{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T16:45:01Z","timestamp":1791218701152,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T00:00:00Z","timestamp":1764460800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T00:00:00Z","timestamp":1764460800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Clinical Apheresis"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>In this study we analyzed 12\u2009years 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\u20132023) 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\u2009567 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\u2010specific analysis of the WAA Registry data, bringing prior safety reporting into even sharper focus. Device\u2010specific 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.<\/jats:p>","DOI":"10.1002\/jca.70079","type":"journal-article","created":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T06:00:25Z","timestamp":1764568825000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Real\u2010World Safety Data From the World Apheresis Association Registry for the Spectra Optia Apheresis System"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-0494-6971","authenticated-orcid":false,"given":"Aaron","family":"Haubner","sequence":"first","affiliation":[{"name":"Department of Patient Access Terumo Blood and Cell Technologies  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Mendoza","sequence":"additional","affiliation":[{"name":"Department of Patient Access Terumo Blood and Cell Technologies  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Vrielink","sequence":"additional","affiliation":[{"name":"Unit of Transfusion Medicine of Sanquin Blood Supply Sanquin Blood Supply Foundation in Amsterdam  Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Volker","family":"Witt","sequence":"additional","affiliation":[{"name":"Department for Pediatrics St. Anna Kinderspital, Medical University of Vienna  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dries","family":"Deeren","sequence":"additional","affiliation":[{"name":"AZ Delta  Roeselare Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2985-7847","authenticated-orcid":false,"given":"Ines","family":"Bojanic","sequence":"additional","affiliation":[{"name":"Department of Transfusion Medicine and Transplantation Biology University Hospital Centre Zagreb  Zagreb Croatia"},{"name":"School of Medicine University of Zagreb  Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zdenka","family":"Gasova","sequence":"additional","affiliation":[{"name":"Apheresis Department Institute of Hematology and Blood Transfusion  Prague Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Astrid","family":"Aandahl","sequence":"additional","affiliation":[{"name":"Department of Immunology and Transfusion Medicine Akershus University Hospital  Lorenskog Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanya Nadia","family":"Glatt","sequence":"additional","affiliation":[{"name":"South African National Blood Service  Johannesburg South Africa"},{"name":"Department of Molecular Medicine and Haematology University of Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Maria","family":"Vasilache","sequence":"additional","affiliation":[{"name":"Department of Clinical Immunology and Transfusion Medicine, and Department of Biochemical and Clinical Sciences Linkoping University  Linkoping Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Newman","sequence":"additional","affiliation":[{"name":"Bone Marrow Transplant &amp; Apheresis, Apheresis &amp; Cell Therapies Unit Concord Repatriation General Hospital  Concord Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Strineholm","sequence":"additional","affiliation":[{"name":"Apheresis Center University Hospital  Orebro Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yona","family":"Skosana","sequence":"additional","affiliation":[{"name":"South African National Blood Service  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2694-7035","authenticated-orcid":false,"given":"Bernd","family":"Stegmayr","sequence":"additional","affiliation":[{"name":"Department of Public Health and Clinical Medicine Umea University  Umea Sweden"},{"name":"The Northern Sweden Registry Center, Region Vasterbotten  Umea Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.22043"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.2920010107"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537\u20102995.1999.39399219285.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537\u20102995.1998.381098440858.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.22009"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21629"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.2147\/IJCTM.S104333"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.20143"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21706"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2017.11.027"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102020\u2010138895"},{"issue":"7","key":"e_1_2_10_13_1","first-page":"589","article-title":"World Apheresis Registry\u2010First Data Report. (Abstract 101)","volume":"27","author":"Stegmayr B.","year":"2004","journal-title":"Journal of Artificial Organs"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1159\/000513123"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2023.103831"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102008\u201008\u2010175323"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737175.2022.2147827"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1744\u20109987.2008.00608.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.17392\/1171\u201020"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12288\u2010018\u20100920\u20106"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21802"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.5301\/ijao.2011.6315"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21969"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.4103\/0973\u20106247.53877"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12189"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12948"}],"updated-by":[{"DOI":"10.1002\/jca.70154","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T00:00:00Z","timestamp":1782172800000}}],"container-title":["Journal of Clinical Apheresis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jca.70079","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jca.70079","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jca.70079","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T03:52:41Z","timestamp":1780545161000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jca.70079"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,30]]},"references-count":25,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/jca.70079"],"URL":"https:\/\/doi.org\/10.1002\/jca.70079","archive":["Portico"],"relation":{},"ISSN":["0733-2459","1098-1101"],"issn-type":[{"value":"0733-2459","type":"print"},{"value":"1098-1101","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,30]]},"assertion":[{"value":"2025-02-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70079"}}