The incidence of surgical site infection following major lower limb amputation: A systematic review.

Surgical site infections (SSIs) following major lower limb amputation (MLLA) in vascular patients are a major source of morbidity. The objective of this systematic review was to determine the incidence of SSI following MLLA in vascular patients. This review was prospectively registered with the International Prospective Register of Systematic Reviews (CRD42023460645). Databases were searched without date restriction using a pre-defined search strategy. The search identified 1427 articles. Four RCTs and 21 observational studies, reporting on 50 370 MLLAs, were included. Overall SSI incidence per MLLA incision was 7.2% (3628/50370). The incidence of SSI in patients undergoing through-knee amputation (12.9%) and below-knee amputation (7.5%) was higher than the incidence of SSI in patients undergoing above-knee amputation, (3.9%), p < 0.001. The incidence of SSI in studies focusing on patients with peripheral arterial disease (PAD), diabetes or including patients with both was 8.9%, 6.8% and 7.2%, respectively. SSI is a common complication following MLLA in vascular patients. There is a higher incidence of SSI associated with more distal amputation levels. The reported SSI incidence is similar between patients with underlying PAD and diabetes. Further studies are needed to understand the exact incidence of SSI in vascular patients and the factors which influence this.

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.

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.

The PReliMinAry (Pain Relief in Major Amputation) Survey.

OBJECTIVES: Major Lower Limb Amputation (MLLA) is associated with significant peri- and post-operative pain and has been identified as a research priority by patient and healthcare groups. The PReliMinAry survey was designed to evaluate existing MLLA analgesia strategies; identifying areas of equipoise and informing future research. METHODS: A targeted multi-national, multi-disciplinary survey was conducted via SurveyMonkey® (October 5, 2020-November 3, 2020) and advertised via social media and society email lists. The 10-questions explored 'pain-team' services, pre-operative neuroleptic medication, pre-incision peripheral nerve blocks and catheters, surgically placed nerve catheters, post-operative adjunctive regimens, future research engagement and equipoise. RESULTS: Seventy-six responses were received from 60 hospitals worldwide. Twelve hospitals(20%) had a dedicated MLLA pain team, 7(12%) had none. Most pain teams (n = 52; 87%) assessed pain with a 0-10 numerical rating scale. Over half of respondents "never" preloaded patients with oral neuroleptic agents(n= 42/76; 55%). Forty-seven hospitals(78%) utilized patient controlled opioid analgesia. Most hospitals are able to provide pre-incision loco-regional peripheral nerve blocks, nerve catheters and surgical nerve catheters (95%, 77%, and 90% respectively), but use was variable. Ultrasound(US) guided peripheral nerve catheters were "infrequently" or "never" used in 57% of hospitals, whilst 23% "infrequently" or "never" utilize surgically placed nerve catheters. CONCLUSIONS: The survey revealed a preference towards 'single-shot' nerve blocks and surgical catheters. A difference between the use of US guided nerve catheters and those surgically placed likely reflects the difference of literature evaluating these techniques. Most respondents felt there was equipoise surrounding future trials evaluating nerve blocks/catheters, but less so for surgical catheters.

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.

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.

Income Deprivation and Groin Wound Surgical Site Infection: Cross-Sectional Analysis from the Groin Wound Infection after Vascular Exposure Multicenter Cohort Study.

