FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4310241131> ?p ?o ?g. }

• W4310241131 abstract "HomeJournal of the American Heart AssociationVol. 11, No. 23Putting a Halt to HALT: Does Anticoagulation Matter? Open AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessEditorialPDF/EPUBPutting a Halt to HALT: Does Anticoagulation Matter? Abe DeAndaJr and Hani Jneid Abe DeAndaJrAbe DeAndaJr *Correspondence to: Abe DeAnda, MD, Division of Cardiothoracic Surgery, UTMB‐Galveston, 301 University Boulevard, Galveston, TX 77551. Email: E-mail Address: [email protected] https://orcid.org/0000-0001-6253-6917 , Division of Cardiovascular and Thoracic Surgery, , UTMB‐Galveston, , Galveston, , TX, Search for more papers by this author and Hani JneidHani Jneid https://orcid.org/0000-0002-8754-358X , Division of Cardiovascular Medicine, , UTMB‐Galveston, , Galveston, , TX, Search for more papers by this author Originally published29 Nov 2022https://doi.org/10.1161/JAHA.122.028275Journal of the American Heart Association. 2022;11:e028275This article is a commentary on the followingNatural History of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A 5‐Year Follow‐Up StudyOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: November 29, 2022: Ahead of Print A temporary set‐back to the then rapidly emerging field of transcatheter aortic valve replacement (TAVR) occurred in September of 2014, when St. Jude Medical temporarily halted implantation of their transcatheter valve. As part of PORTICO IDE (Portico Re‐sheathable Transcatheter Aortic Valve System US IDE Trial), a subgroup of enrolled patients underwent postimplant imaging with multidetector computed tomography (MDCT) assessment of the stent frame of the implanted valve. In one patient who had experienced a cerebral embolic event, the MDCT had identified decreased leaflet motion consistent with thrombosis. Subsequent analysis of other patients as well as later data from 2 registries (the RESOLVE [Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and Its Treatment With Anticoagulation] registry and the SAVORY [Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With Four‐Dimensional Computed Tomography] registry) confirmed the low but real rate of either hypoattenuated leaflet thickening (HALT) or reduced leaflet motion, both presumably secondary to leaflet thrombosis.1 In most cases, patients with HALT or reduced leaflet motion were asymptomatic or had subclinical findings.The Food and Drug Administration (FDA) weighed in, requesting computed tomographic evaluation as part of all future studies. Significantly, while the FDA recognized the presence of HALT, they also noted that the significance of this finding was unknown.2 As data from the registries as well as other studies,3 including a subgroup analysis of the PARTNER (Placement of Aortic Transcatheter Valves) 3 trial,4 demonstrated a not insignificant occurrence of subclinical valve thrombosis, it became apparent that PORTICO IDE was not alone with this finding, and the study recommenced with eventual FDA approval.As transcatheter aortic valve replacement expands into younger and lower surgical risk patients, continued concern remains of structural valve failure/dysfunction, including valve thrombosis. These concerns are not limited to TAVR only, as similar findings of HALT and reduced leaflet motion have been shown with surgically implanted tissue valves, with varying degrees of incidence and significance and various types of TAVR platforms.1, 3, 4, 5, 6, 7In the current study in this issue of the Journal of the American Heart Association (JAHA), Imaeda et al have retrospectively reviewed patients who had implantation of the Edwards Sapien XT TAVR, performed during October 2013 to December 2015.8 Their analysis of MDCT data included the presence or absence of HALT at 1 year, and further reviewed outcomes out to a median follow‐up period of 4.7 years. Valve function was assessed with transthoracic echocardiography and included indexed effective orifice area, mean pressure gradient, and indexed stroke volume. The primary outcome was a composite of all‐cause mortality, heart failure readmission, and ischemic stroke. There was no surgical valve