially curative treatment for patients affected by Wiskott-Aldrich syndrome (WAS). Reported HSCT outcomes have improved over time with respect to overall survival, but some studies have identified older age and HSCT from alternative donors as risk factors predicting poorer outcome. We analyzed 197 patients undergoing transplant at European Society for Blood and Marrow Transplantation centers between 2006 and 2017 who received conditioning as recommended by the Inborn Errors Working Party (IEWP): either busulfan (n = 103) or treosulfan (n = 94) combined with fludarabine ± thiotepa. After a median follow-up post-HSCT of 44.9 months, 176 patients were alive, resulting in a 3-year overall survival of 88.7% and chronic graft-versus-host disease (GVHD)-free survival (events include death, graft failure, and severe chronic GVHD) of 81.7%. Overall survival and chronic GVHD-free survival were not significantly affected by conditioning regimen (busulfan- vs treosulfan-based), donor type (matched sibling donor/matched family donor vs matched unrelated donor/mismatched unrelated donor vs mismatched family donor), or period of HSCT (2006-2013 vs 2014-2017). Patients aged <5 years at HSCT had a significantly better overall survival. The overall cumulative incidences of grade III to IV acute GVHD and extensive/moderate/severe chronic GVHD were 6.6% and 2.1%, respectively. Patients receiving treosulfan-based conditioning had a higher incidence of graft failure and mixed donor chimerism and more frequently underwent secondary procedures (second HSCT, unconditioned stem cell boost, donor lymphocyte infusion, or splenectomy). In summary, HSCT for WAS with conditioning regimens currently recommended by IEWP results in excellent survival and low rates of GVHD, regardless of donor or stem cell source, but age ≥5 years remains a risk factor for overall survival., (© 2022 by The American Society of Hematology.)

Objectives: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics., Background: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating., Methods: Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes., Results: At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores., Conclusions: The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676)., Competing Interests: Funding Support and Author Disclosures The study was funded by Alvimedica. Dr Steiner has served as a consultant for Bayer, Boston Scientific, and Cook Medical; and received research funding from C.R. Bard. Dr Chiesa has served as a consultant for W.L. Gore and Cordis. Dr Kahlberg has served as a consultant or lecturer for Abbott, Alvimedica, Biovascular, Boston Scientific, Cordis, Medtronic, Terumo, and W.L. Gore. Dr Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, W.L. Gore and Associates, Medtronic, Philips-Spectranetics, and Shockwave; and has served as a consultant for Boston Scientific, W.L. Gore and Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical; and owns common stock in QT Medical. Dr Commeau has served as a consultant for Medtronic, Abbott, Terumo, Boston SCI, and Edwards Lifesciences. Dr Cremonesi has served as a consultant or on the advisory board for Abbott, Medtronic, Boston Scientific, and Terumo. Dr Marone has served as a consultant for QMedics. Dr Scheinert has served as a consultant or on the advisory board for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, and Upstream Peripheral Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches., Methods: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique., Results: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively., Conclusions: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To propose an endovascular-oriented classification of celiac trunk aneurysms (CTa) and discuss single center results of this rare pathology., Methods: Data of all patients admitted to our institution for CTa from 2011 to 2021 were prospectively collected. Of them, those who underwent endovascular treatment were retrospectively analyzed. All preoperative CT scans were reviewed and CTa were classified in 4 different configurations based on progressive distal landing zone. We excluded from the classification all cases with median arcuate ligament syndrome (MALS), patients with coexistent aortic dilation or no endovascular proximal neck. Preoperative demographics, intraoperative data and post-operative complications were recorded. All-cause late mortality and complications were identified through a review of office charts and telephone assessment., Results: During the study period 19 patients were referred to our Institution for CTa. Ten patients underwent endovascular treatment (ET). In 6 cases