Armario, Xavier ORCID: 0000-0002-4662-0251, Rosseel, Liesbeth, Kharbanda, Rajesh, Khogali, Saib, Abdel-Wahab, Mohamed, Van Mieghem, Nicolas M., Tchetche, Didier, Dumonteil, Nicolas, De Backer, Ole, Cotton, James, McGrath, Brian, Balakrishnan, Deepu, Ali, Noman, Farhan, Serdar, Joseph, Jubin, Charbonnier, Gaetan, Okuno, Taishi, McHugh, Fiachra, Hildick-Smith, David, Gilgen, Nicole, Hokken, Thijmen, Spence, Mark S., Frerker, Christian, Angelillis, Marco, Grygier, Marek, Cockburn, James, Bjursten, Henrik, Jeger, Raban, V, Teles, Rui, Petronio, Anna S., Pilgrim, Thomas, Sinning, Jan-Malte, Nickenig, Georg, Sondergaard, Lars, Blackman, Daniel J. and Mylotte, Darren (2021). Transcatheter Aortic Valve Replacement With the LOTUS Edge System Early European Experience. JACC-Cardiovasc. Interv., 14 (2). S. 172 - 182. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1876-7605

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Abstract

OBJECTIVES The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. BACKGROUND The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. METHODS A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported. RESULTS Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 +/- 6.9 years and 5.2 +/- 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 +/- 0.9 cm(2), and the mean transvalvular gradient was 11.9 +/- 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients. CONCLUSIONS Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation. (c) 2021 by the American College of Cardiology Foundation.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Armario, XavierUNSPECIFIEDorcid.org/0000-0002-4662-0251UNSPECIFIED
Rosseel, LiesbethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kharbanda, RajeshUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Khogali, SaibUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Abdel-Wahab, MohamedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Van Mieghem, Nicolas M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tchetche, DidierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dumonteil, NicolasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Backer, OleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cotton, JamesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McGrath, BrianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balakrishnan, DeepuUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ali, NomanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Farhan, SerdarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Joseph, JubinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Charbonnier, GaetanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Okuno, TaishiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McHugh, FiachraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hildick-Smith, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gilgen, NicoleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hokken, ThijmenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spence, Mark S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Frerker, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Angelillis, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grygier, MarekUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cockburn, JamesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bjursten, HenrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jeger, Raban, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Teles, RuiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petronio, Anna S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pilgrim, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sinning, Jan-MalteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nickenig, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sondergaard, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blackman, Daniel J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mylotte, DarrenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-605335
DOI: 10.1016/j.jcin.2020.09.044
Journal or Publication Title: JACC-Cardiovasc. Interv.
Volume: 14
Number: 2
Page Range: S. 172 - 182
Date: 2021
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1876-7605
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
HIGH-RISK PATIENTS; IMPLANTATION; OUTCOMES; STENOSIS; REGURGITATION; MORTALITY; IMPACTMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60533

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