A preoperative supervised exercise program potentially improves long-term survival after elective abdominal aortic aneurysm repair.

OBJECTIVE: A preoperative supervised exercise program (SEP) improves cardiorespiratory fitness and perioperative outcomes for patients undergoing elective abdominal aortic aneurysm (AAA) repair. The aim of this study was to assess the effect of a preoperative SEP on long-term survival of these patients. A secondary aim was to consider long-term changes in cardiorespiratory fitness and quality of life. METHODS: Patients scheduled for open or endovascular AAA repair were previously randomized to either a 6-week preoperative SEP or standard management, and a significant improvement in a composite outcome of cardiac, pulmonary, and renal complications was seen following SEP. For the current analysis, patients were followed up to 5 years post-surgery. The primary outcome for this analysis was all-cause mortality. Data were analyzed on an intention to treat (ITT) and per protocol (PP) basis, with the latter meaning that patients randomized to SEP who did not attend any sessions were excluded. The PP analysis was further interrogated using a complier average causal effect (CACE) analysis on an all or nothing scale, which adjusts for compliance. Additionally, patients who agreed to follow-up attended the research center for cardiopulmonary exercise testing and/or provided quality of life measures. RESULTS: ITT analysis demonstrated that the primary endpoint occurred in 24 of the 124 participants at 5 years, with eight in the SEP group and 16 in the control group (P = .08). The PP analysis demonstrated a significant survival benefit associated with SEP attendance (4 vs 16 deaths; P = .01). CACE analysis confirmed a significant intervention effect (hazard ratio, 0.36; 95% confidence interval, 0.16-0.90; P = .02). There was no difference between groups for cardiorespiratory fitness measures and most quality of life measures. CONCLUSIONS: These novel findings suggest a long-term mortality benefit for patients attending a SEP prior to elective AAA repair. The underlying mechanism remains unknown, and this merits further investigation.

Supervised Exercise Therapy for Intermittent Claudication: A Propensity Score Matched Analysis of Retrospective Data on Long Term Cardiovascular Outcomes.

OBJECTIVE: This study aimed to explore the long term outcomes of patients with intermittent claudication (IC) who completed supervised exercise therapy (SET) vs. those who declined or prematurely discontinued SET, focusing on the incidence of chronic limb threatening ischaemia (CLTI), revascularisation, major adverse limb events (MALE), and major adverse cardiovascular events (MACE). METHODS: A retrospective registry analysis of consecutive patients with IC who were referred for SET between March 2015 and August 2016 and followed up for a minimum of five years. Serial univariable analysis and logistic regression were performed to identify the statistically significant clinical variables that were independent predictors of each outcome measure. The resulting statistically significant variables were used to guide 1:1 propensity score matching (PSM) using the nearest neighbour method with a calliper of 0.2. Cox proportional hazards regression was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) for the association between SET and the outcomes of interest. RESULTS: Two hundred and sixty-six patients were referred to SET between March 2015 and August 2016. Of these, 64 patients completed SET and 202 patients did not. After PSM, 49 patients were analysed in each cohort. The Cox proportional hazards analysis revealed a significant association between completion of SET and revascularisation requirement (HR 0.46 95% CI 0.25 - 0.84; p = .011), completion of SET and progression to CLTI (HR 0.091, 95% CI 0.04 - 0.24; p < .001), completion of SET and MACE (HR 0.52; 95% CI 0.28 - 0.99; p = .05) and completion of SET and MALE (HR 0.28, 95% CI 0.13 - 0.65; p = .003). The Harrell's C index for all of these models was greater than 0.75, indicating good predictive accuracy. CONCLUSION: Completion of SET is associated with better outcomes in patients who completed SET compared with patients who declined or discontinued SET with respect to clinically important cardiovascular outcomes over seven years.

Provision of NICE-recommended varicose vein treatment in the NHS.

