Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration.

BACKGROUND: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers. METHODS: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol. RESULTS: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective. CONCLUSION: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com).

Tract-Based Spatial Statistics in Preterm-Born Neonates Predicts Cognitive and Motor Outcomes at 18 Months.

BACKGROUND AND PURPOSE: Adverse neurodevelopmental outcome is common in children born preterm. Early sensitive predictors of neurodevelopmental outcome such as MR imaging are needed. Tract-based spatial statistics, a diffusion MR imaging analysis method, performed at term-equivalent age (40 weeks) is a promising predictor of neurodevelopmental outcomes in children born very preterm. We sought to determine the association of tract-based spatial statistics findings before term-equivalent age with neurodevelopmental outcome at 18-months corrected age. MATERIALS AND METHODS: Of 180 neonates (born at 24-32-weeks' gestation) enrolled, 153 had DTI acquired early at 32 weeks' postmenstrual age and 105 had DTI acquired later at 39.6 weeks' postmenstrual age. Voxelwise statistics were calculated by performing tract-based spatial statistics on DTI that was aligned to age-appropriate templates. At 18-month corrected age, 166 neonates underwent neurodevelopmental assessment by using the Bayley Scales of Infant Development, 3rd ed, and the Peabody Developmental Motor Scales, 2nd ed. RESULTS: Tract-based spatial statistics analysis applied to early-acquired scans (postmenstrual age of 30-33 weeks) indicated a limited significant positive association between motor skills and axial diffusivity and radial diffusivity values in the corpus callosum, internal and external/extreme capsules, and midbrain (P < .05, corrected). In contrast, for term scans (postmenstrual age of 37-41 weeks), tract-based spatial statistics analysis showed a significant relationship between both motor and cognitive scores with fractional anisotropy in the corpus callosum and corticospinal tracts (P < .05, corrected). Tract-based spatial statistics in a limited subset of neonates (n = 22) scanned at <30 weeks did not significantly predict neurodevelopmental outcomes. CONCLUSIONS: The strength of the association between fractional anisotropy values and neurodevelopmental outcome scores increased from early-to-late-acquired scans in preterm-born neonates, consistent with brain dysmaturation in this population.

Incidental non-inguinals hernias in totally extra-peritoneal hernia repair.

INTRODUCTION: Totally extra-peritoneal (TEP) inguinal hernia repair allows identification and repair of incidental non-inguinal groin hernias. We assessed the prevalence of incidental hernias during TEP inguinal hernia repair and identified the risk factors for incidental hernias. MATERIALS AND METHODS: Consecutive patients undergoing TEP repair from May 2005 to November 2012 were the study cohort. Inspection for ipsilateral femoral, obturator and rarer varieties of hernia was undertaken during TEP repair. Patient characteristics and operative findings were recorded on a prospectively collected database. RESULTS: A total of 1,532 TEP repairs were undertaken in 1,196 patients. Ninety-three patients were excluded due to incomplete data, leaving 1,103 patients and 1,404 hernias for analyses (1,380 male; 802 unilateral and 301 bilateral repairs; median age, 59 years). Among the 37 incidental hernias identified (2.6% of cases), the most common type of incidental hernia was femoral (n=32, 2.3%) followed by obturator (n=2, 0.1%). Increasing age was associated with an increased risk of incidental hernia, with a significant linear trend (p<0.01). The risk for patients >60 years of age was 4.0% vs 1.4% for those aged <60 years (p<0.01). Incidental hernias were found in 29.2% of females vs 2.2% of males, (p<0.0001). Risk of incidental hernia in those with a recurrent inguinal hernia was 3.0% vs 2.6% for primary repair (p=0.79). CONCLUSIONS: Incidental hernias during TEP inguinal hernia repair were found in 2.6% of cases and, though infrequent, could cause complications if left untreated. The risk of incidental hernia increased with age and was significantly higher in patients aged >60 years and in females.

Maggots as a wound debridement agent for chronic venous leg ulcers under graduated compression bandages: A randomised controlled trial.

