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J Clin Apher. 2019 Oct;34(5):528-536. doi: 10.1002/jca.21706. Epub 2019 Apr 5.

Adverse events during apheresis: A 10-year experience at a tertiary academic medical center.

Author information

1
Department of Pathology, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
2
Department of Pathology, Division of Transfusion Medicine, Case Western Reserve University School of Medicine, Cleveland, OH.

Abstract

BACKGROUND:

Apheresis can be associated with adverse events (AEs). Available studies published on apheresis-associated AEs lack uniformity of data. Unfortunately, there is no common database in the United States (US) to report apheresis-associated AEs. We evaluated our institutional incidence of apheresis-associated AEs and compared it with published literature.

STUDY DESIGN AND METHODS:

We conducted a 10-year retrospective study of apheresis procedures and associated AEs at our facility, a tertiary academic medical center, from 2007 to 2016. Concurrently, a literature search was conducted on AEs associated with apheresis procedures. Twenty-eight studies including data from US and other countries' facilities were analyzed.

RESULTS:

The overall AE incidence was 6.9% (396/5684 procedures). Frequency of AEs associated with therapeutic plasma exchange (TPE) was higher (8.5%, P < .0001) compared to other apheresis procedures. Significant correlation between number of TPE and AEs (Spearman rho [rs ] = 0.7, P = .002) was encountered. Furthermore, there was a significant decrease over time of moderate and severe AEs (rs  = -0.64, P = .04 and rs  = -0.83, P = .003 respectively). Comparison of our institutional AEs (6.9%) to data from other countries (9.8%) and US (22.6%) indicated a significant difference (P < .0001).

CONCLUSION:

Overall our incidence of AEs was significantly lower than current published literature. Incidence of AEs published in other countries is significantly lower than US rates. Differences in incidence of AEs emphasize need for uniform reporting and stratification of AEs and development of a common database to report AEs. Therefore, we propose a grading rationale in order to standardize reporting of AEs.

KEYWORDS:

adverse events; apheresis; complications; hematopoietic stem cell collection; red cell exchange; therapeutic plasma exchange

PMID:
30951224
DOI:
10.1002/jca.21706

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