A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.

Medium-term outcomes of EXTra-design engineering inner-branch ENdografts for the treatment of complex aortic aneurysms from a multicenter collaboration.

OBJECTIVE: This study aims to present the medium-term outcomes of Extra-Design engineering endografts with inner branches (EDE-iBEVARs, Artivion) in endovascular aortic repairs of complex aneurysms building upon promising early results. METHODS: A retrospective, international, multi-center study was conducted including consecutive patients who underwent complex endovascular aortic repairs using EDE-iBEVARs between 2018 and 2022. Patient demographics, aneurysm anatomical features, procedural details, reinterventions, complications, and endograft failures during follow-up were assessed. The primary outcome was aneurysm-related mortality. Secondary outcome measures included the freedom from all-cause mortality and reintervention, technical and clinical success, and late related complications including branch instability, endoleaks, and serious adverse events. RESULTS: Our study encompassed a total of 260 patients across 13 European centers. The cohort included patients with thoracoabdominal aortic aneurysms (n = 116), suprarenal or juxta-renal aneurysms (n = 95), and those who had previous open repair or previous endovascular aortic repair with type 1A endoleak (n = 49). Of 982 possible inner branches (937 antegrade and 45 retrograde), 962 (98%) were successfully cannulated and bridged with covered stents during the index procedure. Overall, the endograft was successfully deployed in 98% of patients, and 93% were discharged from hospital following surgery. At 3 years, freedom from aneurysm-related mortality was 97%, whereas the freedom of all-cause mortality was 89%. Freedom from reinterventions was 91% and 76% at 1 and 3 years, respectively. The rate of late complications such as endoleaks or branch instability events was 12% (n = 30). The late branch occlusion rate during follow-up was 1.5% (n = 15), of which 12 were renal branches. CONCLUSIONS: EDE-iBEVARs demonstrate satisfactory medium-term outcomes with reintervention rates comparable to other endografts. Encouragingly, rates of branch patency were high, and major adverse events were low. This technology could expand the treatment options for patients with challenging complex aortic conditions.

Systematic Review and Network Meta-analysis of Vessel Preparation Techniques With Plain Balloon Angioplasty, Atherectomy, or Intravascular Lithotripsy Before Application of a Drug Coated Balloon to Treat Atherosclerotic Femoropopliteal Disease.

OBJECTIVE: To compare one year outcomes after atherectomy, intravascular lithotripsy vs. plain balloon angioplasty before application of drug coated balloons for treating femoropopliteal atherosclerotic disease. DATA SOURCES: MEDLINE, EMBASE, and Cochrane Library were screened until May 2023 for randomised controlled trials. REVIEW METHODS: This was a systematic review and network meta-analysis. The inclusion criteria were patients with claudication and those with critical limb threatening ischaemia with lesion characteristics of all lengths, stenosis, calcification, and occlusions. The primary outcome was freedom from target lesion re-intervention at one year. Secondary outcomes were rate of bailout stenting, major amputation, and all cause mortality at one year. Pooled point estimates were calculated with a standard random effects model. Further sensitivity analyses were completed with a mixed treatment Bayesian model. Risk of bias was assessed by the Revised Cochrane Risk of Bias tool 2 (RoB2) and certainty of evidence assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. RESULTS: Four RCTs comprising 549 patients (two studies evaluating directional atherectomy, one evaluating rotational atherectomy, one evaluating intravascular lithotripsy against plain balloon angioplasty) were included. The weighted mean length of femoropopliteal lesions was 103.4 ± 6.67 mm. Results of the mixed treatment Bayesian analysis were consistent with pooled analysis for all outcomes. There were no significant differences in freedom from target lesion revascularisation (GRADE, high) (RoB2, low), major amputation (GRADE, low), or mortality (GRADE, moderate). Bailout stenting rates were significantly reduced with intravascular lithotripsy and atherectomy compared with plain balloon angioplasty (RR 0.25, 95% CI 0.07 - 0.89) (GRADE, moderate) (RoB2, low). CONCLUSION: This review found that intravascular lithotripsy or atherectomy did not appear to incur a statistically significant advantage in freedom from target lesion revascularisation, major amputation, or mortality rate at one year. There was moderate certainty of evidence that bailout stenting is significantly reduced after vessel preparation with intravascular lithotripsy and atherectomy.