BACKGROUND: Standardization of access to treatment and compliance with clinical guidelines are important to ensure the delivery of high-quality care to people with varicose veins. In the National Health Service (NHS) in England, commissioning of care for people with varicose veins is performed by Clinical Commissioning Groups (CCGs) and clinical guidelines have been developed by the National Institute for Health and Care Excellence (NICE CG168). The Evidence-Based Intervention (EBI) programme was introduced in the NHS with the aim of improving care quality and supporting implementation of NICE CG168. The aim of this study was to assess access to varicose vein treatments in the NHS and the impact of EBI. METHODS: CCG policies for the delivery of varicose vein treatments in the NHS in England were obtained from 2017 (before EBI introduction) and 2019 (after EBI introduction) and categorized by two independent reviewers into levels of compliance with NICE CG168. Hospital Episode Statistics data were compared with the NICE commissioning model predictions. A quality-adjusted life-year was valued at £20 000 (Euro 23 000 15 November 2022). RESULTS: Despite the introduction of the EBI programme, CCG compliance with NICE CG168 fell from 34.0 per cent (64 of 191) to 29.0 per cent (55 of 191). Some 33.0 per cent of CCG policies (63 of 191) became less compliant and only 7.3 per cent (14 of 191) changed to become fully compliant. Overall, 66.5 per cent of CCGs (127 of 191) provided less than the recommended intervention rate before EBI and this increased to 73.3 per cent (140 of191) after EBI. The overall proportion of patients estimated to require treatment annually who received treatment fell from 44.0 to 37.0 per cent. The associated estimated loss in net health benefit was between £164 and 174 million (Euro 188 million and 199 million 15 November 2022) over 3 years. A compliant policy was associated with a higher intervention rate; however, commissioning policy was associated with only 16.8 per cent of the variation in intervention rate (R2 = 0.168, P < 0.001). CONCLUSION: Many local varicose vein commissioning policies in the NHS are not compliant with NICE CG168. More than half of patients who should be offered varicose vein treatment are not receiving it, and there is widespread geographical variation. The EBI programme has not been associated with any improvement in commissioning or access to varicose vein treatment.

Endovenous ablation for venous leg ulcers.

BACKGROUND: Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing. OBJECTIVES: To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease. SEARCH METHODS: In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence. MAIN RESULTS: The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.

The Edinburgh Claudication Questionnaire has poor diagnostic accuracy in people with intermittent claudication.

BACKGROUND: The screening and diagnosis of intermittent claudication is a challenging process and often relies on the expertise of specialist vascular clinicians. We sought to investigate the diagnostic performance of the Edinburgh Claudication Questionnaire (ECQ) as a screening tool for referrals of suspected intermittent claudication from primary to secondary care. METHOD: Prospectively, 100 referrals from primary care with a stated diagnosis or query regarding intermittent claudication were recruited. All participants who completed the ECQ, underwent an anklebrachial pressure index (ABPI) assessment and treadmill exercise testing. Outcomes of the ECQ were compared to clinical diagnoses of intermittent claudication. RESULTS: The ECQ had a sensitivity of 46.8% (95% CI: 27-65%), specificity of 63.2% (95% CI: 43-82%) and accuracy of 53.0% (95% CI: 43-63%). The diagnostic performance was not changed by combining the ECQ with a positive ABPI or post-exercise ABPI outcome for PAD. CONCLUSION: The ECQ had a poor diagnostic performance in this cohort. Considering the results found here and in other recent studies, the utility of the ECQ as a screening tool and epidemiological survey tool must be questioned. Novel, low-resource diagnostic tools are needed in this population.

Extracorporeal shockwave therapy for diabetic foot ulcers: a feasibility study.

