Title: Atrial Fibrillation After Resection (AFAR): A PROGRESS III Study
Funder: Department of Health and Social Care

Abstract: Background Atrial fibrillation is an irregularly irregular heartbeat and occurs in around 1.5% of the population. It is associated with negative clinical outcomes such as cardiac failure and mortality. It is strongly implicated in the evolution of stroke, which carries significant burden and cost to patients and the NHS. Atrial fibrillation can be triggered by major physiological stresses such as surgery. The literature suggests that symptomatic atrial fibrillation occurs in 10% of patients within 90 days of surgery. This means that a proportion of patients may have undetected atrial fibrillation, and require treatment to reduce their risk of complications. As we move towards stratified and personalised medicine, it is important to identify the characteristics of the patients at risk of developing atrial fibrillation after surgery in order to mitigate the effects of the condition. This research group has proposed a basic model to stratify patients into high risk groups for post-operative atrial fibrillation, although this requires testing and refinement in a prospective study. Aims To estimate the rate of atrial fibrillation following colorectal cancer surgery and to characterise patients at highest risk of atrial fibrillation following surgery for colorectal cancer. Method A prospective study of patients over the age of 65 undergoing colorectal cancer resection will be conducted across 15 colorectal units in the UK. It will recruit 720 patients over an 18 month period. The study has been designed with regard to public and patient involvement. Patients over the age of 65 undergoing surgery for colorectal cancer with curative intent and no prior diagnosis of atrial fibrillation will be eligible for inclusion. Participants will be screened prior to entry with an ECG. Following consent, routine demographic data, EQ-5D-5L, and blood sample for Brain Natriuretic Peptide (BNP) will be collected. A 24-hour cardiac rhythm recording will be undertaken prior to surgery to confirm the absences of atrial fibrillation. ECG will be repeated on the day of discharge and 24 hour rhythm recordings repeated at 30 and 90 days post surgery. EQ-5D will be recorded at 90 days along with any use of health services for cardiac symptoms. Participants diagnosed with atrial fibrillation during the study will be directed to local inpatient or primary care services as appropriate. Demographic characteristics, ECG parameters and BNP will be combined with a previously derived model and tested for ability to predict atrial fibrillation. Timelines for delivery Ethical and HRA approvals will be secured Jun-Sep 2019. Site set up Sep 2019-Dec 2019. Recruitment over18 months from Jan 2020, with follow-ups completed by end ofOctober 2021. Analysis from November-December 2021 and reports and dissemination activities in Jan and Feb 2022. Anticipated impact and dissemination If we are able to identify patients at risk of atrial fibrillation, this study could benefit patients within a year of publishing findings. The results will be shared with NICE local exemplar guideline and South London AHSN atrial fibrillation best practice databases. Open access peer-reviewed publications will be prepared. Patient facing information will be prepared with the support of the lay co-applicant.

Lay abstract: Atrial fibrillation (AF) is a condition where the heart beats irregularly. Untreated, AF is associated with other health problems such as heart failure (accumulation of fluid on the lungs and tiredness/shortness of breath), stroke, and clots in blood vessel, and even early death. This affects around 4% of the population over 60 years old. Studies suggest the rate of AF following abdominal surgery is much higher at around 12% in the same age group. This may be due to the strain of surgery on the heart, which causes the change in rhythm. Because of how these studies were designed, we think that this underestimates the real number of people with an irregular heart beat after surgery. Our research has generated a risk prediction model, which we think we can use to identify people who are likely to get AF after surgery. The aims of this study are to identify the true rate of AF after colorectal cancer surgery, and to test whether our risk model can predict who is at risk. The AFAR study will undertake active surveillance for atrial fibrillation following colorectal cancer surgery. We will invite 720 patients awaiting surgery for colorectal cancer at one of 15 UK centres to participate. There will be no changes to treatment for the cancer, but participants will use portable monitors to record their heart rhythm for a 24 hour period in the weeks before surgery, and then at 30 & 90 days after surgery to see if people have developed an irregular heartbeat. We will undertake a standard heart tracing (ECG) on the day of discharge. We will also measure quality of life before surgery and at 90 days after surgery, as well as the need for any treatment for new heart problems. The results of this study may lead to routine screening for an irregular heartbeat after surgery, within 1-2 years of completion. If our predictive model is shown to work, this may also be used in clinical practice in a short period of time. We will share the findings through research publications, conferences, and with local health commissioners and cancer networks to help guide patient care. This study may help researchers to design research to prevent AF after surgery.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CARDIOVASCULAR;CANCER AND NEOPLASMS