OBJECTIVES: Slough in chronic venous leg ulcers may be associated with delayed healing. The purpose of this study was to assess larval debridement in chronic venous leg ulcers and to assess subsequent effect on healing. METHODS: All patients with chronic leg ulcers presenting to the leg ulcer service were evaluated for the study. Exclusion criteria were: ankle brachial pressure indices <0.85 or >1.25, no venous reflux on duplex and <20% of ulcer surface covered with slough. Participants were randomly allocated to either 4-layer compression bandaging alone or 4-layer compression bandaging + larvae. Surface areas of ulcer and slough were assessed on day 4; 4-layer compression bandaging was then continued and ulcer size was measured every 2 weeks for up to 12 weeks. RESULTS: A total of 601 patients with chronic leg ulcers were screened between November 2008 and July 2012. Of these, 20 were randomised to 4-layer compression bandaging and 20 to 4-layer compression bandaging + larvae. Median (range) ulcer size was 10.8 (3-21.3) cm(2) and 8.1 (4.3-13.5) cm(2) in the 4-layer compression bandaging and 4-layer compression bandaging + larvae groups, respectively (Mann-Whitney U test, P = 0.184). On day 4, median reduction in slough area was 3.7 cm(2) in the 4-layer compression bandaging group (P < 0.05) and 4.2 cm(2) (P < 0.001) in the 4-layer compression bandaging + larvae group. Median percentage area reduction of slough was 50% in the 4-layer compression bandaging group and 84% in the 4-layer compression bandaging + larvae group (Mann-Whitney U test, P < 0.05). The 12-week healing rate was 73% and 68% in the 4-layer compression bandaging and 4-layer compression bandaging + larvae groups, respectively (Kaplan-Meier analysis, P = 0.664). CONCLUSIONS: Larval debridement therapy improves wound debridement in chronic venous leg ulcers treated with multilayer compression bandages. However, no subsequent improvement in ulcer healing was demonstrated.

Prenatal and postnatal inflammation in relation to cortisol levels in preterm infants at 18 months corrected age.

OBJECTIVE: To examine whether early inflammation is related to cortisol levels at 18 months corrected age (CA) in children born very preterm. STUDY DESIGN: Infants born ≤ 32 weeks of gestational age were recruited in the neonatal intensive care unit (NICU), and placental histopathology, magnetic resonance imaging (MRI) and chart review were obtained. At 18 months CA, developmental assessment and collection of three salivary cortisol samples were carried out. Generalized least squares was used to analyze data from 85 infants providing 222 cortisol samples. RESULT: Infants exposed to chorioamnionitis with funisitis had a significantly different pattern of cortisol across the samples compared with infants with chorioamnionitis alone or no prenatal inflammation (F(4, 139)=7.3996, P<0.0001). Postnatal infections, necrotizing enterocolitis and chronic lung disease were not significantly associated with the cortisol pattern at 18 months CA. CONCLUSION: In children born very preterm, prenatal inflammatory stress may contribute to altered programming of the hypothalamic-pituitary-adrenal (HPA) axis.

Brain injury patterns in hypoglycemia in neonatal encephalopathy.

BACKGROUND AND PURPOSE: Low glucose values are often seen in term infants with NE, including HIE, yet the contribution of hypoglycemia to the pattern of neurologic injury remains unclear. We hypothesized that MR features of neonatal hypoglycemia could be detected, superimposed on the predominant HIE injury pattern. MATERIALS AND METHODS: Term neonates (n = 179) with NE were prospectively imaged with day-3 MR studies and had glucose data available for review. The predominant imaging pattern of HIE was recorded as watershed, basal ganglia, total, focal-multifocal, or no injury. Radiologic hypoglycemia was diagnosed on the basis of selective edema in the posterior white matter, pulvinar, and anterior medial thalamic nuclei. Clinical charts were reviewed for evidence of NE, HIE, and hypoglycemia (<46 mg/dL). RESULTS: The predominant pattern of HIE injury imaged included 17 watershed, 25 basal ganglia, 10 total, 42 focal-multifocal, and 85 cases of no injury. A radiologic diagnosis of hypoglycemia was made in 34 cases. Compared with laboratory-confirmed hypoglycemia, MR findings had a positive predictive value of 82% and negative predictive value of 78%. Sixty (34%) neonates had clinical hypoglycemia before MR imaging. Adjusting for 5-minute Apgar scores and umbilical artery pH with logistic regression, clinical hypoglycemia was associated with a 17.6-fold higher odds of MR imaging identification (P < .001). Selective posterior white matter and pulvinar edema were most predictive of clinical hypoglycemia, and no injury (36%) or a watershed (32%) pattern of injury was seen more often in severe hypoglycemia. CONCLUSIONS: In term infants with NE and hypoglycemia, specific imaging features for both hypoglycemia and hypoxia-ischemia can be identified.

Effect of foam sclerotherapy on healing and long-term recurrence in chronic venous leg ulcers.

