Device Success and 30-day Clinical Outcome in Patients Undergoing Preimplant Valvuloplasty in Transfemoral Versus Omitting Valvuloplasty in Transapical Transcatheter Aortic Valve Replacement

J Thorac Cardiovasc Surg. 2015 Nov;150(5):1111-7. doi: 10.1016/j.jtcvs.2015.07.050. Epub 2015 Jul 26.

Abstract

Objectives: The study objective was to evaluate the impact of preimplantation balloon valvuloplasty on procedural outcomes in high-risk or no-option patients with aortic stenosis undergoing Edwards Lifesciences (Irvine, Calif) Sapien valve placement. Paravalvular aortic regurgitation has been associated with long-term mortality after transcatheter aortic valve replacement. Whether omitting preimplant balloon valvuloplasty affects paravalvular aortic regurgitation after Edwards Sapien transcatheter aortic valve replacement is currently unknown.

Methods: We retrospectively analyzed the clinical outcome of 121 consecutive patients undergoing transapical (N = 50) or transfemoral (N = 71) Edwards Sapien transcatheter aortic valve replacement. Routinely, no preimplant balloon valvuloplasty was performed in transapical procedure as opposed to uniform preimplant balloon valvuloplasty in transfemoral cases. The incidence and severity of total and paravalvular aortic regurgitation and 30-day clinical outcomes were compared between the 2 cohorts.

Results: The average patient's age was 84.4 years, with a higher prevalence of smoking history (68% vs 42%, P = .005) and peripheral vascular disease (38% vs 20%, P = .03) in the patients undergoing transapical replacement. The preprocedural transthoracic echocardiographic and computed tomography findings were similar between the 2 cohorts. After transcatheter aortic valve replacement, the incidence of mild to moderate total aortic regurgitation (42% transfemoral vs 38% transapical), paravalvular aortic regurgitation (39% transfemoral vs 30% transapical), device success (88.7% transfemoral vs 94.0% transapical), and 30-day composite end points (9.9% transfemoral vs 14.0% transapical) were comparable in both groups. Multivariate regression analysis revealed male gender (odds ratio, 2.7; 95% confidence interval, 1.18-6.35; P = .02) but not preimplant balloon valvuloplasty as an independent predictor for mild or greater total aortic regurgitation.

Conclusions: Compared with transapical transcatheter aortic valve replacement without preimplant balloon valvuloplasty, preimplant balloon valvuloplasty before transfemoral transcatheter aortic valve replacement resulted in a similar degree of prosthesis-related regurgitation, device success, and 30-day composite safety outcomes.

Keywords: aortic stenosis; predilation; transcatheter aortic valve replacement; valvuloplasty.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Insufficiency / diagnosis
  • Aortic Valve Insufficiency / etiology
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Aortic Valve* / physiopathology
  • Balloon Valvuloplasty* / adverse effects
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation
  • Cardiac Catheterization / methods*
  • Chi-Square Distribution
  • Female
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / methods*
  • Humans
  • Logistic Models
  • Male
  • Multivariate Analysis
  • Odds Ratio
  • Prosthesis Design
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome