Frequently Asked Questions

How is MCG different from a conventional ECG?

MCG analysis is the first system of its kind to adopt a computational biology approach in clinical medicine, and begins a new era for more accurate and earlier detection of coronary disease non-invasively, without the risk of test-related consequences such as radiation or contrast-induced reactions.

Conventional ECG Reduction Approach	MCG ECG Systems Analysis Approach
Simplifies the ECG data by mapping it to a single dipole, plotted on a two-dimensional scale (time vs. voltage — the Einthoven ECG Model).	Processes the ECG data to produce a LaGrange-EÃler model which accurately represents the solid/liquid interaction of a living heart.
Segmental, single-cycle approach, focusing on a single lead at a time, and evaluating sections of the waveform (eg. ST Segment, T-Wave, QT intervals)	Operates on two leads simultaneously (II & v5), and across multiple cardiac cycles. Mathematical transformations extract non-linear funcational relationships from the ECG signal which are not captured by conventional techniques.
Requires experienced expert interpretations or over-reads to avoid misdiagnosis. No normalized/standardized empirical reference database comparing to "gold standard" (angiography).	Compares transformed ECG data to a large, normalized, retrospectively verified and prospectively validated empirical reference database developed through over two decades of research. Reference database is derived using the "gold standard" (angiography) for diagnostic validation.
Using surrogate to infer "possible ischemia", accuracy impaired by ECG abnormalities (eg. arrhythmias, bundle branch blocks).	Directly measures coronary ischemia without surrogate. Accuracy unaffected by most resting ECG abnormalities
Provides a subjective and qualitative assessment	Provides an objective, quantitative measure of disease severity

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.

How can MCG provide better accuracy with 2 leads compared to a conventional 12-lead ECG?

The key to MCG's accuracy is in the MCG analysis algorithms — MCG offers several advantages over a conventional ECG, notably:

• The MCG Analysis expands the analog ECG signal into a series of mathematical functions, more closely representing the complexity of a living heart.
  
• MCG 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 MCG database exceeds the capacity of an individual clinician reviewing a conventional ECG.
• The accuracy of the MCG 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.).
• MCG 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.

How has the accuracy of MCG been validated?

The 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 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.

If MCG 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 excells 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.

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 MCG analysis. Patients who suffer heart attacks following their first MCG testing will show greater anomalies as the result of the addional damaged cells.

In addition to detecting the damage, the MCG analysis quantifies the damage based on the severity of the abnormalities observed, giving a measure of the severty 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.

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 MCG evaluation may provide the first indication of coronary ischemia and enable intervention prior to a life-threatening coronary event.

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 MCG 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.

Why have I not heard of MCG before?

Premier Heart did not begin formally selling the MCG technology until late 2007, folliwng 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.

What is the cost and practicality of this technology in typical use?

MCG testing is a cost-effective solution for cardiac assessment, with field units available at a variety of price points. Data analysis and reporting are available for a low per-test cost, as part of a bulk pre-paid plan, or on dedicated infrastructure for high-volume institutional customers.

As a two-lead resting ECG procedure MCG can provide results in minutes, without the contraindications or risks of other diagnostic tests.
MCG testing can be performed in virtually any clinical setting from primary care offices to hospital emergency departments to field clinics. Anyone can be trained to perform the test, and the MCG reports are designed for clarity and ease of interpretation.

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.

What are some disadvantages of the MCG system?

While 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 seperate 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.