Understanding the Use of Impella in Patients Undergoing High-Risk Protected Percutaneous Coronary Interventions in the UK (24 NAPCI 01).

The Data will be used for the purpose of a service evaluation, “Understanding the Use of Impella in Patients Undergoing High-Risk Protected Percutaneous Coronary Interventions in the UK (24 NAPCI 01).”

• To understand the use of Impella (catheter-based ventricular assist devices (VADs) used to support the heart's pumping function heart pump) in patients Undergoing High-Risk Protected Percutaneous Coronary Interventions in the UK (patients treated with intra-aortic balloon pumps during (high risk) protected PCI are analysed as a separate cohort.)

• To understand differences in patient clinical presentation and treatments (diagnostic vs interventional), in cohorts treated with Impella and balloon pumps.

• This evaluation is descriptive only, that will help understand how Impella is utilised in the UK at the current time and to help determine the extent to which current clinical practice aligns with NICE Health Technology Guidelines.

Abiomed Inc, as the manufacturer of the Impella device, has a legitimate commercial interest in understanding how its technology and the patients indicated for it are currently being treated within the UK NHS. The company led the first randomised controlled trial demonstrating that Impella provides superior outcomes compared to standard care in supporting critically ill patients.

Through this service evaluation, Abiomed Inc seeks to analyse the characteristics of UK patients treated with Impella over the past decade and compare them with those receiving intra-aortic balloon pumps. The evaluation is also focused on understanding practice and service delivery within the NHS and how it aligns to against NICE Health Technology Guidelines which require clinicians to seek enhanced consent for use of Impella. Importantly aggregated patient characteristics will help inform the design of future studies to further evaluate the safety and effectiveness of the Impella device.

Specifically, Abiomed Inc. believes that multiple patients currently in the UK could be benefiting from mechanical circulatory support during their treatment, ultimately reducing need for repeated procedures, reducing rates of adverse events, reducing risks of patients’ lack of adherence and increasing survival. Analysing the requested data and evaluating where best practice is being followed could help understand the unmet need in England and Wales, and the opportunity for positive impact on patients outcomes from employing solutions from Abiomed Inc. and other manufacturers.

The evaluation could inform the future development and assessment of mechanical circulatory support devices, ultimately supporting Abiomed Inc’s product innovation and strategic positioning in the market. From a commercial perspective, the insights gained may lead to broader adoption of the Impella device, enabling more patients to benefit from advanced circulatory support. The findings could help identify which patient profiles are most suited to the device, enhance physician training, and deepen understanding of clinical severity. This, in turn, may guide the design of next-generation Impella systems tailored to meet the needs of high-risk patient groups.

While there is a commercial dimension to this work, the proposed use of data is hoped to yield broader public interest. The evaluation of the data aims to understand how mechanical circulatory support devices could be utilised in the UK, recognising that clinical protocols and definitions of risk vary internationally. By identifying unmet needs and variations in care, Abiomed Inc. can better tailor its technologies to support NHS priorities and improve patient outcomes.

Ultimately, the findings are hoped to contribute to a more informed approach to device development and deployment, supporting both innovation and evidence-based decision-making in UK cardiovascular care.

While Abiomed Inc has a commercial interest, the primary intent of the data use is service evaluation with potential benefits for NHS patients. This aligns with NHS England’s expectation that commercial applications must demonstrate clear public value.

This project was reviewed and supported by the NICOR Research Access Committee (RAC) on 31/10/2024.

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 National Audit of Percutaneous Coronary Interventions (NAPCI) datasets to Johnson & Johnson Medical Limited.

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 be stored on servers at Johnson & Johnson Medical Limited (UK). The Data will not be transferred to any other location.

The Data will be accessed by authorised personnel via remote access by one individual from Abiomed Inc.

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 be processed in England/ Wales and The USA.

Access is restricted to one employee of Johnson & Johnson Medical Limited who has authorisation from the Principal Investigator to store the data. And one employee of Abiomed Inc accessing the data remotely in the USA. Analysts accessing the data are prohibited and will not have the technical ability to download the record level data.

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

The Data will not be linked with any other data.

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

Analysts from Abiomed Inc will process/analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer reviewed journals

• Presentations to clinical cardio vascular conferences

• Single arm abstracts to Presentations at specific conferences or ‘appropriate conferences’ such as cardio vascular conferences.

• Study group level: Descriptive tables of the characteristics of patients treated with an Impella device during PCI in the UK.

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 (scientific peer reviewed).

• Tables of patients if relevant to physicians maybe shared at conferences.

Target dates for production and dissemination of the outputs would be 6 months post dissemination of the data.

This service evaluation will help Abiomed Inc better understand the severity and treatment pathways of patients currently receiving mechanical cardiovascular support in the UK. It will offer valuable insights into how the Impella device is being used across the NHS. It will also allow insights into how interventional cardiologists make decisions when selecting technologies for high-risk populations. These findings will inform the design of future studies aimed at demonstrating the benefits of mechanical circulatory support devices.

The use of this data has the potential to:

• Better understand how practice varies across the NHS, the evaluation can help highlight opportunities to improve adherence to NICE recommendations, ultimately supporting improved clinical outcomes.

• Improve understanding of population health and care needs.

• Support the identification and refinement of treatments, interventions, and system design to enhance outcomes and patient experience.

• Enable exploratory analyses and innovation in cardiovascular care.

Depending on the results, the analysis is anticipated to generate patient benefits by enhancing understanding of how care is delivered and how mechanical circulatory devices are used in practice across the NHS. This may, in turn, inform the design of future mechanical circulatory support devices and support improvements in service delivery.

The results will contribute to the broader evidence base used by policymakers, healthcare organisations, and clinicians in the NHS to guide treatment and policy decisions.

Abiomed Inc will commit to publish findings in the UK in a timely manner and may collaborate with UK-based cardiologists to ensure findings are submitted to appropriate peer-reviewed journals and presented at relevant conferences.

Yielded Benefits is not a requirement for new applications.