Stent-Assisted Balloon-Induced Intimal Disruption and Relamination in Aortic Dissection Repair (STABILISE): A Meta-Analysis of Early Outcomes.

BACKGROUND: This meta-analysis aims to determine the early clinical outcomes and rate of complete false lumen obliteration associated with the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the management of aortic dissection. METHODS: Electronic databases searches were performed on PubMed, Embase, and the Cochrane Library to identify studies reporting early outcomes of the STABILISE technique. In addition, we retrospectively analyzed all patients treated with the STABILISE technique for aortic dissection at our institution. The case series data were pooled with relevant studies to perform a meta-analysis of proportions using random-effects models. RESULTS: One hundred and ninety two patients from 9 relevant studies were pooled with an additional 13 patients undergoing STABILISE at our institution over a 3-year period. Pooled in-hospital mortality rate was 6% [95% confidence interval (CI); 3%-10%, I2 = 0.00%] and the overall rate of intraoperative aortic rupture was 4% [95% CI; 2%-8%, I2 = 0.00%]. The rate of in-hospital reintervention was 8% [95% CI; 5%-14%, I2 = 13.37%]. Median follow-up ranged from 8 to 36 months. Pooled cumulative mortality at follow-up was 8% [95% CI; 4%-18%, I2 = 23.15%]. The overall rate of late reintervention was 11% [95% CI; 7%-17%, I2 = 0.00%]. Complete obliteration of the false lumen in the thoracic aorta was achieved in 93% of patients [95% CI; 84%-97%, I2 = 47.49%] and in the abdominal aorta in 86% of patients [95% CI; 79%-91%, I2 = 0.00%]. CONCLUSIONS: The STABILISE technique carries an acceptable operative safety profile with low in-hospital morbidity and mortality and excellent complete false lumen obliteration.

Wound healing with "spray-on" autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: an open-label randomised controlled trial.

There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes-related foot wounds. In this randomised, open-label trial, participants were randomised to receive an application of non-cultured autologous skin cells ("spray-on" skin; ReCell) or standard care interventions for large (>6 cm2 ), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty-nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8-17.6) cm2 . A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray-on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35-3.65), P = .845). Lower body mass index (P = .002) and non-plantar wounds (P = .009) were the only patient- or wound-related factors associated with complete healing at 6 months. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).

Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety.

BACKGROUND: Diabetes-related foot ulcers result in significant mortality, morbidity and economic costs. Pressure offloading is important for ulcer healing, but patients with diabetes-related foot ulcers are presented with a dilemma, because whilst they are often advised to minimise standing and walking, there are also clear guidelines which encourage regular, sustained exercise for patients with diabetes. To overcome these apparently conflicting recommendations, we explored the feasibility, acceptability and safety of a tailored exercise program for adults admitted to hospital with diabetes-related foot ulcers. METHODS: Patients with diabetes-related foot ulcers were recruited from an inpatient hospital setting. Baseline demographics and ulcer characteristics were collected, and participants undertook a supervised exercise training session comprising aerobic and resistance exercises followed by prescription of a home exercise programme. Exercises were tailored to ulcer location, which complied with podiatric recommendations for pressure offloading. Feasibility and safety were assessed via recruitment rate, retention rate, adherence to inpatient and outpatient follow up, adherence to home exercise completion, and recording of adverse events. RESULTS: Twenty participants were recruited to the study. The retention rate (95%), adherence to inpatient and outpatient follow up (75%) and adherence to home exercise (50.0%) were all acceptable. No adverse events occurred. CONCLUSIONS: Targeted exercise appears safe to be undertaken by patients with diabetes-related foot ulcers during and after an acute hospital admission. Recruitment in this cohort may prove challenging, but adherence, retention and satisfaction with participation in exercise were high. TRIAL REGISTRATION: The trial is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12622001370796).

Feasibility of the Complete Endovascular Reconstruction of the Trifurcation (CERT) Technique for Revascularisation in Chronic Limb Threatening Ischemia.

