In a groundbreaking development, a study published in
the Journal of Vascular Surgery reveals for the first time
that coronary CTA (CCTA) with fractional flow reserve (FFRCT) care
significantly reduces mortality by over 60 percent at five years in
patients with PAD undergoing major vascular surgery, far surpassing
the current standard of care.1
Atherosclerosis is a systemic disease
that affects multiple vascular regions and is particularly severe
in PAD patients, where up to 80 percent suffer from concurrent
coronary artery disease (CAD), historically linked with a mortality
rate exceeding 50 percent within five years.2-4 HeartFlow’s
non-invasive FFRCT technology has emerged as a leading frontline
strategy for accurately diagnosing hemodynamically significant
coronary lesions in patients suspected of having
CAD.5 Revascularization to improve blood flow to the heart has
been shown to reduce mortality in stable chest pain patients.6
This novel study marks a significant
milestone in the field, evaluating the effectiveness of FFRCT in
detecting ischemia-producing coronary stenosis in patients with
severe PAD. Among 522 surgical PAD patients with previously
undiagnosed CAD, systematic FFRCT testing combined with targeted
coronary revascularization resulted in a 63 percent reduction in
all-cause mortality, an 89 percent decrease in cardiovascular
death, and an 87 percent reduction in myocardial infarction during
the five-year follow-up, compared to patients receiving standard
cardiac evaluation.
“PAD affects over 230 million people
globally, presenting a significantly underrecognized risk of CAD,”
said Dr. Frank Arko, Chief of Vascular and Endovascular Surgery at
Atrium Health Sanger Heart & Vascular Institute. “In an
additional study looking at a similar patient population, we
studied 170 high-risk PAD patients, where we utilized systematic
FFRCT testing. Remarkably, 70 percent of these patients had
hemodynamically significant CAD, which is a major risk factor for
cardiac complications. This first-of-its-kind evidence firmly
establishes the life-saving potential of FFRCT-guided diagnosis and
treatment in improving long-term survival.”7
HeartFlow leads the market in non-invasive CAD diagnosis and
management. This publication showcases the company’s continued
commitment to revolutionizing patient care with innovative and
scientifically validated technologies.
Dr. Christopher Zarins, Senior Vice President of Medical Affairs
at HeartFlow, commented, “Despite advances in peripheral vascular
disease treatment, the mortality rate following vascular surgery
remains distressingly high. With our AI-powered approach, HeartFlow
addresses a critical and longstanding clinical challenge by
noninvasively determining the presence of significant CAD and
facilitating its effective treatment. Ultimately, the result is
that patients with atherosclerotic disease can receive access to a
more accurate diagnosis and treatment, dramatically reducing their
likelihood of death.”
HeartFlow is dedicated to defeating heart disease through
partnering with physicians to generate robust, high quality
clinical evidence. HeartFlow has been adopted by over 1,000
institutions globally and continues to strengthen its commercial
presence to make this cutting-edge solution more widely available
to an increasingly diverse patient population worldwide.
The HeartFlow FFRCT Analysis is part of a clinical pathway for
evaluation and diagnosis of CAD that provides clear insight into a
patient’s heart condition with a personalized visual model of the
heart’s blood flow, helping physicians make more accurate diagnoses
and treatment decisions.*
About HeartFlow HeartFlow is transforming
precision coronary care with the only non-invasive integrated heart
care solution across the CCTA pathway. As the pioneer of FFRCT,
which is now supported by the ACC/AHA Chest Pain Guidelines,
HeartFlow continues to advance the diagnosis and management of CAD.
Our suite of non-invasive technologies helps clinicians identify
stenoses in the coronary arteries (RoadMap™Analysis), assess
coronary blood flow (FFRCT Analysis), and characterize and quantify
coronary atherosclerosis (Plaque Analysis). To date, more than 500
peer-reviewed publications have validated our approach and, more
importantly, our technologies have helped clinicians diagnose and
manage over 250,000 patients. For more information, visit
www.heartflow.com and connect on Twitter and LinkedIn.
Contact Linly Ku HeartFlow
media@heartflow.com
References 1 Krievins, Dainis K., et al.
“Diagnosis and treatment of ischemia-producing coronary stenoses
improves 5-year survival of patients undergoing major vascular
surgery.” Journal of Vascular Surgery, Mar. 2024,
https://doi.org/10.1016/j.jvs.2024.02.043.
2 Halliday, Alison, and Jeroen J. Bax. “The 2017 ESC guidelines
on the diagnosis and treatment of peripheral arterial diseases, in
collaboration with the European Society for Vascular Surgery
(ESVS).” European Journal of Vascular and Endovascular Surgery,
vol. 55, no. 3, Mar. 2018, pp. 301–302,
https://doi.org/10.1016/j.ejvs.2018.03.004.
3 Secemsky, Eric A., et al. “Longitudinal
assessment of safety of FEMOROPOPLITEAL endovascular treatment with
paclitaxel-coated devices among Medicare beneficiaries.” JAMA
Internal Medicine, vol. 181, no. 8, 1 Aug. 2021, p. 1071,
https://doi.org/10.1001/jamainternmed.2021.2738.
4 Bradbury, Andrew W, et al. “A vein bypass
first versus a best endovascular treatment first revascularisation
strategy for patients with chronic limb threatening ischaemia who
required an infra-popliteal, with or without an additional more
proximal infra-inguinal revascularisation procedure to restore limb
perfusion (basil-2): An open-label, randomised, Multicentre, phase
3 trial.” The Lancet, vol. 401, no. 10390, May 2023, pp. 1798–1809,
https://doi.org/10.1016/s0140-6736(23)00462-2.
5 Gulati, Martha, et al. “2021
AHA/ACC/ASE/Chest/Saem/SCCT/SCMR guideline for the evaluation and
diagnosis of chest pain: A report of the American College of
Cardiology/American Heart Association Joint Committee on Clinical
Practice Guidelines.” Circulation, vol. 144, no. 22, 30 Nov. 2021,
https://doi.org/10.1161/cir.0000000000001029.
6 Navarese EP, Lansky AJ, Kereiakes DJ, Kubica
J, Gurbel PA, Gorog DA, et al. Cardiac mortality in patients
randomised to elective coronary revascularization plus medical
therapy or medical therapy alone: a systematic review and
meta-analysis. Eur Heart J 2021;42:4638-4651.
7 Stanley, Gregory A., et al. “Utilization of coronary computed
tomography angiography and computed tomography-derived fractional
flow reserve in a critical limb-threatening ischemia cohort.”
Journal of Vascular Surgery Cases, Innovations and Techniques, vol.
10, no. 2, Apr. 2024, p. 101272,
https://doi.org/10.1016/j.jvscit.2023.101272.
*The HeartFlow Analysis is an AI–based medical device software
for the clinical quantitative and qualitative analysis of
previously acquired Computed Tomography DICOM data for patients
with suspected coronary artery disease. It provides anatomic data,
plaque identification and characterization, as well as the
calculations of FFRCT, a coronary physiological simulation,
computed from simulated pressure, velocity and blood flow
information obtained from a 3D computer model generated from static
coronary CT images. The HeartFlow Analysis is intended to support
the risk assessment and functional evaluation of coronary artery
disease.
The HeartFlow Analysis is provided to support qualified
clinicians to aid in the evaluation and risk assessment of coronary
artery disease. The HeartFlow Analysis is intended to be used by
qualified clinicians in conjunction with the patient’s clinical
history, symptoms, and other diagnostic tests, as well as the
clinician’s professional judgment.
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