Tools and resources

Adoption support resource – insights from the NHS

5 How to implement NICE's guidance on HeartFlow FFRCT

5 How to implement NICE's guidance on HeartFlow FFRCT

Site specific criteria

Requirements for HeartFlow are consistent with the Society of Cardiovascular Computed Tomography (SCCT) Performance of Cardiac CT Guidance Document:

  • 64-slice or greater CT scanner with cardiac gating capability

  • dual syringe injector for 2‑phase injection

  • access to scheduled time on the scanner for coronary CT angiography (CCTA)

  • experience, willingness and staffing to use glycerine trinitrate and beta blockers (oral or intravenous) for proper vessel visualisation and heart rate control

  • accredited CCTA reader (or equivalent experience of more than 150 cardiac CTs) – may be SCCT Level 1+ or accredited through other organisations or fellowships

  • at least 1 radiographer trained in CCTA and experienced with cardiac reconstructions

  • ability to meet minimum quality requirements for HeartFlow process (minimum 8 out of 10 consecutive cases pass initial quality acceptance)

  • HeartFlow onsite review of the institution's CCTA programme, training for imagers on HeartFlow requirements, review of CCTA best practices, and SCCT guidelines for performance of CCTA.

NHS contributors to this resource have worked with NICE to develop practical suggestions for how to implement NICE guidance on HeartFlow FFRCT. Local organisations will need to assess their applicability taking into consideration the time, resources and costs of an implementation programme.

Project management

NICE has produced a generic into practice guide that includes a section on what organisations need to have in place to support the implementation of NICE guidance using a project management approach.

Project team

The first step is to form a local project team who will work together to implement the technology efficiently and manage the challenges specific to implementing HeartFlow FFRCT.

Individual NHS organisations will determine the membership of this team and the length of the implementation process. Project team membership could include:

  • Clinical champion(s): could be a senior clinician/manager with an interest in cardiology imaging such as a consultant radiologist or imaging cardiologist. They should have the relevant knowledge and understanding to be able to drive the project, answer any clinical queries and champion the project at a senior level.

  • Project manager: could be someone in a clinical or managerial role who will be responsible for the day-to-day running of the project, co‑ordinating the project team and ensuring the project is running as planned.

  • Management sponsor: could be the directorate manager, directorate accountant or directorate business manager. They will be able to help assess the financial viability of the project, drive the formulation of a business case and help to demonstrate the cost savings achieved.

  • Picture archiving and communications system (PACS) manager: to assist with return data if digital imaging and communications in medicine (DICOM) data are needed.

  • IT manager: to work with manufacturer during the setup phase.

  • Administration representative: to help map and manage the downstream shifting of tasks and to potentially support data transfer on behalf of clinicians.

  • Information governance lead: to help initiate the information governance process at the hospital.

  • Clinical audit facilitator: to help set up mechanisms to collect and analyse local data related to the project metrics and audit needs.

  • Interventional cardiologist or other function test operators who may wish to be involved to understand the wider impact on their service.

Early questions and considerations for the team include:

  • What is the current CT compatibility (is at least 64-slice)?

  • Is there capability to scan in accordance with Royal College of Radiology and SCCT guidelines to produce desired CT image quality?

  • Consider any internal IT setup costs and IT infrastructure compatibility for establishing software setup.

  • Consider the need for HeartFlow Analysis PACS Integration (optional): a HeartFlow FFRCT DICOM pdf summary can be automatically delivered to hospital PACS systems.

  • How will the project be funded? Can local payment arrangements be implemented with the clinical commissioning group to support adoption? (See the resource impact report.)

  • Who should receive manufacturer training and when should this happen?

  • Are there any obvious local challenges and how can these be overcome?

Care pathway mapping

Give due consideration to patient selection criteria as part of care pathway mapping. Some patients may still need invasive CT, but HeartFlow FFRCT may become less cost effective if additional functional tests are done.

