Now showing items 21-40 of 48

    • Editor's Choice - PRINciples of optimal antithrombotiC therapy and coagulation managEment during elective fenestrated and branched EndovaScular aortic repairS (PRINCESS): An International Expert Based Delphi Consensus Study.

      D'Oria, Mario; Bertoglio, Luca; Bignamini, Angelo Antonio; Mani, Kevin; Kölbel, Tilo; Oderich, Gustavo; Chiesa, Roberto; Lepidi, Sandro; Adam, Donald; Surgery; et al. (Elsevier, 2022-03-12)
      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.
    • Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

      Kingsmore, David B; Edgar, Ben; Aitken, Emma; Calder, Francis; Franchin, Marco; Geddes, Colin; Inston, Nick; Jackson, Andrew; Jones, Rob G; Karydis, Nikolaos; et al. (Sage Publications, 2024-03-19)
      Background: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. Method: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. Results: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. Conclusion: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.
    • Arterial and venous thromboembolism in critically ill, COVID 19 positive patients admitted to Intensive care unit.

      Elboushi, Amro; Syed, Arooj; Pasenidou, Ketino; Elmi, Liban; Keen, Irfan; Heining, Chris; Vasudev, Ashish; Tulmuntiha, Sidra; Karia, Kishan; Ramesh, Priyavarshini; et al. (Elsevier, 2022-03-04)
      No abstract available
    • A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS) : a study protocol

      Patel, Shaneel R; Ormesher, David C; Smith, Samuel R; Wong, Kitty H F; Bevis, Paul; Bicknell, Colin D; Boyle, Jonathan R; Brennan, John A; Campbell, Bruce; Cook, Andrew; et al. (BMJ Publishing Group, 2021-11-30)
      Introduction: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?' Methods and analysis: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years. Ethics and dissemination: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences. Trial registration number: ISRCTN85731188.
    • A comparison of contemporary clinical outcomes following femoro-popliteal plain balloon angioplasty and bypass surgery for chronic limb threatening ischemia.

      Meecham, Lewis; Popplewell, Mathew A; Bate, Gareth R; Patel, Smitaa; Bradbury, Andrew W; Bate, Gareth R; Surgery; Nursing and Midwifery Registered (SAGE Publications, 2021-04-22)
      Introduction: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). Methods: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). Results: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. Conclusion: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.
    • Association of SARC-F Score and Rockwood Clinical Frailty Scale with CT-derived muscle mass in patients with aortic aneurysms.

      Brown, K; Cheng, Y; Harley, S; Allen, C; Claridge, M; Adam, D; Lord, J M; Nasr, H; Juszczak, M; Harley, Sarah; et al. (Elsevier, 2022)
      Objectives: Patients with aortic aneurysms (AA) are often co-morbid and susceptible to frailty. Low core muscle mass has been used as a surrogate marker of sarcopenia and indicator of frailty. This study aimed to assess association between core muscle mass with sarcopenia screening tool SARC-F and Clinical Frailty Scale (CFS) in patients with AA. Methods: Prospective audit of patients in pre-operative aortic clinic between 01/07/2019-31/01/2020 including frailty assessment using Rockwood CFS and sarcopenia screening using SARC-F questionnaire. Psoas and sartorius muscle area were measured on pre-operative CT scans and adjusted for height. Association was assessed using Spearman's rank correlation coefficient. Results: Of 84 patients assessed, median age was 75 years [72,82], 84.5% were men, 65.5% were multimorbid and 63.1% had polypharmacy. Nineteen percent were identified as frail (CFS score >3) and 6.1% positively screened for sarcopenia (SARC-F score 4 or more). Median psoas area (PMA) at L3 was 5.6cm2/m2 [4.8,6.6] and L4 was 7.4cm2/m2 [6.3,8.6]. Median sartorius area (SMA) was 1.8 cm2/m2 [1.5,2.2]. CFS demonstrated weak but statistically significant negative correlation with height-adjusted PMA at L3 (r=-0.25, p=0.034) but not at L4 (r=-0.23, p=0.051) or with SMA (r=-0.22, p=0.065). No association was observed between SARC-F score and PMA or SMA (L3 PMA r=-0.015, p=0.9; L4 PMA r=-0.0014, p= 0.99; SMA r=-0.051, p=0.67). Conclusion: CFS showed higher association with CT-derived muscle mass than SARC-F. Comprehensive pre-operative risk-stratification tools which incorporate frailty assessment and body composition analysis may assist in decision making for surgery and allow opportunity for pre-habilitation.
    • Association between time to treatment and clinical outcomes in endovascular thrombectomy beyond 6 hours without advanced imaging selection.

      Dhillon, Permesh Singh; Butt, Waleed; Podlasek, Anna; McConachie, Norman; Lenthall, Robert; Nair, Sujit; Malik, Luqman; Bhogal, Pervinder; Makalanda, Hegoda Levansri Dilrukshan; Spooner, Oliver; et al. (BMJ Publishing Group, 2022-03-16)
      Background: The effectiveness and safety of endovascular thrombectomy (EVT) in the late window (6-24 hours) for acute ischemic stroke (AIS) patients selected without advanced imaging is undetermined. We aimed to assess clinical outcomes and the relationship with time-to-EVT treatment beyond 6 hours of stroke onset without advanced neuroimaging. Methods: Patients who underwent EVT selected with non-contrast CT/CT angiography (without CT perfusion or MR imaging), between October 2015 and March 2020, were included from a national stroke registry. Functional and safety outcomes were assessed in both early (<6 hours) and late windows with time analyzed as a continuous variable. Results: Among 3278 patients, 2610 (79.6%) and 668 (20.4%) patients were included in the early and late windows, respectively. In the late window, for every hour delay, there was no significant association with shift towards poorer functional outcome (modified Rankin Scale (mRS)) at discharge (adjusted common OR 0.98, 95% CI 0.94 to 1.01, p=0.27) or change in predicted functional independence (mRS ≤2) (24.5% to 23.3% from 6 to 24 hours; aOR 0.99, 95% CI0.94 to 1.04, p=0.85). In contrast, predicted functional independence was time sensitive in the early window: 5.2% reduction per-hour delay (49.4% to 23.5% from 1 to 6 hours, p=0.0001). There were similar rates of symptomatic intracranial hemorrhage (sICH) (3.4% vs 4.6%, p=0.54) and in-hospital mortality (12.9% vs 14.6%, p=0.33) in the early and late windows, respectively, without a significant association with time. Conclusion: In this real-world study, there was minimal change in functional disability, sICH and in-hospital mortality within and across the late window. While confirmatory randomized trials are needed, these findings suggest that EVT remains feasible and safe when performed in AIS patients selected without advanced neuroimaging between 6-24 hours from stroke onset.
    • Distal Repair After Total Aortic Arch Replacement With Frozen Elephant Trunk in Patients With Chronic Multilevel Thoracic Aortic Disease.

      Doonan, Robert-James; Senanayake, Eshan; Claridge, Martin; Juszczak, Maciej; Torella, Francesco; Mascaro, Jorge; Field, Mark; Adam, Donald J; Senanayake, Eshan; Adam, Donald, J; et al. (Elsevier, 2024-02-23)
      Objective: To examine the management of distal aortic disease after total arch replacement with the frozen elephant trunk (TAR + FET) in patients with chronic thoracic aortic disease. Methods: Two centre retrospective study of consecutive patients treated between January 2010 and December 2019. Primary endpoint was 30 day/in hospital mortality. Secondary end point was mid-term survival. Data are presented as median (IQR). Chi squared or Fisher's exact test was used as appropriate. Estimated survival (standard error) was assessed by the calculating Kaplan-Meier product limit estimator with right censoring of survival data. A p value of < .050 was considered to be statistically significant. STROBE guidelines were followed. Results: A total of 158 patients (72 men; median age 70, IQR 64, 75; median distal aortic diameter 58 mm (46, 68; 127 aneurysmal disease, 31 chronic dissection) underwent TAR + FET. Peri-operative mortality was 10.1% (9/107 elective, 7/51 non-elective). Of 74 (46.8%) patients with a primary distal seal, seven (9.5%) died peri-operatively, distal seal was maintained during follow up in 51, nine underwent late distal repair (two planned, seven unplanned; one open, eight endovascular; one peri-operative death) with a median interval to unplanned repair of 777 days (462, 1480), and seven with loss of seal had no intervention. Distal seal failed in 2/28 (7%) patients with a distal seal length > 30 mm and device oversizing > 10%, compared with 12/39 (31%) patients who did not meet these criteria (p = .031). In 84 patients without primary distal seal, nine (10.7%) died peri-operatively, the distal aorta remained below the size threshold for repair during follow up in 12 patients, 44 had distal repair (median aortic diameter 64 mm, 60, 75; eight open, one hybrid, 35 endovascular repairs; no mortality) at a median of 256 days (135, 740), and 19 did not have distal repair at the end of the follow up period: six died before planned repair at a median interval of 115 days (85, 120); eight were considered unfit; one was assessed as fit but declined; and four patients were awaiting assessment). Median follow up was 46 months (26, 75): no patients were lost to follow up. Estimated ± standard error five year survival was 61.5 ± 4.1%: elective 70.6 ± 4.7%, non-elective 43.2 ± 7.2%. Conclusion: TAR + FET achieved primary distal seal in 47% of patients, but late failure occurred in 21% of patients. Distal repair was ultimately indicated in 84% of survivors without primary distal seal and of these 70% underwent repair, almost 10% died before planned repair, and 13% were considered unfit. Earlier distal endovascular repair and better assessment of patient fitness may improve mid-term outcomes.
    • The Complementary Roles of Open and Endovascular Repair of Extent I -III Thoracoabdominal Aortic Aneurysms in a United Kingdom Aortic Centre.

      Donald, Adam J; Juszczak, Maciej; Vezzosi, Massimo; Claridge, Martin; Quinn, David; Senanayake, Eshan; Clift, Paul; Mascaro, Jorge; Vascular Surgery; Medical and Dental; et al. (Elsevier, 2024-02-23)
      Objective: A multidisciplinary approach offering both open surgical (OSR) and complex endovascular repair (cEVAR) is essential if patients with thoraco-abdominal aortic aneurysms (TAAAs) are to receive optimal care. This study reports early and mid-term outcomes of elective and non-elective OSR and cEVAR for extent I - III TAAA in a UK aortic centre. Methods: Retrospective study of consecutive patients treated between January 2009 and December 2021. Primary endpoint was 30 day/in hospital mortality. Secondary end point was Kaplan-Meier estimates of mid-term survival. Data are presented as median (IQR). Results: In total, 296 patients (176 men; median age 71 years [IQR 65, 76]; aneurysm diameter 66 mm [61, 75]) underwent repair (222 elective, 74 non-elective). OSR patients (n = 66) were significantly younger with a higher incidence of heritable disease and chronic dissection, while cEVAR patients (n = 230) had a significantly higher prevalence of coronary, pulmonary, and renal disease. Overall, in hospital mortality after elective and non-elective repair was 3.2% (n = 7) and 23.0% (n = 17), respectively, with no significant difference between treatment modalities (elective OSR 6.5% vs. cEVAR 2.3%; p = .14; non-elective OSR 25.0% vs. cEVAR 20.3%; p = .80). Major non-fatal complications occurred in 15.3% (33/215) after elective repair (OSR 39.5%, 17/43, vs. cEVAR 9.3%, 16/172; p < .001) and 14% (8/57) after non-elective repair (OSR 26.7%, 4/15, vs. cEVAR 9.5%, 4/42; p = .19). Median follow up was 52 months (IQR 23, 78). Estimated survival ± standard error at one, three, and five years for the entire cohort was 89.6 ± 2.0%, 76.6 ± 2.9%, and 69.0% ± 3.2% after elective repair, and 67.6 ± 5.4%, 52.1 ± 6.0%, and 41.0 ± 6.2% after non-elective repair. There was no difference in five year survival comparing modalities after elective repair for patients less than 70 years, and those with post-dissection aneurysms. Conclusion: A multidisciplinary approach offering OSR and cEVAR can deliver comprehensive care for extent I - III TAAA with low early mortality and good mid-term survival. Further studies are required to determine the optimal complementary roles of each treatment modality.
    • Safety and efficacy of adjunctive intra-arterial antithrombotic therapy during endovascular thrombectomy for acute ischemic stroke: a systematic review and meta-analysis