BackgroundRevascularisation of patients with chronic limb threatening ischaemia due to arterial lesions in the below the knee segment can be challenging. This study describes a novel technique that allows a complete endovascular reconstruction of the trifurcation (CERT) utilising stents in the below the knee segment when conventional techniques are exhausted, or have failed to deliver an acceptable result, leading to remaining outflow compromise. Methods: Eight patients with Rutherford 5 chronic limb threatening ischaemia underwent CERT between January 1st, 2018 and January 1st, 2020. All patients underwent ultrasound at 6 weeks post operatively and then at variable intervals until the completion of the follow up period in March 2020. Results: Technical success of the CERT technique was achieved in all patients. Six patients had anterior tibial artery/Tibioperoneal trunk reconstructions, whilst 2 patients were stented directly into posterior tibial and peroneal artery. Five patients (63%) achieved wound healing. All-cause mortality was 25% (2 patients) with 1 patient achieving wound healing prior to death. Two stents were occluded during the follow up period. The first was asymptomatic and had achieved wound healing. The second was symptomatic with stent occlusion and a delayed presentation with Rutherford 3 acute limb ischaemia. Conclusions: Complete endovascular reconstruction of the trifurcation is a feasible option to achieve revascularisation in patients with tissue loss and below the knee arterial lesions allowing a continuous reconstruction of the trifurcation segment keeping the anatomical configuration intact. Clinical outcomes appear acceptable however larger series are needed.

Australian guideline on diagnosis and management of peripheral artery disease: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Peripheral artery disease (PAD) is implicated in up to 50% of diabetes-related foot ulcers (DFU) and significantly contributes to morbidity and mortality in this population. An evidence-based guideline that is relevant to the national context including consideration of the unique geographical and health care system differences between Australia and other countries, and delivery of culturally safe care to First Nations people, is urgently required to improve outcomes for patients with PAD and DFU in Australia. We aimed to identify and adapt current international guidelines for diagnosis and management of patients with PAD and DFU to develop an updated Australian guideline. METHODS: Using a panel of national content experts and the National Health and Medical Research Council procedures, the 2019 International Working Group on the Diabetic Foot (IWGDF) guidelines were adapted to the Australian context. The guideline adaptation frameworks ADAPTE and Grading of Recommendations Assessment, Development and Evaluation (GRADE) were applied to the IWGDF guideline for PAD by the expert panel. Recommendations were then adopted, adapted or excluded, and specific considerations for implementation, population subgroups, monitoring and future research in Australia were developed with accompanying clinical pathways provided to support guideline implementation. RESULTS: Of the 17 recommendations from the IWGDF Guideline on diagnosis, prognosis and management of PAD in patients with diabetes with and without foot ulcers, 16 were adopted for the Australian guideline and one recommendation was adapted due to the original recommendation lacking feasibility in the Australian context. In Australia we recommend all people with diabetes and DFU undergo clinical assessment for PAD with accompanying bedside testing. Further vascular imaging and possible need for revascularisation should be considered for all patients with non-healing DFU irrespective of bedside results. All centres treating DFU should have expertise in, and/or rapid access to facilities necessary to diagnose and treat PAD, and should provide multidisciplinary care post-operatively, including implementation of intensive cardiovascular risk management. CONCLUSIONS: A guideline containing 17 recommendations for the diagnosis and management of PAD for Australian patients with DFU was developed with accompanying clinical pathways. As part of the adaptation of the IWGDF guideline to the Australian context, recommendations are supported by considerations for implementation, monitoring, and future research priorities, and in relation to specific subgroups including Aboriginal and Torres Strait Islander people, and geographically remote people. This manuscript has been published online in full with the authorisation of Diabetes Feet Australia and can be found on the Diabetes Feet Australia website: https://www.diabetesfeetaustralia.org/new-guidelines/ .

Routine bacterial culture of proximal bone specimens during minor amputation in patients with diabetes-related foot infections has little clinical utility in predicting re-operation or ulcer healing.

