Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort)

Blackman, Daniel J.; Meredith, Ian T.; Dumonteil, Nicolas; Tchétché, Didier; Hildick-Smith, David; Spence, Mark S.; Walters, Darren L.; Harnek, Jan; Worthley, Stephen G.; Rioufol, Gilles; Lefèvre, Thierry; Houle, Vicki M.; Allocco, Dominic J.; Dawkins, Keith D.

Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort)

Mark

Blackman, Daniel J. ; Meredith, Ian T. ; Dumonteil, Nicolas ; Tchétché, Didier ; Hildick-Smith, David ; Spence, Mark S. ; Walters, Darren L. ; Harnek, Jan ^LU ; Worthley, Stephen G. and Rioufol, Gilles , et al. (2017) In American Journal of Cardiology 120(2). p.292-299

Abstract: Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System – Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural... (More); Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System – Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.
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Please use this url to cite or link to this publication: https://lup.lub.lu.se/record/9b88ec52-f160-43cb-8dce-9a4b3a22ff81

author

Blackman, Daniel J. ; Meredith, Ian T. ; Dumonteil, Nicolas ; Tchétché, Didier ; Hildick-Smith, David ; Spence, Mark S. ; Walters, Darren L. ; Harnek, Jan ^LU ; Worthley, Stephen G. and Rioufol, Gilles , et al. (More)

Blackman, Daniel J. ; Meredith, Ian T. ; Dumonteil, Nicolas ; Tchétché, Didier ; Hildick-Smith, David ; Spence, Mark S. ; Walters, Darren L. ; Harnek, Jan ^LU ; Worthley, Stephen G. ; Rioufol, Gilles ; Lefèvre, Thierry ; Houle, Vicki M. ; Allocco, Dominic J. and Dawkins, Keith D. (Less)

publishing date

2017-07-15

type

Contribution to journal

publication status

published

subject

Cardiac and Cardiovascular Systems

in

American Journal of Cardiology

volume

120

issue

2

pages

8 pages

publisher

Excerpta Medica

external identifiers

scopus:85019894453
pmid:28535962

ISSN

0002-9149

DOI

10.1016/j.amjcard.2017.04.026

language

English

LU publication?

no

id

9b88ec52-f160-43cb-8dce-9a4b3a22ff81

date added to LUP

2017-06-27 08:31:19

date last changed

2024-06-09 18:58:18

@article{9b88ec52-f160-43cb-8dce-9a4b3a22ff81,
  abstract     = {{<p>Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System – Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p &lt;0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was &lt;1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and &gt;10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.</p>}},
  author       = {{Blackman, Daniel J. and Meredith, Ian T. and Dumonteil, Nicolas 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 Houle, Vicki M. and Allocco, Dominic J. and Dawkins, Keith D.}},
  issn         = {{0002-9149}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{2}},
  pages        = {{292--299}},
  publisher    = {{Excerpta Medica}},
  series       = {{American Journal of Cardiology}},
  title        = {{Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort)}},
  url          = {{http://dx.doi.org/10.1016/j.amjcard.2017.04.026}},
  doi          = {{10.1016/j.amjcard.2017.04.026}},
  volume       = {{120}},
  year         = {{2017}},
}

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Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort)