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Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk : Results from the Nordic Lotus-TAVR registry

De Backer, Ole; Götberg, Matthias LU ; Ihlberg, Leo; Packer, Erik; Savontaus, Mikko; Nielsen, Niels E.; Jørgensen, Troels H.; Nykänen, Antti; Baranowski, Jacek and Niemelä, Matti, et al. (2016) In International Journal of Cardiology 219. p.92-97
Abstract

Background Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. Methods and results The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N = 154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization,... (More)

Background Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. Methods and results The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N = 154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30 days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30 days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N = 79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4 mm and a device/annulus ratio <1.05. Conclusions The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.

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publication status
epub
subject
keywords
Aortic valve stenosis, Efficacy, Intermediate risk, Safety, Transcatheter aortic valve replacement
in
International Journal of Cardiology
volume
219
pages
6 pages
publisher
Elsevier
external identifiers
  • Scopus:84976564393
ISSN
0167-5273
DOI
10.1016/j.ijcard.2016.05.072
language
English
LU publication?
yes
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214c57be-5eff-49b3-bd3e-046693627d7c
date added to LUP
2016-07-18 13:43:43
date last changed
2016-11-08 15:05:34
@misc{214c57be-5eff-49b3-bd3e-046693627d7c,
  abstract     = {<p>Background Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. Methods and results The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N = 154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30 days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30 days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N = 79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth &lt;4 mm and a device/annulus ratio &lt;1.05. Conclusions The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.</p>},
  author       = {De Backer, Ole and Götberg, Matthias and Ihlberg, Leo and Packer, Erik and Savontaus, Mikko and Nielsen, Niels E. and Jørgensen, Troels H. and Nykänen, Antti and Baranowski, Jacek and Niemelä, Matti and Eskola, Markku and Bjursten, Henrik and Søndergaard, Lars},
  issn         = {0167-5273},
  keyword      = {Aortic valve stenosis,Efficacy,Intermediate risk,Safety,Transcatheter aortic valve replacement},
  language     = {eng},
  month        = {09},
  pages        = {92--97},
  publisher    = {ARRAY(0xa6e9640)},
  series       = {International Journal of Cardiology},
  title        = {Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk : Results from the Nordic Lotus-TAVR registry},
  url          = {http://dx.doi.org/10.1016/j.ijcard.2016.05.072},
  volume       = {219},
  year         = {2016},
}