Seminars in Nuclear Medicine
Volume 38, Issue 6 , Pages 462-470 , November 2008

Methods of Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)

  • Paul D. Stein, MD

      Affiliations

    • Department of Research, St. Joseph Mercy Oakland Hospital, Pontiac, MI, and Department of Medicine, Wayne State University, Detroit, MI
    • Corresponding Author InformationAddress reprint requests to Paul D. Stein, MD, St. Joseph Mercy Oakland, 44405 Woodward Ave, Pontiac, MI 48341-5023
  • ,
  • Alexander Gottschalk, MD

      Affiliations

    • Department of Radiology, Michigan State University, East Lansing, MI
  • ,
  • H. Dirk Sostman, MD

      Affiliations

    • Office of the Dean, Weill Cornell Medical College and Methodist Hospital, Houston, TX
  • ,
  • Thomas L. Chenevert, PhD

      Affiliations

    • Department of Radiology, University of Michigan, Ann Arbor, MI
  • ,
  • Sarah E. Fowler, PhD

      Affiliations

    • The Biostatistics Center, Department of Epidemiology and Biostatistics, George Washington University, Rockville, MD
  • ,
  • Lawrence R. Goodman, MD

      Affiliations

    • Department of Radiology, Medical College of Wisconsin, Milwaukee, WI
  • ,
  • Charles A. Hales, MD

      Affiliations

    • Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA
  • ,
  • Russell D. Hull, MBBS, MSc

      Affiliations

    • Department of Medicine, University of Calgary, Calgary, Alberta, Canada
  • ,
  • Emanuel Kanal, MD

      Affiliations

    • Department of Radiology, University of Pittsburgh, Pittsburgh, PA
  • ,
  • Kenneth V. Leeper Jr, MD

      Affiliations

    • Department of Medicine, Emory University, Atlanta, GA
  • ,
  • David P. Nadich, MD

      Affiliations

    • Department of Radiology, New York University Medical Center, New York, NY
  • ,
  • Daniel J. Sak, DO

      Affiliations

    • Department of Medicine, St. Joseph Mercy Oakland Hospital, Pontiac, MI
  • ,
  • Victor F. Tapson, MD

      Affiliations

    • Department of Medicine, Duke University, Durham, NC
  • ,
  • Thomas W. Wakefield, MD

      Affiliations

    • Department of Surgery, University of Michigan, Ann Arbor, MI
  • ,
  • John G. Weg, MD

      Affiliations

    • Department of Medicine, University of Michigan, Ann Arbor, MI
  • ,
  • Pamela K. Woodard, MD