INTRODUCTION: The ESCHAR trial showed that superficial venous surgery and compression in chronic venous ulceration achieved a 24-week healing rate of 65% and 12-month recurrence rate of 12%. Foam sclerotherapy treatment is an alternative to surgery. The aim of this study is to assess the effect of foam sclerotherapy on ulcer healing and recurrence in chronic venous leg ulcers. METHODS: Chronic venous leg ulcers (CEAP [clinical, aetiological, anatomical and pathological elements] 5 and CEAP 6) with superficial venous reflux were treated between March 2006 and June 2011 with ultrasound-guided foam sclerotherapy and compression.Venous duplex was performed on all legs before and after treatment. Twenty-four-week ulcer healing and one- and four-year ulcer recurrence rates were calculated using Kaplan­Meier survival analysis. RESULTS: Two hundred legs (186 patients) with chronic venous ulcers (CEAP 5: n » 163 and CEAP 6: n » 37) were treated with foam sclerotherapy. Complete occlusion was achieved in 185/200 (92.5%) limbs, short segment occlusion in 14/200 (7%) limbs and one leg segment failed to occlude. One patient suffered an asymptomatic non-occlusive deep vein thrombosis (DVT) diagnosed on duplex scan at one week and one presented with an occlusive DVT three weeks following a normal scan at one week. One patient developed an asymptomatic occlusive DVT at two weeks following a non-occlusive DVT diagnosed on initial one-week scan. Eighteen patients were lost to follow-up (3 moved away and 15 died of unrelated causes). The 24-week healing rate was 71.1% and one- and four-year recurrence rates were 4.7% and 28.1%, respectively. CONCLUSION: Foam sclerotherapy is effective in abolition of superficial venous reflux and may contribute to similar ulcer healing and long-term recurrence rates to superficial venous surgery. Foam sclerotherapy is an attractive alternative to surgery in this group of patients.

The need for a National Service Framework for leg ulcers.

Leg ulcers are common and costly to treat, and the quality of care provided to patients with this condition varies widely across the UK. The introduction of specialized community-based leg ulcer clinics in Gloucestershire has been associated with increased ulcer healing rates and decreased rates of ulcer recurrence, but this model of care has not been widely replicated. One way of ending this 'postcode lottery' is to produce a National Service Framework for leg ulcers, with the aim of delivering high-quality evidence-based care via such clinics under the supervision of local consultant vascular surgeons. Existing National Service Frameworks cover a range of common conditions that are, like leg ulceration, associated with significant morbidity, disability and resource use. These documents aim to raise quality and decrease regional variations in health care across the National Health Service, and leg ulceration fulfils all the necessary criteria for inclusion in a National Service Framework. Centrally defined standards of care for patients with leg ulceration, and the reorganization and restructuring of local services to allow the accurate assessment and treatment of such patients are required. Without a National Service Framework to drive up the quality of care across the country, the treatment of patients with leg ulcers will remain suboptimal for the majority of those who suffer from this common and debilitating condition.

Pre-operative inspiratory muscle training preserves postoperative inspiratory muscle strength following major abdominal surgery - a randomised pilot study.

INTRODUCTION: The aim of this pilot study was to assess the effect of pre-operative inspiratory muscle training (IMT) on respiratory variables in patients undergoing major abdominal surgery. PATIENTS AND METHODS: Respiratory muscle strength (maximum inspiratory [MIP] and expiratory [MEP] mouth pressure) and pulmonary functions were measured at least 2 weeks before surgery in 80 patients awaiting major abdominal surgery. Patients were then allocated randomly to one of four groups (Group A, control; Group B, deep breathing exercises; Group C, incentive spirometry; Group D, specific IMT). Patients in groups B, C and D were asked to train twice daily, each session lasting 15 min, for at least 2 weeks up to the day before surgery. Outcome measurements were made immediately pre-operatively and postoperatively. RESULTS: In groups A, B and C, MIP did not increase from baseline to pre-operative assessments. In group D, MIP increased from 51.5 cmH(2)O (median) pre-training to 68.5 cmH(2)O (median) post-training pre-operatively (P < 0.01). Postoperatively, groups A, B and C showed a fall in MIP from baseline (P < 0.01, P < 0.01) and P = 0.06, respectively). No such significant reduction in postoperative MIP was seen in group D (P = 0.36). CONCLUSIONS: Pre-operative specific IMT improves MIP pre-operatively and preserves it postoperatively. Further studies are required to establish if this is associated with reduced pulmonary complications.

Randomized clinical trial of mesh versus sutured wound closure after open abdominal aortic aneurysm surgery.

