OxValve - Survival following a diagnosis of Valvular Heart Disease in a primary care population (OxValve-Survive)

The main function of the heart is to pump blood around the body. There are four main valves in the heart which ensure the blood travels in the right direction. If the valves become narrowed or leaky, this can mean the heart functions less efficiently.

Valvular heart disease (VHD) occurs when one or more valves does not form properly before birth (congenital) or if they are damaged (acquired) during life. In the developing world, infections such as rheumatic fever are still prevalent and can cause valve damage. In the UK and other developed countries, the most common cause of VHD is degeneration - wear and tear - over time.

When the heart valves don’t work properly, the heart muscle may need to work harder to cope. If valves become narrowed (stenosis), more pressure is needed to force the blood through them, and if they become leaky (regurgitation), more blood flows back into the heart chamber and needs to be pumped out again.

Over time, VHD can cause the heart to stop working properly. Some people may experience symptoms such as breathlessness, chest pain or passing out, while for others, problems with their valves will not cause them any difficulties. The treatment for severe VHD is surgery but this has risks. Identifying people who need to have an operation to deal with symptoms, or prevent future problems, and are well enough to have the procedure, is important.

The burden of VHD in the community population was poorly understood and therefore a cardiology team at the Oxford University Hospital NHS Foundation Trust embarked on finding out how common VHD was in the older population. In 2009, the team started the OxValve study with the aim of screening people age 65 years and over from primary care to determine how many participants had VHD. The study received ethical approval from the Southampton and South West Hampshire Research Ethics Committee (REC ref. no. 09/H0502/58) under consent versions 1 to 7 which was used to recruit 4,009 participants in total between 2009 and May 2016. Each participant underwent detailed examination including echocardiography to establish the presence, and severity, of VHD and 3,515 patients met the criteria of the study.

The findings of the first 2,500 participants were reported in the European Heart Journal in 2016. The mean age (Standard Deviation) was 73 (6) years, 51.5% were female and 99% were of White ethnicity. VHD was found in 1,269 participants (50.8% of the cohort). Most VHD was mild with only 159 participants having a new diagnosis of clinically significant disease at screening (12.5% of those with VHD, 6.4% of the OxValve cohort). A further 4.9% had pre-existing VHD making a total prevalence of 11.3% of the cohort with moderate-severe VHD. Multivalve disease was found in 38.5% of the screened population. The most common individual valve lesions were aortic sclerosis (34%), mitral regurgitation (22.1%) and aortic regurgitation (15.2%). Aortic stenosis was present in 1.3% of the cohort. The total number of participants in the cohort was 3,515 up to May 2016. The cohort is currently undergoing a 5 year follow up where participants are asked if they are willing to be rescreened.

The long-term outlook for people with VHD is not fully understood. It is not known how long people with VHD, detected at screening, live for and whether they die from heart-related problems or something else. The OxValve-Survive study aims to report the survival rates of people in the OxValve cohort with and without VHD. The study will provide estimates of one, five and ten year survival, and the cause of death. This study is in the interests of the public and therefore is processed under GDPR article 6(1)(e) and 9(2)(j).

Oxford University Hospitals Foundation Trust is the sole data controller. The data is processed by the Nuffield Department of Primary Care Health Sciences at the University of Oxford and allows reporting of long term outcomes in the well-phenotyped OxVALVE cohort. The study requires identifiable data from participants in the OxVALVE study to determine their date and cause of death from the civil death registry held by NHS Digital. OxVALVE is a well-established screening study with participants from socioeconomically diverse practice in Oxfordshire. Access to mortality data for the next three years will allow further reporting of the long term outcomes for the OxVALVE cohort. There is no alternative way to report the mortality of the cohort which is as reliable as using civil mortality data from NHS Digital. When designing the study, consideration was given to data minimisation and the University of Oxford request the minimum information (date and cause of death) required to achieve the study's aim of reporting prognosis for this large cohort.

