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.

Patient Perceptions of Surveillance of Small Abdominal Aortic Aneurysms in the Over 85s.

BACKGROUND: Recently instigated local practice for patients with small abdominal aortic aneurysms (AAAs) involves contacting all patients, aged ≥85 years, to discuss with them the advantages and disadvantages of removal from surveillance. However, reasons why patients opt to remain on, or come off, surveillance, are currently unknown. The present study's objective is to explore patient perception of surveillance decision-making. METHODS: A mixed-methods exploratory evaluation was undertaken using patient feedback obtained from a telephone survey. All patients aged ≥85 years, who had a consultation regarding ongoing surveillance of small AAAs (30-49 mm), and consented, were contacted by researchers, who conducted semi-structured interviews concerning factors influencing decision-making. RESULTS: A total of 24 patients (20 male; mean age = 86.9 years) were interviewed; 16 of 24 (66%) had opted to remain on surveillance, with no age difference between those opting in or out. Most felt surveillance was important (91%), and that it made them feel safer (73%). The majority (73%) thought they knew what happened when their AAA reached threshold (5.5 cm), what happened when a threshold AAA is not fixed (64%), and how major AAA surgery is (59%). However, actual knowledge was poor: most (91%) correctly understood surgery was major, but 56% thought that threshold AAA meant certain death or rupture; and 38% thought immediate surgery was required. Thematic analysis expounded patients' beliefs regarding surveillance, which were summarized in 3 distinct subgroups: reliance on professionals' opinions, needing peace of mind, and poor understanding. CONCLUSIONS: While most patients find surveillance reassuring, patient knowledge of AAA management at threshold is poor, potentially impacting surveillance decision-making. Elderly patients, with small AAAs contemplating ongoing surveillance, need to be better informed about AAA management at threshold to support shared decision-making.

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.

Surgical Techniques of, and Outcomes after, Distal Muscle Stabilization in Transfemoral Amputation: A Systematic Review and Narrative Synthesis.

BACKGROUND: Distal muscle stabilization, such as myodesis (suturing muscles to bone) or myoplasty (suturing agonistic-antagonistic muscles together), can aid residual limb stabilization, provide a good soft-tissue covering, and increase rehabilitation potential. However, surgical practice varies due to scant clinical data. The aim of this review is to summarize and evaluate the literature regarding techniques and associated outcomes of distal muscle stabilization in transfemoral amputation (TFA). METHODS: A systematic review and narrative synthesis was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Resources, including observational studies, nonobservational scientific papers, conference proceedings, and textbooks, detailing techniques of TFA distal muscle stabilization were identified from standard medical repositories and library search. A supplementary search of YouTube and Google was undertaken to identify additional resources. Quality assessment was undertaken using Risk Of Bias In Nonrandomized Studies-of Interventions; Authority, Accuracy, Coverage, Objectivity, Date, Significance; and modified-Discern tools. RESULTS: Forty seven resources were identified, including 17 journal articles, 17 textbooks, 5 educational websites/eBooks, 5 videos, 2 online presentations, and 1 webpage. Thirty seven described myodesis, 11 described myoplasty, and 6 described closure without distal muscle stabilization. Eight observational studies presented outcome data for 302 TFAs. No studies comparing closure with or without distal muscle stabilization were identified. All papers describing myodesis secured the adductors to the femur, and most also secured the quadriceps and/or hamstrings to this complex. Number of femoral drill holes varied from 1 to 6. Early wound complications occurred in 17% of amputations, whereas myodesis failure occurred in 9.5%. Prosthetic fitting rates were 73% and, where reported, 100% of patients maintained neutral femoral alignment. CONCLUSIONS: Distal muscle stabilization, particularly myodesis, is a commonly described technique for TFA, although operative techniques are heterogenous. There is a paucity of outcome data, and no studies comparing it to closures without distal muscle stabilization. However, these low-quality data suggest wound healing rates are equivalent to TFA without distal muscle stabilization while demonstrating improvement to patients' rehabilitation potential.

