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

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

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

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

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

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

Telemedicine for sustainable postoperative follow-up: a prospective pilot study evaluating the hybrid life-cycle assessment approach to carbon footprint analysis

IntroductionSurgical site infections (SSI) are the most common healthcare-associated infections; however, access to healthcare services, lack of patient awareness of signs, and inadequate wound surveillance can limit timely diagnosis. Telemedicine as a method for remote postoperative follow-up has been shown to improve healthcare efficiency without compromising clinical outcomes. Furthermore, telemedicine would reduce the carbon footprint of the National Health Service (NHS) through minimising patient travel, a significant contributor of carbon dioxide equivalent (CO2e) emissions. Adopting innovative approaches, such as telemedicine, could aid in the NHS Net-Zero target by 2045. This study aimed to provide a comprehensive analysis of the feasibility and sustainability of telemedicine postoperative follow-up for remote diagnosis of SSI.MethodsPatients who underwent a lower limb vascular procedure were reviewed remotely at 30 days following the surgery, with a combined outcome measure (photographs and Bluebelle Wound Healing Questionnaire). A hybrid life-cycle assessment approach to carbon footprint analysis was used. The kilograms of carbon dioxide equivalent (kgCO2e) associated with remote methods were mapped prospectively. A simple outpatient clinic review, i.e., no further investigations or management required, was modelled for comparison. The Department of Environment, Food, and Rural Affairs (DEFRA) conversion factors plus healthcare specific sources were used to ascertain kgCO2e. Patient postcodes were applied to conversion factors based upon mode of travel to calculate kgCO2e for patient travel. Total and median (interquartile range) carbon emissions saved were presented for both patients with and without SSI.ResultsAltogether 31 patients (M:F 2.4, ±11.7 years) were included. The median return distance for patient travel was 42.5 (7.2–58.7) km. Median reduction in emissions using remote follow-up was 41.2 (24.5–80.3) kgCO2e per patient (P &lt; 0.001). The carbon offsetting value of remote follow-up is planting one tree for every 6.9 patients. Total carbon footprint of face-to-face follow-up was 2,895.3 kgCO2e, compared with 1,301.3 kgCO2e when using a remote-first approach (P &lt; 0.001). Carbon emissions due to participants without SSI were 700.2 kgCO2e by the clinical method and 28.8 kgCO2e from the remote follow-up.DiscussionThis model shows that the hybrid life-cycle assessment approach is achievable and reproducible. Implementation of an asynchronous digital follow-up model is effective in substantially reducing the carbon footprint of a tertiary vascular surgical centre. Further work is needed to corroborate these findings on a larger scale, quantify the impact of telemedicine on patient's quality of life, and incorporate kgCO2e into the cost analysis of potential SSI monitoring strategies