Skip to main content
Top
Published in: Journal of Nuclear Cardiology 4/2011

01-08-2011 | Review Article

The ninth annual Mario S. Verani memorial lecture

Testing our tests: The evidence bar is rising. Regulatory considerations in the development of cardiac imaging agents

Author: James E. Udelson, MD

Published in: Journal of Nuclear Cardiology | Issue 4/2011

Login to get access

Excerpt

It is indeed an enormous honor and a privilege to have been invited to present the ninth annual Mario S. Verani memorial lecture. It has been almost 10 years since Mario left us, and it is likely that many here with us today at the American Society of Nuclear Cardiology Annual meeting are not very aware of the major contributions he made to our field. As one of the purposes of this annual lectureship is to honor that body of work, and carry on its legacy, I thought it would be fitting to start with a reminiscence of the mark he made on the field of Nuclear Cardiology. …
Literature
1.
go back to reference Verani MS, Marcus ML, Razzak MA, Ehrhardt JC. Sensitivity and specificity of thallium-201 perfusion scintigrams under exercise in the diagnosis of coronary artery disease. J Nucl Med 1978;19:773-82.PubMed Verani MS, Marcus ML, Razzak MA, Ehrhardt JC. Sensitivity and specificity of thallium-201 perfusion scintigrams under exercise in the diagnosis of coronary artery disease. J Nucl Med 1978;19:773-82.PubMed
2.
go back to reference Verani MS, Mahmarian JJ, Hixson JB, Boyce TM, Staudacher RA. Diagnosis of coronary artery disease by controlled coronary vasodilation with adenosine and thallium-201 scintigraphy in patients unable to exercise. Circulation 1990;82:80-7.PubMedCrossRef Verani MS, Mahmarian JJ, Hixson JB, Boyce TM, Staudacher RA. Diagnosis of coronary artery disease by controlled coronary vasodilation with adenosine and thallium-201 scintigraphy in patients unable to exercise. Circulation 1990;82:80-7.PubMedCrossRef
3.
go back to reference He ZX, Cwajg E, Hwang W, Hartley CJ, Funk E, Michael LH, et al. Myocardial blood flow and myocardial uptake of (201)Tl and (99m)Tc-sestamibi during coronary vasodilation induced by CGS-21680, a selective adenosine A(2A) receptor agonist. Circulation 2000;102:438-44.PubMed He ZX, Cwajg E, Hwang W, Hartley CJ, Funk E, Michael LH, et al. Myocardial blood flow and myocardial uptake of (201)Tl and (99m)Tc-sestamibi during coronary vasodilation induced by CGS-21680, a selective adenosine A(2A) receptor agonist. Circulation 2000;102:438-44.PubMed
4.
go back to reference Verani MS, Hartung GH, Hoepfel-Harris J, Welton DE, Pratt CM, Miller RR. Effects of exercise training on left ventricular performance and myocardial perfusion in patients with coronary artery disease. Am J Cardiol 1981;47:797-803.PubMedCrossRef Verani MS, Hartung GH, Hoepfel-Harris J, Welton DE, Pratt CM, Miller RR. Effects of exercise training on left ventricular performance and myocardial perfusion in patients with coronary artery disease. Am J Cardiol 1981;47:797-803.PubMedCrossRef
5.
go back to reference Medrano R, Lowry RW, Young JB, Weilbaecher DG, Michael LH, Afridi I, et al. Assessment of myocardial viability with 99mTc sestamibi in patients undergoing cardiac transplantation. A scintigraphic/pathological study. Circulation 1996;94:1010-7.PubMed Medrano R, Lowry RW, Young JB, Weilbaecher DG, Michael LH, Afridi I, et al. Assessment of myocardial viability with 99mTc sestamibi in patients undergoing cardiac transplantation. A scintigraphic/pathological study. Circulation 1996;94:1010-7.PubMed
6.
