COHORT MULTIPLE RANDOMISED TRIALS A plan to address the research priorities identified by the James Lind Alliance Priority Setting Partnership in Adult Cardiac Surgery.
Funded by In partnership with
SCTS Society for Cardiothoracic Surgery in Great Britain and Ireland UNIVERSITY OF LEICESTER UNIVERSITY OF LEICESTER
FOREWORD
UK cardiovascular research is world leading in terms of quality and impact. This is attributable to our unique NIHR research infrastructure and funding that makes the NHS the best environment in the world to undertake clinical research, combined with over £100m per year from the British Heart Foundation, the world’s largest funder of research into cardiovascular disease. Cardiac surgery in the UK has the capacity to deliver world class clinical research, and has produced many pivotal trials over the last 5-10 years. However, as a specialty, cardiac surgery is undergoing a period of transition, with increasingly elderly and frail patients referred for surgery, and the continuous development of new less invasive techniques and devices. Continuing to deliver the best personalised care to patients in these circumstances requires high quality evidence based on research. The research environment is also changing; clinical research is now undertaken by interdisciplinary teams of professionals with diverse skills. Important questions are also often best addressed by national and international networks of researchers. Patients and the public must also be central to all our research activities. This report describes an approach to cardiac surgery research that will address the changing environment, capitalise on our unique research infrastructure, and result in the best care for our patients. First, we will focus our endeavours on the questions that matter most to patients and clinicians. Patients must be at the centre of our research, and continue as partners and advocates through the lifetime of the research programme. Second, we will come together as a specialty to undertake high quality research in every UK cardiac centre. This research must be interdisciplinary and of the highest quality. Third, we must develop a cohort of young researchers, both trainee surgeons as well as nurses and allied health professionals, who will emerge as research leaders within the next decade. Finally we must create lean, pragmatic research platforms that are attractive to industry partners to enable accelerated technology transfer and device evaluation, as these represent the future of our specialty. This report we hope will form the basis for a conversation that will enable all stakeholders to contribute to the process, and ensure that we can translate CONTENTS our research priorities into a research programme that will lead to better care for patients. 3 FOREWORD
4 A NATIONAL CLINICAL TRIALS PROGRAMME IN ADULT CARDIAC SURGERY
5 PROJECT MILESTONES
6 THE TOP TEN PRIORITIES FOR ADULT CARDIAC SURGERY RESEARCH
8 ADDRESSING RESEARCH PRIORITIES USING A COHORT MULTIPLE RCT DESIGN Professor Gavin Murphy, BHF Chair of Cardiac Surgery 12 FORMULATING RESEARCH QUESTIONS
16 BIBLIOGRAPHY
17 NEXT STEPS
18 ACKNOWLEDGEMENTS AND DISCLAIMER
2 3 UNIVERSITY OF LEICESTER
A NATIONAL CLINICAL PROJECT TRIALS PROGRAMME IN MILESTONES ADULT CARDIAC SURGERY
RATIONALE IMPLEMENTATION THE NEXT 10 YEARS Patients undergoing cardiac surgery in the Infrastructure: In 2017, the BHF The UK presents a unique environment for United Kingdom benefit from the highest established a clinical trials funding clinical research and innovation in cardiac quality care. However, as a discipline, committee with an emphasis on the surgery that will benefit patients and the FEBRUARY 2017 cardiac surgery faces multiple challenges. delivery of large pragmatic trials. In NHS. The next step is to develop a platform Patients referred for cardiac surgery are addition, in 2018, the BHF also established that can deliver a portfolio of clinical British Heart Foundation identifies the need to develop increasingly elderly, often with multiple a new Clinical Research Collaborative to trials that address the national research a consensus around clinical research priorities. chronic conditions, and require more coordinate interdisciplinary multicentre priorities. complex surgery than historical cohorts. trials in cardiovascular disease. NOVEMBER 2017 In addition, new and potentially better Heart Research