title: Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis.
abstract: OBJECTIVE
  We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS).
  
  
  BACKGROUND
  Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT.
  
  
  METHODS
  We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria.
  
  
  RESULTS
  A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups.
  
  
  CONCLUSIONS
  In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Tannas
authors.identifier: http://orcid.org/0000-0003-2245-2131
authors.initials: T
authors.lastname: Jatene
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Antonio
authors.initials: A
authors.lastname: Castro-Filho
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Rafael A
authors.initials: RA
authors.lastname: Meneguz-Moreno
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Dimytri A
authors.initials: DA
authors.lastname: Siqueira
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Alexandre A C
authors.initials: AAC
authors.lastname: Abizaid
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Auristela I O
authors.initials: AIO
authors.lastname: Ramos
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Magaly
authors.initials: M
authors.lastname: Arrais
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: David C S
authors.initials: DCS
authors.lastname: Le Bihan
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Rodrigo B M
authors.initials: RBM
authors.lastname: Barretto
authors.affiliation: Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Adriana C
authors.initials: AC
authors.lastname: Moreira
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: Amanda G M R
authors.initials: AGMR
authors.lastname: Sousa
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.|Associação do Sanatório Sírio, Hospital do Coração, São Paulo, Brazil.
authors.forename: J
authors.initials: J
authors.lastname: Eduardo Sousa
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*; D001938:Brazil; D005260:Female; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D008297:Male; D010348:Patient Care Team; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome
keywords: aortic stenosis; aortic valve disease; new devices (in general); percutaneous intervention; percutaneous valve therapy; structural heart disease intervention; transcatheter aortic valve implantation (TAVI)