BACKGROUND: Incisional herniation is a common complication of abdominal aortic aneurysm (AAA) repair. This study investigated whether prophylactic mesh placement could reduce the rate of postoperative incisional hernia after open repair of AAA. METHODS: This randomized clinical trial was undertaken in three hospitals. Patients undergoing elective open AAA repair were randomized to routine abdominal mass closure after AAA repair or to prophylactic placement of polypropylene mesh in the preperitoneal plane. RESULTS: Eighty-five patients with a mean age of 73 (range 59-89) years were recruited, 77 (91 per cent) of whom were men. There were five perioperative deaths (6 per cent), two in the control group and three in the mesh group (P = 0.663), none related to the mesh. Sixteen patients in the control group and five in the mesh group developed a postoperative incisional hernia (hazard ratio 4.10, 95 per cent confidence interval 1.72 to 9.82; P = 0.002). Hernias developed between 170 and 585 days after surgery in the control group, and between 336 and 1122 days in the mesh group. Four patients in the control group and one in the mesh group underwent incisional hernia repair (P = 0.375). No mesh became infected, but one was subsequently removed owing to seroma formation during laparotomy for small bowel obstruction. CONCLUSION: Mesh placement significantly reduced the rate of postoperative incisional hernia after open AAA repair without increasing the rate of complications.

Clinically silent preoperative brain injuries do not worsen with surgery in neonates with congenital heart disease.

OBJECTIVE: Preoperative brain injury, particularly stroke and white matter injury, is common in neonates with congenital heart disease. The objective of this study was to determine the risk of hemorrhage or extension of preoperative brain injury with cardiac surgery. METHODS: This dual-center prospective cohort study recruited 92 term neonates, 62 with transposition of the great arteries and 30 with single ventricle physiology, from 2 tertiary referral centers. Neonates underwent brain magnetic resonance imaging scans before and after cardiac surgery. RESULTS: Brain injury was identified in 40 (43%) neonates on the preoperative magnetic resonance imaging scan (median 5 days after birth): stroke in 23, white matter injury in 21, and intraventricular hemorrhage in 7. None of the brain lesions presented clinically with overt signs or seizures. Preoperative brain injury was associated with balloon atrial septostomy (P = .003) and lowest arterial oxygen saturation (P = .007); in a multivariable model, only the effect of balloon atrial septostomy remained significant when adjusting for lowest arterial oxygen saturation. On postoperative magnetic resonance imaging in 78 neonates (median 21 days after birth), none of the preoperative lesions showed evidence of extension or hemorrhagic transformation (0/40 [95% confidence interval: 0%-7%]). The presence of preoperative brain injury was not a significant risk factor for acquiring new injury on postoperative magnetic resonance imaging (P = .8). CONCLUSIONS: Clinically silent brain injuries identified preoperatively in neonates with congenital heart disease, including stroke, have a low risk of progression with surgery and cardiopulmonary bypass and should therefore not delay clinically indicated cardiac surgery. In this multicenter cohort, balloon atrial septostomy remains an important risk factor for preoperative brain injury, particularly stroke.

Intracranial hypertension secondary to sigmoid sinus compression by group A streptococcal epidural abscess.

OBJECTIVE: We present an extremely rare case of severe intracranial hypertension secondary to sigmoid sinus compression by a group A streptococcal epidural abscess. METHOD: Case report and review of the world literature. RESULTS: A five-year-old boy was treated for acute otitis media and group A streptococcal bacteraemia, but subsequently developed severe intracranial hypertension. Computed tomography revealed that, although the sigmoid sinuses were not thrombosed, the patient had a dominant right sigmoid sinus that was almost completely compressed by a small epidural abscess. After surgical decompression of the epidural abscess, with aggressive debridement of the granulation tissue from the sigmoid sinus wall, the patient awoke from general anaesthesia with complete resolution of his symptoms and signs of intracranial hypertension. He suffered no sequelae over the subsequent six months' follow up. CONCLUSION: This is the first reported case of intracranial hypertension due to an epidural abscess causing sigmoid sinus compression without thrombosis. This case illustrates the fact that, even in the absence of thrombosis of the sigmoid sinus, a small epidural abscess may require urgent surgical treatment.

The importance of early carotid endarterectomy in symptomatic patients.