Elective Surgical Repair of Popliteal Artery Aneurysms with Posterior Approach vs. Endovascular Exclusion: Early and Long Term Outcomes of Multicentre PARADE Study.

OBJECTIVE: The aim of this study was compare elective surgical repair of popliteal artery aneurysms (PAAs) via a posterior approach vs. endovascular exclusion, analysing early and five year outcomes in a multicentre retrospective study. METHODS: Between January 2010 and December 2023, a retrospectively maintained dataset of all consecutive asymptomatic PAAs that underwent open repair with posterior approach or endovascular repair in 37 centres was investigated. An aneurysm length of ≤ 60 mm was considered the only inclusion criterion. A total of 605 patients were included; 440 PAAs (72.7%) were treated via a posterior approach (open group) and the remaining 165 PAAs (27.3%) were treated using covered stents (endo group). Continuous data were expressed as median with interquartile range. Thirty day outcomes were assessed and compared. At follow up, primary outcomes were freedom from re-intervention, secondary patency, and amputation free survival. Secondary outcomes were survival and primary patency. Estimated five year outcomes were compared using log rank test. RESULTS: At 30 days, no differences were found in major morbidity, mortality, graft occlusion, or re-interventions. Three patients (0.7%) in the open group experienced nerve injury. The overall median duration of follow up was 32.1 months. At five year follow up, freedom from re-intervention was higher in the open group (82.2% vs. 68.4%; p = .021). No differences were observed in secondary patency (open group 90.7% vs. endo group 85.2%; p = .25) or amputation free survival (open group 99.0% vs. endo group 98.4%; p = .73). A posterior approach was associated with better survival outcomes (84.4% vs. 79.4%; p = .050), and primary patency (79.8% vs. 63.8%; p = .012). CONCLUSION: Early and long term outcomes following elective repair of PAAs measuring ≤ 60 mm via a posterior approach or endovascular exclusion seem comparable. Nerve injury might be a rare but potential complication for those undergoing open surgery. Endovascular repair is associated with more re-interventions.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 Trial: Analysis of the Timing and Causes of Death in Participants Randomised to an Infrapopliteal Vein Bypass or Best Endovascular Treatment First Revascularisation Strategy.

OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim of the present study was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality. METHODS: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac. RESULTS: In 151 of 168 deaths (89.9%), the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16 of 77 deaths (21%) were classified as probably cardiac compared with 32 of 91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64 of 344 (18.6%), 40 of 342 (11.7%), and 37 of 344 (10.8%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI. CONCLUSION: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings.

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Different endovascular modalities of treatment for isolated atherosclerotic popliteal artery lesions (EMO-POP) registry.

BACKGROUND: The mid-term results after treatment of isolated popliteal lesions have been limited. The aim of the present study was to report the mid-term outcomes after endovascular treatment of isolated atherosclerotic popliteal artery lesions. METHODS: A multicenter (15 hospitals in five countries) retrospective cohort study was performed. Between June 2016 and June 2021, 651 consecutive patients who had been treated for isolated popliteal lesions using endovascular methods exclusively were included in the present study. Six techniques were identified, including plain balloon angioplasty (PTA; n = 286; 43.9%), drug-coated balloon angioplasty (n = 98; 15.1%), stenting with low-chronic outward force (COF) stents (n = 84; 12.9%), stenting with high-COF stents (n = 76; 11.7%), atherectomy alone (n = 17; 2.6%), and directional atherectomy with drug-coated balloons (n = 90; 13.8%). The primary outcomes measures were primary and secondary patency and freedom from clinically driven target lesion revascularization (F-CDTLR). RESULTS: The mean patient age was 74.5 years. Most of the patients (n = 409; 62.9%) had had chronic limb-threatening ischemia. Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. The median follow-up was 26 months (range, 6-42 months). The actuarial rate for all patients at 26 months (per outcome measure) was as follows: primary patency, 73.9%; secondary patency, 88%; and F-CDTLR, 76.5%. When comparing PTA vs all other treatments in an adjusted regression analysis, the F-CDTLR was 75.2% for PTA vs 76.5% for all other treatment (hazard ratio, 1.06; 95% confidence interval, 0.75-1.48; P = .46, adjusted regression). The difference in secondary patency also was not statistically significant (85.7% for PTA vs 88%; P = .20). Adjusted Kaplan-Meier analysis revealed that the estimated primary patency was inferior for PTA in pairwise comparisons vs other treatments (P < .001 vs atherectomy; P = .002 vs directional atherectomy with drug-coated balloons; and P = .002 vs low-COF stenting). CONCLUSIONS: The results from our study have shown that endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and F-CDTLR in the mid-term.

