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OBJECTIVE: Intra-operative blood loss is a significant complication of major lower limb amputation (MLLA). This systematic review and meta-analysis assessed the effect of tourniquet use on patients undergoing amputation. DATA SOURCES: Embase, MEDLINE, and Cochrane databases were searched from inception to April 2024. REVIEW METHODS: Inclusion criteria were any study design assessing MLLA with and without tourniquet use. Primary outcomes were peri-operative blood loss and transfusion requirements. Secondary outcomes were operative duration, surgical site infection, stump revision, and death. Articles were screened and data extracted independently by two reviewers, then pooled using random effects meta-analysis, and presented with their GRADE certainty. Risk of bias was assessed using ROBINS-I and Cochrane RoB 2 tools. RESULTS: Seven studies (one randomised controlled trial [RCT] and six cohort studies) were included, totalling 1 018 limbs (412 tourniquet, 606 non-tourniquet). Intra-operative blood loss was lower with tourniquet use (mean difference [MD] -192.09 mL; 95% confidence interval [CI] -291.67 - -92.52; p < .001); however, there was no statistically significant difference in total blood loss measured over the first three to four post-operative days (MD -254.66 mL; 95% CI -568.12 - 58.80; p = .11). Post-operative haemoglobin decrease was lower for tourniquet patients (MD -0.55 g/dL; 95% CI -0.80 - -0.31; p < .001). The odds ratio (OR) for requiring blood transfusion was 0.65 (95% CI 0.38 - 1.11; p = .11) for tourniquet vs. non-tourniquet patients, with no statistically significant difference in number of units transfused per patient (MD -0.35, 95% CI -0.72 - 0.03; p = .070). Operation length was shorter with tourniquet use (MD -8.69 minutes, 95% CI -15.95 - -1.42; p = .020). There was no statistically significant difference in rates of surgical site infection (OR 1.07, 95% CI 0.60 - 1.90; p = .82), stump revision (OR 0.71, 95% CI 0.43 - 1.16; p = .17), or death (OR 0.80, 95% CI 0.49 - 1.30; p = .36). GRADE certainty was low or very low for all outcomes. CONCLUSION: Tourniquet use may be associated with reduced post-operative haemoglobin decrease and operative duration, without negative consequences on stump infection, revision, and mortality. However, most data are observational. Further RCTs are needed to generate higher quality evidence.

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Background: Timely and economic provision of revascularisation procedures is a major healthcare need. We aimed to examine the safety and efficacy of daycase-based lower extremity endovascular revascularisation procedures in patients with peripheral artery disease. Methods: In this systematic review and meta-analysis, we searched MEDLINE and Embase for studies from Jan 01, 2000 through Apr 01, 2024 reporting complications of lower limb endovascular revascularisation procedures with same-day discharge. Eligibility-criteria, complications, and patient characteristics were extracted, methodological quality assessed (adapted Newcastle-Ottawa Scale), and meta-analyses of complications and technical success performed to provide pooled estimates. This study is registered with PROSPERO, CRD42022316466. Findings: Thirty observational studies (17 retrospective, 13 prospective) and 1 RCT reported 2427 minor and 653 major complications after 99,600 daycase procedures (93,344 patients). Eighteen studies reported daycase eligibility-criteria including 'responsible adult companion' (78%), 'proximity to hospital', and 'telephone availability' and excluding unstable and severe co-morbidities, offset coagulation, and severe chronic kidney disease. Pooled incidences of minor (4.7% [95% CI 3.8-5.6%], I 2 = 96%) and major (0.64% [95% CI 0.48-0.79%], I 2  = 46%) complications were low and technical success high (93% [95% CI 91-96%], I 2 = 97%). Most complications were related to the puncture site. Pooled conversion-to-hospitalisation rates and re-admission after discharge were 1.6% (95% CI 1.1-2.2%, I 2 = 82%) and 0.11% (95% CI 0.095-0.23%, I 2 = 97%), respectively. Meta-regression identified that minor complications decreased since 2000. Male sex and coronary artery disease were associated with more frequent, and higher age and closure device use with less minor complications. Diabetes mellitus and chronic kidney disease were associated with less major complications. Six studies reported complication rates both in daycases and inpatients and there was no significant difference (-0.8% [95% CI -1.9 to 0.3%]). Interpretation: After careful evaluation of eligibility, lower limb angioplasty can be performed safely with high technical success in a daycase setting. Most complications arise from the puncture site and not the procedure itself highlighting the importance of optimal access site management. The heterogeneity between studies warrants standardised monitoring of complications and outcomes. Funding: European Partnership on Metrology, co-financed from European Union's Horizon Europe Research and Innovation Programme and UK Research and Innovation, and Medical Research Council.

