Factors associated with delays in revascularization in patients with chronic limb-threatening ischaemia: population-based cohort study.

BACKGROUND: Prompt revascularization in patients with chronic limb-threatening ischaemia (CLTI) is important, and recent guidance has suggested that patients should undergo revascularization within 5 days of an emergency admission to hospital. The aim of this cohort study was to identify factors associated with the ability of UK vascular services to meet this standard of care. METHODS: Data on all patients admitted non-electively with CLTI who underwent open or endovascular revascularization between 2016 and 2019 were extracted from the National Vascular Registry. The primary outcome was interval between admission and procedure, analysed as a binary variable (5 days or less, over 5 days). Multivariable Poisson regression was used to examine the relationship between time to revascularization and patient and admission characteristics. RESULTS: The study analysed information on 11 398 patients (5973 open, 5425 endovascular), 50.6 per of whom underwent revascularization within 5 days. The median interval between admission and intervention was 5 (i.q.r. 2-9) days. Patient factors associated with increased risk of delayed revascularization were older age, greater burden of co-morbidity, non-smoking status, presentation with infection and tissue loss, and a Fontaine score of IV. Patients admitted later in the week were less likely undergo revascularization within 5 days than those admitted on Sundays and Mondays (P < 0.001). Delays were slightly worse among patients having open compared with endovascular procedures (P = 0.005) and in hospitals with lower procedure volumes (P < 0.001). CONCLUSION: Several factors were associated with delays in time to revascularization for patients with CLTI in the UK, most notably the weekday of admission, which reflects how services are organized. The results support arguments for vascular units providing revascularization to have the resources for a 7-day service.

Chronic limb-threatening ischaemia (CLTI) is a severe form of peripheral artery disease that reduces blood flow to the legs and can lead to amputation. Between 2016 and 2019, only 50.6 per cent of patients admitted to UK vascular units urgently with CLTI underwent revascularization within 5 days from admission. Several factors were associated with delays in time to revascularization, most notably the weekday of admission, which reflects how services are organized. The results support arguments for vascular units providing revascularization to have resources for a 7-day service.

Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins.

BACKGROUND: Clinical guidelines recommend endovenous laser ablation (EVLA) over surgery based on short-term evidence, yet there are few studies reporting mid- to long-term outcomes. The aim of this study was to report the 5-year outcomes from an RCT of surgery versus EVLA for treatment of symptomatic great saphenous varicose veins. METHODS: Patients with symptomatic varicose veins due to great saphenous vein (GSV) incompetence were followed up 5 years after enrolment in a randomized trial of either surgery (saphenofemoral junction ligation, GSV strip to the knee and multiple avulsions of varicosities) or EVLA plus multiple avulsions. Outcomes included: clinical recurrence, defined as new varicose veins greater than 3 mm in diameter; Venous Clinical Severity Score (VCSS); quality of life measured by means of Short Form 36, EuroQol Five Dimensions (EQ-5D™) and Aberdeen Varicose Vein Questionnaire (AVVQ); patient satisfaction; and duplex ultrasound examination (DUS) findings. RESULTS: Some 218 of the 276 patients enrolled in the trial (79·0 per cent) were available for follow-up. Clinical recurrence was more frequent following surgery than EVLA at 5 years (34·3 versus 20·9 per cent; P = 0·010). Both groups demonstrated sustained significant improvements at 5 years over baseline in VCSS (surgery: median (i.q.r.) 1 (0-2) from 4 (3-5), P < 0·001; EVLA: 0 (0-1) from 4 (3-5), P < 0·001), AVVQ (surgery: 4·59 (0·56-9·78) from 13·69 (9·81-18·11), P < 0·001; EVLA: 3·35 (0·17 to 6·55) from 12·73 (9·41-17·32), P < 0·001) and EQ-5D™ (surgery: 1·000 (0·796-1·000) from 0·859 (0·796-1·000), P = 0·002; EVLA: 1·000 (0·796-1·000) from 0·808 (0·796-1·000), P = 0·002). VCSS was better for EVLA than surgery at 5 years (P = 0·031). Technical success assessed by DUS remained high at 5 years (85·4 per cent for surgery and 93·2 per cent for EVLA; P = 0·074). DUS-detected anatomical patterns of recurrence differed between the groups. CONCLUSION: EVLA was more effective than surgery in preventing clinical recurrence 5 years after treatment of great saphenous varicose veins. Patient-reported outcome measures were similar. Registration number: NCT00759434 (http://www.clinicaltrials.gov).

