Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation

JACC Cardiovasc Interv. 2013 May;6(5):462-8. doi: 10.1016/j.jcin.2012.12.128.

Abstract

Objectives: This report sought to study the impact of the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve (THV) stent frame geometry and position on outcomes of transcatheter aortic valve replacement (TAVR).

Background: Post-implant THV geometry and position might impact atrioventricular conduction, hemodynamic performance, and annular sealing.

Methods: Eighty-nine consecutive patients who underwent TAVR with a Sapien XT THV had pre- and post-implant multidetector computed tomography, transthoracic echocardiography, and electrocardiograms performed to assess THV stent geometry, atrioventricular conduction, and hemodynamic performance.

Results: The THV Circularity (THV eccentricity <10% [eccentricity = minimum stent diameter/maximum stent diameter]) and under-expansion (THV area/nominal THV area <90%) were present in 97.8% (2 of 89) and 0%, respectively. Low THV implantation was associated with new left bundle branch block and complete heart block (3.4 ± 2.0 mm vs. 5.5 ± 2.9 mm, p = 0.01) and with the need for permanent pacemaker implantation (3.5 ± 2.0 mm vs. 7.1 ± 2.5 mm, p = 0.001). In contrast, labeled THV size and THV area oversizing was not associated with atrioventricular conduction disturbances. The relation between inflow stent frame area and annular area was related to paravalvular regurgitation (p = 0.025). Labeled prosthesis size but not prosthesis expansion or eccentricity was related to valve gradient (p = 0.005) and effective orifice area (p < 0.001).

Conclusions: Low implantation depth of balloon-expandable THVs is associated with clinically significant new conduction disturbances and permanent pacemaker implantation. Importantly, annular area oversizing was not associated with these complications.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / physiopathology*
  • Aortic Valve Insufficiency / diagnosis
  • Aortic Valve Insufficiency / etiology*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / therapy*
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Cardiac Pacing, Artificial
  • Echocardiography
  • Electrocardiography
  • Female
  • Heart Block / diagnosis
  • Heart Block / etiology*
  • Heart Block / physiopathology
  • Heart Block / therapy
  • Heart Conduction System / physiopathology
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Heart Valve Prosthesis Implantation* / instrumentation
  • Heart Valve Prosthesis Implantation* / methods
  • Heart Valve Prosthesis*
  • Hemodynamics*
  • Humans
  • Male
  • Multidetector Computed Tomography
  • Predictive Value of Tests
  • Prosthesis Design
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Treatment Outcome