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OBJECTIVE: Patient characteristics and patterns of disease in chronic limb threatening ischaemia (CLTI) have changed markedly in recent years. Urgent specialist referral and timely revascularisation are recommended in international guidelines. UK guidelines now recommend revascularisation within 5 days of referral for inpatients and 2 weeks in outpatients. This study compared the contemporary one year major amputation incidence in patients with CLTI with a historical cohort at a single UK centre. METHODS: This was a single centre, observational cohort study with historical controls. A prospective cohort was recruited between May 2019 and March 2022. A historical cohort presenting between 2013 and 2015 inclusive was identified retrospectively. Significant changes in management pathways, including establishing a rapid access limb salvage clinic, occurred between these periods aiming to expedite time from referral to revascularisation. The one year primary outcome was major amputation, and the secondary outcome was death. Major amputation was analysed by Fine-Gray competing risks models (death as the competing risk), presented as subdistribution hazard ratios (SHRs). One year mortality was analysed by Cox regression, presented as hazard ratios. Analyses were adjusted for propensity score. RESULTS: A total of 928 patients were included (432 prospective and 496 historical). Proportions of patients presenting with tissue loss (72.2% vs. 71.6%; p = .090) were similar in both cohorts. At one year, 48 patients (11.1%) in the prospective cohort and 124 patients (25.0%) in the historical cohort had undergone a major amputation (p < .001). Risk of major amputation was 57.0% lower in the prospective cohort compared with the historical cohort after adjustment for propensity score (SHR 0.43, 95% confidence interval 0.29 - 0.63; p < .001). CONCLUSION: An encouraging reduction in major amputation incidence was observed after improvements to CLTI management pathways, but residual confounding is likely. The generalisability of these results is uncertain.

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Background: Peripheral artery disease (PAD) is a common health problem. There are several technologies, medications, and interventions that aim to improve or treat PAD in people with symptomatic disease. Most of these technologies, however, have been untested in high-quality randomised studies assessing effectiveness and their interactions remain unknown. We developed a proposed design for an international randomised controlled trial assessing multiple PAD treatments. Methods: Over the course of 11 months (2023) several workshops and reviews of the literature took place. More specific, the proposed platform trial was designed with 44 people with PAD and 112 experts from across the world, in five work packages. The most relevant PAD treatment with unproven effectiveness were identified and key trial components as well as success criteria were defined. With input from five clinical trials units, the final format of a potential platform PAD trial in primary and secondary care was then proposed for funding. Results: The proposed platform PAD randomised trial involved two major multi-arm multi-stage randomised studies, assessing PAD treatments in the community setting (1 st package) and then secondary care (2 nd package). The 1 st package involved people with claudication and the 2 nd package involves people with chronic limb threatening ischaemia (CLTI). Conclusions: A platform PAD trial involves many challenges in terms of both design and delivery. The proposed design involving both people with claudication and CLTI will hopefully act as a blueprint for future work in this area.

Background: One in five people over 55 years of age have blockages in the arteries carrying blood to their legs. This is called peripheral artery disease or PAD. It can cause severe leg pain or skin and muscles of the legs dying due to limited blood supply. Doctors have been treating PAD using surgery for years. Keyhole artery surgery has recently been developed. Also, new medications are available for people with blocked arteries. Several new devices and medications are invented every year for PAD. Unfortunately, we don't know whether these new medications and devices actually work. This is causing uncertainty when making treatment decisions, leads to unnecessary leg amputations, and deaths. Also, these new treatments might be costing society far more money than the older treatments. In this work, we designed the best possible research to assess all these new PAD treatments in the next few years. Design & methods: This project took place in 2023 in five different stages (called work packages), involving 44 patients, carers, and 112 experts from many countries and the NHS. We looked up all treatments and medications available for this condition. We then agreed on what would make our future research successful. After that, we set up groups of patients and experts to design the research. We agreed on the final design of this research. Results: The proposed study should involve people with claudication in the 1 st stage and people with leg gangrene in the 2 nd stage. We agreed to test treatment like exercise and open surgery vs. keyhole surgery. The best way to assess treatments is to look at which one leads to less deaths and leg amputations. The results of this work described in this article will act as a blueprint for future research in this area.

