Late Mortality in TAVR Is Mainly Due to Non-Cardiac Causes

Late Mortality in TAVRTranscatheter 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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