Identifying the research priorities of healthcare professionals in UK vascular surgery: modified Delphi approach.

BACKGROUND: The Vascular Research Collaborative was established to develop a national research strategy for patients with vascular disease in the UK. This project aimed to establish national research priorities in this patient group. METHODS: A modified Delphi approach, an established method for reaching a consensus opinion among a group of experts in a particular field, was used to survey national multidisciplinary vascular clinical specialists. Two rounds of online surveys were conducted involving the membership of the Vascular Society, Society of Vascular Nurses, Society for Vascular Technology, and the Rouleaux Club (vascular surgical trainees). The first round invited any suggestions for vascular research topics. A steering group then collated and rationalized the suggestions, categorizing them by consensus into pathological topics and research categories, and amalgamating the various questions relating to the same fundamental issue into a single question. The second round involved recirculating these questions to the same participants for priority scoring. RESULTS: Round 1 resulted in 1231 suggested research questions from 481 respondents. Steering group collation and rationalization resulted in 83 questions for ranking in round 2. The second round resulted in a hierarchical list of vascular research priorities. The highest scoring priorities addressed topics related to critical lower-limb ischaemia, diabetic foot disease, amputation, wound healing, carotid plaque morphology, and service organization/delivery. CONCLUSION: It is anticipated that these results will drive the UK national vascular research agenda for the next 5-10 years. It will facilitate focused development and funding of new research projects in current clinical areas of unmet need where potential impact is greatest.

High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study.

INTRODUCTION: The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC. METHODS AND ANALYSIS: This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85%-90% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20%-25% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes. ETHICS AND DISSEMINATION: Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs. TRIAL REGISTRATION NUMBER: NCT04042311; Pre-results.

Patients with surgical wounds healing by secondary intention: A prospective, cohort study.

BACKGROUND: Surgical wounds healing by secondary intention can be difficult and costly to manage and are profoundly under researched. This prospective inception, cohort study aimed to derive a better understanding of surgical wounds healing by secondary intention and to facilitate the design of future research investigating effective treatments. OBJECTIVES: To investigate the clinical characteristics of patients with surgical wounds healing by secondary intention and the surgeries that preceded their wounds; to clearly delineate the clinical outcomes of these patients, specifically focusing on time to wound healing and its determinants; to explore the types of treatments for surgical wounds healing by secondary intention; and to assess the impact surgical wounds healing by secondary intention have on patients' quality of life. DESIGN: Prospective, inception cohort study. SETTING: Acute and community settings in eight sites across two large centres in the United Kingdom (Hull and Leeds, UK). METHODS: Patients with a surgical wounds healing by secondary intention (an open wound, <3 weeks' duration, resulting from surgery), were recruited and followed up for at least 12 months. Key outcome events included: time to healing; treatment type; infection; hospital re-admission and further procedures; health-related quality of life and pain. RESULTS: In total, 393 patients were recruited. Common co-morbidities were cardiovascular disease (38%), diabetes (26%) and peripheral vascular disease (14.5%). Baseline median SWHSI area was 6 cm2 (range 0.01-1200). Abdominal (n = 132), foot (n = 59), leg (n = 58) and peri-anal (n = 34) wounds were common. The majority of wounds (236, 60.1%) were intentionally left open following surgery; the remainder were mostly dehisced wounds. Healing was observed in 320 (81.4%) wounds with a median time to healing of 86 days (95% CI: 75-130). Factors associated with delayed healing included wound infection at any point and baseline wound area above the median. Health-related quality of life scores were low at baseline but improved with time and healing. CONCLUSIONS: This is the first inception cohort study in patients with surgical wounds healing by secondary intention. Patient characteristics have been clearly defined, with prolonged healing times and adverse events being common impacting on patient's health-related quality of life. Areas for, and factors crucial to the design of, future research have been identified.

Variable life adjusted display methodology for continuous performance monitoring of carotid endarterectomy.

Introduction The aim of this study was to use variable life-adjusted display (VLAD) methodology to monitor performance of six vascular surgeons undertaking carotid endarterectomy in a single institution. Materials and methods This was a prospective study with continuous analysis. A risk score model to predict 30-day stroke or death for individual patients was developed from data collected from 839 patients from 1992 to 1999. The model was used to monitor performance of six surgeons from 2000 to 2009. Individual risk factors and 30-day outcomes were analysed and VLAD plots were created for the whole unit and for each surgeon. Results Among the 941 carotid endarterectomies in the performance analysis, 28 adverse events were recorded, giving an overall stroke or death rate of 3.06%. The risk model predicted there would be 33 adverse events. There was no statistical difference between the predicted and the observed adverse events (P > 0.2, χ2 value 1.25, 4 degrees of freedom). The VLAD plot for the whole unit shows an overall net gain in operative performance, although this could have been chance variation. The individual VLAD plot showed that surgeons 1, 2, 3 and 6 to have an overall net gain in the number of successful operations. The changes observed between the surgeons was not significant (P > 0.05) suggesting chance variation only. Conclusions Performance of carotid endarterectomy can be continuously assessed using VLAD methodology for units and individual surgeons. Early identification and correction of performance variation could facilitate improved quality of care.