The Oxford University Hospital NHS Foundation Trust is the sole data controller who is working with the Primary Care team at Nuffield Department of Primary Care Health Sciences (NDPCHS) leading on the primary care theme of the OxValve programme. Only individuals at the NDPCHS will do the data linkage and analysis for the data received from NHS Digital and thus are the sole data processor. The reason for this is that NDPCHS have expertise in survival analysis and experience with mortality linkage. NDPCHS do not determine the purpose for processing or the manner in which the data will be processed and is therefore not a joint data controller. The original OxValve team (at Oxford University Hospitals NHS Foundation Trust) will not be involved in processing the data for this purpose and will have no access to the data in its raw form. Oxford University Hospitals NHS Foundation Trust will only have access to aggregated reports with small numbers suppressed in line with the HES Analysis Guide.

The aim of the OxValve-Survive study is to report the one and five year survival rates of participants with and without VHD, and report the most common causes of death.

The findings from the OxValve-Survive study have been presented at the British Cardiovascular Society meeting in 2018 and the European Society of Cardiology Congress 2019. Further analysis was also due to be presented at the Society of Academic Primary Care Annual Scientific Meeting in 2020 but this was cancelled due to the Covid-19 pandemic. The full paper with the results was published in the journal ‘Heart’ in 2021: https://heart.bmj.com/content/107/16/1336. To support dissemination of the study findings, the study created an infographic to summarise the results which has been shared on their social media channels. The study has also published findings on the OxValve-Survive webpage: https://www.phc.ox.ac.uk/research/heart/projects/oxvalve-primary-care.

The OxValve study is ongoing, with a plan to rescreen participants from the original cohort who are willing to participate. The study is funded by Oxford Biomedical Research until 31/08/2022 and the applicant has applied to the British Heart Foundation for further funding to support this work. Ongoing linkage with mortality data from NHS Digital will provide key information on the outcome of participants. The study will use these data to report the longer-term mortality rates, and causes of death, for the OxValve cohort.

The findings will be presented at relevant future conferences such as the Annual Scientific Meeting of the Society for Academic Primary Care and the British Cardiovascular Society Annual Conference. The choice of conference will depend on the timing of completion of the statistical analyses and deadline for submission of the abstract. Dissemination of the findings of the project at either of these meetings will inform frontline clinicians that interact with these patients on a daily basis. This project will help to provide an evidence base to inform decisions that are likely to improve the quality of care for patients with VHD in the UK and similar countries.

The findings of the ongoing OxValve-Survive project will also be published in peer reviewed scientific journals approximately one year after receiving the mortality data. Target journals will include the British Medical Journal, European Heart Journal, Heart and the British Journal of General Practice. Depending on obtaining the necessary funding, the aim will be to publish open-access.

The findings of this project will also be disseminated through the OxValve study website, the Nuffield Department of Primary Care Health Sciences website, and through relevant social media channels. Through these platforms, clinicians, academics, media, patients, and the public will be reached.

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Two of the authors wrote a blog to translate the research findings into practical advice for general practitioners: https://oxfordbrc.nihr.ac.uk/blog-the-implications-of-the-oxvalve-survive-study-on-gp-practice/ . The key finding to date supports GP knowledge for patients with mild valvular heart disease on their echo report who can be reassured that it is unlikely to affect long-term outcome.

The main function of the heart is to pump blood around the body. There are four main valves in the heart which ensure the blood travels in the right direction. If the valves become narrowed or leaky, this can mean the heart functions less efficiently.

Valvular heart disease (VHD) occurs when one or more valves does not form properly before birth (congenital) or if they are damaged (acquired) during life. In the developing world, infections such as rheumatic fever are still prevalent and can cause valve damage. In the UK and other developed countries, the most common cause of VHD is degeneration - wear and tear - over time.

When the heart valves don’t work properly, the heart muscle may need to work harder to cope. If valves become narrowed (stenosis), more pressure is needed to force the blood through them, and if they become leaky (regurgitation), more blood flows back into the heart chamber and needs to be pumped out again.

Over time, VHD can cause the heart to stop working properly. Some people may experience symptoms such as breathlessness, chest pain or passing out, while for others, problems with their valves will not cause them any difficulties. The treatment for severe VHD is surgery but this has risks. Identifying people who need to have an operation to deal with symptoms, or prevent future problems, and are well enough to have the procedure, is important.