UK funds the Heart Surgery National Priority Setting: In 2017, diagnostic tests, less invasive treatments, Priority Setting Partnership (PSP). Heart Research UK funded the James and devices, are being introduced into Lind Alliance Priority Setting Partnership MARCH 2018 clinical care at an accelerating rate. The in Adult Cardiac Surgery. This identified best way to adapt to these challenges, and Launch of First PSP Survey at Society for the Top 10 research priorities for patients, to maintain the highest standards of care Cardiothoracic Surgeons (SCTS) in the UK carers and clinicians. These priorities have for patients, is through research. It is only and Ireland Annual Meeting, Glasgow. been converted to research questions that through the generation of high quality @heartsurgerypsp Twitter account launched. can be answered by clinical trials evidence that we will be able to direct the JUNE 2018 (see below). best care, to the individual patient, at the Cochrane Heart Group joins the right time. Academic training: In 2017, the Society Priority Setting Partnership for Cardiothoracic Surgery in Great Britain STRATEGY and Ireland, along with the Royal College of Surgeons of England’s Clinical Trials In 2017, the British Heart Foundation Initiative funded the training of junior NOVEMBER 2018 Workshop for Cardiovascular Surgery surgeons in clinical trial methodology and First Survey closes. 1080 questions submitted Research identified priority areas for the establishment of an Interdisciplinary by 629 participants. Duration was 9 months, development: Research Network of Associate Principal DECEMBER 2018 averaging 70 participants per month. 1. The need for investment in clinical Investigators in every UK cardiothoracic trials research infrastructure. centre. These initiatives will, we hope, Literature review, duplicate questions combined, nurture next generation of research already-addressed questions removed. 2. The development of a portfolio of leaders. 49 unanswered summary questions identified. pragmatic trials based on a national priority setting process. Partnerships: Accelerated technology transfer and strategic partnerships with 3. The need for investment in industry are embedded in the 2018 Life MARCH 2019 academic training. Sciences Sector Deal. Cardiovascular Second Survey launched at SCTS Annual 4. The development of strategic surgery is characterised by rapid Meeting, Westminster, London. partnerships with industry and technological advancement and universities to facilitate technology innovation and represents an area JUNE 2019 for further growth in industry funded transfer and the rapid evaluation Second Survey closes. 492 participants. evaluation of percutaneous and of devices. Questions narrowed down to 21 summary questions. minimally invasive techniques. JULY 2019 Final Workshop, attended by patient, carer and clinician representatives at Leicester. TOP 10 PRIORITISED QUESTIONS
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THE TOP TEN PRIORITIES FOR ADULT CARDIAC SURGERY RESEARCH
1 2 3 4 5
QUALITY OF LIFE FRAILTY CHRONIC CONDITIONS PREHABILITATION HEART VALVE INTERVENTION
How does a patient’s quality of life How can we address frailty and How can we improve the outcomes Does prehabilitation (a programme When should heart valve intervention (QOL) change (e.g. disability-free improve the management of frail of heart surgery patients with of nutritional, exercise and occur for patients without symptoms? survival) following heart surgery patients in heart surgery? chronic conditions (obesity, psychological interventions before and what factors are associated diabetes, hypertension, renal failure, surgery) benefit heart surgery with this? autoimmune diseases etc.)? patients?
6 7 8 9 10
SURGICAL METHODS ORGAN DAMAGE 3D BIO-PRINTING ATRIAL FIBRILLATION INFECTION
How does minimally invasive heart How do we minimise damage to Can we use 3D bio-printing or stem What are the most effective ways How do we reduce and manage surgery compare to traditional organs from the heart-lung machine/ cell technology to create living tissues of preventing and treating post- infections after heart surgery open surgery? heart surgery (heart, kidney, lung, (heart valves/heart) and repair failing operative atrial fibrillation? including surgical site/sternal wound brain and gut)? hearts (myocardial regeneration)? infection and pneumonia?
