Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement
(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)
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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.
- author
- Berntorp, Karolina LU ; Koul, Sasha LU ; Nozohoor, Shahab LU ; Harnek, Jan LU ; Bjursten, Henrik LU and Götberg, Matthias LU
- organization
- publishing date
- 2019-02-26
- 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
- article number
- 44
- publisher
- BioMed Central (BMC)
- external identifiers
-
- scopus:85062466529
- pmid:30808296
- ISSN
- 1471-2261
- DOI
- 10.1186/s12872-019-1021-7
- project
- Transcatheter treatment of structural heart disease
- Outcome after transcatheter valve interventions
- language
- English
- LU publication?
- yes
- id
- 43ce3178-5cd5-41c9-b84c-aa085330e9ea
- date added to LUP
- 2019-03-13 10:59:00
- date last changed
- 2024-03-19 02:56:48
@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>}}, author = {{Berntorp, Karolina and Koul, Sasha and Nozohoor, Shahab and Harnek, Jan and Bjursten, Henrik and Götberg, Matthias}}, issn = {{1471-2261}}, keywords = {{Paravalvular leak; Permanent pacemaker; Transcatheter aortic valve replacement}}, language = {{eng}}, month = {{02}}, number = {{1}}, publisher = {{BioMed Central (BMC)}}, 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}}, doi = {{10.1186/s12872-019-1021-7}}, volume = {{19}}, year = {{2019}}, }