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Background/Objectives: Chronic limb-threatening ischaemia (CLTI) is a significant life and limb-threatening condition. Two recent seminal trials, BEST-CLI and BASIL-2, have provided seemingly conflicting results concerning the optimal treatment modality for patients with CLTI. We sought to investigate the outcomes of patient undergoing infrainguinal bypass at two centres in Aotearoa New Zealand. Methods: A cross-sectional retrospective review of all patients who underwent infrainguinal bypass grafting for CLTI at Auckland City Hospital and Waikato Hospital between January 2020 and December 2021 was performed. The primary outcome was a composite of death, above-ankle amputation, and major limb reintervention. The secondary outcome was minor limb reintervention. Kaplan-Meier survival analysis was performed to determine time to the primary and secondary endpoints. Demographic factors were examined using the log-rank test to examine the effect on the outcome. Results: One hundred and nineteen patients who underwent infrainguinal bypass for CLTI in the study period were identified. Of these, 93 patients had a bypass with ipsilateral or contralateral GSV. The median follow-up time was 1.85 years. The most common indication for surgery was tissue loss (69%, n = 63), with the most common distal bypass target being the below-knee popliteal artery (45%, n = 41). The primary composite outcome occurred in 42.8% of the cohort (n = 39). Death was the most common component of the primary outcome (26%, n = 24). Male sex (HR 0.48, 95% CI 0.26-0.88, p = 0.018) and statin use (HR 0.49, 95% CI 0.24-0.98, p = 0.044) were independent predictors of protection from the composite outcome on multivariate analysis. Dialysis dependence (HR 3.32, 95% CI 1.23-8.99, p = 0.018) was an independent predictor for patients meeting the composite outcome. Conclusions: This study's results are consistent with the published outcomes of BEST-CLI. The patient cohorts examined, anatomical disease patterns, and conduit use may explain some of the differences observed between this study, BEST-CLI and BASIL-2. Further work is required to define the specific patient populations who will benefit most from an open surgical or endovascular first approach to the management of CLTI.

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OBJECTIVE: The aim of this study was compare all cause mortality across three time periods with a focus on sex differences after revascularisation for chronic limb threatening ischaemia between 1994 and 2013 in Sweden. METHODS: In this observational registry study, patients registered in the Swedish vascular registry (Swedvasc), revascularised between 1994 and 2013 with open or endovascular infra-inguinal procedures, were divided into three time periods: 1994 - 1999, 2000 - 2006, and 2007 - 2013. Patients were followed for five years. Poisson regression was used to compare 30 day mortality, presented as adjusted relative risk ratio (aRR). Adjusted restricted mean survival time (aRMST) differences at five years were compared with a generalised linear model. The analyses were adjusted for age, comorbidities, and endovascular or open surgery. Comparison with the general Swedish population was also conducted with age adjusted standardised mortality ratios. Results are presented with the 95% confidence intervals (CI). RESULTS: The study showed increasing 30 day mortality, with an aRR of 1.47 (95% CI 1.31 - 1.65) for women and aRR of 1.20 (95% CI 1.06 - 1.35) for men, per time period. In women, the five year RMST decreased from the first to the third period, with an aRMST of -45 (95% CI -59 - -32) days per period. In men, the aRMST increased 32 (95% CI 18 - 47) days per period. When comparing sexes, women showed lower 30 day mortality and higher five year survival than men in the first time period, but a significantly worse development over time periods than for men. Corresponding findings were observed in comparison with the general Swedish population. CONCLUSION: This study showed an increased 30 day mortality in women and men across the periods, most evident in women. Men showed an increased five year survival across the periods, whereas opposite findings were recorded for women. The dismal trend over time for women could not be explained by increased age or a higher prevalence of comorbidities.