      Marei, Omar; Podlasek, Anna; Soo, Emma; Butt, Waleed; Gory, Benjamin; Nguyen, Thanh N; Appleton, Jason P; Richard, Sébastien; Rice, Hal; de Villiers, Laetitia; et al. (BMJ Publishing Group, 2024-01-19)
      Background: Half of patients who achieve successful recanalization following endovascular thrombectomy (EVT) for acute ischemic stroke experience poor functional outcome. We aim to investigate whether the use of adjunctive intra-arterial antithrombotic therapy (AAT) during EVT is safe and efficacious compared with standard therapy (ST) of EVT with or without prior intravenous thrombolysis. Methods: Electronic databases were searched (PubMed/MEDLINE, Embase, Cochrane Library) from 2010 until October 2023. Data were pooled using a random-effects model and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Risk of bias was assessed using ROBINS-I and ROB-2. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes were successful recanalization (modified Thrombolysis In Cerebral Infarction (TICI) 2b-3), symptomatic intracranial hemorrhage (sICH), and 90-day mortality. Results: 41 randomized and non-randomized studies met the eligibility criteria. Overall, 15 316 patients were included; 3296 patients were treated with AAT during EVT and 12 020 were treated with ST alone. Compared with ST, patients treated with AAT demonstrated higher odds of functional independence (46.5% AAT vs 42.6% ST; OR 1.22, 95% CI 1.07 to 1.40, P=0.004, I2=48%) and a lower likelihood of 90-day mortality (OR 0.71, 95% CI 0.61 to 0.83, P<0.0001, I2=20%). The rates of sICH (OR 1.00, 95% CI 0.82 to 1.22,P=0.97, I2=13%) and successful recanalization (OR 1.09, 95% CI 0.84 to 1.42, P=0.52, I2=76%) were not significantly different. Conclusion: The use of AAT during EVT may improve functional outcomes and reduce mortality rates compared with ST alone, without an increased risk of sICH. These findings should be interpreted with caution pending the results from ongoing phase III trials to establish the efficacy and safety of AAT during EVT.
    • International survey of radiocephalic arteriovenous fistula: ISRAF survey

      Kordzadeh, Ali; Mohaghegh, Vahaj; Inston, Nicholas; Inston, Nicholas; Renal Transplant; Medical and Dental; Mid and South Essex NHS Foundation Trust; Anglia Ruskin University; University Hospitals Birmingham NHS Foundation Trust (SAGE Publications, 2024-01-22)
      Aims: The objective of this survey was to encompass the full scope of international practice, entailing all technical, non-technical, preoperative stratification and functional maturation (FM) of RCAVF. Methods: The survey contained n = 19 questionnaires with n = 46 variables completed by n = 85 providers from n = 21 nations across n = 5 continents. The numerical values were subjected to mean with standard error whereas the nominal data to a non-parametric (Kruskal-Wallis & Spearman correlation test) and analysis of variance (ANOVA). The test of homogeneity, & probability was reported 95% confidence intervals (CI) alongside error plots. Furthermore, a decision and higher attribute tree model was constructed based on current survey for higher FM in RCAVF. Results: FM is independently associated with volume of surgeon per year (procedures performed) (p < 0.01) [High Volume: 73% (95% CI, 68-77%) versus Average volume: 63% (95% CI, 59-66%) vs Low volume: 56% (95% CI, 51-61%)]. FM increased by 8% with every 20 more procedures per group of surgeons on end point of FM. Amongst continents: Australia, America, Asia and South America demonstrated higher FM to Africa & Europe (p < 0.05). UK possessed a lower FM 58% (95% CI, 48-68%) in comparison to the world & Europe respectively [65% (95% CI, 61-70%) vs 61% (95% CI, 58--65%)]. There was a positive causal link between angle of anastomosis at 30-76° (p < 0.01), longitudinal & S-shaped incision & arteriotomy length of 3 & 4 mm to higher FM (p < 0.05). Conclusion: FM in RCAVF is independently & incrementally associated with the volume of surgeon per year. There is a diverse inclusion, exclusion and technical approach in RCAVF creation. This survey advocates the importance of international collaboration and/or registry in assimilation, consolidate and development of consensus.
    • Complex endovascular repair of paravisceral infective native aortic aneurysms

      Juszczak, Maciej; Mann, Harvinder; Riste, Michael; Woodhouse, Andrew; Sörelius, Karl; Claridge, Martin; Adam, Donald J; Juszczak, Maciej; Claridge, Martin; Adam, Donald; et al. (SAGE Publications, 2022-09-04)
      Objective: To report the early and mid-term outcome of complex endovascular repair (EVAR) for paravisceral infective native aortic aneurysms (INAA). Methods: Interrogation of a prospectively maintained database identified consecutive patients who underwent non-elective complex EVAR for paravisceral INAAs in a single institution between December 2013 and June 2020. All patients were considered to have definite INAAs based on diagnostic criteria. Patients who had prior aortic repair were excluded. Results: A total of 26 patients (19 men; mean age 67 years [SD = 11.4]; median diameter 60 mm [IQR: 55-73]) with acute symptomatic (n = 24) or contained ruptured (n = 2) aneurysms underwent surgeon-modified fenestrated EVAR (SM-FEVAR; n = 24) or chimney-periscope EVAR (CHIMPS; n = 2). Median observed follow-up was 36.2 months (18.3-53.5). Nine patients had positive venous blood cultures and a further seven had recent or concomitant infection. All patients received pre- and post-operative antibiotic therapy and rifampicin-soaked endografts. A total of 95 vessels were targeted for preservation and 86 were stent-grafted. One vessel occluded intra-operatively and a further 3 occluded within 30 days. The 30-day/in-hospital mortality was 11.5% (n = 3), and the estimated 1- and 3-year survival (±SD) was 85% ± 7%. Infection-related complications (IRCs) occurred in two patients: both developed new INAA within 30 days of index repair and were treated by EVAR with no mortality. Estimated 3-year freedom from late re-intervention was 100%. One patient required infrarenal EVAR for a non-infective aneurysm at 43 months. Conclusion: Complex EVAR for paravisceral INAAs is associated with acceptable early and mid-term outcomes and is an acceptable alternative to open surgery. We propose that these patients are managed with long-term antimicrobials, impregnation of graft material with rifampicin, and rigorous post-operative surveillance. Clinical impact: A multi-disciplinary approach is required to deliver the best possible outcome for patients with this challenging aortic pathology.
    • Comparison of transverse versus longitudinal skin incisions for femoral endarterectomy and patchplasty

      Kuyumdzhiev, Smilen; Kuyumdzhieva, Galena; Tiwari, Alok; Kuyumdzhiev, Smilen; Tiwari, Alok; Vascular Surgery; Medical and Dental (SAGE Publications, 2021-12-04)
      Introduction: Access to the femoral artery for a femoral endarterectomy and patchplasty (CFE) can be undertaken either through transverse (TI) or longitudinal incision (LI). LIs have been shown in previous studies to have higher groin complications though these were undertaken in multiple types of vascular procedures. We looked at wound complications for patients undergoing elective CFE procedures only with or without angioplasty via TI or LI. Methods: All patients who had undergone CFE were retrospectively analysed from a prospective database. Length of stay, wound complications and readmission rates were recorded. Factors for wound complication were looked at using logistic regression with backward elimination. Results: 122 CFE procedures were performed (30 TI) over the study period. 92 (76.7%) of patients had a prosthetic patch used, whilst 57 (46.7%) patients underwent an adjunctive endovascular procedure, namely, iliac angioplasty and stenting. Median length of stay was 3 days for both groups. The wound complication rate was 6.7% in the TI group and 22.6% in the LI group. 85.6% of the wound complications were identified after discharge. 6/122 (4.9%) were readmitted for intravenous antibiotics, whilst others were managed in the outpatient setting. TI (aOR = 0.15; 95% 0.03-0.75) and combined open FE with endovascular revascularisation (aOR = 0.33; 95% 0.11-0.95) had protective effects on wound complications. Type of the patch used was not associated with any wound complications (p = 0.07). Conclusion: Compared to traditional LI, TI for CFE and OTA have lower risk of wound complications and reduced readmission rates in our series. We advocate adopting TI as the standard for femoral artery procedures rather than LI.
    • Recruitment into randomised trials of arteriovenous grafts: a systematic review.