comparison. This study focused on the clinical outcomes of patients with and without HALT. The authors found an incidence of HALT at 1 year of 21.8% (27 of 124 patients), which was similar to the incidence of 24% seen in the PARTNER 3 trial. When comparing the two groups over the median time period of 4.7 years, there was no significant difference in the primary outcome or in the secondary outcomes of all‐cause mortality, cardiovascular death, heart failure readmission, or ischemic stroke. Of the valve function measurements from transthoracic echocardiography, only indexed effective orifice area decreased significantly in the HALT group over the 5‐year period.The anticoagulation strategy used by Imaeda et al consisted of dual antiplatelet therapy for 6 months, followed by indefinite therapy with either aspirin or clopidogrel.8 Significantly, if HALT was detected, the therapy was not altered or expanded. In the current study, this approach did not alter the incidence of either the composite primary outcome or ischemic stroke. One weakness was the specification of ischemic stroke as it pertains to a neurological event, ie, this did not include transient ischemic attacks or reversible ischemic neurological deficits. The incidence of either of these entities is unknown, as is the significance. In an evaluation of the RESOLVE/SAVORY registries, HALT was associated with an increased risk of transient ischemic attack (5% versus 1%, P=0.002).5HALT is a dynamic process with still unknown significance in the long term. The finding of HALT at any time point does not extrapolate to worsening valve function or adverse clinical outcomes, at least in the short term. In both the SAVORY registry9 and the PARTNER 3 trial4 there were instances of resolution of HALT as well as new findings of HALT after an earlier MDCT, which did not detect the leaflet findings.The authors conclude that anticoagulation may not be critical for the management of HALT, especially in the elderly cohort, of which their patients were. They go further in questioning whether monitoring with MDCT is necessary especially when the treatment will not change based on the results because there was no difference in adverse outcomes between patients with and without HALT. However, as TAVR moves into the realm of younger patients and as valve‐in‐valve procedures become more frequent, both which conceptually increase the risk of developing leaflet dysfunction, it would be important to not accept the results of Imaeda et al as pertinent to all patients with TAVR. Instead, it would be prudent to heed the original concern of the FDA when the PORTICO IDE was being evaluated—“Whether reduced leaflet motion is clinically meaningful or represents a subclinical advanced‐imaging phenomenon, the loss of leaflet mobility renders the valve dysfunctional and demands additional investigation.”DisclosuresNone.Footnotes*Correspondence to: Abe DeAnda, MD, Division of Cardiothoracic Surgery, UTMB‐Galveston, 301 University Boulevard, Galveston, TX 77551. Email: [email protected]eduSee Article by Imaeda et al.For Disclosures, see page 2.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.References1 Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med.2015; 373:2015–2024. doi: 10.1056/NEJMoa1509233CrossrefMedlineGoogle Scholar2 Laschinger JC, Wu C, Ibrahim NG, Shuren JE. Reduced leaflet motion in bioprosthetic aortic valves – The FDA perspective. N Engl J Med. 2015; 373:1996–1998. doi: 10.1056/NEJMp1512264CrossrefMedlineGoogle Scholar3 Leetmaa T, Hansson NC, Leipsic J, Jensen K, Poulsen SH, Andersen HR, Jensen JM, Webb J, Blanke P, Tang M, et al. Early aortic transcatheter heart valve thrombosis: diagnostic value of contrast‐enhanced multidetector computer tomography. Circ Cardiovasc Interv.2015; 8:e001596. doi: 10.1161/CIRCINTERVENTIONS.114.001596LinkGoogle Scholar4 Makkar RR, Blanke P, Leipsic J, Thourani V, Chakravarty T, Brown D, Trento A, Guyton R, Babaliaros V, Williams M, et al. Subclinical leaflet thrombosis in transcatheter and surgical bioprosthetic valves. PARTNER 3 cardiac computed tomography substudy. J Am Coll Cardiol. 