National Cardiac Audit Programme / Transcatheter Aortic Valve Implantation (TAVI) Registry - Welsh mortality data

Digital Health and Care Wales (DHCW) requires access to NHS England data for the purpose of the six national cardiovascular audits (named below) and the UK Transcatheter Aortic Valve Implantation (TAVI).

The cardiovascular audits and TAVI registry are based on prospectively collected, patient-level data on patients in all NHS providers in England and Wales. The audits included in NCAP are:

• Myocardial Ischaemia National Audit Project (MINAP- heart attack) - Includes all adult patients with acute coronary syndromes (any condition resulting from the sudden reduction of blood flow to the heart, which leads to shortness of breath and sudden chest pain), collecting information on the management of patients admitted with a diagnosis of myocardial infarction (heart attack) and other acute coronary syndromes.

• National Heart Failure Audit (NHFA): Includes all patients with an unscheduled admission to hospital with heart failure, collecting data on patients discharged from acute hospitals with a primary diagnosis of heart failure

• National Congenital Heart Disease Audit (NCHDA): Includes cardiac (relating to the heart) or intrathoracic (within the chest) great vessel procedures carried out in patients under the age of 16 years, and all adult congenital cardiac procedures performed for a cardiac defect present from birth

• National Adult Cardiac Surgery Audit (NACSA): Includes all adult patients undergoing major heart surgery

• National Audit for Cardiac Rhythm Management (NACRM): Includes all adult patients with implanted devices or receiving interventional procedures for the management of cardiac rhythm disorders

• National Audit for Percutaneous Coronary Interventions (NAPCI): Includes all adult patients on whom a percutaneous cardiovascular intervention (PCI) procedure (a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) is performed

• The UK TAVI registry: Includes all patients who have undergone a procedure to implant a TAVI device (a percutaneous method to implant a new aortic valve)

The aim of these audits/ registries is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions.

The following NHS England data will be accessed:

• Civil Registration Mortality and Demographics – necessary to provide high quality comparative information of the clinical practice/processes and patient outcomes in these clinical areas. For example, it enables the comparison of disease and treatment options and outcome by Trust, hospital, unit and in some audits by consultant (NACSA and NAPCI).

The level of the data will be identifiable – necessary to evaluate the success of the data linkage.

The data will be minimised as follows:

- Limited to data for a cohort supplied by National Institute for Cardiovascular Outcomes Research (NICOR – hosted at NHS Arden & Greater East Midlands (GEM) Commissioning Support Unit (CSU)), including any individual meeting the inclusion criteria for one or more of the aforementioned clinical audits/ the TAVI registry.

The NCAP audits and TAVI registry are commissioned by NHS England.

NHS England are controllers for the English aspect of the registry. All data flows for this aspect are reflected under DARS-NIC-359940-W1R7B.

Digital Health and Care Wales (DHCW) are the controller for Welsh data in the NCAP audits and TAVI registry, including from the Civil Registration (Deaths) and Demographics data released under DARS-NIC-359940-W1R7B. The permissions for the flow of the Welsh mortality data are represented under DARS-NIC-717493-V2R4K.

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)(i) – processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

The processing is in the public interest because the audits and registries aim to drive improvements in the quality and safety of care and to improve outcomes for all patients.

NHS Arden & GEM CSU is a processor acting under the instructions of DHCW. NHS Arden & GEM CSU’s role is limited to managing the NCAP audits and TAVI registry.

Redcentric PLC provide server housing facilities to NHS Arden & GEM CSU. Redcentric PLC are not able to access the data stored on NICOR servers managed by NHS Arden & GEM CSU.

Under DARS-NIC-359940-W1R7B, NHS Arden & GEM CSU will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Surname, Forename, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the Civil Registrations (Deaths) and Demographics datasets to NHS Arden & GEM CSU. The data will contain directly identifying data items including NHS Number which is required to link the data at record level with data already held by the recipient.

The data will be stored on National Institute for Cardiovascular Outcomes Research (NICOR) servers managed by NHS Arden & GEM CSU. Servers are housed and maintained by Redcentric PLC. Redcentric PLC is not permitted to access the data.

The data will be accessed onsite at the premises of NHS Arden & GEM CSU, or by authorised personnel via remote access. The data will remain on the servers at NHS Arden & GEM CSU at all times.

The data will not leave England and Wales at any time.

Access is restricted to employees of NHS Arden & GEM CSU.

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

The data will not be transferred to any other locations.

The data will be linked at person record level with other data collected for the purposes of the respective audits. After validation of the linkage, all health data is stored in a pseudonymised format.

The identifying details will be stored in a separate database to the linked dataset used for analysis.