      Kingsmore, David; White, Richard D; Mestres, Gaspar; Stephens, Mike; Calder, Francis; Papadakis, Georgios; Aitken, Emma; Jackson, Andrew; Inston, Nick; Jones, Rob G; et al. (SAGE Publications, 2023-03-11)
      Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.
    • Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) Prospective Cohort Study and the Generalisability of the BASIL-2 Randomised Controlled Trial

      Popplewell, Matthew A; Meecham, Lewis; Davies, Huw O B; Kelly, Lisa; Ellis, Tracy; Bate, Gareth R; Moakes, Catherine A; Bradbury, Andrew W; Ellis, Tracy; Kelly, Lisa; et al. (Elsevier, 2023-09-29)
      Objective: The Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2) randomised controlled trial has shown that, in patients with chronic limb threatening ischaemia (CLTI) who require an infrapopliteal (IP) revascularisation a vein bypass (VB) first revascularisation strategy led to a 35% increased risk of major amputation or death when compared with a best endovascular treatment (BET) first revascularisation strategy. The study aims are to place the BASIL-2 trial within the context of the CLTI patient population as a whole, and to investigate the generalisability of the BASIL-2 outcome data. Methods: This was an observational, single centre prospective cohort study. Between 24 June 2014 and 31 July 2018, the BASIL Prospective Cohort Study (PCS) was performed which used BASIL-2 trial case record forms to document the characteristics, initial and subsequent management, and outcomes of 471 consecutive CLTI patients admitted to the vascular centre. Ethical approval was obtained, and all patients provided fully informed written consent. Follow up data were censored on 14 December 2022. Results: Of the 238 patients who required an infrainguinal revascularisation, 75 (32%) had either IP bypass (39 patients) or IP BET (36 patients) outside BASIL-2. Seventeen patients were initially randomised to BASIL-2. A further three patients who did not have an IP revascularisation as their initial management were later randomised in BASIL-2. Therefore, 95/471 (20%) of patients had IP revascularisation (16% outside, 4% inside BASIL-2). Differences in amputation free survival, overall survival, and limb salvage between IP bypass and endovascular revascularisation performed outside BASIL-2 were not subject to hypothesis testing due to the small sample size. Reasons for non-randomisation into the trial were numerous, but often due to anatomical and technical considerations. Conclusion: CLTI patients who required an IP revascularisation procedure and were subsequently randomised into BASIL-2 accounted for a small subset of the CLTI population as a whole. For a wide range of patient, limb, anatomic and operational reasons, most patients in this cohort were deemed unsuitable for randomisation in BASIL-2. The results of BASIL-2 should be interpreted in this context.
    • Device implantation complicated by a retrosternal goiter

      Elshafie, Sally; Tariq, Abu Taher; Leon, Francisco Leyva; Leon, Francisco Leyva; Cardiology; Medical and Dental (Wiley, 2023-08-18)
      Central venous obstruction in the cardiac implantable electronic devices (CIED) population is commonly due to thrombosis and fibrosis secondary to the passage of pre-existing leads. However, vein occlusion before CIED implantation is uncommon, and one cause is retrosternal goiters. We report a case where the failure of the initial implantation of a primary CIED led to an unusual implantation route without goiter excision. The patient had an indication for cardiac resynchronization therapy (CRT) given his left ventricular (LV) function was impaired and had second-degree heart block Mobitz Type II; however, he had occluded bilateral subclavian veins due to a sizeable retrosternal goiter. This obstruction led to the implantation of a single lead pacemaker via the right femoral vein after multiple failed attempts at CRT, dual chamber pacemaker and left bundle branch area pacing (LBBaP).
    • Phantom Limb Pain and Painful Neuroma After Dysvascular Lower-Extremity Amputation: A Systematic Review and Meta-Analysis

