The need for triple assessment and predictors for diagnosis of breast cancer in patients <40 years of age.

AIM: To assess the safety of selective use of triple assessment with omission of radiological assessment proposed in patients <40-years old. MATERIALS AND METHODS: Data were collected retrospectively for all patients seen in the one-stop breast clinic between January 2014 and August 2015. Demographics, symptoms, diagnostics, and treatment details were recorded. Subgroup and logistic regression analysis was performed to identify predictors for breast cancer. RESULTS: Of the 3,305 patients included, 95.6% (n=3,161) were first-time referrals. 57.6% (n=1,903) had a breast lump, and 4% (n=133) had a high-risk family history; 75.6% (n=2,499) underwent imaging and 16.7% (n=552) underwent a biopsy. The median age was 29 years (interquartile range [IQR]=25-34). Breast cancer was diagnosed in 29 cases (0.88%) and 3.2% (n=105) had surgery. Median referral-to-diagnosis time was 13 days (IQR=9-14) and referral-to-surgery time was 44 days (IQR=34-95). Patients with breast cancer were significantly older (33 versus 28 years, p=0.016). All patients were first-time referrals. Most patients had a breast lump with low suspicion on clinical examination and breast cancer identified on imaging. Time-to-diagnosis (12 versus 14 days, p=0.017) and time-to-surgery (37 versus 67 days, p=0.012) was significantly shorter in the breast cancer group. Comparative older age (odds ratio [OR]=1.08, 95% confidence interval [CI]: 1.01-1.15) and breast lump (OR=11.43,95% CI: 2.72-48.07) were the only significant predictors of cancer on uni/multivariate regression. CONCLUSIONS: Triple assessment is also the best practice for all patients in the younger age group. This cohort should not be treated any differently regarding one-stop clinic infrastructure as the cancers detected were not clinically malignant. Missed cancers in this age group would have significant personal, clinical, and legal consequences.

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).

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.

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.

Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.

BACKGROUND: Endovenous laser ablation (EVLA) is a popular minimally invasive treatment for varicose veins. Surgical treatment, featuring junctional ligation and inversion stripping, has shown excellent clinical and cost effectiveness. The clinical effectiveness of both treatments was compared within a randomized trial. METHODS: Some 280 patients were randomized equally into groups receiving either surgery or EVLA. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein. Outcomes included: quality of life (QoL), Venous Clinical Severity Score (VCSS), pain scores and time taken to return to normal function. Owing to the nature of the procedures, blinding was not possible. RESULTS: Both groups had significant improvements in VCSS after treatment (P < 0.001), which resulted in improved disease-specific QoL (Aberdeen Varicose Vein Questionnaire, P < 0.001) and quality-adjusted life year (QALY) gain (P < 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight Short Form 36 (SF-36(®)) domains (P < 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P < 0.001), six of eight SF-36(®) domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 4 days; P < 0.001). Complications were rare. CONCLUSION: EVLA was as effective as surgery for varicose veins, but had a less negative impact on early postintervention QoL. REGISTRATION NUMBER: NCT00759434 (http://www.clinicaltrials.gov).

Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity.

AIM: The durability of occlusion post endovenous laser therapy (EVLT) for varicose veins is linked to the magnitude of energy delivered to the vein and consequently increasing amounts of energy are employed. The aim of this study is to establish whether increasing the energy results in greater periprocedural morbidity or complications. METHODS: Linear and logistic regression models were built to study the effect of energy delivery on outcome. The models controlled for age, gender, BMI, pre-operative quality of life and vein dimension. The outcomes were pain and analgesia requirement in week 1, change in disease specific quality of life (Aberdeen varicose vein questionnaire (AVVQ), change in generic quality of life (Short Form-36 (SF-36) and Euroqol (EQ5D)at week 1 and 6 and complication rates. The sample size calculation established that 115 patients would be required to detect any significant relationship. RESULTS: 232 patients were included. The mean (range) age was 50 (18-83) years. 63% were women. The mean (range) energy delivery was 89.8 (44.5-158.4) J/cm. There was no significant effect on any outcome related to increasing energy delivery. CONCLUSION: Up to 160 J/cm, increasing energy delivery has no significant effect upon the morbidity or complications of EVLT for superficial venous insufficiency.

Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication.