OBJECTIVE: The purpose of this study was to assess the feasibility of delivering extracorporeal shockwave therapy (ESWT) to patients with diabetic foot ulcers (DFUs). It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT offers any patient-reported benefits. METHOD: In this single-centre, mixed methods feasibility study, patients with a DFU who met the eligibility criteria underwent ESWT three times over a seven-day period. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFUs healed at 12 weeks and quality of life (QoL). Semi-structured interviews explored participants' experience of undergoing ESWT. RESULTS: Of 106 patients screened, 24 (22.6%) were recruited. Following recruitment, two patients were withdrawn from the study with 22 patients included in the final analysis. The mean attendance at clinic was 90.9% and 65.1% for follow-up. The mean score for acceptability and tolerability was 9.86±0.48 (95% confidence interval (CI): 9.62-10.01) and 9.15±2.57 (95% CI: 7.87-10.42), respectively. There were no serious adverse events or side-effects. Of the DFUs, 45.5% healed during follow-up and QoL scores improved until eight weeks. Key themes identified from the qualitative interviews were: desire for fast healing; improved QoL; flexibility of new treatments; and accessibility of transport. CONCLUSION: This study has shown that it is possible to recruit and retain patents into a single-arm study of ESWT for DFUs. This study supports development of a large randomised control trial to determine the clinical and cost-effectiveness of ESWT for DFU healing.

Extracorporeal shockwave therapy compared with standard care for diabetic foot ulcer healing: An updated systematic review.

Emerging evidence suggests that extracorporeal shockwave therapy (ESWT) may improve time to DFU healing. The aim of this review was to appraise the evidence on role of ESWT in DFU healing and impact of different ESWT doses. Databases were searched for trials comparing ESWT plus standard care to standard care alone in participants with DFUs. Search results were reviewed by two independent reviewers. The Cochrane Risk of Bias 2 tool and GRADE approach was used to assess bias and certainty. The primary outcome was time to healing. The search identified 345 papers after duplicates removed. Six trials consisting of 471 participants were included. There was unclear or high risk of bias across all domains. Time to ulcer healing was probably shorter in patients treated with ESWT compared with standard ulcer care alone (GRADE: low certainty). Patients treated with ESWT were more likely to heal at 20 weeks post-ESWT compared with those treated with standard ulcer care alone (GRADE: low certainty). There was significant heterogeneity. ESWT remains a promising new treatment but the translation into routine clinical practice is still limited by the low certainty of evidence surrounding its effectiveness, case selection and optimum dose.

The local physiological effects of a single-use topical negative pressure device in healthy volunteers: the PICO-1 study.

OBJECTIVE: This study aimed to investigate the effects of a single-use negative pressure wound therapy (sNPWT) device on tissue perfusion, oxygenation and pressure in the intact skin of healthy volunteers. METHOD: Healthy volunteers wore a PICO sNPWT device (Smith+Nephew, UK) on their right medial calf for one week. Perfusion, tissue oxygenation and tissue pressure were recorded in superficial and deep tissues over a period of seven days. At the baseline visit, measurements were recorded before and after dressing application without activation. Macrovascular flow and transduced needle pressure measures were recorded at 0 minutes, 30 minutes and 60 minutes after device activation. Superficial tissue perfusion and both oxygenation measures were recorded continuously over the hour following activation. All outcome measures were repeated at 24 hours and again after seven days, both with the dressing and following dressing removal. RESULTS: The device was associated with a measurable increase in perfusion of the limb in 12 healthy volunteers. Superficial tissue oxygenation adjacent to the dressing was reduced during wear, while deeper tissue demonstrated an increase in oxygenation levels. Superficial skin perfusion was observed to differ between skin overlying muscle and that overlying bone. Pressure in tissue underneath the dressing pad was increased throughout dressing wear and returned to baseline levels on dressing removal. CONCLUSION: sNPWT produced measurable changes in local physiology in healthy volunteers with intact skin, despite the absence of a wound. Effects may differ according to anatomical site and the composition of underlying tissues. Other factors that promote healing were not explored in this study. DECLARATION OF INTEREST: This study was funded by Smith+Nephew investigator-initiated grant IIS 684. The funder had no input into study design, conduct, analysis, manuscript preparation or dissemination. The authors have no conflicts of interest to declare.

An updated systematic review and meta-analysis of home-based exercise programs for individuals with intermittent claudication.

