title: Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.
abstract: Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV).
  
  
  
  Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2).
  
  
  
  The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation.
  
  
  
  ClinicalTrials.gov #NCT01314313.
authors.affiliation: Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA skodali@columbia.edu.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA.
authors.forename: Jonathon
authors.initials: J
authors.lastname: White
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: S Chris
authors.initials: SC
authors.lastname: Malaisrie
authors.affiliation: University of Virginia, Charlottesville, VA, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Lim
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.affiliation: NYU Langone Medical Center, New York, NY, USA.
authors.forename: Mathew
authors.initials: M
authors.lastname: Williams
authors.affiliation: NorthShore University HealthSystem, Evanston, IL, USA.
authors.forename: Mayra
authors.initials: M
authors.lastname: Guerrero
authors.affiliation: Central Maine Heart and Vascular Institute, Lewiston, ME, USA Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Eisenhauer
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: The Christ Hospital, Cincinnati, OH, USA.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.affiliation: Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA.
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.affiliation: Laval University, Quebec, QC, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Pibarot
authors.affiliation: Medstar Health Research Institute and Georgetown University, Washington, DC, USA.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.affiliation: St Paul's Hospital, Vancouver, BC, Canada.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: St Paul's Hospital, Vancouver, BC, Canada.
authors.forename: Philipp
authors.initials: P
authors.lastname: Blanke
authors.affiliation: Intermountain Medical Center, Salt Lake City, UT, USA.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Whisenant
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Rakesh M
authors.initials: RM
authors.lastname: Suri
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Girma M
authors.initials: GM
authors.lastname: Ayele
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: St Paul's Hospital, Vancouver, BC, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Baylor Scott and White Healthcare, Plano, TX, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, Room 501, New York, NY 10032, USA.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D001021:Aortic Valve; D001024:Aortic Valve Stenosis; D002170:Canada; D006328:Cardiac Catheterization; D004452:Echocardiography; D006801:Humans; D011446:Prospective Studies; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
keywords: TAVI; TAVR; Transcatheter aortic valve replacement