International Cross-Sectional Survey of Bullying, Undermining, and Harassment in the Vascular Workplace.

OBJECTIVE: Bullying, undermining behaviour, and harassment (BUH) may exist in healthcare settings, impacting on patient care. The aim of this international study was to evaluate the characteristics of BUH experienced by physicians treating vascular diseases at various career stages. METHODS: This was an anonymous international structured non-validated cross-sectional survey distributed via relevant professional societies in collaboration with the Research Collaborative in Peripheral Artery Disease. The survey was disseminated through societies' newsletters, emails, and social media. Data were collected online, allowing free text entries alongside structured multiple choice questions based on previous surveys. Demographics, geographical information, and data relating to stage and training environment were collected. RESULTS: Of 587 respondents from 28 countries, 86% were working in vascular surgery, mostly at a university hospital (56%); 81% were aged between 31 and 60 years, 57% were working as a consultant, and 23% as a resident. Respondents were mostly white (83%), male (63%), heterosexual (94%), and without disability (96%). Overall, 253 (43%) reported experiencing BUH personally, 75% had witnessed BUH toward colleagues, and 51% witnessed these in the last 12 months. Female sex and non-white ethnicity were associated with BUH (53% vs. 38% and 57% vs. 40% respectively; p < .001 in both cases). While working as a consultant, 171 (50%) reported experiencing BUH, more often among females, non-heterosexuals, those who were not working in their country of birth, and non-white people. Specialty and hospital type were not associated with BUH. CONCLUSION: BUH remains a major problem in the vascular workplace. Female sex, non-heterosexuality, and non-white ethnicity are associated with BUH at various career stages.

Endovascular Versus Surgical Treatment for All Comer Patients With Prosthetic Bypass Graft Occlusion: The Multicentre ENSUPRO Study.

OBJECTIVE: Bypass surgery plays a key role in complex lower limb lesions. However, there is a lack of evidence regarding the management of symptomatic prosthetic bypass graft (PBG) occlusion. This study aimed to report outcomes following open, hybrid, or endovascular management of patients presenting with symptomatic PBG occlusion. METHODS: A multicentre, retrospective cohort study was conducted, including patients presenting with PBG occlusion between January 2014 and December 2021 from 18 centres. It assessed the comparative value of treatment strategies, including (1) recanalisation of native vessels, (2) endovascular treatment of the failed PBG, (3) hybrid treatment, and (4) open surgery. The primary outcome measure was amputation free survival (AFS, time to major amputation and or death), whereas all cause mortality, major amputation, PBG re-occlusion, target lesion revascularisation (TLR), and Rutherford category (RC) improvement during follow up were considered as secondary endpoints. RESULTS: Of 260 patients with occluded PBGs, 108 (41.5%) were treated endovascularly (24 [22.2%] by recanalisation of native vessels and 84 [77.7%] by PBG re-opening), 57 (21.9%) underwent hybrid revascularisation, and 58 (22.3%) had surgery. In addition, 27 (10.4%) were treated conservatively and 10 (3.8%) received systemic thrombolysis. With a median follow up of 1.4 (0.6 - 3.0) years, AFS was 95.5%, 76.4%, 45.5%, and 37.1%, respectively in Groups 1 - 4 (p = .007). Older age and non-endovascular treatment (HR 1.05 and 1.70; p < .01 for both) were independent predictors of poor AFS. Endovascular treatment was associated with lower rates of major amputation (p = .04), PBG re-occlusion (p < .001), and TLR (p = .037), and higher RC improvements (p < .001), whereas all cause mortality was comparable between treatment groups (p = .21). CONCLUSION: Endovascular treatment is associated with higher rates of AFS and RC improvement and lower rates of PBG re-occlusion and TLR in patients with PBG occlusion.

Editor's Choice - RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study).