BACKGROUND: To compare angioplasty (PTA), supervised exercise (SEP) and PTA + SEP in the treatment of intermittent claudication (IC) due to femoropopliteal disease. METHODS: Over a 6-year period, 178 patients (108 men; median age, 70 years) with femoropopliteal lesions suitable for angioplasty were randomized to PTA, SEP, or PTA + SEP. Patients were assessed prior to and at 1 and 3 months post treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and quality of life (QoL) questionnaires (SF-36 and VascuQoL) were analyzed. RESULTS: All groups were well matched at baseline. Twenty-one patients withdrew. Results are as follows: Intragroup analysis: All groups demonstrated significant clinical and QoL improvements (Friedman test, p < 0.05). SEP (60 patients, 8 withdrew)-62.7% of patients (n = 32) improved following treatment [20 mild, 9 moderate, 3 marked], 27.4% (n = 14) demonstrated no improvement, and 9.8% (n = 5) deteriorated. PTA (60 patients, 3 withdrew)-66.6% patients (n = 38) improved following treatment [19 mild, 10 moderate, 9 marked], 22.8% (n = 13) demonstrated no improvement, and 10.5% (n = 6) deteriorated. PTA + SEP (58 patients, 10 withdrew)-81.6% of patients (n = 40) improved following treatment [10 mild, 17 moderate, 3 marked], 14.2% (n = 7) demonstrated no improvement, and 4.0% (n = 2) deteriorated. Intergroup analysis: PTA + SEP produce a much greater improvement in clinical outcome measures than PTA or SEP alone, but there was no significant QoL advantage (Kruskal-Wallis test, p > 0.05). CONCLUSION: SEP should be the primary treatment for the patients with claudication and PTA should be supplemented by an SEP.

Comparing the treatment response of great saphenous and small saphenous vein incompetence following surgery and endovenous laser ablation: a retrospective cohort study.

OBJECTIVE: Many venous trials mix patients with great saphenous vein (GSV) and small saphenous vein (SSV) diseases. There is no evidence that both respond similarly to treatment and our aim was to test this assumption. METHOD: This cohort study compares patients with isolated GSV and SSV incompetence following treatment with open surgical ligation or endovenous laser ablation (EVLA). Outcomes included: quality of life (QoL; Aberdeen Varicose Vein Questionnaire [AVVQ]; Short Form 36 [SF36]; Euroqol [EQ5D]; and Venous Clinical Severity Score [VCSS]). RESULTS: A total of 370 patients with no differences in baseline QoL, underwent treatment. Despite equivalent morbidity, SSV sufferers had a lower VCSS (P < 0.001). Following surgery, SSV patients scored higher (worse) on AVVQ (P = 0.045) than GSV sufferers, but lower (better) following EVLA (P = 0.042). CONCLUSION: The morbidity associated with SSV incompetence is greater than suggested by its clinical severity and responds differently following treatment to that of the GSV. Trials should consider patients with GSV and SSV reflux separately. EVLA may offer additional benefits to SSV sufferers.

Saphenopopliteal ligation and stripping of small saphenous vein: does extended stripping provide better results?

OBJECTIVE: Saphenopopliteal ligation (SPL) for venous insufficiency is a challenging procedure, with mixed results being reported. The role of stripping of the small saphenous vein (SSV) is contentious. This prospective observational study aimed to assess the risks and benefits of this procedure. METHODS: Fifty patients underwent SPL under general anaesthesia by a single surgeon in a tertiary referral vascular centre. The aim was to perform inversion stripping in each case, but in a proportion this was not possible. Patients were grouped into SPL with short segment excision ≤5 cm (n = 23) and SPL with extended stripping >5 cm (n = 27). Outcome measures included venous clinical severity scores (VCSS), quality of life (QoL), Aberdeen varicose vein questionnaire (AVVQ), patient satisfaction, recurrence and complication rates. RESULTS: Intragroup analysis demonstrated statistically significant improvements in VCSS (P < 0.001), and QoL measures (generic and disease-specific AVVQ) (P < 0.050) with both treatments. Intergroup analysis demonstrated statistically significant superior VCSS scores at one year (P = 0.001), AVVQ at three months and one year (P < 0.05), and cosmetic satisfaction at one year (P = 0.011) in the SPL extended stripping group. There was no difference in clinical recurrence 1/23 (4.3%) versus 1/27 (3.7%) (P = 0.900) or complication rates (P > 0.050). CONCLUSIONS: SPL with or without stripping is an effective procedure improving clinical severity and QoL in the short term. Early outcomes favour SPL with extended stripping to offer greater improvement in disease-specific QoL, venous severity and cosmesis. With this small sample, there is no evidence of increased complications following stripping, or increased short-term recurrence without it. Greater numbers and follow-up are required to make firm conclusions.

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.