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<h1>ECG-based Signal Analysis Technologies: Disposition of Comments</h1>
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<h3>Disposition of Comments</h3>
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<div class="page-description"><span>Comments received from draft review on ECG-based signal analysis technologies.</span></div>
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<h2><a id="tab2" name="tab2"> </a>Table 2. Public Review Comments</h2>
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<table border="1" cellpadding="2" cellspacing="0" width="95%"><tbody>
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<tr valign="top">
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<th scope="col">Reviewer Name <sup><a href="#note1">1</a></sup></th>
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<th scope="col">Reviewer Affiliation<sup><a href="#note2">2</a></sup></th>
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<th scope="col">Section<sup><a href="#note3">3</a></sup></th>
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<th scope="col">Reviewer Comments</th>
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<th scope="col">Author Response<sup><a href="#note4">4</a></sup></th>
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<td scope="row">Lance Austein, MD, FACP</td>
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<td>Primary care physician, Brooklyn, NY</td>
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<td>General comment</td>
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<td>I have reviewed this Draft Report. I am a primary care physician in a diverse urban private practice. I have had much practical experience with Premier Heart's technology. The advantages for a primary care practice are significant. It can be done promptly, there is no need for a referral, preauthorization or other “barrier to care.” It is standardized. A conventional electrocardiogram has limited sensitivity for detecting CAD, and is “interpreter dependent.” The 3DMP test is standardized and interpreted with mathematical formulas by an online-computer. The scoring system and pathological suggestions are standardized and easier to interpret affording the practitioner a “risk assessment and stratification,” that has practical “bedside” utility. My practice has been utilizing Premier Heart's 3CMP technology since Spring, 2007. I have found it especially useful for chest pain and for patients with multiple coronary risk factors to guide my work-up and interventions, sometimes avoiding cardiology consultations and the accompanying costly diagnostic evaluation. I look forward to more peer-reviewed literature on the utility and cost-effectiveness of this technology.</td>
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<td>Thank you for the comment about your experience.</td>
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</tr>
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<td scope="row">V. Desiderio</td>
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<td>Patient</td>
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<td>General comment</td>
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<td>I owe my life to MCG. As a middle aged Caucasian male I was tested by the usual procedures: EKG, Stress Test, Echo and CT, only to be told I was fine and everything was ok. WRONG!! When tested by MCG I learned that I had severe CAD. I've been able to reverse the degree level of CAD from an MCG severity score of 9 (Dangerous) to a manageable 4.</td>
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<td>Thank you for the comment about your experience.</td>
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</tr>
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<td scope="row">Mary Drake</td>
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<td>NA</td>
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<td>General comment</td>
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<td>My observation and comments related to the importance of improvement in detection of CAD is based on personal experience. The following excerpt from this report grabbed my attention. “An enhanced ECG-based test might demonstrate greater positive or negative predictive values, thereby limiting the harms associated with delays in treatment, or by providing the diagnostic information necessary to avoid invasive diagnostic or therapeutic interventions [pgs 1, 10].” Had there been more accurate test methods I would not have been subjected to an unnecessary heart cath six years ago. The heart cath was clear and no blockages found. It was only after such an intrusive test, that I was diagnosed with muscle spasms due to anxiety!!! Diagnostic intervention was totally backwards and was a waste of medical dollars. Yes, if I had had a cardiac event, it wwould have been a good thing that they pursued every diagnostic measure possible, but I was not victim to CAD and the procedure placed me under undue risk. Although I understand the liability the medical facility carried and the need for informed patient consent this procedure could have been avoided with enhanced diagnostic equipment. I am a widow with 2 minor children at home and had to sign documents acknowledging I could die on the table during this procedure. If I had died unnecessarily, as a result of this procedure, who would have taken care of my children? How many other people in the U.S. are subjected to this invasive form of testing unnecessarily? Being subjected to this unnecessary heart cath procedure also presented a vasospasm due to eht intern moving too aggressively within the heart chamber. To this day (on occasion) I can sense a vasospasm, where I had never had that condition before (prior to the heart cath). There is a vital need to improve non-invasive testing for CAD.</td>
