Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee.

PURPOSE: To develop a new adverse event (AE) classification for the interventional radiology (IR) procedures and evaluate its clinical, research, and educational value compared with the existing Society of Interventional Radiology (SIR) classification via an SIR member survey. MATERIALS AND METHODS: A new AE classification was developed by members of the Standards of Practice Committee of the SIR. Subsequently, a survey was created by a group of 18 members from the SIR Standards of Practice Committee and Service Lines. Twelve clinical AE case scenarios were generated that encompassed a broad spectrum of IR procedures and potential AEs. Survey questions were designed to evaluate the following domains: educational and research values, accountability for intraprocedural challenges, consistency of AE reporting, unambiguity, and potential for incorporation into existing quality-assurance framework. For each AE scenario, the survey participants were instructed to answer questions about the proposed and existing SIR classifications. SIR members were invited via online survey links, and 68 members participated among 140 surveyed. Answers on new and existing classifications were evaluated and compared statistically. Overall comparison between the two surveys was performed by generalized linear modeling. RESULTS: The proposed AE classification received superior evaluations in terms of consistency of reporting (P < .05) and potential for incorporation into existing quality-assurance framework (P < .05). Respondents gave a higher overall rating to the educational and research value of the new compared with the existing classification (P < .05). CONCLUSIONS: This study proposed an AE classification system that outperformed the existing SIR classification in the studied domains.

Safety of percutaneous tunneled hemodialysis catheter procedures in patients receiving concurrent clopidogrel therapy.

PURPOSE: Patients on clopidogrel are at increased risk of bleeding. This study was commenced to assess the incidence of bleeding in dialysis patients who underwent tunneled hemodialysis catheter procedures while on clopidogrel therapy. METHODS: This is a single center retrospective study of 25 (10 men, 15 women; median age 70) dialysis patients in whom clopidogrel could not be discontinued and underwent tunneled hemodialysis catheter insertion, removal or exchange between the period March 2010 to November 2011. The medical records of patients were reviewed and complications were classified according to the Society of Interventional Radiology system. Fifty-three procedures (22 insertions, 11 exchanges and 20 removals) were performed in these patients. The pre-procedural median platelet count, International Normalized Ratio and partial thromboplastin time were 195×103/dL (range 50-666), 1.1 (range 0.9-3.3) and 26.3 seconds (range 22.5-69.8) respectively. RESULTS AND CONCLUSIONS: Forty-six procedures were performed in patients on clopidogrel and aspirin treatment. Five procedures were performed in patients while on clopidogrel in combination with aspirin and warfarin, and two procedures were performed with patients on clopidogrel alone. There were no documented bleeding complications from tunneled hemodialysis catheter procedures performed in patients on concurrent clopidogrel therapy in our study. Further prospective assessment with a larger cohort is necessary in order to validate these findings.