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ADDRESSING RESEARCH PRIORITIES USING A COHORT MULTIPLE RCT DESIGN
WHAT: WHY: HOW: COCHRANE COLLABORATION Cohort Multiple RCTs recruit participants This approach combines the advantages of Cochrane Heart will commission a to a longitudinal cohort study with long- traditional RCTs (high quality evidence) and ESTABLISH THE UK CARDIAC series of systematic reviews to address term follow-up, preferably using routinely registry data sources (lean, efficient design) SURGERY TRIALS COHORT the research questions generated by collected healthcare data. The cohort and is particularly suited to pragmatic trials. A consecutive cohort of adult cardiac the Priority Setting Partnership. These also serves to identify those patients who surgery patients in every UK unit who will will define knowledge gaps that can should be eligible for randomisation within consent to storage of their clinical records be addressed by RCTs, and inform individual RCTs of interventions that also including imaging and laboratory data, trial design. utilise the cohort follow-up mechanism to linkage of their Hospital Episode Statistics assess outcomes. and Office of National Statistics data, and IN SILICO TRIALS agree to remote follow-up using digital Trials will be modelled in silico using data capture from smartphones to measure existing HES and ONS data. This provides quality of life, and activity. information on patient populations, A COHORT MULTIPLE RANDOMISED TRIALS APPROACH TO ADDRESS Participants will be phenotyped for frailty numbers of eligible patients and sites, THE NATIONAL RESEARCH PRIORITIES IN CARDIAC SURGERY and chronic conditions at baseline and event rates for short- and long-term screening for recruitment to trials of novel outcomes and unwarranted variation tests, devices and interventions. in care. Statistical techniques in causal inference will be used to model This work will be supported by the new Regular cohort follow up via HES/ONS treatment effects. Routinely collected BHF Cardiovascular Data Science Centre/ health data can also be used to model Health Data Research UK partnership. treatment effects within subgroups, as well as generalisability to the MULTIPLE RCTS patient population. The cohort will serve as a platform to UK Cardiac Surgery Platform Cohort recruit patients to trials of novel diagnostic PATIENT AND PUBLIC tests and interventions that aim to reduce INVOLVEMENT Consent for access to all digital records, HES data, and ONS data. Baseline phenotyping of the risk of organ failure in the short term The programme will build on established (Priority 7), and/or improve long-term chronic conditions and frailty, assessment of long-term quality of life with e-monitoring PPI networks such as the Priority Setting outcomes and quality of life (Priority 1). Partnership Steering Committee, Aortic Candidates for novel interventions are Dissection Awareness, The UK Mini Prehabilitaion (Priority 4), minimally invasive Mitral Trial, the National Cardiac surgery (Priority 6), percutaneous devices Benchmarking Collaborative, and patient for valve repair (Priority 19), or surgical groups affiliated to the British Heart site infection prevention (Priority 10). The Patients eligible for Trial A Foundation and Heart Research UK. randomised to treatment nature of the cohort platform design will allow evaluation of the interaction between and control frailty phenotypes and treatment effects within trials, thereby providing evidence Patients eligible for Trial B for personalised medicine in higher risk cohorts. randomised to treatment and control
Patients eligible for Trial C (industry/Pharma) randomised to treatment and control
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MIXED METHODS EVALUATION CLINICAL TRIALS UNITS ADDED VALUE The NIHR Research Design Service will Methodological support will be provided Interdisciplinary research networks: advise on the development of an integrated by researchers from the UKCRC Accredited In the UK cardiothoracic surgery trainees, mixed methods approach to these trials. Clinical Trials Units in Bristol, Oxford, nurses and allied health professionals This will directly inform decision makers Newcastle, Leicester, and Leeds. have formed an interdisciplinary research and commissioners as to the value of network of associate principal investigators implementation of new treatments GOVERNANCE who are participating in multiple research and tests. projects. This initiative will attract, train The BHF Clinical Research Collaborative and develop the next generation of clinical Process: Process evaluations within these will host governance committees. The researchers. It has already identified young trials will assess the fidelity and quality of Executive of the Society for Cardiothoracic researchers who are currently undergoing implementation of interventions, clarify Surgery will host an oversight committee. training in research methods as part of causal mechanisms, and identify An external oversight committee will be the Royal College of Surgeons Clinical contextual factors associated with composed of an international panel of Trials Initiative. It is envisaged that these variation in outcomes. leading clinical researchers. individuals will lead the UK Cardiac Surgery Behaviour: The QUINTET approach Trials Cohort and associated trials in future. will be used to enhance participation by Technology Transfer and Strategic medical staff, recruitment of participants, Partnerships with Industry: The UK adherence, and follow-up. Cardiac Surgery Cohort will be attractive Quality of life: Long-term quality of life to device manufacturers and will facilitate will be assessed during follow-up using a the evaluation and introduction of new smartphone app. This facilitates message technologies. reminders to complete the assessments, Translational Research: The BHF NIHR and enables direct, secure, data transfer Cardiovascular Partnership brings together to trial databases. the BHF Centres of Research Excellence Health economics: Hospital Episode and Research Accelerators with the NIHR Statistics were originally designed for audit Biomedical Research Centres that have and billing and allow health technology cardiovascular themes. Areas of potential assessments to evaluate cost effectiveness. synthesis include the rapid translation of successful early stage trials to evaluation of clinical and cost effectiveness, as well as potentially reverse translation through the collection of human tissue biopsies for early phase research and molecular phenotyping.