go back to reference Verani MS, Jeroudi MO, Mahmarian JJ, Boyce TM, Borges-Neto S, Patel B, et al. Quantification of myocardial infarction during coronary occlusion and myocardial salvage after reperfusion using cardiac imaging with technetium-99m hexakis 2-methoxyisobutyl isonitrile. J Am Coll Cardiol 1988;12:1573-81.PubMedCrossRef Verani MS, Jeroudi MO, Mahmarian JJ, Boyce TM, Borges-Neto S, Patel B, et al. Quantification of myocardial infarction during coronary occlusion and myocardial salvage after reperfusion using cardiac imaging with technetium-99m hexakis 2-methoxyisobutyl isonitrile. J Am Coll Cardiol 1988;12:1573-81.PubMedCrossRef
7.
go back to reference Gibbons RJ, Miller TD, Christian TF. Infarct size measured by single photon emission computed tomographic imaging with (99m)Tc-sestamibi: A measure of the efficacy of therapy in acute myocardial infarction. Circulation 2000;101:101-8.PubMed Gibbons RJ, Miller TD, Christian TF. Infarct size measured by single photon emission computed tomographic imaging with (99m)Tc-sestamibi: A measure of the efficacy of therapy in acute myocardial infarction. Circulation 2000;101:101-8.PubMed
8.
go back to reference Mahmarian JJ, Boyce TM, Goldberg RK, Cocanougher MK, Roberts R, Verani MS. Quantitative exercise thallium-201 single photon emission computed tomography for the enhanced diagnosis of ischemic heart disease. J Am Coll Cardiol 1990;15:318-29.PubMedCrossRef Mahmarian JJ, Boyce TM, Goldberg RK, Cocanougher MK, Roberts R, Verani MS. Quantitative exercise thallium-201 single photon emission computed tomography for the enhanced diagnosis of ischemic heart disease. J Am Coll Cardiol 1990;15:318-29.PubMedCrossRef
9.
go back to reference Verani MS, Lacy JL, Guidry GW, Nishimura S, Mahmarian JJ, Athanasoulis T, et al. Quantification of left ventricular performance during transient coronary occlusion at various anatomic sites in humans: A study using tantalum-178 and a multiwire gamma camera. J Am Coll Cardiol 1992;19:297-306.PubMedCrossRef Verani MS, Lacy JL, Guidry GW, Nishimura S, Mahmarian JJ, Athanasoulis T, et al. Quantification of left ventricular performance during transient coronary occlusion at various anatomic sites in humans: A study using tantalum-178 and a multiwire gamma camera. J Am Coll Cardiol 1992;19:297-306.PubMedCrossRef
10.
go back to reference Verani MS, Gaeta J, LeBlanc AD, Poliner LR, Phillips L, Lacy JL, et al. Validation of left ventricular volume measurements by radionuclide angiography. J Nucl Med 1985;26:1394-401. (Erratum in: J Nucl Med 1987;28:401-2).PubMed Verani MS, Gaeta J, LeBlanc AD, Poliner LR, Phillips L, Lacy JL, et al. Validation of left ventricular volume measurements by radionuclide angiography. J Nucl Med 1985;26:1394-401. (Erratum in: J Nucl Med 1987;28:401-2).PubMed
11.
go back to reference He ZX, Scarlett MD, Mahmarian JJ, Verani MS. Enhanced accuracy of defect detection by myocardial single-photon emission computed tomography with attenuation correction with gadolinium 153 line sources: Evaluation with a cardiac phantom. J Nucl Cardiol 1997;4:202-10.PubMedCrossRef He ZX, Scarlett MD, Mahmarian JJ, Verani MS. Enhanced accuracy of defect detection by myocardial single-photon emission computed tomography with attenuation correction with gadolinium 153 line sources: Evaluation with a cardiac phantom. J Nucl Cardiol 1997;4:202-10.PubMedCrossRef
12.
go back to reference Verani MS. Stress myocardial perfusion imaging versus echocardiography for the diagnosis and risk stratification of patients with known or suspected coronary artery disease. Semin Nucl Med 1999;29:319-29.PubMedCrossRef Verani MS. Stress myocardial perfusion imaging versus echocardiography for the diagnosis and risk stratification of patients with known or suspected coronary artery disease. Semin Nucl Med 1999;29:319-29.PubMedCrossRef
13.
