Frequency and outcomes of pulmonary valve replacement by valve type in England and Wales over 20 years (24 CONG 01)

University Hospitals Birmingham NHS Foundation Trust (UHB NHS FT) requires access to NHS England data for the purpose of the following project:

Frequency and outcomes of pulmonary valve replacement by valve type in England and Wales over 20 years

The following is a summary of the aims of the project provided by UHB NHS FT:

Over 95% of children born with congenital heart disease (CHD) in UK now reach adulthood and many require repeat surgical interventions. In the recent James Lind Alliance Priority Setting Partnership, reducing the frequency or need for reoperations in adults with CHD was identified as a national priority for evaluation.

Bioprosthetic pulmonary valve replacement (PVR) is one of the most common operations in adolescents and adults with CHD. As no bespoke surgical pulmonary prosthesis is available, valves designed for the aortic position are used routinely, such as the Perimount and Hancock II bioprostheses (porcine valves or valves made from bovine pericardium). Whilst both valve types demonstrate similar long-term freedom from structural valve deterioration (SVD), reintervention and mortality in the aortic position, data on their use in the pulmonary position is limited and relative differences in haemodynamics (opening pressures, ventricular compliance) may impact on outcomes. This is especially relevant as there are differences between the process and effect of SVD in pericardial (calcification, restricted leaflet motion, mixed stenosis/regurgitation) and xenograft (tearing, excessive leaflet motion, acute regurgitation) bioprostheses. Recent observational data from Korea suggests a higher rate of SVD and redo-PVR with the Perimount compared with the Hancock II, supporting the need for direct comparison in a multi-centre clinical trial.

By evaluating the frequency and outcomes of PVR by valve type using routinely collected data from all centres in England and Wales over a 20-year period, the study team will determine changes in practice over time, freedom from pulmonary valve prosthesis reintervention and survival by valve type. These data will also be used to inform the development of a multi-centre clinical trial, including the impact of other factors such as valve size and age at implantation to inform the anticipated effect size.

The following NHS England Data will be accessed:

> Civil Registration Mortality

> National Congenital Heart Disease Audit (NCHDA) patient data from the National Institute for Cardiovascular Outcomes Research (NICOR) database.

This Data is necessary to determine changes in practice over time, freedom from pulmonary valve prosthesis reintervention and survival by valve type.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified from the National Congenital Heart Disease Audit (NCHDA) database of patients undergoing PVR. It is estimated that ~8,000 individuals will be identified.

> Limited to data between 01/01/2003 to 31/12/2023. 20 years of Data is required to maximise the number of procedures (sample size) and determine changes in practice over time which may impact on the design of a future clinical trial. It will also inform the likely effect size in a UK population and the impact of related factors on freedom from pulmonary valve prosthesis reintervention.

UHB NHS FT is the sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This study is in the public interest because bioprosthetic pulmonary valve replacement is one of the most common operations in adolescents and adults with CHD. The findings of this study will inform the development of a clinical trial to determine which type of valve prosthesis has the best longevity, thereby reducing the frequency of reinterventions.

The funding is provided by Birmingham Women’s and Children’s Hospital Charity. The funding is specifically for the project described.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Microsoft Limited provides IT hosting services to UHB NHS FT and will store the Data as contracted by UHB NHS FT.

Data will be accessed by:

• Substantive employees of UHB NHS FT

In the recent James Lind Alliance Priority Setting Partnership, involving patients, parents, charities and healthcare professionals, reducing the frequency or need for reoperations in those with CHD was identified as a national priority for evaluation and informed the development of this study. The findings of this study will inform the development of a clinical trial to determine which type of valve prosthesis has the best longevity, thereby reducing the frequency of reinterventions.

The NICOR team (within NHS England) will transfer the cohort identifiers to NHS England data provisioning team. The data will consist of identifying details: NHS Number, Date of Birth, Postcode, Gender, Forename, Surname and a unique person ID to be linked with NHS England data.

The cohort will consist of patients who would have been recorded in the NCHDA database as having undergone PVR.

NHS England will provide the relevant records from the mortality dataset to NICOR.

The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient (NICOR).

NICOR will link the mortality data with clinical data from the NCHDA audit specifically for the individuals in the cohort.

NICOR will fully pseudonymise and clean the data and send the complete pseudonymised record level data extract to UHB NHS FT’s West Midlands Secure Data Environment (WMSDE).

The Data (that NICOR will disseminate to UHB NHS FT) will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will be stored within the WMSDE hosted by University Hospitals Birmingham NHS FT.

University Hospitals Birmingham NHS FT stores Data on the Azure Cloud provided by Microsoft Limited.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England. The data will not leave England at any time.

Access is restricted to substantive employees of UHB NHS FT who have authorisation from the Principal Investigator.

One individual from The University of Birmingham will act in an advisory capacity, supporting the team of analysts with clinical input in determining the analysis approach and interpreting aggregated results. This individual will not be processing any patient level data.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

Analysts from the UHB NHS FT will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> Submissions to peer reviewed journals; the expectation is to submit up to 3 manuscripts to peer-reviewed journals in the second half of 2025

> Presentations at national and international scientific meetings

> Data will also be used to inform the development of a multi-centre clinical trial, including the impact of other factors such as valve size and age at implantation to inform the anticipated effect size.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Conferences

Outputs are expected by December 2025.

This work hopes to determine whether one type of valve prosthesis is better than the other in the pulmonary position. If this is determined, it is hoped that the frequency of reinterventions in patients, both in the UK and worldwide, will be reduced.

The use of the data could:

> help the system to better understand the health and care needs of populations.

> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

> advance understanding of regional and national trends in health and social care needs.

> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

> provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

>support knowledge creation or exploratory service evaluation (and the innovations and developments that might result from that exploratory work).

By providing evidence to support whether one type of valve prosthesis is better than another, this is expected to inform the development of a multi-centre clinical trial to determine which type of valve is best. Using valves that last longer, overall or in different sub-groups, is expected to reduce the frequency of reinterventions on patients and the NHS.

UBH NHS FT work closely with national charity partners, including the Children’s Heart Federation and Somerville Heart Foundation, to reach a wide audience of those affected by CHD. The findings of the study will be shared through their newsletters and social media, as well as published in peer-reviewed journals. It will also inform the development on a multi-centre clinical trial in which UBH NHS FT will involve charity partners.

Yielded Benefits is not a requirement for new applications.