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

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.

September 12, 2011

September 16, 2011

October 17, 2011

November 7, 2011

November 7, 2011

November 10, 2011

February 8, 2012

• Webcast of meeting
• Registration (closes November 4)
• Information about visiting CMS

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

8:00 - 8:15 AM

8:15 - 8:25 AM

8:25 - 9:05 AM

9:05 - 9:25 AM

9:25 - 10:00 AM

10:00 - 10:15 AM

10:15 - 11:00 AM

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

Public Attendees who wish to address the panel will be given that opportunity

11:15 - 12:00 PM

12:00 - 1:00 PM

1:00 - 2:00 PM

2:00 - 3:00 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

3:00 - 4:00 PM

4:00 - 4:30 PM

Download PDF [PDF, 26KB] of agenda.

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. How confident are you that there is adequate evidence to determine whether or not SAECG technologies are able to reliably and accurately detect:
   1. coronary artery disease in asymptomatic patients at risk for the disease
   2. patients with signs and symptoms suggestive of ACS with or without chest pain

2. 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:
   1. coronary artery disease in asymptomatic patients at risk for the disease
   2. patients with signs/symptoms suggestive of ACS with or without chest pain

(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.)

3. 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 :
   1. coronary artery disease in asymptomatic patients at risk for the disease
   2. patients with signs/symptoms suggestive of ACS with or without chest pain

4. 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:
   1. coronary artery disease in asymptomatic patients at risk for the disease
   2. patients with signs/symptoms suggestive of ACS with or without chest pain

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
   1. diagnostic laboratory testing (e.g. troponin)
   2. noninvasive tests of cardiac anatomy/functioning (e.g. stress testing, echocardiography, etc)
   3. invasive test of cardiac anatomy/functioning (i.e. coronary angiography)

6. 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
   1. diagnostic laboratory testing
   2. noninvasive tests of cardiac anatomy/functioning (e.g. stress testing, echocardiography, etc)
   3. invasive test of cardiac anatomy/functioning (i.e. coronary angiography)

7. How confident are you that there is adequate evidence to determine whether or not the use of SAECG technologies significantly improves patient health outcomes?

8. 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?

9. What evidence gaps exist in the field of signal analysis ECG devices?

10. How confident are you that these conclusions are generalizable to:
    1. The Medicare patient population?
    2. Community based settings?

Download scoresheet [PDF, 65KB]