Indications

Heartflow Analysis Intended Use (Roadmap Analysis, Plaque Analysis, and FFR_CT Analysis Sites)

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 adult patients (ages 22 years and older) with suspected coronary artery disease. It provides anatomic data, plaque localization and characterization, as well as the calculations of FFR_CT, 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.

Heartflow Analysis Intended Use (FFR_CT Analysis Sites)

The Heartflow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFR_CT, a mathematically derived quantity, 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 functional evaluation of coronary artery disease.

The Heartflow Analysis is provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. 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.

US Region

Product Warnings and Precautions

Patient Population

The following warnings are related to the potential patient populations for the Heartflow Analysis.

WARNING:

The safety and effectiveness of the Heartflow Analysis has not been evaluated for the following populations:

1. Suspicion of acute coronary syndrome (where acute myocardial infarction or unstable angina have not been ruled out)
2. Recent prior myocardial infarction within 30 days
3. Complex congenital heart disease
4. Prior coronary artery bypass graft (CABG) surgery
5. Patients with a Body Mass Index >35
6. Patients who require emergent procedures or have any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, severe congestive heart failure (New York Heart Association [NYHA] III or IV) or acute pulmonary edema

Due to the potential for artifacts in the CT data or degradation of CT data quality, the safety and effectiveness of the Heartflow Analysis has not been clinically evaluated for the following populations:

1. Patients with intracoronary metallic stents
2. Patients with prior pacemaker or internal defibrillator lead implantation
3. Patients with prosthetic heart valves
4. Patients with significant arrhythmias or tachycardia (uncontrolled by medication) that would preclude CT acquisition
5. Coronary vessels with excessive calcification

WARNING:

The Heartflow Analysis has been studied in patients with prior PCI, but the FFR_CT values have only been validated in vessels without metallic stents.

WARNING:

The diagnostic performance of the Heartflow Analysis has been validated in patients who are candidates for invasive coronary angiography based on clinical presentation and/or non-invasive testing.

Provision of Data

The following warnings identify anatomy or image acquisition factors that may impact the Heartflow Analysis.

WARNING:

The Heartflow Analysis may be adversely affected by the following:

1. Marginal quality of the submitted imaging data (motion, blooming, misalignment, etc.)
2. Regionalized or global myocardial dysfunction
3. Myocardial mass abnormalities (hypertrophic right ventricle for example)
4. Abnormal patient physiology (e.g., severe congenital disease or excess calcification)

WARNING:

The Heartflow Analysis has not been validated with software-based motion correction algorithms. CT datasets with significant coronary motion may require application of software-based motion correction algorithms which use information from multiple phases (time points) to recreate the lumen and correct for motion. Motion correction algorithms improve acceptability for standard visual interpretation, however they may distort the anatomy such that it is no longer representative of actual patient anatomy. The Heartflow Analysis is predicated upon the anatomy in the provided data, which may not represent actual patient anatomy.

WARNING:

The Heartflow Analysis simulates maximal hyperemia, which results in vasodilation of the epicardial coronary arteries. This condition is commonly induced using nitrates. Therefore, Heartflow recommends following SCCT guidelines for coronary CTA acquisition, which recommends the use of sublingual nitrates at the time of image acquisition unless contraindicated. Absence of nitrates during coronary CTA may adversely affect the Heartflow Analysis.

WARNING:

The Heartflow Analysis has been clinically validated using DICOM data acquired from the following CT scanner manufacturers: Siemens Healthineers, Toshiba (now Canon Medical Systems), GE Healthcare, and Philips. Performance of the Heartflow Analysis using DICOM data acquired from scanners for which it has not been clinically validated is unknown, and therefore the safety and effectiveness of its use has not been established.

WARNING:

The Heartflow Analysis provision timeframes are contractually defined and are subject to delay. The Heartflow Analysis should not be used for patients with unstable coronary syndromes, or in patients where urgent and timely workup and evaluation is critical.

Reviewing the Heartflow Analysis

The following warnings provide cautionary guidance for viewing and interpretation of the Heartflow Analysis.

(US Only) WARNING:

When reviewing the Heartflow Roadmap Overview, proper consideration should be given to the possibility of false negatives and false positives. The information provided should be reviewed as one of several clinical data points when considering ordering a Heartflow Analysis.