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OBJECTIVE: Major adverse limb events (MALEs) are frequent in patients with lower extremity peripheral arterial disease (PAD). However, routine care MALE rate estimations after revascularisation are scarce. This study aimed to determine post-procedural MALE rates in revascularised patients with PAD and identify predictors of post-procedural MALEs. METHODS: This was a population based observational study on merged national registry data. Patients with PAD undergoing lower limb revascularisation between 2008 and 2016 were retrieved from the Swedish National Registry for Vascular Surgery. Information on comorbidities, medications, and post-procedural MALE endpoints were identified in national healthcare registries. Primary outcomes of interest were categorised as 2 - 4 point MALE composites that included limb amputation, acute lower limb ischaemia, progression to or relapse of chronic limb threatening ischaemia (CLTI), and ipsilateral re-interventions regardless of indication. Patients with intermittent claudication (IC) and CLTI were analysed separately using Kaplan-Meier estimates. Stepwise Cox proportional hazard models were used for predictor candidate analysis. RESULTS: Overall, 28 021 revascularised patients with PAD were analysed (IC, n = 10 506, 37.5%; CLTI, n = 17 515, 62.5%). During a mean follow up ± standard deviation of 3.2 ± 2.4 years, 5 226 (18.7%), 9 423 (33.6%), and 12 696 (45.3%) patients experienced a 2, 3, and 4 point MALE, respectively. The estimated one year 4 point MALE rates were 21.4% (95% confidence interval [CI] 20.6 - 22.2%) in IC and 46.9% (95% CI 46.1 - 47.7%) in CLTI. Adjusted predictors for experiencing a 4 point MALE in IC were chronic kidney disease (CKD) (hazard ratio [HR] 1.33, 95% CI 1.12 - 1.59) and previous lower limb revascularisation (HR 1.29, 95% CI 1.19 - 1.40). In CLTI, previous contralateral lower limb amputation (HR 1.60, 95% CI 1.47 - 1.73) and CKD (HR 1.25, 95% CI 1.17 - 1.34) were adjusted predictors. CONCLUSION: This study emphasises the very high MALE rates in revascularised patients with lower limb PAD, especially in CLTI. Prior lower limb revascularisation correlated with increased MALE rates in IC patients, while prior lower limb amputation was linked to subsequent MALEs in CLTI. In both IC and CLTI, CKD was associated with poorer outcomes, regardless of applied MALE definition.

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OBJECTIVE: Percutaneous deep venous arterialisation (pDVA) is a state of the art technique for treating patients with chronic limb threatening ischaemia (CLTI) with no conventional option for revascularisation. There are limited large scale data examining the clinical effectiveness of pDVA for patients with end stage CLTI. DATA SOURCES: MEDLINE, Embase, Google Scholar, and Cochrane databases. REVIEW METHODS: Four databases were searched from January 2018 to June 2024 to identify studies investigating the feasibility and clinical outcomes of pDVA for patients with CLTI with no conventional revascularisation options. Meta-analysis of time to event outcomes (mean ± standard deviation) was performed for amputation free survival as the primary outcome, and freedom from amputation and overall survival as secondary outcomes. Other secondary outcomes (mean and 95% confidence interval [CI]) were procedural success rate, patency, re-intervention, and complete wound healing. RESULTS: Ten non-randomised studies were included with 351 patients. Mean patient age was 70.3 years, and 67.6% were male. Most procedures utilised the posterior tibial artery. The aggregated rate of amputation free survival at six and 12 months (five studies, 260 patients) was 72.6 ± 2.8% and 66.0 ± 3.1%, respectively, while the overall survival at six and 12 months (five studies, 260 patients) was 85.0 ± 2.3% and 77.7 ± 2.9%, respectively. The procedural success rate (nine studies, 330 patients) was 95.5% (95% CI 92.4 - 98.7%). Primary and secondary patency at six months (four studies, 241 patients) was 23.4% (95% CI 13.6 - 33.2%) and 54.9% (95% CI 34.3 - 75.5%), respectively. The rates of re-intervention (four studies, 190 patients) and complete wound healing (seven studies, 266 patients) at six and 12 months were 15.5% (95% CI 1.4 - 29.6%) and 41.7% (95% CI 25.7 - 57.7%), respectively, for re-intervention, and 19.3% (95% CI 9.6 - 29.0%) and 46.0% (95% CI 31.7 - 60.3%) for wound healing. CONCLUSION: This meta-analysis demonstrated acceptable feasibility for no-option CLTI at highly specialised institutions for patients undergoing pDVA. Meta-analysis of time to event outcomes revealed that pDVA provides reasonable amputation free survival for up to 12 months, albeit with a overall low certainty of evidence. Wider adoption of pDVA may be considered in selective patients with CLTI, although its clinical impact and cost effectiveness require further evaluation.

