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Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement

Berntorp, Karolina LU ; Koul, Sasha LU ; Nozohoor, Shahab LU ; Harnek, Jan LU ; Bjursten, Henrik LU and Götberg, Matthias LU (2019) In BMC Cardiovascular Disorders 19(1).
Abstract


Background: The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure. Methods: We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national... (More)


Background: The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure. Methods: We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry. Results: Mean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm
2
. There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular complication rate was 2%. The 12-month mortality rate was 14%. At discharge 87% of patients had no/trace PVL, 12% had mild PVL and one patient had a moderate PVL. A total of 13% received a new PPM post valve implantation. Among patients who did not have a PPM before the procedure, the PPM rate was 15.3%. Conclusions: This single-center evaluation of the Lotus Valve System demonstrated a good clinical outcome with a low mortality, in a high-risk population. Introduction of a new implantation technique resulted in lower PPM rates than previously reported without negatively affecting PVL. Trial registration: Current Controlled Trials ISRCTN14952278, retrospectively registered 06/11/2017.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Paravalvular leak, Permanent pacemaker, Transcatheter aortic valve replacement
in
BMC Cardiovascular Disorders
volume
19
issue
1
publisher
BioMed Central
external identifiers
  • scopus:85062466529
ISSN
1471-2261
DOI
10.1186/s12872-019-1021-7
language
English
LU publication?
yes
id
43ce3178-5cd5-41c9-b84c-aa085330e9ea
date added to LUP
2019-03-13 10:59:00
date last changed
2019-03-13 10:59:00
@article{43ce3178-5cd5-41c9-b84c-aa085330e9ea,
  abstract     = {<p><br>
                                                         Background: The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure. Methods: We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry. Results: Mean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm                             <br>
                            <sup>2</sup><br>
                                                         . There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular complication rate was 2%. The 12-month mortality rate was 14%. At discharge 87% of patients had no/trace PVL, 12% had mild PVL and one patient had a moderate PVL. A total of 13% received a new PPM post valve implantation. Among patients who did not have a PPM before the procedure, the PPM rate was 15.3%. Conclusions: This single-center evaluation of the Lotus Valve System demonstrated a good clinical outcome with a low mortality, in a high-risk population. Introduction of a new implantation technique resulted in lower PPM rates than previously reported without negatively affecting PVL. Trial registration: Current Controlled Trials ISRCTN14952278, retrospectively registered 06/11/2017.                         <br>
                        </p>},
  articleno    = {44},
  author       = {Berntorp, Karolina and Koul, Sasha and Nozohoor, Shahab and Harnek, Jan and Bjursten, Henrik and Götberg, Matthias},
  issn         = {1471-2261},
  keyword      = {Paravalvular leak,Permanent pacemaker,Transcatheter aortic valve replacement},
  language     = {eng},
  month        = {02},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {BMC Cardiovascular Disorders},
  title        = {Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement},
  url          = {http://dx.doi.org/10.1186/s12872-019-1021-7},
  volume       = {19},
  year         = {2019},
}