NICOR at NHS Arden & GEM CSU analyse the linked audit outcomes to produce statistical analyses and identify NHS organisations whose performance is an outlier of expected outcomes, in order to identify and exploit improvement opportunities.

NICOR anticipate producing the NCAP 2023 Annual Aggregate Report along with the Summary Domain Reports as well as the NCAP Patients' Report to be published in 2023.

The aim is to publish annual National Cardiac Audit Programme (NCAP) reports based on 2021/22 data in each of the domains of NCAP during 2023. NHS England information is essential to be able to provide appropriate case ascertainment and mortality outcome for these publications. Without such data the essential analysis and core reporting and subsequent quality improvement cannot be done.

The intended audience are clinicians, healthcare professionals, Medical Directors, Chief Executives, audit managers, commissioners, NHS England, public and patients. Trusts will use the outcomes in the annual reports to assess their care against national standards and benchmark against other trusts, and make improvements which in turn will benefit patients. The Audit is able to identify and report the following year whether improvements have been made. The outputs will show whether the trusts are meeting national guidance and whether there is any variation in the provision of care.

• Each audit domain will produce and publish a summary report alongside the main NCAP Annual Report and the Annual Report for Patients and the Public.

• The National Adult Cardiac Surgery Audit and the National Audit for Percutaneous Coronary Interventions domains may publish consultant level outcomes on the professional society websites in 2023. Consultant-level outcomes likely to be reported are volume of operations and risk-adjusted in-hospital survival rate (adult cardiac surgery) and number of procedures, data completeness, freedom form major adverse events, survival 30-days post-procedure and proportion of patients treated using radial artery access (NAPCI): This is to provide transparency, quality assurance and to assist in patient choice.

• The process creates a single cardiovascular dataset in which patients can be tracked as they develop cardiac conditions, present with clinical complications and receive cardiovascular treatments. The NCHDA (Congenital) audit is hoping to develop a programme to track outcomes for specific patient groups over the next 2-3 years.

• The dataset provides additional insight into outcomes (especially adverse reactions such as stroke, bleeding or renal failure) which NICOR can then include in annual reports used to inform quality improvement work. Several NCAP domains are actively looking at how to utilise the linked data over the next 2-3 years to develop new outputs to support these aims.

• The linkages make it possible to investigate and publish outcomes beyond survival in each of the audits. These could include other post-procedure/care pathway complications, longer-term outcome or process measures. For example, both the disease-based and procedure-based domains are investigating analytical plans to explore the number of and reason for readmissions.

• The linkages enable the development and implementation of new clearly defined audit-specific quality improvement questions and plans.

• Linkages will enhance plans in the NACRM (arrhythmia management) audit to publish pacemaker and complex procedure numbers by implanter and by responsible consultant, but including follow-up outcomes such as requirements for additional procedures. In addition, analytical plans are considering how many patients in the disease-specific domains (MINAP and NHFA) receive appropriate treatment with implantable device therapy.

• The enhanced analytical platform enables the publication of results, where appropriate, in peer-reviewed journals which allows greater discussion of the strengths and weaknesses of the results and will provide the benefit of peer-review of the work from third parties. The work is highly relevant to current clinical practice and publication will allow NICOR to disseminate the findings widely amongst health professionals.

• All reports and outputs will be made available on the NICOR website, and websites of the associated professional societies to make them further accessible by healthcare professionals and patients and the public.

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 NCAP 2022 Annual Aggregate Report, the six Summary Domain Reports and the NCAP Report for Patients and the Public were published in June 2022: https://www.nicor.org.uk/2022/06/09/nicor-publishes-national-cardiac-audit-programme-ncap-annual-report-2022/

The 2022 Reports (https://www.hqip.org.uk/resource/national-cardiac-audit-programme-2022-report-the-heart-in-lockdown/#.Y8Z6_JjP2Uk) and earlier annual reports are also available to view on the Healthcare Quality Improvement Partnership's website.

A number of future benefits are expected to be applicable to all the audits. For example:

• Investigating cumulative missed opportunities for patient care and major cardiovascular and cerebrovascular events. Patients tend to benefit from national clinical audits as the audit process assesses the quality of care provided by different specialist units to patients with cardiovascular heart disease and the treatment outcomes. Care providing units are benchmarked against others nationally. This enables patients to see which units / clinicians are better care providers than others which also facilitates patient choice when they are referred for hospital specialist care.

• Determining case ascertainment rates and under-reporting of procedures and patient admissions. The information analysed by NICOR on the treatment outcomes and benchmarking of specialist units and clinicians is used by hospitals for service planning and quality improvement. The hospitals are able to use the Information and Communications Technology reporting tools that NICOR has provided to the hospital units submitting data to NICOR (e.g. comparison of unit’s performance with the national average or with the top 10 hospitals in the country) for planning and quality improvement purposes. Similarly the audit information outputs developed by NICOR are also used by the regulators for example the Care Quality Commission (CQC) to monitor the performance of the individual units. This is expected to be a major public/health service benefit as it leads to safe care being provided by hospitals.

