Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

Vascular Services

Key Contacts

Name Role
Dr Steve Thomas
steven.thomas@sth.nhs.uk
Research Lead
Dr Ed Mulkern Clinical Director
Chris Monk General Manager
David Bassenger Service Manager
Joanna Myers Finance Manager
Yasmin Hussain Directorate Accountant
Louese Dunn
Directorate Research Coordinator
Charlotte Culver
Directorate Research Coordinator
Nana Theodorou
nana.theodorou@sth.nhs.uk
Clinical Research Office Coordinator (Portfolio and Non-Portfolio Studies)
Gaurika Kapoor
gaurika.kapoor@sth.nhs.uk
Clinical Research Office Coordinator
(Industry-Sponsored Studies)

Introduction

The Sheffield Vascular Institute is one of the largest Academic Vascular Units in the UK and as such is well placed to carry out high quality research into vascular diseases.. The Institute has clinical facilities based at the Northern General Hospital site in Sheffield providing specialist vascular services to the population of Sheffield and many of the surrounding districts including Barnsley and Rotherham. Much research takes place within the clinical unit. This is both for conventional open surgical techniques, and for minimally invasive endovascular techniques. The directorate has been involved in all of the major multicentre trials into vascular diseases, such as the small aneurysm trial, the EVAR trials, CAVATAS, ICSS, ACST, and the BASIL trials. The clinical research occurs with and alongside the Academic Vascular Unit, which is part of the University of Sheffield, and housed within the School of Health and Related Research at Regent Court.

Research Strategy

The vascular directorate is committed to expanding the evidence base for the management of vascular disease and also to encourage the research skills and awareness of its staff. Its research strategy is focused on research into establishing the effectiveness and cost-effectiveness of different treatments for vascular disease, particularly new technologies and interventions. The research is divided into a number of themes relating to service delivery and organisation and the main disease areas dealt with by vascular services including: peripheral arterial disease, leg ulceration, carotid disease and aortic aneurysms. An extensive programme of clinical research in partnership with other NHS centres and the University of Sheffield (ScHARR) has been created. The collaboration is multidisciplinary, and includes medical, nursing and academic staff.

Research Topics and Leaders

Cost Effectiveness Research - Dr Steven Thomas, Prof Jonathan Michaels, Dr P Shakley.
Carotid Stenting - Dr Trevor Cleveland, Dr Doug Turner.
Peripheral Artery Disease - Dr Steven Thomas, Prof Peter Gaines, Dr Trevor Cleveland, Mr Jonathan Beard.
Aneurysms -Dr Steven Thomas, Prof Peter Gaines, Dr Trevor Cleveland, Mr Jonathan Beard.
Varicose Veins And Venous Ulcers - Prof Jonathan Michaels, Mr Simon Palfreyman, Mr Dominic Dodd

Topic 1: Cost Effectiveness Research

There is ongoing work into the cost effectiveness of new technologies in treating arterial disease in the SFA. This is in collaboration with ScHARR within the University of Sheffield and is supported by NIHR HTA grants.

Important Publications

Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial)

A prospective randomised controlled trial and economic modelling of antimicrobial silver dressings versus non-adherent control dressings for venous leg ulcers: the VULCAN trial.

Topic 2: Carotid Stenting

Research Direction

The Management of disease of the carotid arteries has been the subject of a number of large multi-centre and international clinical trials. The SVI has taken an important part in the many of these trials and in recent years has led in the development and evaluation of endovascular treatments for disease of the carotid arteries. Studies in this area have included evaluation of new devices including cerebral protection devices, randomised controlled trials comparing surgery and endovascular treatments, the development and evaluation of fast track services including the use of economic modelling techniques to evaluate their potential cost effectiveness and primary and secondary research relating to diagnostic methods.

Important Publications

  • Validation of video-based skill assessment in carotid artery stenting.
  • Who benefits most from intervention for asymptomatic carotid stenosis: patients or professionals?
  • Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.
  • A follow on randomised controlled trial comparing carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (ICSS) has been performed and results published in the Lancet.

