Utilisation & Outcomes of Perioperative Temporary Mechanical Circulatory Support in Contemporary Practice of Adult Cardiac Surgery in the UK (ACTACC National Audit Project 2024-2025) (25-NACSA-01)

King’s College Hospital NHS Foundation Trust (KCH) requires access to NHS England data for the purpose of the following Service Evaluation / Audit:

Utilisation & Outcomes of Perioperative Temporary Mechanical Circulatory Support in Contemporary Practice of Adult Cardiac Surgery in the UK (ACTACC National Audit Project 2024-2025) (25-NACSA-01).

Patients undergoing heart surgery may be very sick from heart failure before the operation, for example due to a recent heart attack, or after the operation. The mainstay of management is usually with medications, however, in about 1-2% of patients, the heart failure is so profound that they require help from mechanical devices to support the heart.

Currently the understanding of how these devices are used in the UK is limited, often focusing on a single centre, a single type of device, or for a single procedure. There is no unified, mandatory place for recording the use of all these devices, and the patient factors that make them necessary, nor the relevant patient outcomes. Therefore, the team at KCH & Association for Cardiothoracic Anaesthesia & Critical Care (ACTACC) are undertaking a service-evaluation, that all cardiac surgery centres in the UK were invited to participate in, looking to collect all these data.

This project has two strands, one of which involves a year-long national service evaluation, completed contemporaneously, with the second element involving the NACSA dataset, enabling a case ascertainment check for the service evaluation data, as well as enabling a description of temporal trends in temporary mechanical circulatory support. At no point will there be any linkage of the service evaluation data collected from the cardiac surgery centres with individual cases from the NACSA dataset.

The primary project is a year-long national service evaluation project. All adult cardiac surgical centres in the UK have been invited to participate, with 28 centres currently participating. Any patients requiring temporary mechanical circulatory support preoperatively, or within 48h postoperatively, are eligible.

The service evaluation is supported by the ACTACC Linkperson network, with local respondents collecting pseudonymised data (with local clinical governance approval), relating to the aetiology of the shock state, the cardiac surgical procedure, the support requirements, and the relevant postoperative clinical outcomes.

Given the lack of a comprehensive reporting framework capturing all relevant aspects of tMCS use in the UK, and a relatively low incidence (1-2%) of support requirement, a year-long reporting window was felt to be appropriate.

Whilst the vast majority of UK centres are participating, it is not currently in all centres, and the reporting framework is not mandatory. Therefore, there is the potential for cases to be missed. None of the reported cases will be linked to the NACSA dataset, with the safeguard that this would not be readily possible with the case report data from each cardiac surgical centre, and the pseudonymised data from NICOR.

The following is a summary of the aims of the Service Evaluation: provided by KCH:

• To establish the contemporary usage of temporary mechanical circulatory support (tMCS) for adult cardiac surgery, including the different devices used and the rates of major complications associated with perioperative tMCS.

• To establish key outcomes for patients receiving tMCS, including ICU and hospital length of stay and in-hospital mortality.

• Improve understanding about the size of the service required in the UK, which will have implications for the bodies that commission healthcare, as well as those that provide education and training, and regulation or oversight.

The following NHS England data will be accessed:

• National Adult Cardiac Surgery Audit (NACSA) - Necessary as fields related to the use of mechanical circulatory support devices (e.g., IABP, Impeller, VAD, Other Device) and relevant patient outcomes ensures the data collected by KCH provide an accurate ‘denominator’ for the number of annual cardiac surgical cases and type of procedure, including for the participating centres. Contextualisation of the completeness of the reported number of tMCS cases based upon the reports to NICOR. Will allow an understanding of the key clinical outcomes and help the description of temporal trends in tMCS usage.

The level of the Data will be Pseudonymised.

The data will be minimised as follows:

• Limited to a cohort identified by NICOR, consisting of patients treated perioperatively using mechanical circulatory support.

• Limited to data between 01/04/2014 and 28/02/2025.

King’s College Hospital NHS Foundation Trust is the sponsor and 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 it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

Funding is provided by The European Association of Cardiothoracic Anaesthesiology and Intensive Care (EACTAIC). The funder will have no ability to suppress or otherwise limit the publication of findings.

KCH is the sole controller who will also process the Data.