Long-term outcomes of a randomized clinical trial of supervised exercise, percutaneous transluminal angioplasty or combined treatment for patients with intermittent claudication due to femoropopliteal disease.

BACKGROUND: The aim was to compare the long-term outcomes of percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA + SEP) in patients with intermittent claudication owing to femoropopliteal disease. METHODS: Patients recruited to an RCT comparing these treatments were invited for long-term follow-up from 2010 to 2011. Indicators of limb ischaemia were recorded (ankle : brachial pressure index (ABPI) and treadmill walking distances). Duplex ultrasound imaging was also done. Patients completed Short Form 36 and VascuQol quality-of-life (QoL) questionnaires. RESULTS: Of 178 patients initially recruited to the trial, 139 were alive at the time of follow-up (PTA 46, SEP 47, PTA + SEP 46). Assessments were completed for 111 patients. Median time to follow-up was 5·2 (i.q.r. 3·8-7·4) years. Sixty-nine patients (62·2 per cent) were symptomatic; 18 (16·2 per cent) had experienced a major cardiovascular event since their last follow-up visit. Improvement was observed in ABPI in all groups. QoL outcomes were inconsistent across individual groups. PTA and PTA + SEP groups had a significantly higher ABPI than the SEP group. No significant difference was observed in treadmill walking distances, QoL outcomes, restenosis rates, and new ipsilateral and contralateral lesions on duplex imaging. Patients in all groups required reinterventions (PTA 14, SEP 10, PTA + SEP 6). The total number of reinterventions was higher after PTA (29) compared with SEP (17) and PTA + SEP (9), but failed to reach statistical significance. CONCLUSION: PTA, SEP and combined treatment were equally effective long-term treatment options for patients with claudication owing to femoropopliteal disease. The addition of a SEP to PTA can reduce the rate of symptomatic restenosis and reintervention. Registration number: NCT00798850 (http://www.clinicaltrials.gov).

Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review.

OBJECTIVE: Dialkylcarbomoyl chloride (DACC)-coated dressings (Leukomed Sorbact and Cutimed Sorbact) irreversibly bind bacteria at the wound surface that are then removed when the dressing is changed. They are a recent addition to the wound care professional's armamentarium and have been used in a variety of acute and chronic wounds. This systematic review aims to assess the evidence supporting the use of DACC-coated dressings in the clinical environment. METHOD: We included all reports of the clinical use of DACC-coated dressings in relation to wound infection. Medline, Embase, CENTRAL and CINAHL databases were searched to September 2016 for studies evaluating the role of DACC-coated dressings in preventing or managing wound infections. RESULTS: We identified 17 studies with a total of 3408 patients which were included in this review. The DACC-coating was suggested to reduce postoperative surgical site infection rates and result in chronic wounds that subjectively looked cleaner and had less bacterial load on microbiological assessments. CONCLUSION: Existing evidence for DACC-coated dressings in managing chronic wounds or as a surgical site infection (SSI) prophylaxis is limited but encouraging with evidence in support of DACC-coated dressings preventing and treating infection without adverse effects.

A survey of patients with surgical wounds healing by secondary intention; an assessment of prevalence, aetiology, duration and management.

