Real-World Safety Data From the World Apheresis Association Registry for the Spectra Optia Apheresis System

In this study we analyzed 12 years of adverse events, (AE) data from the World Apheresis Association, (WAA) Registry specific to the Spectra Optia Apheresis System. We queried WAA Registry data, (2012-2023) on apheresis procedures performed exclusively on the Spectra Optia Apheresis System. We categorized AEs by severity, (mild, moderate, and severe), and ordered them by year. We then analyzed and presented AEs associated with the following variables: diagnosis, procedure type, vascular access, and replacement fluid type, and causes of procedural interruption. We identified 51 567 apheresis procedures specific to the Spectra Optia Apheresis System within the data set. AE rates from 2012 to 2023 for mild, moderate, and severe were 1.43%, 2.81%, and 0.21%, respectively. Procedures associated with the lowest AE rates include red blood cell exchange and therapeutic plasma exchange. The most common mild and moderate AEs include tingling and hypotension and AEs related to vascular access. The highest rates of mild and moderate AEs were associated with cellular collections. The highest rate of severe AEs was associated with the use of 3.5% albumin as replacement fluid. Other variables impacting patient safety are identified. AE rates could not be compared to the median length of procedure since this time variable is not currently collected in the Registry. This is the first device-specific analysis of the WAA Registry data, bringing prior safety reporting into even sharper focus. Device-specific safety analysis like this will help practitioners better understand potential safety concerns associated with a commonly used apheresis device, including various separation modalities and accessories, thus supporting improved procedure management.