Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry

Circulation. 2014 Apr 1;129(13):1415-27. doi: 10.1161/CIRCULATIONAHA.113.002677. Epub 2014 Feb 24.

Abstract

Background: Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear.

Methods and results: TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P=0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery (P=0.04), larger aortic annulus (P=0.0004), and smaller prosthesis diameter (P=0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery(P=0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P=0.0001) and SE-TAVR (hazard ratio=2.11; P=0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR<grade 2 at baseline (31%), low transaortic gradient (35%), or nonfemoral delivery (45%).

Conclusions: Postprocedural AR≥grade 2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of 1-year mortality. The use of the SE device was a powerful independent predictor of postprocedural AR≥grade 2.

Keywords: aortic valve; aortic valve insufficiency; aortic valve stenosis.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Aortic Valve Insufficiency / diagnostic imaging
  • Aortic Valve Insufficiency / epidemiology*
  • Aortic Valve Insufficiency / mortality*
  • Aortic Valve Insufficiency / surgery
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / surgery
  • Balloon Valvuloplasty / methods*
  • Echocardiography
  • Female
  • Follow-Up Studies
  • France
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / methods*
  • Humans
  • Incidence
  • Longitudinal Studies
  • Male
  • Postoperative Complications / epidemiology*
  • Postoperative Complications / mortality*
  • Predictive Value of Tests
  • Prognosis
  • Registries
  • Survival Rate
  • Time Factors
  • Treatment Outcome