17 results on '"Popplewell MA"'
Search Results
2. A case of pseudoaneurysm of the marginal artery of Drummond post-open abdominal aortic aneurysm (AAA) repair.
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Shahid M, Alawattegama LH, Latif SA, Popplewell MA, Garnham A, and Wall ML
- Abstract
We present the first published account of a pseudoaneurysm of the Marginal artery of Drummond (MAoD) following an emergency open surgical repair of an inflammatory abdominal aortic aneurysm, in which the inferior mesenteric artery was ligated. This was hypothesized to be an iatrogenic injury secondary to retraction of the colonic mesentery during dissection of the aneurysm neck. The risk of pseudoaneurysm growth and rupture versus bowel ischaemia were evaluated in the post-operative phase. Ultimately, the patient underwent successful interventional embolization of the MAoD with no signs of bowel ischaemia post-intervention., Competing Interests: None declared., (Published by Oxford University Press and JSCR Publishing Ltd. © The Author(s) 2024.)
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- 2024
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3. Responses to the Main Critiques of the Bypass Versus Angioplasty in Severe Ischemia of the Leg (BASIL)-2 Trial.
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Popplewell MA and Bradbury AW
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- Humans, Treatment Outcome, Randomized Controlled Trials as Topic, Lower Extremity blood supply, Ischemia surgery, Ischemia diagnostic imaging, Ischemia physiopathology, Ischemia therapy, Severity of Illness Index, Angioplasty adverse effects, Angioplasty instrumentation, Vascular Grafting adverse effects, Risk Factors, Research Design, Peripheral Arterial Disease therapy, Peripheral Arterial Disease surgery, Peripheral Arterial Disease diagnostic imaging
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- 2024
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4. The obese population's views on the symptoms and risks of chronic venous insufficiency - 2 (OBVIOUS-2) cross-sectional survey.
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Popplewell MA, Mahesh S, Nandra S, Juszczak M, Ashby H, and Wall ML
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Introduction: Individuals with high body mass index (BMI) are more likely to have symptomatic LLVD than age matched populations with normal BMI. National priorities in venous disease set by the James Lind Alliance focus on improving access to healthcare and patient education. The aims of this study are to determine patient knowledge and potential burden of LLVD in a population of patients attending a UK, regional weight management service., Methods: A postal questionnaire containing 12 questions relating to LLVD and obesity was distributed to the active list of patients under the weight management medical service at Dudley Group of Hospitals between May 2022-23. Respondents were provided with a stamped, addressed envelope to return the questionnaire. Ethical approval was granted by the Hampshire Research & Ethics Committee., Results: Some 367 questionnaires were distributed to patients currently enrolled in specialist weight management services. 103 complete responses were received (28%), Most patients were between 50 and 70 years of age. 25% of patients already had a formal diagnosis of LLVD, with a further 84 (82%) reported signs or symptoms which may be related to LLVD. Almost half (49/103, 48%) had concerns over their skin quality with a similar proportion (25/103, 51%) having sought medical help. The majority (71/103, 69%) were unaware of the association between obesity and LLVD. Twelve participants had education regarding simple adjuncts designed to improve symptoms and/or prevent ulceration (emollients, dressings, stockings, or leg elevation). Four participants had previously undergone treatment for varicose veins., Conclusion: In a population of patients accessing weight management services, we have demonstrated that a quarter of patients have already received a diagnosis of LLVD, however there is for a greater undiagnosed burden of LLVD in part due to lack of patient and possibly clinician awareness., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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5. Editor's Choice - Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) Prospective Cohort Study and the Generalisability of the BASIL-2 Randomised Controlled Trial.
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Popplewell MA, Meecham L, Davies HOB, Kelly L, Ellis T, Bate GR, Moakes CA, and Bradbury AW
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Objective: The Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2) randomised controlled trial has shown that, for 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 an academic 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 IP BET 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, anatomical 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., (Crown Copyright © 2023. Published by Elsevier B.V. All rights reserved.)
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- 2024
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6. A vascular multi-arm multi-stage trial to prevent groin wound surgical site infection: A feasibility survey.