INTRODUCTION: Early carotid endarterectomy (CEA) in symptomatic patients may prevent repeat cerebral events. This study investigates the relationship between waiting time for CEA and the incidence of repeat cerebral events prior to surgery in symptomatic patients. PATIENTS AND METHODS: A prospective database of consecutive patients undergoing CEA between January 2002 and December 2006 was reviewed. Repeat event rates prior to surgery were calculated using Kaplan-Meier analysis and predictive factors identified using Cox regression analysis. RESULTS: A total of 118 patients underwent CEA for non-disabling stroke, TIA and amaurosis fugax. Repeat cerebral events occurred in 34 of 118 (29%) patients at a median 51 days (range, 2-360 days) after the first event. The estimated risk of repeat events was 2% at 7 days and 9% at 1 month after first event (Kaplan-Meier survival analysis). Age (HR 1.059; 95% CI 1.014-1.106; P = 0.009] was identified as a predictor of repeat events. Patients underwent surgery at median 97 days (range, 7-621 days) after the first event. Eleven of 60 (18%) patients waiting < or = 97 days for surgery and 23 of 58 (40%) patients waiting > 97 days had repeat events. (P = 0.011, chi-squared test). CONCLUSIONS: Delays in surgery should be reduced in order to minimise repeat cerebral events in patients with symptomatic carotid stenosis, particularly in the elderly population.

Intracranial calcification after cord blood neonatal transplantation for krabbe disease.

Infantile-onset Krabbe disease results from a deficiency of the lysosomal enzyme galactocerebrosidase and leads to death from profound central and peripheral demyelination. Neonatal hematopoietic cell transplantation may result in near-normal cognitive development and partial rescue of gross motor development. The long-term course of the disorder for treated patients seems to involve slowly progressive neurological impairment. We describe the detailed 3-year outcomes of this experimental procedure using umbilical cord blood in a prenatally-diagnosed newborn with Krabbe disease. Substantial perivascular calcifications and atrophy of the white matter developed in the first year post-transplantation. Despite persistent neuroradiological and electrophysiological evidence of leukodystrophy, at age 3 years she has had only mildly impaired non-motor development and moderately impaired motor skills. The cause of these severe white matter changes may have been due to ongoing Krabbe disease or to effects of the chemotherapy regimen or to an interaction of these factors. Extended long-term follow-up of children neonatally transplanted for Krabbe disease is needed before the full utility and limitations of neonatal transplantation can be determined.

Significance of limb trauma as an initiating factor in chronic leg ulceration.

OBJECTIVES: To assess differences in clinical outcomes between patients with traumatic and spontaneous leg ulcers. METHODS: Consecutive leg ulcer follow-up patients seen between April 2004 and October 2005 in a specialist leg ulcer clinic were asked about the mechanism of the original ulceration. Twenty-four-week healing and 12-month recurrence rates were calculated using Kaplan-Meier analysis and outcomes were compared between groups with traumatic and spontaneous ulcers. RESULTS: Of the 300 patients assessed, 38 were excluded (incomplete data). In the remaining 262 patients, cause of ulceration was traumatic in 116/262 (44%) and spontaneous in 146/262 (56%). Age, ankle brachial pressure index <0.85 and venous reflux were equally distributed between groups with traumatic and spontaneous ulcers (P = 0.470, 0.793, 0.965 respectively, Chi-square test). Twenty-four-week healing rates were 81% for traumatic and 67% for spontaneous ulcers (P = 0.015, Log-Rank test). Twelve-month recurrence rates were 32% for traumatic and 33% for spontaneous ulcers (P = 0.970, Log-rank test). Patients with traumatic ulcers suffered a total of 53 ulcer recurrences (median 0, range 0-4) compared with 89 in patients with spontaneous ulcers (median 0, range 0-8) (P < 0.001, Mann-Whitney U test). CONCLUSION: Approximately half of all leg ulcer patients recall a traumatic event. When managed in leg ulcer clinic, traumatic ulcers heal faster and recur less frequently than spontaneous ulcers.

Spinal cord magnetic resonance imaging for investigation of nonneurogenic lower urinary tract dysfunction--can the yield be improved?

