Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial

Importance Intermittent lower limb claudication limits function and quality of life. Supervised exercise programs are not readily available, and a noninvasive alternative is needed.Objective To assess extracorporeal corporeal shockwave therapy in improving quality of life in patients with claudication.Design, Setting, and Participants In this double-blind, placebo-controlled randomized clinical trial, patients in the outpatient setting at a single tertiary center for vascular surgery were randomized in a 1:1 ratio to extracorporeal shockwave therapy or placebo therapy with no shockwaves delivered. Recruitment was between June 2015 and January 2020, with 12-week follow-up ending in March 2020. A convenience sample of patients with claudication and conservative treatment requirements who refused or were unable to participate in supervised exercise were eligible. Patients receiving anticoagulation therapy or with an active cancer were excluded. Of 522 patients screened, 389 were eligible, 138 were enrolled, and 110 completed follow-up and were included in the primary analysis. Statistical analysis was completed by May 2021.Intervention In the intervention group, patients received 100 impulses of 0.1mJ/mm/cm2 in an area of the gastrocnemius muscle 3 times weekly for 3 weeks. The steps for treatment were replicated for the control group without delivering the treatment.Main Outcomes and Measures The primary outcome was the Physical Functioning domain of the 36-item Short-Form Quality of Life Questionnaire at 12-week follow-up. Secondary outcomes included walking distances, ankle brachial pressure index, and other quality-of-life measures.Results Of 138 patients recruited and randomized, 92 (67%) were male, and the mean (SD) age of the study population was 67 (9.6) years. The intervention group had a significantly higher physical function score at 12 weeks (estimated median difference 3.8; 95% CI, 0.0-7.7; P = .03). However, this significance did not remain when adjusting for covariates. At 12 weeks, the intervention group had significantly longer pain-free and maximum walking distances (pain-free estimated median difference, 34.1, 95% CI, 11.4-56.8; P = .004; maximum estimated median difference, 51.4; 95% CI, 10.7-86.5; P = .01).Conclusions and Relevance To our knowledge, this is the first double-blind, placebo-controlled, randomized clinical trial to consider extracorporeal shockwave therapy for the management of intermittent claudication. It demonstrated efficacy for walking distances, may have a positive effect on quality of life, and may provide a safe, noninvasive alternative therapy for patients with intermittent claudication

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 ofhigh-quality care to people with varicose veins. In the National Health Service (NHS) in England, commissioning of care for people withvaricose veins is performed by Clinical Commissioning Groups (CCGs) and clinical guidelines have been developed by the NationalInstitute for Health and Care Excellence (NICE CG168). The Evidence-Based Intervention (EBI) programme was introduced in theNHS with the aim of improving care quality and supporting implementation of NICE CG168. The aim of this study was to assessaccess 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 EBIintroduction) and 2019 (after EBI introduction) and categorized by two independent reviewers into levels of compliance with NICECG168. Hospital Episode Statistics data were compared with the NICE commissioning model predictions. A quality-adjusted life-yearwas 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 fullycompliant. Overall, 66.5 per cent of CCGs (127 of 191) provided less than the recommended intervention rate before EBI and this increasedto 73.3 per cent (140 of191) after EBI. The overall proportion of patients estimated to require treatment annually who received treatmentfell 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 and199 million 15 November 2022) over 3 years. A compliant policy was associated with a higher intervention rate; however, commissioningpolicy 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 patientswho should be offered varicose vein treatment are not receiving it, and there is widespread geographical variation. The EBI programmehas not been associated with any improvement in commissioning or access to varicose vein treatment

Extracorporeal Shockwave Therapy compared to 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 of471 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

Tailored risk assessment and forecasting in intermittent claudication

BackgroundGuidelines recommend cardiovascular risk reduction and supervised exercise therapy as the first line of treatment in intermittent claudication, but implementation challenges and poor patient compliance lead to significant variation in management and therefore outcomes. The development of a precise risk stratification tool is proposed through a machine-learning algorithm that aims to provide personalized outcome predictions for different management strategies.MethodsFeature selection was performed using the least absolute shrinkage and selection operator method. The model was developed using a bootstrapped sample based on patients with intermittent claudication from a vascular centre to predict chronic limb-threatening ischaemia, two or more revascularization procedures, major adverse cardiovascular events, and major adverse limb events. Algorithm performance was evaluated using the area under the receiver operating characteristic curve. Calibration curves were generated to assess the consistency between predicted and actual outcomes. Decision curve analysis was employed to evaluate the clinical utility. Validation was performed using a similar dataset.ResultsThe bootstrapped sample of 10 000 patients was based on 255 patients. The model was validated using a similar sample of 254 patients. The area under the receiver operating characteristic curves for risk of progression to chronic limb-threatening ischaemia at 2 years (0.892), risk of progression to chronic limb-threatening ischaemia at 5 years (0.866), likelihood of major adverse cardiovascular events within 5 years (0.836), likelihood of major adverse limb events within 5 years (0.891), and likelihood of two or more revascularization procedures within 5 years (0.896) demonstrated excellent discrimination. Calibration curves demonstrated good consistency between predicted and actual outcomes and decision curve analysis confirmed clinical utility. Logistic regression yielded slightly lower area under the receiver operating characteristic curves for these outcomes compared with the least absolute shrinkage and selection operator algorithm (0.728, 0.717, 0.746, 0.756, and 0.733 respectively). External calibration curve and decision curve analysis confirmed the reliability and clinical utility of the model, surpassing traditional logistic regression.ConclusionThe machine-learning algorithm successfully predicts outcomes for patients with intermittent claudication across various initial treatment strategies, offering potential for improved risk stratification and patient outcomes

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

Preferred exercise modalities in patients with intermittent claudication

Conventional supervised exercise programs (SEPs) for claudicants are traditionally based on time-constrained, groupbased structured programs usually at a hospital site. Uptake of an SEP is poor, despite the high-level evidence demonstrating its clinical effectiveness; therefore, alternative forms of exercise programs are needed which are more acceptable to patients. This study aimed to explore a range of exercise modalities to determine patient preferences for exercise delivery on a national level. This was a questionnaire survey to identify and incorporate patient preferences when designing a multicenter nationwide health-service evaluation of patient preference to exercise in the United Kingdom’s National Health Service (the PREFER study). Patients with documented stable intermittent claudication who were suitable for an SEP were given a questionnaire to fill out at their clinic visit. Data were recorded using the Bristol Online Survey tool (http://www.survey.bris.ac.uk/) and analyzed descriptively. Thirty complete questionnaires were analyzed. Participants were generally unilateral claudicants (80%) with symptoms for over 1 year (64%). Only 6 of the 30 patients had engaged in a lifelong routine of exercise. Eighty-seven percent of patients indicated that they had not taken part in an exercise program, but 73% of those indicated that they would be willing to participate to improve their walking. Most patients expressed a preference for a home exercise program (50%) followed by a hospital SEP. The majority of patients (43%) were happy to exercise 3 days per week using a walking-based program (53%). There was however no consensus on the duration or intensity of the exercise program. The SEP is the recommended first-line treatment for intermittent claudication patients; however, the vast majority of patients fail to engage with or complete an exercise program. This study demonstrates that exercise therapy should be individualized and take a patient-centered approach. Commissioning groups should incentivize hospitals and clinicians to engage with their patient populations to understand their needs and deliver an appropriate servic

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

The DEFINITE Audit - A Prospective Audit of Diabetic Foot Debridement in Theatre: A Protocol

BackgroundPeople with diabetes are commonly affected by foot ulceration (DFU) and subsequent or concurrent infection (DFI). Surgical debridement is often needed to contain infection. Despite international guidelines, there remains significant variation in surgical practice of diabetic foot wound debridement in the operating theatre.MethodsDiabetic Foot Ulcer Debridement in Theatre Audit (DEFINITE) is a global multicentre, prospective audit of consecutive patients undergoing a debridement or minor amputation in theatre for a diabetic foot complication. DEFINITE is led by the Vascular and Endovascular Research Network (VERN). The primary outcome is adherence to recommended practice as outlined in the International Working Group on the Diabetic Foot and Global Vascular Guidelines. Secondary outcomes are incidence of healing, re-admission, further amputation (minor and major) and mortality at 90 days. Anonymised data will be collected via REDCap. All hospital institutions performing in-theatre management of diabetic foot complications are eligible to participate after obtaining appropriate institutional level audit approvals. A lead clinician will be responsible for approvals and data management.Pathway to impactThis audit addresses shared patient-clinician priorities and is supported by the UK Vascular Society multidisciplinary Special Interest Group on the Diabetic Foot. The results will be presented at international scientific meetings and submitted for publication in peer reviewed publications. The results will also be used to initiate improvement in patient care

Dosing and Efficacy of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing: A Systematic Review Protocol

AbstractBackgroundEffective interventions to improve diabetic foot ulcer (DFU) healing are urgently required. Extracorporeal shockwave therapy (ESWT) has the potential to transform DFU care but is limited by uncertainties around clinical effectiveness and optimal dosing regimen. This protocol outlines the methodology of a systematic review that will address these unknowns. MethodsDatabases and the grey literature will be searched for randomised controlled trials (RCT) comparing ESWT plus standard ulcer care to standard ulcer care ± sham ESWT in patients with a DFU. The primary outcome of the review is time to ulcer healing. Two independent reviewers will screen search results against pre-determined eligibility criteria and extract data onto a pre-piloted spreadsheet. A meta-analysis is planned to compare time to healing for ESWT versus standard care and different doses of ESWT. The Risk of Bias 2 and GRADE tool will be used to assess the quality of the evidence. Outputs, Dissemination, ImpactThe review will provide an estimate of the effect ESWT on DFU healing and impact of ESWT dose on DFU healing. The systematic review will be submitted for publication in a peer review journal. A plain English summary will be produced. Outputs from the review will guide patient care and research