The burden of VHD in the community population was poorly understood and therefore a cardiology team at the Oxford University Hospital NHS Foundation Trust embarked on finding out how common VHD was in the older population. In 2009, the team started the OxValve study with the aim of screening people age 65 years and over from primary care to determine how many participants had VHD. The study received ethical approval from the Southampton and South West Hampshire Research Ethics Committee (REC ref. no. 09/H0502/58) under consent versions 1 to 7 which was used to recruit 4,009 participants in total between 2009 and May 2016. Each participant underwent detailed examination including echocardiography to establish the presence, and severity, of VHD.

The findings of the first 2,500 participants were reported in the European Heart Journal in 2016. The mean age (Standard Deviation) was 73 (6) years, 51.5% were female and 99% were of White ethnicity. VHD was found in 1,269 participants (50.8% of the cohort). Most VHD was mild with only 159 participants having a new diagnosis of clinically significant disease at screening (12.5% of those with VHD, 6.4% of the OxValve cohort). A further 4.9% had pre-existing VHD making a total prevalence of 11.3% of the cohort with moderate-severe VHD. Multivalve disease was found in 38.5% of the screened population. The most common individual valve lesions were aortic sclerosis (34%), mitral regurgitation (22.1%) and aortic regurgitation (15.2%). Aortic stenosis was present in 1.3% of the cohort. The total number of participants in the cohort was 4,009 up to May 2016. The cohort is currently undergoing a 5 year follow up where participants are asked if they are willing to be rescreened.

The long-term outlook for people with VHD is not fully understood. It is not known how long people with VHD, detected at screening, live for and whether they die from heart-related problems or something else. The OxValve-Survive study aims to report the survival rates of people in the OxValve cohort with and without VHD. The study will provide estimates of one, five and ten year survival, and the cause of death. This study is in the interests of the public and therefore is processed under GDPR article 6(1)(e) and 9(2)(j).

The cardiology team at Oxford University Hospital NHS Foundation Trust are the sole data controller and are working partnership with the Nuffield Department of Primary Care Health Sciences (NDPCHS) at the University of Oxford working with the primary care team at NDPCHS which is leading on the primary care theme of the OxValve programme. Only individuals at the NDPCHS will do the data linkage and analysis for the data received from NHS Digital and thus are the sole data processor. The reason for this is that NDPCHS have expertise in survival analysis and experience with mortality linkage. The original OxValve team (at Oxford University Hospitals NHS Foundation Trust) will not be involved in processing the data for this purpose and will have no access to the data in its raw form. Oxford University Hospitals NHS Foundation Trust will only have access to aggregated reports with small numbers suppressed in line with the HES Analysis Guide.

The OxValve-Survive study will report the one and five year survival rates of participants with and without VHD, and report the most common causes of death.

The findings will be presented at a relevant conference such as the Annual Scientific Meeting of the Society for Academic Primary Care or the British Cardiovascular Society Annual Conference. The choice of conference will depend on the timing of completion of the statistical analyses and deadline for submission of the abstract. Dissemination of the findings of the project at either of these meetings, will inform frontline clinicians that interact with these patients on a daily basis. This project will help to provide an evidence base to inform decisions that are likely to improve the quality of care for patients with VHD in the UK and similar countries.

The findings of this project will also be published in a peer reviewed scientific journal approximately one year after receiving the mortality data i.e., before the end of 2020. Target journals will include the British Medical Journal, European Heart Journal and the British Journal of General Practice. Depending on obtaining the necessary funding, the aim will be to publish open-access.

The findings of this project will also be disseminated through the OxValve study website, the Nuffield Department of Primary Care Health Sciences website, and through relevant social media channels. Through these platforms, clinicians, academics, media, patients, and the public will be reached.

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

The findings have been presented at the British Society of Cardiology conference. The OxValve study (at NDPCHS) are currently drafting a manuscript for submission to a peer-reviewed journal.

The main function of the heart is to pump blood around the body. There are four main valves in the heart which ensure the blood travels in the right direction. If the valves become narrowed or leaky, this can mean the heart functions less efficiently.

Valvular heart disease (VHD) occurs when one or more valves does not form properly before birth (congenital) or if they are damaged (acquired) during life. In the developing world, infections such as rheumatic fever are still prevalent and can cause valve damage. In the UK and other developed countries, the most common cause of VHD is degeneration - wear and tear - over time.

When the heart valves don’t work properly, the heart muscle may need to work harder to cope. If valves become narrowed (stenosis), more pressure is needed to force the blood through them, and if they become leaky (regurgitation), more blood flows back into the heart chamber and needs to be pumped out again.

