Transcatheter aortic valve replacement (TAVR) has revolutionized the management of high-risk patients with severe aortic stenosis. However, survival after the procedure and severe complications have been assessed in relatively small populations with limited follow-up.
This article reports long-term clinical results in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry.
The FRANCE-2 registry prospectively included all patients who received TAVRs in France. Follow-up was scheduled at 30 days, 6 months, and annually, from the first to the fifth year.
VARC (Valve Academic Research Consortium) definitions were used for all events.
A total of 4201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were as follows:
- Transfemoral: 73%
- Subclavian: 6%
- Transaortic or transcarotid: 3%
- Transapical: 18%
Mean follow-up was 3.8 years and was available for 97.2% of the population. Mortality at 3 years was 42.0% and cardiovascular mortality was 17.5%.
In a multivariate analysis, the following predictors of mortality were identified:
- 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 EuroSCORE (p <0.001)
- Transapical or subclavian approach (p <0.001 for both vs. transfemoral approach)
- Need for a permanent pacemaker (p = 0.02)
- Paravalvular insufficiency grade ≥2 (p <0.001)
Severe adverse events according to VARC criteria occurred mainly during the first month and subsequently at a rate below 2% of patients/year.
Gradient, valve area, and residual insufficiency were stable during follow-up.
Conclusion
The FRANCE-2 registry represents the largest database available on long-term outcomes of TAVR. Long-term mortality is mainly related to non-cardiac causes. The incidence rate of events is low after the first month.
Original title: Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients. The FRANCE-2 Registry.
Reference: Martine Gilard et al. J Am Coll Cardiol. 2016;68(15):1637-1647.
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