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(F 18 FDG PET) for Cardiac Indications Medical Review of F-18 Fluorodeoxyglucose Positron Emission Tomography (F-18 FDG PET) for Cardiac Indications Victor F.C. Raczkowski, MD, MS I. Introduction The purpose of this review is to determine whether existing clinical data are sufficient to demonstrate the safety and efficacy of F-18 FDG PET imaging in support of an indication for cardiac use.1 Positron emission tomography (PET) imaging with F-18 fluorodeoxyglucose (F-18 FDG) has been used in cardiology primarily to evaluate myocardial hibernation. This review summarizes and evaluates a number of literature studies in which PET imaging with F-18 FDG was used to assess myocardial hibernation in patients with coronary artery disease and left ventricular dysfunction. F-18 FDG is an analog of glucose that contains the radionuclide Fluorine F-18. Fluorine F-18 decays by positron (β+) emission and has a physical half-life of 109.7 minutes. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (i.e., positron annihilation). As a glucose analog, F-18 FDG is transported into myocytes by the glucose transporter and can enter metabolic glucose pathways. After phosphorylation by hexokinase, F-18 FDG is not metabolized further, and the reverse reaction (dephosphorylation by glucose-6-phosphatase) is minimal. Phosphorylated F-18 FDG is therefore trapped within myocytes. Under normal aerobic conditions, the myocardium meets the bulk of its energy requirements by oxidizing free fatty acids, and most of the exogenous glucose taken up by the myocyte is converted into glycogen. However, under ischemic conditions, the oxidation of free fatty acids decreases, exogenous glucose becomes the preferred myocardial substrate, glycolysis is stimulated, and glucose taken up by the myocyte is metabolized immediately instead of being 1 On 21 November 1997, the President signed the Food and Drug Administration Modernization Act (FDAMA) into law. Section 121 of FDAMA requires FDA to develop appropriate procedures for the approval of PET drugs pursuant to section 505 of the Federal Food , Drug, and Cosmetic Act (21 U.S.C. 355). As part of FDA's efforts, this review is being conducted to determine whether the medical literature supports approval of F-18 FDG, one of the more commonly used PET radiopharmaceuticals, for use in cardiac imaging. Raczkowski; 3 August 1999 −1− converted into glycogen. Under these conditions, as described above, phosphorylated F-18 FDG accumulates in the cell and can be detected with PET imaging. Myocardial hibernation is defined as chronic, reversible left ventricular dysfunction due to coronary artery disease.i The ability to identify hibernating myocardial tissue is potentially of great clinical significance. Hibernating myocardium with longstanding systolic dysfunction may be able to regain some, or all, of its function after successful coronary revascularization with procedures such as coronary artery bypass grafting (CABG) or coronary angioplasty. However, infarcted or scarred myocardium will not regain function after such procedures. Thus, the ability to distinguish hibernating from infarcted tissue before revascularization may be useful clinically in helping to predict the likelihood of left ventricular functional recovery after revascularization. Because uptake and phosphorylation of F-18 FDG are active cellular processes, the localization of F-18 FDG in asynergic myocardium has been investigated as being a marker for myocardial viability. On PET imaging, increased accumulation of F-18 FDG in myocardial regions with reduced perfusion, or flow-metabolism mismatch, has been used to detect hibernating myocardium. Conversely, a matched defect, with concordant reductions in both perfusion and F-18 FDG accumulation, has been viewed as being a marker for a myocardial scar. Other imaging methods which have been used to assess myocardial hibernation include stress echocardiography with dobutamine, single-photon-emission-computed tomography (SPECT) with thallium-201, radionuclide imaging with technetium-99m sestamibi, and PET imaging with C-11 acetate. However, none of these other methods have indications for the evaluation of myocardial hibernation. II. Evaluating the Effectiveness Data for F-18 FDG PET Imaging for Identifying Myocardium with Reversible Loss of Systolic Function in Patients with Coronary Artery Disease and Left Ventricular Dysfunction A. Data Sources FDA's Center for Drug Evaluation and Research (CDER) conducted a literature search of recent peer-reviewed medical journals to evaluate the F-18 FDG effectiveness data. The search criteria included the following items: studies published from January 1990 to July 1, 1998 identified as