David Mitchell

Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial

BACKGROUND Chronic venous leg ulceration can be managed by compression treatment, elevation of the leg, and exercise. The addition of ablative superficial venous surgery to this strategy has not been shown to affect ulcer healing, but does reduce ulcer recurrence. We aimed to assess healing and recurrence rates after treatment with compression with or without surgery in people with leg ulceration. METHODS We did venous duplex imaging of ulcerated or recently healed legs in 500 consecutive patients from three centres. We randomly allocated those with isolated superficial venous reflux and mixed superficial and deep reflux either compression treatment alone or in combination with superficial venous surgery. Compression consisted of multilayer compression bandaging every week until healing then class 2 below-knee stockings. Primary endpoints were 24-week healing rates and 12-month recurrence rates. Analysis was by intention to treat. FINDINGS 40 patients were lost to follow-up and were censored. Overall 24-week healing rates were similar in the compression and surgery and compression alone groups (65% vs 65%, hazard 0.84 [95% CI 0.77 to 1.24]; p=0.85) but 12-month ulcer recurrence rates were significantly reduced in the compression and surgery group (12% vs 28%, hazard -2.76 [95% CI -1.78 to -4.27]; p<0.0001). Adverse events were minimal and about equal in each group. INTERPRETATION Surgical correction of superficial venous reflux reduces 12-month ulcer recurrence. Most patients with chronic venous ulceration will benefit from the addition of simple venous surgery.

Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial

Objective To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression. Design Randomised controlled trial. Setting Specialist nurse led leg ulcer clinics in three UK vascular centres. Participants 500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux. Interventions Compression alone or compression plus saphenous surgery. Main outcome measures Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time. Results Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test). Conclusion Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time. Trial registration Current Controlled Trials ISRCTN07549334.

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

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.

Randomized clinical trial of compression plus surgery versus compression alone in chronic venous ulceration (ESCHAR study)—haemodynamic and anatomical changes

The aim of this study was to evaluate the anatomical and haemodynamic effects of superficial venous surgery and compression on legs with chronic venous ulceration.

Remodelling of Vascular (Surgical) Services in the UK

The last few years have seen major changes in the delivery of vascular services in the UK. An increasingly elderly population with greater expectations from their medical services has challenged established methods. It also became apparent that outcomes for low volume, high risk index vascular interventions such as abdominal aortic aneurysm repair were poor in the UK compared to the rest of Europe. Other ongoing challenges were the introduction of a national aortic aneurysm screening programme and the development of vascular surgery as a separate speciality. This article details the approach taken to modernise vascular services in the UK, using a quality framework agreed by vascular specialists, which drove the structural change to move vascular interventions into fewer, higher volume centres. The introduction of modern networks is designed to maintain services in surrounding hospitals without on site vascular inpatient services. The initial effects of this service remodelling are positive, with elective aortic aneurysm mortality rates falling nationally from 7.5 to 2.4 per cent.

Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial.