WARNING:

Due to the variability in the Heartflow Analysis, the output should be reviewed as one of several clinical data points to be used in conjunction with the patient’s original CT images, clinical history, symptoms and other diagnostic tests, as well as an appropriately trained clinician’s clinical judgment, to evaluate the patient.

WARNING:

The Heartflow Analysis process is dependent on the quality of the imaging data provided. FFR_CT values may be affected by assumptions needed to resolve anatomy in areas of uncertainty, whether provided by the physician or made by Heartflow Case Analysts.

WARNING:

The Heartflow Analysis represents patient conditions at the time of CT acquisition. The duration of time and changes to patient health after CT acquisition must be assessed during interpretation. Clinical validation that supports FFR_CT values was limited to subjects whose CT acquisition occurred within 60 days of invasive FFR (mean 18 +/- 13 days).

WARNING:

The Heartflow FFR_CT Overview provides images based on vessel view. If a vessel of interest is obscured, FFR_CT values may be interrogated with the Interactive Model.

WARNING:

Use of an unsupported Operating System (OS) and/or browser may compromise website functionality and/or content presentation. A warning will be displayed on the login page if the application detects you are using an unsupported OS or browser. Please refer to the PRODUCT USE REQUIREMENTS for a list of supported OS, browser, and browser versions.

WARNING:

Because of physiologic changes in pressure and flow within regions of complex or turbulent flow (i.e. stenosis, bifurcations), pressure measurements may vary, potentially affecting measured FFR. Similarly, computed FFR_CT values may be affected by flow disturbances in stenoses and bifurcations. This is representative of physiology and is not a product limitation.

WARNING:

Qualitative anatomical information presented on the 3D/2D computer generated anatomical models is for orientation purposes only. Quantitative lumen diameter is representative of the geometric model and the accuracy is dependent on the quality of the CT data provided. It does not represent artery diameter and should not be used for treatment decisions.

WARNING:

The performance of the Heartflow Analysis has not been fully characterized in small vessels. Vessels with modeled lumen diameters less than 1.8 mm are grayed, and FFR_CT values are unavailable. When modeled lumen diameter decreases below 1.8 mm due to disease, but distally recovers to 1.8 mm or greater, FFR_CT values remain available. In some instances, continued distal disease and/or recovery may not be presented in the model.

WARNING:

The performance of the Heartflow Analysis has not been fully characterized in small vessels. Vessels with modeled lumen diameters less than 1.8 mm are grayed, and plaque volumes are non-reportable. When modeled lumen diameter decreases below 1.8 mm due to disease, but distally recovers to 1.8 mm or greater, plaque volumes remain reportable. In some instances, continued distal disease and/or recovery may not be presented in the model.

WARNING

The Heartflow FFR_CT Overview provides selected FFR_CT values. To interpret the FFR_CT values, please review the color images of the FFR_CT model and/or the Interactive Model to evaluate FFR_CT changes in the modeled vessel systems. Refer to the Instructions For Use for details on the selection of FFR_CT values.

WARNING:

Absence of nitrate administration during coronary CTA acquisition may adversely affect the accuracy of the Heartflow FFR_CT Analysis. The Heartflow Analysis simulates maximal coronary hyperemia. Induction of coronary hyperemia commonly includes vasodilation of the epicardial coronary arteries via nitrate administration. Therefore, Heartflow recommends following SCCT Guidelines for coronary CTA acquisition, which include the use of sublingual nitrates at the time of image acquisition^[1].

^[1] SCCT guidelines for the performance and acquisition of coronary computed tomographic angiography. Abbara S, et al. JCCT 2016; DOI: 10.1016/j.jcct.2016.10.002.

WARNING:

Diagnostic performance of FFR_CT using invasive FFR as the reference standard is: 84% accurate, 82% sensitive, and 85% specific. Refer to product Instructions For Use for patient populations in which FFR_CT has been clinically evaluated, relevant clinical data, and product warnings.

Precautions

The following precautions provide guidance for use of the Heartflow Analysis:

IMPORTANT:

If the DICOM Patient Name or Patient ID displayed in the web application exceeds the available display space, the data will be truncated and displayed with an ellipsis (…). Hovering the cursor over the field will display the full information.

IMPORTANT:

Display of the visual color model/images in the Heartflow Analysis is dependent on monitor and/or printer settings, and individual ability to interpret shades of color.