title: Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study.
abstract: OBJECTIVE
  We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population.
  
  
  BACKGROUND
  Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry.
  
  
  METHODS
  Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria.
  
  
  RESULTS
  Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR.
  
  
  CONCLUSIONS
  RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Rocco A
authors.identifier: http://orcid.org/0000-0002-6439-1018
authors.initials: RA
authors.lastname: Montone
authors.affiliation: Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.affiliation: Department of Cardiology, University Hospital of Padova, Padova, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Fraccaro
authors.affiliation: Department of Cardiology, IRCCS Ospedale San Raffaele, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.affiliation: Interventional Cardiology, Maria Cecilia Hospital, GVM care & research, Cotignola, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Castriota
authors.affiliation: Interventional Cardiology, Maria Cecilia Hospital, GVM care & research, Cotignola, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Nerla
authors.affiliation: Department of Cardiology, Ospedale Cisanello, University of Pisa, Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Angelillis
authors.affiliation: Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tusa
authors.affiliation: Department of Cardiology, IRCCS Ospedale San Raffaele, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giannini
authors.affiliation: IRCCS Policlinico San Donato, Cardiac Surgery, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Garatti
authors.affiliation: Department of Cardiology, University Hospital of Padova, Padova, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: Department of Cardiology, Ospedale Cisanello, University of Pisa, Pisa, Italy.
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.affiliation: Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Nedy
authors.initials: N
authors.lastname: Brambilla
authors.affiliation: Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D007558:Italy; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011474:Prosthesis Design; D020127:Recovery of Function; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome
keywords: aortic valve disease; percutaneous intervention; structural heart disease intervention; transcatheter valve implantation