BACKGROUND: Surgical wounds healing by secondary intention (SWHSI) are often difficult and costly to treat. There is a dearth of clinical and research information regarding SWHSI. The aim of this survey was to estimate the prevalence of SWHSI and to characterise the aetiology, duration and management of these wounds. METHODS: Anonymised data were collected from patients with SWHSI receiving treatment in primary, secondary and community settings. Over a two weeks period, data were collected on the patients, their SWHSI, clinical and treatment details. RESULTS: Data were collected from 187 patients with a median age of 58.0 (95% CI = 55 to 61) years. The prevalence of SWHSI was 0.41 (95% CI = 0.35 to 0.47) per 1000 population. More patients with SWHSI were being treated in community (109/187, 58.3%) than in secondary (56/187, 29.9%) care settings. Most patients (164/187, 87.7%) had one SWHSI and the median duration of wounds was 28.0 (95% CI = 21 to 35) days. The most common surgical specialities associated with SWHSI were colorectal (80/187, 42.8%), plastics (24/187, 12.8%) and vascular (22/187, 11.8%) surgery. Nearly half of SWHSI were planned to heal by secondary intention (90/187, 48.1%) and 77/187 (41.2%) were wounds that had dehisced. Dressings were the most common single treatment for SWHSI, received by 169/181 (93.4%) patients. Eleven (6.1%) patients were receiving negative pressure wound therapy. CONCLUSIONS: This survey provides a previously unknown insight into the occurrence, duration, treatment and types of surgery that lead to SWHSI. This information will be of value to patients, health care providers and researchers.

Systematic review of compression following treatment for varicose veins.

BACKGROUND: Consensus regarding compression following treatment of varicose veins has yet to be reached. This systematic review aims to establish the optimal compression regimen after venous treatment. METHODS: A systematic review of MEDLINE, Embase and CENTRAL was performed to identify randomized clinical trials (RCTs) investigating different compression strategies following treatment for superficial venous insufficiency. RESULTS: Seven RCTs comparing different durations and methods of compression fulfilled the inclusion criteria. The treatment modality was open surgery in three trials, foam sclerotherapy in two and endovenous laser ablation (EVLA) in two trials. The quality of the studies was variable, and significant sources of potential bias were present. Both the studies and compression regimens used were heterogeneous. Ten products were used in six general regimens for a duration of 0-42 days. One study suggested that 7 days rather than 2 days of stockings following EVLA was associated with superior quality of life and less pain at 1 week. Another study reported that, following surgery, application of a compression stocking after 3 days of bandaging was associated with a slightly longer recovery than no compression after 3 days. One study recorded compliance clearly, finding it to be only 40 per cent. The quality and heterogeneity of the studies precluded meta-analysis. CONCLUSION: There is currently little quality evidence upon which to base any recommendations concerning compression following treatment for varicose veins.

Prediction of organ-specific complications following abdominal aortic aneurysm repair using cardiopulmonary exercise testing.

This study aimed at assessing whether measures of aerobic fitness can predict postoperative cardiac and pulmonary complications, 30-day mortality and length of hospital stay following elective abdominal aortic aneurysm repair. We prospectively collected cardiopulmonary exercise testing data over two years for 130 patients. Upon multivariate analysis, a decreased anaerobic threshold (OR (95% CI) 0.55 (0.37-0.84); p = 0.005) and open repair (OR (95% CI) 6.99 (1.56-31.48); p = 0.011) were associated with cardiac complications. Similarly, an increased ventilatory equivalent for carbon dioxide (OR (95% CI) 1.18 (1.05-1.33); p = 0.005) and open repair (OR (95% CI) 14.29 (3.24-62.90); p < 0.001) were associated with pulmonary complications. Patients who had an endovascular repair had shorter hospital and critical care lengths of stay (p < 0.001). Measures of fitness were not associated with 30-day mortality or length of hospital stay. Cardiopulmonary exercise testing variables, therefore, seem to predict different postoperative complications following abdominal aortic aneurysm repair, which adds value to their routine use in risk stratification and optimisation of peri-operative care.

Randomized clinical trial of selective versus routine preoperative duplex ultrasound imaging before arteriovenous fistula surgery.