OBJECTIVE: Supervised exercise programs (SEP) are effective for improving walking distance in patients with intermittent claudication (IC) but provision and uptake rates are suboptimal. Access to such programs has also been halted by the Coronavirus pandemic. The aim of this review is to provide a comprehensive overview of the evidence for home-based exercise programs (HEP). METHODS: This review was conducted in according with the published protocol and PRISMA guidance. Medline, EMBASE, CINAHL, PEDro, and Cochrane CENTRAL were searched for terms relating to HEP and IC. Randomized and nonrandomized trials that compared HEP with SEP, basic exercise advice, or no exercise controls for IC were included. A narrative synthesis was provided for all studies and meta-analyses conducted using data from randomized trials. The primary outcome was maximal walking distance. Subgroup analyses were performed to consider the effect of monitoring. Risk of bias was assessed using the Cochrane tool and quality of evidence via GRADE. RESULTS: We included 23 studies with 1907 participants. Considering the narrative review, HEPs were inferior to SEPs which was reflected in the meta-analysis (mean distance [MD], 139 m; 95% confidence interval [CI], 45-232 m; P = .004; very low quality of evidence). Monitoring was an important component, because HEPs adopting this strategy were equivalent to SEPs (MD, 8 m; 95% CI, -81 to 97; P = .86; moderate quality of evidence). For HEPs vs basic exercise advice, narrative review suggested HEPs can be superior, although not always significantly so. For HEPs vs no exercise controls, narrative review and meta-analysis suggested HEPs were potentially superior (MD, 136 m; 95% CI, -2 to 273 m; P = .05; very low quality of evidence). Monitoring was also a key element in these comparisons. Other elements such as appropriate frequency (≥3× a week), intensity (to moderate-maximum pain), duration (20 progressing to 60 minutes) and type (walking) of exercise were important, as was education, self-regulation, goal setting, feedback, and action planning. CONCLUSIONS: When SEPs are unavailable, HEPs are recommended. However, to elicit maximum benefit they should be structured, incorporating all elements of our evidence-based recommendations.

Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations.

BACKGROUND: Diabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral vascular disease, worldwide. When a lower limb amputation is considered, preservation of the knee in a below-knee amputation allows for superior functional recovery when compared with amputation at a higher level. When a below-knee amputation is not feasible, the most common alternative performed is an above-knee amputation. Another possible option, which is less commonly performed, is a through-knee amputation which may offer some potential functional benefits over an above-knee amputation. OBJECTIVES: To assess the effects of through-knee amputation compared to above-knee amputation on clinical and rehabilitation outcomes and complication rates for all patients undergoing vascular and non-vascular major lower limb amputation. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials register to 17 February 2021. We undertook reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) comparing through-knee amputation and above-knee amputation were eligible for inclusion in this study. Primary outcomes were uncomplicated primary wound healing and prosthetic limb fitting. Secondary outcomes included time taken to achieve independent mobility with a prosthesis, health-related quality of life, walking speed, pain, and 30-day survival. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed all records identified by the search. Data collection and extraction were planned in line with recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using the GRADE approach. MAIN RESULTS: We did not identify RCTs that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: No RCTs have been conducted to determine comparative clinical or rehabilitation outcomes of through-knee amputation and above-knee amputation, or complication rates. It is unknown whether either of these approaches offers improved outcomes for patients. RCTs are needed to guide practice and to ensure the best outcomes for this patient group.

Presurgery exercise-based conditioning interventions (prehabilitation) in adults undergoing lower limb surgery for peripheral arterial disease.

