title: Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.
abstract: OBJECTIVE
  The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV).
  
  
  BACKGROUND
  The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath.
  
  
  METHODS
  The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days.
  
  
  RESULTS
  All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm(2), predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm(2) to 1.5 ± 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 ± 10.3 mm Hg to 11.9 ± 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II.
  
  
  CONCLUSIONS
  The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.
authors.affiliation: St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Ronald K
authors.initials: RK
authors.lastname: Binder
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.forename: David A
authors.initials: DA
authors.lastname: Wood
authors.forename: Michael
authors.initials: M
authors.lastname: Mok
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.forename: Robert
authors.initials: R
authors.lastname: De Larochellière
authors.forename: Stefan
authors.initials: S
authors.lastname: Toggweiler
authors.forename: Eric
authors.initials: E
authors.lastname: Dumont
authors.forename: Melanie
authors.initials: M
authors.lastname: Freeman
authors.forename: Alexander B
authors.initials: AB
authors.lastname: Willson
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000628:therapy*; D063126:Balloon Valvuloplasty; D001955:British Columbia; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011792:Quebec; D011857:Radiographic Image Interpretation, Computer-Assisted; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome