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University of Bristol researchers at the Bristol Heart Institute (BHI) have pioneered the development and clinical take-up of the novel technique of off-pump coronary artery bypass (OPCAB) surgery. Over ten clinical trials and several large cohort analyses have assessed the impact of this technique on elective and high-risk patients. The results have shown that it is as safe as the conventional coronary artery bypass grafting (CABG) technique that uses a cardiopulmonary bypass pump and cardioplegic arrest. Most importantly, however, OPCAB significantly reduces the risk of post-operative complications, and reduces morbidity and mortality. It also uses less hospital resources, reducing time in intensive care and length of hospital stay. In 2011 (the last year for which data are available), 20% of CABG operations in the UK were carried out with the OPCAB technique and it has had significant take-up overseas (for example, 18% of CABG operations in the US and 21% in the EU in 2010). NICE has recommended the safety and efficacy of OPCAB surgery.
Narrowing of one of the carotid arteries in the neck (carotid stenosis) is an important cause of stroke, a major public health problem. The results of an international multicentre randomised clinical trial, organised and led by Professor Martin Brown at the UCL Institute of Neurology, have been incorporated into national and international guidelines on the treatment of carotid stenosis. The trial evaluated carotid artery stenting (CAS), a new treatment to prevent stroke from carotid stenosis, in comparison to the standard treatment, carotid endarterectomy (CEA) (carotid surgery). The number of patients treated by CAS in England did not increase between 2006 and 2012, whereas the numbers of patients treated by CEA increased by 30%, a finding consistent with a response to the findings of our trials indicating that CEA was safer than CAS.
The MRC Conventional versus Laparoscopic-Assisted Surgery In Colorectal Cancer trial (CLASICC) is the largest and most successful UK trial of a technology applied to general surgery. It addressed an area of huge clinical uncertainty, providing a rigorous evaluation of a new technology and enabling its safe and widespread implementation. The impact of CLASICC has been global, confirming the advantages for patients (quicker recovery) and healthcare providers (cost-effectiveness) and so influencing national and international policy in favour of the laparoscopic technique. It informed NICE guidance and led to a major DH initiative that has seen the UK become one of the largest providers in the world of laparoscopic colorectal cancer surgery. CLASICC is regarded as a benchmark surgical trial, combining high quality trial design with rigorous quality assurance, which has informed the design of many subsequent colorectal cancer studies.
An artificial cervical joint, designed by Mr Steven Gill, honorary Chair in the University of Bristol and consultant in Neurosurgery at Frenchay Hospital, is widely used for the treatment of degenerative cervical disc disease. Patients who have received the device have retained neck mobility and have experienced less neck pain and better neurological function than patients who have undergone conventional treatment involving fusion of the vertebrae. The device has also yielded substantial long-term savings as far fewer patients require secondary surgery. Gill's device was the first artificial cervical joint approved by the US Food and Drug Administration (FDA), in 2007. In early 2008, the global medical technology company Medtronic launched the device commercially in the US. The device is now used in 60 countries and has so far generated more than $137 million in sales.
In the last two decades researchers at King's College London (KCL) have revolutionized the management of benign surgical salivary disease (obstruction and tumours). Understanding the pathophysiology of the salivary glands has translated into a complete change of treatment away from traditional gland removal to minimally invasive gland preserving management. In obstructive disease >90% of stones can be released and <3% of glands removed. Similarly most parotid tumours can be removed safely by extracapsular dissection preserving the gland and significantly reducing risk of facial nerve injury. In children, >80% of childhood ranulas now can be treated without sublingual gland removal. KCL's Dental Institute has become a UK referral centre for minimally invasive salivary procedures and the procedures are now used worldwide.
Severe Limb Ischaemia (SLI), in which there is reduced blood flow to the leg(s), is the commonest cause worldwide of gangrene and limb loss. The BASIL trial, led by Professor Andrew Bradbury at the University of Birmingham, was the first (and remains the only) randomised controlled trial to investigate whether surgical bypass or endovascular (`keyhole') treatment is best at relieving symptoms and preventing amputation and/or death in patients with SLI. The outcomes of the study have been of worldwide interest, and the recommendations put forward by the team have been endorsed by a number of high profile clinical organisations. These findings are also nowincorporated within a series of national and international guidelines on SLI.
Impact: Health and welfare; a UK clinical trial of uterine artery embolisation (UAE), with five-year follow-up, defined the risk- and cost-benefit of UAE versus surgery.
Significance: The trial informed guidelines/recommendations internationally and changed clinical practice. Women worldwide can now make an informed choice about their treatment; economic factors have been quantitated.
Beneficiaries: Uterine fibroid patients, the NHS, healthcare providers.
Attribution: G. Murray, UoE, developed and delivered innovative trial methodology; clinical aspects led by University of Glasgow.
Reach: UK guidelines; worldwide (Australia, USA, Europe) effect on clinical practice that will impact up to 25% of women.
In response to inadequately designed assessment systems for patients recovering from orthopaedic surgery, researchers from the University of Oxford developed a series highly reliable and sensitive patient recorded questionnaires, known as the Oxford Scores. Providing a set of standardised outcomes for appraisal and on-going monitoring of patients, the Oxford Scores enable the informed assessment of clinical outcomes. Used to predict and detect early failure of poorly performing surgical interventions, the Oxford Scores have been adopted by health providers and regulators worldwide, leading to policy and treatment guideline changes and significant improvements in the quality of life of patients.
This case study describes the healthcare impact arising from the trial and introduction of a new clinical treatment used in patients with acute coronary syndromes. Research at Sheffield provided robust evidence as to the effectiveness of the anti-thrombotic drug ticagrelor, which directly contributed to its approval by global regulatory authorities and its recommendation by the European Society of Cardiology and the National Institute for Health and Care Excellence as a first-line treatment in the management of acute coronary syndromes. South Yorkshire hospitals were early adopters in February 2012 and ticagrelor has been progressively adopted across other parts of the United Kingdom, with over half of UK hospitals now having adopted it. It has also been adopted in over 80 other countries.
Research at UCL firmly established tacrolimus as the optimal calcineurin inhibitor to use in immunosuppressive regimens following liver transplantation. Compared to ciclosporin its use improved graft survival by 6% and patient survival by 7%. Assuming 550 liver transplants per year in the UK since 2008, we can estimate that, with 90% of patients treated with tacrolimus and 10% ciclosporin, tacrolimus-based immunosuppression has resulted in 165 grafts and 192 lives being saved during the period 2008-13.