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.

Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins.

BACKGROUND: Surgical ligation and stripping (surgery) and endothermal ablation are both effective treatments for varicose veins, improving quality of life (QoL) up to 5 years. Few data are available on long-term outcomes. The aim of this study was to evaluate the outcomes 10 years after interventions in an RCT. Previously this RCT demonstrated that endothermal ablation is associated with superior postprocedural QoL, more rapid recovery, and lower rates of early clinical recurrence. This analysis reports outcomes at 10 years. METHODS: Patients with symptomatic varicose veins owing to unilateral great saphenous vein reflux were randomized to either surgery or endovenous laser ablation (EVLA). Outcomes at 10 years included clinical recurrence and QoL. RESULTS: Data were obtained for 206 of 280 patients (73.6%) at 10 years. Both groups retained significant QoL improvement compared with pretreatment levels (Aberdeen Varicose Vein Questionnaire (AVVQ), Short Form 36 (SF-36®), and EQ-5D™; P < 0.001). Clinical disease progression from baseline was observed in only 10.7% of patients. The clinical recurrence rate was lower in the EVLA group (37 versus 59%; P = 0.005). The number needed to treat with EVLA to avoid one clinical recurrence within 10 years was five. This was associated with significantly higher (better) generic QoL scores with EVLA in several SF-36® domains, including bodily pain (median 84 (i.q.r. 51-100) versus 62 (41-84); P = 0.009) and general health (77 (62-87) versus 67 (52-82); P = 0.017). AVVQ scores in the EVLA group were also lower (better) (3.1 (0-7.7) versus 6.3 (0.7-13.3); P = 0.029). CONCLUSION: Both surgery and endothermal ablation are effective treatments for varicose veins at 10 years, with durable improvement in QoL and a very low rate of disease progression. However, endothermal ablation was associated with superior clinical and QoL outcomes. Registration number: NCT00759434 (http://www.clinicaltrials.gov).

Short-term psychosocial outcomes of adding a non-contrast abdominal computed tomography (CT) scan to the thoracic CT within lung cancer screening.

OBJECTIVES: To evaluate psychological, social, and financial outcomes amongst individuals undergoing a non-contrast abdominal computed tomography (CT) scan to screen for kidney cancer and other abdominal malignancies alongside the thoracic CT within lung cancer screening. SUBJECTS AND METHODS: The Yorkshire Kidney Screening Trial (YKST) is a feasibility study of adding a non-contrast abdominal CT scan to the thoracic CT within lung cancer screening. A total of 500 participants within the YKST, comprising all who had an abnormal CT scan and a random sample of one-third of those with a normal scan between 14/03/2022 and 24/08/2022 were sent a questionnaire at 3 and 6 months. Outcomes included the Psychological Consequences Questionnaire (PCQ), the short-form of the Spielberger State-Trait Anxiety Inventory, and the EuroQoL five Dimensions five Levels scale (EQ-5D-5L). Data were analysed using regression adjusting for participant age, sex, socioeconomic status, education, baseline quality of life (EQ-5D-5L), and ethnicity. RESULTS: A total of 380 (76%) participants returned questionnaires at 3 months and 328 (66%) at 6 months. There was no difference in any outcomes between participants with a normal scan and those with abnormal scans requiring no further action. Individuals requiring initial further investigations or referral had higher scores on the negative PCQ than those with normal scans at 3 months (standardised mean difference 0.28 sd, 95% confidence interval 0.01-0.54; P = 0.044). The difference was greater in those with anxiety or depression at baseline. No differences were seen at 6 months. CONCLUSION: Screening for kidney cancer and other abdominal malignancies using abdominal CT alongside the thoracic CT within lung cancer screening is unlikely to cause significant lasting psychosocial or financial harm to participants with incidental findings.

End-of-life care and advance care planning for outpatients with inoperable aortic aneurysms.