      Affiliations

    • Department of Radiology, Washington University, St. Louis, MO

References 

  1. Agency for Healthcare Research and Quality. Evidence Report/Technology Assessment No. 68, Diagnosis and treatment of deep venous thrombosis and pulmonary embolism. www.ahrq.gov/clinic/epcsums/dvtsum.htm
  2. Wells PS, Anderson DR, Rodger M, et al. Excluding pulmonary embolism at the bedside without diagnostic imaging: Management of patients with suspected pulmonary embolism presenting to the emergency department by using a simple clinical model and d-dimer. Ann Intern Med. 2001;135:98–107
  3. Meaney JF, Weg JG, Chenevert TL, et al. Diagnosis of pulmonary embolism with magnetic resonance angiography. N Engl J Med. 1997;336:1422–1427
  4. Oudkerk M, van Beek EJ, Weilopolski P, et al. Comparison of contrast-enhanced magnetic resonance angiography and conventional pulmonary angiography for the diagnosis of pulmonary embolism: A prospective study. Lancet. 2002;359:1643–1647
  5. Gupta A, Frazer CK, Ferguson JM, et al. Acute pulmonary embolism: Diagnosis with MR angiography. Radiology. 1999;210:353–359
  6. Blum A, Bellou A, Guillemin F, et al. GENEPI study group Performance of magnetic resonance angiography in suspected acute pulmonary embolism. Thromb Haemost. 2005;93:503–511
  7. Wells PS, Ginsberg JS, Anderson DR, et al. Use of a clinical model for safe management of patients with suspected pulmonary embolism. Ann Intern Med. 1998;129:997–1005
  8. Shellock FG. Manual for Magnetic Resonance Safety Implants and Devices. 2004 Edition. Los Angeles, CA: Biomedical Research Publishing Co; 2004;
  9. U.S. Food and Drug Administration. Healthcare professional sheet (Gadolinium-containing contrast agents for magnetic resonance imaging (MRI)). (marketed as Omniscan, OptiMARK, Magnevist, ProHance and MultiHance) 6/23/06 http://www.fda.gov/cder/drug/InfoSheets/HCP/gccaHCP.htmAccessed July 9, 2008
  10. Cowper SE International Center for Nephrogenic Fibrosing Dermopathy Research (ICNFDR). http://www.pathmax.com/dermweb/Accessed July 9, 2008
  11. U.S. Food and Drug Administration: Public health advisory. Update on magnetic resonance imaging (MRI) contrast agents containing gadolinium and nephrogenic fibrosing dermopathy. Accessed September 5, 2008 http://www.fda.gov/cder/drug/advisory/gadolinium_agents_20061222.htm
  12. U.S. Food and Drug Administration. Information for healthcare professionals (Gadolinium-based contrast agents for magnetic resonance imaging scans). (marketed as Omniscan, OptiMark, Magnevist, ProHance, and MultiHance .Updated 12/2006 http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200612HCP.htmAccessed September 5, 2008
  13. Sadowski EA, Bennett LK, Chan MR, et al. Nephrogenic systemic fibrosis: Risk factors and incidence estimation. Radiology. 2007;243:148–157
  14. Thomsen HS. Nephrogenic systemic fibrosis: A serious late adverse reaction to gadodiamide. Eur Radiol. 2006;16:2619–2621
  15. Kuo PH, Kanal E, Abu-Alfa AK, et al. Gadolinium-based MR contrast agents and nephrogenic systemic fibrosis. Radiology. 2007;242:647–649
  16. Medicine and Healthcare Products Regulatory Agency. Nephrogenic systemic fibrosis (NSF) and gadolinium-containing MRI contrast agents. http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON2030229Accessed July 9, 2008
  17. Waknine Y. High-dose gadolinium may be linked to NSF/NFD in patients with renal failure. http://www.medscape.com/viewarticle/535842Accessed July 9, 2008
  18. Kanal E, Barkovich AJ, Bell C, et al. ACR Guidance Document for Safe MR Practices: 2007. AJR Am J Roentgenol. 2007;188:1447–1474
  19. Gault MH, Longervich LL, Harnett JD, et al. Predicting glomerular function from adjusted serum creatinine. Nephron. 1992;62:249–256
  20. Levey AS, Coresh J, Greene T, et al. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006;145:247–254
  21. Levey AS, Coresh J, Greene T, et al. Expressing the MDRD study equation for estimating GFR with IDMS traceable (gold standard) serum creatinine values. J Am Soc Nephrol. 2005;16:69A;(abstr)
  22. Stein PD, Gottschalk A. Review of criteria appropriate for a very low probability of pulmonary embolism on ventilation-perfusion lung scans: A position paper. Radiographics. 2000;20:99–105
  23. Gottschalk A, Stein PD, Sostman HD, et al. Very low probability interpretation of ventilation-perfusion lung scans in combination with low probability clinical assessment reliably excludes pulmonary embolism: Data from PIOPED II. J Nucl Med. 2007;48:1411–1415