BackgroundDespite advances in perioperative care, elective abdominal aorta aneurysm (AAA) repair carries significant morbidity and mortality. Remote ischaemic preconditioning (RIC) is a physiological phenomenon whereby a brief episode of ischaemia-reperfusion protects against a subsequent longer ischaemic insult. Trials in cardiovascular surgery have shown that RIC can protect patients’ organs during surgery. The aim of this study was to investigate whether RIC could be successfully introduced in elective AAA repair and to obtain the information needed to design a multi-centre RCT.MethodsConsecutive patients presenting for elective AAA repair, using an endovascular (EVAR) or open procedure, in a single large city hospital in the UK were assessed for trial eligibility. Patients who consented to participate were randomized to receive RIC (three cycles of 5 min ischaemia followed by 5 min reperfusion in the upper arm immediately before surgery) or a sham procedure. Patients were followed up for 6 months. We assessed eligibility and consent rates, the logistics of RIC implementation, randomization, blinding, data capture, patient and staff opinion, and variability and frequency of clinical outcome measures.ResultsBetween January 2010 and December 2012, 98 patients were referred for AAA repair, 93 were screened, 85 (91 %) were eligible, 70 were approached for participation and 69 consented to participate; 34 were randomized to RIC and 35 to the sham procedure. There was a greater than expected variation in the complexity of EVAR that impacted the outcomes. Acute kidney injury occurred in 28 (AKIN 1: 23 %; AKIN 2: 15 % and AKIN 3: 3 %) and 7 (10 %) had a perioperative myocardial infarction. Blinding was successful, and interviews with participants and staff indicated that the procedure was acceptable. There were no adverse events secondary to the intervention in the 6 months following the intervention.ConclusionsThis study provided essential information for the planning and design of a multi-centre RCT to assess effectiveness of RIC for improving clinical outcomes in elective AAA repair. Patient consent was high, and the RIC intervention was carried out with minimal disruption to clinical care. The allocation scheme for a definite trial should take into account both the surgical procedure and its complexity to avoid confounding the effect of the RIC, as was observed in this study.Trial registrationCurrent Controlled Trials ISRCTN19332276 (date of registration: 16 March 2012). The trial protocol is available from the corresponding author.

Current practice of carotid endarterectomy in the UK

Carotid endarterectomy (CEA) reduces the risk of stroke in patients with internal carotid stenosis of 50–99 per cent. This study assessed national surgical practice through audit of CEA procedures and outcomes.

Don’t blame individuals for organisational failures

The Vascular Society has published numerous reports on the performance of vascular procedures.1 In March 2012, we published mortality data after elective abdominal aortic aneurysm repair for every trust in the UK and were disappointed that it was not accepted for publication in the BMJ .2 The report showed that a quality …

Elizabeth McKenzie Newton (Mrs Mitchell)

The daughter of Scottish medical missionaries, Elizabeth McKenzie Newton was born in Smyrna (now Izmir in Turkey). She grew up and was educated in Edinburgh. She qualified in medicine at Edinburgh University during the second world war and started her career at Winchester Emergency War Hospital. She trained in …

Mesh closure can prevent incisional herniation after open aneurysm repair

Objective: Prosthetic grafts must resist thrombosis and intimal hyperplasia (IH) ideally by endothelialisation. We have developed a nanocomposite graft (POSS-NC), mechanically strong and biostable, which induces in situ endothelialisation. However, between implantation and development of complete endothelialisation there is a possible risk of thrombosis and IH on the bare patches. Nitric oxide (NO) has a complex powerful protective role and the aims of this study were to: i) incorporate NO donors and test the effects on platelet activity and coagulation; ii) test the synergistic effect of peptides-NO on accelerating endothelial progenitor cell (EPC) adhesion and endothelialisation. Method: POSS-NC-NO grafts were incorporated with SNAP, a NO donor. NO elution was tested using Griess assay. Platelet adhesion was measured after 120-minute incubation using scanning electron microscopy (SEM). Thromboelastography using polymer-coated cups measured coagulation patterns. EPC adhesion on SNAP-incorporated peptide biofunctionalised-POSS-NC was measured under static conditions and endothelialisation of the material under pulsatile flow. Alamar-Blue assay determined cell adhesion/proliferation. Cell morphology was assessed with SEM, and endothelialisation by RT-PCR and immunostaining for CD31, vWF and eNOS. Results: The POSS-NO graft successfully eluted NO and significantly prevented platelet adhesion. Thrombo-elastography studies with SNAP showed a narrower maximum amplitude (related to clot strength) and longer time for initial fibrin formation. Peptides and NO synergistically enhanced EPC adhesion/proliferation. SEM, immunostaining and RT-PCR confirmed enhanced endothelialisation. Conclusion: This NO-eluting nanocomposite graft demonstrated enhanced antithrombogenic properties and greater efficiency for in situ endothelialisation from circulating EPC. This graft has the potential for accelerated spontaneous endothelialisation in addition to inherent resistance to thrombosis.