The other expected benefits of NHS England linked data with national cardiac audit programme data are that the specialised commissioners, regulators (e.g. CQC, Medicines and Healthcare products Regulatory Agency) and other stakeholders should find the outcomes data useful for ensuring they are purchasing high quality of services, and that the cardiac services received by patients are of high/consistent quality. This is made more relevant to the key stakeholders by NICOR standardising and harmonising the approach to conducting the 6 clinical domains of NCAP in terms of methodology, data collection, data completeness, data quality, statistical methodology for analysis and reporting, thus making the NCAP reports truly relevant and useful for all key stakeholders, commissioners, trusts, patients and the public and clinicians, which will lead to improvements in the quality of care provided to patients.

The use of the information provided by NICOR 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.

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

• 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 research (and the innovations and developments that might result from that exploratory work).

The audits are continuously evolving and developing. Selected examples of some of the future specific expected measurable benefits/developments for the audits include:

• National Congenital Heart Disease Audit:

o Developing additional outcome measures other than life status. This is particularly important for this cohort of patients undertaking complex procedures at a very young age – often neonates.

o Developing a risk model for adult congenital cases to measure the safety of patient services. Without the audit data this would not be possible.

• National Audit for Percutaneous Coronary Interventions:

o Data used to develop clinical service quality markers for heart attack services - an expected benefit for health services.

• National Heart Failure Audit (NHFA):

o Use of audit data to develop a heart failure risk adjustment model for ensuring that variations in patient types/casemix are accounted for

o Use of audit data to develop Clinical Service Quality Measures (CSQM) which should benefit the health services

o Data used by hospitals in the NHS to support best practise tariff (BpT) – a quality improvement initiative to reward hospitals that provide a high standard of care. Improving efficiency and good use of limited resources would be beneficial for both patients and the system.

• MINAP:

o Development of a risk model that reflects the complexity of the heart attack care pathway. Audit data is crucial to this work due to the complexity of the pathways within England and Wales.

o Publication of risk adjusted survival rates is both a patient benefit as it improves patient choice as well as a system benefit.

• National Audit for Cardiac Rhythm Management:

o Provide commissioning level reports which should benefit both patients with improved levels of commissioning, and the health services.

o reporting one year re-intervention rates for first-time pacemaker and complex implants at each centre. This is an important index of major complications.

• National Adult Cardiac Surgery Audit:

o Develop methods for rapid analysis of local and national data for individual consultant performance and unit level reporting. A national “pre-alert” system will be introduced to anticipate and prevent deviation from agreed performance standards (alerts and alarms) which is of expected benefit to patients and health services.

NICOR’s harmonisation of the six national clinical cardiovascular audits into a national cardiac audit programme with 6 separate specialist audit domains, led to a standardised approach to methodology (data collection, data completeness, data quality, analysis and reporting). As part of this harmonisation process an annual report for the benefits of the patients and the public has been produced each year using lay terminology, written by patients and non-clinician staff. These reports have been used by patients extensively, enhancing patient choice and understanding, informing patients about what they can expect when going into hospital for their procedure, and provision of other useful sources of information.

Another benefit is that NICOR has used audit data linked with Civil Registrations data for developing risk adjustment models for Heart Failure and MINAP. These models are now in their final stages of implementation (validation). These will ensure that the reports produced for these domains are reliable and that the data are being interpreted accurately and meaningfully. This should impact patient care as well as health service delivery.

Linkage of the NCAP data to ONS data was essential for a range of outputs performed by NICOR and academic colleagues to assess the early impact of the COVID-19 pandemic on cardiovascular services.

Some examples of key benefits realised from the audits are:

1) National Congenital Heart Disease Audit (NHCDA):

• The use of linked NCHDA data with Civil Registration Mortality data to calculate expected treatment outcomes using the PRAiS2 (risk model) to report centre level differences in case-mix adjustment for paediatric congenital heart disease patients undergoing cardiac surgery. These linked data are used to recalibrate the risk adjustment model. The results show high survival rates, just under 98%, at 30 days following paediatric cardiac surgery which compare very favourably to results reported in similar developed countries in Europe and North America.

• The PRAiS2 risk model for paediatric surgery was updated using NCHDA data. The software was updated in July 2016, such that PRAiS2 is the most up-to-date model, reflecting recent national outcomes (2009-15). Work is on-going to perform a further re-calibration using more recent data.

o The NCHDA now includes rates of significant complications after paediatric surgical intervention and provides comparative data for individual hospitals to consider.

o A risk-adjustment model has also been applied to patients undergoing surgical or percutaneous interventions in older patients and has been able to provide assurance on the quality of care.