BACKGROUND: Anatomical suitability for arteriovenous fistula (AVF) formation was formerly determined by clinical examination alone. There are potential benefits from imaging to assess anatomical suitability. Existing studies examined the role of routine preoperative ultrasonography versus clinical examination alone. The role of a selective duplex ultrasound imaging policy is unknown. This study aimed to compare a policy of selective versus routine ultrasound assessment before AVF formation. METHODS: All patients referred for fistula formation were assessed for inclusion. Suitable patients were randomized to either routine or selective preoperative ultrasound imaging; selective imaging was performed only when clinical criteria were not met. The primary outcome measures were site of AVF formation and 30-day primary failure rate, and secondary outcome measures included the rate of complications. RESULTS: A total of 106 patients were assessed, and 94 were randomized: 47 to selective and 47 to routine duplex ultrasonography. The groups were well matched for age, co-morbidities and medications. The primary failure rate (29 per cent overall) was not significantly different between the selective and routine imaging groups: 36 per cent (14 of 39) and 21 per cent (8 of 38) respectively (P = 0·144). There were no significant differences in the sites of AVF formation or complication rates. CONCLUSION: Routine preoperative ultrasound vessel imaging did not significantly reduce early failure rates, influence the site of AVF formation or reduce complications. If clinical evaluation detects anatomy suitable for AVF formation, duplex imaging may not be needed. REGISTRATION NUMBER: NCT01004627 (http://www.clinicaltrials.gov).

Clinical outcomes and quality of life 5 years after a randomized trial of concomitant or sequential phlebectomy following endovenous laser ablation for varicose veins.

BACKGROUND: Endovenous laser ablation (EVLA) is a popular treatment for superficial venous insufficiency. Debate continues regarding the optimal management of symptomatic varicose tributaries following ablation of the main saphenous trunk. This randomized trial compared the 5-year outcomes of endovenous laser therapy with ambulatory phlebectomy (EVLTAP) with concomitant ambulatory phlebectomy, and EVLA alone with sequential treatment if required following a delay of at least 6 weeks. METHODS: Patients undergoing EVLA for great saphenous vein insufficiency were randomized to receive EVLTAP or EVLA alone with sequential phlebectomy, if required. Outcomes included disease-specific quality of life (QoL) (Aberdeen Varicose Vein Questionnaire; AVVQ), requirement for secondary procedures, clinical severity (Venous Clinical Severity Score; VCSS), residual and recurrent varicose tributaries, and generic QoL. Patients were followed up for 5 years. RESULTS: Fifty patients were randomized equally into two parallel groups. The EVLTAP group had lower VCSS scores at 12 weeks (median 0 (i.q.r. 0-1) versus 2 (0-2); P <0·001), and lower AVVQ scores at 6 weeks (median 7·9 (i.q.r. 4·1-10·7) versus 13·5 (10·9-18·1); P < 0·001) and 12 weeks (2·0 (0·4-7·7) versus 9·6 (2·2-13·8); P = 0·015). VCSS and AVVQ scores were equivalent by 1 year, but only after 16 of 24 patients in the EVLA group, compared with one of 25 in the EVLTAP group (P < 0·001), had received a secondary intervention. From 1 to 5 years both groups had equivalent outcomes. CONCLUSION: EVLA with either concomitant or sequential management of tributaries is acceptable treatment for symptomatic varicose veins, with both treatments achieving excellent results at 5 years. Concomitant treatment of varicosities is associated with optimal improvement in both clinical disease severity and QoL.

Effect of supervised exercise on physical function and balance in patients with intermittent claudication.

