Feasibility study of rehabilitation for cardiac patients aided by an artificial intelligence web-based programme: a randomised controlled trial (RECAP trial)-a study protocol.

INTRODUCTION: Cardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a reduction in cardiac mortality and recurrent myocardial infarction. This trial assesses the feasibility of a home-based CR programme delivered using a mobile application (app). METHODS: The Rehabilitation through Exercise prescription for Cardiac patients using an Artificial intelligence web-based Programme (RECAP) randomised controlled feasibility trial is a single-centre prospective study, in which patients will be allocated on a 1:1 ratio to a home-based CR programme delivered using a mobile app with accelerometers or standard hospital-based rehabilitation classes. The home-based CR programme will employ artificial intelligence to prescribe exercise goals to the participants on a weekly basis. The trial will recruit 70 patients in total. The primary objectives are to evaluate participant recruitment and dropout rates, assess the feasibility of randomisation, determine acceptability to participants and staff, assess the rates of potential outcome measures and determine hospital resource allocation to inform the design of a larger randomised controlled trial for clinical efficacy and health economic evaluation. Secondary objectives include evaluation of health-related quality of life and 6 minute walk distance. ETHICS AND DISSEMINATION: RECAP trial received a favourable outcome from the Berkshire research ethics committee in September 2022 (IRAS 315483).Trial results will be made available through publication in peer-reviewed journals and presented at relevant scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN97352737.

A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER).

OBJECTIVE: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. METHODS: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates. RESULTS: Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings. CONCLUSION: Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR. TRIAL REGISTRATION: ISRCTN80441309 (prospectively registered on 24/01/2019).

Disparity in clinical outcomes after cardiac surgery between private and public (NHS) payers in England.

BACKGROUND: There is little known about how payer status impacts clinical outcomes in a universal single-payer system such as the UK National Health Service (NHS). The aim of this study was to evaluate the relationship between payer status (private or public) and clinical outcomes following cardiac surgery from NHS providers in England. METHODS: The National Adult Cardiac Surgery Audit (NACSA) registry was interrogated for patients who underwent adult cardiac surgery in England from 2009 to 2018. Information on socioeconomic status were provided by linkage with the Iteration of the English Indices of Deprivation (IoD). The primary outcome was in-hospital mortality. Secondary outcomes included incidence of in-hospital postoperative cerebrovascular accident (CVA), renal dialysis, sternal wound infection, and re-exploration. To assess whether payer status was an independent predictor of in-hospital mortality, binomial generalized linear mixed models (GLMM) were fitted along with 17 items forming the EuroSCORE and the IoD domains. FINDINGS: The final sample consisted of 280,209 patients who underwent surgery in 31 NHS hospitals in England from 2009 to 2018. Of them, 5,967 (2.1%) and 274,242 (97.9%) were private and NHS payers respectively. Private payer status was associated with a lower risk of in-hospital mortality (OR 0.79; 95%CI 0.65 - 0.97;P = 0.026), CVA (OR 0.77; 95%CI 0.60 - 0.99; P = 0.039), need for re-exploration (OR 0.84; 95%CI 0.72 - 0.97; P = 0.017) and with non-significant lower risk of dialysis (OR 0.84; 95%CI 0.69 - 1.02; P = 0.074). Private payer status was found to be independently associated with lower risk of in-hospital mortality in the elective subgroup (OR 0.76; 95%CI 0.61 - 0.96; P = 0.020) but not in the non-elective subgroup (OR 1.01; 95%CI 0.64 - 1.58; P = 0.976). INTERPRETATION: In conclusion, using a national database, we have found evidence of significant beneficial effect of payer status on hospital outcomes following cardiac surgery in favour of private payers regardless their socioeconomic factors.

A nationwide survey of UK cardiac surgeons' view on clinical decision making during the coronavirus disease 2019 (COVID-19) pandemic.

BACKGROUND: No firm recommendations are currently available to guide decision making for patients requiring cardiac surgery during the coronavirus disease 2019 (COVID-19) pandemic. Systematic appraisal of senior surgeons' consensus can be used to generate interim recommendations until data from clinical observations become available. Hence, we aimed to collect and quantitatively appraise nationwide UK consultants' opinions on clinical decision making for patients requiring cardiac surgery during the COVID-19 pandemic. METHODS: We E-mailed a Web-based questionnaire to all consultant cardiac surgeons through the Society for Cardiothoracic Surgery in Great Britain and Ireland mailing list on the April 17, 2020, and we predetermined to close the survey on the April 21, 2020. This survey was primarily designed to gather information on UK surgeons' opinions using 12 items. Strong consensus was predefined as an opinion shared by at least 60% of responding consultants. RESULTS: A total of 86 consultant surgeons undertook the survey. All UK cardiac units were represented by at least 1 consultant. Strong consensus was achieved for the following key questions: (1) before any hospital admission for cardiac surgery, nasopharyngeal swab, polymerase chain reaction, and computed tomography of the chest should be performed; (2) the use of full personal protective equipment should to be adopted in every case by the theater team regardless of the patient's COVID-19 status; (3) the risk of COVID-19 exposure for patients undergoing heart surgery should be considered moderate to high and likely to increase mortality if it occurs; and (4) cardiac procedures should be decided based on a rapidly convened multidisciplinary team discussion for every patient. The majority believed that both aortic and mitral surgery should be considered in selected cases. The role of coronary artery bypass graft surgery during the pandemic was controversial. CONCLUSIONS: In this unprecedented pandemic period, this survey provides information for generating interim recommendations until data from clinical observations become available.

Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial.

BACKGROUND: Aortic valve replacement is one of the most common cardiac surgical procedures performed worldwide. Conventional aortic valve replacement surgery is performed via a median sternotomy; the sternum is divided completely from the sternal notch to the xiphisternum. Minimally invasive aortic valve replacement, using a new technique called manubrium-limited ministernotomy, divides only the manubrium from the sternal notch to 1 cm below the manubrio-sternal junction. More than one third of patients undergoing conventional sternotomy develop clinically significant bleeding requiring post-operative red blood cell transfusion. Case series data suggest a potentially clinically significant difference in red blood cell transfusion requirements between the two techniques. Given the implications for National Health Service resources and patient outcomes, a definitive trial is needed. METHODS/DESIGN: This is a single-centre, single-blind, randomised controlled trial comparing aortic valve replacement surgery using manubrium-limited ministernotomy (intervention) and conventional median sternotomy (usual care). Two hundred and seventy patients will be randomised in a 1:1 ratio between the intervention and control arms, stratified by baseline logistic EuroSCORE and haemoglobin value. Patients will be followed for 12 weeks from discharge following their index operation. The primary outcome is the proportion of patients who receive a red blood cell transfusion post-operatively within 7 days of surgery. Secondary outcomes include red blood cell and blood product transfusions, blood loss, re-operation rates, sternal wound pain, quality of life, markers of inflammatory response, hospital discharge, health care utilisation, cost and cost effectiveness and adverse events. DISCUSSION: This is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and provide the community with the knowledge required to inform future care for patients requiring aortic valve replacement surgery. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN29567910 . Registered on 3 February 2014.