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Popplewell MA, Gwilym BL, Benson RA, Juszczak M, Bosanquet D, Pinkney TD, Chetter I, and Wall M
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- Humans, Surgical Wound Infection prevention & control, Feasibility Studies, Vascular Surgical Procedures adverse effects, Surveys and Questionnaires, Groin surgery, Surgical Wound
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Surgical site infection (SSI) is common following arterial surgery involving a groin incision. There is a lack of evidence regarding interventions to prevent groin wound SSI, therefore, a survey of vascular clinicians was undertaken to assess current opinion and practice, equipoise and feasibility of a randomised controlled trial (RCT). Participants at the Vascular Society of Great Britain and Ireland 2021 Annual Scientific Meeting were surveyed regarding three separate interventions designed to prevent SSI in the groin; impregnated incise drapes, diakylcarbomoyl chloride dressings and antibiotic impregnated collagen sponges. Results were collated via an online survey using the Research Electronic Data Capture platform. Seventy-five participants completed the questionnaire, most were consultant vascular surgeons (50/75, 66.7%). The majority agree that groin wound SSI is a major problem (73/75, 97.3%), and would be content using either of the three interventions (51/61, 83.6%) and had clinical equipoise to randomise patients to any of the three interventions versus standard of care (70/75, 93.3%). There was some reluctance to not use impregnated incise drapes as may be considered "standard of care". Groin wound SSI is perceived as major problem in vascular surgery, and a multicentre RCT of three preventative interventions appears acceptable to vascular surgeons., (© 2023 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)
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- 2023
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7. Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemia.
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Popplewell MA, Andronis L, Davies HOB, Meecham L, Kelly L, Bate G, and Bradbury AW
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- Aged, Aged, 80 and over, Amputation, Surgical statistics & numerical data, Angioplasty methods, Angioplasty statistics & numerical data, Chronic Limb-Threatening Ischemia economics, Cost-Benefit Analysis statistics & numerical data, Female, Follow-Up Studies, Humans, Limb Salvage methods, Limb Salvage statistics & numerical data, Lower Extremity blood supply, Lower Extremity surgery, Male, Middle Aged, Operative Time, Patient Readmission economics, Patient Readmission statistics & numerical data, Popliteal Artery surgery, Prospective Studies, Treatment Outcome, Amputation, Surgical economics, Angioplasty economics, Chronic Limb-Threatening Ischemia surgery, Hospital Costs statistics & numerical data, Limb Salvage economics
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Objective: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis., Methods: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study., Results: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis)., Conclusions: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2022
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8. A Review of UK-based National and International Scientific Meeting Published Abstracts in Response to the Draft NICE Aortic Aneurysm Guidelines.
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Youssef S, Elkawafi M, Peysner R, Popplewell MA, and Rajagopalan S
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- Abstracting and Indexing, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Bibliometrics, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Congresses as Topic, Consensus, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Evidence-Based Medicine standards, Health Care Sector, Humans, Periodicals as Topic, Risk Assessment, Risk Factors, Stakeholder Participation, Treatment Outcome, United Kingdom, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation standards, Endovascular Procedures standards, Practice Guidelines as Topic standards
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Background: UK National Institute for Health and Care Excellence (NICE) draft clinical guidelines (CG) (2018) regarding aortic aneurysm repair were disputed internationally. We aim to appraise the academic response to the draft CG in terms of quantity and scientific quality by reviewing published conference abstracts from three major national and international, UK meetings., Methods: Abstracts related to aortic practice from The Vascular Societies Annual Scientific Meeting, British Society for Endovascular Therapy (BSET) & Charing Cross (CX) meetings from 2019 were reviewed for methodology, sample size, data collection period, scientific quality and conclusions that supported or conflicted the draft guideline., Results: A total of 549 abstracts were identified from VSGBI, BSET and CX abstract books of which, 226 (41.2%) were related to aortic practices. Of these, 115 (50.9%) were related to EVAR. Twenty-two of these abstracts (19.1%) were identified as having findings relevant to the draft guidelines. Eighteen (15.7%) were identified as findings that potentially conflict the draft CG and 4 (3.5%) that could support the initial recommendations. Six abstracts (5.2%) made direct reference to or challenged the draft CG. The median data collection period was 4 years. The median sample size was 102 patients. In general, scientific quality was poor, with 82% of selected abstracts were graded at level 2b., Conclusion: We have demonstrated a concerted response to the draft NICE clinical guidelines relating to the treatment of abdominal aortic aneurysms at three large scientific meetings. As a result of which and other factors, significant changes were made to the finalized NG156. There is still paucity in evidence regarding the long-term safety and cost-effectiveness of EVAR., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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9. A Comparison of Contemporary Clinical Outcomes Following Femoro-Popliteal Plain Balloon Angioplasty and Bypass Surgery for Chronic Limb Threatening Ischemia.
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Meecham L, Popplewell MA, Bate GR, Patel S, and Bradbury AW
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- Aged, Aged, 80 and over, Amputation, Surgical, Chronic Disease, Female, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Humans, Ischemia diagnostic imaging, Ischemia physiopathology, Limb Salvage, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease mortality, Peripheral Arterial Disease physiopathology, Popliteal Artery diagnostic imaging, Popliteal Artery physiopathology, Progression-Free Survival, Retrospective Studies, Time Factors, Angioplasty, Balloon adverse effects, Angioplasty, Balloon mortality, Femoral Artery surgery, Ischemia therapy, Peripheral Arterial Disease therapy, Popliteal Artery surgery, Vascular Grafting adverse effects, Vascular Grafting mortality
- Abstract
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.
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- 2021
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10. Comparison of Clinical Outcomes in Patients Selected for Infra-Popliteal Bypass or Plain Balloon Angioplasty for Chronic Limb Threatening Ischemia Between 2009 and 2013.
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Popplewell MA, Davies HOB, Meecham L, Bate G, and Bradbury AW
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Introduction: A published subgroup analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial suggests that, in patients with chronic limb threatening ischemia (CLTI) due to infra-popliteal (IP) disease, clinical outcomes are better following vein bypass surgery (BS) than after plain balloon angioplasty (PBA). The aim of the present study is to determine if clinical outcomes following IP revascularization in our unit are concordant with those found in BASIL-1., Methods: We analyzed prospectively gathered data pertaining to 137 consecutive CLTI patients undergoing IP PBA or BS between 2009 and 2013. We compared 30-day morbidity and mortality, days in hospital (index admission and out to 12-months), amputation free survival (AFS), overall survival (OS), limb salvage (LS), and freedom from arterial re-intervention (FFR). Patient outcomes were censored on 1 February 2017, providing a minimum 3 years follow-up., Results: Patients undergoing BS (73/137, 47%) tended to be younger, have less comorbidity, and were more likely to be on best medical therapy (BMT). BS patients spent more days in hospital during the index admission (median 9 vs 5, p = .003), but not out to 12 months (median 15 vs 13, NS). BS patients suffered more 30-day morbidity (36% vs 10%, p < .001), mainly due to infective complications, but not mortality (3.1% vs 6.8%, NS). AFS (p = .001) and OS (p < .001), but not LS or FFR, were better after BS., Conclusions: CLTI patients selected for revascularization by means of IP BS had better long-term outcomes in terms of AFS and OS, but not FFR or LS. Although we await the results of the BASIL-2 trial, current data support the BASIL-1 sub-group analysis which suggests that patients requiring revascularization for IP disease should have BS where possible and that PBA should usually be reserved for patients who are not suitable for BS.
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- 2020
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11. Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013).
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Popplewell MA, Davies HOB, Renton M, Bate G, Patel S, Deeks JJ, and Bradbury AW
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- Aged, Aged, 80 and over, Amputation, Surgical, Chronic Disease, Databases, Factual, Female, Humans, Ischemia diagnostic imaging, Ischemia physiopathology, Length of Stay, Male, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease physiopathology, Progression-Free Survival, Randomized Controlled Trials as Topic, Risk Factors, Time Factors, Vascular Patency, Angioplasty, Balloon adverse effects, Ischemia therapy, Peripheral Arterial Disease therapy, Popliteal Artery diagnostic imaging, Popliteal Artery physiopathology
- Abstract
Objectives: To compare outcomes in patients randomized to infrapopliteal (IP) plain balloon angioplasty (PBA) for chronic limb-threatening ischemia within the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL)-1 trial between 1999 and 2004 with outcomes in consecutive patients undergoing IP PBA at an academic vascular unit a decade later (2009-2013, Contemporary series [CS])., Methods: Individual patient data were obtained from prospective BASIL-1 (48 patients) and CS databases (73 patients). All had a minimum of 3-years of follow-up. Outcomes studied were amputation-free survival (AFS), overall survival (OS), major (above ankle) limb amputation, arterial reintervention, immediate technical success, and length of hospital stay for the index procedure and during the following 12-month period. Statistical analysis was performed using SAS version 9.4., Results: The BASIL and CS cohorts were well matched for gender, age, diabetes, previous stroke, myocardial infarction and arterial intervention, and presence of tissue loss. More patients in BASIL-1 underwent concomitant treatment of the superficial femoral (60% vs 37%, P = .01) and above knee popliteal (60% vs 34%, P = .005) arteries. Immediate technical success increased from 73% in BASIL-1 to 90% in the CS ( P = .01). Between the two cohorts, there were no differences in AFS (hazard ratio [HR] = 1.00, 95% confidence interval [CI]: 0.65-1.54, P = 1.0), OS (HR = 1.04, 95% CI: 0.66-1.62, P = .9), major amputation (HR = 0.86, 95% CI: 0.37-1.97, P = .7), or reintervention (HR = 0.61, 95% CI: 0.29-1.27, P = .2). Contemporary series patients spent significantly fewer days in hospital following the index procedure ( P = .02) and also over the following 12 months ( P = .002)., Conclusions: Despite improvements in the immediate technical angiographic success of IP PBA between BASIL and the CS, there were no significant improvements in survival outcomes. Results from BASIL-2 and BEST-CLI are required in order to properly define the clinical and cost-effectiveness of endovascular treatment in such patients.
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- 2020
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12. A Comparison of Outcomes in Patients with Infrapopliteal Disease Randomised to Vein Bypass or Plain Balloon Angioplasty in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial.
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Popplewell MA, Davies HOB, Narayanswami J, Renton M, Sharp A, Bate G, Patel S, Deeks J, and Bradbury AW
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- Aged, Aged, 80 and over, Amputation, Surgical, Disease-Free Survival, Female, Humans, Ischemia diagnosis, Ischemia physiopathology, Kaplan-Meier Estimate, Length of Stay, Limb Salvage, Male, Middle Aged, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease mortality, Peripheral Arterial Disease physiopathology, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, United Kingdom, Wound Healing, Angioplasty, Balloon adverse effects, Angioplasty, Balloon mortality, Ischemia therapy, Lower Extremity blood supply, Peripheral Arterial Disease therapy, Popliteal Artery physiopathology, Veins transplantation
- Abstract
Objective: The aim was to compare outcomes in a subgroup of patients with infrapopliteal (IP) disease randomised to infrapopliteal vein bypass (VB) or plain balloon angioplasty (PBA) in the original BASIL trial., Methods: A comparison of outcomes from patients randomised to VB or PBA undergoing revascularisation for severe limb ischaemia (SLI) because of IP disease with or without femoropopliteal disease. Data were extracted from case report forms from the BASIL trial. The primary outcome was amputation free survival (AFS); secondary outcomes included overall survival (OS), 30 day mortality and morbidity, freedom from arterial re-intervention, immediate technical success, repeat and crossover interventions, length of hospital stay, and quality of revascularisation., Results: A total of 104 patients were identified in the BASIL study with IP disease, 56 randomised to IP VB, and 48 to IP PBA. Groups were similar at baseline except for more chronic kidney disease and non-steroidal anti-inflammatory drug use in the VB group, and more previous surgical arterial intervention and antihypertensive use in the PBA group. There were no statistically significant differences in AFS or OS; however, clinically important trends were apparent in favour of a VB first strategy. Patients allocated to VB demonstrated significantly quicker relief of rest pain when compared with PBA (p = .005), but no significant differences in improved tissue healing. Median length of index hospital admission was significantly greater in the VB than in the PBA group (18 vs. 10 days, p < .0001) but there was no difference between the two groups in median total hospital stay between randomisation and the primary endpoint (VB 43.5 vs. PBA 42 days)., Conclusions: Further randomised trials, like BASIL-2 and BEST-CLI, are required to determine whether patients with severe limb ischaemia who require IP revascularisation and who are suitable for VB should have bypass or endovascular intervention as their primary revascularisation procedure., (Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.)
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- 2017
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13. BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial.
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Hunt BD, Popplewell MA, Davies H, Meecham L, Jarrett H, Bate G, Grant M, Patel S, Hewitt C, Andronis L, Deeks JJ, and Bradbury A
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- Amputation, Surgical, Angioplasty, Balloon adverse effects, Angioplasty, Balloon economics, Cardiovascular Agents adverse effects, Clinical Protocols, Cost-Benefit Analysis, Disease-Free Survival, Health Care Costs, Humans, Ischemia diagnosis, Ischemia economics, Ischemia physiopathology, Limb Salvage, Metals, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease economics, Peripheral Arterial Disease physiopathology, Prosthesis Design, Quality-Adjusted Life Years, Regional Blood Flow, Sample Size, Severity of Illness Index, State Medicine economics, Time Factors, Treatment Outcome, United Kingdom, Vascular Patency, Angioplasty, Balloon instrumentation, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible economics, Drug-Eluting Stents economics, Ischemia therapy, Lower Extremity blood supply, Peripheral Arterial Disease therapy, Stents economics, Vascular Access Devices economics
- Abstract
Background: Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources., Methods: The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with 'multilevel' disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years., Discussion: BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease., Trial Registration: ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.