Information governance

During guidance development, the medical technology advisory committee considered the protection and oversight of data transferred during the administration of HeartFlow FFRCT to be an important factor in its adoption. It was satisfied on the basis of the information available that the company's data transfer protocols meet regulatory requirements.

Local information governance involvement and approval is essential to adoption of HeartFlow.

All data uploaded to HeartFlow Inc is secure via HTTPS (port 443) using TLS1.2 industry standards. Personal Identifiable Information is encrypted at rest with Advanced Encryption Standards (AES256).

CTA DICOM images are de-identified by the HeartFlow Connect VM Appliance installed onsite on the Provider's network. Personal Identifiable Information is extracted from CTA DICOM images and securely held within HeartFlow Virtual Private Cloud (UK), encrypted at rest with Advanced Encryption Standards (AES256).

De-identified DICOM images are securely uploaded to HeartFlow USA for processing.

HeartFlow FFRCT is:

  • evaluated against the NHS Digital Security Protection Toolkit: Organisation code: 8K799

  • registered with the ICO: Notification No. ZA455456, HeartFlow Technology UK Limited

  • certified with ISO/IEC 27001: 2013 standards and best practices

  • CE certified indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).

Patient information

In HeartFlow contracts with Providers it is stated that all person identifiable information will remain within the EU whilst de-identified image data will be analysed in the USA.

The hospital obtains patient consent for HeartFlow fractional flow reserve CT analysis. Patient information sheets should include information on the secure transfer of data as described above.

North Tees and Hartlepool NHS Trust have shared an example of a cardiac CT checklist that includes a patient consent statement.

Measuring success

In order to demonstrate the benefits of adoption, it is important to take measurements before, during and after implementation (when appropriate). Some of these measures will not need to be routinely collected and sites should consider a data collection methodology that is appropriate for the service. Suggested measures from the sites involved in developing this resource are:

  • number of invasive coronary angiographies (ICAs) requested

  • outcome data (cardiac events/need for revascularisation) on patients discharged without further investigation

  • costs (at department and trust level)

  • image quality

  • frequency of ordering further investigation (for clarification) after HeartFlow FFRCT (clinical confidence)

  • number of patients taken to catheter lab for ICA after a positive HeartFlow FFRCT that was found to be incorrect (false positives)

  • patient experience.

A number of NHS sites have collected (or are collecting) data as part of clinical trials and a research registry (ADVANCE). The registry includes the following clinical information and 1‑year outcome data:

  • basic demographic information

  • medical history

  • CCTA scan results

  • recent invasive and non-invasive test results

  • FFRCT results (if the patient has had a HeartFlow FFRCT analysis)

  • clinic or hospital visits

  • coronary procedures

  • major adverse cardiac events

  • resource use.

Education

The manufacturer provides training to radiologists, radiographers and cardiologists as well as other support staff as appropriate. The planned package of training includes:

  • Introductory training:

    • an overview of HeartFlow FFRCT, delivered through in-person sessions and a range of media

    • didactic and case-based training on the clinical use of HeartFlow FFRCT

    • the user interface, warnings and precautions

    • CCTA image specifications for HeartFlow FFRCT analysis; HeartFlow's CCTA quality requirements are consistent with those of the Royal College of Radiology, British Society of Cardiovascular Imaging and the Society of Cardiovascular Computed Tomography performance of CCTA guidance document.

  • Additional education programmes for radiographers and clinicians.

  • Reference scanning protocols for all major manufacturer models with 64-slice or higher multi-detector CT. These include post-processing techniques.

  • Bespoke training materials. These include clinical protocols and clinician led webinars on CCTA acquisition.

Users will be invited to educational seminars and there is a plan to establish a UK users group to help sharing of best practice around HeartFlow FFRCT's use.

Business case

Developing a business case should be a priority for the implementation team. Local arrangements for developing and approving business plans will vary from trust to trust, and each organisation is likely to have its own process in place.

