Approximately 112 million people globally are affected by angina and undergo coronary angiography, the primary diagnostic test for angina.1 Unfortunately, angiography is limited to assessing the epicardial arteries and cannot assess the microcirculation, which is largely responsible for the regulation and distribution of blood flow to the myocardium.2 Additionally, too often patients with ischemia with non-obstructive coronary arteries (INOCA) on angiography remain undiagnosed.3 About 40-60% of chronic coronary syndrome (CCS) patients undergoing angiography have INOCA, and a large proportion of these patients may have coronary microvascular dysfunction (CMD).4,5 Proper diagnosis of CMD and treatment is the only way to improve outcomes in these patients at high risk for major adverse cardiac events (MACE).4
Prevalence and Purpose of Diagnosing Coronary Microvascular Dysfunction (CMD)
Prof. Divaka Perera, Consultant Cardiologist, London, UK
Ischemic heart disease continues to be the leading cause of death globally.6 Yet chest pain—while often ischemic in nature—could have many etiologies, as illustrated.7 When chest pain is caused by ischemia (angina), proper management depends on accurately identifying and treating the underlying cause of angina.
Marinescu MA, Löffler Al, Ouellette M, et al. Coronary microvascular dysfunction and microvascular angina: a systematic review of therapies. JACC Cardiovasc Imaging. 2015; 8:210-220.
Kunadian V, Chieffo A, Cmici PG, et al. EAPCI Expert Consensus Document. EHJ. 2020; 0:1-21.
Only 41% of patients assessed for angina are found to have obstructive chronic coronary artery disease.4 The majority (59%) have no angiographic abnormalities,4 but still have symptoms of a coronary disorder.9
Patel et al. Low diagnostic yield of elective coronary angiography. NEJM 2010.
20-30% of patients experience recurrent angina in 1 year after percutaneous coronary intervention (PCI).10
INOCA patients with persistent angina frequently remain underdiagnosed. Without a clear diagnosis and treatment, this may result in recurrent hospitalizations, poor functional health, and adverse cardiovascular outcomes.11
Up to 50-65% of patients who have angina but non-obstructive CAD are believed to have coronary microvascular dysfunction (CMD).7
The microcirculation carries far more myocardial blood volume compared to the epicardial arteries. CMD can be defined as impaired CFR in the absence of epicardial obstructive CAD—i.e., downstream vasomotor dysfunction.12
Patients with INOCA, including those diagnosed with CMD, have an increase in major adverse cardiac events (MACE) including:
Coronary Flow Reserve Associated with MACE Risks12
Image adapted from Taqueti et al, J Am Coll Cardiol 201812
Clinical Spectrum of CMD
Image adapted from Taqueti et al, J Am Coll Cardiol 201812
The clinical spectrum of CMD may be characterized by three factors:12
$2,100 - $7,300
INOCA frequently impacts patient quality of life (QOL) and consumes significant health care expenditures.14,15 With multiple evaluations and frequent hospitalization14,15, each additional hospitalization can add $2,100 (the Netherlands) to $7,300 (the U.S.) in healthcare costs.16
Nevertheless, it is possible to accurately diagnose patients on their first visit to the cath lab and to provide effective treatment.
MAT-2006712 v1.0
Coroventis‡ CoroFlow‡ Cardiovascular System
Indications: CoroFlow‡ is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.
CoroFlow‡ is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.
Contraindications: The system has no patient alarm functions. Do not use for cardiac/vital signs monitoring.
Warnings:
Precautions:
PressureWire™ X Guidewire
Indications: The PressureWire™ X Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.
Contraindications: This guidewire is contraindicated for use in the cerebral vasculature.
Warnings:
Precautions:
Potential Adverse Events: Potential complications which may be encountered during all catheterization procedures include, but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias, or death.
MAT-2103602 v1.0
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