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<td>Thank you for the comment about your experience.</td>
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</tr>
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<td scope="row">Michael Imhoff, MD PhD</td>
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<td>Ruhr-University Bochum, Germany</td>
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<td>General comment</td>
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<td>I am pleased to provide my opinion to the draft TA (TA) “ECG-based Signal Analysis Technologies” Prepared by the Duke Evidence-Based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ). My comments relate to the referenced evaluation of Premier Heart MCG (or 3DMP). As I was involved in the detailed statistical analysis of three of the four trials of MCG included in the TA, namely Grube 2007, Grube 2008, Hosokawa 2008, I would like to comment on some apparent misperceptions by the authors of the draft TA.</td>
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<td>Thank you for the comments. Specific comments by this reviewer are addressed below.</td>
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</tr>
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<td scope="row">Michael Imhoff, MD PhD</td>
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<td>Ruhr-University Bochum, Germany</td>
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<td>General comment</td>
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<td>Of all methods reviewed in the draft TA only MCG was directly compared against the diagnostic “gold standard” for the detection of coronary stenosis (CS), namely coronary angiography (CA). To the best of my knowledge these studies (and the previous study with MCG by Weiss 2002) were the only published studies to directly compare a resting ECG method against CA for the detection of CS in sufficiently large patient populations. In these three studies the observed actually incidence of hemodynamically relevant CS was 32%, 40.7% and 48% respectively. This is considered intermediate risk (ACC/AHA 2002), and not “high risk” as falsely stated by the authors of the draft TA.</td>
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<td>These three studies (Grube 2007, Gruge 2008, Hosokawa 2008) enrolled patients scheduled for coronary angiography. Clinical symptoms and/or indications for angiography were not reported. Therefore, we were uncertain about the clinical risk profile of these patients for CAD. The text has been revised to describe the sample studied more clearly (pg 30). The rates of CAD described by the reviewer are accurately reported in the evidence tables. In addition, a 4th study (Weiss 2002), using a similar approach, found a 57% prevalence of CAD.</td>
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</tr>
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<td scope="row">Michael Imhoff, MD PhD</td>
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<td>Ruhr-University Bochum, Germany</td>
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<td>Pg 50, lines 1-3</td>
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<td>The sample sizes of these three individual studies each and the size of the metaanalysis (Strobeck 2009) are sufficient to have confidence that sensitivity and specificity of MCD for the detection of CS is applicable to other patients with CS. It should be noted that in the studies by Grube et al. the presence of risk factors for CS did not alter the diagnostic performance of MCG. Therefore, there is no reason to assume that MCG does not perform with similar sensitivity and specificity in populations with low or very low risk of CS. Using Bayes' correction for positive (PPV) and negative predictive values (NPV) it can be shown that MCG may be highly suitable for ruling out CS in low and very low risk subject. Based on the study results an NPV of nearly 99% can be expected for these subjects, i.e., a negative MCG (score < 4.0) will rule out hemodynamically relevant CS with 99% certainty. From a biostatistical perspective the conclusion by the authors of the draft TA that “Test performance characteristics for this device appear to be generally good, but the findings from the published studies do not apply to the target population for this report” [p.50; II. 1-3] is not justified by the study results. Quite on the contrary, the study results for MCG indicate that MCG may very suitable to rule out CS in the patient populations in question.</td>
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<td>We agree that the sample sizes are sufficient to produce relatively precise estimates of sensitivity and specificity as shown by our summary estimates and 95% confidence interval. However, we disagree that these results can be applied with confidence to populations at low to intermediate risk. For diagnostic test accuracy studies, the best documented design factors that affect risk of bias or variation include: demographic features, disease prevalence and severity, and distorted selection of participants (Whiting P et al. Ann Intern Med 2004;140:189-202).</td>
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</tr>
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<td scope="row">Michael Imhoff, MD PhD</td>
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<td>Ruhr-University Bochum, Germany</td>
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<td>Pg 51, lines 8-9</td>
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<td>The authors of the draft TA also state “Only the PRIME ECG has been directly compared to the standard 12-lead ECG” [p.51, II. 8-9]. This statement seems unjustified, as MCG was also compared to 12-lead ECG in the study by Weiss 2002 (see table 5 of the original article). Of course, I am available for further discussion of this matter. Thank you very much for the opportunity to comment on the draft TA.</td>
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<td>Thank you for the comment. We have included data on the ECG from the Weiss et al. study (pg 32 and elsewhere).</td>
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</tr>
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<td scope="row">Mitchell W. Krucoff MD, FACC</td>
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<td>Duke University Medical Center/Duke Clinical Research Institute</td>
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<td>General comment</td>
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<td>In addition to the strengths/weaknesses of coronary angiography as a gold standard for comparison, it should be pointed out that low risk patients who are referred for coronary angiography constitute a heavily selected, and almost certainly biased, subset of low risk patients in clinical practice for whom novel ECG technologies apply. Thus, another option not mentioned in this report is the use of combined assessments in prospectively assigned subgroups, eg. Low risk who go to cath and low risk who do not go to cath. The latter group might fall into either an imaging co-gold standard, and/or even a clinical diagnostic time period (eg did/did not have coronary diagnosis over 12 month follow up). The current paper's approach to the diagnostic comparator (gold standard) is very traditional, at a time when AHRQ, CMS and other federal agencies, as well as health care in general, are in need of more efficient, practical and clinically relevant directions for new technology assessments.</td>
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<td>We revised the text to describe the potential utility of a reference standard that uses imaging plus followup (pg 22).</td>
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</tr>
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<td scope="row">Daniele Marangoni MS</td>
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<td>Advanced Consultants & Engineering, Verona, Italy</td>
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<td>General comment</td>
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<td>I have a MS in BioMedical Engineering. I have been a co-author of several peer review published papers on Risk assessment of Cardiac events (see my web page). I have been a technology expert in several Clinical trials. I work as a Consultant and Editor of the Biotechnology Web Page: www.alternans.org. What I found incorrect in the Draft TA “ECG-based Signal Analysis Technologies” document to lump the MCG with SAECG: there is no link and the averaging technique is only used as a input filter to improve Signal/Noise ratio to perform later a optimized frequency domain analysis. The key theory concept of this MCG method is the Cross Correlation between 2 biological signals (lead II and V5) in the frequency domain. The Cross Correlation and Phase Shift (together with other 4 mathematical transformations) provides the information about the abnormal response of the Heart system (Myocardium and intracardiac flow) between 2 signals used as input/output in the Systems Theory. With analogy to Acoustic system, the stereo output of a broken bell sound or earthquake (frequency domain recordings in 2 sites) provides the location and size of the bell defect or earthquake. Therefore there is no link between the MCG system and other ECG systems. The MCG is a very innovative system and the Meta-Analysis of the published papers provides the clinical results. Please ask the authors of this TA to correct this remark. Presently, I am conducting as Technology Expert a Clinical Evaluation Project using MCG technology comparing to Coronary Angiography, before and after angioplasty. My evaluation of MCG methodology has been very positive. If you have questions ot comments, please contact me.</td>
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<td>Thank you for the comment. The text has been revised throughout to clarify that the 3DMP/MCG uses mathematical signal analysis that is distinct from signal averaging technology.</td>
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</tr>
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<td scope="row">Charles K. Miceli, MD, FACC, FACP, FCCP</td>
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<td>Private practice, NY</td>
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<td>General comment</td>
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<td>I have been in practice for over thirty years in the field of Cardiology and Internal Medicine. For the past two years I have had the opportunity to use the MCG technology in the diagnosis and treatment of coronary artery disease. I have found it to be invaluable. I am sure you will be innundated with responses such as mine that will tell you that the MCG technology should not be lumped with Signal Analysis Technology. Please find a number of cases that I have compiled from my private practice to show you how I use it and how it will benefit all in the diagnosis and treatment of CAD. [Here Dr. Miceli provides nine case reports of his patients. Go to <a href="/research/findings/ta/comments/misccomments/ecgtable2-appendix.html">Appendix A</a> for the full comments.] Conclusion:<br />
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In my practice, the MCG test is invaluable.<br />
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How do I use it?<br />
