FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4360614909> ?p ?o ?g. }

• W4360614909 abstract "<h3>Background and Importance</h3> In 2021, cardiologists reported to the medical-devices-vigilance sector serious incidents in four patients with a first-generation Trifecta™ bioprosthesis that resulted in three aortic valve replacement (AVR) and one death. The question of degeneration of their bioprosthesis arose. <h3>Aim and Objectives</h3> The aim was to evaluate the intrinsic imputability of Trifecta™ for dysfunction in patients implanted and to reassess their referencing in our centre. <h3>Material and Methods</h3> A retrospective, single-centre and observational study of computerised patient records (CPR) was conducted between 02/04/2011, date of our centre’s first implantation, and 12/31/2016 to have 5 years of follow-up per patient. Trifecta™ valves and data related to the implantation were extracted from the traceability software. The collection of echographic and clinical follow-up data was based on the CPR with an extended follow-up period until 03/31/2022. Dysfunctions were classified according to the VARC-3 classification criteria : structural valve deterioration (SVD), non-structural valve dysfonction (NSVD), thrombosis and endocarditis. The study was approved by our local research department. <h3>Results</h3> A total of 382 bioprostheses was implanted in 378 patients, mean age 73.0 years and 60.7% male. Data were missing for 253 bioprostheses and 15 patients died perioperatively. Among the 114 bioprostheses with conclusive data, 50 functionned properly (mean follow-up time of 6.6 years) and 64 presented dysfunctions : 34 SVD, 10 NSVD (8 paravalvular regurgitation, 2 prosthesis-patient mismatches) and 20 endocarditis. AVR occurred for 20 patients following SVD and for 11 patients following endocarditis (4 of whom had a second Trifecta™) within a mean time of 6.7 years and 3.4 years, respectively. <h3>Conclusion and Relevance</h3> The classification of failures according to VARC-3 allowed us to confirm the intrinsic imputability of the Trifecta™ bioprostheses regarding to the number of SVD-type dysfunctions. Although this study has limitations, it shows the understatement of medical-devices-vigilance cases by the medical staff. The 64 files with dysfunstions will be transmitted to the natonal health autority. The patients will be reviewed to complete the data and perform an echographic follow-up. According to the manufacturer, degenerations could be related to the expansion system that was improved in the second-generation Trifecta™ marketed in 2016. Since this study, the Trifecta™ has been removed from the hospital formulary. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest" @default.
• W4360614909 created "2023-03-24" @default.
• W4360614909 creator A5000419041 @default.
• W4360614909 creator A5015155942 @default.
• W4360614909 creator A5031542762 @default.
• W4360614909 creator A5037812280 @default.
• W4360614909 creator A5052056417 @default.
• W4360614909 creator A5077748257 @default.
• W4360614909 date "2023-03-01" @default.
• W4360614909 modified "2023-10-01" @default.
• W4360614909 title "5PSQ-091 Trifecta™ bioprostheses : evaluation of the safety based on the study of degenerations according to the varc-3 classification" @default.
• W4360614909 doi "https://doi.org/10.1136/ejhpharm-2023-eahp.296" @default.
• W4360614909 hasPublicationYear "2023" @default.
• W4360614909 type Work @default.
• W4360614909 citedByCount "0" @default.
• W4360614909 crossrefType "proceedings-article" @default.
• W4360614909 hasAuthorship W4360614909A5000419041 @default.
• W4360614909 hasAuthorship W4360614909A5015155942 @default.
• W4360614909 hasAuthorship W4360614909A5031542762 @default.
• W4360614909 hasAuthorship W4360614909A5037812280 @default.
• W4360614909 hasAuthorship W4360614909A5052056417 @default.
• W4360614909 hasAuthorship W4360614909A5077748257 @default.
• W4360614909 hasBestOaLocation W43606149091 @default.
• W4360614909 hasConcept C126322002 @default.
• W4360614909 hasConcept C141071460 @default.
• W4360614909 hasConcept C164705383 @default.
• W4360614909 hasConcept C167135981 @default.
• W4360614909 hasConcept C195910791 @default.
• W4360614909 hasConcept C2775872228 @default.
• W4360614909 hasConcept C2778715743 @default.
• W4360614909 hasConcept C2909389395 @default.
• W4360614909 hasConcept C71924100 @default.
• W4360614909 hasConceptScore W4360614909C126322002 @default.
• W4360614909 hasConceptScore W4360614909C141071460 @default.
• W4360614909 hasConceptScore W4360614909C164705383 @default.
• W4360614909 hasConceptScore W4360614909C167135981 @default.
• W4360614909 hasConceptScore W4360614909C195910791 @default.
• W4360614909 hasConceptScore W4360614909C2775872228 @default.
• W4360614909 hasConceptScore W4360614909C2778715743 @default.
• W4360614909 hasConceptScore W4360614909C2909389395 @default.
• W4360614909 hasConceptScore W4360614909C71924100 @default.
• W4360614909 hasLocation W43606149091 @default.
• W4360614909 hasOpenAccess W4360614909 @default.
• W4360614909 hasPrimaryLocation W43606149091 @default.
• W4360614909 hasRelatedWork W1558981724 @default.
• W4360614909 hasRelatedWork W16989796 @default.
• W4360614909 hasRelatedWork W1981513813 @default.
• W4360614909 hasRelatedWork W1999725385 @default.
• W4360614909 hasRelatedWork W2460687921 @default.
• W4360614909 hasRelatedWork W2746546611 @default.
• W4360614909 hasRelatedWork W2961555043 @default.
• W4360614909 hasRelatedWork W2988969500 @default.
• W4360614909 hasRelatedWork W3042029164 @default.
• W4360614909 hasRelatedWork W4200436839 @default.
• W4360614909 isParatext "false" @default.
• W4360614909 isRetracted "false" @default.
• W4360614909 workType "article" @default.