BACKGROUND: The aim of the study was to identify whether a standard supervised exercise programme (SEP) for patients with intermittent claudication improved specific measures of functional performance including balance. METHODS: A prospective observational study was performed at a single tertiary vascular centre. Patients with symptomatic intermittent claudication (Rutherford grades 1-3) were recruited to the study. Participants were assessed at baseline (before SEP) and 3, 6 and 12 months afterwards for markers of lower-limb ischaemia (treadmill walking distance and ankle : brachial pressure index), physical function (6-min walk, Timed Up and Go test, and Short Physical Performance Battery (SPPB) score), balance impairment using computerized dynamic posturography with the Sensory Organization Test (SOT), and quality of life (VascuQoL and Short Form 36). RESULTS: Fifty-one participants underwent SEP, which significantly improved initial treadmill walking distance (P = 0·001). Enrolment in a SEP also resulted in improvements in physical function as determined by 6-min maximum walking distance (P = 0·006), SPPB score (P < 0·001), and some domains of both generic (bodily pain, P = 0·025) and disease-specific (social domain, P = 0·039) quality of life. Significant improvements were also noted in balance, as determined by the SOT (P < 0·001). CONCLUSION: Supervised exercise improves both physical function and balance impairment.

Ruptured AAA: suitability for endovascular repair is associated with lower mortality following open repair.

OBJECTIVES: Perioperative mortality of open repair of ruptured abdominal aortic aneurysms (rAAA) remains unacceptably high: 30-day mortality ≈ 40 %. This study aimed to assess, quantify, and determine the consequences of anatomic suitability for endovascular repair of rAAA. DESIGN: A retrospective analysis of the prospectively maintained database identified patients with rAAA. METHODS: Preoperative CT scans were assessed for anatomic suitability for emergency EVAR and precluding factors recorded. Demographic information was collected and analysed for all patients. RESULTS: A total of 141 patients underwent open surgical repair of rAAA. Forty-six patients had preoperative CT scans suitable for reconstruction. Morphological measurements indicated that 41 % would have been anatomically suitable for EVAR. Suitability was associated with lower mortality rates than unsuitability: 0, 11, and 20 % (24 h, 30 days, and 1 year respectively) versus 11, 33, and 59 % (statistically significant at 1 year; p = 0.02). The groups were comparable excepting diabetes incidence, which was higher in those suitable for EVAR (p = 0.003). CONCLUSIONS: A minority of patients with ruptured AAA are anatomically suitable for EVAR. Anatomical suitability appears to identify patients at low risk from open surgery. Whether this is due to technically less demanding open surgery is unknown. This may be resolved by the IMPROVE trial results, which are eagerly awaited.

Randomized clinical trial of angiotensin-converting enzyme inhibitor, ramipril, in patients with intermittent claudication.

BACKGROUND: The aim was to investigate the effect of ramipril on clinical parameters in patients with peripheral arterial disease. METHODS: Patients with intermittent claudication were randomized to receive ramipril or placebo for 24 weeks in a double-blind study. Outcome measures were walking distance, arterial stiffness measurement and quality of life (QoL). RESULTS: A total of 33 patients were included (25 men; mean(s.d.) age 64.6(7.8) years); 14 received ramipril and 19 placebo. After 24 weeks, ramipril improved maximum treadmill walking distance by an adjusted mean (95 per cent confidence interval, c.i.) of 131 (62 to 199) m (P = 0·001), improved treadmill intermittent claudication distance by 122 (56 to 188) m (P = 0.001) and improved patient-reported walking distance by 159 (66 to 313) m (P = 0.043) compared with placebo. Ramipril reduced carotid femoral pulse wave velocity by -1.47 (95 per cent c.i. -2.40 to -0.57) m/s compared with placebo (P = 0.002). Resting ankle : brachial pressure index (ABPI) improved slightly in both ramipril and placebo groups (0.02 (95 per cent c.i. -0.08 to 0.11) versus 0.03 (-0.05 to 0.10); P = 0.830). Ramipril had a slight, non-significant effect on QoL physical domains compared with placebo. CONCLUSION: Ramipril improved walking distance in patients with claudication; however, this improvement was not related to improved ABPI but might have been due to ramipril reducing arterial stiffness. REGISTRATION NUMBER: NCT01037530 (http://www.clinicaltrials.gov).

