First-in-Human Experience With Patient-Specific Computer Simulation of TAVR in Bicuspid Aortic Valve Morphology

JACC Cardiovasc Interv. 2020 Jan 27;13(2):184-192. doi: 10.1016/j.jcin.2019.07.032. Epub 2019 Oct 16.

Abstract

Objectives: The aim of this study was to prospectively evaluate the clinical use of patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) morphology.

Background: Patient-specific computer simulation of TAVR in BAV may predict important clinical outcomes, such as paravalvular regurgitation and conduction disturbance.

Methods: Between May 2018 and April 2019, all patients who were referred for TAVR who had BAV identified on work-up cardiac multidetector computed tomographic imaging prospectively underwent patient-specific computer simulation with a self-expanding transcatheter heart valve (THV) using TAVIguide technology.

Results: Nine patients were included in the study. Sievers classification was type 0 in 2 patients and type 1 in 7 patients. The simulations altered the treatment strategy in 8 patients (89%). The simulations suggested moderate to severe paravalvular regurgitation in 3 patients, who were referred for consideration of surgery. The remaining 6 patients underwent TAVR with a self-expanding THV. In 5 of these patients (83%), THV size and/or implantation depth was altered to minimize paravalvular regurgitation and/or conduction disturbance. In 1 patient, simulations suggested significant conduction disturbance after TAVR, and a permanent pacemaker was implanted before the procedure. Following treatment, all 9 patients had no to mild paravalvular regurgitation. The patient who had a pre-procedure permanent pacemaker implanted became pacing dependent, with underlying third-degree atrioventricular block.

Conclusions: Patient-specific computer simulation of TAVR in BAV can be used to identify those patients where TAVR may be associated with unfavorable clinical outcomes. Patient-specific computer simulation may be useful to guide THV sizing and positioning for potential favorable clinical outcomes.

Keywords: aortic valve stenosis; bicuspid aortic valve; computer simulation; finite element analysis; heart valve prosthesis implantation; transcatheter aortic valve replacement.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / abnormalities*
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery
  • Aortic Valve Insufficiency / etiology
  • Aortic Valve Insufficiency / physiopathology
  • Aortic Valve Insufficiency / prevention & control
  • Arrhythmias, Cardiac / etiology
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / prevention & control
  • Bicuspid Aortic Valve Disease
  • Clinical Decision-Making
  • Female
  • Finite Element Analysis
  • Heart Valve Diseases / diagnostic imaging
  • Heart Valve Diseases / mortality
  • Heart Valve Diseases / physiopathology
  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis
  • Humans
  • Male
  • Models, Cardiovascular*
  • Multidetector Computed Tomography*
  • Patient-Specific Modeling*
  • Predictive Value of Tests
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Transcatheter Aortic Valve Replacement* / mortality
  • Treatment Outcome