Professor Gavin Murphy, who commissioned the Heart Surgery PSP, operates with a colleague during a cardiac surgery procedure at Glenfield Hospital, Leicestershire.
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FORMULATING RESEARCH QUESTIONS
Rationale: The four top research priorities No treatment guideline makes specific Rationale: People with severe valve POTENTIAL RESEARCH address the most commonly expressed recommendations as to the management disease take years to develop symptoms QUESTIONS concerns of patients and clinicians: How of chronic conditions affecting the lungs, that include shortness of breath, chest do we identify and stratify often elderly kidneys, or other organ systems, in patients pain, or even sudden death. Some patients • Can B-type natriuretic peptide (BNP) patients with multiple chronic conditions referred for cardiac surgery. Guidelines may never develop symptoms at all. Major levels guide the timing for intervention where their cardiac disease is considered do make recommendations as to the heart surgery is a very good treatment for on the aortic valve? an indication for surgery? These conditions perioperative management of diabetes, patients with symptoms but can cause • Is aortic flow peak velocity an adequate PRIORITY 1 (3) PRIORITY 5 can contribute to frailty, a poorly defined however these are of low certainty . complications and is often associated criterion to plan surgery on asymptomatic How does a patient’s quality of life condition not incorporated in existing When should heart valve with prolonged recovery. The dilemma is A review of AHA and ESC guidelines for patients? (QOL) change (e.g. disability-free risk scores. Frail patients and those with intervention occur for patients therefore: should we operate in everyone the treatment of ischaemic heart disease survival) following heart surgery multiple comorbidities often do not without symptoms? when valve disease is severe to avoid the • Does mid-wall myocardial fibrosis and valvular disease identifies class I level and what factors are associated experience the long-term benefits of risk of heart failure and death or wait until findings at cardiac magnetic resonance B recommendations for frailty. These with this? surgery that underpin existing treatment symptoms develop so that patients are (CMR) have a role in the timing of recognise the need for frailty assessment guidelines. Personalised interventions that spared unnecessary major surgery? surgery in asymptomatic patients with in guiding clinical practice, but there is no target these conditions, or treatments severe aortic valve disease? consensus as to which score or thresholds Evidence gap: Recommendations for valve stratified by objective markers of frailty can inform treatment decisions (4). interventions in asymptomatic patients • Does longitudinal strain measurement may have patient benefits. are of low certainty (4, 5). Advancements have a role in the timing of surgery in (1, 2) asymptomatic mitral valve regurgitation? Evidence gap: Systematic reviews POTENTIAL RESEARCH in medical therapy, new risk stratification report low to moderate certainty as to QUESTIONS tools such as cardiac Magnetic Resonance PRIORITY 2 the long-term benefits in quality of life Imaging, and changes in the diagnostic following cardiac surgery, due primarily to • Can we identify specific frailty criteria of severity create new areas of How can we address frailty poor data, non-random attrition in existing phenotypes that do not derive benefits uncertainty to be addressed by research and improve the management of trials, and poor validation of existing quality from surgery versus other treatments? in the future. frail patients in heart surgery? of life metrics in non-coronary artery • Are there specific pre-surgery disease populations. interventions that can be targeted to patients with chronic conditions or frailty POTENTIAL RESEARCH • Do specific surgical techniques QUESTIONS (e.g. minimally invasive surgery), • What is the best tool to assess or percutaneous approaches improve Quality of Life (QOL) in specific outcomes in populations with chronic Rationale: New techniques have been POTENTIAL RESEARCH PRIORITY 3 cardiac surgery disease? diseases? developed that allow surgery to be QUESTIONS performed through smaller incisions, or How can we improve the outcomes • What modifiable factors can be • Are pre-surgery interventions feasible without the use of the heart lung machine. • Is minimally invasive surgery clinically of heart surgery patients with targeted to improve QOL. in non-elective surgery? These operations reduce the extent of the or cost effective? chronic conditions (obesity, • Are there important QOL benefits • Does prehabilitation improve outcomes surgical incision, but they are technically • What is the optimal communication diabetes, hypertension, renal in elderly patients who undergo in frail patients? PRIORITY 6 more challenging and therefore have strategy to present the choice between failure, autoimmune diseases etc.)