Topic 3: Peripheral Arterial Disease

Research Direction

The SVI has been a leading centre in the development of new endovascular treatments for peripheral arterial disease. The SVI has led randomised controlled trials of stenting and angioplasty in the iliac arteries, has investigated stents for treatment of femoral artery disease and was one of the leading contributors to the BASIL Study which was a multi-centre randomised controlled trial comparing open surgery to endovascular treatment or severe ischaemia of the legs.

The Sheffield Vascular Institute in collaboration with the Centre for Sports and Exercise Physiology at Sheffield Hallam University has undertaken a programme of research regarding the effects of exercise in patients with intermittent claudication. This included the development of the shuttle-walk, as an assessment tool and were comparing the clinical benefits and physiological effects of lower limb and upper limb exercise. The Unit has also participated in the multi-centre MIMIC study which has looked at the use of exercise with our without angioplasty in patients with intermittent claudication and has a further study in progress considering the effect of the use of walking poles.

The Sheffield Vascular Institute has a research interest in the configuration of vascular services. This has led to a large Health Technology Assessment funded project considering overall service configuration. The Unit has also pioneered the development of nurse led clinics and has set up and evaluated the effectiveness of a nurse led clinic for intermittent claudication. The HTA report on the organisation of services is available from the HTA website.

Topic 4: Aneurysms

Research Direction

In recent years there have been a number of important developments related to the management of aneurysms. This has included a number of large multi-centre randomised controlled trials and development work relating to new procedures and devices. The SVI has been at the forefront of these developments. Major areas of research have included the development of the new technique of endovascular abdominal aortic aneurysm repair and developments in respect to the management of small abdominal aortic aneurysms particularly in relation to the development of screening programmes. In addition the SVI has been a leading centre in the development of endovascular treatments for thoracic aortic aneurysms.

Over the past fifteen years have been rapid advances in the development of techniques to treat aortic aneurysms through the introduction of an endovascular stent graft – the SVI has been at the forefront of these developments and has undertaken clinical evaluation of many of the new devices, developed the registry of endovascular treatment of aneurysms (RETA), participated in large multi-centre randomised controlled trials and has carried out extensive systematic literature reviewing and economic analysis including commissioned work for the NICE Interventional Procedures Advisory Committee and the NICE Appraisal Committee.

The work for the NICE Appraisal Committee including collaboration with the University of York in the development of a systematic review and economic modelling of EVAR which was used in the recent appraisal of endovascular repair. Further details of the assessment report and the NICE appraisal are available on the NICE website.

There have been rapid advances in the area of decision making relating to abdominal aortic aneurysm treatment with the publication of evidence from a large multi-centre randomised controlled trials including the small aneurysm trial and a multi-centre aneurysm screening study (MASS). This research has led to the introduction of a National Screening Programme for abdominal aortic aneurysms. For further details see the links to the right. Other important areas of recent research undertaken by the SVI include analysis of predictors of outcome including service configuration and work loads. The ongoing programme of research is addressing issues around clinical decision making and the configuration of services using decision modelling techniques and cost effectiveness modelling.

The use of endovascular techniques has revolutionised the management of thoracic aortic aneurysms which were previously only treatable through complex cardiothoracic surgery associated with very high operative risks. The SVI has been leading in this research evaluating new techniques and has set up and managed a registry of endovascular repair of thoracic aortic aneurysms.

Topic 5: Varicose Veins And Venous Ulcers

Sheffield Vascular Institute is actively recruiting patients in the the CLASS trial (Comparison of Laser, Surgery and foam Sclerotherapy). This is a randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins. The study is a multi-centre, UK-wide study, funded by the NIHR HTA programme. Principal Investigator in Sheffield is Mr Dominic Dodd.

Important Publications

• Exercise training improves cutaneous microvascular endothelial function in post-surgical varicose vein patients.
• Impaired microvascular endothelial function is restored by acute lower-limb exercise in post-surgical varicose vein patients.
• Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial).
• A prospective randomised controlled trial and economic modelling of antimicrobial silver dressings versus non-adherent control dressings for venous leg ulcers: the VULCAN trial.
• A systematic review of compression hosiery for uncomplicated varicose veins.