OBJECTIVE: The aim was to assess the proportion of patients undergoing endovascular therapy for femoropopliteal arterial disease (FP) who would be eligible to take part in seven major randomised controlled trials (RCTs) that investigated the efficacy of some of the currently available paclitaxel based (PTX) devices used in this clinical context. Various RCTs have shown a potential clinical benefit from the use of paclitaxel in FP endovascular therapy. Nonetheless, patients enrolled were highly selected and the generalisability of these findings in pragmatic cohorts is unclear. METHODS: Between 1 January and 31 December 2021, all consecutive patients who underwent endovascular procedures for symptomatic FP disease in 16 European centres were retrospectively screened and included in this analysis. The primary outcome measure was individual patient eligibility for inclusion into at least one of the seven RCTs. The reasons for exclusion (clinical and or radiological) as well as in hospital death and morbidity were also reported. RESULTS: A total of 1 567 consecutive patients (959 male, 61%), corresponding to 1 567 lower limbs, were included. Most patients (1 009 patients, 64.39%) were treated for chronic limb threatening ischaemia (CLTI). A total 1 280 patients (81.68%) were not eligible for inclusion in any of the evaluated RCTs. Of them, 741 (47.28%) were excluded for clinical and 1 125 (71.79%) for radiological reasons. CONCLUSION: The analysed RCTs assessing the efficacy or effectiveness of PTX based endovascular therapies do not seem representative of the patient population with FP disease receiving endovascular therapy in routine clinical practice.

Impact of COVID-19 Pandemic on the Outcomes in Patients With Critical Limb Threatening Ischaemia and Diabetic Foot Infection.

OBJECTIVE: Examine the impact of COVID-19 pandemic on the outcomes in patients with CLTI or DFI. BACKGROUND: Patients with CLTI and/or DFI are at risk of amputations if not treated in a timely manner. METHODS: We compared the outcomes in patients with CLTI or DFI during 2 periods; Period 1[P1] (15/03/2019-31/05/2019) and period 2[P2] (15/03/ 2020-31/05/2020- corresponding to COVID-19 pandemic). RESULTS: One hundred thirty-nine patients were treated in P1 [mean age 70 years (±11), Male:Female = 102:37] whereas 95 patients were treated in P2 [mean age 67 (±12), Male:Female = 64:31]. The 2 cohorts were matched regarding Rutherford category (P = 0.25) and GLASS classification (P = 0.38). Notably, the time from onset of symptom to clinical presentation was significantly longer [31 (1-105) days vs 27 (0-78) days, (P = 0.017)], whereas the time from presentation to first intervention was significantly shorter [3 (0-61) days vs 5 (0-65) days, (P = 0.013)] in P2 compared to P1. There was a significantly higher white cell count (P = 0.014) and CRP (P = 0.004) on admission in P2. Having treatment for CLTI or DFI in P2 was an independent predictor of worse primary patency rate and freedom from major adverse limb events. At 90 days, amputation-free survival and limb salvage were noticeably worse in P2 compared to P1 (amputation-free survival was 80% and 87% whereas limb salvage was 64% and 72% in P2 and P1, respectively). CONCLUSIONS: Patients with CLTI and DFI experienced a significantly delayed presentation with features of sepsis on admission in P2. Treatment in P2 was a predictor of worse primary patency and freedom from major adverse limb events and therefore close and long follow-up is advisable.

Predictors of outcome in diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. METHODS: Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. RESULTS: A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P = .015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P = .033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P = .023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P = .014). CONCLUSIONS: Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group.

Long-Term Effects of Acute Kidney Injury Following Endovascular Femoropopliteal Intervention: Insights From a Multicenter Trial.