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-score of 0----Reassuarance.<br />
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-score of 1 or 2---Exercise, life style modification, asa and Statin. Retest in 1 year.<br />
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-score of 3---Most likely like scores of 1 and 2. Treat the same but add stress test.<br />
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If abnormal stres, treat as 4-7.<br />
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-score of 4-7---Treat as 1-3, but add stress testing. If positive send for cath. If negative (50% will have negative stress test), consider adding beta blocker or other agents as in the Courage Trial and retest in 3 months. Follow carefully. Cath if symptoms occur.<br />
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-scores greater than 7---Verify the accuracy with repeat testing , treat as 4-7 and consider cath or at least cta of coronary arteries.<br />
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-MCG provides a role for the detection of coronary artery disease, the continued followup and evaluation of coronary artery disease, as well as in the pre-operative evaluation. Coronary artery spasm can be detected, as well.</td>
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<td valign="top">Thank you for the comment about your experience.</td>
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<td scope="row">Kotaro Obunai, MD</td>
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<td>Makiminato Central Hospital</td>
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<td>General comment</td>
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<td>I am pleased to submit a brief comment on the draft technology assessment report regarding, “ECG-based Signal Analysis Technologies” prepared by the Duke Evidence-Based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ). My comment relates to the above-referenced evaluation of the MCG (or 3DMP) technology of Premier Heart, Inc. and is based on my knowledge of the published data and personal clinical experiences with the MCG technology. After reading the TA reports I became concerned that there might be a misconception that the MCG technology is a form of signal averaging ECG or body surface mapping ECG technology. MCG technology uses an entirely new integrative approach, building a mathematical model of the entire cardiac system and ignoring conventional time-based ECG technology, which signal averaging ECG and body surface mapping ECG does employ. MCG technology has been developed to evaluate which symptomatic patients need (or do not need) further tests, such as stress imaging or coronary angiography. This explains why the MCG technology has been evaluated in such a manner described in the published data.</td>
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<td>Thank you for the comment. The text has been revised throughout to clarify that the 3DMP/MCG uses mathematical signal analysis that is distinct from signal averaging technology.</td>
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<td scope="row">Kotaro Obunai, MD</td>
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<td>Makiminato Central Hospital</td>
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<td>General comment</td>
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<td>As stated in the draft report, stress test with imaging has been accepted as a non-invasive way to diagnose myocardial ischemia. However, it is well known that stress test with imaging is time and labor consuming, expensive, and not completely non-invasive. Also stress test is operator dependent and the test quality varies from one institution to another depends on the skills and experiences of the physicians and personnel performing the test. In the real world practice, the accuracy of the stress test with imaging could be poorer than we believe from the published data, which was demonstrated at well qualified institutions. As a board certified interventional cardiologist, trained both in the US and Japan, I have seen so many patients globally who had undergone unnecessary coronary angiogram just because of abnormal stress imaging. Many physicians have been looking for a true non-invasive, operator-independent testing which they can utilize in their office to detect/rule-out ischemia in their patients. Based on my experience with MCG technology in my practice, MCG is accurate, safe, and can be reliably performed by trained personnel within 10 minutes. I would hope that authors will re-examine the uniqueness of MCG technology, re-evaluate the appropriateness of the study design and study results, and re-consider their conclusions in their report.</td>
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<td>Stress testing is minimally invasive, requiring only peripheral intravenous access to administer pharmacological agent or radioisotope for imaging.</td>
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<td scope="row">Franz Ritucci, MD</td>
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<td>American Academy of Urgent Care Medicine</td>
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<td>General comment</td>
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<td>I have read the Draft TA and I am very concerned because it appears that there is not a clear understanding of what MCG technology is really all about. It appears that the authors tried to "fit" this technology into an existing paragram, which truly does not exist for this new technology. I am forced to call your attention to this very basic concept. This ultimately effects the manner in which clinical trials are designed and how one would apply this technology in every day clinical practice. I believe the authors need to look at the the studies that were performed with MCG the comparison to coronary angiography, the pre-test risk of the study population, the meta-analysis of the trials and the consistency of the data in multiple important sub groups of patients, the authors should re-evaluate the fundamental assumptions fo the TA report and re-exam the answers. I believe that the study in it's existing format does not properly position MCG technology.</td>
