Rehabilitation experiences following major lower limb amputation due to complications of vascular disease: a UK qualitative study.

PURPOSE: Rehabilitation experiences of lower limb amputees with poorer physical health have not been fully explored. This study aimed to qualitatively explore experiences of rehabilitation amongst patients who had recently undergone amputation due to complications of vascular disease. METHODS: Semi-structured, face-to-face interviews were conducted with 14 patients participating in the PLACEMENT randomised controlled feasibility trial (ISRCTN: 85710690; EudraCT: 2016-003544-37), which investigated the effectiveness of using a perineural catheter for postoperative pain relief following major lower limb amputation. Framework analysis was used to identify key themes and compare participant data. FINDINGS: Three main themes and corresponding sub-themes were identified: (i) other patients as inspiration; (ii) other patients as competition; and (iii) imagined futures. Perceptions relating to other patients played a key role in rehabilitation, providing a source of motivation, support, and competition. Participants' imagined futures were uncertain, and this was compounded by a lack of information and delays in equipment and/or adaptations. CONCLUSIONS: Findings highlight the importance of fellow patients in supporting rehabilitation following lower limb amputation. Enabling contact with other patients should thus be a key consideration when planning rehabilitation. There is a clear unmet need for realistic information relating to post-amputation recovery, tailored to the needs of individual patients.

There is a clear unmet need for patient information on rehabilitation following major lower limb amputation.Information about future mobility - particularly prosthesis use - should be realistic and individually tailored.The key role of fellow patients should be fully considered when planning post-amputation rehabilitation.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Long-term risk prediction after major lower limb amputation: 1-year results of the PERCEIVE study.

BACKGROUND: Decision-making when considering major lower limb amputation is complex and requires individualized outcome estimation. It is unknown how accurate healthcare professionals or relevant outcome prediction tools are at predicting outcomes at 1-year after major lower limb amputation. METHODS: An international, multicentre prospective observational study evaluating healthcare professional accuracy in predicting outcomes 1 year after major lower limb amputation and evaluation of relevant outcome prediction tools identified in a systematic search of the literature was undertaken. Observed outcomes at 1 year were compared with: healthcare professionals' preoperative predictions of death (surgeons and anaesthetists), major lower limb amputation revision (surgeons) and ambulation (surgeons, specialist physiotherapists and vascular nurse practitioners); and probabilities calculated from relevant outcome prediction tools. RESULTS: A total of 537 patients and 2244 healthcare professional predictions of outcomes were included. Surgeons and anaesthetists had acceptable discrimination (C-statistic = 0.715), calibration and overall performance (Brier score = 0.200) when predicting 1-year death, but performed worse when predicting major lower limb amputation revision and ambulation (C-statistics = 0.627 and 0.662 respectively). Healthcare professionals overestimated the death and major lower limb amputation revision risks. Consultants outperformed trainees, especially when predicting ambulation. Allied healthcare professionals marginally outperformed surgeons in predicting ambulation. Two outcome prediction tools (C-statistics = 0.755 and 0.717, Brier scores = 0.158 and 0.178) outperformed healthcare professionals' discrimination, calibration and overall performance in predicting death. Two outcome prediction tools for ambulation (C-statistics = 0.688 and 0.667) marginally outperformed healthcare professionals. CONCLUSION: There is uncertainty in predicting 1-year outcomes following major lower limb amputation. Different professional groups performed comparably in this study. Two outcome prediction tools for death and two for ambulation outperformed healthcare professionals and may support shared decision-making.

Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review.

OBJECTIVE: Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD). DATA SOURCES AND REVIEW METHODS: A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials. RESULTS: After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored. CONCLUSION: The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported. PROSPERO registration number: CRD42022288214.

Clinical Effects of Tourniquet Use for Nontraumatic Major Lower Limb Amputation: A Two-Center Retrospective Cohort Study.

BACKGROUND: To investigate the effect of tourniquet use on outcomes after major lower limb amputation (MLLA) due to peripheral arterial disease or complications from diabetes mellitus. METHODS: In this 2-center retrospective observational study, vascular patients who underwent MLLA between January 1, 2016 and December 31, 2020 at 2 UK hospitals were identified using operating theater databases. Hospital databases were used to access medical records, operation notes, and laboratory reports. The use of a tourniquet in each MLLA was noted. The primary outcome was postoperative hemoglobin (Hb) drop (g/L). Secondary outcomes were units of allogeneic blood transfused perioperatively, 90-day revision rates, 90-day wound breakdown rates, surgical site infection (SSI) rates (at 30 days), and 90-day mortality. A follow-up index (a measure of follow-up completeness) was calculated for all 30-day and 90-day outcomes. RESULTS: Four hundred seventy two patients underwent MLLA, of which 124 had a tourniquet applied. The median postoperative Hb drop was significantly lower in the tourniquet group compared to the nontourniquet group (13 [interquartile range 5-22] g/L vs. 20 [interquartile range 11-28] g/L; P ≤ 0.001). Thirty three point one percent (41) of tourniquet patients received a blood transfusion perioperatively, compared to 35.6% (124) of nontourniquet patients (P = 0.82). Sixteen percent (76) of patients required surgical revision within 90 days, with no significant difference between the tourniquet and nontourniquet group (20.2% tourniquet vs. 14.7% no tourniquet; P = 0.15). SSI rates (12.0% tourniquet vs. 10.6% no tourniquet, P = 0.66) and 90-day mortality (6.5% tourniquet vs. 10.1% no tourniquet; P = 0.23) were similar. Multivariable regression demonstrated that tourniquet use was independently associated with a reduced hemoglobin drop (ß = -4.671, 95% confidence interval -7.51 to -1.83, P ≤ 0.001) but was not associated with wound breakdown, revision surgery, or SSI. Hypertension, SSI, and below-knee amputation using the skew flap technique were all significant predictors of revision surgery. All follow-up indices were ≥ 0.97. CONCLUSIONS: Tourniquet use in MLLA was associated with a significantly lower fall in postoperative Hb without evidence of harm in terms of SSI, wound breakdown/revision rates, or mortality.

Editor's Choice - Quality Assessment of European Society for Vascular Surgery Clinical Practice Guidelines.

OBJECTIVE: An increasing number of clinical practice guidelines (CPGs) have emerged over recent years. To have clinical utility, they need to be rigorously developed and scientifically robust. Instruments have been developed to assess the quality of clinical guideline development and reporting. The aim of this study was to evaluate CPGs from the European Society for Vascular Surgery (ESVS) using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. METHODS: CPGs published by the ESVS during the period January 2011 to January 2023 were included. Two independent reviewers assessed the guidelines after receiving training in the use and application of the AGREE II instrument. Inter-reviewer reliability was assessed with the intraclass correlation coefficient. Maximum scaled scores were 100. Statistical analysis was performed using SPSS Statistics v.26. RESULTS: Sixteen guidelines were included in the study. Good inter-reviewer score reliability was found on statistical analysis (> 0.9). The mean ± standard deviation domain scores were 68.1 ± 20.3% for scope and purpose, 57.1 ± 21.1% for stakeholder involvement, 67.8 ± 19.5% for rigour of development, 78.1 ± 20.6% for clarity of presentation, 50.3 ± 15.4% for applicability, 77.6 ± 17.6% for editorial independence, and 69.8 ± 20.1% for overall quality. Stakeholder involvement and applicability have improved in quality over time but are still the lowest scoring domains. CONCLUSION: Most ESVS clinical guidelines are of high quality and reporting. There is scope for improvement, specifically by addressing the domains of stakeholder involvement and clinical applicability.

Protocol for a systematic review of reporting standards of lower limb endovascular interventions in peripheral arterial disease.

INTRODUCTION: Techniques and devices for the endovascular treatment of peripheral arterial disease (PAD) are continuously evolving. High-quality clinical trials limit the variation in how endovascular interventions are described, performed and reported. The aim of this systematic review is to assess the quality of reporting standards in randomised controlled trials (RCTs) of endovascular lower limb interventions against the Consolidated Standards of Reporting Trials for Non-Pharmacologic Treatments (CONSORT-NPT) and template for intervention description and replication (TIDieR) framework. METHODS: Randomised trials including participants with peripheral arterial disease undergoing any infra-inguinal lower limb endovascular arterial intervention, searched from Medline, Embase and Cochrane Library databases from inception to December 2021, will be included. All study data, including details of the procedure investigated, will be extracted in keeping with the CONSORT-NPT and TIDieR checklist. Descriptive statistics will be used to summarise general study details and reporting standards of the trials. DISCUSSION: The results will be used to inform the design of future RCTs in this area by optimising the way the interventions are described, standardised, and monitored. The systematic review will be disseminated via peer-reviewed manuscripts and presentations at relevant conferences. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022288214.