      Langeveld, Mirte; Bosman, Romy; Hundepool, Caroline A; Duraku, Liron S; McGhee, Christopher; Zuidam, J Michiel; Barker, Tom; Juszczak, Maciej; Power, Dominic M; Langeveld, Mirte; et al. (SAGE Publications, 2023-08-24)
      Background: Phantom limb pain (PLP) and symptomatic neuroma can be debilitating and significantly impact the quality of life of amputees. However, the prevalence of PLP and symptomatic neuromas in patients following dysvascular lower limb amputation (LLA) has not been reliably established. This systematic review and meta-analysis evaluates the prevalence and incidence of phantom limb pain and symptomatic neuroma after dysvascular LLA. Methods: Four databases (Embase, MEDLINE, Cochrane Central, and Web of Science) were searched on October 5th, 2022. Prospective or retrospective observational cohort studies or cross-sectional studies reporting either the prevalence or incidence of phantom limb pain and/or symptomatic neuroma following dysvascular LLA were identified. Two reviewers independently conducted the screening, data extraction, and the risk of bias assessment according to the PRISMA guidelines. To estimate the prevalence of phantom limb pain, a meta-analysis using a random effects model was performed. Results: Twelve articles were included in the quantitative analysis, including 1924 amputees. A meta-analysis demonstrated that 69% of patients after dysvascular LLA experience phantom limb pain (95% CI 53-86%). The reported pain intensity on a scale from 0-10 in LLA patients ranged between 2.3 ± 1.4 and 5.5 ± .7. A single study reported an incidence of symptomatic neuroma following dysvascular LLA of 5%. Conclusions: This meta-analysis demonstrates the high prevalence of phantom limb pain after dysvascular LLA. Given the often prolonged and disabling nature of neuropathic pain and the difficulties managing it, more consideration needs to be given to strategies to prevent it at the time of amputation.
    • Multicenter Study to Evaluate Endovascular Repair of Extent I-III Thoracoabdominal Aneurysms Without Prophylactic Cerebrospinal Fluid Drainage.

      Marcondes, Giulianna B; Cirillo-Penn, Nolan C; Tenorio, Emanuel R; Adam, Donald J; Timaran, Carlos; Austermann, Martin J; Bertoglio, Luca; Jakimowicz, Tomasz; Piazza, Michele; Juszczak, Maciej T; et al. (Lippincott, Williams & Wilkins, 2022-08-04)
      Objective: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). Background: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. Methods: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. Results: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P =0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7-11.1], patent collateral network (OR: 0.3, 95% CI: 0.1-0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01-1.10). Patient survival at 3 years was 72%±3%. Conclusion: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.
    • A Systematic Review Network Meta-Analysis and Meta-Regression on Surgical and Endovenous Interventions for the Treatment of Lower Limb Venous Ulcer Disease

      Bontinis, Vangelis; Ktenidis, Kiriakos; Bontinis, Alkis; Koutsoumpelis, Andreas; Antonopoulos, Constantine N; Giannopoulos, Argirios; Rafailidis, Vasileios; Chorti, Angeliki; Bradbury, Andrew W; Bradbury, Andrew W; et al. (SAGE Publications, 2023-08-17)
      Background: Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU. Methods: We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications. Results: Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, β = -0.27 (95% CI: -2.55 to 1.85), recurrence, β = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, β = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence. Conclusion: This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required. Clinical impact: Our review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.
    • Fenestrated-branched endovascular repair for distal thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk.

      Shalan, Ahmed; Tenorio, Emanuel R; Mascaro, Jorge G; Juszczak, Maciej T; Claridge, Martin W; Melloni, Andrea; Bertoglio, Luca; Chiesa, Roberto; Oderich, Gustavo S; Adam, Donald J; et al. (Elsevier, 2022-06-10)
      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.