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<td>Thank you for the comment. The text has been revised throughout to clarify that the 3DMP/MCG uses mathematical signal analysis that is distinct from signal averaging technology. The Premier Heart website claims “The results from MCG have been (http://www.premierheart.com/webapp/contents/trials.php) validated in double-blind clinical studies where our system has demonstrated accuracy comparable to coronary angiography (90% overall sensitivity, 85% specificity)” and “…provides a quick, accurate, non-invasive and stress-free method for detection and diagnosis of myocardial ischemia.” Our stakeholders were specifically interested in evidence on how these technologies perform in patients with chest pain at low to intermediate risk for CAD.</td>
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<td scope="row">Joseph T. Shen, MD</td>
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<td>Premier Heart, LLC</td>
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<td>General comment</td>
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<td>I am pleased to submit comments on the draft technology assessment “ECG-based Signal Analysis Technologies” Prepared by the Duke Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ). Our comments relate to the evaluation of the 3DMP (or MCG or mfEMT) by Premier Heart (hereinafter referred to as MCG). Dr. John Strobeck has informed me1 that he has been invited to perform a peer review of the technology assessment (TA), and has shared his reviews of the TA with the coauthors2 of the four published peer-reviewed articles describing the results of double blind, prospective, clinical trials validating the ability of MCG to accurately identify patients with relevant coronary stenosis. As the principle architect of the MCG technology I agree with his masterful explanations of the underlying technology, the detailed analysis of the results of the clinical trials, and his overall views on the TA. In the spirit of providing accurate, genuine and truthful information to the interested public and supporting AHRQ, I am submitting clinical and technical MCG Technology white papers, to contribute to further understanding of MCG technology in preparation of the final TA. 1 I am also the patent holder for the MCG technology and a shareholder of Premier Heart<br />
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2 Aside from myself none of the coauthors of the papers serves as paid consultants to Premier Heart, shareholders of Premier Heart or have any financial relationship with Premier Heart. They have generously contributed their time and expertise in the interest of public health & advancing diagnostic technology. Dr. Shen included the following papers:<br />
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Shen JT. The Multiphase Functional Cardiogram: A Clinical Overview. Premier Heart, LLC, 2010<br />
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Shen JT, Fedel E, Graziano M. The Multiphase Functional Cardiogram: Diagnostic Technology Overview. Premier Heart, LLC, 2010</td>
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<td>Thank you for the additional materials. We have used the material provided to revise the text and ensure that our description of the technology is accurate.</td>
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<td scope="row">John E. Strobeck, MD, PhD</td>
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<td>Heart-Lung Associates of America, PC</td>
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<td>General comment</td>
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<td>Note: Dr. Strobeck also includes some comments and perspectives from Dr. Shen. After reading the draft TA I became concerned that there was no clear understanding of exactly what MCG technology is, how the MCG device actually works, and therefore, how and why the published clinical trials were designed the way they were, and how the device should be positioned as an effective tool in clinical practice. It is my hope that by calling attention to the uniqueness of the MCG technology, highlighting the differences between it and traditional ECG-based technologies, further explaining the clinical trial design, the reasons for the comparison to coronary angiography, the pre-test risk of the study population, the meta-analysis of the trials, and the consistency of the data in multiple important subgroups of patients, the authors will re-evaluate the basic assumptions of the TA report, reexamine the answers to some of their key questions with respect to MCG, and re-consider many of their conclusions regarding the MCG, and reflect those changes in the final TA. [Dr. Strobeck included an 18-page Review Report including 4 tables and a figure, plus 28 citations. We have included his major concerns from his introductory paragraph, as well as the complete text of his “Conclusion and Summary.” Go to <a href="/research/findings/ta/comments/misccomments/ecgtable2-appendix.html">Appendix B</a> for the full document.] The final TA should include MCG and contain a more detailed discussion of, the technology. To this end, I have three major concerns about the draft TA that will be discussed in my peer review: 1) the author's description of the MCG technology is inaccurate, 2) the assessment