a watchful waiting strategy was adopted, 2 (10.5 %) patients refused ET and one patient without suitable proximal landing zone (< 10 mm) was not proposed to open surgical repair for surgical contraindication but is followed by strict instrumental and clinical evaluation. Six (60%) patients presented type 2 CTa; all of them underwent ET requiring positioning of covered stent-graft and SA embolization. Three (30%) patients presented type 3 CTa; all of them underwent ET with covered stent-graft deployment over the GDA with preliminary embolization. One (10%) patient presented type 4 CTa that was treated by means of covered stent-graft deployment along the right hepatic artery with left hepatic artery embolization. Overall, no major complications and perioperative mortality was observed., Conclusion: Celiac trunk aneurysms are rare, and no classifications have still been presented. Stent-graft exclusion provides excellent short-term outcome with no significant morbidity and mortality rate when technically feasible., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: The best management of renal artery aneurysms (RAAs) remains controversial, especially when they are located from the mid to distal portions of the main renal artery. Our aim is to evaluate our 10-year experience with in situ open surgical repairs from a cohort of non-proximal RAAs at a single vascular surgery center., Methods: A retrospective review of a prospectively maintained database of all patients who underwent RAA in situ repairs located from the mid to distal portions of the renal artery at our Institution was performed between 2009 and 2020. Data on patient demographics, comorbidities, aneurysm location and morphology, type of in situ technique, and perioperative data were assessed. Postoperative biomarkers and renal function were collected, and mid-term follow-up results were analyzed., Results: A total of 15 RAA located at mid and distal portions of the renal artery repaired with in situ techniques were performed in 15 patients (nine men, mean age 62.4 ± 6.36 years). At diagnosis, 12 patients were asymptomatic; a history of abdominal pain was found in one patient, and two patients had drug-resistant hypertension. Two patients had already undergone previous unsuccessful attempts of endovascular treatment. All patients presented an aneurysm diameter >20 mm (mean diameter 2.75 ± 5 mm). At admission, mean serum creatinine and glomerular filtration rate were 1.10 ± 0.23 mg/dL and 69.8 ± 9.8 mL/min/1.73 m 2 , respectively. Nine lesions were present in the distal portion of the renal artery, with 4 cases having ≥3 efferent branches and the other 5 with two efferent branches. The other six RAAs were in the mid-portion: in 4 cases, one efferent branch, and in 2 cases, two efferent branches were involved. All patients underwent in situ open repair: an end-to-end anastomosis was performed in 9 cases, aneurysm resection with primary closure in 3 cases, bypass with graft interposition in 2 cases (one iliac-renal reconstruction), and with vein interposition in 1 case. The mean renal ischemia time was 21.8 ± 9.4 min. A significant decrease on renal function was not observed (mean glomerular filtration rate at discharge: 64.8 ± 12.0 mL/min/1.73m 2 ; P > 0.22). During recovery, one patient developed retroperitoneal hematoma treated conservatively. During follow-up (mean 46 months, range 2-135), one patient developed occlusion of a terminal renal artery branch without decreased kidney function., Conclusion: In situ techniques for RAA from the mid to distal portions of the renal artery are technically complex; however, based on our results, these procedures were safe and effective, providing satisfactory early and mid-term outcomes., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Complex aortic aneurysms (juxtarenal aortic aneurysms [JAAA], pararenal aortic aneurysms [PAAAs], thoracoabdominal aortic aneurysms TAAAs) are treated with increasing frequency through fenestrated and branched endovascular repair (F/B-EVAR); however, the outcome of these procedures is usually reported separately by single experiences and wider overviews are not frequent. The aim of this study was therefore to report an Italian experience analyzing the results obtained in four academic centers to evaluate the predictors of outcomes., Methods: Between 2008 and 2019, all consecutive patients undergoing F/B-EVAR in four Italian university centers were recorded prospectively and analyzed retrospectively. Preoperative comorbidities and postoperative complications were classified according with the Society for Vascular Surgery reporting standard. Postoperative complications and 