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Gadolinium-Enhanced Magnetic Resonance Angiography for Pulmonary Embolism: A Multicenter Prospective Study (PIOPED III)

Paul D. Stein, MD; Thomas L. Chenevert, PhD; Sarah E. Fowler, PhD; Lawrence R. Goodman, MD; Alexander Gottschalk, MD; Charles A. Hales, MD; Russell D. Hull, MBBS, MSc; Kathleen A. Jablonski, PhD; Kenneth V. Leeper Jr., MD; David P. Naidich, MD; Daniel J. Sak, DO; H. Dirk Sostman, MD; Victor F. Tapson, MD; John G. Weg, MD; Pamela K. Woodard, MD, PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators
[+] Article and Author Information

For a list of the PIOPED III investigators, see the Appendix.


From Michigan State University College of Osteopathic Medicine and Michigan State University, East Lansing, St. Joseph-Mercy Oakland Hospital, Pontiac, and University of Michigan, Ann Arbor, Michigan; George Washington University, Rockville, Maryland; Medical College of Wisconsin, Milwaukee, Wisconsin; Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; University of Calgary, Calgary, Alberta, Canada; Emory University, Atlanta, Georgia; New York University Medical Center, New York, New York; Weill Cornell Medical College and Methodist Hospital, Houston, Texas; Duke University, Durham, North Carolina; and Washington University of St. Louis, St. Louis, Missouri.


Grant Support: By the U.S. Department of Health and Human Service, Public Health Service, National Heart, Lung, and Blood Institute (NHLBI), Bethesda, Maryland (grants HL081593, HL177150, HL077149, HL077151, HL077154, HL081594, HL077358, HL077155, and HL077153).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-1652.

Reproducible Research Statement:Study protocol and data set: Will be released to the NHLBI in May 2010. Interested parties should contact the NHLBI (www.nhlbi.nih.gov/resources/deca/directry.htm) after this date to obtain copies. Statistical code: Not available.

Requests for Single Reprints: Paul D. Stein, MD, Michigan State University, College of Osteopathic Medicine, Department of Internal Medicine, Michigan State University Venous Thromboembolism Research Unit, St. Joseph-Mercy Oakland Hospital, 44405 Woodward Avenue, Pontiac, MI 48341-5023; e-mail, steinp@trinity-health.org.

Current Author Addresses: Dr. Stein: Michigan State University, College of Osteopathic Medicine, Department of Internal Medicine, Michigan State University Venous Thromboembolism Research Unit, St. Joseph-Mercy Oakland Hospital, 44405 Woodward Avenue, Pontiac, MI 48341-5023.

Dr. Chenevert: University of Michigan Health System, Department of Radiology–MRI, 1500 East Medical Center Drive, Room UH B2A209, Ann Arbor, MI 48109-0030.

Drs. Fowler and Jablonski: Biostatistics Center, George Washington University, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852.

Dr. Goodman: 9200 Wisconsin Avenue, Milwaukee, WI 53226-3596.

Dr. Gottschalk: Michigan State University, 184 Radiology Building, East Lansing, MI 48824-1303.

Dr. Hales: Pulmonary and Critical Care Department, Bulfinch 148, 55 Fruit Street, Boston, MA 02114.

Dr. Hull: Thrombosis Research Unit, Foothills Hospital, 601 South Tower, 1403-29 Street Northwest, Calgary, Alberta T2N 2T9, Canada.

Dr. Leeper: Pulmonary and Critical Care Medicine, 550 Peachtree Street, Suite 5350, Atlanta, GA 30308.

Dr. Naidich: Department of Radiology, New York University Medical Center, 560 First Avenue, New York, NY 10016.

Dr. Sak: St. Joseph-Mercy Oakland Hospital, 44405 Woodward Avenue, Suite 402, Pontiac, MI 48341-5023.

Dr. Sostman: The Methodist Hospital, 6565 Fannin Street, Houston, TX 77030.

Dr. Tapson: Pulmonary and Critical Care Medicine, Duke School of Medicine, 351 Bell Building, Erwin Road, Durham, NC 27710.

Dr. Weg: University of Michigan Medical Center, 1500 East Medical Center Drive, Level B-1, H245-A, Ann Arbor, MI 48109-0329.

Dr. Woodard: Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 South Kingshighway Boulevard, St. Louis, MO 63110.

Author Contributions: Conception and design: P.D. Stein, S.E. Fowler, L.R. Goodman, A. Gottschalk, C.A. Hales, R.D. Hull, K.A. Jablonski, H.D. Sostman, V.F. Tapson, J.G. Weg, P.K. Woodard.

Analysis and interpretation of the data: P.D. Stein, S.E. Fowler, L.R. Goodman, A. Gottschalk, C.A. Hales, R.D. Hull, K.A. Jablonski, K.V. Leeper, D.P. Naidich, D.J. Sak, H.D. Sostman, V.F. Tapson, J.G. Weg, P.K. Woodard.

Drafting of the article: P.D. Stein, T.L. Chenevert, S.E. Fowler, C.A. Hales, R.D. Hull, K.A. Jablonski, H.D. Sostman, J.G. Weg, P.K. Woodard.

Critical revision of the article for important intellectual content: P.D. Stein, T.L. Chenevert, S.E. Fowler, L.R. Goodman, A. Gottschalk, C.A. Hales, R.D. Hull, K.A. Jablonski, K.V. Leeper, H.D. Sostman, V.F. Tapson, J.G. Weg, P.K. Woodard.