of the population selected for the clinical trials data is inaccurate, and 3) the conclusions with respect to the demonstrated clinical usefulness of MCG and its current status as a diagnostic tool are inaccurate. MCG is a computer-based, computational electrophysiology systems analysis tool that physicians can use to make accurate and timely diagnosis of relevant CAD at the point of care. It is not comparable to SAECG or other direct ECG-based waveform analysis techniques, and has many distinct differences and advantages over those older technologies. The MCG clinical trials conducted thus far have clearly included patients with “intermediate pre-test risk” of CAD, not “high pre-test risk” patients as the draft TA concluded. I agree with the authors desire to have all new non-invasive, ECG-based technologies designed to detect coronary disease, compared to coronary angiography. To my knowledge, MCG is the only technology where such a comparison has been done. Furthermore, in my opinion, it is not appropriate to compare a technology like MCG to an “add-on” ECG-based technology, the intended use of which is entirely different from the intended use of MCG. I believe that the accuracy of MCG for the diagnosis of relevant coronary disease has been definitively validated through well-designed prospective double-blind clinical trials comparing MCG to coronary angiography, and that it has performed very well over a 2 1/2 year time frame as a clinically useful early diagnostic tool for physicians at the point of care treating symptomatic patients with known or suspected coronary disease. It has definitely reduced the number and complexity of “add-on” stress or stress-imaging tests I have ordered since beginning to use the device.</td>
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<td>Concern #1. Thank you for the comment. The text has been revised throughout to clarify that the 3DMP/MCG uses mathematical signal analysis that is distinct from signal averaging technology. Concern #2. The three studies mentioned by the reviewer enrolled patients scheduled for angiography. Clinical symptoms and indications for angiography were not reported. Therefore, we were uncertain about the clinical risk for CAD. The text has been revised to describe the sample studied more clearly (pg 30). The rates of CAD described by the reviewer are accurately reported in the evidence tables. In addition, a 4th study (Weiss 2002), using a similar approach, found a 57% prevalence of CAD. Concern #3. We have included and described all published literature identified by our search or by peer reviewers. We have not found any reports that provide data on the effects on further diagnostic testing, treatment, or clinical outcomes.</td>
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<td scope="row">John E. Strobeck, MD, PhD</td>
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<td>Heart-Lung Associates of America, PC</td>
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<td>General comment</td>
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<td>I believe that the stated goals of the draft TA assume an existing US coronary diagnostic paradigm into which the MCG technology does not fit. The core assumption of the TA is that new ECG-based technologies will be better than the traditional ECG at “evaluating” symptomatic patients who are at low or intermediate risk of coronary events (according to the ACC/AHA 2002 Guideline Update for Exercise Testing [8]) or coronary artery disease. Thus, the diagnostic paradigm assumed in the TA document is that newer ECG technologies are “add-on” technologies that will merely improve the treating physician's ability to select patients for stress-ECG testing or stress-imaging with either echocardiography or scintigraphy. The MCG is not designed to fit this paradigm because it is designed to be a highly <u>accurate predictor of who does not need stress testing or coronary angiography</u>.</td>
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<td>Our mandate was to evaluate these devices for the detection of CAD in patients with chest pain with a low to intermediate prior probability of CAD (see key questions). We agree that another application of these devices might be to evaluate patients with a higher prior probability of CAD, such as those with symptoms of acute coronary syndrome. Our report does not assume the diagnostic paradigm of MCG as an “add-on” test; rather, we discuss alternative paradigms (e.g., add-on, substitution) that might be applied to evaluating a new diagnostic test.</td>
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<td scope="row">John E. Strobeck, MD, PhD</td>
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<td>Heart-Lung Associates of America, PC</td>
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<td>General comment</td>
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<td>With reference to the selection methodology, it is clearly stated in all four trial publications that the study populations represented convenience samples of patients scheduled for coronary angiography. Since patients with acute coronary syndrome or acute coronary ischemia schedule for emergency cardiac catheterization were not included in the study populations. The final sample did represent a “consecutive” sample of patients scheduled for elective coronary angiography.</td>
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<td>These studies enrolled patients scheduled for coronary angiography. Clinical symptoms and/or indications for angiography were not reported. Therefore, we were uncertain about the clinical risk profile of these patients for CAD. The text has been revised to describe the sample studied more clearly, including the description of a “convenience sample” (pg 23). We have not described the samples as consecutive samples, since the primary reports did not describe them in this way.</td>
