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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
Copenhagen University Hospital, Denmark.
Skåne University Hospital, Sweden.
Helsinki University Hospital, Finland.
Haukeland Hospital, Norway.
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2016 (English)In: International Journal of Cardiology, ISSN 0167-5273, E-ISSN 1874-1754, Vol. 219, 92-97 p.Article in journal (Refereed) Published
Abstract [en]

Background: Transcatheter aortic valve replacement (TAVR) has becomean 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 amp;lt;4 mm and a device/annulus ratio amp;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. (C) 2016 Elsevier Ireland Ltd. All rights reserved.

Place, publisher, year, edition, pages
Elsevier, 2016. Vol. 219, 92-97 p.
Keyword [en]
Aortic valve stenosis, Transcatheter aortic valve replacement, Intermediate risk, Safety, Efficacy
National Category
Cardiac and Cardiovascular Systems
URN: urn:nbn:se:liu:diva-131161DOI: 10.1016/j.ijcard.2016.05.072ISI: 000380817400015PubMedID: 27288972OAI: diva2:972254
Available from: 2016-09-20 Created: 2016-09-12 Last updated: 2016-09-26Bibliographically approved

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Nielsen, Niels Erik
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Division of Cardiovascular MedicineFaculty of Health SciencesDepartment of Cardiology in LinköpingHeart and Medicine Center
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International Journal of Cardiology
Cardiac and Cardiovascular Systems

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