Economic analysis of a randomized trial of percutaneous angioplasty, supervised exercise or combined treatment for intermittent claudication due to femoropopliteal arterial disease.

BACKGROUND: The aim was to compare costs and utilities of percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA + SEP) in patients with intermittent claudication (IC) to establish the most cost-effective treatment. METHODS: Patients with IC due to femoropopliteal disease were randomized to receive PTA, SEP or PTA + SEP. Assessments were performed before, and at 1, 3, 6 and 12 months postintervention. Clinical and quality-of-life indicators were recorded. The SF-6D Health Utilities index was calculated from the Short Form 36, plotted, and quality-adjusted life-years (QALYs) were generated by calculating the area under the curve. Costs were calculated using National Health Service 2009-2010 payment-by-results tariffs and the National Institute for Health Research Clinical Research Network Investigation pricing index, and adjusted for reinterventions. Cost per QALY and incremental costs were calculated, and sensitivity analyses performed. RESULTS: A total of 178 patients (PTA, 60; SEP, 60; PTA + SEP, 58) were randomized. All treatments resulted in significant improvement in the SF-6D index (P < 0.001). There was no significant difference between treatments in mean QALYs gained (PTA: 0.620, 95 per cent confidence interval 0.588 to 0.652; SEP: 0.629, 0.597 to 0.660; PTA + SEP: 0.649, 0.622 to 0.675). The adjusted mean cost per procedure was significantly higher for PTA (€7301.74) compared with SEP (€3866.49) and PTA + SEP (€6911.68) (P < 0.001). The cost per QALY was significantly higher for PTA (€11,777.00) compared with SEP (€6147.04) and PTA + SEP (€10,649.74). QALYs were lost when PTA alone was used as first-line treatment in comparison with SEP or PTA + SEP. These results were robust and valid in sensitivity analyses. CONCLUSION: Supervised exercise is the most cost-effective first-line treatment for IC, and when combined with PTA is more cost-effective than PTA alone.

PRESS survey: PREvention of surgical site infection-a global pan-specialty survey of practice protocol.

Background: Surgical site infections (SSI) complicate up to 40% of surgical procedures, leading to increased patient morbidity and mortality. Previous research identified disparities in SSI prevention guidelines and clinical practices across different institutions. The study aims to identify variations in SSI prevention practices within and between specialties and financial systems and provide a representation of existing SSI preventative measures to help improve the standardization of SSI prevention practices. Methods: This collaborative cross-sectional survey will be aimed at pan-surgical specialties internationally. The study has been designed and will be reported in line with the CROSS and CHERRIES standards. An international study steering committee will design and internally validate the survey in multiple consensus-based rounds. This will be based on SSI prevention measures outlined in the CDC (2017), WHO (2018), NICE (2019), Wounds UK (2020) and the International Surgical Wound Complications Advisory Panel (ISWCAP) guidelines. The questionnaire will include demographics, SSI surveillance, preoperative, peri-operative and postoperative SSI prevention. Data will be collected on participants' surgical specialty, operative grade, of practice and financial healthcare system of practice. The online survey will be designed and disseminated using QualtricsXM Platform™ through national and international surgical colleges and societies, in addition to social media and snowballing. Data collection will be open for 3 months with reminders, and raking will be used to ascertain the sample. Responses will be analyzed, and the chi-square test used to evaluate the impact of SSI prevention variables on responses. Discussion: Current SSI prevention practice in UK Vascular surgery varies considerably, with little consensus on many measures. Given the inconsistency in guidelines on how to prevent SSIs, there is a need for standardization. This survey will investigate the disparity in SSI preventative measures between different surgical fields and countries.

A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6): study protocol for a pragmatic, multicentre, parallel-group, three-arm randomised controlled trial.

