How does MCG's accuracy compare to other diagnostic techniques
Clinical trials and real-world experience has shown the MCG system to be superior to other common clinical techniques such as stress tests, nuclear perfusion imaging and CT angiography.
For full details, please see this comparison chart.
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How can the MCG provide better accuracy with 2 leads compared to a conventional 12-lead ECG?
The key to MCG's accuracy is in the mfEMT analysis algorithms — mfEMT offers several advantages over a conventional ECG, notably:
The mfEMT Analysis expands the analog ECG signal into a series of mathematical functions, more closely representing the complexity of a living heart.
- mfEMT analysis compares the results of the above functions to a clinically validated database containing thousands of patients, including healthy individuals and those with pathologies confirmed through conventional diagnostic modalities.
- The breadth of the mfEMT database exceeds the capacity of an individual clinician reviewing a conventional ECG.
- The accuracy of the mfEMT analysis is not affected by most abnormalities in the resting ECG, arrhythmias, gender or age due to the nature of the analysis, which focuses on the relationship between two leads as opposed to the traditional method of analyzing complexes (P, QRS, S-T, etc.).
- mfEMT views the ECG data in both the time domain (as a conventional ECG) and the frequency domain, using experimentally proven and empirically validated signal processing techniques to extract latent information from the ECG signal which is not available with conventional techniques.
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How has the accuracy of MCG been validated?
MCG technology has been validated through numerous peer-reviewed studies, demonstrating its accuracy, sensitivity and specificity to be equal to or better than experienced clinical judgment.
Additionally, the MCG system is currently used by discriminating cardiologists, internists and family practitioners in their daily practices domestically and internationally.
The technology has withstood intense scrutiny and and has consistently demonstrated a high level of accuracy based upon feedback from our user base.
Additional information and results from our clinical trials may be found on our Clinical Trials page.
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If mfEMT analysis is more accurate, why do a conventional ECG?
Conventional ECGs are a traditional tool, and physicians are trained and accustomed to using it in their daily practice.
Conventional ECG technology also excels in detecting and differentiating cardiac arrhythmia.
Premier Heart is actively working on techniques to improve the MCG technology to enable it to function as a complete replacement for conventional ECG.
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Can MCG detect a previous MI and determine its severity?
Yes — Patients who have suffered heart attacks will have heart muscle damage, which is detected as abnormalities by the mfEMT analysis. Patients who suffer heart attacks following their first MCG testing will show greater anomalies as the result of the additional damaged cells.
In addition to detecting the damage, the mfEMT analysis quantifies the damage based on the severity of the abnormalities observed, giving a measure of the severity of the heart attack based on the degree of deviation detected.
The MCG system can be used during follow-up visits to monitor patient improvement after a heart attack and determine if a treatment is effective for a given patient.
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Is MCG useful for screening asymptomatic patients?
Yes — A large number of patients with clinically significant coronary artery obstruction remain asymptomatic up until their first heart attack — at this point it is too late to reverse the damage done to the heart.
Because of its high positive and negative predictive values, MCG is an excellent first-line screening tool prior to using more invasive techniques such as coronary angiography.
Evaluation with the MCG system can detect coronary disease in its earliest stages, allowing intervention before damage is done. If testing reveals early-stage CAD, lifestyle changes and medication may be all that is necessary to avoid a potentially life-threatening heart attack.
For more advanced disease progression an mfEMT evaluation may provide the first indication of coronary ischemia and enable intervention prior to a life-threatening coronary event.
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How widespread is the use of MCG?
The MCG technology has been in use for more than ten years. Since the peer-reviewed publication of our most recent clinical trials in 2007 3DMP systems have been used in daily clinical practice by cardiologists, internists, urgent care specialists and family practitioners in New York, New Jersey, Connecticut, Florida, and California.
Internationally, units have been deployed in China, India, Japan, Dubai, Mexico and Guyana.
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Why have I not heard of MCG before?
Premier Heart did not begin formally selling the MCG technology until late 2007, following a significant amount of preparation — US FDA approval, acceptance for reimbursement by several major insurance carriers and the submission of our initial articles for publication in peer-reviewed journals including Circulation, CHEST, the International Journal of Medical Sciences (2007 and 2008) and others.
With this foundation Premier Heart is able to confidently supply the MCG technology as a clinically proven system, and we are now expanding our distribution network to make the technology available to a wider audience.
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Why is the MCG procedure more costly than a typical ECG?
MCG is not a conventional ECG — While the in-office testing procedure is nearly identical to a conventional resting ECG the detailed analysis performed by Premier Heart's servers enables substantially more accurate diagnoses than can be made from conventional ECGs. The cost of MCG testing is actually significantly lower than other widely used techniques (Stress testing, CT Angiography) while the results are substantially more accurate.
The cost of the MCG test also represents Premier Heart's investment in research and development, including compiling the largest database of its kind to aid physicians in reaching rapid, accurate, evidence-based diagnoses and our ongoing commitment to research and development to improve the accuracy of this groundbreaking technology.
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What are some disadvantages of the MCG system?