BACKGROUND: Trans-phalangeal and trans-metatarsal amputation, collectively termed 'minor amputations' are important procedures for managing infections of diabetes-related foot ulcers (DFU). Following minor amputation, international guidelines recommend a prolonged course of antibiotics if residual infected bone on intra-operative bone samples are identified, but the quality of the evidence underpinning these guidelines is low. In this study, we examined the concordance of microbiological results from proximal bone cultures compared to results from superficial wound swabs in relation to patient outcomes; with the aim of determining the utility of routinely obtaining marginal bone specimens. METHODS: Data was retrospectively collected on 144 individuals who underwent minor amputations for infected DFU at a large Australian tertiary hospital. Concordance was identified for patients with both superficial wound swabs and intra-operative bone samples available. Patient outcomes were monitored up to 6 months post-amputation. The primary outcome was complete healing at 6 months; and secondary outcome measures included further surgery and death. Mann Whitney U testing was performed for bivariate analyses of continuous variables, Chi-Squared testing used for categorical variables and a logistic regression was performed with healing as the dependent variable. RESULTS: A moderate-high degree of concordance was observed between microbiological samples, with 38/111 (35%) of patients having discordant wound swab and bone sample microbiology. Discordant results were not associated with adverse outcomes (67.2% with concordant results achieved complete healing compared with 68.6% patients with discordant results; P = 0.89). Revascularisation during admission (0.37 [0.13-0.96], P = 0.04) and amputation of the 5th ray (0.45 [0.21-0.94], P = 0.03) were independent risk factors for non-healing. CONCLUSION: There was a moderate-high degree of concordance between superficial wound swab results and intra-operative bone sample microbiology in this patient cohort. Discordance was not associated with adverse outcomes. These results suggest there is little clinical utility in routinely collecting proximal bone as an adjunct to routine wound swabs for culture during minor amputation for an infected DFU.

Outcome of infra-inguinal bypass grafts using vein conduit with less than 3 millimeters diameter in critical leg ischemia.

OBJECTIVE: The purpose of this study was to evaluate the difference in amputation-free survival and patency rates of infra-inguinal bypass grafts in patients with critical leg ischemia (CLI) with vein conduits with an internal diameter <3 mm compared to those with vein conduits with a diameter of ≥ 3 mm. METHODS: Retrospective analysis of all consecutive patients with CLI undergoing infra-inguinal bypass. Preoperative duplex scan mapping and measurement of potential vein grafts were performed on all patients. Patients were recruited in a 1-year duplex scan graft surveillance program. Primary end points were amputation-free survival and patency rates at 1 year postoperatively. Kaplan-Meier and χ(2) test were used for statistical analysis. RESULTS: Between January 2004 and April 2010, 157 consecutive patients with CLI underwent 171 bypasses using vein conduits (111 men, 46 women; median age, 75 years; range, 45-96 years). Ninety-three bypasses (54.4%) were performed for tissue loss, 44 (25.7%) for gangrene, and for rest pain. Of the 157 patients, 113 (72.0%) had diabetes mellitus, 40 (25.5%) had renal impairment, 131 (83.4%) had hypertension, and 64 (40.8%) had ischemic heart disease. Femoro-popliteal bypass was performed in 38 cases (22.2%), whereas 133 (77.8%) of the bypasses were femoro-distal. Autogenous great saphenous vein (GSV) was used in all cases. All grafts were reversed. The diameter of 31 (18%) vein conduits measured <3 mm (range, 2-2.9 mm) on preoperative duplex scan. One hundred thirty-four grafts had at least 1-year follow-up. The primary, assisted primary, and secondary patency rates at 1 year for vein conduits <3 mm were 51.2%, 82.6%, and 82.6%, respectively, compared to 68.4%, 93.3%, and 95.2%, respectively, in the ≥ 3 mm group. This was only significant for the secondary patency (P = .0392). The amputation-free survival at 48 months was 70.8% for vein conduits <3 mm and 57.3 for vein conduits ≥ 3 mm. CONCLUSION: This series has shown that primary and assisted primary patency rates in small veins are not significantly different at 1 year but the secondary patency rates are better in the larger veins. Similarly, the amputation-free survival was also comparable. The authors would, therefore, advocate the use of small veins >2 mm in diameter in patients with CLI. Duplex scan surveillance followed by early salvage angioplasty for threatened grafts is needed to achieve good patency rates in both groups.