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- 2017
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14. Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial.
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Popplewell MA, Davies H, Jarrett H, Bate G, Grant M, Patel S, Mehta S, Andronis L, Roberts T, Deeks J, and Bradbury A
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- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Sample Size, Angioplasty methods, Clinical Protocols, Endovascular Procedures methods, Ischemia therapy, Leg blood supply
- Abstract
Background: Severe limb ischaemia is defined by ischaemic rest/night pain, tissue loss, or both, secondary to arterial insufficiency and is increasingly caused by infra-popliteal (below the knee) disease, mainly as a result of the increasing worldwide prevalence of diabetes. Currently, it is unknown whether vein bypass surgery or the best endovascular treatment (angioplasty or stenting) represents the optimal revascularisation strategy in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and cost-effective use of health care resources., Methods/design: The Bypass vs. Angioplasty in Severe Ischaemia of the Leg - 2 Trial is a UK National Institute of Health Research, Health Technology Assessment funded, multi-centre randomised controlled trial that compares, at the point of clinical equipoise, the clinical and cost-effectiveness of a 'vein bypass first' and a 'best endovascular treatment first' revascularisation strategy for severe limb ischaemia due to infra-popliteal disease. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the trial limb or death from any cause. The primary outcome for the cost-effectiveness analysis is cost per quality-adjusted life year. Secondary outcomes include overall survival, quality of life, in-hospital mortality and morbidity, repeat and crossover interventions, healing of tissue loss and haemodynamic changes following revascularisation. Sample size is estimated at 600 patients. An economic evaluation will be conducted from the perspective of the National Health Service and comprise a 'within-study' analysis, based on prospectively collected trial data and a 'model-based' analysis, which will extrapolate and compare costs and effects beyond the study follow-up period., Discussion: The BASIL-2 trial is designed to be pragmatic and represent current practice within the United Kingdom. Patients with severe limb ischaemia can only be randomised into the trial where clinical equipose exists. The advent of hybrid operating procedures should not be a barrier to randomisation, should a patient require inflow correction prior to tibial revascularisation., Isrctn: 27728689 Date of registration: 12 May 2014.
- Published
- 2016
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15. Re: 'more studies are needed to determine which exercise programmes for intermittent claudication should be funded'.
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Popplewell MA and Bradbury AW
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- Humans, Exercise Therapy economics, Health Care Costs, Health Expenditures, Intermittent Claudication therapy, State Medicine economics
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- 2015
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16. A new technique to explant an infected aortic endograft.
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Popplewell MA, Garnham AW, and Hobbs SD
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- Aged, 80 and over, Axillofemoral Bypass Grafting, Blood Vessel Prosthesis Implantation methods, Endovascular Procedures, Humans, Male, Prosthesis Design, Prosthesis-Related Infections diagnostic imaging, Prosthesis-Related Infections etiology, Radionuclide Imaging, Treatment Outcome, Vascular Surgical Procedures, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis adverse effects, Blood Vessel Prosthesis Implantation adverse effects, Device Removal, Prosthesis-Related Infections surgery, Stents adverse effects
- Abstract
The management of an infected aortic endograft can be challenging both operatively and clinically. Although aortic endograft infection is rare, the incidence is likely to increase in the coming years because of ever rising numbers of endovascular aneurysm repairs. Definitive management involves the removal of the endograft through laparotomy. Removal of the graft is technically challenging; no manufacturer's device is available to assist in disengagement of barbed hooks that hold the endograft in position. We present a new technique using the disposable proctoscope as a device to facilitate safe removal of the endograft with minimal damage to the aortic wall., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2015
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17. Why do health systems not fund supervised exercise programmes for intermittent claudication?
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Popplewell MA and Bradbury AW
- Subjects
- Attitude of Health Personnel, Evidence-Based Medicine economics, Health Knowledge, Attitudes, Practice, Humans, Intermittent Claudication economics, Intermittent Claudication physiopathology, Patient Compliance, Practice Patterns, Physicians' economics, Treatment Outcome, United Kingdom, Exercise Therapy economics, Health Care Costs, Health Expenditures, Intermittent Claudication therapy, State Medicine economics
- Published
- 2014
- Full Text
- View/download PDF
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