  24. Goodman LR, Stein PD, Matta F, et al. CT Venography and compression sonography are diagnostically equivalent: Data from PIOPED II. Am J Roentgenol. 2007;189:1071–1076
  25. Stein PD, Athanasoulis C, Alavi A, et al. Complications and validity of pulmonary angiography in acute pulmonary embolism. Circulation. 1992;85:462–468
  26. Stein PD, Fowler SE, Goodman LR, et al. PIOPED II Investigators Multidetector computed tomography for acute pulmonary embolism. N Eng J Med. 2006;354:2317–2327
  27. The PIOPED Investigators. Value of the ventilation/ perfusion scan in acute pulmonary embolism: Results of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED). J Am Med Assoc. 1990;263:2753–2759
  28. Bossuyt PM, Reitsma JB, Bruns DE, et al. The STARD statement for reporting studies of diagnostic accuracy: Explanation and elaboration. Ann Intern Med. 2003;138:W1–W12
  29. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. Ann Intern Med. 2003;138:40–44
  30. Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design related bias in studies of diagnostic tests. J Am Med Assoc. 1999;282:1061–1066
  31. Dotter CT. Acquired abnormalities of the pulmonary arteries. In:  Abrams HL editors. Angiography. (ed 3). Boston: Little Brown; 1983;p. 743–761
  32. Berthezene Y, Croisille P, Wiart M, et al. Prospective comparison of MR lung perfusion and lung scintigraphy. J Magn Reson Imaging. 1999;9:61–68
  33. Stein PD, O'Connor JF, Dalen JE, et al. The angiographic diagnosis of acute pulmonary embolism: evaluation of criteria. Am Heart J. 1967;73:730–741
  34. Roberts DA, Rizi RR, Lipson DA, et al. Dynamic observation of pulmonary perfusion using continuous arterial spin labeling in a pig model. J Magn Reson Imaging. 2001;14:175–180
  35. Levin DL, Chen Q, Zhang M, et al. Evaluation of regional pulmonary perfusion using ultrafast magnetic resonance imaging. Magn Reson Med. 2001;46:166–171
  36. Mai VM, Chen Q, Bankier AA, et al. Effect of lung inflation on arterial spin labeling signal in MR perfusion imaging of human lung. J Magn Reson Imaging. 2001;13:954–959
  37. Amundsen T, Kvaerness J, Jones RA, et al. Pulmonary embolism: detection with MR perfusion imaging of lung: a feasibility study. Radiology. 1997;203:181–185
  38. Zheng J, Leawoods JC, Nolte M, et al. Combined MR proton lung perfusion/angiography and helium ventilation: potential for detecting pulmonary emboli and ventilation defects. Magn Reson Med. 2002;47:433–438
  39. Swan JS, Carroll TJ, Kennell TW, et al. Time-resolved three-dimensional contrast-enhanced MR angiography of the peripheral vessels. Radiology. 2002;225:43–52
  40. Carr JC, Laub G, Zheng J, et al. Time-resolved three-dimensional pulmonary MR angiography and perfusion imaging with ultrashort repetition time. Acad Radiol. 2002;9:1407–1418
  41. Loud PA, Katz DS, Klippenstein DL, et al. Combined CT venography and pulmonary angiography in suspected thromboembolic disease: Diagnostic accuracy for deep venous evaluation. AJR Am J Roentgenol. 2000;174:61–65
  42. Cham MD, Yankelevitz DF, Shaham D, et al. Pulmonary Angiography-Indirect CT Venography Cooperative Group Deep venous thrombosis: Detection by using indirect CT venography. Radiology. 2002;216:744–751
  43. Brink JA, Woodard PK, Horesh L, et al. Depiction of pulmonary emboli with spiral CT: Optimization of display window settings in a porcine model. Radiology. 1997;204:703–708
  44. Remy-Jardin M, Remy J, Cauvain O, et al. Diagnosis of central PE with helical CT: Role of two-dimensional multiplanar reformations. AJR Am J Roentgenol. 1995;165:1131–1138
  45. Stein PD, Hull RD, Patel KC, et al. D-dimer for the exclusion of acute deep venous thrombosis and pulmonary embolism: A systematic review. Ann Intern Med. 2004;140:589–602
  46. Gottschalk A, Stein PD, Goodman LR, et al. Overview of Prospective Investigation of Pulmonary Embolism Diagnosis II. Semin Nucl Med. 2002;32:173–182
  47. Gottschalk A, Sostman HD, Coleman RE, et al. Ventilation-perfusion scintigraphy in the PIOPED study (Part II: Evaluation of the scintigraphic criteria and interpretations). J Nucl Med. 1993;34:1119–1126

 Supported by grants from the U.S. Department of Health and Human Services, Public Health Services, National Heart, Lung, and Blood Institute, Bethesda, Maryland: HL081593, HL177150, HL077149, HL077151, HL077154, HL081594, HL077358, HL077155, and HL077153.

PII: S0001-2998(08)00080-9

doi: 10.1053/j.semnuclmed.2008.06.003

Seminars in Nuclear Medicine
Volume 38, Issue 6 , Pages 462-470 , November 2008