BACKGROUND: Lower limb peripheral arterial disease (PAD) is a type of cardiovascular disease where the blood vessels that carry the blood to the legs are hardened and narrowed. The most severe manifestation of PAD is critical limb ischaemia (CLI). This condition results in symptoms of intractable rest pain, non-healing wounds and ulceration, gangrene or both. PAD affects more than 200 million people worldwide and approximately 3% to 5% of people aged over 40 have PAD, rising to 18% in people over 70 years of age. Between 5% to 10% of symptomatic PAD patients will progress to CLI over a five-year period and the five year cumulative incidence rate for asymptomatic patients with PAD deteriorating to intermittent claudication is 7%, with 21% of these progressing to CLI. Treatment options include angioplasty, bypass or amputation of the limb, when life or limb is threatened. People with CLI have a high risk of mortality and morbidity. The mortality rates during a surgical admission are approximately 5%. Within one year of surgery, the mortality rate rises to 22%. Postoperative complications are as high as 30% and readmission rates vary between 7% to 18% in people with CLI. Despite recent advances in surgical technology, anaesthesia and perioperative care, a proportion of surgical patients have a suboptimal recovery. Presurgery conditioning (prehabilitation) is a multimodal conditioning intervention carried out prior to surgery using a combination of exercise, with or without nutritional or psychological interventions, or both. The use of prehabilitation is gaining momentum, particularly in elderly patients undergoing surgery and patients undergoing colorectal cancer surgery, as a means of optimising fitness to improve the prognosis for people undergoing the physiological stress of surgery. People with PAD are characterised by poor mobility and physical function and have a lower level of fitness as a result of disease progression. Therefore, prehabilitation may be an opportunity to improve their recovery following surgery. However, as multimodal prehabilitation requires considerable resources, it is important to assess whether it is superior to usual care. This review aimed to compare prehabilitation with usual care (defined as a preoperative assessment, including blood and urine tests). The key outcomes were postoperative complications, mortality and readmissions within 30 days of the surgical procedure, and one-year survival rates. OBJECTIVES: To assess the effectiveness of prehabilitation (preoperative exercise, either alone or in combination with nutritional or psychological interventions, or both) on postoperative outcomes in adults with PAD undergoing open lower limb surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 25 September 2019. SELECTION CRITERIA: We considered all published and unpublished randomised controlled trials (RCTs) comparing presurgery interventions and usual care. Primary outcomes were postoperative complications, mortality and readmission to hospital within 30 days of the surgical procedure. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed all records identified by the searches conducted by the Cochrane Vascular Information Specialist. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: We found no RCTs that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: We found no RCTs conducted to determine the effects of prehabilitation on mortality or other postoperative outcomes when compared to usual care for patients with PAD. As a consequence, we were unable to provide any evidence to guide the treatment of patients with PAD undergoing surgery. To perform a randomised controlled trial of presurgery conditioning would be challenging but trials are warranted to provide solid evidence on this topic.

A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication.

BACKGROUND: Intermittent claudication (IC) is the most common symptom of peripheral arterial disease, which significantly affects walking ability, functional capacity and quality of life. Supervised exercise programs (SEP) are recommended as first-line treatment, but recruitment and adherence rates are poor. The time required to complete a SEP is the most common barrier to participation cited by patients who decline. High-intensity interval training (HIIT) is more time efficient than current SEPs and therefore has the potential to overcome this barrier. We conducted a systematic review to appraise the evidence for HIIT programs for IC. METHODS: MEDLINE, Embase, and CENTRAL databases were searched for terms related to HIIT and IC. Randomized and nonrandomized trials that investigated HIIT for the treatment of IC were included, with no exclusions based on exercise modality, protocol, or use of a comparator arm. Outcome measures were walking distances, peak oxygen uptake, recruitment and adherence rates, and quality of life. The risk of bias was assessed using the Cochrane tool and study quality using a modified Physiotherapy Evidence Database scale. RESULTS: Nine articles reporting eight studies were included in the review. HIIT seems to improve walking distances and oxygen uptake in relation to controls, with improvements attainable in just 6 weeks. When HIIT was compared with low-intensity exercise, it seemed that longer low-intensity programs were required to obtain similar benefits to those from short-term HIIT. CONCLUSIONS: Initial evidence suggests that HIIT may provide benefits for patients with IC. Initially, pilot studies of low-volume, short-term HIIT vs usual SEPs are required. This strategy will allow for larger randomized, controlled trials to be appropriately designed and adequately powered to further explore the potential benefits of HIIT in IC.

The Intrarater and Interrater Reliability of Measures Derived from Cardiopulmonary Exercise Testing in Patients with Abdominal Aortic Aneurysms.