go back to reference Zaret BL, Strauss HW, Martin ND, Wells HP, Flamm MD. Noninvasive regional myocardial perfusion with radioactive potassium—study of patients at rest, with exercise and during angina pectoris. N Engl J Med 1973;288:809-12.PubMedCrossRef Zaret BL, Strauss HW, Martin ND, Wells HP, Flamm MD. Noninvasive regional myocardial perfusion with radioactive potassium—study of patients at rest, with exercise and during angina pectoris. N Engl J Med 1973;288:809-12.PubMedCrossRef
14.
go back to reference Dilsizian V, Rocco TP, Freedman NM, Leon MB, Bonow RO. Enhanced detection of ischemic but viable myocardium by the reinjection of thallium after stress-redistribution imaging. N Engl J Med 1990;323:141-6.PubMedCrossRef Dilsizian V, Rocco TP, Freedman NM, Leon MB, Bonow RO. Enhanced detection of ischemic but viable myocardium by the reinjection of thallium after stress-redistribution imaging. N Engl J Med 1990;323:141-6.PubMedCrossRef
20.
go back to reference Boucher CA, Wackers FJ, Zaret BL, Mena IG. Technetium-99m sestamibi myocardial imaging at rest for assessment of myocardial infarction and first-pass ejection fraction. Multicenter Cardiolite Study Group. Am J Cardiol 1992;69:22-7.PubMedCrossRef Boucher CA, Wackers FJ, Zaret BL, Mena IG. Technetium-99m sestamibi myocardial imaging at rest for assessment of myocardial infarction and first-pass ejection fraction. Multicenter Cardiolite Study Group. Am J Cardiol 1992;69:22-7.PubMedCrossRef
24.
go back to reference Thygesen K, Alpert JS, White HD, on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. ESC/ACCF/AHA/WHF EXPERT CONSENSUS DOCUMENT: Universal definition of myocardial infarction. J Am Coll Cardiol 2007;50:2173-95.PubMedCrossRef Thygesen K, Alpert JS, White HD, on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. ESC/ACCF/AHA/WHF EXPERT CONSENSUS DOCUMENT: Universal definition of myocardial infarction. J Am Coll Cardiol 2007;50:2173-95.PubMedCrossRef
25.
go back to reference Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, et al. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med 2000;343:1445-53.PubMedCrossRef Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, et al. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med 2000;343:1445-53.PubMedCrossRef
26.
go back to reference Wagner A, Mahrholdt H, Holly TA, Elliott MD, Regenfus M, Parker M, et al. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: An imaging study. Lancet 2003;361:374-9.PubMedCrossRef Wagner A, Mahrholdt H, Holly TA, Elliott MD, Regenfus M, Parker M, et al. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: An imaging study. Lancet 2003;361:374-9.PubMedCrossRef
27.
go back to reference Gould KL, Westcott RJ, Albro PC, Hamilton GW. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilatation. II. Clinical methodology and feasibility. Am J Cardiol 1978;41:279-87.PubMedCrossRef Gould KL, Westcott RJ, Albro PC, Hamilton GW. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilatation. II. Clinical methodology and feasibility. Am J Cardiol 1978;41:279-87.PubMedCrossRef
28.
go back to reference Al Suwaidi J, Hamasaki S, Higano ST, Nishimura RA, Holmes DR, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation 2000;101:948-54. Al Suwaidi J, Hamasaki S, Higano ST, Nishimura RA, Holmes DR, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation 2000;101:948-54.
29.
go back to reference Senior R, Monaghan M, Main ML, Zamorano JL, Tiemann K, Agati L, et al. Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: Two Phase 3 international trials in comparison with radionuclide perfusion imaging. Eur J Echocardr 2009;10:26-35.CrossRef Senior R, Monaghan M, Main ML, Zamorano JL, Tiemann K, Agati L, et al. Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: Two Phase 3 international trials in comparison with radionuclide perfusion imaging. Eur J Echocardr 2009;10:26-35.CrossRef