? cardiac surgery? potential additional risks. Whether these minimally invasive and traditional surgery • What are the best nutritional strategies How does minimally invasive operations are better than traditional open to the patients? • What is the long-term comparison in for prehabilitation? heart surgery compare to surgery or new percutaneous techniques terms of QOL between surgical and traditional open surgery? • What are the requirements for the • Does prehabilitation have long-term and devices is unclear. interventional approach? provision of specialised minimally invasive benefits? Evidence gap: Minimally invasive cardiac surgery services? • Should we design prehabilitation procedures have been shown to limit • Is there a difference in long-term programs specific to patient groups perioperative bleeding and blood QOL between minimally invasive and PRIORITY 4 and type of cardiac surgery? transfusion in trials. However, there is uncertainty as to the clinical benefits to traditional surgery? Does prehabilitation patients from minimally invasive valve (a programme of nutritional, or endovascular treatments of aortic exercise and psychological disease (6, 7). interventions before surgery) benefit heart surgery patients?
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Rationale: Organ injury or failure POTENTIAL RESEARCH Rationale: New onset atrial fibrillation can POTENTIAL RESEARCH affecting the heart, lung, brain, or kidneys, QUESTIONS occur in about 30% of people undergoing QUESTIONS complicates up to 50% of all cardiac heart surgery where it is associated with • Does pre-surgery optimisation of chronic • Do preoperative lifestyle interventions surgery operations and costs the NHS morbidity including stroke, prolonged kidney, lung, or metabolic diseases such as weight loss or exercise have a £125m per year. hospitalisation, and increased healthcare reduce post-surgery lung and kidney role in postoperative atrial fibrillation costs. There are no effective interventions Evidence gap: Organ protection is a major injury or infection. prevention? that prevent or reduce the frequency of PRIORITY 7 theme in cardiac surgery research and PRIORITY 9 • Do personalised perioperative treatment postoperative atrial fibrillation. • Does attenuating the inflammatory strategies tailored to optimise this outcome How do we minimise damage to algorithms based on enhanced What are the most effective response to surgery reduce post- are considered in all major guidelines (3-5, Evidence Gap: The evidence in organs from the heart-lung machine/ monitoring of tissue oxygenation or ways of preventing and treating operative atrial fibrillation? 8-10). However, despite decades of research, favour of both pharmacological and heart surgery (heart, kidney, lung, vascular function during surgery prevent post-operative atrial fibrillation? the pathogenesis of these conditions non-pharmacological prophylaxis is • Is rhythm control or rate control the brain and gut)? organ injury. remains poorly understood and effective low because of the quality and the optimal management strategy in every organ protection interventions are not in • Are there pharmacological strategies heterogeneity of the data, and choice of patient subgroup? widespread use. or other interventions (fluid restriction, the best individualized intervention for • Is surgical ablation safe and effective in enhanced recovery, extracorporeal circuit patients is still problematic (13). Moreover, longstanding persistent atrial fibrillation? modification) that attenuate the effects recommendations for management of of surgery on organ function. anticoagulation in postoperative atrial • Is hybrid (endocardial + epicardial) atrial fibrillation in the EACTS guidelines are fibrillation ablation superior to surgical • Can novel myocardial protection still class IIa level C (3). and transcatheter interventions? strategies improve clinical outcomes. • What is the optimal management of • Which perfusion strategy should we post-operative atrial fibrillation in heart adopt for aortic dissection? failure patients?