Availability and service provision of multidisciplinary diabetes foot units in Australia: a cross-sectional survey.

BACKGROUND: With growing global prevalence of diabetes mellitus, diabetes-related foot disease (DFD) is contributing significantly to disease burden. As more healthcare resources are being dedicated to the management of DFD, service design and delivery is being scrutinised. Through a national survey, this study aimed to investigate the current characteristics of services which treat patients with DFD in Australia. METHODS: An online survey was distributed to all 195 Australian members of the Australian and New Zealand Society for Vascular Surgery investigating aspects of DFD management in each member's institution. RESULTS: From the survey, 52 responses were received (26.7%). A multidisciplinary diabetes foot unit (MDFU) was available in more than half of respondent's institutions, most of which were tertiary hospitals. The common components of MDFU were identified as podiatrists, endocrinologists, vascular surgeons and infectious disease physicians. Many respondents identified vascular surgery as being the primary admitting specialty for DFD patients that require hospitalisation (33/52, 63.5%). This finding was consistent even in centres with MDFU clinics. Less than one third of MDFUs had independent admission rights. CONCLUSIONS: The present study suggests that many tertiary centres in Australia provide their diabetic foot service in a multidisciplinary environment however their composition and function remain heterogeneous. These findings provide an opportunity to evaluate current practice and, to initiate strategies aimed to improve outcomes of patients with DFD.

Cognitive Impairment in People with Diabetes-Related Foot Ulceration.

AIMS: To determine whether there is an excess of cognitive impairment in patients with type 2 diabetes and foot ulceration. METHODS: 55 patients with type 2 diabetes and foot ulcers attending Multidisciplinary Diabetes Foot Ulcer clinics (MDFU cohort) were compared with 56 patients with type 2 diabetes attending Complex Diabetes clinics (CDC cohort) using commonly used screening tests for cognitive impairment (Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA)), as well as foot self-care, mood and health literacy. MMSE was also compared between the MDFU cohort and a historical community-based cohort of patients with type 2 diabetes (FDS2 cohort). RESULTS: Median MMSE scores were the same in all three groups (28/30). Median MOCA scores did not differ between the MDFU and CDC cohorts (25/30). There were no significant differences in the percentages of patients with MMSE ≤ 24 or MOCA ≤ 25 between MDFU and CDC cohorts (3.6% versus 10.7%, p = 0.27 and 56.4% versus 51.8%, p = 0.71, respectively), findings that did not change after adjustment for age, sex, education, diabetes duration, and random blood glucose. CONCLUSIONS: Using conventionally applied instruments, patients with type 2 diabetes and foot ulceration have similar cognition compared with patients without, from either hospital-based clinic or community settings.

Outcome of lower limb distal bypass in Afro-Caribbean populations.

There is little data on outcome following lower limb bypass surgery in ethnic minorities in the United Kingdom. We looked at the results of distal bypass surgery in Afro-Caribbeans (AFCs) and compared it to caucasians (CAs). Patients undergoing distal bypass between 2004 and 2009 were analyzed. Life table analyses and log rank were used to compare graft patency and amputation-free survival. A total of 86 CA and 39 AFC patients, with a median age of 78 years and 73 years, respectively (P = .01), underwent bypass. There were more women in AFC groups (41.1%) compared to CA group (19.2%, P = .01). Tissue loss as indication for surgery was more in AFC than in CA group (92.3% vs73.9%, P = .03). Primary, primary-assisted and secondary patency rates, and amputation-free survival at 12 months for AFCs compared to CAs (51.3 vs 44.6; 85.2 vs 80.9; 91.2 vs 84.4; and 84.9 vs 75.1). Graft patency after lower limb distal revascularization in AFCs is comparable to CAs.