Prevalence of idiopathic ventricular fibrillation in England (PIVF)

Royal Papworth Hospital NHS Foundation Trust requires access to NHS England data for the purpose of the following service evaluation project:

Prevalence of idiopathic ventricular fibrillation in England (PIVF)

The following is a summary of the aims of the project provided by Royal Papworth Hospital NHS Foundation Trust:

The aim of this work is to provide an accurate estimate of the prevalence of idiopathic ventricular fibrillation (IVF), a rare but important condition. This prevalence may then be used to direct future research and allocate increased funding into the investigation and management of IVF.

The annual incidence of sudden cardiac death (SCD) and out-of-hospital cardiac arrests (OOHCA) in Europe (including UK) is significantly high, estimated at 249,500 and 343,500 respectively. Cardiac arrest survival rates are improving, and even though coronary heart disease is the cause in approximately 80% of sudden cardiac arrests (SCA), no causative diagnosis will be identified after initial assessment in a significant proportion of SCA survivors leading to a diagnosis of unexplained cardiac arrest (UCA). Subsequent systemic evaluation will reveal a specific underlying diagnosis in approximately half of UCAs but there is still a proportion of patients who a diagnosis will not be found, and these are labelled as IVF.

Processing of this Data is therefore necessary to inform what proportion of the public is diagnosed as IVF to direct appropriate resources towards its diagnosis, management as well as potential development of preventative measures, for example, family/genetic screening.

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary to capture SCD survivors as they are often admitted to hospital for initial management and subsequent investigations, as well as getting an ICD implanted during the same admission.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by Royal Papworth Hospital NHS Foundation Trust as meeting the following criteria: patients who have had a cardiac arrest secondary to ventricular fibrillation and have subsequently had an implantable cardiac defibrillator (ICD) or cardiac resynchronisation therapy device -with defibrillator (CRT-D).

Inclusion criteria:

1. Cardiac arrest with successful resuscitation: ICD-10 146 AND Ventricular fibrillation: ICD-10 149.0 AND [CRT-D/ICD implant: ICD-10 Z95.0 **OR** OPCS-4 code: PCSK 59.6 (CRT/ICD implant)]

2. Cardiac arrest with successful resuscitation: ICD-10 146 AND Non-specified arrhythmia: ICD-10 149.9 AND [CRT-D/ICD implant: ICD-10 Z95.0 **OR** OPCS-4 code: PCSK 59.6 (CRT/ICD implant)]

Exclusion criteria:

1. Coronary artery disease: ICD-10 121,122,124,125

2. Cardiomyopathy: ICD-10 142, 143

There is no specific ICD-10 code for Idiopathic ventricular fibrillation because it is a diagnosis of exclusion. The whole dataset of patients with an ICD-10 code for cardiac arrest as well as an ICD-10/OPCS-4 code for ICD/CRT-D implantation is therefore required.

However, to minimise the data required, all patients who also subsequently have an ICD-10 code for coronary artery disease or cardiomyopathy as the cause for the cardiac arrest will be excluded. This will leave only patients with an arrhythmia as the cause of cardiac arrest in the requested dataset.

> Limited to data between 2014/15 - 2023/24. 9-years of data is required to be able to compare data pre and post pandemic. Some of the investigations performed in establishing an underlying cause for a cardiac arrest are on an outpatient basis once a defibrillator is implanted. Any non-urgent/outpatient or elective work was significantly affected by the coronavirus pandemic.

> Following receipt of NHS England Data, Royal Papworth Hospital NHS Foundation Trust will further minimise the Data to the period of interest: 01/01/2015 to 01/01/2024.

> Following receipt of NHS England Data, Royal Papworth Hospital NHS Foundation Trust will also further minimise the Data to cover only patients who have had a cardiac arrest secondary to ventricular fibrillation and have subsequently had an implantable cardiac defibrillator (ICD) or cardiac resynchronisation therapy device -with defibrillator (CRT-D). The cohort will then go under a further filter check to remove individuals who also subsequently have an ICD-10 code for coronary artery disease or cardiomyopathy as the cause for the cardiac arrest.

> All of England data required.

Royal Papworth Hospital NHS Foundation Trust is 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 IVF is a known cause of sudden cardiac death (SCD) and out-of-hospital cardiac arrests (OOHCA), but the prevalence of IVF in England is unknown.

The funding will be provided by The Royal Papworth Hospital Charity. The funding is for work into inherited cardiac conditions/family screening of which this study will be eligible.

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

Iron Mountain provides off-site back up services to Royal Papworth Hospital NHS Foundation Trust and will store copies of the Data as contracted by Royal Papworth Hospital NHS Foundation Trust.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the HES dataset to Royal Papworth Hospital NHS Foundation Trust. The Data 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.

Royal Papworth Hospital NHS Foundation Trust will securely transfer the Data to Iron Mountain.

The Data will not be transferred to any other location.

The Data will be stored on servers at Royal Papworth Hospital NHS Foundation Trust and Iron Mountain.

Royal Papworth Hospital NHS Foundation Trust uses offsite back-up services provided by Iron Mountain.

The Data will be accessed onsite at the premises of Royal Papworth Hospital NHS Foundation Trust only.

The Data will not leave England at any time.

Access is restricted to employees or agents of Royal Papworth Hospital NHS Foundation Trust who have authorisation from the Principal Investigator.

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

The Data will not be linked with any data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts from Royal Papworth Hospital NHS Foundation Trust will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> Submissions to peer reviewed journals

> Presentations at appropriate conferences

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

> Website updates

> Social media: including, but not limited to 'X' (formally Twitter) and Instagram

> Posters displayed at conferences

The target date for dissemination of outcomes is May 2025.

Royal Papworth hospital is a national heart and lung hospital, managing patients with complex conditions from across the country. The Data to be processed is national and therefore the outcome statistics will apply nationally and the benefits will extend beyond just Royal Papworth Hospital. The main benefit of finding the prevalence of IVF in England is to allow Royal Papworth Hospital NHS Foundation Trust to make recommendations for appropriate resources towards its diagnosis and management, as well as potential development of preventative measures such as family/genetic screening. The results of this data analysis are also expected to inform the need for further research into diagnostics in the cardiac arrest survivor, with the aim of reducing the number of idiopathic cases.

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.

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

> inform decisions on how to effectively allocate and evaluate funding according to health needs.

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

Having an ICD implanted can have a significant psychosocial impact on patients and their families, particularly if the device delivers any therapy i.e. a shock. Understanding the prevalence of idiopathic VF to improve diagnosis/identification of underling cause of SCA has the potential to reduce device therapies in some patients if the underlying cause is addressed/managed. SCA survivors are expected to have better access to specialist investigations and for there to be better genetic/family screening of relatives of SCD.

It is envisaged that the propose outputs will lead to the expected benefits detailed above through the direction of appropriate resources towards investigating SCA survival. Outputs are also expected to provide evidence for funding of research into potential preventative measures, for example, family/genetic screening.

Yielded Benefits is not a requirement for new applications.