• Antenatal diagnosis continues to improve to now over 50% of those requiring an intervention in infancy. This is hugely important for mothers and families and for their care services in planning treatment and also the necessary advisory and support services required.

2) National Audit for Percutaneous Coronary Interventions (NAPCI):

• Year-on-year improvements in various processes of care (known to be associated with improved outcomes) have been achieved (e.g., primary PCI (PPCI) is now the default treatment for patients with ST-elevation myocardial infarction (big heart attacks), use of radial procedures, use of drug-eluting stents).

• The standards for “door to needle” and “door to balloon” times continue to be met although increased times with inter-hospital transfer were observed

• There has been a reduction in the use of thrombectomy devices in PPCI procedures, reducing costs without impacting on outcomes.

• However, the NICOR data reveal continuing issues with a number of processes of care including the overall time taken for patients to receive treatment for ST-elevation MI (“call-to-balloon” times) which have initiated a national debate and a work programme within NHS England to address this.

• Similarly, systems reviews are needed to address the issue of timely treatment for patients with non-ST-elevation myocardial infarction [smaller heart attacks] and for all heart attack patients requiring an inter-hospital transfer.

• The implementation of a risk adjustment model has enabled a comparison of outcomes of individual hospitals and operators, adjusting for case mix.

3) National Heart Failure Audit (NHFA):

• In spite of fears that outcomes would be worse during the COVID-19 pandemic, this did not prove to be the case. However, there was a dramatic fall-off of admissions to hospital with heart failure.

• Best outcomes, in terms of processes of care and outcomes, are seen in those patients who are managed by specialist cardiac care.

• The prescription of key disease-modifying medicines for patients with heart failure and a reduced left ventricular ejection fraction (HF-REF) continues to increase. These treatments are both life-saving and inexpensive. However, there is still evidence that too many patients are being discharged with some of these drugs, but not all the indicated medications they should have received.

• On-going analysis is investigating the prescription of newer classes of drugs that impact favourably on outcomes.

• The Heart Failure audit data are used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care.

4) MINAP:

• As with NHFA, the outcomes of patients admitted to hospital during the COVID-19 pandemic were not significantly altered and processes of care were, largely, maintained or improved.

• As per the NAPCI findings, there is a national concern about the deteriorating call-to-balloon times for patients with ST-elevation myocardial infarction (large heart attacks) and the on-going delays associated with inter-hospital transfers for treatment for patients with all forms of heart attack.

• During the COVID-19 pandemic, patients requiring angiography following presentation with non-ST-elevation myocardial infarction (smaller heart attack) received the investigation and subsequent treatment faster than seen in previous years and more received treatment within the guideline-recommended 72 hours from admission. This related to a reduction in the number of admissions and greater access to the catheter laboratories whilst elective work was postponed.

• There are improvements in the number of patients being assessed with in-patient echocardiography prior to discharge. This helps direct which additional treatments they should receive.

• The proportion of patients receiving secondary prevention medications has been maintained at a high level.

• There has been a gradual improvement in the number of patients being referred for cardiac rehabilitation following a heart attack.

• MINAP data are used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care.

5) National Audit for Cardiac Rhythm Management

• Procedure numbers, especially for elective ablation procedures fell dramatically during the early part of the COVID-19 pandemic.

• The audit has identified quite significant regional variations in rates of device implants and ablation methods for control of arrhythmias.

• The number of hospitals performing fewer than the recommended minimum number of procedures has been falling progressively.

• Although there is overall high compliance with national standards, documentation of indications for procedures varies and some hospitals need to improve.

• There is a significant variation in the need for second treatments during follow-up after an initial procedure.

6) National Adult Cardiac Surgery Audit:

• There was a significant fall in all types of elective cardiac surgery during the early part of the COVID-19 pandemic.

• Analysis has demonstrated the likely increased mortality for patients with aortic valve disease during this period.

• Waits for cardiac surgery had been falling but increased again during the COVID-19 pandemic.

• There has been an overall reduction in complications following surgery with a reduction in the variation between hospitals.

• The development and implementation of the risk model for cardiac surgery has been an essential part of quality assurance in the NHS.

There is considerable use of the cardiac national data which has become a valuable source of data for commissioners, the Department of Health, patients, clinicians, and managers. The audit data, linked to HES and/or mortality data, has and will continue to be used to:

• Improve standards of care

• Facilitate completeness of data

• Inform Patient choice

• Inform effective commissioning

• Inform regulatory and monitoring bodies (e.g. CQC)

• Provide new evidence