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OBJECTIVE: Nutritional status plays a complex role in the pathophysiology and outcomes of chronic limb threatening ischaemia (CLTI). Undernutrition may be a modifiable risk factor. Given the variability in nutritional status concepts in CLTI outcomes studies, a systematic review examining the association between undernutrition and outcomes in patients with CLTI was conducted. DATA SOURCES: A systematic literature search of nine databases (Allied and Complementary Medicine Database [AMED], CINAHL Complete, Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection databases) was conducted up to 23 May 2023. REVIEW METHODS: Inclusion criteria were randomised controlled trials, cohort studies, and case-control studies of patients with CLTI conducted after 1982 that reported the effect size for a nutritional status measure and the outcomes of death, amputation, or a composite of the two. Two reviewers independently performed screening, data extraction, and quality assessment, with a third independent reviewer resolving conflicts. RESULTS: A total of 6 818 citations were screened, with 49 observational studies (31 from Japan) included in the review. The mean patient age ranged 56.0 - 86.9 years. Most included patients were undergoing revascularisation. Unidimensional indicators of undernutrition (including low serum albumin, low body mass index, and zinc deficiency) as well as multidimensional measures (such as nutritional screening tool scores indicating undernutrition) were found to be associated with a statistically significant increased risk of death, amputation, and composite events in most studies. Effect sizes of the association were generally larger when multidimensional nutritional screening tools were used. However, the quality of evidence was poor and certainty of evidence was very low. CONCLUSION: Undernutrition is consistently associated with an increased risk of death and amputation in patients with CLTI, regardless of the measure used. Broader efforts to understand the framework of nutritional status and validation of nutritional screening tools in CLTI populations are needed.

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OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim of the present study was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality. METHODS: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac. RESULTS: In 151 of 168 deaths (89.9%), the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16 of 77 deaths (21%) were classified as probably cardiac compared with 32 of 91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64 of 344 (18.6%), 40 of 342 (11.7%), and 37 of 344 (10.8%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI. CONCLUSION: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings.

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Introduction: An arteriovenous fistula (AVF) is a potential complication of endovascular therapy (EVT). Arteriovenous fistula steal syndrome sometimes leads to severe limb ischaemia; however, assessment of peripheral perfusion in AVF has not yet been established. Report: A 90 year old woman diagnosed with chronic limb threatening ischaemia underwent EVT. However, subintimal angioplasty of infrapopliteal lesions resulted in AVF formation in the posterior tibial artery (PTA). Revascularisation of the anterior tibial artery and PTA was performed, but severe AVF steal syndrome persisted and wound healing was delayed. An attempt to physiologically assess the effects of AVF closure and perform an AVF closing manoeuvre, if necessary, was performed. The physiological assessment was performed by laser Doppler flowmetry (LDF) and blood flow was temporarily blocked via the AVF at the distal PTA using a 6 F guiding extension catheter. A significant increase in blood flow was observed in the perfused area of the plantar artery. Coil embolisation and covered stent implantation in the PTA completely closed the AVF. During the procedure, peripheral perfusion with LDF gradually increased in the heel and fifth toe. After AVF closure, the skin perfusion pressure values increased significantly, wound healing was accelerated, and complete healing was achieved. Discussion: Laser Doppler flowmetry measurements under simulated AVF closure using a guiding extension catheter may be useful for the physiological assessment of peripheral perfusion before percutaneous AVF closure.

