Mechanisms of Excess Risk in Aortic STEnosis after Aortic Valve Replacement (MASTER)

University College London (UCL) requires access to NHS England Data for the purpose of the following research project:

Mechanisms of Excess Risk in Aortic STEnosis after Aortic Valve Replacement (MASTER)

The main aim of this study is to better understand the risks for people with severe aortic stenosis (AS) (a serious heart condition) who have had a procedure called aortic valve replacement (AVR). Specifically, UCL want to find out if damage to the heart muscle, like scarring or reduced blood flow, can increase the chances of being hospitalized for heart failure or developing dangerous heart rhythms.

Aortic stenosis is a condition where one of the heart valves becomes narrowed, reducing blood flow. When the narrowing becomes severe, the only effective treatment is valve replacement. However, even after this procedure, half of the patients are left with permanent damage to the heart muscle, and about one in four patients die within just a few years.

It is believed that the damage from this procedure causes problems with the heart’s rhythm and ability to pump blood properly, however, it is not fully understood how or why. This research aims to use advanced heart scans (MRI) to detect damage and then monitor patients for 3 years using a small device inserted under the skin. This device continuously tracks the heart's rhythm and sends information to the hospital. This helps the researchers learn if heart muscle scarring leads to dangerous heart rhythm problems or heart failure after valve surgery.

UCL will also request access to NHS England Data. This is to better understand visits related to heart failure or abnormal heart rhythms in these patients. By identifying which patients are most at risk, UCL can offer early treatments such as medications or special devices like pacemakers or defibrillators to prevent serious complications or death.

The following NHS England Data will be accessed:

• Hospital Episode Statistics

Admitted Patient Care - Access to hospital episode Data is vital to track hospitalisations related to heart failure and arrhythmias following AVR. This dataset will help identify the incidence of these events in relation to the presence of heart muscle scarring or ischemia. Analysing the frequency and outcomes of hospitalisations will allow UCL to examine the clinical consequences of AS cardiomyopathy and its relationship with patient outcomes.

The level of the Data will be identifiable.

The Data will be minimised as follows:

• The Data is only being requested for the participants who are recruited on to the MASTER study.

• The Data requested will be from March 2021 onwards (from when the first participant was recruited).

University College London (UCL) is the research 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 processing is in the public interest because by understanding the role of scarring for individuals who have undergone AVR, it can be predicted which patients are at risk and steps can be taken to improve their outcomes. Many patients receive valve replacement too late, after irreversible damage has occurred. This research can help develop better guidelines for earlier intervention, preventing damage before it is too late.

The funding is provided by British Heart Foundation specifically for Mechanisms of Excess Risk in Aortic STEnosis after Aortic Valve Replacement (MASTER) project and is in place until the 31st of July 2025 .

UCL is the sole Data processor.

UCL have established a Patient Advisory Panel (PAP) comprising of participants of RELIEF-AS and ATTRact-AS. These participants have helped formulate key research questions and have helped to tailor the protocol to balance the burden of investigations with the scientific yield.

UCL will transfer data to NHS England. The data will consist of identifying details, specifically, name, date of birth, NHS number and a unique person ID for the cohort to be linked with NHS England Data.

NHS England will provide the relevant records from the requested datasets to UCL. 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.

The Data will not be transferred to any other location.

The Data will be stored on servers at UCL.

The Data will be accessed onsite at the premises of UCL only and will be backed up at UCL.

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

UCL 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).

The Data will not leave England/Wales at any time.

Access is restricted to employees of UCL who have authorisation from the Principal Investigator.

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

The NHS England Data will be linked at person record level with the clinical data obtained during the research visits (datasets will be demographics, biomarkers, imaging data).

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the UCL will process the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to patient groups

• Submissions to peer reviewed journals. These journals include International cardiovascular Journals (EHJ, JACC, Circulation, JAMA Cardiology) and their imaging sub - journals (JCMR, EHJ CVI, JACC CVI, Circulation CVI).

• Presentations at specific conferences. These conferences include Conferences – National and international cardiology and cardiovascular imaging conferences (ESC, BSC, ACC, AHA, EACVI, SCMR, BSCMR).

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

• Patient Information leaflets

• Participant newsletters

• Reports aimed at participants

• Press/media engagement

• Report to funder

The target date for production and dissemination of outputs is Summer 2026.

The benefits relating to health and/or social care include:

• Improved Risk Stratification: By analysing patient data, the study will enhance risk prediction, enabling targeted, timely care for those at highest risk of heart failure or arrhythmias.

• Enhanced Clinical Decision-Making: Findings will support better diagnostic and treatment pathways, leading to personalized care strategies.

• Reduced Hospitalizations and Mortality: Better risk stratification and treatment could reduce hospital admissions, length of stay, and mortality.

• Improved Quality of Life: The study aims to improve patient symptoms and quality of life through more effective interventions.

• Cost-Effectiveness: The research may identify ways to reduce healthcare costs by decreasing hospital admissions and improving care efficiency.

Overall, this research has the potential to transform clinical practice, improving patient outcomes and reducing healthcare-related costs both in the UK and internationally.

The specific benefits to patients include better risk stratifications and timing of intervention for patients with severe aortic stenosis undergoing aortic valve replacement.

The proposed outputs will help identify patients with aortic stenosis who remain at high risk of heart failure or sudden death even after valve replacement. By understanding how heart muscle scarring contributes to these outcomes, UCL can better target therapies—such as heart failure medications or implantable defibrillators—to those who will benefit most. These findings have the potential to inform updates to national and international clinical guidelines, influence policy decisions, and shape future models of care. This would enable earlier intervention, reduce hospital admissions, and improve long-term survival—delivering measurable public health benefits.

To maximise the public benefit of this research, UCL will actively disseminate findings through peer-reviewed journals, national and international cardiology conferences, and public health forums. Should the findings warrant broader attention, UCL will engage with media outlets, produce lay summaries, and share insights via UCL’s and NHS Trust communication channels.

One of the supporters of the study is Heart Valve Voice – a patient group that helps publicise findings through platforms such as the British Heart Foundation’s social media channels, allowing UCL to reach a wider audience including patients and carers.

UCL also aim to work closely with organisations such as the British Cardiovascular Society to ensure the results inform clinical guidelines and influence national policy. Patient groups and relevant charities will be engaged to support outreach, especially where results may lead to changes in care pathways or help identify high-risk individuals earlier.

Yielded Benefits is not a requirement for new applications.