“What is now proved was once only imagined.” – Charles Darwin
Having recently celebrated its 75th birthday, England’s National Health Service (NHS) has been a source of pride to Britons for decades. Treating over 1 million patients in England daily, NHS clinicians are asked to do increasingly more as they focus on population wellness, treat advanced diseases, and drive impactful clinical research.1 Of course, there are difficulties, but the majority of Britons indicate that having access to free healthcare delivered via the NHS is both a right and a reason to be proud.2
At the 2023 European Society of Cardiology (ESC) meeting, there were even more reasons for Britions to be proud of the work happening in the NHS. Specifically, new data demonstrate that the NHS has extended Briton’s lives and at the same time reduced redundant testing to which Britons have been subjected by enabling rapid adoption of innovative cardiovascular technologies, namely coronary computed tomography angiography (CCTA) and Fractional Flow Reserve derived from CCTA (FFRCT), over the last several years.
This process began in 2016 when the NHS adopted clinical guidelines for patients with chest pain or other symptoms indicative of cardiac disease which prioritized CCTA as the initial diagnostic test, supplanting stress testing and invasive angiography.3 Clinical adoption of CCTA increased, and UK regions with greater CCTA usage saw greater improvements in CAD mortality then regions with less CCTA adoption.4
Following this, based on a detailed assessment by the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP), the NHS identified the HeartFlow FFRCT Analysis as a clinically valuable tool within the CCTA-first pathway.5 Next, in 2018, to increase patient access to the then-nascent HeartFlow FFRCT Analysis technology, NHS England included FFRCT in the Innovation and Technology Payment (ITP) program designed to remove “financial and procurement barriers to introducing new technologies”6 and enabled a rapid “switch” from diagnosis using CCTA alone to diagnosis using CCTA coupled with FFRCT when appropriate.
This “switch’ has now enabled a fascinating, and in many ways unprecedented, real-world opportunity for understanding the population health implications of an improved diagnostic pathway for an extremely high-prevalence disease: at ESC 2023, investigators leveraging the NHS’s robust digital database capabilities, presented the initial results of the FISH&CHIPS study7, which included 2-year follow-up on 90,553 Britons who underwent a CCTA from 2017-2020 at one of 25 NHS England hospitals. 35,688 (39%) underwent CCTA prior to the ITP program being launched at each respective hospital, when FFRCT was not available, and the remaining 54,865 (61%) underwent CCTA during the ITP program when FFRCT was available. The comparison was robust, as it examined outcomes at the same hospitals with largely the same doctors, and the comparison therefore was a focused lens on how adding FFRCT on top of the already effective CCTA programs affects outcomes and efficiency of care at a national level.
The findings were remarkable. While many major cardiovascular trials have required five or more years to identify statistical differences in primary hard clinical endpoint,8,9 FISH&CHIPS found that adding FFRCT availability yielded clear improvement in endpoints within just 24 months. Among patients receiving a CCTA, those scanned during the period of FFRCT availability had:
Importantly, these findings are in line with a multitude of learnings from prior clinical research on the CCTA+FFRCT pathway.
For example, at 1-year follow-up, the PRECISE trial demonstrated that, when compared to a usual care pathway of stress testing or invasive angiography, a pathway centered on CCTA+FFRCT informed clinical decision-making such that clinical events were reduced approximately 70%, non-invasive and invasive cardiac testing were reduced, preventive medication usage was increased, and the PCI:ICA ratio was improved.10 FISH&CHIPS now expands upon the PRECISE data to demonstrate that the informed clinical decisions enabled by CCTA+FFRCT and observed in PRECISE extend the lives of patients and have no adverse impact on other clinical events.
Additionally, in a FISH&CHIPS secondary endpoint analysis, compared to patients with normal FFRCT values, patients with severely abnormal FFRCT values (≤0.50) had 2x risk of all-cause death, 3x risk of cardiovascular death, and 3x risk of MI. These observations reinforce the 3-year follow-up of the ADVANCE-DK registry as follows: (1) the highly prognostic value of FFRCT information, e.g., information available at the very outset of a newly-diagnosed patient’s journey informs a patient’s risk in the coming years, and (2) the continuous nature of FFRCT as a metric, e.g., decreasing FFRCT values correlate to increasing patient risk.11
Findings from FISH&CHIPS strongly validate that diligent and data-driven innovation efforts of the NHS to incorporate selected promising technologies is first and foremost a clinical effort. Through FFRCT adoption, the lives of Britons have been extended, an outcome that was onlyimagined in 2016 when NHS England began leading the way by establishing bold innovation and clinical pathways to evaluate and manage cardiovascular disease.
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REFERENCES
2 How the public views the NHS at 75. The Health Foundation 2023.
3 Clinical Guideline 95: Recent-onset chest pain of suspected cardiac origin: assessment and diagnosis
4 National Trends in Cardiac Imaging: Associations with Health Care Outcomes & Costs. JACC CVI 2022.
5 Medical Technologies Guidance 32: HeartFlow FFRCT for estimating FFR from CCTA
6 NHS England Innovation and Technology Payment programme
7 Fairbairn, et al. FFRCT In Stable Heart disease and CCTA Helps Improve Patient care and Societal costs. Presented at ESC 2023.
8 SCOT-HEART 5-Year Results. N Engl J Med 2018.
9 ISCHEMIA-EXTEND. Circulation 2023.
10 Primary findings of the PRECISE trial. JAMA Cardiol 2023.
11 3-Year findings of the ADVANCE-DK registry. Presented at SCCT 2022.
HeartFlow Analysis is consisted of four main functions; FFRCT, Planner, Roadmap, and Plaque. All four functions are cleared for clinical use in the United States, Bahrain, Israel, and United Arab Emirates. Only FFRCT and Planner functions are cleared cleared for clinical use in Europe, United Kingdom, Australia, Canada, and Japan. Please see HeartFlow Analysis Indications for Use and Instructions for Use for more information.
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HeartFlow FFRCT 分析は、有資格の臨床医による臨床的に安定した症状のある冠状動脈疾患患者への使用を目的とした個別化された心臓検査です。 HeartFlow Analysis によって提供される情報は、資格のある臨床医が患者の病歴、症状、その他の診断検査、および臨床医の専門的判断と組み合わせて使用することを目的としています。
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The HeartFlow FFRCT Analysis is a personalized cardiac test indicated for use in clinically stable symptomatic patients with coronary artery disease by qualified clinicians. The information provided by the HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgement.
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Executive Vice President and Chief Medical Officer
Campbell brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.
He received his A.B. from Harvard College and his M.D. from Harvard Medical School.