Over the term of this data sharing agreement, a substantive employee from Kings College Hospital as part of their rotational training may hold an honorary contract if redeployed to an NHS trust not named on this agreement. In such instance the individual will access the Data under the supervision of a substantive employee of Kings College Hospital NHS Foundation Trust for the purposes described in this DSA only. The Trust must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

A steering committee is made up of team members (the Chief Investigators and named investigators) at two centres; King's College Hospital & Glenfield Hospital (University Hospitals of Leicester NHS Trust). The Leicester team will only access aggregated outputs prepared for the manuscript. The committee will, if required, discuss any emerging issues raised by the linkmen/local respondents, with the midway meeting specifically required to discuss the completeness of data collection/participation and optimise as able.

The Association for Cardiothoracic Anaesthesia & Critical Care (ACTACC) Scientific Committee endorsed and approved the service evaluation, but are not involved in the study itself. The key clinical stakeholders (cardiac anaesthetists, cardiac surgeons, and intensivists) have provided input into this evaluation in an advisory capacity only, as the aim is to firmly understand the national requirement for these devices. The overall intention will be to devise other observational (and interventional) studies, which investigate patient-relevant outcomes, at which point the team at KCH will engage with a Public and Patient Involvement and Engagement group.

This service evaluation was reviewed and supported by the NICOR Research Access Committee (RAC) on 03/03/2025.

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

The NICOR data management team at NHS England will provide the relevant records from the NICOR Adult Cardiac Surgery datasets to KCH. 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.

The Data will not be transferred to any other location.

The data will be stored on servers at King’s College Hospital NHS Foundation Trust.

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).

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

Data maybe accessed by an individual holding an honorary contract with KCH. The individual will act as an agent of KCH at all times under supervision from employees of KCH. Aside from this individual, access is restricted to employees or agents of KCH who have authorisation from the Principal Investigator.

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

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

Analysts from KCH will process the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to relevant recipients such as participating hospitals; Association for Cardiothoracic Anaesthesia & Critical Care (ACTACC) Scientific Committee; and, their sister specialty societies (e.g. Society of Cardiothoracic Surgeons).

• Submissions to peer-reviewed journals such as Anaesthesia, and Critical Care & Perioperative Medicine.

• Presentations at appropriate conferences, examples include the ACTACC Annual Scientific Meeting; the EACTAIC Annual Congress; and the IACA (International Association of Cardiothoracic Anaesthesiology) World Congress.

• Publication of dashboards on the organisation’s website.

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:

• Peer-reviewed publications in journals;

• Webinars or presentations to relevant clinical stakeholders (e.g. physicians and surgeons) via professional associations (ACTACC, etc);

• A public report via the national organisation running the project - The Association for Cardiothoracic Anaesthesia & Critical Care (ACTACC).

The target date for production and dissemination of the initial report is 30th June 2026. Subsequent reports will be disseminated beyond June 2026.

The outcomes of the Service Evaluation are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

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 interventions, and health system design to improve health and care outcomes.

• Advance understanding of regional and national trends in health and care needs.

• Inform planning health services and programmes, for example to improve equity of access 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).

Currently, there are narrow clinical criteria for commissioned temporary mechanical circulatory support services in the UK. Publication of the ‘Shock to Survival’ report has outlined a nationwide expansion to the provision of cardiogenic shock support. Perioperative cardiac surgical patients will undoubtedly form a significant proportion of the patients requiring such support. Therefore, a national service evaluation, assessing the current landscape for tMCS, and identifying key trends in device requirement, as well as enabling a better understanding of clinical outcomes, will be an important step in understanding the perioperative service required. An accurate estimation of device usage will also have implications for education and training, clinical governance and quality improvement. The provision of NACSA data will ensure this is as accurate and complete as possible.

An accurate estimation of device usage will have implications for education and training, clinical governance, and quality improvement for patients.

It is hoped that through publication of findings in appropriate media, the outcomes of the Service Evaluation will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, decision makers might consider the expansion of regional referral networks to enable wider access to advanced support modalities in post-cardiac surgery cardiogenic shock.

KCH expect to communicate outcomes to a wider audience through various dissemination channels such as journals, workshops, public reports, and direct bilateral engagement with relevant recipients.

Yielded Benefits is not a requirement for new applications.