Final approval of the article: P.D. Stein, S.E. Fowler, L.R. Goodman, A. Gottschalk, C.A. Hales, R.D. Hull, K.A. Jablonski, K.V. Leeper, D.P. Naidich, D.J. Sak, H.D. Sostman, V.F. Tapson, J.G. Weg, P.K. Woodard.

Provision of study materials or patients: C.A. Hales, R.D. Hull, K.V. Leeper, D.P. Naidich, J.G. Weg, P.K. Woodard.

Statistical expertise: S.E. Fowler, R.D. Hull, K.A. Jablonski, H.D. Sostman.

Obtaining of funding: P.D. Stein, C.A. Hales, R.D. Hull, J.G. Weg, P.K. Woodard.

Administrative, technical, or logistic support: P.D. Stein, T.L. Chenevert, R.D. Hull, K.A. Jablonski.

Collection and assembly of data: P.D. Stein, T.L. Chenevert, S.E. Fowler, C.A. Hales, R.D. Hull, K.A. Jablonski, K.V. Leeper, D.P. Naidich, D.J. Sak, J.G. Weg, P.K. Woodard.


Ann Intern Med. 2010;152(7):434-443. doi:10.7326/0003-4819-152-7-201004060-00008
Text Size: A A A

Background: The accuracy of gadolinium-enhanced magnetic resonance pulmonary angiography and magnetic resonance venography for diagnosing pulmonary embolism has not been determined conclusively.

Objective: To investigate performance characteristics of magnetic resonance angiography, with or without magnetic resonance venography, for diagnosing pulmonary embolism.

Design: Prospective, multicenter study from 10 April 2006 to 30 September 2008. (ClinicalTrials.gov registration number: NCT00241826)

Setting: 7 hospitals and their emergency services.

Patients: 371 adults with diagnosed or excluded pulmonary embolism.

Measurements: Sensitivity, specificity, and likelihood ratios were measured by comparing independently read magnetic resonance imaging with the reference standard for diagnosing pulmonary embolism. Reference standard diagnosis or exclusion was made by using various tests, including computed tomographic angiography and venography, ventilation–perfusion lung scan, venous ultrasonography, d-dimer assay, and clinical assessment.

Results: Magnetic resonance angiography, averaged across centers, was technically inadequate in 25% of patients (92 of 371). The proportion of technically inadequate images ranged from 11% to 52% at various centers. Including patients with technically inadequate images, magnetic resonance angiography identified 57% (59 of 104) with pulmonary embolism. Technically adequate magnetic resonance angiography had a sensitivity of 78% and a specificity of 99%. Technically adequate magnetic resonance angiography and venography had a sensitivity of 92% and a specificity of 96%, but 52% of patients (194 of 370) had technically inadequate results.

Limitation: A high proportion of patients with suspected embolism was not eligible or declined to participate.

Conclusion: Magnetic resonance pulmonary angiography should be considered only at centers that routinely perform it well and only for patients for whom standard tests are contraindicated. Magnetic resonance pulmonary angiography and magnetic resonance venography combined have a higher sensitivity than magnetic resonance pulmonary angiography alone in patients with technically adequate images, but it is more difficult to obtain technically adequate images with the 2 procedures.

Primary Funding Source: National Heart, Lung, and Blood Institute.

Figures

Grahic Jump Location
Figure.
Study flow diagram.

MRA = magnetic resonance angiography; PE = pulmonary embolism; PIOPED III = Prospective Investigation of Pulmonary Embolism Diagnosis III.

* Exclusion criteria (number of patients): age <18 y (23), no suspected PE (23), no consent from medical team (438), no PIOPED III informed consent (829), could not complete MRA in ≤72 h (315), could not confirm not pregnant (171), contraindications to gadolinium MRA or magnetic resonance venography (2047), critically ill (1657), glomerular filtration rate <60 mL/min per 1.73 m2 (2922), receiving renal dialysis (418), hemodynamically unstable (552), shock or hypotension (167), receiving ventilatory support (779), ventricular fibrillation or tachycardia (90), received gadolinium in past 3 mo (693), expected to receive gadolinium within 3 mo (176), history of allergy to contrast agent (337), myocardial infarction in past month (437), current symptomatic asthma (184), pregnant (97), nursing mother (103), previously enrolled in PIOPED III (14), prisoner (17), mentally handicapped (262), institutionalized (179), could not give informed consent (1022), evidence of acute renal failure (771), not assessed (2368).

Grahic Jump Location

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Summary for Patients

Diagnosis of Pulmonary Embolism With Magnetic Resonance Angiography

The summary below is from the full report titled “Gadolinium-Enhanced Magnetic Resonance Angiography for Pulmonary Embolism. A Multicenter Prospective Study (PIOPED III).” It is in the 6 April 2010 issue of Annals of Internal Medicine (volume 152, pages 434-443). The authors are P.D. Stein, T.L. Chenevert, S.E. Fowler, L.R. Goodman, A. Gottschalk, C.A. Hales, R.D. Hull, K.A. Jablonski, K.V. Leeper Jr., D.P. Naidich, D.J. Sak, H.D. Sostman, V.F. Tapson, J.G. Weg, and P.K. Woodard, for the PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators.

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