PURPOSE: To examine the association between acute kidney injury (AKI) severity and duration with cardiovascular mortality, following endovascular treatment of femoropopliteal disease, and whether it is AKI in itself that confers an increased risk of cardiovascular mortality. METHODS: A retrospective analysis of prospectively collected data obtained between 2014 and 2019 from 3 vascular centers. Renal function was followed up for a minimum of 90 days. Electronic records were queried to establish a cause of death, where applicable. Patients were excluded if unable to provide written informed consent or if presenting with acute limb ischemia. Primary outcomes were the hazard ratios for cardiovascular death (AKI patients vs no AKI; no AKI vs stage 1 AKI vs stage 3 AKI; and no AKI vs transient AKI vs established AKI). Propensity score-matched analysis was used to establish whether developing AKI, in patients with similar demographics and procedural characteristics, is associated with a higher risk of cardiovascular death. RESULTS: Overall 239 patients developed AKI, and this was associated with an increased risk of cardiovascular mortality (hazard risk [HR]: 4.3, 95% confidence intervals [CIs]: 2.1-6.8, pairwise comparison p value=0.006]. This was dependent on the severity of the AKI stage (HR 5.4, 95% CI: 2.4-7.3, pairwise comparison p value=0.01) and duration (HR 4.2, 95% CI: 2.3-6.2, pairwise comparison p value=0.04). The propensity score-matched analysis showed that even when patients are matched for comorbidity and procedural characteristics, AKI confers an increased risk of mortality (p=0.04). CONCLUSIONS: Acute kidney injury is common after femoropopliteal endovascular therapy. It confers an increased risk of long-term cardiovascular mortality, which is still present when renal decline is transient, and highest for patients with established decline in renal function. CLINICAL IMPACT: This is the first study in the setting of peripheral arterial disease to show that acute kidney injury has an adverse effect on cardiovascular mortality, in the long-term, that is dependent on its severity, and present even when the AKI is transient. We have also shown that this difference in cardiovascular mortality becomes more pronounced from the medium-term, and thus closer follow-up of these patients is required.

Editor's Choice - Covered vs. Bare Metal Stents in the Reconstruction of the Aortic Bifurcation: Early and Midterm Outcomes from the COBRA European Multicentre Registry.

OBJECTIVE: To report outcomes following endovascular revascularisation for severe aorto-iliac occlusive disease (AIOD) using covered (CS) or bare metal (BMS) stent(s). METHODS: This was a retrospective cohort study including patients who underwent treatment with CS or BMS for AIOD between November 2012 and March 2020 in 12 European centres. Outcome measures included death, freedom from target lesion revascularisation (TLR), major amputation, and major adverse cardiac and cerebrovascular events (MACCE). RESULTS: Overall, 252 patients (53% males; mean age 65 ± 10 years) were included (102 with a bare metal and 150 with a covered aortic stent); 122 (48%) presented with chronic limb threatening ischaemia (CLTI). Severe arterial calcification was noted in > 65% of patients, 70% presented with Trans-Atlantic Societies Consensus (TASC) D lesions, 32% and 46% had aortic or iliac chronic total occlusion (CTO), respectively. Median follow up was 17 months (range 6 - 40; none lost to follow up). Median inpatient stay was two days (range two to four). During the first 30 days, two patients died (both with covered aortic stents, because of cardiovascular events), none required TLR, two (1%) patients had a major amputation (all presented with CLTI), and three (1%) had a MACCE. At 17 months, mortality (BMS 14% vs. CS 7%, hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.42 - 2.26, p = .94, log rank test) and TLR (11% vs. 10%, HR 1.98, 95% CI 0.89 - 4.43, p = .095) did not differ statistically significantly between the two groups; only three patients had a major limb amputation during late follow up (all with a covered stent). In a multivariable model, the use of an aortic CS did not influence TLR. In a conditional Cox regression, however, the concomitant use of aortic and iliac CSs was associated with improved freedom from TLR. CONCLUSION: Endovascular reconstruction with aortic CSs or BMSs for severe AIOD showed comparable midterm performance. The use of both aortic and iliac CSs seems to be associated with reduced TLR.

Editor's Choice - Eligibility of Common Femoral Artery Atherosclerotic Disease for Endovascular Treatment - the CONFESS Study.

