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Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients : Results from the REPRISE II trial with extended cohort

Dumonteil, Nicolas; Meredith, Ian T.; Blackman, Daniel J.; Tchétché, Didier; Hildick-Smith, David; Spence, Mark S.; Walters, Darren L.; Harnek, Jan LU ; Worthley, Stephen G. and Rioufol, Gilles, et al. (2017) In EuroIntervention 13(7). p.796-803
Abstract

Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. Methods and results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were... (More)

Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. Methods and results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06). Conclusions: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.

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type
Contribution to journal
publication status
published
subject
keywords
Aortic stenosis, Aortic valve implantation, Clinical trials, Transcatheter
in
EuroIntervention
volume
13
issue
7
pages
8 pages
publisher
Société Europa Edition
external identifiers
  • scopus:85030102997
ISSN
1774-024X
DOI
10.4244/EIJ-D-16-01025
language
English
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no
id
e243fee1-e408-4546-8fb8-5eb2f4474c8b
date added to LUP
2017-11-03 08:26:15
date last changed
2018-01-21 04:25:33
@article{e243fee1-e408-4546-8fb8-5eb2f4474c8b,
  abstract     = {<p>Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. Methods and results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and &gt;10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p&lt;0.001) and LVOT overstretch &gt;10% (OR 3.4, 95% CI: 1.7, 6.7; p&lt;0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% &gt;5 mm depth from LCS; p=0.06). Conclusions: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.</p>},
  author       = {Dumonteil, Nicolas and Meredith, Ian T. and Blackman, Daniel J. and Tchétché, Didier and Hildick-Smith, David and Spence, Mark S. and Walters, Darren L. and Harnek, Jan and Worthley, Stephen G. and Rioufol, Gilles and Lefèvre, Thierry and Modine, Thomas and Van Mieghem, Nicolas and Houle, Vicki M. and Allocco, Dominic J. and Dawkins, Keith D.},
  issn         = {1774-024X},
  keyword      = {Aortic stenosis,Aortic valve implantation,Clinical trials,Transcatheter},
  language     = {eng},
  month        = {09},
  number       = {7},
  pages        = {796--803},
  publisher    = {Société Europa Edition},
  series       = {EuroIntervention},
  title        = {Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients : Results from the REPRISE II trial with extended cohort},
  url          = {http://dx.doi.org/10.4244/EIJ-D-16-01025},
  volume       = {13},
  year         = {2017},
}