Enabling better care decisions for more patients - A collaboration between Siemens Healthineers and HeartFlow

Courtesy of HeartFlow Inc. Enabling better care decisions for more patients A collaboration between Siemens Healthineers and HeartFlow SIEMENS Healthineers siemens.com/healthineers Siemens Healthineers and HeartFlow collaboration 2 Siemens Healthineers and HeartFlow collaboration Transforming the way coronary artery disease is managed Cardiovascular disease is the leading single cause of death globally, claiming 17.7 million lives annually. Of that, approximately 7.4 million deaths result annually from coronary artery disease (CAD) alone (1). Coronary CT angiography (CTA) has been shown, in both clinical studies and real- world usage, to provide clinicians with valuable information about patients at risk for CAD. Coronary CTA as frontline assessment While other non-invasive tests may overlook patients with heart disease, the detailed information available from coronary CTA draws attention to those who may otherwise be missed (2,3). Recently updated guidelines recommend coronary CTA as a frontline assessment in symptomatic stable patients with low to intermediate pre-test probability of obstructive CAD (4,5). CAD diagnosis and management requires understanding of two fundamental questions While coronary CTA allows clinicians to identify and quantify the severity of coronary artery disease, determining the impact that any specific stenosis has on downstream ischemia is still a challenge, meaning that many patients may have disease that will not benefit from invasive intervention. This reality drives the low diagnostic yield of invasive coronary angiography (ICA) seen globally today. In many cases, further testing before referral to ICA is needed (6). Helping to identify ischemia-causing lesions Today, CT-derived Fractional Flow Reserve (FFRCT) is the only non-invasive test that provides actionable information to aid clinicians in determining, vessel-by-vessel, the functional significance of coronary artery lesions. In three prospective multicenter trials, the HeartFlow® FFRCT Analysis has shown higher specificity and positive predictive value (PPV) compared to coronary CTA alone (7-9). Now, Siemens Healthineers and HeartFlow are working together to provide clinicians with improved access to the benefits of coronary CTA and HeartFlow FFRCT within an optimized workflow. 3 Siemens Healthineers and HeartFlow collaboration When excellent image quality is key Every HeartFlow FFRCT Analysis begins with a standard coronary CTA. After the acquisition of high quality images, HeartFlow is able to extract a personalized anatomical model from the coronary CTA data and perform a detailed segmentation of the coronary arteries for each patient. Delivering the technical solutions needed Acquiring these high quality images requires sharp, motion-free visualization of the coronary arteries. To make this possible, Siemens Healthineers provides solutions that are designed to maximize both temporal Courtesy of University Hospital Erlangen, Germany and spatial resolution. Temporal resolution Spatial resolution With an unprecedented native temporal resolution of up High spatial resolution is necessary to fully grasp the to 66 ms, motion artifacts are reduced even in high and/or anatomical detail of the coronary arteries. Insufficient irregular heart rates. Siemens Healthineers’ unique Dual spatial resolution and partial-volume effect may cause Source hardware delivers this purely by the inherent hard- blooming artifacts, which can make interpretation of ware without having to rely on retrospective software coronary CTA datasets and precise segmentation chal- corrections. lenging. The Stellar Detector reduces blooming and enhances vessel delineation with a very high spatial resolution. Additionally, Siemens Healthineers offers dedicated edge-enhancing kernels for coronary imaging and image sharpening for a thorough evaluation of calcified lesions. 