Over time, VHD can cause the heart to stop working properly. Some people may experience symptoms such as breathlessness, chest pain or passing out, while for others, problems with their valves will not cause them any difficulties. The treatment for severe VHD is surgery but this has risks. Identifying people who need to have an operation to deal with symptoms, or prevent future problems, and are well enough to have the procedure, is important.

The burden of VHD in the community population was poorly understood and therefore a cardiology team at the Oxford University Hospital NHS Foundation Trust embarked on finding out how common VHD was in the older population. In 2009, the team started the OxValve study with the aim of screening people age 65 years and over from primary care to determine how many participants had VHD. The study received ethical approval from the Southampton and South West Hampshire Research Ethics Committee (REC ref. no. 09/H0502/58) under consent versions 1 to 7 which was used to recruit 4,009 participants in total between 2009 and May 2016. Each participant underwent detailed examination including echocardiography to establish the presence, and severity, of VHD.

The findings of the first 2,500 participants were reported in the European Heart Journal in 2016. The mean age (Standard Deviation) was 73 (6) years, 51.5% were female and 99% were of White ethnicity. VHD was found in 1,269 participants (50.8% of the cohort). Most VHD was mild with only 159 participants having a new diagnosis of clinically significant disease at screening (12.5% of those with VHD, 6.4% of the OxValve cohort). A further 4.9% had pre-existing VHD making a total prevalence of 11.3% of the cohort with moderate-severe VHD. Multivalve disease was found in 38.5% of the screened population. The most common individual valve lesions were aortic sclerosis (34%), mitral regurgitation (22.1%) and aortic regurgitation (15.2%). Aortic stenosis was present in 1.3% of the cohort. The total number of participants in the cohort was 4,009 up to May 2016. The cohort is currently undergoing a 5 year follow up where participants are asked if they are willing to be rescreened.

The long-term outlook for people with VHD is not fully understood. It is not known how long people with VHD, detected at screening, live for and whether they die from heart-related problems or something else. The OxValve-Survive study aims to report the survival rates of people in the OxValve cohort with and without VHD. The study will provide estimates of one, five and ten year survival, and the cause of death. This study is in the interests of the public and therefore is processed under GDPR article 6(1)(e) and 9(2)(j).

The cardiology team at Oxford University Hospital NHS Foundation Trust are the sole data controller and are working partnership with the Nuffield Department of Primary Care Health Sciences (NDPCHS) at the University of Oxford working with the primary care team at NDPCHS which is leading on the primary care theme of the OxValve programme. Only individuals at the NDPCHS will do the data linkage and analysis for the data received from NHS Digital and thus are the sole data processor. The reason for this is that NDPCHS have expertise in survival analysis and experience with mortality linkage. The original OxValve team (at Oxford University Hospitals NHS Foundation Trust) will not be involved in processing the data for this purpose and will have no access to the data in its raw form. Oxford University Hospitals NHS Foundation Trust will only have access to aggregated reports with small numbers suppressed in line with the HES Analysis Guide.

The OxValve-Survive study will report the one and five year survival rates of participants with and without VHD, and report the most common causes of death.

The findings will be presented at a relevant conference such as the Annual Scientific Meeting of the Society for Academic Primary Care or the British Cardiovascular Society Annual Conference. The choice of conference will depend on the timing of completion of the statistical analyses and deadline for submission of the abstract. Dissemination of the findings of the project at either of these meetings, will inform frontline clinicians that interact with these patients on a daily basis. This project will help to provide an evidence base to inform decisions that are likely to improve the quality of care for patients with VHD in the UK and similar countries.

The findings of this project will also be published in a peer reviewed scientific journal approximately one year after receiving the mortality data i.e., before the end of 2020. Target journals will include the British Medical Journal, European Heart Journal and the British Journal of General Practice. Depending on obtaining the necessary funding, the aim will be to publish open-access.

The findings of this project will also be disseminated through the OxValve study website, the Nuffield Department of Primary Care Health Sciences website, and through relevant social media channels. Through these platforms, clinicians, academics, media, patients, and the public will be reached.

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

The findings have been presented at the British Society of Cardiology conference. The OxValve study (at NDPCHS) are currently drafting a manuscript for submission to a peer-reviewed journal.