BACKGROUND: Venous leg ulcer(s) are common, recurring, open wounds on the lower leg, resulting from diseased or damaged leg veins impairing blood flow. Wound healing is the primary treatment aim for venous leg ulceration, alongside the management of pain, wound exudate and infection. Full (high) compression therapy delivering 40 mmHg of pressure at the ankle is the recommended first-line treatment for venous leg ulcers. There are several different forms of compression therapy available including wraps, two-layer hosiery, and two-layer or four-layer bandages. There is good evidence for the clinical and cost-effectiveness of four-layer bandage and two-layer hosiery but more limited evidence for other treatments (two-layer bandage and compression wraps). Robust evidence is required to compare clinical and cost-effectiveness of these and to investigate which is the best compression treatment for reducing time to healing of venous leg ulcers whilst offering value for money. VenUS 6 will therefore investigate the clinical and cost-effectiveness of evidence-based compression, two-layer bandage and compression wraps for time to healing of venous leg ulcers. METHODS: VenUS 6 is a pragmatic, multi-centre, three-arm, parallel-group, randomised controlled trial. Adult patients with a venous leg ulcer will be randomised to receive (1) compression wraps, (2) two-layer bandage or (3) evidence-based compression (two-layer hosiery or four-layer bandage). Participants will be followed up for between 4 and 12 months. The primary outcome will be time to healing (full epithelial cover in the absence of a scab) in days since randomisation. Secondary outcomes will include key clinical events (e.g. healing of the reference leg, ulcer recurrence, ulcer/skin deterioration, amputation, admission/discharge, surgery to close/remove incompetent superficial veins, infection or death), treatment changes, adherence and ease of use, ulcer related pain, health-related quality of life and resource use. DISCUSSION: VenUS 6 will provide robust evidence on the clinical and cost-effectiveness of the different forms of compression therapies for venous leg ulceration. VenUS 6 opened to recruitment in January 2021 and is currently recruiting across 30 participating centres. TRIAL REGISTRATION: ISRCTN67321719 . Prospectively registered on 14 September 2020.

Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease.

BACKGROUND: The aim was to compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA plus SEP) for intermittent claudication due to femoropopliteal arterial disease. METHODS: Consenting patients with femoropopliteal arterial lesions were randomized to one of three treatment arms: PTA, SEP, or PTA plus SEP. All patients received optimal medical treatment. Patients were assessed at baseline and 1, 3, 6 and 12 months after intervention. Clinical (ankle pressures, walking distances, symptoms) and quality-of-life (QoL) outcomes (Short Form 36, VascuQol) were analysed. RESULTS: A total of 178 patients (108 men, median age 70 years) were included. All three treatment groups demonstrated significant clinical and QoL improvements. One year after PTA (60 patients, 8 withdrew), 37 patients (71 per cent) had improved (16 mild, 16 moderate, 5 marked), nine (17 per cent) showed no improvement and six (12 per cent) had deteriorated. After SEP (60 patients, 14 withdrew), 32 patients (70 per cent) had improved (19 mild, 10 moderate, 3 marked), six (13 per cent) showed no improvement and eight (17 per cent) had deteriorated. After PTA plus SEP (58 patients, 11 withdrew), 40 patients (85 per cent) had improved (18 mild, 20 moderate, 2 marked), seven (15 per cent) showed no improvement and none had deteriorated. On intergroup analysis, PTA and SEP alone were equally effective in improving clinical outcomes, although the effect was short-lived. PTA plus SEP produced a more sustained clinical improvement, but there was no significant QoL advantage. CONCLUSION: For patients with intermittent claudication due to femoropopliteal disease, PTA, SEP, and PTA plus SEP were all equally effective in improving walking distance and QoL after 12 months. REGISTRATION NUMBER: NCT00798850 (http://www.clinicaltrials.gov).

Intraluminal thrombus has a selective influence on matrix metalloproteinases and their inhibitors (tissue inhibitors of matrix metalloproteinases) in the wall of abdominal aortic aneurysms.