4 Siemens Healthineers and HeartFlow collaboration Initial clinical experience The work performed at Aarhus University Hospital, a facility equipped with Siemens Healthineers’ unique Dual Source technology, demonstrates the impact that this continuous introduction of powerful product innovations provides to both patients and clinicians. Adapting their standard clinical workflow – Frontline cCTA combined with selective FFRCT In assessing their standard clinical practice, Dr. Jensen and his colleagues changed their diagnostic workflow to include frontline coronary CTA with selective use of the HeartFlow FFRCT Analysis testing in all symptomatic patients with suspected stable CAD (10). Coronary CTA was acquired in 774 patients with high diagnostic image quality found in 97% of scans. Out of the 212 patients submitted for downstream testing with FFRCT, 99% of the low/intermediate risk group and 97% of the high-risk group were accepted for the HeartFlow FFRCT Analysis. Excellent diagnostic image quality 97%–99% Furthermore, an earlier evaluation of the work at Aarhus University Hospital showed similar findings: of 1,248 of images accepted for HeartFlow FFRCT patients referred for coronary CTA performed using a Siemens Dual Source scanner, 97% were of excellent diagnostic image quality (11). Here, 189 patients were referred for FFRCT, with a HeartFlow FFRCT Analysis obtained in 185 (98%). These results are exemplary, and highlight the value of high-quality coronary CTA, especially when taking into This shows that through the combination of latest- account the more challenging clinical realities of Aarhus’ generation scanner equipment, acquisition protocols high-risk patient group, including patients with higher and trained staff, Jensen et al. were able to achieve mean Agatston scores. a very high acceptance rate . 5 Siemens Healthineers and HeartFlow collaboration Delivering the data clinicians need Together, coronary CTA and the HeartFlow FFRCT Analysis enable clinicians to identify significant coronary artery disease and determine the optimal treatment pathway. Greatly reduce unnecessary invasive testing The PLATFORM Study, a prospective comparative While ICAs were reduced, coronary revascularizations effectiveness trial enrolling 584 patients at 11 medical were maintained (13), meaning that the patients needing centers, compared a coronary CTA and HeartFlow coronary interventions were still treated. FFRCT guided pathway to usual care for patients with suspected CAD. Clinical sites across the world have demonstrated that the real-world adoption of a coronary CTA and HeartFlow When utilizing a coronary CTA and HeartFlow FFRCT FFRCT guided pathway has led to similar reductions in ICAs guided pathway, physicians were able to safely cancel while maintaining revascularizations. 61% of scheduled invasive coronary angiograms (ICAs) (12) with zero adverse clinical events occurring through one year among patients whose ICA was canceled. (13) $ Improved patient experience Reduce costs to the healthcare system Patients reported a significant improvement in quality of The coronary CTA and HeartFlow FFRCT guided pathway life and experienced a reduction in unnecessary invasive has been shown to reduce overall costs to the healthcare procedures due to a coronary CTA and HeartFlow FFRCT system by 26% compared with usual care testing for guided pathway. (12) patients with suspected CAD. This was a savings of over $3,000 (USD) per patient over one year. (13) 6 Siemens Healthineers and HeartFlow collaboration The future arrives now Siemens Healthineers and HeartFlow are Once registered in the Ecosystem, customers will be able now working together to increase the clinical to access, explore and purchase services from HeartFlow availability of a better treatment pathway for and many other innovative software solutions in a secure and HIPAA compliant environment. all patients with suspected coronary artery disease. Bringing these tools together allows clinicians to bring cutting-edge technologies with clinical value to the patients who need them most. From efficiently tracking The Siemens Healthineers Digital Ecosystem, based on and managing care for patients to changing the clinical the cloud-based network teamplay, will provide clinicians pathway for patients with suspected CAD, solutions like with a seamless work stream to submit scans to HeartFlow are designed to aid in daily clinical practice HeartFlow and review information from each completed and be easily integrated into existing protocols. HeartFlow FFRCT Analysis. Already in use at hundreds of customer sites, teamplay provides cutting edge security Siemens Healthineers can now offer the HeartFlow FFRCT and has been awarded for its handling of data privacy. Analysis to healthcare providers in the United States and will expand into other markets in the future. Home Protocols2) Dose Images3) Usage Cardio4) Constant update cycles Rad1) ... More to come 7 On account of certain regional limitations of sales rights Siemens Healthineers reserves the right to modify the and service availability, we cannot guarantee that all design, packaging, specifications and options described products included in this brochure are available through herein without prior notice. Please contact your local the Siemens sales organization worldwide. Availability Siemens sales representative