PURPOSE: Magnetic resonance imaging has been used to detect occult neuropathy in patients with nonneurogenic lower urinary tract dysfunction. There is substantial controversy surrounding the role of this test for lower urinary tract dysfunction. We identified factors associated with positive magnetic resonance imaging to improve patient selection. MATERIALS AND METHODS: A case-control study was done in all pediatric patients referred to our radiology department for spinal magnetic resonance imaging primarily because of lower urinary tract symptoms between 1995 and 2004. Patients with known neurological disorders or anomalies associated with neurogenic bladder (overt spinal dysraphism, imperforate anus, etc) were excluded. A total of 80 patients with a median age of 6.5 years (range 4 to 17) were identified, of whom 47 (59%) were female. Bivariate analysis was used to evaluate the association of certain variables with positive magnetic resonance imaging findings, including patient age, gender, type of urinary symptoms, fecal soiling, abnormal neuro-orthopedic examination, lumbar cutaneous findings, resistance to medical management and urodynamic findings. RESULTS: Magnetic resonance imaging revealed spinal abnormalities in 6 cases (7.5%), including intradural arachnoid cyst in 1, sacral dysgenesis in 3, syrinx/hydromyelia in 1 and tethered cord in 1. An abnormal lumbar cutaneous finding was the only variable associated with positive magnetic resonance imaging (Fisher's exact test p = 0.002). CONCLUSIONS: Spinal magnetic resonance imaging has a low impact in the management of lower urinary tract dysfunction. With proper patient selection the pretest probability of positive magnetic resonance imaging may be increased and, therefore, many unnecessary studies may be avoided. Abnormal cutaneous findings are associated with abnormal magnetic resonance imaging.

Isolated sulfite oxidase deficiency in the newborn: lactic acidaemia and leukoencephalopathy.

We report a newborn with progressive leukoencephalopathy and lactic acidaemia, diagnosed with isolated sulfite oxidase deficiency. We show that low plasma total homocysteine (PTHcy) is a valuable early indicator of sulfite oxidase dysfunction, providing a crucial first-line screen, whereas plasma cystine is not always informative in the first few days of life.

Management of mixed arterial and venous leg ulcers.

BACKGROUND: The aim was to assess healing in patients with mixed arterial and venous leg ulcers after protocol-driven treatment in a specialist leg ulcer clinic. METHODS: The study included consecutive patients referred with leg ulceration and venous reflux over 6 years. Legs without arterial disease (ankle : brachial pressure index (ABPI) above 0.85) were treated with multilayer compression bandaging and patients with severe disease (ABPI 0.5 or less) were considered for immediate revascularization. Those with moderate arterial compromise (ABPI above 0.5 up to 0.85) were initially managed with supervised modified compression and considered for revascularization if their ulcer did not heal. Healing rates were determined using life-table analysis. RESULTS: Of 2011 ulcerated legs, 1416 (70.4 per cent) had venous reflux. Of these 1416, 193 (13.6 per cent) had moderate and 31 (2.2 per cent) had severe arterial disease. Healing rates by 36 weeks were 87, 68 and 53 per cent for legs with insignificant, moderate and severe arterial disease respectively (P < 0.001). Seventeen legs with moderate and 15 with severe arterial disease were revascularized. Of these, ulcers healed in four legs with moderate and seven with severe disease within 36 weeks of revascularization (P = 0.270). Combined 30-day mortality for revascularization was 6.5 per cent. CONCLUSION: A protocol including supervised modified compression and selective revascularization achieved good healing rates for mixed arterial and venous leg ulceration.

Residual venous reflux after superficial venous surgery does not predict ulcer recurrence.

OBJECTIVE: The aim of this study was to investigate the importance of venous reflux in ulcer recurrence following saphenous surgery. METHODS: Ulcerated legs (CEAP 5 and 6) with saphenous reflux were treated with superficial venous surgery plus compression as part of a clinical trial. Patients unfit for general anaesthesia (GA) underwent limited surgery under local anaesthesia (LA). Reflux in superficial and deep segments and venous refill times (VRTs) were assessed before surgery and 3-12 months post-operatively using duplex and digital photoplethysmography respectively. RESULTS: Of 185 patients treated with surgery, 15 failed to heal and 26 did not have a follow-up duplex. Within 3 years, 25 of the remaining 144 patients (17%) developed ulcer recurrence. Using a Cox regression model, the presence of residual venous reflux and change in reflux pattern were not found to be risk factors for ulcer recurrence (p=ns). LA was used in 4/25 patients who recurred compared to 28/119 who did not (p=0.60; Chi-square test). For legs with recurrence, median VRT before surgery was 10.5s (range 5-29) compared to 11s (range 6-36) after surgery (p=0.097, Wilcoxon Signed Rank test). However, in legs without recurrence, median VRT increased from 10s (range 3-48) to 15s (range 4-48) after surgery (p<0.001). CONCLUSION: Residual reflux following saphenous surgery is not the most important predictor of venous ulcer recurrence. Poor venous function as demonstrated by VRT may be a better predictor of recurrence in these patients.