MCG analysis is more accurate than other diagnostic techniques it is not 100% accurate.
Clinical studies have shown that for diagnosis of ischemia due to coronary artery disease MCG has a sensitivity of 90% with 7±2% false negative results. Specificity is 85% or better, with 15±3% false positive results.
It is possible for MCG to report a negative result for a small subset of patients with coronary artery disease. Likewise it is possible for MCG to report a positive result for a subset of healthy patients.
Additionally, the current generation of MCG does not determine the location of coronary artery blockages — A separate test (angiography) is required for this.
Premier Heart is actively researching ways to improve the accuracy and utility of the MCG technology.
We are confident that ongoing research and refinements will continue to improve the results available from our system.
Does the MCG really work? How?
Yes, it does. In the peer-reviewed trials, it clearly performs as virtually no other device can. (Show the meta-analysis of the trials). With a sensitivity of over 90%, and a specificity of over 85%, it will find those people who have myocardial ischemia without giving lots of false positives.
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How?
By measuring electrical impulses of the heart, similar to an EKG, instead of focusing on one lead-at-a-time and one-cardiac-cycle-at-a-time analysis, Multifunction Cardiogram or MCG takes multiple cardiac cycles (in 5.12 seconds time frame) of the EKG signals from leads V5 and II simultaneously, digitizing and performing the discrete Fourier transform (DFT*) on them and then further transforming those measurements to six mathematical transformations to compare and contrast the interaction between the two leads in order to express and quantify the physiological relationship between the myocardium (the solid) and the intracardiac blood flow (the liquid) in order to analyze the heart as a whole system.
Although it at first may seem like an EKG, the true POWER of this device is in the mathematical model and the huge empirical digital database back in NY. So instead of looking at an EKG reading in isolation for one patient, and instead of relying on subjective skills trying to read ambiguous tracings that an EKG produces, the MCG systematically analyzes the data and compares the results to its database of readings from 41,000 patients (including healthy patients and those with various conditions, validated through the “gold standard” of a coronary angiogram). By correlating the analyzed measurements of your single patient to the patterns of these 41,000 records, MCG can detect anomalies that indicate presence (or absence) of myocardial ischemia in many of your patients which may surprise you and even your cardiologists.
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Doesn’t an EKG do this already? Or does this replace my EKG?
A traditional EKG cannot detect myocardial ischemia with any reasonable degree of accuracy – studies have shown only 20% sensitivity for resting EKG, and 40% sensitivity for stress test (exercising) EKG. MCG has consistently shown 90% or better sensitivity for detecting ischemia. An EKG does many good things, and since it is inexpensive, it is an excellent diagnostic tool, but MCG is a completely new tool for the doctor to use in the point-of-care settings for their patients at risk.
The MCG test does not replace a traditional EKG. Continue using the EKG to detect arrhythmia, heart damage from prior myocardial infarctions, etc., but use the MCG any time you want to check for myocardial ischemia and other functional disorders of the heart relating to imbalance between the myocardial demand and intracardiac blood flow supplies. MCG provides new dimensions conventional EKG technology lacks.
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I just send all my at-risk patients to the cardiologist, or at least give them the option. Why should I need this?
The answer is simple: At least 50% of acute myocardial ischemia cases are “silent,” with very few, if any, symptoms to help you even determine whether to send a patient to a cardiologist. Thousands die each year from heart attacks that hit without warning. With approximately 85% of fifty-year-old Caucasian males having at least one coronary artery blocked at 50%, Primary Care physicians actually see 85% of the patient with various degrees of CAD with knowing who they are or how severe their conditions are. These 50-year-old plus patients are the ones ended up dying prematurely due to a rupture plaque in one of their major coronary arteries. MCG technology changes game, it empowers you the first-line care giver. You can be much more proactive in diagnosing your at-risk patients, finding those patients who need additional care but slipped through the crack before. Virtually every GP we talk to has stories about patients who had major heart attacks, many who died, shortly after seeing the GP for a checkup.
So the better question is – how can you afford to not have and MCG?
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I can’t do this because I can’t risk the liability. Malpractice insurance is ridiculously expensive, and this would just expose me more.
Actually, this new procedure works in the reverse, reducing your liability substantially. It gives you new capability that you never had before to detect very serious disease. Today, for a GP, a resting EKG is about all you have to detect myocardial ischemia, and that is a very poor tool. And although you can send “at-risk” patients to a cardiologist, you don’t have good tools to even determine who is at-risk. So many people have serious myocardial ischemia but do not exhibit enough at-risk symptoms (detectable by the GP today) that we have an epidemic of catastrophic heart attacks in patients who were never sent to the cardiologist.
So this will ADD to your arsenal of diagnostic tools. Malpractice occurs when a GP omits a test that would normally be run, and thus misses a diagnosis. This is the opposite – it gives a new tool that can help diagnose. Clearly, in a few years, the MCG will be the “community standard of care,” and omitting testing an at-risk patient with an MCG will then be a cause for malpractice, increasing the liability of those physicians who have not yet adopted it.
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