30-day/in-hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions and target visceral vessels patency were assessed as follow-up outcomes by Kaplan-Meier analysis. Risk factors for 30-day/in-hospital mortality and spinal cord ischemia (SCI) were determined by multivariate analysis. Risk factors for follow-up mortality and reinterventions were evaluated by Cox regression model., Results: Five hundred ninety-six patients underwent F/B-EVAR for 124 JAAAs (21%), 121 PAAAs (20%), and 351 TAAAs (59%). Elective and urgent procedures were performed in 520 (87%) and 76 (13%) cases, respectively. Postoperative cardiac, pulmonary, and renal complications were reported in 41 (7%), 50 (8%), and 80 (13%) patients, respectively. Seven bowel ischemia (1%) and 23 cerebrovascular complications (4%) occurred. Forty-seven (8%) patients suffered SCI with 17 cases (3%) of permanent paraplegia. Crawford's extent I-II-III TAAAs (odds ratio [OR], 13.41; 95% confidence interval [CI], 1.77-101.65; P = .012) and postoperative renal complications (OR, 3.84; 95% CI, 1.70-8.69; P = .001) independently predicted SCI. Thirty-two patients (5%) died in the perioperative period. Preoperative chronic renal failure (OR, 7.81; 95% CI, 7.81-26.31; P = .001), postoperative bowel ischemia (OR, 26.97; 95% CI, 3.37-215.5; P = .002), cardiac complications (OR, 5.77; 95% CI, 1.41-23.64; P ≤ .001), cerebrovascular complications (OR, 28.63; 95% CI, 5.20-157.5; P < .001), and SCI (OR, 5.99; 95% CI, 1.12-32.5; P = .036) were independently correlated with 30-day/in-hospital mortality. The mean follow-up was 25 ± 7 months. Freedom from target visceral vessels occlusion and freedom from reintervention were 96% and 92% at 1 year and 93% and 85% at 3 years, respectively. TAAAs (hazard ratio [HR]. 3.16; 95% CI, 1.68-5.92; P ≤ .001), postdissection TAAAs (HR, 2.20; 95% CI, 1.30-4.90; P = .05) and postoperative bowel ischemia (HR, 11.98; 95% CI, 1.53-93.31; P = .018) were independent predictors of reinterventions. Survival was 88% and 78% at 1 and 3 years, respectively. Preoperative chronic renal failure (HR, 2.39; 95% CI, 1.59-3.59; P ≤ .001), urgent repair (HR, 1.80; 95% CI, 1.03-3.20; P = .039), TAAAs (HR, 2.01; 95% CI, 1.13-3.56; P = .017), postoperative bowel ischemia (HR, 5.55; 95% CI, 2.11-14.59; P = .001), cardiac complications (HR, 3.89; 95% CI, 2.25-6.71; P ≤ .001), and pulmonary complications (HR, 1.97; 95% CI, 1.56-3.35; P = .013) were independent predictors of mortality during follow-up., Conclusions: F/B-EVAR is associated with satisfactory midterm outcomes in a nationwide experience. A variety of risk factors should be considered in F/B-EVAR indications and postoperative patient management to decrease the risk of postoperative complications and improve midterm outcomes., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We compared the theoretical anatomic feasibility of endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with three off-the-shelf multibranched stent-grafts: t-Branch (Zenith t-Branch; Cook Medical, Bloomington, Ind), Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz), and E-nside (E-nside multibranch stent graft system; Jotec GmbH, Hechingen, Germany)., Methods: Computed tomography scans of patients with degenerative TAAAs treated from 2007 to 2019 were reviewed, and the anatomic feasibility of the multibranched stent-grafts was assessed according to the manufacturer's instructions for use. The anatomic factors determining the overall feasibility were divided into access feasibility, aortic feasibility, and visceral vessel feasibility., Results: Degenerative TAAAs in 268 patients were analyzed. The overall feasibility did not differ significantly (TAMBE, 33%; t-Branch, 39%; E-nside, 43%; P = .271). Access, aortic, and visceral vessel feasibility alone excluded 18% to 22%, 35% to 49% and 21% to 26% of the patients respectively. The only significant difference between the devices was in aortic feasibility (P = .005), which was more frequently limited by the proximal aortic neck diameter in the TAMBE cohort and the inner visceral aortic diameter in the t-Branch cohort. The overall treatment feasibility using any of the three devices would have been 58%., Conclusions: The new investigational off-the-shelf multibranched stent-grafts did not significantly improve the theoretical applicability in an extensive cohort of patients with TAAAs. Improvements are warranted to increase their overall feasibility., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection., Methods: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed., Results: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material., (Copyright © 2021. Published by Elsevier Inc.)

