The Use of ECG Based Signal Analysis Technologies to Detect Myocardial Ischemia or Coronary Artery Disease

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=61 | meeting_date=2011-11-09

Myocardial ischemia occurs due to an imbalance between myocardial oxygen supply and demand. It presents with or without chest pain and/or a constellation of signs and symptoms including difficulty breathing, nausea, profuse sweating, and confusion. Myocardial ischemia is commonly caused by coronary artery disease (CAD). Due to the variability of its clinical presentation, the diagnosis and management of this condition may be a challenge. Patients with symptoms suggestive of myocardial ischemia often have a standard 12 lead electrocardiogram (ECG). However, a number of studies have demonstrated the limitations of the ECG in diagnosing acute cardiac conditions. Other noninvasive studies are also used to determine the likelihood of ischemia or infarction, such as biomarkers, and stress testing with ECG with or without imaging, but coronary angiography (CA) is considered the gold standard for diagnosing CAD. Although CA is generally considered a safe procedure, it has been associated with serious complications, including death and myocardial infarction. Therefore new strategies are being developed intending to more accurately and rapidly distinguish between individuals with and without myocardial ischemia or identify asymptomatic CAD. Among the new technologies available are those that seek to augment the diagnostic capabilities of ECG based signal analysis technology (SAECG). This meeting will review the evidence and hear public presentations on SAECG technologies used to manage myocardial ischemia. We are particularly interested in evidence speaking to the impact of these technologies on health outcomes.