BACKGROUND: Patients with abdominal aortic aneurysms (AAAs) often have low exercise tolerance due to comorbidities and advanced age. Cardiopulmonary exercise testing (CPET) is predictive of postoperative morbidity and mortality in patients with AAA. We aimed to assess the intrarater and interrater reliability of both treadmill-based and cycle ergometer-based CPET variables. METHODS: Patients with an AAA (>3.5 cm) were randomized to a treadmill or bike CPET. Patients were asked to perform two separate CPETs seven days apart after a familiarization protocol. All CPETs were carried out using a ramp cycle or modified Bruce treadmill protocol with breath-by-breath gas analysis. RESULTS: Twenty-two male and 2 female patients, aged 73.6 ± 6.0 years, completed the study. Intrarater analysis (intraclass correlation coefficients) demonstrated high reliability on both the treadmill and bike for ventilatory anaerobic threshold (r = 0.834 and r = 0.975, respectively). All other CPET variables demonstrated high intrarater reliability on both modalities, bar the highest point for the ventilatory slope of oxygen (VE/VO2) on the treadmill (substantial agreement r = 0.755). Furthermore, interrater reliability demonstrated high agreement for ventilatory anaerobic threshold on both the treadmill and cycle (r = 0.983 and r = 0.905, respectively). All other CPET variables demonstrated high intrarater reliability on both modalities, with the exception of VO2Peak on the cycle ergometer (fair agreement r = 0.400). CONCLUSION: CPET in patients with AAAs is a reliable tool test and among CPET test reviewers for common testing modalities/protocols. These findings provide further support for the use of CPET, especially treadmill walking, as a clinical measure of perioperative cardiorespiratory fitness in patients with AAAs.

Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis.

BACKGROUND: Diabetes mellitus is one of the most common chronic diseases worldwide. Diabetic foot ulcers (DFUs) occur in over 10% of diabetic patients and are associated with high morbidity. Clinical trials have shown benefit from extracorporeal shockwave therapy (ESWT) in a DFU healing. This systematic review aims to assess the currently available evidence examining the efficacy of ESWT on healing of DFU. METHODS: Electronic databases including PubMed, Ovid MEDLINE, Web of Science, Embase, CINAHL Plus, Cochrane Central Registry of Controlled Trials, and Clinical Trials Registry were searched up to November 2017 for terms related to ESWT in DFU. Articles were identified, and data were extracted by 2 independent reviewers onto Review Manager 5.3 software. RESULTS: This review included 5 trials of 255 patients published between 2009 and 2016. Three studies compared ESWT to standard wound care, and 2 studies compared ESWT to hyperbaric oxygen therapy (HBOT). All studies contained unclear to high risk of bias assessed by the Cochrane Risk of Bias Tool. ESWT was superior to standard wound care at complete wound healing (odds ratio [OR] 2.66 95% confidence interval [CI] 1.03, 6.87, I2 0%) and time to healing (64.5 ± 8.06 days versus 81.17 ± 4.35 days). DFU healing improved more with ESWT than HBOT (OR 2.45 95% CI 1.07, 5.61 I2 28%). There was variable evidence of effect on the blood flow perfusion rate. Infection rate and amputation rate were not reported. CONCLUSIONS: This systematic review concludes that ESWT has the potential to improve healing in DFUs, although there is, as yet, insufficient evidence to justify its use in routine clinical practice. The meta-analysis has a high risk of bias and is unlikely to reflect true effect size because of problematic risk of bias in included studies. This review highlights the variable quality of methodology of trials and dosing of shockwave therapy and the need for robust adequately powered research into this promising therapy.

A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection.

A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)-impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean-contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC-coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC-coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large-scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full-scale RCT.

Use of photograph-based telemedicine in postoperative wound assessment to diagnose or exclude surgical site infection.

