Transfusion-related acute lung injury and potential risk factors among the inpatient US elderly as recorded in Medicare claims data, during 2007 through 2011
Corresponding Author
Mikhail Menis
Food and Drug Administration, Rockville, Maryland
Address reprint requests to: Mikhail Menis, PharmD, MS, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, 1401 Rockville Pike, HFM-225, Rockville, MD 20852; e-mail: [email protected].Search for more papers by this authorSteven A. Anderson
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorRichard A. Forshee
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorPaul D. Mintz
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorLeslie Holness
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorChristopher M. Worrall
Centers for Medicare & Medicaid Services, Baltimore, Maryland
Search for more papers by this authorJeffrey A. Kelman
Centers for Medicare & Medicaid Services, Baltimore, Maryland
Search for more papers by this authorHector S. Izurieta
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorCorresponding Author
Mikhail Menis
Food and Drug Administration, Rockville, Maryland
Address reprint requests to: Mikhail Menis, PharmD, MS, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, 1401 Rockville Pike, HFM-225, Rockville, MD 20852; e-mail: [email protected].Search for more papers by this authorSteven A. Anderson
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorRichard A. Forshee
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorPaul D. Mintz
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorLeslie Holness
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorChristopher M. Worrall
Centers for Medicare & Medicaid Services, Baltimore, Maryland
Search for more papers by this authorJeffrey A. Kelman
Centers for Medicare & Medicaid Services, Baltimore, Maryland
Search for more papers by this authorHector S. Izurieta
Food and Drug Administration, Rockville, Maryland
Search for more papers by this authorAbstract
Background
Transfusion-related acute lung injury (TRALI) is a serious complication leading to pulmonary edema and respiratory failure. This study's objective was to assess TRALI occurrence and potential risk factors among inpatient US elderly Medicare beneficiaries, ages 65 and older, during 2007 through 2011.
Study Design and Methods
This retrospective claims-based study utilized large Medicare administrative databases. Transfusions were identified by recorded procedure and revenue center codes. TRALI was ascertained via ICD-9-CM diagnosis code. The study evaluated TRALI rates among the inpatient elderly overall and by calendar year, age, sex, race, blood components, and units transfused. Logistic regression analyses were used to assess potential risk factors.
Results
Of 11,378,264 inpatient transfusion stays for elderly Medicare beneficiaries, 2556 had a recorded TRALI diagnosis code, an overall rate of 22.46 per 100,000 stays. TRALI rates were higher for platelet (PLT)- and plasma-containing transfusions and increased by year and number of units transfused (p < 0.0001). Significantly higher odds of TRALI were also found for persons ages 65 to 79 years versus more than 79 years (OR, 1.19; 95% confidence interval CI, 1.09-1.29), females versus males (OR, 1.26; 95% CI, 1.16-1.38), white versus nonwhite (OR, 1.43; 95% CI, 1.27-1.66), and with 6-month histories of postinflammatory pulmonary fibrosis (OR, 1.89; 95% CI, 1.52-2.20), tobacco use (OR, 1.16; 95% CI, 1.00-1.26), and other diseases.
Conclusion
Our study among the elderly suggests TRALI to be a severe event and identifies a substantially increased TRALI occurrence with greater number of units and with PLT- or plasma-containing transfusions. The study also suggests importance of underlying health conditions, prior recipient alloimmunization, and nonimmune mechanism in TRALI development among the elderly.
Supporting Information
| Filename | Description |
|---|---|
| trf12626-sup-0001-si.doc714.5 KB | Fig. S1. Average number of units per stay by blood components for all transfusion stays vs. TRALI transfusion stays during 2007-2011. Fig. S2. Adjusted odds of TRALI by age, while controlling for covariates in the final regression model, among elderly Medicare beneficiaries during 2007-2011. Fig. S3. Adjusted odds of TRALI by number of units transfused, while controlling for covariates in the final regression model, among elderly Medicare beneficiaries during 2007-2011. Fig. S4. The overall sensitivity multivariate regression analysis, with age treated as continuous variable, to assess TRALI occurrence among inpatient elderly during 2007-2011. Fig. S5. The overall sensitivity multivariate regression analysis which assesses the effects of 6-month histories of transfusion, transplant, and mechanical ventilation on TRALI occurrence among inpatient elderly during 2007-2011. |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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