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<td scope="row">John E. Strobeck, MD, PhD</td>
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<td>Heart-Lung Associates of America, PC</td>
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<td>General comment</td>
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<td>MCG is a technology that has been prospectively shown to accurately predict the presence of relevant coronary stenosis in patients at intermediate risk of CAD in well-designed clinical trials. [2, 7, 24-26] While I appreciate that the draft TA described the MCG trials as well-designed, I disagree with the conclusion that MCG is merely a “promising” diagnostic tool. I believe that the foregoing discussion of MCG technology, and of the design, and statistical evaluation of the MCG clinical trials in this peer review demonstrates that the accuracy and validity of MCG in detecting relevant coronary stenosis is well validated and supported by the trial results. It is my hope that the final TA will incorporate these concepts and conclude that MCG is a validated, clinically useful early diagnostic test for patients at low to intermediate risk for coronary disease. <u>References:</u><br />
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2. Weiss MB, Narasimhadevara SM, Feng GQ, Shen JT. Computer-enhanced frequency domain and 12-lead electrocardiography accurately detect abnormalities consistent with obstructive and nonobstructive coronary artery disease. Heart Dis. 2002;4:2-12.<br />
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7. Strobeck JE, Shen JT, Singh B, et al. Comparison of a two-lead, computerized, resting ECG signal analysis device, the MultiFunction-CardioGram or MCG (a.k.a. 3DMP), to quantitative coronary angiography for the detection of relevant coronary artery stenosis (>70%) - a meta-analysis of all published trials performed and analyzed in the US. Int J Med Sci 2009;6(4):143-55.<br />
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24. Hosokawa J, Shen JT, Imhoff M. Computerized two-lead resting ECG analysis for the detection of relevant coronary artery stenosis in comparison with angiographic findings. Congestive Heart Failure 2008 14: 25 1 -260.<br />
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25. Grube E, Bootsveld A, Buellesfeld, L Yuecel S, Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis after coronary revascularization Int. J. Med. Sci. 2008, 5(2): 50-61.<br />
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26. Grube E, Bootsveld A, Yuecel S, et al. Computerized two -lead resting ECG analysis for the detection of coronary artery stenosis. Int. J. Med Sci. 2007; 7: 249-263.</td>
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<td>Thank you for the comment. We have carefully updated the report to respond to peer review comments, but the revisions did not warrant a change to the final conclusions. MCG has been evaluated carefully in samples selected for coronary angiography, and we report that it has performed well in this setting. However, our mandate was to focus on patients with chest pain at low to intermediate pre-test probability for CAD as described in our key questions and analytic framework. The differences in our report's target population vs. the samples in which MCG has been evaluated, along with the absence of data for effects on diagnostic/treatment decisionmaking and clinical outcomes, lead us to stand by the conclusion that MCG is a promising diagnostic tool in patients at high risk or with known CAD.</td>
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<td scope="row">Tom Williams</td>
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<td>None stated</td>
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<td>General comment</td>
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<td>I found too many innaccuries in the assessment for 3DMP/MCG. MCG is "not" signal averaged based. This technology is not an add on to currrent ecg technology. ECG's are a snapshot in time, if you will. MCG appears to examine the differences from cycle to cycle and compares them to a database of normal and abnormal cases similar to the native databases found in bone-densitometry units. I do not see this approach in current modalities, per se. I feel that the AHRQ may have made some false assumptions and a more indepth understanding of this diagnostic tool is neccessary and warranted before an adequate assessment can be made.</td>
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<td>Thank you for the comment. The text has been revised throughout to clarify that the 3DMP/MCG uses mathematical signal analysis that is distinct from signal averaging technology.</td>
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</tbody></table>
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<p class="size2"><a href="/research/findings/ta/comments/misccomments/cardiacspectral.html">Return to Contents</a></p>
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</div>
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<div class="current-as-of">Page last reviewed September 2012</div>
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<div class="citation">
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<span>Internet Citation: ECG-based Signal Analysis Technologies: Disposition of Comments: Disposition of Comments.
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September 2012. Agency for Healthcare Research and Quality, Rockville, MD. http://archive.ahrq.gov/research/findings/ta/comments/misccomments/ecgcommtab2.html</span>
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