Direct Transcatheter Aortic Valve Implantation With Self-Expandable Bioprosthesis: Feasibility and Safety

Cardiovasc Revasc Med. 2014 Jun;15(4):200-3. doi: 10.1016/j.carrev.2014.03.005. Epub 2014 Mar 15.

Abstract

Background: Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve.

Material and methods: Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI.

Results: High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups.

Conclusion: Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.

Keywords: Balloon valvuloplasty pre-dilation; TAVI.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / pathology*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / therapy*
  • Balloon Valvuloplasty
  • Bioprosthesis*
  • Calcinosis / diagnosis
  • Calcinosis / mortality
  • Calcinosis / therapy*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / mortality
  • Feasibility Studies
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Italy
  • Male
  • Prospective Studies
  • Prosthesis Design
  • Severity of Illness Index
  • Time Factors
  • Tomography, X-Ray Computed
  • Treatment Outcome

Supplementary concepts

  • Aortic Valve, Calcification of