2020; 75:3003–3015. doi: 10.1016/j.jacc.2020.04.043CrossrefMedlineGoogle Scholar5 Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abranowitz Y, Jorgensen TH, et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017; 389:2059–2069. doi: 10.1016/S0140-6736(17)30757-2CrossrefGoogle Scholar6 Ruile P, Minners J, Breitbart P, Schoechlin S, Gick M, Pache G, Neumann FJ, Hein M. Medium‐term follow‐up of early leaflet thrombosis after transcatheter aortic valve replacement. JACC Cardiovasc Interv.2018; 11:1164–1171. doi: 10.1016/j.jcin.2018.04.006CrossrefMedlineGoogle Scholar7 Yanagisawa R, Tanaka M, Yashima F, Arai T, Jinzaki M, Shimizu H, Fukuda K, Watanabe Y, Naganuma T, Higashimori A, et al. Early and late leaflet thrombosis after transcatheter aortic valve replacement. Circ Cardiovasc Interv.2019; 12:e007349. doi: 10.1161/CIRCINTERVENTIONS.118.007349LinkGoogle Scholar8 Imaeda S, Inohara T, Yoshijima N, Kobari Y, Myojin S, Ryuzaki T, Hattori O, Shinada K, Tsuruta H, Takahashi T, et al. Natural history of leaflet thrombosis after transcatheter aortic valve replacement: a 5‐year follow‐up study. J Am Heart Assoc.2022. doi: 10.1161/JAHA.122.026334LinkGoogle Scholar9 Sondergaard L, De Backer O, Kofoed KF, Jilaihawi H, Fuchs A, Chakravarty T, Kashif M, Kazuno Y, Kawamori H, Maeno Y, et al. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J. 2017; 38:2201–2207. doi: 10.1093/eurheartj/ehx369CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesNatural History of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A 5‐Year Follow‐Up StudyShohei Imaeda, et al. Journal of the American Heart Association. 2022;11 December 6, 2022Vol 11, Issue 23 Article InformationMetrics Copyright © 2022 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.122.028275PMID: 36444849 Originally publishedNovember 29, 2022 KeywordsanticoagulantsTAVIEditorialsPDF download SubjectsAortic Valve Replacement/Transcatheter Aortic Valve Implantation" @default.
• W4310241131 created "2022-11-30" @default.
• W4310241131 creator A5026578587 @default.
• W4310241131 creator A5087598163 @default.
• W4310241131 date "2022-12-06" @default.
• W4310241131 modified "2023-09-26" @default.
• W4310241131 title "Putting a Halt to HALT: Does Anticoagulation Matter?" @default.
• W4310241131 cites W2022311307 @default.
• W4310241131 cites W2318441640 @default.
• W4310241131 cites W2326261929 @default.
• W4310241131 cites W2601913781 @default.
• W4310241131 cites W2729496411 @default.
• W4310241131 cites W2808121323 @default.
• W4310241131 cites W2911982531 @default.
• W4310241131 cites W3034950144 @default.
• W4310241131 cites W4310239181 @default.
• W4310241131 doi "https://doi.org/10.1161/jaha.122.028275" @default.
• W4310241131 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36444849" @default.
• W4310241131 hasPublicationYear "2022" @default.
• W4310241131 type Work @default.
• W4310241131 citedByCount "0" @default.
• W4310241131 crossrefType "journal-article" @default.
• W4310241131 hasAuthorship W4310241131A5026578587 @default.
• W4310241131 hasAuthorship W4310241131A5087598163 @default.
• W4310241131 hasBestOaLocation W43102411311 @default.
• W4310241131 hasConcept C177713679 @default.
• W4310241131 hasConcept C71924100 @default.
• W4310241131 hasConceptScore W4310241131C177713679 @default.
• W4310241131 hasConceptScore W4310241131C71924100 @default.
• W4310241131 hasIssue "23" @default.
• W4310241131 hasLocation W43102411311 @default.
• W4310241131 hasLocation W43102411312 @default.
• W4310241131 hasLocation W43102411313 @default.
• W4310241131 hasOpenAccess W4310241131 @default.
• W4310241131 hasPrimaryLocation W43102411311 @default.
• W4310241131 hasRelatedWork W1506200166 @default.
• W4310241131 hasRelatedWork W1995515455 @default.
• W4310241131 hasRelatedWork W2039318446 @default.
• W4310241131 hasRelatedWork W2080531066 @default.
• W4310241131 hasRelatedWork W2748952813 @default.
• W4310241131 hasRelatedWork W2899084033 @default.
• W4310241131 hasRelatedWork W3031052312 @default.
• W4310241131 hasRelatedWork W3032375762 @default.
• W4310241131 hasRelatedWork W3108674512 @default.
• W4310241131 hasRelatedWork W4252371801 @default.
• W4310241131 hasVolume "11" @default.
• W4310241131 isParatext "false" @default.
• W4310241131 isRetracted "false" @default.
• W4310241131 workType "article" @default.