Short-term risk prediction after major lower limb amputation: PERCEIVE study.

BACKGROUND: The accuracy with which healthcare professionals (HCPs) and risk prediction tools predict outcomes after major lower limb amputation (MLLA) is uncertain. The aim of this study was to evaluate the accuracy of predicting short-term (30 days after MLLA) mortality, morbidity, and revisional surgery. METHODS: The PERCEIVE (PrEdiction of Risk and Communication of outcomE following major lower limb amputation: a collaboratIVE) study was launched on 1 October 2020. It was an international multicentre study, including adults undergoing MLLA for complications of peripheral arterial disease and/or diabetes. Preoperative predictions of 30-day mortality, morbidity, and MLLA revision by surgeons and anaesthetists were recorded. Probabilities from relevant risk prediction tools were calculated. Evaluation of accuracy included measures of discrimination, calibration, and overall performance. RESULTS: Some 537 patients were included. HCPs had acceptable discrimination in predicting mortality (931 predictions; C-statistic 0.758) and MLLA revision (565 predictions; C-statistic 0.756), but were poor at predicting morbidity (980 predictions; C-statistic 0.616). They overpredicted the risk of all outcomes. All except three risk prediction tools had worse discrimination than HCPs for predicting mortality (C-statistics 0.789, 0.774, and 0.773); two of these significantly overestimated the risk compared with HCPs. SORT version 2 (the only tool incorporating HCP predictions) demonstrated better calibration and overall performance (Brier score 0.082) than HCPs. Tools predicting morbidity and MLLA revision had poor discrimination (C-statistics 0.520 and 0.679). CONCLUSION: Clinicians predicted mortality and MLLA revision well, but predicted morbidity poorly. They overestimated the risk of mortality, morbidity, and MLLA revision. Most short-term risk prediction tools had poorer discrimination or calibration than HCPs. The best method of predicting mortality was a statistical tool that incorporated HCP estimation.

Antithrombotic Therapy for Aortic Aneurysms: A Systematic Review and Meta-Analysis.

OBJECTIVES: The role of antithrombotic therapy in the management of aortic and peripheral aneurysms is unclear. This systematic review and meta-analysis aimed to assess the impact of antithrombotics on clinical outcomes for aortic and peripheral aneurysms. METHODS: Medline, Embase, and CENTRAL databases were searched. Randomised controlled trials and observational studies investigating the effect of antithrombotic therapy on clinical outcomes for patients with any aortic or peripheral artery aneurysm were included. RESULTS: Fifty-nine studies (28 with antiplatelet agents, 12 anticoagulants, two intra-operative heparin, and 16 any antithrombotic agent) involving 122 102 patients were included. Abdominal aortic aneurysm (AAA) growth rate was not significantly associated with the use of antiplatelet therapy (SMD -0.36 mm/year; 95% CI -0.75 - 0.02; p = .060; GRADE certainty: very low). Antithrombotics were associated with increased 30 day mortality for patients with AAAs undergoing intervention (OR 2.30; 95% CI 1.51 - 3.51; p < .001; GRADE certainty: low). Following intervention, antiplatelet therapy was associated with reduced long term all cause mortality (HR 0.84; 95% CI 0.76 - 0.92; p < .001; GRADE certainty: moderate), whilst anticoagulants were associated with increased all cause mortality (HR 1.64; 95% CI 1.14 - 2.37; p = .008; GRADE certainty: very low), endoleak within three years (OR 1.99; 95% CI 1.10 - 3.60; p = .020; I2 = 60%; GRADE certainty: very low), and an increased re-intervention rate at one year (OR 3.25; 95% CI 1.82 - 5.82; p < .001; I2 = 35%; GRADE certainty: moderate). Five studies examined antithrombotic therapy for popliteal aneurysms. Meta-analysis was not possible due to heterogeneity. CONCLUSIONS: There was a lack of high quality data examining antithrombotic therapy for patients with aneurysms. Antiplatelet therapy was associated with a reduction in post-intervention all cause mortality for AAA, whilst anticoagulants were associated with an increased risk of all cause mortality, endoleak, and re-intervention. Large, well designed trials are still required to determine the therapeutic benefits of antithrombotic agents in this setting.