OBJECTIVE: Advances in endovascular technologies have allowed the treatment of common femoral artery (CFA) steno-occlusive disease by minimally invasive means; however, the proportion of lesions treated with common femoral artery endarterectomy (CFAE) which would be amenable to endovascular treatment is unknown. This observational study aimed to describe the morphology and composition of CFA lesions treated with CFAE and report the proportion that would be amenable to endovascular treatment with modern technologies. METHODS: Patients presenting with symptomatic peripheral artery disease who underwent CFAE from January 2014 to December 2018 in two tertiary NHS hospitals were included. Extensive data relating to patient demographics, risk factors, clinical outcomes, as well as anatomical and morphological characteristics of the CFA atherosclerotic lesions, were collected which included detailed plaque analysis using 3D reconstruction of pre-operative computed tomography angiograms. CFA lesions were considered suitable for endovascular treatment if presented with patent iliac inflow, at least one patent outflow vessel (superficial femoral artery [SFA] or profunda femoral artery [PFA]), and stenotic rather than occluded CFA. RESULTS: A total of 829 CFAs in 737 consecutive patients who underwent CFAE were included (mean age 71 ± 10 years; 526 males, 71%); 451 (62%) presented with chronic limb threatening ischaemia. Overall, 35% of CFAs had a localised lesion (no bifurcation disease) that could possibly be treated endovascularly. In total, 376 (45%) target vessels did not feature severe calcium load, with a patent CFA, PFA, and proximal SFA and therefore would have been amenable to endovascular treatment; while 271 CFAs (33%) featured a significant calcium load which would have potentially required stenting. CONCLUSION: A significant proportion of patients with atherosclerotic CFA lesions who undergo surgery could potentially be candidates for endovascular treatment. A randomised trial comparing CFAE and new endovascular techniques in this clinical context is required.

Use of the Off-The-Shelf Pre-Cannulated E-Nside Endograft to Overcome Anatomical Challenges in Urgent Complex Endovascular Aortic Repair.

Treatment options for large or symptomatic complex aortic aneurysms that require urgent intervention remain limited. Patient factors and comorbidities often make open surgery unappealing, leading to increasing interest in endovascular solutions that can be employed in the urgent setting, such as off-the-shelf endografts. The E-nsideTM (Jotec GmbH, Hechingen, Germany) is a new off-the-shelf endograft with 4 pre-cannulated inner branches that has recently become available in Europe. We report the urgent treatment of 2 large complex aortic aneurysms using this device and discuss the benefits of this new technology. The E-nside off-the-shelf endograft with inner branches is a useful addition to our treatment options for complex aortic aneurysms, particularly those with a narrow aortic lumen. Pre-cannulation of branches provides consistent access to the branches and a readily available option for establishment of a through and through wire for added stability during cannulation and bridging stent-grafts placement. The design of inner branches provides flexibility during deployment of the endograft and cannulation of the target vessels in varied, challenging anatomies.

The Impact of the COVID-19 Pandemic on the Workload, Case Mix and hospital Resources at a Tertiary Vascular Unit.

BACKGROUND: The aim of this study was to examine the COVID-19 pandemic and its associated impact on the provision of vascular services, and the pattern of presentation and practice in a tertiary referral vascular unit. METHODS: This is a retrospective observational study from a prospectively maintained data-base comparing two time frames, Period 1(15th March-30th May 2019-P1) and Period 2(15th March-30th May 2020-P2)All the patients who presented for a vascular review in the 2 timeframes were included. Metrics of service and patient care episodes were collected and compared including, the number of emergency referrals, patient encounters, consultations, emergency admissions and interventions. Impact on key hospital resources such as critical care and imaging facilities during the two time periods were also examined. RESULTS: There was an absolute reduction of 44% in the number of patients who required urgent or emergency treatment from P1 to P2 (141 vs 79). We noted a non-significant trend towards an increase in the proportion of patients presenting with Chronic Limb Threatening Ischaemia (CLTI) Rutherford 5&6 (P=0.09) as well as a reduction in the proportion of admissions related to Aortic Aneurysm (P=0.21). There was a significant absolute reduction of 77% in all vascular interventions from P1 to P2 with the greatest reductions noted in Carotid (P=0.02), Deep Venous (P=0.003) and Aortic interventions (P=0.016). The number of lower limb interventions also decreased though there was a significant increase as a relative proportion of all vascular interventions in P2 (P=0.001). There was an absolute reduction in the number of scans performed for vascular pathology; Duplex scans reduced by 86%(P<0.002), CT scans by 68%(P<0.003) and MRIs by 74%(P<0.009). CONCLUSION: We report a decrease in urgent and emergency vascular presentations, admissions and interventions. The reduction in patients presenting with lower limb pathology was not as significant as other vascular conditions, resulting in a significant rise in interventions for CLTI and DFI as a proportion of all vascular interventions. These observations will help guide the provision of vascular services during future pandemics.

