title: Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: a comparison with the Sapien XT.
abstract: OBJECTIVE
  This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform.
  
  
  BACKGROUND
  The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known.
  
  
  METHODS
  Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography.
  
  
  RESULTS
  Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR.
  
  
  CONCLUSIONS
  Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada; Inje University Busan Paik Hospital, Busan, South Korea.
authors: Tae-Hyun
authors: TH
authors: Yang
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: John G
authors: JG
authors: Webb
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: Philipp
authors: P
authors: Blanke
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: Danny
authors: D
authors: Dvir
authors: Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.
authors: Nicolaj C
authors: NC
authors: Hansson
authors: Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.
authors: Bjarne L
authors: BL
authors: Nørgaard
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: Christopher R
authors: CR
authors: Thompson
authors: Department of Cardiology, St. Thomas's Hospital, London, United Kingdom.
authors: Martyn
authors: M
authors: Thomas
authors: Department of Surgery, King's College Hospital/King's Health Partners, London, United Kingdom.
authors: Olaf
authors: O
authors: Wendler
authors: Department of Cardiology, Bichat Hospital, Paris, France.
authors: Alec
authors: A
authors: Vahanian
authors: Department of Cardiology, Bichat Hospital, Paris, France.
authors: Dominique
authors: D
authors: Himbert
authors: Department of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors: Susheel K
authors: SK
authors: Kodali
authors: Department of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors: Rebecca T
authors: RT
authors: Hahn
authors: Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.
authors: Vinod H
authors: VH
authors: Thourani
authors: Department of Cardiology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.
authors: Gerhard
authors: G
authors: Schymik
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: Bruce
authors: B
authors: Precious
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: Adam
authors: A
authors: Berger
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors: David A
authors: DA
authors: Wood
authors: Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Philippe
authors: P
authors: Pibarot
authors: Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Josep
authors: J
authors: Rodés-Cabau
authors: Cleveland Clinic, Cleveland, Ohio.
authors: Wael A
authors: WA
authors: Jaber
authors: Department of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors: Martin B
authors: MB
authors: Leon
authors: Department of Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors: Thomas
authors: T
authors: Walther
authors: Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: JLeipsic@providencehealth.bc.ca.
authors: Jonathon
authors: J
authors: Leipsic
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging* / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000453:epidemiology* / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D002170:Canada / Q000453:epidemiology; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005060:Europe / Q000453:epidemiology; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation*; D006439:Hemodynamics; D006801:Humans; D015994:Incidence; D008297:Male; D061330:Multidetector Computed Tomography; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: annulus area; multidetector computed tomography; paravalvular aortic regurgitation; transcatheter aortic valve replacement