Objective: The analysis of endovascular treatment of thoracic aortic diseases using new low-profile stent grafts in large series is crucial to understanding the durability of these devices. The present study reports the midterm outcomes of a single-center experience using the Zenith Alpha thoracic endovascular stent graft., Methods: The outcomes of 270 procedures performed on 262 patients (197 men; mean age, 70.5 ± 9.5 years) using the Zenith Alpha thoracic endovascular stent graft from November 2013 to December 2019 for different thoracic aortic diseases were analyzed. The primary endpoints were 30-day clinical success and midterm (5-year) clinical success. The secondary endpoints were the adverse event rate at 30 days and midterm and access- and device-related complications. The follow-up of surviving patients was performed using computed tomography angiography and office visits at 1, 6, and 12 months and annually thereafter. Kaplan-Meier analysis was performed for overall survival, and freedom from thoracic aortic endovascular repair-related mortality and related reinterventions., Results: The overall 30-day mortality was 5.2% (2.5% for elective and 30.8% for nonelective cases). Type I endoleaks were identified in six patients. The 30-day primary technical and clinical success rates were 97.8% and 92.6%, respectively. Femoral cutdown was used in 41.1% of cases and percutaneous access in 58.5%. The rate of femoral artery complications after the percutaneous approach was 5.1%, with the need for surgical conversion in 1.9%. The stroke rate was 4.1% (major stroke, 2.2%), and the spinal cord ischemia rate was 3.7% (permanent paraplegia, 0.7%). Of the 248 survivors, 239 complied with the follow-up protocol with adequate computed tomography angiograms available images. Overall follow-up survival was 94.0% at 1 year, 91.6% at 2 years, 88.9% at 3 years, and 88.5% at 5 years. The unplanned secondary endovascular procedure rate was 5.3%. No stent fractures or new-onset type I endoleaks due to stent graft migration were observed in the study cohort., Conclusions: The midterm outcomes of this new generation of low-profile devices were satisfactory. The reported low incidence of secondary procedures and the absence of migrations are promising for the long-term durability of these devices., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To determine the relationship between the value of fibrinogen assessed by the FIBTEM clot amplitude at 10 minutes (A10 FIBTEM) measured on admission to the intensive care unit (ICU) and the amount of drainage output at 24 hours, to investigate whether the A10 FIBTEM predicts severe bleeding (SB), and to define A10 FIBTEM thresholds to prevent (trigger) and treat (target) severe bleeding by fibrinogen supplementation., Methods: In a single centre, retrospective observational study, 166 patients underwent elective open thoraco-abdominal aortic aneurysm (TAAA) repair between March 2016 and January 2019. Exclusion criteria were emergency, congenital, or acquired coagulopathy, or administration of P 2 Y 12 inhibitor antiplatelet agents in the five days before surgery. All patients were managed intra-operatively and post-operatively according to a rotational thromboelastometry driven transfusion protocol. The principal endpoint was a composite outcome, which included bleeding, large volume transfusion, and re-operation., Results: FIBTEM clot amplitude after 10 minutes measured on ICU admission and post-operative bleeding at 24 hours showed an inverse linear relationship (R 2  = .03; p = .026). Performance of A10 FIBTEM in predicting SB evaluated by Receiving Operating Curve analysis showed an area under the curve of 0.63 (95% CI 0.56 - 0.70; p = .026) with a best cutoff of 9 mm. An A10 FIBTEM of 3 mm was the cutoff associated with a positive predictive value of 50%, while an A10 FIBTEM of 9 mm showed a negative predictive value of 92%. On multivariable analysis, an A10 FIBTEM ≤ 3 mm remained independently associated with SB., Conclusion: The present investigation shows for the first time in a population undergoing open TAAA repair that an A10 FIBTEM ≤ 3mm on ICU admission is associated with post-operative severe bleeding. Trigger and target values for fibrinogen supplementation, based on A10 FIBTEM, have been provided. The transferability and reliability of these cutoff values require further study., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The characteristics and outcomes of patients undergoing vascular surgery hospitalised and managed in Lombardy are described with a comparison of patients tested positive for COVID-19 (CV19-pos) vs. those tested negative (CV19-neg)., Methods: This was a multicentre, retrospective, observational cohort study which involved all vascular surgery services in Lombardy, Northern Italy. Data were retrospectively merged into a combined dataset covering the nine weeks of the Italian COVID-19 pandemic phase 1 (8 March 2020 to 3 May 2020). The primary outcome was freedom from in hospital death, secondary outcomes were re-thrombosis rate after peripheral revascularisation, and freedom from post-operative complication., Results: Among 674 patients managed during the outbreak, 659 (97.8%) were included in the final analysis: 121 (18.4%) were CV19-pos. CV19-pos status was associated with a higher rate of complications (OR 4.5; p < .001, 95% CI 2.64 - 7.84), and a higher rate of re-thrombosis after peripheral arterial revascularisation (OR 2.2; p = .004, 95% CI 1.29 - 3.88). In hospital mortality was higher in CV19-pos patients (24.8% vs. 5.6%; OR 5.4, p < .001;95% CI 2.86 - 8.92). Binary logistic regression analysis identified CV19-pos status (OR 7.6; p < .001, 95% CI 3.75 - 15.28) and age > 80 years (OR 3.2; p = .001, 95% CI 1.61 - 6.57) to be predictors of in hospital death., Conclusion: In this experience of the vascular surgery group of Lombardy, COVID-19 infection was a marker of poor outcomes in terms of mortality and post-operative complications for patients undergoing vascular surgery treatments., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: During the most aggressive phase of the COVID-19 outbreak in Italy, the Regional Authority of Lombardy identified a number of hospitals, named Hubs, chosen to serve the whole region for highly specialised cases, including vascular surgery. This study reports the experience of the four Hubs for Vascular Surgery in Lombardy and provides a comparison of in hospital mortality and major adverse events (MAEs) according to COVID-19 testing., Methods: Data from all patients who were referred to the Vascular Surgery Department of Hubs from 9 March to 28 April 2020 were collected prospectively and analysed. A positive COVID-19 polymerase chain reaction swab test, or symptoms (fever > 37.5 °C, upper respiratory tract symptoms, chest pain, and contact/travel history) associated with interstitial pneumonia on chest computed tomography scan were considered diagnostic of COVID-19 disease. Patient characteristics, operative variables, and in hospital outcomes were compared according to COVID-19 testing. A multivariable model was used to identify independent predictors of in hospital death and MAEs., Results: Among 305 included patients, 64 (21%) tested positive for COVID-19 (COVID group) and 241 (79%) did not (non-COVID group). COVID patients presented more frequently with acute limb ischaemia than non-COVID patients (64% vs. 23%; p < .001) and had a significantly higher in hospital mortality (25% vs. 6%; p < .001). Clinical success, MAEs, re-interventions, and pulmonary and renal complications were significantly worse in COVID patients. Independent risk factors for in hospital death were COVID (OR 4.1), medical treatment (OR 7.2), and emergency setting (OR 13.6). COVID (OR 3.4), obesity class V (OR 13.5), and emergency setting (OR 4.0) were independent risk factors for development of MAEs., Conclusion: During the COVID-19 pandemic in Lombardy, acute limb ischaemia was the most frequent vascular disease requiring surgical treatment. COVID-19 was associated with a fourfold increased risk of death and a threefold increased risk of major adverse events., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF., Methods: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed., Results: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality., Conclusions: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to evaluate the proportion of pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs) that could theoretically be treated with the investigational GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz) off-the-shelf multibranched endograft., Methods: The preoperative computed tomography scans of patients with pararenal aortic aneurysms and TAAAs treated at a single institution between 2007 and 2017 were reviewed. This cohort included both open and endovascular repairs performed in either elective or urgent/emergent settings. These studies were included in a retrospective feasibility study to verify anatomic feasibility of the TAMBE graft (with four antegrade portals) employed within the manufacturer's investigational instructions for use during the U.S. pivotal trial. The patient cohort was divided into two groups: extended thoracoabdominal aneurysm (E-TAA)-extent I, II, and III TAAA; and limited pararenal and thoracoabdominal aneurysm (L-TAA)-pararenal aortic aneurysm and extent IV TAAA. The anatomic factors determining the overall theoretical feasibility were further divided into three groups: vascular access feasibility, aortic feasibility, and visceral vessel feasibility., Results: Computed tomography scans of 227 patients with degenerative aneurysms were analyzed, 166 with E-TAA and 61 with L-TAA. In the L-TAA group, 49% of the cases could have been treated with the TAMBE endograft alone; access feasibility was 85%, aortic feasibility 74%, and visceral vessel feasibility 72%. In the E-TAA group, only 23% of the cases could have been treated with a TAMBE combined with a GORE CTAG proximal thoracic stent graft; access feasibility was 79%, aortic feasibility 48%, and visceral vessel feasibility 63%. The different feasibility rate was related to a difference in aortic feasibility between L-TAA and E-TAA (74% vs 48%; P = .0008) because of the lack of a dedicated tapered thoracic component., Conclusions: The TAMBE multibranched endograft can theoretically be employed in half of an all-comers cohort of patients with degenerative L-TAA. Development of a dedicated tapered thoracic component is warranted to increase the feasibility for E-TAA, and comparative studies are required to investigate differences with other available off-the-shelf stent grafts., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Carotid artery stenting (CAS) has been proposed as the treatment of choice in case of restenosis (RES) after carotid endarterectomy (CEA). The aim of this study was to analyze periprocedural results of CAS for the treatment of post-CEA RES compared with those of CAS performed for primary carotid stenosis (PRS)., Methods: Data from consecutive patients submitted to CAS at our institution from 2008 to 2016 were retrospectively reviewed. Patients with in-stent RES were excluded. Initially, preoperative risk factors, demographics, intraoperative variables, and perioperative outcomes were analyzed according to the indication groups (PRS and RES). Then, propensity score matching was performed obtaining 2 homogeneous groups of patients. Covariates included were age, gender, hypertension, hyperlipidemia, cardiac disease, chronic renal disease, symptomatic carotid plaque, and positive ipsilateral brain computed tomography scan. Intraoperative data and perioperative outcomes were then compared between the 2 matched groups., Results: Of 480 included patients, 300 (62.5%) underwent CAS for PRS, and 180 (37.5%) for RES. After propensity score analysis (158 patients/group), no significant difference was observed in terms of technical success, number, and type of stent used, except for need of intraoperative atropine administration that was higher in the PRS group (38.6% vs. 13.3%, respectively; P < 0.001). In the perioperative period, composite neurologic event was significantly higher in the PRS group (7.6% vs. 1.9%; P = 0.017). Moreover, need of ionotropic support was higher in the PRS group (8.9% vs. 1.9%; P = 0.0069). Myocardial infarction rate and 30-day mortality were similar in both groups (P = 0.317; P = 1, respectively)., Conclusions: In a large single-center experience, CAS for post-CEA RES was associated with a significantly lower risk of any neurologic event and hemodynamic instability in the perioperative period compared with CAS performed for primary carotid lesions. Our results confirm that post-CEA RES may represent an elective indication for CAS., (Copyright © 2020. Published by Elsevier Inc.)

Objective: The objective of this study was to evaluate the performance of percutaneous femoral access with large-bore sheaths (>21F outer diameter) mainly employed for thoracic and thoracoabdominal aortic endovascular treatment and to stratify the outcomes on the basis of the introducer size., Methods: Between December 2015 and December 2018, all consecutive patients who received endovascular repair through a percutaneous approach with a suture-mediated vascular closure device (VCD) and the preclose technique were included in a retrospective single-center study called Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO). The morphologic characteristics of the access vessels and patients' demographics were recorded, and 30-day closure success was defined as the primary end point. Analysis of the closure success comparing large-bore sheaths vs small-bore sheaths (≤21F outer diameter) was performed after 1:1 propensity score matching of preoperative confounding variables., Results: The closure success rate of the entire study cohort was 94% (622 femoral accesses in 360 patients; median age, 74 years; 84% male). Univariate analysis identified eight different factors associated with failure, but only two remained significant on multivariate analysis: diabetes (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.2; P = .011) and common femoral artery stenosis >50% (OR, 4.5; 95% CI, 1.3-13.7; P = .019). After propensity score matching (1:1, 172 femoral accesses per group), closure success rate was not significantly different between large-bore and small-bore sheaths (90.7% vs 93.0%; P = .43). Multivariate analysis of the large-sheath group identified two factors associated with failure: small (<9 mm) femoral arteries (OR, 6.9; 95% CI, 1.5-31.6; P = .13) and access vessel calcifications involving more than one-third of the circumference (OR, 7.9; 95% CI, 2.1-29.4; P = .002). Neither previous femoral cutdown (44 accesses [23%]) nor percutaneous closure with VCDs (38 accesses [20%]) affected the closure success rate in the large-sheath group. Closure failure did not significantly increase the need for postoperative blood transfusions or hospital length of stay., Conclusions: Off-label use of VCDs and the preclose technique for percutaneous approach with large-bore sheaths needed for complex aortic endovascular procedures is safe and feasible. Closure success rate is not significantly different from that obtained with on-label application of VCDs with smaller sheaths., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study was to report the experience of one of the major "hubs" for vascular surgery in Lombardy, Italy, during the first 7 weeks after total lockdown due to COVID-19 pandemic., Methods: Data from all patients treated at our Department since the decision of the regional healthcare authorities of Lombardy to centralize surgical specialties creating a hub/spoke system (March 9, 2020) were prospectively collected and compared with a retrospectively collected cohort from the same period of year 2019. Primary study end point was defined as primary clinical success. Secondary end points were defined as in-hospital mortality and/or any in hospital major adverse event or lower limb amputation., Results: One hundred sixteen patients were treated (81 men, 70%; median age: 71 years, IQR 65-81). Thirty-two patients (28%) were addressed from spoke hospitals directly referring to our hub, 19 (16%) from hospitals belonging to other hub/spoke nets, 48 (41%) came directly from our emergency department, and 17 (15%) were already hospitalized for COVID-19 pneumonia. Acute limb ischemia was the most observed disease, occurring in 31 (26.7%), 12 (38.7%) of whom were found positive for COVID-19 pneumonia on admission, whereas 3 (9.7%) became positive during hospitalization. Chronic limb ischemia was the indication to treatment in 24 (20.7%) patients. Six (5.2%) patients underwent primary amputation for irreversible ischemia. Aortic emergencies included 21 cases (18.1%), including 13 (61.9%) symptomatic abdominal aortic or iliac aneurysms, 4 (19.0%) thoracoabdominal aortic aneurysms, 2 (9.5%) cases of acute type B aortic dissection (one post-traumatic). Seventeen (14.7%) patients were admitted for symptomatic carotid stenosis (no COVID-19 patients); all of them underwent carotid endarterectomy. Seventeen (14.7%) cases were treated for other vascular emergencies. Overall, at a median follow-up of 23 ± 13 days, primary clinical success was 87.1% and secondary clinical success was 95.9%. We recorded 3 in-hospital deaths for an overall mortality rate of 2.6%. Compared with the 2019 cohort, "COVID era" patients were older (72 vs. 63 years, P = 0.002), more frequently transferred from other hospitals (44% vs. 21%, P = 0.014) and more frequently with decompensated chronic limb threatening ischemia (21% vs. 3%, P = 0.015); surgical outcomes were similar between the 2 cohorts., Conclusions: Since its appearance, SARS-CoV-2 has been testing all national healthcare systems which founds themselves facing an unprecedented emergency. Late referral in the pandemic period could seriously worsen limb prognosis; this aspect should be known and addressed by health care providers. Vascular surgical outcomes in pre-COVID and COVID era were comparable in our experience., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Chronic granulomatous disease (CGD) is a primary immunodeficiency resulting in life-threatening infections and inflammatory complications. Allogeneic hematopoietic cell transplantation (allo-HCT) can cure the disease, but the indication to transplant remains controversial. We performed a retrospective multicenter study of 712 patients with CGD who underwent allo-HCT transplantation from March 1993 through December 2018. We studied 635 children (aged <18 years) and 77 adults. Median follow-up was 45 months. Median age at transplantation was 7 years (range, 0.1-48.6). Kaplan-Meier estimates of overall survival (OS) and event-free survival (EFS) at 3 years were 85.7% and 75.8%, respectively. In multivariate analysis, older age was associated with reduced survival and increased chronic graft-versus-host disease. Nevertheless, OS and EFS at 3 years for patients ≥18 years were 76% and 69%, respectively. Use of 1-antigen-mismatched donors was associated with reduced OS and EFS . No significant difference was found in OS, but a significantly reduced EFS was noted in the small group of patients who received a transplant from a donor with a >1 antigen mismatch. Choice of conditioning regimen did not influence OS or EFS. In summary, we report an excellent outcome after allo-HCT in CGD, with low incidence of graft failure and mortality in all ages. Older patients and recipients of 1-antigen-mismatched grafts had a less favorable outcome. Transplantation should be strongly considered at a younger age and particularly in the presence of a well-matched donor., (© 2020 by The American Society of Hematology.)