OBJECTIVE: This study aims to assess whether a clinician reviewing photographs of a wound was an acceptable substitute for clinical review in order to identify or exclude surgical site infection (SSI). METHOD: We undertook a mixed methods study consisting of a qualitative public involvement exercise and a prospective, non-randomised, single-centre study of patients undergoing clean or clean-contaminated vascular surgery. For the qualitative study, two semi-structured focus group interviews were conducted. For the prospective study, patients were invited to attend a wound review at 5-7 days and 30 days postoperatively. At review, wounds were scored by a study nurse or doctor, according to the ASEPSIS scale. Anonymised wound photographs were taken and independently reviewed, and ASEPSIS scored by two independent investigators blinded to the original 'clinical review' ASEPSIS score. RESULTS: In the qualitative study, three female patients were interviewed across two dates. Emerging themes included the burden of SSI, hospital follow-up and telemedical follow-up. A total of 37 patients with a mean age of 61.14 years were included in the quantitative analysis. There was a total of 53 wound reviews. There was >85% agreement between photograph and clinical reviewers in all categories except erythema. The specificity of photograph review for diagnosis of SSI was 90%. The intraclass correlation coefficient for total ASEPSIS score was R=0.806 (95% CI 0.694, 0.881), indicating strong reliability between reviewers. CONCLUSION: Our data shows that, in the assessment of SSI, there is good correlation between face-to-face clinical and remote photographic review. Incorporating this method of wound assessment into a postoperative follow-up care pathway may save patients and clinicians from unnecessary hospital visits, particularly when conducting health research.

A systematic review of muscle morphology and function in intermittent claudication.

OBJECTIVE: Intermittent claudication (IC) is frequently associated with deterioration in walking capacity and physical function, and it can often result in an impairment in balance. Whereas supervised exercise is recommended by the National Institute for Health and Care Excellence as the first-line treatment, the mechanism behind walking improvement is poorly understood. The existing literature suggests that there may be some physiologic change to the skeletal muscle contributing to the functional impairment, but these data are conflicting. We therefore sought to undertake a systematic review to clarify the muscle properties of patients with IC. METHODS: A systematic review of randomized and nonrandomized trials that investigated the role of muscle function in patients diagnosed with IC was undertaken using MEDLINE, Cochrane Central Register of Controlled Trials, and Embase databases. The searches were limited from 1947 to June 2016 in the English language. RESULTS: The search yielded a total of 506 articles, of which 206 were duplicate articles. Of the remaining 300, a total of 201 were excluded from full-text analysis; 99 full-text articles were assessed for eligibility, with 30 articles deemed appropriate for inclusion in the review. There were four main categories of functional outcome measures: muscle strength, muscle size, muscle fiber type, and muscle metabolism. A total of 2837 patients were included in the study. Nine studies reported on muscle strength, incorporating isometric, concentric, eccentric, and endurance measures. Eight studies reported on muscle size, incorporating circumference, computed tomography scans, and ultrasound imaging techniques. Eleven studies reported on muscle fibers, incorporating fiber type proportions, fiber size, and capillarity measures. Seven papers reported on muscle metabolism, incorporating adenosine diphosphate recovery and phosphocreatine recovery measures. CONCLUSIONS: Previous literature has found clear evidence that strength (of the calf and thigh musculature) and calf characteristics are related to mortality and functional declines. However, this review has demonstrated the vast array of muscle groups assessed and multiple methods employed to determine strength; therefore, it is unclear exactly what measure of "strength" is impaired. Furthermore, the underlying morphologic causes of potential changes in strength are unclear. This information is essential for designing optimal exercise interventions. The data acquired during this systematic review are heterogeneous, with a substantial lack of high-quality intervention-based studies. Future research should endeavor to establish standardized testing procedures and to implement randomized controlled trials for targeted therapeutic interventions.

Dialkylcarbamoyl Chloride Dressings in the Prevention of Surgical Site Infections after Nonimplant Vascular Surgery.