BACKGROUND: The influence of intraluminal thrombus (ILT) on the proteolytic environment within the wall of an abdominal aortic aneurysm (AAA) is unknown. This is the first study to examine the correlation between ILT thickness and the levels of matrix metalloproteinases (MMPs) and their natural inhibitors (tissue inhibitors of matrix metalloproteinases [TIMPs]) within the adjacent AAA wall. METHODS: Thirty-five patients undergoing elective repair of AAAs were studied. A single full-thickness infrarenal aortic sample was obtained uniformly from the arteriotomy site from each patient. All samples were snap frozen and analyzed for total and active MMP 2, 8, and 9 and TIMP 1 and 2. Thrombus thickness at the specimen site was measured on the preoperative contrast computed tomographic angiograms. RESULTS: There was a statistically significant correlation between ILT thickness, concentration of TIMP 1, and active concentration of MMP 9. MMP 2 (active and total) and TIMP 2 demonstrated a positive correlation with ILT thickness, although not statistically significant. CONCLUSION: In this novel study, we found a significant positive correlation of ILT thickness with active MMP 9 and TIMP 1 concentration in the adjacent AAA wall, and this may have implications for AAA expansion and eventual rupture.

Modelling the effect of venous disease on quality of life.

BACKGROUND: A clear understanding of the relationship between venous reflux, clinical venous disease and the effects on quality of life (QoL) remains elusive. This study aimed to explore the impact of venous disease, and assess any incremental direct effect of progressive disease on health-related QoL, with the ultimate aim to model venous morbidity. METHODS: Consecutive patients with venous disease were assessed for inclusion in the study. Patients with isolated, unilateral, single superficial axial incompetence diagnosed on duplex imaging were included. Clinical grading was performed with the Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification and Venous Clinical Severity Score (VCSS). Patients completed generic (Short Form 36, SF-36(®); EuroQol 5D, EQ-5D(™)) and disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ) QoL instruments. Multivariable regression modelling was performed, taking account of demographic and anatomical factors, to explore the effect of clinical severity on QoL impairment. RESULTS: Some 456 patients with C2-6 venous disease were included, along with control data for 105 people with C0-1 disease. Increasing clinical grade corresponded strongly with deterioration in disease-specific QoL (P < 0.001). This could be stratified into three distinguishable groups: C0-1, C2-4 and C5-6 (P < 0.001 to P = 0.006). Increasing clinical grade also corresponded with deterioration in the physical domains of SF-36(®) (P < 0.001 to P = 0.016), along with EQ-5D(™) index utility (quality-adjusted life year) scores (P < 0.001). CONCLUSION: Demonstrable morbidity was seen, even with uncomplicated venous disease. The physical impairment seen with venous ulceration was comparable with that seen in congestive cardiac failure and chronic lung disease.

Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.

BACKGROUND: This report describes the clinical effectiveness and recurrence rates from a randomized trial of endovenous laser ablation (EVLA) and surgery for varicose veins. METHODS: Some 280 patients were randomized equally using sealed opaque envelopes to two parallel groups: surgery and EVLA. Inclusion criteria included symptomatic disease secondary to primary, unilateral, isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein (GSV). Outcomes were: technical success, recurrent varicose veins on clinical examination, patterns of reflux on duplex ultrasound examination, and the effect of recurrence on quality of life, assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). Assessments were at 1, 6, 12 and 52 weeks after the procedure. RESULTS: Initial technical success was greater following EVLA: 99.3 versus 92.4 per cent (P = 0.005). Surgical failures related mainly to an inability to strip the above-knee GSV. The clinical recurrence rate at 1 year was lower after EVLA: 4.0 versus 20.4 per cent (P < 0.001). The number of patients needed to treat with EVLA rather than surgery to avoid one recurrence at 1 year was 6.3 (95 per cent confidence interval 4.0 to 12.5). Twelve of 23 surgical recurrences were related to an incompetent below-knee GSV and ten to neovascularization. Of five recurrences after EVLA, two were related to neoreflux in the groin tributaries and one to recanalization. Clinical recurrence was associated with worse AVVQ scores (P < 0.001). CONCLUSION: EVLA treatment had lower rates of clinical recurrence than conventional surgery in the short term.