A vascular multi-arm multi-stage trial to prevent groin wound surgical site infection: A feasibility survey.

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.

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.

Telemedicine in Vascular Surgery During COVID-19 Pandemic: A Systematic Review and Narrative Synthesis.

BACKGROUND: The COVID-19 pandemic resulted in seismic changes to healthcare service delivery. The use of telemedicine was widely adopted during the pandemic, although its value in the safe care of vascular patients is unknown. METHODS: A systematic review was undertaken to identify studies that described outcomes or patient/clinician views of telemedicine (telephone or video) services in vascular surgery during or after the pandemic. Two reviewers independently searched medical databases, selected studies, extracted data, and undertook a narrative synthesis. RESULTS: Twelve studies were included. Most studies reported increased telemedicine use during the pandemic. Most patients (80.6%-100%) were satisfied with telephone or video consultation. More than 90% of the patients felt that telemedicine was a good substitute during the pandemic to avoid travelling and reduce transmission risk. Three studies showed patients had a strong preference for continuing telemedicine consultations postpandemic. Two studies evaluating patients with arterial ulceration and venous diseases reported no significant difference in clinical outcome between patients reviewed face-to-face and those seen remotely. One study showed clinicians preferred face-to-face consultations. No study conducted cost analysis. CONCLUSIONS: Patients and clinicians viewed telemedicine favorably as an alternative to face-to-face clinics during the pandemic and included studies did not identify any safety concerns. Its role postpandemic is not clearly defined, although these data suggest a significant proportion of patients would appreciate, and be suitable for, such consultations in the future.

Initial Reduction in Ulcer Size As a Prognostic Indicator for Complete Wound Healing: A Systematic Review of Diabetic Foot and Venous Leg Ulcers.

Significance: Percent area reduction (PAR) is commonly reported in trials including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). It is unclear how well PAR performs as a surrogate marker for complete wound closure. This review aimed to summarize all available evidence evaluating PAR as a predictor of complete DFU and VLU healing. Recent Advances: A review searching the CENTRAL, MEDLINE, EMBASE, and EMCARE databases was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Randomized-controlled trials and observational studies reporting PAR and any measure of its predictive ability were included. Outcomes included performance measures of PAR, timing of PAR, outcome measurement, and specific PAR cutoffs. Critical Issues: Meta-analysis was not possible due to high variability in wound duration at study start (2-48 weeks), PAR timing (2-8 weeks), PAR cutoff (-3% to 90%; determined post hoc in most studies), and outcome assessment (10-24 weeks). Six studies (21,430 DFU patients) report PAR as having acceptable to outstanding discriminatory ability (C-statistic 0.720-0.910). Five studies (29,775 VLU patients) report PAR as having poor to excellent discriminatory ability (C-statistic 0.680-0.830). One study (241 DFU and VLU patients) reports PAR sensitivity and specificity of 58.5% and 90.5%, respectively. All studies were determined to have high risk of bias. Future Directions: Despite promising discriminatory ability, most studies report post hoc analysis of patients in randomized trials, are highly heterogenous in study design, and have high risk of bias. There is scant evidence to support PAR in isolation as a surrogate for complete DFU or VLU healing in routine clinical practice.

Impact of closed-incision negative pressure wound dressings on surgical site infection following groin incisions in vascular surgery; a single-centre experience.

