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.
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.


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 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days 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 <4mm 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.
The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: ole.debacker@gmail.com.
Ole
O
De Backer
Department of Cardiology, Skåne University Hospital, Lund, Sweden.
Matthias
M
Götberg
Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
Leo
L
Ihlberg
Department of Cardiology, Haukeland University Hospital, Bergen, Norway.
Erik
E
Packer
Heart Center, Turku University Hospital, Turku, Finland.
Mikko
M
Savontaus
Heart Center, Linköping University Hospital, Linköping, Sweden.
Niels E
NE
Nielsen
The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Troels H
TH
Jørgensen
Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
Antti
A
Nykänen
Heart Center, Linköping University Hospital, Linköping, Sweden.
Jacek
J
Baranowski
Department of Cardiology, Oulu University Hospital, Oulu, Finland.
Matti
M
Niemelä
Department of Cardiology, Tampere University Hospital, Tampere, Finland.
Markku
M
Eskola
Department of Cardiology, Skåne University Hospital, Lund, Sweden.
Henrik
H
Bjursten
The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Lars
L
Søndergaard
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D009026:Mortality / Q000639:trends; D011474:Prosthesis Design / Q000295:instrumentation / Q000379:methods; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D012537:Scandinavian and Nordic Countries / Q000453:epidemiology; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
Aortic valve stenosis; Efficacy; Intermediate risk; Safety; Transcatheter aortic valve replacement