FRANCE 2 Registry Compares Outcomes for Balloon-Expandable and Self-Expandable TAVR Procedures

February 24, 2014—Findings from the FRANCE 2 registry were published by Eric Van Belle, MD, et al online ahead of print in Circulation. The FRANCE 2 investigators conducted an analysis of predictors of and impact on long-term mortality in postprocedural aortic regurgitation (AR) in balloon-expandable (BE) and self-expandable (SE) transcatheter aortic valve replacement (TAVR) procedures. 

The FRANCE 2 investigators found that postprocedural AR ≥ grade 2 was observed in 15.8% of successful TAVR procedures 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.

As noted in Circulation, the background of the study is that significant postprocedural AR is observed in 10% to 20% of cases after TAVR. However, the prognostic value and the predictors of such a complication in BE and SE TAVR remain unclear.

In FRANCE 2, TAVR was performed in 3,195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2,769 (92%) of the eligible population and constituted the study group. 

As summarized in Circulation, the median follow-up was 306 days. BE and SE devices were implanted in 67.6% (n = 1,872) and 32.4% (n = 897) of patients, respectively. Femoral delivery was used in 75.3% of cases, and nonfemoral delivery was used in 24.7% of cases. 

For BE TAVR, eight independent predictors of postprocedural AR ≥ grade 2 were identified, including femoral delivery (P = .04), larger aortic annulus (P = .0004), and smaller prosthesis diameter (P = .0001). 

For SE TAVR, femoral delivery (P = .0001) was found to be an independent predictor of AR. 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, 2.5; P = .0001) and SE TAVR (hazard ratio, 2.11; P = .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%), reported the FRANCE 2 investigators in Circulation.