Rationale: 3D printing in combination POTENTIAL RESEARCH Rationale: The 2017 Public Health England POTENTIAL RESEARCH with stem cell technology offers the QUESTIONS SSI report (PHER 2017) stated that the QUESTIONS potential for surgical prosthesis that have incidence of SSIs in UK cardiac surgery This research is still largely in the early • How effective is preoperative skin enhanced durability, low thrombogenicity, centres was 3.8% following coronary translational phase in cardiac surgery and antisepsis in preventing surgical and plasticity. This would reduce the artery bypass grafts (CABG) and 1.7% in no specific research questions that could infection? requirements for repeated procedures over non-CABG operations. This is associated be addressed by pragmatic clinical trials the lifetime of the patient, as well as both with a 10-fold increase in mortality, a • What is the optimal ventilation PRIORITY 8 were identified. PRIORITY 10 the need for anticoagulation and risk six-fold increase in the risk of readmission management to prevent postoperative Can we use 3D bio printing or stem of thrombosis. How do we reduce and manage to hospital. In the UK the annual costs pneumonia? cell technology to create living infections after heart surgery of treating in SSIs in cardiac surgery is Evidence gap: No RCTs were identified • How do we manage steroid therapy tissues (heart valves/heart) and including surgical site/sternal approximately £30m. Likewise, pulmonary regarding 3D bio-printing using the in the perioperative period to avoid repair failing hearts (myocardial wound infection and pneumonia? complications such as lower respiratory tailored search strategy we adopted. complication on wound healing? regeneration)? tract infection can lead to prolonged ICU Systematic reviews identified a total of and hospital stay and result in a six-fold • Do microbial sealants prevent surgical 1907 participants in 38 trials on stem cell increase in mortality. site infection? therapy for chronic ischaemic heart disease (CHD) and 2732 participants in 41 trials on Evidence Gap: The Cardiothoracic • Which interventions should be part of stem cell treatment for acute myocardial Interdisciplinary Research Network has a care bundle to prevent surgical site infarction (AMI) (11, 12). These trials did not recently completed a Cochrane systematic infection in cardiac surgery? demonstrate efficacy however there were review of trials of interventions to prevent • What is the optimal surgical antibiotic important design limitations in all of these or reduce surgical site infections in cardiac prophylaxis and duration? trials that limited interpretation. The most surgery. Identified evidence gaps related effective mode of stem cell delivery was not to choice of preoperative skin antiseptic, • Are interventions to prevent infection resolved by these trials. antibiotic prophylaxis duration and choice, applicable to hybrid cardiac surgery dexamethasone effect on wound healing, procedures? dressing removal time, and benefits of microbial sealants. Evidence on the prevention of post-surgery lower respiratory tract infection has developed in largely non-cardiac surgical settings.