Background: To report the use of the Oscor Destino steerable sheath in challenging target visceral vessel (TVV) cannulation/bridging stenting in fenestrated and branched endovascular aneurysm repair (FB-EVAR)., Methods: Between 2016 and 2018, patients undergoing FB-EVAR for juxtarenal/pararenal aneurysms (j/p-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) were recorded. Cases requiring the use of the steerable sheath as planned or unplanned maneuvers were analyzed. Technical success, freedom from reinterventions, and TVV patency were assessed., Results: Two hundred sixty patients underwent FB-EVAR to treat j/p-AAAs and TAAAs, for an overall of 956 TVVs. Among these, the Oscor Destino steerable sheath was used in 33 (13%) cases to cannulate a total of 62 (7%) TVVs. FB-EVAR was performed for 7 (21%) j-AAAs, 4 (12%) p-AAAs, 11 (61%) TAAAs, and 2 (6%) previously failed EVAR. The TVVs were 37 (60%) renal arteries, 9 (15%) superior mesenteric arteries, and 16 (25%) celiac trunks. The Oscor Destino steerable sheath was used as the primary cannulation approach in 29 (47%) cases and after failure of the standard cannulation technique in 33 (53%) cases. Technical success was achieved in 61/62 (98%) TVVs. There was no 30-day mortality or bowel ischemia. At the discharge, there were no type I/III endoleaks, whereas 4 type II endoleaks were detected. The median follow-up was 12 months (interquartile range: 8). One patient died at 6 months because of aneurysm-unrelated cause. No TVV occlusion or TVV-related reinterventions occurred. There were no type I-III endoleaks., Conclusions: The use of the steerable sheath could be an effective adjunctive tool and can be used primarily as a planned technique or in case of failure of the standard cannulation technique in challenging TVV anatomy during FB-EVAR., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to assess the feasibility and safety of percutaneous axillary access with vessel closure device closure after puncturing the first segment during endovascular treatment of complex aneurysms with fenestrated and branched endografts (F/BEVAR)., Methods: The PAXA (Percutaneous AXillary Access) study is a physician initiated, single centre, ambispective, non-randomised study (clinicaltrials.gov: NCT03223311). The primary endpoint was the closure success rate defined as the absence of any vascular injury to achieve haemostasis at the puncture site, requiring any treatment other than manual compression or adjunctive endovascular ballooning. The secondary endpoints were minor access complications, cerebrovascular complication rate, short term access vessel patency, and study cohort anatomical evaluation of the axillary artery., Results: Sixty-four patients required an upper extremity access during F/BEVAR procedure during study period (November 2016 to July 2019) and were screened for the PAXA study: 59 patients (47 males; median age: 75 years, IQR 69-78) met the study inclusion criteria and were enrolled (one patient had bilateral access). Closure success was obtained in 54 cases (90%) with no open conversion required: five patients received a bare or covered stenting to the AXA and in one patient mechanical failure of the delivery system was recorded. No 30 day permanent peripheral nerve injuries and two non-ipsilateral ischaemic strokes (3.4%) were recorded. Seven patients (12%) had access haematomas managed conservatively associated with closure failure (p = .002), oral anticoagulants therapy (p = .005) and procedure length (p = .028). At short term follow up (6 months), no late complications were observed, and all access vessels were patent., Conclusion: PAXA on the first segment using a large sheath (10-16F) is technically feasible, relatively safe with no need for open conversion but it may require access related secondary endovascular procedures. Further prospective studies are needed to modify the device instruction for use and to put the procedure on label., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)