Background: Myocardial perfusion imaging (MPI) has evolved over the last several decades with improvements in equipment and isotopes. Despite these limitations sensitivity and specificity of this study remains 65%-85% principally due to “qualitative” interpretation of the results. Numerous investigators have recommended changes in protocols and quantification of data to increase the diagnostic accuracy of this non-invasive physiologic test. Initial investigations have demonstrated the ability to “quantitatively” measure isotope redistribution with planar, SPECT and PET using FMTVDM©℗. This study was designed to compare the diagnostic and treatment outcomes of U.S. Veterans undergoing conventional “stress-rest” “qualitative” imaging using Technetium 99m isotopes (Sestamibi and Myoview) compared with FMTVDM©℗ “quantification” isotope redistribution using a single dose of the isotope.Methods: Forty-one U.S. Veterans were studied using pharmacologic and exercise stress approaches with either Sestamibi or Myoview following routine MPI Imaging protocols compared with FMTVDM©℗. The results were compared with coronary angiography.Result: Angiographic coronary artery disease (CAD) was defined using both 50% and 70% diameter narrowing/ stenosis (%DS). Accuracy of a “qualitative” (yes/no) test in the determination of the presence or absence of CAD is measured by the ability of the test to find CAD when present (sensitivity) and to show that CAD is not present (specificity) when absent, based upon the arbitrarily assigned value for %DS. The sensitivity, specificity and accuracy of “qualitative” MPI assessment of 50% DS CAD was 50.0%, 88.2% and 70.7% for the left coronary artery system and 29.2%, 64.7% and 43.9% respectively for the right coronary artery system. These values improved to 59.1%, 89.5% and 73.2% for the left coronary artery system and 64.3%, 85.2% and 78.0% respectively for the right coronary artery system when 70%DS was used as the cutoff for CAD. No differences noted between either of the technetium 99m isotopes or cameras used for either the “qualitative” or “quantitative” (FMTVDM©℗) methods. FMTVDM©℗ provides the First Ever “quantitative” Nuclear Cardiology MPI test, which consequently defines CAD not on a yes/no basis, but “quantitatively.” As such, the accuracy of FMTVDM©℗ must be compared first to a “quantitative” measure which is known; viz. isotope decay using TFM. Results of FMTVDM©℗ is then not simply a yes/no result, but rather a “quantitative” value which places the “extent” of CAD on a measured continuum much as a coronary angiogram would, specifically a quantitative coronary angiogram (QCA). FMTVDM©℗ demonstrated a statistically significant relationship between CAD and %DS (r=0.75, p < 0.001).Conclusion: Modern Nuclear Cameras have relied completely upon “quality” control methods, which do exactly that; they provide for “qualitative” control but not “quantitative” control. The accuracy of the cameras ability to correctly count the resulting scintillations from which “quantitative” analysis and even “qualitative” images are displayed for clinician interpretation are dependent, has never been established or used in either the experimental or clinical areas of Medicine. This study demonstrated the importance of first using TFM from the FMTVDM©℗ for “quantitative” camera calibration and correction prior to conducting MPI. Even with the correction of the “quantitative” errors in the Nuclear Cameras, errors in “qualitative” MPI resulted in a conservative estimate of misdiagnosis of CAD 35% of the time. These errors result in potential life threatening CAD being missed as demonstrated here. This same CAD is accurately measured using the new “quantitative” MPI test (FMTVDM©℗), which accurately “quantify” the extent of CAD. FMTVDM©℗ provides the first “quantitative” Nuclear Cardiology and Medicine test, ushering in the era of “machine learning” and “quantitative” Nuclear Cardiology and Medicine providing accurate, reproducible measurement of CAD in less time and with less radiation than the prior “qualitatively” applied method of “physician interpretation” of CAD, reducing healthcare costs and improving patient throughput and clinical management.
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