Warren Clements, Matthew Lukies, Adil Zia, Mark Fitzgerald, Helen Kavnoudias
{"title":"让我们来解决争议--海绵是一种安全的血管内栓塞剂。","authors":"Warren Clements, Matthew Lukies, Adil Zia, Mark Fitzgerald, Helen Kavnoudias","doi":"10.1093/bjr/tqae047","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>A 2021 safety alert restricted endovascular gelfoam use in Australia and resulted in an embargo on gelfoam sales to Interventional Radiology departments. This study aimed to show that gelfoam is safe in a population of trauma patients with pelvic injury, and discuss the basis of the recent controversies.</p><p><strong>Methods: </strong>Retrospective cohort study was conducted between 1 January 2010 and 21 May 2021 for the patients who underwent gelfoam embolization for pelvic arterial haemorrhage. Primary outcome was the rate of adverse events related to intravascular gelfoam administration.</p><p><strong>Results: </strong>Inclusion criteria met in 50 patients, comprising 58% males median age 59.9 years, and median injury severity score 31. There were 0 complications related to gelfoam use and 100% technical success. Thirty-five patients (70%) received a non-targeted embolization approach. All-cause mortality was observed in 5 patients (10%), unrelated to gelfoam.</p><p><strong>Conclusions: </strong>Gelfoam is a safe and effective embolic agent in pelvic trauma. Patients are in urgent need of universal on-label registration of endovascular gelfoam products, as it is life-saving in major haemorrhage after trauma.</p><p><strong>Advances in knowledge: </strong>Endovascular gelfoam is mandatory for a high-quality trauma service, and this study shows that it is safe to use intentionally in the endovascular space. Companies should work with interventional radiologists, sharing and collaborating to ensure positive outcomes for patients.</p>","PeriodicalId":9306,"journal":{"name":"British Journal of Radiology","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11075981/pdf/","citationCount":"0","resultStr":"{\"title\":\"Let us settle the controversy-gelfoam is a safe intravascular embolic agent.\",\"authors\":\"Warren Clements, Matthew Lukies, Adil Zia, Mark Fitzgerald, Helen Kavnoudias\",\"doi\":\"10.1093/bjr/tqae047\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>A 2021 safety alert restricted endovascular gelfoam use in Australia and resulted in an embargo on gelfoam sales to Interventional Radiology departments. This study aimed to show that gelfoam is safe in a population of trauma patients with pelvic injury, and discuss the basis of the recent controversies.</p><p><strong>Methods: </strong>Retrospective cohort study was conducted between 1 January 2010 and 21 May 2021 for the patients who underwent gelfoam embolization for pelvic arterial haemorrhage. Primary outcome was the rate of adverse events related to intravascular gelfoam administration.</p><p><strong>Results: </strong>Inclusion criteria met in 50 patients, comprising 58% males median age 59.9 years, and median injury severity score 31. There were 0 complications related to gelfoam use and 100% technical success. Thirty-five patients (70%) received a non-targeted embolization approach. All-cause mortality was observed in 5 patients (10%), unrelated to gelfoam.</p><p><strong>Conclusions: </strong>Gelfoam is a safe and effective embolic agent in pelvic trauma. Patients are in urgent need of universal on-label registration of endovascular gelfoam products, as it is life-saving in major haemorrhage after trauma.</p><p><strong>Advances in knowledge: </strong>Endovascular gelfoam is mandatory for a high-quality trauma service, and this study shows that it is safe to use intentionally in the endovascular space. Companies should work with interventional radiologists, sharing and collaborating to ensure positive outcomes for patients.</p>\",\"PeriodicalId\":9306,\"journal\":{\"name\":\"British Journal of Radiology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-05-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11075981/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British Journal of Radiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjr/tqae047\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjr/tqae047","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
Let us settle the controversy-gelfoam is a safe intravascular embolic agent.
Objectives: A 2021 safety alert restricted endovascular gelfoam use in Australia and resulted in an embargo on gelfoam sales to Interventional Radiology departments. This study aimed to show that gelfoam is safe in a population of trauma patients with pelvic injury, and discuss the basis of the recent controversies.
Methods: Retrospective cohort study was conducted between 1 January 2010 and 21 May 2021 for the patients who underwent gelfoam embolization for pelvic arterial haemorrhage. Primary outcome was the rate of adverse events related to intravascular gelfoam administration.
Results: Inclusion criteria met in 50 patients, comprising 58% males median age 59.9 years, and median injury severity score 31. There were 0 complications related to gelfoam use and 100% technical success. Thirty-five patients (70%) received a non-targeted embolization approach. All-cause mortality was observed in 5 patients (10%), unrelated to gelfoam.
Conclusions: Gelfoam is a safe and effective embolic agent in pelvic trauma. Patients are in urgent need of universal on-label registration of endovascular gelfoam products, as it is life-saving in major haemorrhage after trauma.
Advances in knowledge: Endovascular gelfoam is mandatory for a high-quality trauma service, and this study shows that it is safe to use intentionally in the endovascular space. Companies should work with interventional radiologists, sharing and collaborating to ensure positive outcomes for patients.
期刊介绍:
BJR is the international research journal of the British Institute of Radiology and is the oldest scientific journal in the field of radiology and related sciences.
Dating back to 1896, BJR’s history is radiology’s history, and the journal has featured some landmark papers such as the first description of Computed Tomography "Computerized transverse axial tomography" by Godfrey Hounsfield in 1973. A valuable historical resource, the complete BJR archive has been digitized from 1896.
Quick Facts:
- 2015 Impact Factor – 1.840
- Receipt to first decision – average of 6 weeks
- Acceptance to online publication – average of 3 weeks
- ISSN: 0007-1285
- eISSN: 1748-880X
Open Access option