Mark L. Schiebler1, Michael D. Repplinger2, Christopher Lindholm3, John Harringa2, Christopher J. François1, Karl K. Vigen1, Azita G. Hamedani2, Thomas M. Grist1,4,5, Scott B. Reeder1,2,4,6, and Scott K. Nagle1,5,7
1Radiology, UW-Madison, Madison, WI, United States, 2Emergency Medicine, UW-Madison, Madison, WI, United States, 3UW Madison School of Medicine, UW-Madison, Madison, WI, United States, 4Biomedical Engineering, UW-Madison, Madison, WI, United States, 5Medical Physics, UW-Madison, Madison, WI, United States, 6Medicine, UW-Madison, Madison, WI, United States, 7Pediatrics, UW-Madison, Madison, WI, United States
Synopsis
The
aim of this study was to determine the effectiveness of pulmonary magnetic
resonance angiography (PE-MRA) for the primary diagnosis of pulmonary embolism
(PE). We retrospectively reviewed the electronic medical records of 675 consecutive
patients who underwent PE-MRA. Adverse events (venous thromboembolism (VTE), bleeding or death) that were potentially related either to over or
under treatment of PE during the subsequent 6 months were extracted from the electronic
medical record. The negative predictive value for this test was found to be 97%.
Based upon these outcomes, PE-MRA performs similarly to CTA as a primary
test to exclude clinically significant pulmonary embolism in patients
presenting acutely with dyspnea.Purpose
The aim of our study was to determine the six-month
adverse event rate following the use of pulmonary magnetic resonance
angiography (PE-MRA) for the primary diagnosis of pulmonary embolism (PE).
Methods
This was a retrospective HIPAA-compliant, IRB-approved
study. We reviewed the electronic medical records (EMR) of all patients who
underwent PE-MRA scans performed between 4/1/2008-3/31/2013 as a first line
diagnostic test for PE. These exams all used a previously described method.(Ref 1,
2) We excluded patients with current anti-coagulation, pre-existing IVC
filter, or atrial fibrillation. The final radiology report was used to
determine if the exam was technically limited, based upon inclusion of the word
“limited” or a recommendation for additional imaging to rule out PE. If
technically successful, the exam was categorized as positive, negative, or equivocal,
again based upon the final report. Using the standard definitions of major adverse
events derived from the pulmonary computed tomographic angiography (CTA) literature (Ref 3,4), we reviewed the
EMR and recorded the following adverse events: venous thromboembolism (VTE),
major bleeding and all-cause mortality that occurred within 6 months following
the index PE-MRA exam.
Results
A total of 675 patients underwent PE-MRAs during the
inclusion period (Figure 1). Of these, 56/675 (8.3%) were excluded and 2/675 (0.3%) had
incomplete EMR reviews. This resulted in 617/675 (91.4%) being included in the
analysis (Figure 1). Of the included cases, 500/617 (81%) were negative for PE,
17/617 (2.8%) were equivocal, 46/617 (7.5%) were positive for PE (Figure 2), and 54/617
(8.8%) were technically limited. Overall, the major adverse event rate
following a technically successful PE-MRA was 32/563 (5.7%). Outcomes broken
down by subgroup based on the results of the PE-MRA are reported in Table 1.
Following a negative PE-MRA scan, only 3/500 (0.6%) experienced a VTE within 6
months. When all-cause mortality is
included, only 15/500 (3%) patients experienced an adverse event that possibly could
have been related to a false negative test – a 97% negative predictive value
(NPV). Following a positive PE-MRA exam, 2/46 (4.3%) patients experienced a
major bleeding event and 4/46 (8.7%) experienced
adverse events that may have been related to anti-coagulation for treatment of
PE.
Discussion
The 6-month major adverse event rate following PE-MRA
observed in this study was slightly greater than the reported 3-month adverse
event rate following CTA (~3% for those with positive CTA) ( Ref 3) ; ~1.7%
for those with negative CTA (Ref 4). The inclusion of all-cause mortality
as an adverse event likely overstates the risk of adverse events related to PE.
Notably, only 8.8% of the analyzed exams
were reported as technically limited in some way. This is far lower than the 25%
uninterpretable technical failure rate reported in the PIOPED III study (Ref 5).
This improvement in technical success likely reflects the maturation of PE-MRA
methodology since the time of the PIOPED III scans nearly a decade ago
(2006-2008). Limitations of this retrospective outcomes analysis include: (1)
Potential selection bias related to ED physician ordering preferences for younger and female patients; (2) 8.8%
of analyzed exams were reported to be limited within the
radiology report, which is higher than a previously reported technical failure rate of 2.6%,
( Ref 2) which is likely due to
the more conservative criteria used in the present study; and (3) Incomplete
data regarding the cause of patient deaths.
Conclusion
Using a very conservative outcome metric that includes
all-cause mortality and all interval VTE events observed within 6 months of a
negative PE-MRA, we found that the NPV of PE-MRA was 97%. This value compares favorably
to the reported NPV of CTA (98%) for this indication. These clinical outcomes demonstrate that pulmonary magnetic resonance angiography is a safe non-ionizing alternative to computed tomographic angiography for the primary
diagnosis of pulmonary embolism.
Disclosure
The use of Gadolinium based contrast material for pulmonary magnetic resonance angiography is an off label use of these agents.
Acknowledgements
The authors wish to
thank GE Healthcare, Bracco Diagnostics and the Departmental Research and
Development Fund.References
1. François CJ, et al. JMRI 2013; 37:1290–1300.
2.
Schiebler ML, et al. JMRI 2013, 38: 914-925.
3. Piran S, et al. Thromb Res. 2013,
132:515-9.
4. Donato AA, et al. Arch Intern Med. 2003, 163:2033-8.
5. Sostman HD, et al. Int J Cardiovasc
Imaging. 2011, 28: 303-312.