OBJECTIVE: A significant proportion of patients with abdominal and thoracic aortic aneurysms (AA) do not proceed to intervention after reaching treatment threshold diameter due to a combination of poor cardiovascular reserve, frailty, and aortic morphology. This patient cohort has a high mortality; however, until this study, there exist no studies on the end-of-life care conservatively managed patients receive. METHODS: This is a retrospective multicenter cohort study of 220 conservatively managed patients with AA referred to Leeds Vascular Institute (UK) and Maastricht University Medical Centre (the Netherlands) for intervention between 2017 and 2021. Demographic details, mortality, cause of death, advance care planning and palliative care outcomes were analysed to examine predictors of palliative care referral and efficacy of palliative care consultation. RESULTS: A total of 1506 patients with AA were seen over this time period, giving a nonintervention rate of 15%. There was a 3-year mortality rate of 55%, a median survival of 364 days, and rupture was the reported cause of death in 18% of the decedents. Median follow-up was 34 months. Only 8% of all patients and 16% of decedents received a palliative care consultation, which took place a median of 3.5 days before death. Patients >81 years of age were more likely to have advance care planning. Only 5% and 23% of conservatively managed patients had documentation of preferred place of death and care priorities respectively. Patients with a palliative care consultation were more likely to have these services in place. CONCLUSIONS: Only a small proportion of conservatively treated patients had advance care planning and this was far below international guidelines on end-of-life care for adults, which recommends it for each of these patients. Pathways and guidance should be implemented to ensure patients not offered AA intervention receive end-of-life care and advance care planning.

Analyzing Sex Differences in Intensity of Cardiovascular Disease Prevention Medications in Patients With Abdominal Aortic Aneurysms-A Single-Center Cross-Sectional Study.

BACKGROUND: Patients with abdominal aortic aneurysm (AAA) are at a significant risk of cardiovascular events, similar to that of patients who have already experienced a major cardiac event. The European Society for Vascular Society AAA guidelines suggest that antiplatelet therapy and lipid-lowering therapy (LLT) should be considered in all patients with AAA. This study explores the overall prevalence and intensity of antithrombotic therapy and LLT, and lipid profile monitoring in a single center AAA surveillance cohort alongside any sex differences. METHODS: This was a retrospective, single center, cross-sectional study of 614 patients enrolled in the AAA surveillance program of a tertiary vascular surgery unit. All patients undergoing at least 1 surveillance scan from January 1, 2018, to December 31, 2020, were assessed. Electronic hospital records linked to real-time primary care records were interrogated for data on demographics, comorbidities, antiplatelet and LLT prescriptions, and serum cholesterol laboratory results. An analysis of covariance test was used to account for the effects of confounding comorbidities. RESULTS: Twenty-one percent of patients were not on antithrombotic therapy, and 20% of patients were not on LLT which reflects a group of patients receiving sub-optimal clinical care. In total, 47% of the cohort were on low/moderate intensity statin therapy which reflects a group of patients where care can be improved upon. Female sex was independently associated with a reduced likelihood of being prescribed LLT (P = 0.008, eta squared (ηp2) = 0.012, small effect size) but not antithrombotic therapy (P = 0.202). Fewer women underwent low-density lipoprotein cholesterol (LDL-C) monitoring (mean difference 9%, P = 0.040) and achieved the European Society of Cardiology-European Atherosclerosis Society- LDL-C target of <1.4 mmol/L (mean difference 9%, P = 0.040). CONCLUSIONS: Overall, there is room for improvement in these aspects of cardiovascular risk prevention for both sexes. Sex differences in the prescription of LLT, the prevalence of lipid profile monitoring, and likelihood of achieving LDL-C targets exist among patients with AAA, with a lower prevalence in women.

A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial).

OBJECTIVE: This RCT compares the clinical, technical and quality of life outcomes after EVLA and MOCA. SUMMARY OF BACKGROUND DATA: Thermal ablation is the current mainstay treatment for SVI. Newer nonthermal methods of treatment have been developed which do not require the use of tumescent anesthesia. The potential advantages of these newer methods should be tested in RCTs to ascertain their role in the future treatments of SVI. METHODS: This single-center RCT enrolled patients with symptomatic, unilateral, single-axis SVI. Eligible patients were equally randomized to either EVLA or MOCA, both with concomitant phlebectomy when necessary. The joint primary outcomes were intraprocedural axial ablation pain scores and anatomical occlusion at 1 year. Secondary outcomes included postprocedural pain, venous clinical severity score (VCSS), quality of life (Aberdeen varicose veins questionnaire and EuroQol 5-domain utility index), patient satisfaction and complication rates. RESULTS: One hundred fifty patients were randomized equally between the 2 interventions. Both groups reported low intraprocedural pain scores; on a 100 mm visual analog scale, pain during axial EVLA was 22 (9-44) compared to 15 (9-29) during MOCA; P = 0.210. At 1 year, duplex derived anatomical occlusion rates after EVLA were 63/69 (91%) compared to 53/69 (77%) in the MOCA group; P = 0.020. Both groups experienced significant improvement in VCSS and AVVQ after treatment, without a significant difference between groups. Median VCSS improved from 6 (5-8) to 0 (0-1) at one year; P < 0.001. Median AVVQ improved from 13.8 (10.0-17.7) to 2.0 (0.0-4.9); P < 0.001. One patient in the MOCA group experienced DVT. CONCLUSIONS: Both EVLA and MOCA were highly efficacious in treating SVI; patients improved significantly in terms of disease severity, symptoms, and QoL. Both resulted in low procedural pain with a short recovery time. Axial occlusion rates were higher after EVLA. Long term follow-up is warranted to assess the effect of recanalization on the rate of clinical recurrence.

