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

JACC Cardiovasc Interv. 2015 Mar;8(3):462-471. doi: 10.1016/j.jcin.2014.10.014.

Abstract

Objectives: 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.

Keywords: annulus area; multidetector computed tomography; paravalvular aortic regurgitation; transcatheter aortic valve replacement.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging*
  • Aortic Valve / physiopathology
  • Aortic Valve Insufficiency / diagnosis
  • Aortic Valve Insufficiency / epidemiology*
  • Aortic Valve Insufficiency / physiopathology
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / therapy*
  • Canada / epidemiology
  • Cardiac Catheterization / adverse effects*
  • Cardiac Catheterization / instrumentation*
  • Echocardiography, Doppler, Color
  • Echocardiography, Transesophageal
  • Europe / epidemiology
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects*
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Humans
  • Incidence
  • Male
  • Multidetector Computed Tomography*
  • Predictive Value of Tests
  • Prosthesis Design
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Treatment Outcome