Background: Living in deprived areas is associated with poorer outcomes after certain vascular procedures and surgical site infection in other specialties. Our primary objective was to determine whether living in more income-deprived areas was associated with groin wound surgical site infection after arterial intervention. Secondary objectives were to determine whether living in more income-deprived areas was associated with mortality and clinical consequences of surgical site infection. Methods: Postal code data for patients from the United Kingdom who were included in the Groin Wound Infection after Vascular Exposure (GIVE) multicenter cohort study was used to determine income deprivation, based on index of multiple deprivation (IMD) data. Patients were divided into three IMD groups for descriptive analysis. Income deprivation score was integrated into the final multivariable model for predicting surgical site infection. Results: Only patients from England had sufficient postal code data, analysis included 772 groin incisions (624 patients from 22 centers). Surgical site infection occurred in 9.7% incisions (10.3% of patients). Surgical site infection was equivalent between income deprivation tertiles (tertile 1 = 9.5%; tertile 2 = 10.3%; tertile 3 = 8.6%; p = 0.828) as were the clinical consequences of surgical site infection and mortality. Income deprivation was not associated with surgical site infection in multivariable regression analysis (odds ratio [OR], 0.574; 95% confidence interval [CI], 0.038-8.747; p = 0.689). Median age at time of procedure was lower for patients living in more income-deprived areas (tertile 1 = 68 years; tertile 2 = 72 years; tertile 3 = 74 years; p < 0.001). Conclusions: We found no association between living in an income-deprived area and groin wound surgical site infection, clinical consequences of surgical site infection and mortality after arterial intervention. Patients living in more income-deprived areas presented for operative intervention at a younger age, with similar rates of comorbidities to patients living in less income-deprived areas.

PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation: a collaboratiVE study (PERCEIVE)-protocol for the PERCEIVE qualitative study.

INTRODUCTION: Deciding whether to proceed with a major lower limb amputation is life-changing and complex, and it is crucial that the right decision is made at the right time. However, medical specialists are known to poorly predict risk when assessing patients for major surgery, and there is little guidance and research regarding decisions about amputation. The process of shared decision-making between doctors and patients during surgical consultations is also little understood. Therefore, the aim of this study is to analyse in depth the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation. METHODS AND ANALYSIS: Consultations between patients and surgeons at which major lower limb amputation is discussed will be audio-recorded for 10-15 patients. Semi-structured follow-up interviews with patients (and relatives/carers) will then be conducted at two time points: as soon as possible/appropriate after a decision has been reached regarding surgery, and approximately 6 months later. Semi-structured interviews will also be conducted with 10-15 healthcare professionals working in the UK National Health Service (NHS) involved in amputation decision-making. This will include surgeons, anaesthetists and specialist physiotherapists at 2-4 NHS Health Boards/Trusts in Wales and England. Discourse analysis will be used to analyse the recorded consultations; interviews will be analysed thematically. Finally, workshops will be held with patients and healthcare professionals to help synthesise and interpret findings. ETHICS AND DISSEMINATION: The study has been approved by Wales REC 7 (20/WA/0351). Study findings will be published in international peer-reviewed journal(s) and presented at national and international scientific meetings. Findings will also be disseminated to a wide NHS and lay audience via presentations at meetings and written summaries for key stakeholder groups.

Study protocol for the groin wound infection after vascular exposure (GIVE) audit and multicentre cohort study.

INTRODUCTION: Surgical site infections (SSIs) following groin incision for arterial exposure are commonplace and a significant cause of morbidity and mortality following major arterial surgery. Published incidence varies considerably. The primary aim of GIVE will be to compare individual units' practice with established guidelines from The National Institute for Health and Care Excellence (NICE). Secondary aims will be to describe the contemporary rate of SSI in patients undergoing groin incision for arterial exposure, to identify risk factors for groin wound infection, to examine the value of published tools in the prediction of SSI, to identify areas of equipoise which could be examined in future efficacy/effectiveness trials and to compare UK SSI rates with international centres. METHODS AND ANALYSIS: This international, multicentre, prospective observational study will be delivered via the Vascular and Endovascular Research Network (VERN). Participating centres will identify all patients undergoing clean emergency or elective groin incision(s) for arterial intervention during a consecutive 3-month period. Follow up data will be captured at 90 days after surgery. SSIs will be defined according to the Centres for Disease Control and Prevention (CDC) criteria. Data will be gathered centrally using an anonymised electronic data collection tool or secure email transfer. ETHICS AND DISSEMINATION: This study will be registered as a clinical audit at all participating UK centres; research ethics approval is not required. National leads will oversee the appropriate registration and approvals in countries outside the UK as required. Site specific reports of SSI rates will be provided to each participating centre. Study results will be disseminated locally at each site, publicised on social media and submitted for peer-reviewed publication.