The Content of Pre-habilitative Interventions for Patients Undergoing Repair of Abdominal Aortic Aneurysms and Their Effect on Post-Operative Outcomes: A Systematic Review.

OBJECTIVE: Patients requiring abdominal aortic aneurysm (AAA) repair are at risk of post-operative complications due to poor pre-operative state. Pre-habilitation describes the enhancement of functional capacity and tolerance to an upcoming physiological stressor, intended to reduce those complications. The ability to provide such an intervention (physical, pharmacological, nutritional, or psychosocial) between diagnosis and surgery is a growing interest, but its role in AAA repair is unclear. This paper aimed to systematically review existing literature to better describe the effect of pre-habilitative interventions on post-operative outcomes of patients undergoing AAA repair. DATA SOURCES: EMBASE and Medline were searched from inception to October 2020. Retrieved papers, systematic reviews, and trial registries were citation tracked. REVIEW METHODS: Randomised controlled trials (RCTs) comparing post-operative outcomes for adult patients undergoing a period of pre-habilitation prior to AAA repair (open or endovascular) were eligible for inclusion. Two authors screened titles for inclusion, assessed risk of bias, and extracted data. Primary outcomes were post-operative 30 day mortality, composite endpoint of 30 day post-operative complications, hospital length of stay (LOS), and health related quality of life (HRQL) outcomes. The content of interventions was extracted and a narrative analysis of results undertaken. RESULTS: Seven RCTs with 901 patients were included (three exercise based, two pharmacological based, and two nutritional based). Risk of bias was mostly unclear or high and the clinical heterogeneity between the trials precluded data pooling for meta-analyses. The quality of intervention descriptions was highly variable. One exercise based RCT reported significantly reduced hospital LOS and another improved HRQL outcomes. Neither pharmacological nor nutritional based RCTs reported significant differences in primary outcomes. CONCLUSION: There is limited evidence to draw clinically robust conclusions about the effect of pre-habilitation on post-operative outcomes following AAA repair. Well designed RCTs, adhering to reporting standards for intervention content and trial methods, are urgently needed to establish the clinical and cost effectiveness of pre-habilitation interventions.

Cardiovascular and musculoskeletal response to supervised exercise in patients with intermittent claudication.

OBJECTIVE: Intermittent claudication occurs in 20% of the population older than 70 years, and treatment includes a supervised exercise program (SEP). Whereas there is evidence demonstrating walking improvements after an SEP, there are conflicting data on the physiologic changes behind this. This study aimed to explore and to identify the potential cardiovascular and musculoskeletal changes with exercise. METHODS: This was a single-center study at a vascular unit in England. Following written informed consent, 109 patients were recruited for an SEP, three times per week for 12 weeks. Outcome measures included walking distances, quality of life, cardiorespiratory fitness, flow-mediated dilation, and muscle strength and endurance. For normal data, paired sample t-tests were performed to compare baseline data to all time points for significance. For nonparametric data, Wilcoxon signed rank tests were performed. Significance was set at P < .05. The association between functional improvement (ie, walking distance at 3 months after the SEP) and metabolic response and patients' characteristics was determined by multivariable regressions. RESULTS: Maximum walking distance significantly improved from baseline by 117% at 1 week, 143% at 4 weeks, and 143% at 12 weeks after exercise. Claudication distance also significantly improved from baseline by 222% at week 1, 393% at week 4, and 452% at week 12. Quality of life significantly improved at all time points in seven of nine domains of the 36-Item Short Form Health Survey and two of five domains of the Vascular Quality of Life questionnaire. Markers of cardiorespiratory fitness significantly improved at all time points. Flow-mediated dilation demonstrated a 50% improvement, but this was not statistically significant. Muscle strength and muscle endurance significantly improved at all time points. Multivariate regression demonstrated that the ventilatory anaerobic threshold and the physical component summary score for quality of life predicted improvements in 12-week walking distance. CONCLUSIONS: This study identified that the ventilatory anaerobic threshold and physical component summary scores from quality of life were the best predictors of improvement in an SEP. Future studies should prioritize these outcomes and assess whether different SEPs have similar effects. Cardiorespiratory fitness was also a predictor of outcome and should be prioritized in future studies alongside traditional measures.