for the most current and packaging may vary by country and is subject to information. change without prior notice. Some /All of the features and products described herein may not be available in Note: Any technical data contained in this document may the United States. vary within defined tolerances. Original images always lose a certain amount of detail when reproduced. The information in this document contains general technical descriptions of specifications and options The statements contained herein are based on the actual as well as standard and optional features which do experience of Siemens Healthineers customers. Siemens not always have to be present in individual cases. Healthineers maintains data on file to support these claims. However, these statements do not suggest or constitute a warranty that all product experience will yield similar results. Results may vary, based on the particular circumstances of individual sites and users. References (1) http://www.who.int/mediacentre/factsheets/fs317/en/ (8) Min JK et al. Diagnostic accuracy of fractional flow reserve from (2) Meijboom et al. Diagnostic accuracy of 64-slice computed tomography anatomic CT angiography. JAMA 2012;308:1237–45. coronary angiography: a prospective, multicenter, multivendor study. J (9) Nørgaard BL et al. Diagnostic performance of noninvasive fractional Am Coll Cardiol 2008;52:2135–44. flow reserve derived from coronary computed tomography angiography (3) SCOT-HEART Investigators CT coronary angiography in patients with in suspected coronary artery disease: the suspected angina due to coronary heart disease (SCOT-HEART): an open- NXT trial. J Am Coll Cardiol 2014;63:1145–55. label, parallel-group, multicentre trial. Lancet 2015;385:2383–91. (10) Jensen MJ et al. Computed tomography derived fractional flow reserve (4) Moss AJet al. The Updated NICE Guidelines: Cardiac CT as the First-Line testing in stable patients with typical angina pectoris: influence on Test for Coronary Artery Disease. Curr Cardiovasc Imaging Rep. 2017; downstream rate of invasive coronary angiography. Eur Heart J 10(5): 15. Cardiovasc Imaging. 2017. (5) Montalescot G et al. 2013 ESC guidelines on the management of stable (11) Nørgaard BL et al. Clinical Use of Coronary CTA-Derived FFR for coronary artery disease: the Task Force on the management of stable Decision-Making in Stable CAD. JACC Cardiovasc Imaging. 2017 coronary artery disease of the European Society of Cardiology. Eur Heart May;10(5):541-550. J 2013;34:2949–3003. (12) Douglas PS et al. Clinical outcomes of fractional flow reserve by (6) Meijboom WB et al. Comprehensive assessment of coronary artery computed tomographic angiography-guided diagnostic strategies vs. stenoses: computed tomography coronary angiography versus usual care in patients with suspected coronary artery disease: the conventional coronary angiography and correlation with fractional flow prospective longitudinal trial of FFRCT: outcome and resource impacts reserve in patients with stable angina. J Am Coll Cardiol 2008;52:636–43. study. Eur Heart J. 2015;36(47):3359-67. (7) Koo BK et al. Diagnosis of ischemia-causing coronary stenoses by (13) Douglas PS et al. 1-Year Outcomes of FFRCT-Guided Care in Patients with noninvasive fractional flow reserve computed from coronary computed Suspected Coronary Artery Disease. J Am Coll Cardiol. 2016;68(5):435-45. tomographic angiograms. Results from the prospective multicenter DISCOVERFLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol 2011;58:1989–97. 1 Radiology Performance Management Service (RPMS) is not commercially available in all countries and/or for all modalities. The integration of the radiology dashboard (teamplay Rad) into teamplay is currently ongoing. If RPMS is not marketed in countries due to regulatory or other reasons, the availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details. 2 teamplay Protocols supports selected Siemens Healthineers scanners. 3 teamplay Images Research is not intended for clinical use. The DICOM viewer is not intended for diagnostic display. 4 Cardiology Dashboard (realized with teamplay Cardio) is under development. Not available for sale in the U.S. and other countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details. Pre-requisite: an existing installation of syngo Dynamics VA20D with the enhanced data export functionality as well as a teamplay receiver installation. For the Orders category MLA needs to be ordered. Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens.com/healthineers Published by Siemens Healthcare GmbH · Order No. A91CT-09721-13C1-7600 · Printed in Germany · 5413 1117.x · ©Siemens Healthcare GmbH, 2017