30.
go back to reference Zir LM, Miller SW, Dinsmore RE, Gilbert JP, Harthorne JW. Interobserver variability in coronary angiography. Circulation 1976;53:627-32.PubMed Zir LM, Miller SW, Dinsmore RE, Gilbert JP, Harthorne JW. Interobserver variability in coronary angiography. Circulation 1976;53:627-32.PubMed
31.
go back to reference Di Carli M, Czernin J, Hoh CK, Gerbaudo VH, Brunken RC, Huang SC, et al. Relation among stenosis severity, myocardial blood flow, and flow reserve in patients with coronary artery disease. Circulation 1995;91:1944-51.PubMed Di Carli M, Czernin J, Hoh CK, Gerbaudo VH, Brunken RC, Huang SC, et al. Relation among stenosis severity, myocardial blood flow, and flow reserve in patients with coronary artery disease. Circulation 1995;91:1944-51.PubMed
32.
go back to reference Hodgson JM, Dib N, Kern MJ, Bach RG, Barrett RJ. Coronary circulation responses to binodenoson, a selective adenosine A2A receptor agonist. Am J Cardiol 2007;99:1507-12.PubMedCrossRef Hodgson JM, Dib N, Kern MJ, Bach RG, Barrett RJ. Coronary circulation responses to binodenoson, a selective adenosine A2A receptor agonist. Am J Cardiol 2007;99:1507-12.PubMedCrossRef
33.
go back to reference Borer JS, Bacharach SL, Green MV, Kent KM, Epstein SE, Johnston GS, et al. Real-time radionuclide cineangiography in the noninvasive evaluation of global and regional left ventricular function at rest and during exercise in patients with coronary-artery disease. N Engl J Med 1977;296:839-44.PubMedCrossRef Borer JS, Bacharach SL, Green MV, Kent KM, Epstein SE, Johnston GS, et al. Real-time radionuclide cineangiography in the noninvasive evaluation of global and regional left ventricular function at rest and during exercise in patients with coronary-artery disease. N Engl J Med 1977;296:839-44.PubMedCrossRef
34.
go back to reference Zaret BL, Rigo P, Wackers FJT, Hendel RC, Braat SH, Iskandrian AS, et al. Myocardial perfusion imaging with 99mTc tetrofosmin comparison to 201Tl imaging and coronary angiography in a phase III multicenter trial. Circulation 1995;91:313-9.PubMed Zaret BL, Rigo P, Wackers FJT, Hendel RC, Braat SH, Iskandrian AS, et al. Myocardial perfusion imaging with 99mTc tetrofosmin comparison to 201Tl imaging and coronary angiography in a phase III multicenter trial. Circulation 1995;91:313-9.PubMed
36.
go back to reference Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: Results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol 2007;14:645-58.PubMedCrossRef Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: Results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol 2007;14:645-58.PubMedCrossRef
38.
go back to reference Udelson JE. Lessons from the development of new adenosine A2a receptor agonists. J Am Coll Cardiol Imaging 2008;1:317-20. Udelson JE. Lessons from the development of new adenosine A2a receptor agonists. J Am Coll Cardiol Imaging 2008;1:317-20.
39.
go back to reference Udelson JE, Beshansky JR, Ballin DS, Feldman JA, Griffith JL, Handler J, et al. Myocardial perfusion imaging for evaluation and triage of patients with suspected acute cardiac ischemia: A randomized controlled trial. JAMA 2002;288:2693-700.PubMedCrossRef Udelson JE, Beshansky JR, Ballin DS, Feldman JA, Griffith JL, Handler J, et al. Myocardial perfusion imaging for evaluation and triage of patients with suspected acute cardiac ischemia: A randomized controlled trial. JAMA 2002;288:2693-700.PubMedCrossRef
42.