Quality of life in patients with intermittent claudication.

BACKGROUND: Intermittent claudication (IC) is a common condition that causes pain in the lower limbs when walking and has been shown to severely impact the quality of life (QoL) of patients. The QoL is therefore often regarded as an important measure in clinical trials investigating intermittent claudication. To date, no consensus exits on the type of life questionnaire to be used. This review aims to examine the QoL questionnaires used in trials investigating peripheral arterial disease (PAD). MATERIAL AND METHODS: A systematic review of randomised clinical trials including a primary analysis of QoL via questionnaire was performed. Trials involving patients with diagnosed PAD were included (either clinically or by questionnaire). Any trial which had QoL as the primary outcome data was included with no limit being placed on the type of questionnaire used. RESULTS: The search yielded a total of 1845 articles of which 31 were deemed appropriate for inclusion in the review. In total, 14 different QoL questionnaires were used across 31 studies. Of the questionnaires 24.06% were missing at least one domain when reported in the results of the study. Mean standard deviation varied widely based on the domain reported, particularly within the SF36. DISCUSSION: Despite previous recommendations for Europewide standardisation of quality of life assessment, to date no such tool exists. This review demonstrated that a number of different questionnaires remain in use, that their completion is often inadequate and that further evidence-based guidelines on QoL assessment are required to guide future research.

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.

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).

Compression regimes after endovenous ablation for superficial venous insufficiency--A survey of members of the Vascular Society of Great Britain and Ireland.

INTRODUCTION: The optimal compression regime following ultrasound guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) for varicose veins is not known. The aim of this study was to document current practice. METHODS: Postal questionnaire sent to 348 consultant members of the Vascular Society of Great Britain and Ireland. RESULTS: Valid replies were received from 41% (n = 141) surgeons representing at least 68 (61%) vascular units. UGFS was used by 74% surgeons, RFA by 70% and EVLA by 32%, but fewer patients received UGFS (median 30) annually, than endothermal treatment (median 50)--P = 0.019. All surgeons prescribed compression: following UGFS for median seven days (range two days to three months) and after endothermal ablation for 10 days (range two days to six weeks)--P = 0.298. Seven different combinations of bandages, pads and compression stockings were reported following UGFS and four after endothermal ablation. Some surgeons advised changing from bandages to stockings from five days (range 1­14) after UGFS. Following endothermal ablation, 71% used bandages only, followed by compression stockings after two days (range 1­14). The majority of surgeons (87%) also treated varicose tributaries: 65% used phlebectomy, the majority (65%) synchronously with endothermal ablation. Concordance of compression regimes between surgeons within vascular units was uncommon. Only seven units using UGFS and six units using endothermal ablation had consistent compression regimes. CONCLUSION: Compression regimes after treatments for varicose veins vary significantly: more evidence is needed to guide practice.

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.

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.

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).

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.

Endovenous laser ablation in the treatment of small saphenous varicose veins: does site of access influence early outcomes?

OBJECTIVE: The study was performed to evaluate the clinical and technical efficacy of endovenous laser ablation (EVLA) of small saphenous varicosities, particularly in relation to the site of endovenous access. METHODS: Totally 59 patients with unilateral saphenopopliteal junction incompetence and small saphenous vein reflux underwent EVLA (810 nm, 14 W diode laser) with ambulatory phlebectomies. Small saphenous vein access was gained at the lowest site of truncal reflux. Patients were divided into 2 groups: access gained above mid-calf (AMC, n = 33) and below mid-calf (BMC, n = 26) levels. Outcomes included Venous Clinical Severity Scores (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), patient satisfaction, complications, and recurrence rates. RESULTS: Both groups demonstrated significant improvement in VCSS, AVVQ, generic quality of life Short Form 36, and EuroQol scores (P < .05) up to 1 year. No differences were seen between AMC and BMC groups for complications (phlebitis: 2 [6%] and 1 [3.8%], P > .05; paresthesia: 2 [6%] and 5 [19%], P = .223) and recurrence (3 [9%] and 1 [3.8%], P = .623), respectively. CONCLUSIONS: The site of access in our study does not appear to influence complications specifically neural injury or recurrence rates.

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.