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OBJECTIVE: This study aimed to determine the impact of infrapopliteal (IP) revascularisation establishing in line flow to the wound (IFW) on wound healing in chronic limb threatening ischaemia (CLTI), using a core laboratory assessment for wounds and in line flow. METHODS: The Wound directed Angiosome RevasculaRIsation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation. IP revascularisation establishing IFW was defined as revascularisation after which a tibiopedal artery that actually fed an injured pedal unit was patent. The incidence of wound healing was compared between the IFW and non-IFW groups using inverse probability of treatment weighting based on the propensity score. RESULTS: A total of 440 patients with CLTI (median age, 75 years; male, 64.1%; diabetes mellitus, 72.0%; dialysis, 57.7%) with tissue loss (Wound, Ischaemia, and foot Infection stage 4, 66.4%) who underwent IP revascularisation (endovascular procedure, n = 304; bypass grafting, n = 136) between October 2017 and June 2020 were registered. During a median follow up of 23.6 months, 51.1% achieved wound healing. Successful IP revascularisation with IFW was achieved in 68.2%. After analysis, the IFW group had a higher rate of wound healing than the non-IFW group (34.5 vs. 16.1 per 100 person years; p = .030). The association between IFW and wound healing was not statistically different between patients undergoing bypass grafting and those undergoing an endovascular procedure (p for interaction = .38). There was no statistically significant interaction effect between IFW and direct revascularisation for wound healing (p for interaction = .51). CONCLUSION: IP revascularisation establishing IFW was statistically significantly associated with a higher wound healing rate in patients with CLTI.

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OBJECTIVE: Recombinant human hepatocyte growth factor (HGF) plasmids are novel alternatives to salvage limbs in patients with chronic limb threatening ischaemia (CLTI). A systematic review and meta-analysis of data was conducted to assess the therapeutic efficacy of HGF plasmids in patients with CLTI. DATA SOURCES: Randomised controlled studies evaluating HGF plasmid efficacy in patients with CLTI were identified using MEDLINE, Embase, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov databases. REVIEW METHODS: Meta-analyses of the reported relative risk (RR) or mean difference (MD) were conducted. Subgroup analyses were performed to determine the efficacy of HGF plasmids in cohorts excluding Buerger's disease. Certainty of evidence for each outcome was assessed. RESULTS: Seven studies (n = 655 participants) were included. Based on low certainty evidence, patients treated with HGF had a significantly higher complete ulcer healing rate (RR 1.99, 95% confidence interval [CI] 1.30 - 3.04; p = .002) than patients treated with placebo. HGF treatment was associated with reduced visual analogue scale (VAS) scores of pain severity (MD -1.56, 95% CI -2.12 - -1.00; p < .001) vs. placebo in patients with CLTI assessed at three month follow up (low certainty evidence); no significant differences were observed in major amputation (RR 0.91, 95% CI 0.48 - 1.73; p = .77) (low certainty evidence) or all cause mortality rate (RR 0.93, 95% CI 0.38 - 2.27; p = .87) (low certainty evidence) between patients treated with HGF and placebo. Low certainty evidence suggested no significant differences in change in ankle brachial index at six months (MD 0.00, 95% CI -0.09 - 0.09; p = 1.0) between patients treated with HGF and placebo. The complete ulcer healing rate and improved three month VAS scores of pain severity benefits persisted in subgroup analyses (low certainty evidence). CONCLUSION: Low certainty evidence suggested that HGF treatment is associated with an increased complete ulcer healing rate and reduced ischaemic pain in patients with CLTI.

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Patients with chronic limb-threatening ischaemia (CLTI) are at risk of foot infections, which is associated with an increase in amputation rates. The use of antibiotics may lead to a higher incidence of antimicrobial resistance (AMR) in subsequent episodes of ischaemic foot infections (IFI). This retrospective single-centre cohort study included 130 patients with IFI undergoing endovascular revascularisation. Staphylococcus aureus and Pseudomonas aeruginosa were the two most common pathogens, accounting for 20.5% and 10.8% of cases, respectively. The prevalence of antimicrobial resistance (AMR) and multi-drug resistance did not significantly increase between episodes (10.2% vs. 13.4%, p = 0.42). In 59% of subsequent episodes, the identified pathogens were unrelated to the previous episode. However, the partial concordance of identified pathogens significantly increased to 66.7% when S. aureus was identified (p = 0.027). Subsequent episodes of IFI in the same patient are likely to differ in causative pathogens. However, in the case of S. aureus, the risk of reinfection, particularly with S. aureus, is increased. Multi-drug resistance does not appear to change between IFI episodes. Therefore, recommendations for empirical antimicrobial therapy should be based on local pathogen and resistance statistics without the need to broaden the spectrum of antibiotics in subsequent episodes.