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.

A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication.

BACKGROUND: Intermittent claudication is the most common symptom of peripheral arterial disease. Previous research has suggested that extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue. The objective of this feasibility pilot trial was to assess the safety, tolerability, and efficacy of ESWT as a novel treatment. METHODS: Patients with unilateral claudication were randomized to receive ESWT or sham treatment to the calf muscle three times per week for 3 weeks. Primary outcomes were pain-free walking distance (PFWD) and maximum walking distance (MWD). Secondary outcomes included safety and tolerability of ESWT treatment, ankle-brachial index before and after exercise, and quality of life assessed using generic (36-Item Short Form Health Survey, EuroQol-5 Dimension 3-Level) and disease-specific (Vascular Quality of Life) instruments. Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. RESULTS: Thirty patients were recruited in total. Statistically significant (P < .05) improvements at all time points were observed in the active treatment group for both MWD and PFWD compared with the sham treatment group. PFWD improved by 276% in the active group and MWD improved by 167% in the active group at 12 weeks after treatment. There were no immediate or delayed treatment safety concerns or documented adverse effects of treatment with ESWT in this trial. CONCLUSIONS: ESWT is safe and well tolerated when it is applied to the calf and demonstrated significant improvements in walking distances. Current conservative management of intermittent claudication includes supervised exercise. The early results with ESWT as an alternative, noninvasive treatment option show great potential. The mechanism of action, durability of the clinical effect, and cost-effectiveness of ESWT for claudication require further investigation.

A Randomised Clinical Trial of Buffered Tumescent Local Anaesthesia During Endothermal Ablation for Superficial Venous Incompetence.

OBJECTIVE/BACKGROUND: Endovenous thermal ablation (EVTA) is the recommended first line intervention for superficial venous incompetence (SVI). While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort. This randomised controlled trial investigates the potential to reduce peri-procedural pain and improve patient reported outcome measures (PROMs), including quality of life (QoL) using TLA buffered to physiological pH. METHODS: Patients undergoing great saphenous vein EVTA with concomitant phlebectomies were randomised to either standard (ST) or buffered (BT) TLA. Follow up assessments were performed at weeks 1, 6, and 12. The primary outcome was patient reported peri-procedural pain on a 100 mm visual analogue scale (VAS). Secondary outcomes were one week post-procedural pain VAS and analgesia use, QoL (disease specific: Aberdeen Varicose Vein Questionnaire [AVVQ]; generic: Short Form-36 [SF-36] and EuroQol 5 Dimensions Questionnaire [EQ-5D]), patient satisfaction VAS, technical success on duplex ultrasound (DUS) examination, and complications. RESULTS: Ninety-seven patients were randomised: 50 to ST and 47 to BT. The groups had comparable baseline demographics, Clinical Etiologic Anatomic Pathological, Venous Clinical Severity Score, QoL, and DUS parameters. Equally, intra-procedural parameters (volume of TLA, length of ablation, and linear energy delivered) were also comparable. Peri-procedural pain scores were significantly lower in the BT group with a mean ± SD score of 2.86 ± 3.57 versus 4.44 ± 2.94 (p = .001). Pain scores and analgesia use over the subsequent week were equivalent. SF-36 Bodily Pain domain scores were significantly better in the BT group at week 1 (77 vs. 62; p = .008). AVVQ, SF-36, and EQ-5D scores were otherwise similar between the groups throughout follow up, significantly improving over baseline. Technical success was high in both groups, with no major complications and few minor complications. CONCLUSION: Buffered TLA offers a significantly lower peri-procedural pain experience for patients undergoing EVTA and should replace current tumescent formulae.

Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial.