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BIBLIOGRAPHY NEXT STEPS
1. Huffman MD, Karmali KN, Berendsen MA, Andrei AC, Kruse J, McCarthy PM, et al. It is proposed that researchers in DISSEMINATION PARTNERSHIPS Concomitant atrial fibrillation surgery for people undergoing cardiac surgery. the UK undertake a programme of The Priority Setting Partnership The success of this proposal will require The Cochrane database of systematic reviews. 2016(8):Cd011814. world leading clinical trials in adult dissemination plan includes the production successful partnerships with the NIHR cardiac surgery that address these 2. Sibilitz KL, Berg SK, Tang LH, Risom SS, Gluud C, Lindschou J, et al. Exercise-based of a short report that will be shared via Research Design Service, the British research priorities. cardiac rehabilitation for adults after heart valve surgery. The Cochrane database of social media, newsletters, websites, and Heart Foundation Clinical Research systematic reviews. 2016;3:Cd010876. via presentations at conferences and Collaborative, the NIHR BHF Cardiovascular workshops. A full report will be drafted Partnership, the BHF Cardiovascular Data 3. Sousa-Uva M, Head SJ, Milojevic M, Collet JP, Landoni G, Castella M, et al. 2017 for publication in a peer-reviewed journal. Science Centre/Health Data Research EACTS Guidelines on perioperative medication in adult cardiac surgery. Eur J All of the non-clinical members of the UK partnership, the Clinical Research Cardiothorac Surg. 2018;53(1):5-33. Priority Setting Partnership have committed Networks, Patient and Public Groups 4. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Guyton RA, et al. 2014 to further dissemination activities within affiliated to British Heart Foundation, and AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a their own networks and these individuals the Royal College of Surgeons of England report of the American College of Cardiology/American Heart Association Task Force will support the PPI components of the Surgical Trials initiative. on Practice Guidelines. Circulation. 2014;129(23):e521. proposed trials programme. 5. Falk V, Baumgartner H, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al. 2017 ESC/EACTS INDUSTRY Guidelines for the management of valvular heart disease. European journal of FUNDERS The medical directors of technology cardio-thoracic surgery : official journal of the European Association for This document will be shared with NETCC, companies who provide devices for cardiac Cardio-thoracic Surgery. 2017;52(4):616-64. the British Heart Foundation, the Medical surgery will be approached for advice on 6. Abraha I, Romagnoli C, Montedori A, Cirocchi R. Thoracic stent graft versus surgery Research Council, Heart Research UK the design of the cohort to ensure buy-in for thoracic aneurysm. Cochrane Database of Systematic Reviews. 2016(6). and other funders with the intention of for this initiative. informing commissioning and funding calls. 7. Kirmani BH, Jones SG, Malaisrie SC, Chung DA, Williams RJ. Limited versus full INTERNATIONAL sternotomy for aortic valve replacement. The Cochrane database of systematic RESEARCHERS COLLABORATIONS reviews. 2017;4:Cd011793. The Priority Setting Partnership has included The Cardiothoracic Surgical Trials 8. Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, et al. 2014 representatives of Cochrane Heart who Network in North America are now midway ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering have developed a parallel programme of through their second 5-year programme acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. systematic reviews to identify evidence gaps of pragmatic multicentre RCTs. Their The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European related to the Priority Setting Partnership executive group have expressed an interest Society of Cardiology (ESC). European heart journal. 2014;35(41):2873-926. research priorities. in joint projects. Clinical researchers in Australia have also indicated their desire 9. Hiratzka LF, Bakris GL, Beckman JA, Bersin RM, Carr VF, Casey DE, et al. 2010 ACCF/ It is also envisaged that the research to undertake joint projects. AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM guidelines for the diagnosis and priorities will guide the development of management of patients with Thoracic Aortic Disease: a report of the American research programmes and prompt research College of Cardiology Foundation/American Heart Association Task Force on groups to address the resulting research Practice Guidelines, American Association for Thoracic Surgery, American College of questions in future proposals. Radiology, American Stroke Association, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Thoracic Surgeons, and Society for Vascular Medicine. Circulation. 2010;121(13):e266. 10. Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019;55(1):4-90. 11. Fisher SA, Doree C, Mathur A, Taggart DP, Martin-Rendon E. Stem cell therapy for chronic ischaemic heart disease and congestive heart failure. Cochrane Database of Systematic Reviews. 2016(12). 12. Fisher SA, Zhang H, Doree C, Mathur A, Martin-Rendon E. Stem cell treatment for acute myocardial infarction. Cochrane Database of Systematic Reviews. 2015(9). 13. Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, et al. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery.The Cochrane database of systematic reviews. 2013(1):Cd003611.