go back to reference Kontos MC, Dilsizian V, Weiland F, DePuey G, Mahmarian JJ, Iskandrian AE, et al. Iodofiltic acid I 123 (BMIPP) fatty acid imaging improves initial diagnosis in emergency department patients with suspected acute coronary syndromes: A multicenter trial. J Am Coll Cardiol 2010;56:290-9.PubMedCrossRef Kontos MC, Dilsizian V, Weiland F, DePuey G, Mahmarian JJ, Iskandrian AE, et al. Iodofiltic acid I 123 (BMIPP) fatty acid imaging improves initial diagnosis in emergency department patients with suspected acute coronary syndromes: A multicenter trial. J Am Coll Cardiol 2010;56:290-9.PubMedCrossRef
43.
go back to reference Brown KA, Boucher CA, Okada RD, Guiney TE, Newell JB, Strauss HW, et al. Prognostic value of exercise thallium-201 imaging in patients presenting for evaluation of chest pain. J Am Coll Cardiol 1983;1:994-1001.PubMedCrossRef Brown KA, Boucher CA, Okada RD, Guiney TE, Newell JB, Strauss HW, et al. Prognostic value of exercise thallium-201 imaging in patients presenting for evaluation of chest pain. J Am Coll Cardiol 1983;1:994-1001.PubMedCrossRef
44.
go back to reference Ladenheim ML, Pollock BH, Rozanski A, Berman DS, Staniloff HM, Forrester JS, et al. Extent and severity of myocardial hypoperfusion as predictors of prognosis in patients with suspected coronary artery disease. J Am Coll Cardiol 1986;7:464-71.PubMedCrossRef Ladenheim ML, Pollock BH, Rozanski A, Berman DS, Staniloff HM, Forrester JS, et al. Extent and severity of myocardial hypoperfusion as predictors of prognosis in patients with suspected coronary artery disease. J Am Coll Cardiol 1986;7:464-71.PubMedCrossRef
45.
go back to reference Hachamovitch R, Berman DS, Shaw LJ, Kiat H, Cohen I, Cabico JA, et al. Incremental prognostic value of myocardial perfusion single photon emission computed tomography for the prediction of cardiac death: Differential stratification for risk of cardiac death and myocardial infarction. Circulation 1998;97:535-43.PubMed Hachamovitch R, Berman DS, Shaw LJ, Kiat H, Cohen I, Cabico JA, et al. Incremental prognostic value of myocardial perfusion single photon emission computed tomography for the prediction of cardiac death: Differential stratification for risk of cardiac death and myocardial infarction. Circulation 1998;97:535-43.PubMed
46.
go back to reference Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, et al. Myocardial Iodine-123 Meta-iodobenzylguanidine imaging and cardiac events in heart failure: Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) Study. J Am Coll Cardiol 2010;55:2212-21.PubMedCrossRef Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, et al. Myocardial Iodine-123 Meta-iodobenzylguanidine imaging and cardiac events in heart failure: Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) Study. J Am Coll Cardiol 2010;55:2212-21.PubMedCrossRef
47.
go back to reference Young LH, Wackers FJT, Chyun DA, Davey JA, Barrett EJ, Taillefer R, et al. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: The DIAD Study: A randomized controlled trial. JAMA 2009;301:1547-55.PubMedCrossRef Young LH, Wackers FJT, Chyun DA, Davey JA, Barrett EJ, Taillefer R, et al. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: The DIAD Study: A randomized controlled trial. JAMA 2009;301:1547-55.PubMedCrossRef
Metadata
Title
The ninth annual Mario S. Verani memorial lecture
Testing our tests: The evidence bar is rising. Regulatory considerations in the development of cardiac imaging agents
Author
James E. Udelson, MD
Publication date
01-08-2011
Publisher
Springer-Verlag
Published in
Journal of Nuclear Cardiology / Issue 4/2011
Print ISSN: 1071-3581
Electronic ISSN: 1532-6551
DOI
https://doi.org/10.1007/s12350-011-9404-x

Other articles of this Issue 4/2011

Journal of Nuclear Cardiology 4/2011 Go to the issue