A Paired-Comparision of the MultiFunction CardioGram^sm (MCG) and Sestamibi SPECT Myocardial Perfusion Imaging (MPI) to Quantitative Coronary Angiography for the Detection of Relevant Coronary Artery Obstruction (≥70%) - A Single-Center Study of 116 Consecutive Patients Referred for Coronary Angiography

Abstract

Background: An analysis of the US National Cardiovascular Data Registry has revealed that only 38% of patients referred for coronary angiography after non-invasive coronary testing have relevant coronary obstruction (CO) (≥70%) of one or more coronary arteries.Methods: A single-center trial was undertaken in 165 consecutive, symptomatic patients with either known or suspected coronary disease and/or valve disease(VHD) who agreed to undergo cardiac catheterization and coronary angiography if stress myocardial perfusion imaging was abnormal. A total of 116 patients with abnormal SPECT MPI tests, persistent chest pain, or significant VHD underwent final analysis. An MCG coronary obstruction (CO) score of ≥ 4.0 was considered indicative of relevant CO (≥70%) in one or more coronary arteries. Angiographic results were finalized by consensus of two angiographers.Results: CO (≥70%) was present in 53 of 116 patients (46%). The MCG CO score was significantly higher for patients with relevant CO (5.4 ± 1.9 vs. 2.5 ± 1.9). The MCG correctly classified 103 of the 116 patients (89%) enrolled in the study as either having or not having CO (≥70%) (sensitivity- 91%; specificity- 87%; NPV- 92%; PPV- 86%). SPECT MPI was abnormal in 99 of the 116 (85%) patients undergoing catheterization, but correctly classified only 54 of the 116 patients (47%) entered in the study as either having or not having relevant CO (sensitivity-85%; specificity-14%; NPV - 53%; PPV- 45%).Conclusions: The MCG was shown in this paired-comparison trial with SPECT MPI to safely and accurately identify patients with relevant CO (≥70%) prior to catheterization.

Non-invasive assessment of functionally significant coronary stenoses through mathematical analysis of spectral ECG components

“…The MCG device and database used have been previously described. 16 In brief, the database against which the incoming MCG data are compared originated from data gathering trials conducted from 1978 to 2000 in more than 30 institutions in Europe, Asia and North America on ∼100 000 individuals of varying ages and degrees of coronary disease. The MCG reports also indicate the level of myocardial damage and severity integrated into a score; other information such as coronary damage, area of damage, and myocardial pathological and pathophysiological conditions are included in the report.…”

Noninvasive mathematical analysis of spectral electrocardiographic components for coronary lesions of intermediate to obstructive stenosis severity–relationship with classic and functional SYNTAX score

“…Only those tests with a marginal or better quality trace, which was checked automatically by the system, were sent for analysis to the PH LLC data center via the Internet. The MCG device and database used were previously described . In brief, the database against which the incoming MCG data were compared originated from data‐gathering trials conducted from 1978 to 2000 in more than 30 institutions in Europe, Asia, and North America, among ∼100,000 individuals of varying ages and degrees of coronary disease.…”

It All Depends on Your References: Electrophysiology Compared to Angiography

“…7 Also, a study by Strobeck et al comparing MCG with SPECT and CAG concluded that MCG has high predictive value for the presence of hemodynamically relevant CAD. 8 Finally, in the most recent analysis published by Kawaji et al using the same dataset as in their article mentioned above but with different reference MCG severity scores, the authors came to the contrasting conclusion that "MCG with severity score and supplemental reports had high sensitivity to detect angiographic coronary atherosclerosis, and appeared to be useful for noninvasive screening of coronary atherosclerosis." 9 Therefore, that study by Kawaji et al published in this journal raises more concerns about the validity of the reference method employed than it tells about the clinical utility of MCG.…”