Quantitative Aortography Analysis of JenaValve's Trilogy Transcatheter Aortic Valve Implantation System in Patients With Aortic Regurgitation or Stenosis.

Autor:	Tsai TY; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; Cardiovascular Center, Taichung Veterans General Hospital, Taichung, Taiwan., Elzomor H; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland., Wienemann H; Department of Internal Medicine III - Cardiology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Revaiah PC; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland., von Bardeleben RS; Heart Valve Center, Heart and Vascular Center, Universitätsmedizin Mainz, Mainz, Germany., Tamm A; Heart Valve Center, Heart and Vascular Center, Universitätsmedizin Mainz, Mainz, Germany., Garg S; Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK., Soliman O; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland., Onuma Y; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland., Figulla HR; University Heart Center Jena, Friedrich-Schiller University, Jena, Germany., Adam M; Department of Internal Medicine III - Cardiology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Rudolph T; Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany., Serruys PW; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.
Jazyk:	angličtina
Zdroj:	Structural heart : the journal of the Heart Team [Struct Heart] 2024 Jul 23; Vol. 8 (5), pp. 100346. Date of Electronic Publication: 2024 Jul 23 (Print Publication: 2024).
DOI:	10.1016/j.shj.2024.100346
Abstrakt:	Background: JenaValve's Trilogy transcatheter heart valve (THV) (JenaValve Inc, Irvine, CA) is the only conformité européenne -marked THV system for the treatment of aortic regurgitation (AR) or aortic stenosis (AS). However, its efficacy has not been quantitatively investigated pre- and post-implantation using video-densitometric analysis. Methods: Using the CAAS-A-Valve 2.1.2 software (Pie Medical Imaging, Maastricht, the Netherlands), an independent core lab retrospectively analyzed the aortograms of 88 consecutive patients (68 severe AR; 20 severe AS) receiving the JenaValve THV in three European centers. Video-densitometric AR was categorized by the regurgitant fraction (RF) as none/trace AR (RF ≤ 6%), mild (6% < RF ≤ 17%), and moderate/severe AR (RF > 17%). Results: Pre- and post-THV aortograms were analyzable in 17 (22.4%) and 47 (54.0%) patients, respectively. The main reasons preventing analysis were the descending aorta overlap of the outflow tract (30%) and insufficient frame count (6%). The median RF pre- and post-THV implant was 31.0% (interquartile range 21.5-38.6%) and 5.0% (interquartile range 1.0-7.0%, p < 0.001), respectively. The post-THV incidence of none/trace AR was 72.3%, and of mild AR, 27.7%, with no cases of moderate/severe AR. Video-densitometry analysis of the 12 AR cases with paired pre- and post-THV showed a reduction in the RF of 21.8% ± 8.1%. Conclusions: Quantitative aortography confirms the low rates of AR and the large reduction in RF following the implantation of Jenavalve's Trilogy THV, irrespective of implant indication. However, these limited data need corroborating in prospective studies using standardized acquisition protocols. Competing Interests: H. R. Figulla is the cofounder, shareholder, and consultant of JenaValve Inc, Irvine, CA. S. Garg receives consultation with Biosensors. R. von Bardeleben has been a consultant and the recipient of lecture honoraria from Abbott Structural Heart, Boehringer Ingelheim, Cardiac Dimensions, Edwards Lifesciences, GE Health Systems, and Philips Healthcare. H. Wienemann reports travel grants from JenaValve. M. Adam reports personal fees from JenaValve, Abbott, Boston Scientific, and Edwards Lifesciences. P. W. Serruys reports consulting fees from SMT, Novartis, Xeltis, Merillife, and Philips outside the submitted work. The other authors had no conflicts to declare. (© 2024 The Author(s).)
Databáze:	MEDLINE
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