BACKGROUND: Dressings coated with dialkylcarbamoyl chloride (DACC) are highly hydrophobic and irreversibly bind multiple types of bacteria, trapping them in the dressing and reducing the number of organisms at the wound surface. We aimed to assess the impact of DACC-coated postoperative dressings on the incidence of surgical site infection (SSI) in nonimplant vascular surgery patients. METHODS: Two hundred patients undergoing nonimplant vascular surgery were prospectively recruited at a single vascular center. The initial 100 patients had their operative wounds dressed with conventional dressings followed by 100 patients who received DACC-coated postoperative dressings. Wounds were reviewed at day 5 and day 30 to determine the presence of SSI using the ASEPSIS scoring system. The variation in outcomes between groups was assessed using chi-squared test and logistic regression analysis to assess the effects of other variables, which may affect healing. RESULTS: Between August 1, 2015 and February 29, 2016, a total of 120 men and 80 women were recruited. The mean age was 63 (range 27-97) years, 92% were current or ex-smokers and 45.5% were diabetic. Rate of SSI at 5 days was significantly lower in the DACC group compared with standard dressings (1% vs. 10%, P < 0.05). There was no difference in the rates of SSI at 30 days. Logistic regression suggested that the type of dressing used was the most prominent predictor variable for the presence of early SSI (P = 0.028, odds ratio = 0.09, 95% confidence interval: 0.01-0.77). CONCLUSIONS: DACC-coated dressings were associated with a significant reduction in SSI rates in the early postoperative period.

A Systematic Review of Extracorporeal Shockwave Therapy as a Novel Treatment for Intermittent Claudication.

BACKGROUND: Extracorporeal shockwave therapy (ESWT) is emerging as a potential new treatment option for a variety of clinical scenarios including promotion of wound healing and symptom control in end-stage ischemic heart disease. A number of small trials have investigated ESWT in the management of peripheral arterial disease (PAD). A systematic review of the literature was performed investigating the efficacy and potential mechanism of action of ESWT for PAD. METHODS: A systematic review was conducted using MEDLINE and PubMed databases in keeping with the standard reporting guidelines set by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis group to identify any publications relating to the use of ESWT in PAD. RESULTS: Systematic literature review identified 5 studies in 4 articles investigating ESWT in the treatment of symptomatic PAD. Although participant numbers within the identified studies were small, significant improvements in pain-free walking distance and maximum walking distance were demonstrated. The mechanism of action is thought to be due to mechanotransduction and subsequent angiogenesis. CONCLUSIONS: ESWT shows promise as a potentially efficacious novel treatment for symptomatic PAD. However, studies to date are small and record heterogeneous outcomes. Appropriately powered, randomized, sham-controlled data including objective clinical outcomes to comprehensively assess the efficacy of this novel treatment modality is still required before determining if ESWT should be brought into routine clinical practice.

The Impact of Vein Mechanical Compliance on Arteriovenous Fistula Outcomes.

BACKGROUND: Arteriovenous fistulae (AVFs) are the preferred access for hemodialysis but suffer a high early failure rate. The aim of this study was to determine how venous distensibility, as measured in vitro, relates to early outcomes of AVF formed with the sampled vein. METHODS: Ethical approval was obtained for all aspects of this study. During AVF formation a circumferential segment of the target vein was sampled. Mechanical stress testing of the venous segments was undertaken using a dynamic mechanical analyzer, with progressive stress loading at 2 N/min to a maximum of 10 N or until sample disruption. Stress-strain curves were obtained for vein samples and Young's modulus (YM) calculated. Duplex assessment of the fistulae was undertaken at 30 days. RESULTS: Thirty patients consented to participate with 29 samples obtained for analysis. Statistical comparison of YM demonstrated no relationship with common cardiovascular risk factors or dialysis status. Subject age greater than 65 was the only patient factor which showed a significant difference in YM (P = 0.05). Furthermore, a negative correlation was confirmed between age and YM (Pearson's r = -0.465, P < 0.05). Nine of the 29 subjects suffered an early AVF failure. Mann-Whitney U testing for differences in distribution reported that YM was significantly higher in those fistulas which failed (P < 0.005). CONCLUSIONS: Reduced venous compliance appears to result in higher failure rates of AVFs. With the advancement of clinical tools such as speckle tracing ultrasound identification of vessel compliance in vivo may produce valuable additional information for clinicians planning AVF surgery.