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INTRODUCTION: Delays exist at each stage of the chronic limb-threatening ischaemia (CLTI) care pathway, but there is little known about patient factors influencing delay to diagnosis of CLTI. This study explores the experiences and perceptions of patients recently diagnosed with CLTI. METHODS: A qualitative interview study was conducted. Sixteen participants underwent semi-structured interviews. Reflexive thematic analysis was performed on the data, aiming to understand factors which can influence delay in the CLTI care pathway. RESULTS: Five interrelated themes were developed: CLTI is a devastating condition; Reluctance to ask for help; When we are empowered we get better care; Luck plays a role in the process to diagnosis; and Vascular units can do better, comprising sub-themes of information transfer-consider communication and arterial versus non-arterial centres-proximity isn't everything. CONCLUSIONS: The five themes generated from the interview data describe factors relevant to delay given meaning by participants who have lived experience of CLTI. Theme content should be noted by clinicians, commissioners and providers looking to improve care pathways for patients with CLTI. The importance of awareness for the public, patients and clinicians linked ideas in some themes and interventions to raise awareness should be considered.

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Background: Major limb amputation (MLA) can be a common outcome due to severe peripheral artery disease (PAD) and diabetic foot disease (DFD), and it carries a significant mortality burden. In New Zealand (NZ), there is little documentation of the incidence rate and mortality after MLA. The aim was to report the national crude and standardised rates and the mortality post MLA. Methods: This retrospective observational study included all MLAs that occurred within NZ from 1/1/2010 to 31/12/2021 due to DFD and/or PAD. Two national databases (National Minimum Dataset and the Australasian Vascular Audit) were utilised. The crude rates were calculated as cases per 100,000 in the NZ population per year including all ages (using the 2013 and 2018 NZ census figures). The age-standardised rates used the World Health Organization standard population. Post-operative mortality was calculated from the date of first hospitalisation for MLA. Results: From 2010 to 2021, there were 5293 MLA procedures in 4242 patients. On average, there were 8.5 MLAs per week and 441.1 MLAs annually. The overall crude rate was 9.44 per 100,000, and the standardised rate was 6.12 per 100,000. Over the 12 years, the crude rate decreased by 22% (p < 0.001), and the standardised rate decreased by 20.4% (p < 0.001). After MLA, the 30-day and 1-year mortality was 9.5% and 29.6%, respectively. From 2010 to 2021, the relative reduction in 30-day mortality was 45.1% (p < 0.001), and the reduction in 1-year mortality was 24.5% (p < 0.001). Increasing age, female sex and end-stage renal failure were predictors of 30-day and 1-year mortality. Conclusions: A considerable number of MLAs occur in NZ, with substantial perioperative mortality; however, the national incidence rates and mortality have improved over the last 12 years. This data might serve as benchmark to further reduce MLAs and improve patient outcomes.

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PURPOSE: The aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore. METHODS: PRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis < 30%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. RESULTS: Seventy five patients were included. There were 50 (68.0%) males; mean age, 69.0 ± 10.7 years. CLTI severity was based on the Rutherford Scale (R5 = 51; R6 = 17). Significant co-morbidities included diabetes mellitus (n = 68; 91.0%) and end-stage renal failure (n = 28; 37.0%). 112 atherosclerotic lesions were treated (TASC II D = 58 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4 ± 13.9 cm. Primary vessel patencies at 6 and 12 months were 64/86 (74%) and 43/74 (58%) and freedom from clinically driven TLR were 72/86 (84%) and 55/74 (74%) respectively. AFS was 61/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1 ± 0.55 at baseline to 1.1 ± 2.05 (p < 0.05) at one year and there was a wound healing rate of 38/48 (79%) at the same timepoint. CONCLUSIONS: The Selution SLR™ drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS. LEVEL OF EVIDENCE: Level 2b, Individual Cohort Study.

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