Objectives Peripheral arterial disease most commonly presents as intermittent claudication (IC). Early evidence has suggested that extracorporeal shockwave therapy is efficacious in the short term for the management of intermittent claudication. The objective of this pilot trial was to evaluate the medium-term efficacy of this treatment. Methods This double-blind randomised placebo-controlled pilot trial randomised patients with unilateral intermittent claudication in a 1:1 fashion to receive extracorporeal shockwave therapy or a sham treatment for three sessions per week over three weeks. Primary outcomes were maximum walking distance and intermittent claudication distance using a fixed-load treadmill test. Secondary outcomes included pre- and post-exertional ankle-brachial pressure indices, safety and quality of life assessed using generic (SF36, EQ-5D-3L) and disease-specific (vascular quality of life) measures. All outcome measures were assessed at 12 months post-treatment. Results Thirty participants were included in the study (extracorporeal shockwave therapy, n = 15; sham, n = 15), with 26 followed up and analysed at 12 months (extracorporeal shockwave therapy, n = 13; sham, n = 13). Intragroup analysis demonstrated significant improvements in maximum walking distance, intermittent claudication distance and post-exertional ankle-brachial pressure indices ( p < 0.05) in the active treatment group, with no improvements in pre-exertional ankle-brachial pressure indices. Significant improvements in quality of life were observed in 3 out of 19 domains assessed in the active group. A re-intervention rate of 26.7% was seen in both groups. Conclusions These findings suggest that extracorporeal shockwave therapy is effective in improving walking distances at 12 months. Although this study provides important pilot data, a larger study is needed to corroborate these findings and to investigate the actions of this treatment. ISRCTN: NCT02652078.

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.

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 randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins.

BACKGROUND: This randomized clinical trial compared endovenous laser ablation (EVLA) and surgical ligation with attempted stripping in the treatment of small saphenous vein (SSV) insufficiency. The early results demonstrated that EVLA was more likely to eradicate axial reflux and was also associated with a faster recovery, lower periprocedural pain, and fewer sensory complications. The aim of this 2-year follow-up was to establish whether these benefits remained stable over time and whether these improved technical outcomes were associated with less clinical recurrence. METHODS: Patients with primary saphenopopliteal junction and SSV reflux were randomized to EVLA or saphenopopliteal junction ligation and attempted stripping/excision. Outcomes assessed at 2 years included the presence of residual or recurrent reflux, clinical recurrence, sensory complications, the need for secondary intervention, and patient-reported quality of life on the Aberdeen Varicose Veins Questionnaire, SF-36, and EuroQol. RESULTS: Of 106 patients who were equally randomized and successfully treated according to the protocol, 88 (83%) were successfully assessed at 2 years. The groups were comparable at baseline. At 2 years, EVLA remained superior to surgery in eradicating axial reflux in 36 patients (81.2%) compared with 29 (65.9%) in the surgery group (P = .002). There was no significant difference in clinical recurrence (EVLA: seven of 44 [16%] vs surgery: 10 of 44 [23%]; P = .736), sensory disturbance (EVLA: one [2.4%] vs surgery vs three [6.8%]; P = 1.000) or any quality of life domain. CONCLUSIONS: The results of treatment of SSV insufficiency with EVLA appear durable up until 2 years. The study does not appear to suggest that the improved abolition of reflux after EVLA compared with surgery is associated with superior outcomes than those seen after surgery by this time point, because equal effect was shown in both groups. The sensory disturbance associated with surgery appears to settle over this time frame. EVLA is therefore superior in the short-term and not inferior by 2 years.

A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency.

OBJECTIVE: To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency (SVI) have greater benefits from treatment than those with only symptomatic varicose veins. BACKGROUND: A commonly held view is that SVI is only a minor ailment, yet randomized clinical trials (RCTs) show that treatment improves quality of life (QoL) and is cost-effective. In an effort to curb the treatment costs of this common disorder, rationing is applied in many health care systems, often limiting the reimbursement of treatment to those with soft tissue changes. METHODS: This cohort study draws its data from an interventional RCT. After informed consent, consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation. This analysis differentially studies the outcomes of patients with simple varicose veins (C2: n = 191) and soft tissue complications (C3-4: n = 76). Effectiveness outcomes measured up to 1 year included the following: Qol [short form 36 (SF36), EuroQol, and the Aberdeen Varicose Veins Questionnaire], clinical recurrence, and the need for secondary procedures. Multivariable regression analysis was used to control for potential confounding factors. RESULTS: Both groups saw significant improvements in QoL. All improvements were equal between groups apart from the SF36 domain of Bodily Pain, where C2 saw an improvement of 12.8 [95% confidence interval (CI): 4.8-20.8] points over C3-4 participants (P = 0.002), who also suffered more recurrence [odds ratio (OR) = 2.7, 95% CI: 1.2-6.1, P = 0.022] and required more secondary procedures (OR = 4.4, 95% CI: 1.2-16.3, P = 0.028). CONCLUSIONS: This study suggests that rationing by clinical severity contradicts the evidence. Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence. TRIAL REGISTRATION: NCT00759434 Clinicaltrials.gov.