human clinical studies with F-18 FDG in PET, written in English, found by searching on-line databases of Medline (n=250), Embase (n=274), Derwent (n=38), Cochrane (n=33), Cancerlit (n=25), Biosis (n=9), and HSTAR (n=3). Of the articles generated by this search, the medical reviewer further narrowed the search by use of the search terms "viability" and "hibernation." FDA also solicited references from the PET community on the use of F-18 FDG in cardiac PET imaging from any time period published in peer-reviewed journals. Review articles on F-18 FDG PET cardiac imaging were identified, including one recent pooled analysis.ii To ensure completeness, the reference list of Guidelines, Scientific Statements, and Position Statements from three professional organizations were reviewed, as were the reference sections of some of the articles identified in the above searches.iii,iv,v One abstract was also identified because of the number of patients enrolled and because it describes a multicenter study.vi Raczkowski; 3 August 1999 −2− For primary review, I selected ten articles of prospective studies in patients with coronary artery disease and left ventricular dysfunction in which cardiac imaging with F-18 FDG was used to assess regional myocardial hibernation. Each article allowed the results of cardiac PET F-18 FDG imaging to be compared with the functional outcome of the left ventricle ("truth"), as described in the next section. In addition, several other selected articles were reviewed in support of the potential clinical usefulness of such cardiac F-18 FDG PET evaluations. Each of the ten principal studies was considered to be well controlled, and in aggregate, the articles provide an adequate data base upon which to judge the effectiveness of F-18 FDG in identifying myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction. B. Approach to the Review In a dysfunctional left ventricle, hibernating myocardium may be identified operationally by determining whether myocardial regions regain systolic function after coronary revascularization. In each of the principal studies summarized in this review, the performance of PET imaging with F-18 FDG is therefore measured against a functional outcome: the recovery (or lack of recovery) of regional systolic function after myocardial revascularization with either CABG or angioplasty. Thus, in these studies, "truth" is ascertained by a functional outcome-- recovery or lack of recovery--after revascularization. Truth is not ascertained by comparing the results of PET imaging with F-18 FDG to those of a "gold standard." The various technologies by which this recovery of systolic function was assessed in each of these studies (including echocardiography, radionuclide ventriculography, and contrast ventriculography) are each sufficiently valid and reliable to allow such determinations of functional outcome to be made. Stated differently, some of the principal studies assessed myocardial hibernation by additional methods (e.g., stress echocardiography with dobutamine). Although the results of these other methods were noted in this review for completeness, these results were not used to assess the efficacy of PET imaging with F-18 FDG. That is, the efficacy of PET F-18 FDG was assessed on its own merits and by its ability to predict systolic recovery (i.e., by evaluating its predictive validity). Efficacy was not assessed by comparison of PET imaging with F-18 FDG to other modalities or to a gold standard (i.e., by evaluating its criterion validity). Efficacy was evaluated by comparing predictions of functional recovery (made with PET F-18 FDG before revascularization) with actual functional outcome after revascularization. The studies are all of a similar design, even though different technologies may have been used to make the various assessments. Thus, enrolled patients were typically patients with coronary artery disease and left ventricular dysfunction who were scheduled for coronary revascularization. These patient entry criteria were typically documented with coronary arteriography and with either contrast or radionuclide ventriculography. Before revascularization, except as noted, the following core parameters were assessed: • Myocardial metabolism (by positron emission tomography with F-18 FDG). Raczkowski; 3 August 1999 −3− • Myocardial perfusion (by PET with N-13 ammonia, PET with Rb-82, thallium-201 scintigraphy, SPECT with Tc-99m sestamibi, or PET with C-11 acetate, depending on the study). However, in some cases, myocardial perfusion was not assessed as part of the study. • Ventricular function, such as segmental wall motion (by two-dimensional echocardiography, radionuclide ventriculography,
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