While HeartFlow analysis is currently being funded for national spread under a zero-cost model (see NHS England Innovation and Technology Payment 2018/2019), ongoing tariff arrangements are not yet clear. The 2016/17 national tariff system did not cover the full cost of the HeartFlow FFRCT analysis.

A business case would need to emphasise the clinical and financial benefits for the trust and patients. It should also include any locally agreed tariffs based on conversations between providers and commissioners. (See the resource impact report.)

National drivers

When developing a business case, NHS trusts may find it useful to refer to table 1 for details of guidance, standards and advice at a national level that support adoption of HeartFlow FFRCT. For example, an increase in the use of 64-slice CCTA will enable more widespread adoption of HeartFlow FFRCT.

Table 1 Guidance, standards and advice related to HeartFlow FFRCT

Driver

Significance or measure

NHS England Innovation and Technology Payment 2018/2019 – HeartFlow, plus extension for 12 months from April 2019.

HeartFlow analysis is being funded for national spread under a zero-cost model. It can be ordered directly from HeartFlow Inc.

Website information and technical notes can be used in developing a business case and planning adoption.

NICE guideline on chest pain of recent onset.

Recommends a minimum specification CT scanner of 64-slices or above, which is needed for HeartFlow FFRCT.

Clinical Imaging board: CT equipment, operations, capacity and planning in the NHS (2015).

Identifies that 74% of NHS CT has more than or equal to 64-slice capability. Recommends that all NHS radiology departments need a future CT replacement plan, looking forward at least 5 years.

Royal College of Radiologists: Standards of practice of computed tomography CG in adult patients (2014).

Includes recommendations on technical and educational needs for the use of CT scans in line with requirements for HeartFlow FFRCT.

NICE guidance on new generation cardiac CT scanners.

Recommends access to new-generation cardiac CT scanners for patients in whom standard CT is challenging.

Resource impact

At the time of publication, the current UK pricing for the HeartFlow FFRCT analysis is £700 (excluding VAT). There are no other cost components specifically associated with its use.

NICE has published a resource impact report and template that can be used by NHS commissioners and providers to better understand the local costs associated with adopting HeartFlow FFRCT. The national assumptions used in the template can be altered to reflect local circumstances.

NICE estimates that around 89,300 people in England may be eligible for HeartFlow FFRCT. Uptake will increase over 5 years (from 2017), with around 35,600 people having HeartFlow FFRCT from 2021/22 when uptake reaches a steady state. The minimum annual saving estimated from implementing the guidance is around £9.1 million. This is equivalent to around £16,800 per 100,000 population.

Overcoming implementation challenges

Table 2 shows the challenges which contributors to this resource reported may be experienced by NHS sites when implementing HeartFlow FFRCT.

Table 2 Potential implementation challenges when using HeartFlow FFRCT

Challenge

Suggested actions

Capital and ongoing revenue costs in the absence of an appropriate tariff and without the NHS England zero cost model.

Securing the necessary funding will need a collaborative approach between the provider and commissioner.

Prepare a business case including full cost considerations for HeartFlow FFRCT compared with current procedures across a complete service budget.

Transfer of workload, decommissioning of services in other departments and/or deskilling of staff.

Identify all staff who could be affected (see care pathway mapping) and who may want to be involved in the project planning stage.

Data collection to measure actual versus perceived impact on relevant services.

Evaluate opportunity for trust level savings.

Evaluate improvements to patient experience.

See measuring success.

Data security.

Ensure local information governance teams are involved in the adoption process.

The company fulfils regulatory approval standards for data confidentiality and integrity protection for remote processing. This complies with UK data protection law.

IT Department concerns around workload and support

HeartFlow Connect VM appliance requires minimal system resources unlike traditional DICOM Medical Imaging Systems. There are no provider licensing costs or requirements for future storage scalability. The HeartFlow Connect VM appliance is maintained by HeartFlow technical teams in the UK and USA - msupport@heartflow.com

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