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Transcatheter Aortic Valve Replacement With the LOTUS Edge System : Early European Experience

Armario, Xavier ; Rosseel, Liesbeth ; Kharbanda, Rajesh ; Khogali, Saib ; Abdel-Wahab, Mohamed ; Van Mieghem, Nicolas M. ; Tchétché, Didier ; Dumonteil, Nicolas ; De Backer, Ole and Cotton, James , et al. (2021) In JACC: Cardiovascular Interventions 14(2). p.172-181
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... (More)

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 cm2, 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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
aortic valve stenosis, transcatheter aortic valve replacement, transcatheter heart valve
in
JACC: Cardiovascular Interventions
volume
14
issue
2
pages
10 pages
publisher
Elsevier
external identifiers
  • scopus:85098939377
  • pmid:33478633
ISSN
1936-8798
DOI
10.1016/j.jcin.2020.09.044
project
Outcome after transcatheter valve interventions
language
English
LU publication?
no
id
de0d5aa9-9b32-4230-a1c8-aefbaf1462ea
date added to LUP
2021-01-31 13:36:33
date last changed
2024-06-13 06:20:00
@article{de0d5aa9-9b32-4230-a1c8-aefbaf1462ea,
  abstract     = {{<p>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<sup>2</sup>, 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.</p>}},
  author       = {{Armario, Xavier and Rosseel, Liesbeth and Kharbanda, Rajesh and Khogali, Saib and Abdel-Wahab, Mohamed and Van Mieghem, Nicolas M. and Tchétché, Didier and Dumonteil, Nicolas and De Backer, Ole and Cotton, James and McGrath, Brian and Balakrishnan, Deepu and Ali, Noman and Farhan, Serdar and Joseph, Jubin and Charbonnier, Gaetan and Okuno, Taishi and McHugh, Fiachra and Hildick-Smith, David and Gilgen, Nicole and Hokken, Thijmen and Spence, Mark S. and Frerker, Christian and Angelillis, Marco and Grygier, Marek and Cockburn, James and Bjursten, Henrik and Jeger, Raban V. and Teles, Rui and Petronio, Anna S. and Pilgrim, Thomas and Sinning, Jan Malte and Nickenig, Georg and Søndergaard, Lars and Blackman, Daniel J. and Mylotte, Darren}},
  issn         = {{1936-8798}},
  keywords     = {{aortic valve stenosis; transcatheter aortic valve replacement; transcatheter heart valve}},
  language     = {{eng}},
  month        = {{01}},
  number       = {{2}},
  pages        = {{172--181}},
  publisher    = {{Elsevier}},
  series       = {{JACC: Cardiovascular Interventions}},
  title        = {{Transcatheter Aortic Valve Replacement With the LOTUS Edge System : Early European Experience}},
  url          = {{http://dx.doi.org/10.1016/j.jcin.2020.09.044}},
  doi          = {{10.1016/j.jcin.2020.09.044}},
  volume       = {{14}},
  year         = {{2021}},
}