OBJECTIVES: Surgical site infection (SSI) is a common complication in vascular surgery, and is associated with increased patient morbidity, readmission and reintervention. The aim of this study was to assess the impact of closed-incision negative pressure wound therapy (CiNPWT) upon rate of SSI and length of hospital stay. METHODS: This study was reported in line with the STROBE guidelines. We assessed the baseline incidence of SSI from a 12-month retrospective cohort and, following a change in practice intervention with CiNPWT, compared to a 6-month prospective cohort. The primary endpoint was incidence of SSI (according to CDC-NHSN guidelines) while secondary endpoints included length of hospital stay, readmission, reintervention and Days Alive and Out of Hospital (DAOH) to 90-days. RESULTS: A total of 127 groin incisions were performed: 76 (65 patients) within the retrospective analysis and 51 (42 patients) within the prospective analysis (of whom 69% received CiNPWT). The primary endpoint of SSI was seen in 21.1% of the retrospective cohort and 9.8% of the prospective cohort (p = .099). Readmission was found to be significantly associated with the retrospective cohort (p = .016) while total admission (inclusive of re-admission) was significantly longer in those in the retrospective cohort (p = .013). DAOH-90 was 83 days (77-85) following introduction of the CiNPWT protocol as compared to the retrospective cohort (77 days (64-83), p = .04). CONCLUSION: Introduction of CiNPWT was associated with a reduced length of hospital stay and improved DAOH-90. Further trials on CINPWT should include patient-centred outcomes and healthcare cost analysis.

Controlling the controls: what is negative pressure wound therapy compared to in clinical trials?

AIM: Surgical site infections (SSIs) are common following colorectal operations. Clinical trials suggest that closed incision negative pressure wound therapy (ciNPWT) may reduce SSIs compared to a 'standard of care' group. However, wound management in the standard of care group may vary. The aim of this review was to assess the control arms in trials of ciNPWT for potential confounding variables that could influence the rates of SSI and therefore the trial outcomes. METHODS: A mapping review of the PubMed database was undertaken in the English language for randomized controlled trials that assessed, in closed surgical wounds, the use of ciNPWT compared to standard of care with SSI as an outcome. Data regarding wound care to assess potential confounding factors that may influence SSI rates were compared between the ciNPWT and standard of care groups. Included were the method of wound closure, control dressing type, frequency of dressing changes and postoperative wound care (washing). RESULTS: Twenty-seven trials were included in the mapping review. There was heterogeneity in ciNPWT duration. There was little control in the comparator standard of care groups with a variety of wound closure techniques and different control dressings used. Overall standard of care dressings were changed more frequently than the ciNPWT dressing and there was no control over wound care or washing. No standard for 'standard of care' was apparent. CONCLUSION: In randomized trials assessing the intervention of ciNPWT compared to standard of care there was considerable heterogeneity in the comparator groups and no standard of care was apparent. Heterogeneity in dressing protocols for standard of care groups could introduce potential confounders impacting SSI rates. There is a need to standardize care in ciNPWT trials to assess potential meaningful differences in SSI prevention.

Systematic review of groin wound surgical site infection incidence after arterial intervention.

The objectives were to determine the surgical site infection incidence (including superficial/deep) fter arterial intervention through non-infected groin incisions and identify variables associated with incidence. MEDLINE, EMBASE and CENTRAL databases were searched for randomised controlled trials and observational studies of adults undergoing arterial intervention through a groin incision and reported surgical site infection. Infection incidence was examined in subgroups, variables were subjected to meta-regression. One hundred seventeen studies reporting 65 138 groin incisions in 42 347 patients were included. Overall surgical site infection incidence per incision was 8.1% (1730/21 431): 6.3% (804/12 786) were superficial and 1.9% (241/12 863) were deep. Superficial infection incidence was higher in randomised controlled trials (15.8% [278/1762]) compared with observational studies (4.8% [526/11 024]); deep infection incidence was similar (1.7% (30/1762) and 1.9% (211/11 101) respectively). Aneurysmal pathology (ß = -10.229, P < .001) and retrospective observational design (ß = -1.118, P = .002) were associated with lower infection incidence. Surgical site infection being a primary outcome was associated with a higher incidence of surgical site infections (ß = 3.429, P = .017). The three-fold higher incidence of superficial surgical site infection reported in randomised controlled trials may be because of a more robust clinical review of patients. These results should be considered when benchmarking practice and could inform future trial design.

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.