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ACKNOWLEDGEMENTS AND DISCLAIMER
This report is based on a James Lind MEMBERS OF THE STEERING • Professor Rod Stables, British Alliance (JLA) priority setting process, GROUP WERE: Cardiovascular Society, Academic which was commissioned and funded and Research Committee Chair • Anthony Locke, Leicestershire Cardiac by Heart Research UK for adults Surgery Patient and Public Involvement • Carol Akroyd, East Midlands Centre involved in cardiac surgery. The views Group, NIHR Senior PPI panel for Black and Minority Ethnic Health expressed in the publication are those & Collaboration for Leadership in of the author(s) and not necessarily • Peter Read, Leicester Cardiac Surgery Applied Health Research Prevention those of the Heart Research UK, British PPI Group Theme Manager Heart Foundation, James Lind Alliance, • Trevor Fernandes, Cardiovascular Care the NIHR, its arm’s length bodies or • Harpal Ghattoraya, Research Delivery Patients (CPPUK) and Wider Community other government departments. Manager, NIHR Clinical Research Patient Links Network (CRN) • Richard Fitzgerald*, (CPPUK) and Wider REPORT AUTHORS • Mr Peter Braidley, Consultant Cardiac Community Patient Links (deceased) • Professor Gavin Murphy BHF Chair of Surgeon, Sheffield University Hospitals, Cardiac Surgery, University of Leicester, • Zena Jones, Patient Representative, Heart Research UK Trustee Health Watch County Durham Society for Cardiothoracic Surgery in • Dr Nazish Khan, Principal Pharmacist Great Britain and Ireland, Academic • Jonathan Stretton-Downes, Cardiac Services, The Royal and Research Committee Chair Six Times Open Wolverhampton Hospitals NHS Trust • Dr Riccardo Abbasciano, Clinical • Grace Stretton-Downes, Family • Ms Katherine Cowan (PSP Chair, JLA Research Fellow, University of Leicester Member Representative Senior Adviser), The James Lind Alliance (JLA) • Miss Bethany Tabberer, Clinical Trials • Professor Gavin Murphy BHF Chair of Administrator, University of Leicester Cardiac Surgery, University of Leicester, • Mrs Tracy Kumar, Senior Research • Mrs Tracy Kumar, Senior Research Society for Cardiothoracic Surgery in Manager, University of Leicester Great Britain and Ireland, Academic and Manager, University of Leicester • Mrs Florence Lai, Statistician, Research Committee Chair • Mr Hardeep Aujila, Clinical Trial University of Leicester • Mr Enoch Akowuah, Consultant Co-ordinator, University of Leicester • Mrs Clare Gillies, Lecturer in Medical Cardiac Surgeon, James Cook Hospital, Statistics, University of Leicester • Mrs Florence Lai, Statistician, Middlesbrough, member of the British University of Leicester Cardiac Society, Heart Valve Clinical • Mrs Selina Lock, Research Information If you have any queries or comments Studies Group Advisor, University of Leicester about this work, please contact: • Professor Mahmoud Loubani, MEMBERS OF THE PROJECT [email protected] Hon Professor of Cardiothoracic Surgery, University of Hull TEAM WERE: Further information about the project • Mrs Sue Page, PA to Professor Gavin can be found at: • Professor Julie Sanders, Director Clinical Research, Quality and Innovation, Murphy, University of Leicester www.le.ac.uk/heart-surgery-psp St Bartholomew’s Hospital • Mrs Tracy Kumar, Senior Research • Professor John Pepper, Professor of Manager, University of Leicester Cardiothoracic Surgery, Imperial • Mr Hardeep Aujla, Clinical Trial College London Co-ordinator, University of Leicester • Professor Andrew Klein, Mackintosh • Miss Bethany Tabberer, Clinical Trials Professor of Anaesthesia, Royal Papworth Administrator, University of Leicester Hospital NHS Trust, Association of Cardiothoracic Anaesthesia Research • Carrie Ackrill, Heart Surgery PSP Subcommittee Chair Administrator, University of Leicester
The Project Team and Steering Group members would like to thank Richard Fitzgerald 18 19 for his contribution to the Heart Surgery PSP until his passing in 2019. 1234_01/11
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+44 (0)116 258 3021 [email protected] www.le.ac.uk/heart-surgery-psp e: w: t: Glenfield Hospital Leicester LE3 9QP Clinical Sciences Wing Clinical Sciences Heart Surgery PSP Project Team Heart Surgery of Cardiovascular Sciences Department