Early outcomes of Jotec inner-branched endografts in complex endovascular aortic aneurysm repair.

OBJECTIVE: Complex aortic endografts have evolved to include inner branches to overcome specific challenges with existing technologies. We have reported the early outcomes of endovascular aortic aneurysm repair (EVAR) using a Jotec inner branched endograft (iBEVAR). METHODS: All patients who had undergone complex EVARs using extra-design engineering iBEVAR (Jotec GmbH, Hechingen, Germany) from 2018 to 2020 at a single center were reviewed. The patient demographics, cardiovascular risk factors, anatomic features of the aneurysms, and target vessels were recorded. The reasons for using inner branches instead of fenestrated and standard branched endografts and the procedural details, outcomes, and reintervention during follow-up were examined. RESULTS: A total of 110 patients were treated with branched and fenestrated endografts during the study period, of whom 18 patients had had a patient-specific custom-made iBEVAR endograft with downward inner branches. The technical success rate was 100%. A total of 68 target vessels were cannulated, and bridging stent-grafts were placed successfully in all. The reasons for choosing the iBEVAR design included unfavorable target vessel trajectory for fenestrated repair (n = 15), excessive infrarenal aortic angulation and/or adverse iliac access vessels for fenestrated repair (n = 11), the presence of a narrow aortic lumen (n = 14), and/or to reduce aortic coverage compared with that with standard outer branched repair (n = 14). We also used iBEVAR to treat type Ia endoleaks after failed EVAR with a short main body (n = 5). The median contrast volume used was 120 mL (range, 48-200 mL), with a median fluoroscopy screening time of 66 minutes (range, 35-136 minutes) and a median dose-area product of 17,832 dGy∙cm2 (range, 8260-55,070 dGycm2). No 30-day mortality and no major complications occurred. One early intervention was required for a suspected type Ib endoleak from an iliac limb and one late intervention for in-stent stenosis in a renal bridging stent-graft. One patient had died of non-aortic-related causes at 3 months. All other patients continued with follow-up with their aneurysms excluded, patent target vessels, and no type I or III endoleak identified at a median follow-up of 12 months (range, 1-26 months). CONCLUSIONS: The use of Jotec extra-design engineering endografts incorporating downward inner branches resulted in satisfactory early outcomes with a low reintervention rate. The technology has the potential to be a useful addition to our armamentarium for treating complex aortic endografts; however, long-term outcomes data are needed.

"Awake" Spinal Cord Monitoring Under Local Anesthesia and Conscious Sedation in Fenestrated and Branched Endovascular Aortic Repair.

INTRODUCTION: Endovascular repair of thoracoabdominal aortic aneurysms carries a risk of spinal cord ischemia, the causes of which remain uncertain. We hypothesized that local anesthesia (LA) with conscious sedation could abrogate the potential suppressive cardiovascular effects of general anesthesia (GA) and facilitate intraoperative monitoring of neurological function. Here, we examine the feasibility of this technique during fenestrated (FEVAR) or branched endovascular aortic repair (BEVAR). MATERIALS AND METHODS: Consecutive patients undergoing FEVAR or BEVAR under LA and conscious sedation by a team at a single center were analyzed. Patients received conscious sedation using intravenous remifentanil and propofol infusions in conjunction with a local anesthetic agent. No patient had a prophylactic spinal drain inserted. Outcome measures included conversion to GA, need for vasopressors and/or spinal drainage, length of stay, complications, and patient survival. RESULTS: A total of 44 patients underwent FEVAR or BEVAR under LA and conscious sedation. The cohort included thoracoabdominal aortic aneurysms (n=41) and pararenal aneurysms treated with endografts covering the supraceliac segment (n=3). Four patients (9%) required conversion to GA at a median operative duration of 198 minutes (range 97-495 minutes). Vasopressors were required intraoperatively in 3 of the cases that were converted to GA. No patient developed spinal cord ischemia and none had insertion of a spinal drain. The median hospital length of stay was 4 days (range 2-41 days). Postoperative delirium and hospital-acquired pneumonia was seen in 7% of patients. All patients survived to 30 days, with 95% alive at a median follow-up of 15 months (range 3-26 months). CONCLUSION: LA and conscious sedation is a feasible anesthetic technique for the endovascular repair of thoracoabdominal aortic aneurysms.