Abdominal Noncontrast Computed Tomography Scanning to Screen for Kidney Cancer and Other Abdominal Pathology Within Community-based Computed Tomography Screening for Lung Cancer: Results of the Yorkshire Kidney Screening Trial.

BACKGROUND AND OBJECTIVE: The Yorkshire Kidney Screening Trial (YKST) assessed the feasibility of adding abdominal noncontrast computed tomography (NCCT) to lung cancer screening to screen for kidney cancer and other abdominal pathology. METHODS: A prospective diagnostic study offered abdominal NCCT to 55-80-yr-old ever-smokers attending a UK randomised lung cancer screening trial (May 2021 to October 2022). The exclusion criteria were dementia, frailty, previous kidney/lung cancer, and computed tomography (CT) of the abdomen and thorax within previous 6 and 12 mo, respectively. Six-month follow-up was undertaken. KEY FINDINGS AND LIMITATIONS: A total of 4438 people attended lung screening, of whom 4309 (97%) were eligible for and 4019 (93%) accepted abdominal NCCT. Only 3.9% respondents regretted participating. The additional time to conduct the YKST processes was 13.3 min. Of the participants, 2586 (64%) had a normal abdominal NCCT, whilst 787 (20%) required an abdominal NCCT imaging review but no further action and 611 (15%) required further evaluation (investigations and/or clinic). Of the participants, 211 (5.3%) had a new serious finding, including 25 (0.62%) with a renal mass/complex cyst, of whom ten (0.25%) had histologically proven kidney cancer; ten (0.25%) with other cancers; and 60 (1.5%) with abdominal aortic aneurysms (AAAs). Twenty-five (0.62%) participants had treatment with curative intent. Of the participants, 1017 (25%) had nonserious findings, most commonly benign renal cysts (727 [18%]), whereas only 259 (6.4%) had nonserious findings requiring further tests. The number needed to screen to detect one serious abdominal finding was 18; it was 93 to detect one suspicious renal lesion and 402 to detect one histologically confirmed renal cancer. Limitations of the cohort were fixed age range and being prior lung cancer screening attendees. CONCLUSIONS AND CLINICAL IMPLICATIONS: In this first prospective risk-stratified screening study of abdominal NCCT offered alongside CT thorax, uptake and participant satisfaction were high. The prevalence of serious findings, cancers, and AAAs, is in the range of established screening programmes such as bowel cancer. Longer-term outcomes and cost effectiveness should now be evaluated.

Acceptability of adding a non-contrast abdominal CT scan to screen for kidney cancer and other abdominal pathology within a community-based CT screening programme for lung cancer: A qualitative study.

OBJECTIVES: The Yorkshire Kidney Screening Trial (YKST) is a feasibility study of adding non-contrast abdominal CT scanning to screen for kidney cancer and other abdominal malignancies to community-based CT screening for lung cancer within the Yorkshire Lung Screening Trial (YLST). This study explored the acceptability of the combined screening approach to participants and healthcare professionals (HCPs) involved in the trial. METHODS: We conducted semi-structured interviews with eight HCPs and 25 participants returning for the second round of scanning within YLST, 20 who had taken up the offer of the additional abdominal CT scan and five who had declined. Transcripts were analysed using thematic analysis, guided by the Theoretical Framework of Acceptability. RESULTS: Overall, combining the offer of a non-contrast abdominal CT scan alongside the low-dose thoracic CT was considered acceptable to participants, including those who had declined the abdominal scan. The offer of the additional scan made sense and fitted well within the process, and participants could see benefits in terms of efficiency, cost and convenience both for themselves as individuals and also more widely for the NHS. Almost all participants made an instant decision at the point of initial invitation based more on trust and emotions than the information provided. Despite this, there was a clear desire for more time to decide whether to accept the scan or not. HCPs also raised concerns about the burden on the study team and wider healthcare system arising from additional workload both within the screening process and downstream following findings on the abdominal CT scan. CONCLUSIONS: Adding a non-contrast abdominal CT scan to community-based CT screening for lung cancer is acceptable to both participants and healthcare professionals. Giving potential participants prior notice and having clear pathways for downstream management of findings will be important if it is to be offered more widely.