High-Risk TAVR Late Outcomes: FRANCE-2 Registry
What are late clinical outcomes and the determinates of outcomes among high-risk patients undergoing transcatheter aortic valve replacement (TAVR)?
The FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry prospectively included all patients who underwent TAVR in France and Monaco during a 2-year interval. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used to address outcomes.
A total of 4,201 patients in 34 centers were enrolled between January 2010 and January 2012. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or transapical (18% of patients). Median follow-up was 3.8 years. The 3-year all-cause mortality (with 3-year data available in 97.2% of patients) was 42.0%, and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up.
The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality was largely related to noncardiac causes. Incidence rates of severe events are low after the first month, and valve performance remained stable over time.
This large registry from France and Monaco suggests that clinical and hemodynamic outcomes are good after TAVR among high-risk patients. The 3-year all-cause mortality rate of 42% reinforces the role of concomitant comorbidities in limiting life expectancy among these high-risk patients.
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