Actions Taken: September 12, 2011 Announced meeting. September 16, 2011 Posted questions to panel. October 17, 2011 Posted Technology Assessment . November 7, 2011 Posted agenda , roster and speakers list . November 7, 2011 Posted presentations [ZIP, 12MB] and written comments [ZIP, 408KB] for meeting. November 10, 2011 Posted scoresheet [PDF, 65KB] from meeting. February 8, 2012 Posted minutes [PDF, 157KB] and transcript [PDF, 1MB] from meeting Webcast of meeting Registration (closes November 4) Information about visiting CMS Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee November 9, 2011 7:30 AM - 4:30 PM CMS Auditorium Clifford Goodman, PhD, Chair Steve Phurrough, MD, Vice Chair James Rollins, MD, Division Director, Division of Items and Devices, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:15 AM Opening Remarks— Maria Ellis/James Rollins, MD/Clifford Goodman, PhD 8:15 - 8:25 AM CMS Presentation & Voting Questions - Lisa Eggleston, RN, MS 8:25 - 9:05 AM Rob MacLeod, PhD , Associate Professor of Bioengineering and Internal Medicine University of Utah Scientific Computing and Imaging (SCI) Institute 9:05 - 9:25 AM Jerome L. Fleg, MD , National Heart, Lung and Blood Institute, National Institutes of Health 9:25 - 10:00 AM TA Presentation: Remy R. Coeytaux. MD, PhD , Associate Professor, Community and Family Health Medicine, Duke Clinical Research Institute and Philip Leisy, BS , MD Candidate, ECU Brody School of Medicine 10:00 - 10:15 AM BREAK 10:15 - 11:00 AM Scheduled Public Comments (Refer to Speaker List) Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. 11:00 - 11:15 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:15 - 12:00 PM Questions to Presenters 12:00 - 1:00 PM LUNCH (on your own) 1:00 - 2:00 PM Initial Open Panel Discussion: Dr. Goodman 2:00 - 3:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 3:00 - 4:00 PM Final Open Panel Discussion: Dr. Goodman 4:00 - 4:30 PM Closing Remarks/Adjournment: Dr. Rollins & Dr. Goodman Download PDF [PDF, 26KB] of agenda. Issue: Myocardial ischemia occurs due to an imbalance between myocardial oxygen supply and demand. It presents with or without chest pain and/or a constellation of signs and symptoms including difficulty breathing, nausea, profuse sweating, and confusion. Myocardial ischemia is commonly caused by coronary artery disease (CAD). Due to the variability of its clinical presentation, the diagnosis and management of this condition may be a challenge. Patients with symptoms suggestive of myocardial ischemia often have a standard 12 lead electrocardiogram (ECG). However, a number of studies have demonstrated the limitations of the ECG in diagnosing acute cardiac conditions. Other noninvasive studies are also used to determine the likelihood of ischemia or infarction, such as biomarkers, and stress testing with ECG with or without imaging, but coronary angiography (CA) is considered the gold standard for diagnosing CAD. Although CA is generally considered a safe procedure, it has been associated with serious complications, including death and myocardial infarction. Therefore new strategies are being developed intending to more accurately and rapidly distinguish between individuals with and without myocardial ischemia or identify asymptomatic CAD. Among the new technologies available are those that seek to augment the diagnostic capabilities of ECG based signal analysis technology (SAECG). This meeting will review the evidence and hear public presentations on SAECG technologies used to manage myocardial ischemia. We are particularly interested in evidence speaking to the impact of these technologies on health outcomes. Minutes: Download meeting minutes [PDF, 157]. Other Material: Transcript 1 Presentations [ZIP, 12MB} Written Comments [ZIP, 408KB] Panel Voting Questions: The Use of ECG-Based Signal Analysis Technologies to Detect Myocardial Ischemia or Coronary Artery Disease The questions below refer to the use of electrocardiogram (ECG) based signal analysis (SAECG) technologies used for the purpose of detecting coronary artery disease (CAD) in (1) patients who are asymptomatic, but have increased risk factors for CAD or (2) in patients who present with signs/symptoms suggestive of acute coronary syndrome (ACS) with or without chest pain, and who are not triaged for emergent reperfusion therapy. Furthermore, for the purposes of this meeting, SAECG technologies are defined as those that (1) assess electrical activity of the heart, and (2) transform and/or interpret the signal through spatial imaging or advanced mathematical modeling to produce new indices and (3) are commercially available in the United States. This does not include the standard 12 lead ECG or other technologies used only to diagnose arrhythmias. Health outcomes of greatest interest include mortality, myocardial infarction, cardiac function and quality of life. For the voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence How confident are you that there is adequate evidence to determine whether or not SAECG technologies are able to reliably and accurately detect: coronary artery disease in asymptomatic patients at risk for the disease patients with signs and symptoms suggestive of ACS with or without chest pain 1 — 2 — 3 — 4 — 5 If the result of Question 1 is at least intermediate (mean vote ≥ 2.5) in any of the conditions noted, how confident are you that ECG based signal analysis technologies are able to reliably and accurately detect: coronary artery disease in asymptomatic patients at risk for the disease patients with signs/symptoms suggestive of ACS with or without chest pain 1 — 2 — 3 — 4 — 5 (If the result of Question 2 is at least intermediate (mean vote ≥ 2.5) in either of the conditions noted, continue onto the following questions for the specified disease process.) How confident are you that there is adequate evidence to determine whether or not the incremental information obtained from SAECG technologies beyond that provided by the standard 12 lead ECG, improves physician decision making in the management of : coronary artery disease in asymptomatic patients at risk for the disease patients with signs/symptoms suggestive of ACS with or without chest pain 1 — 2 — 3 — 4 — 5 If the result of Question 3 is at least intermediate (mean vote ≥ 2.5), how confident are you that the incremental information obtained from SAECG technologies beyond that provided by the standard 12 lead ECG, improves physician decision making in the management of: coronary artery disease in asymptomatic patients at risk for the disease patients with signs/symptoms suggestive of ACS with or without chest pain 1 — 2 — 3 — 4 — 5 How confident are you that there is adequate evidence to determine whether or not the incremental information obtained from SAECG technologies beyond that provided by the standard 12 lead ECG, can eliminate the need (at the level of an individual patient) for diagnostic laboratory testing (e.g. troponin) noninvasive tests of cardiac anatomy/functioning (e.g. stress testing, echocardiography, etc) invasive test of cardiac anatomy/functioning (i.e. coronary angiography) 1 — 2 — 3 — 4 — 5 If the result of Question 5 is at least intermediate (mean vote ≥ 2.5), how confident are you that the incremental information obtained from SAECG technologies beyond that provided by the standard 12 lead ECG, can eliminate the need (at the level of an individual patient) for diagnostic laboratory testing noninvasive tests of cardiac anatomy/functioning (e.g. stress testing, echocardiography, etc) invasive test of cardiac anatomy/functioning (i.e. coronary angiography) 1 — 2 — 3 — 4 — 5 How confident are you that there is adequate evidence to determine whether or not the use of SAECG technologies significantly improves patient health outcomes? 1 — 2 — 3 — 4 — 5 If the result of Question 7 is at least intermediate (mean vote ≥ 2.5), how confident are you that the use of SAECG technologies significantly improves patient health outcomes? 1 — 2 — 3 — 4 — 5 What evidence gaps exist in the field of signal analysis ECG devices? How confident are you that these conclusions are generalizable to: The Medicare patient population? Community based settings? Download scoresheet [PDF, 65KB] Roster: Clifford Goodman, PhD CHAIR Senior Vice President The Lewin Group Steve E. Phurrough, MD, MPA Vice Chair Chief Operating Officer/Senior Clincal Director Center for Medical Technology Policy Renè Cabral-Daniels, JD, MPH Chief of Staff National Patient Advocate Foundation Peter Heseltine, MD Professor of Clinical Medicine University of California, Irvine Warren Janowitz, MD, JD, FACC, FAHA Director of Molecule Imaging Baptist Hospital of Miami Robert McDonough, MD, JD Head Clinical Policy Research & Development Medical Policy & Program Administration National Medical Services Aetna, Inc. Ryan H. Saadi, MD MPH Vice President World Wide Health Economics Reimbursement and Strategic Pricing CORDIS Corporation Johnson & Johnson David J. Samson, MS Blue Cross Blue Shield Association Robert L. Steinbrook, MD Adjunct Associate Professor of Medicine & Community & Family Medicine Dartmouth Medical School Industry Representative Brian Seal, RPh, MBA, PhD Director Health Economics and Outcomes Research Bayer HealthCare Pharmaceuticals, Inc. Guest Panel Member Yoram Rudy, PhD The Fred Saigh Distinguished Professor of Engineering Professor of Biomedical Engineering, Medicine, Cell Biology & Physiology, Radiology and Pediatrics Director, Cardiac Bioelectricity and Arrhythmia Center Washington University in St. Louis Cardiac Bioelectricity Center Invited Guest Speakers Jerome L. Fleg, MD National Heart, Lung and Blood Institute National Institutes of Health Rob MacLeod, PhD Associate Professor of Bioengineering and Internal Medicine University of Utah Scientific Computing and Imaging (SCI) Institute CMS Liaison James Rollins, MD Director Division of Items and Devices Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Download PDF [PDF, 19KB] of roster Speakers List: Medicare Evidence Development & Coverage Advisory Committee November 9, 2011 SPEAKER LIST *7 MINUTES PER SPEAKER* Joseph T. Shen, MD , MCG Technology Developer, Founder and Managing Member, Premier Heart, LLC Michael Imhoff, MD, PhD , Ruhr-University Bochum, Germany John E. Strobeck, MD, PhD , Heart-Lung Associates, PC, Hawthorne, New Jersey Amir Beker, PhD , Chairman, BSP Biological Signal Processing, Inc. Download PDF [PDF, 14KB] of speakers list