Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients
Male
cardiology esc
Time Factors
definitions
[SDV]Life Sciences [q-bio]
610
outcomes
Transcatheter Aortic Valve Replacement
03 medical and health sciences
0302 clinical medicine
Risk Factors
617
Humans
implantation
Registries
european association
Aged
Proportional Hazards Models
Aged, 80 and over
Heart Failure
heart-failure
Hemodynamics
Aortic Valve Stenosis
Survival Analysis
3. Good health
[SDV] Life Sciences [q-bio]
Stroke
society
predictors
Treatment Outcome
Cardiovascular System & Cardiology
transcatheter aortic valve replacement
pathology
Equipment Failure
Female
heart valves
long-term outcomes
Follow-Up Studies
DOI:
10.1161/circulationaha.118.036866
Publication Date:
2018-12-03T19:00:50Z
AUTHORS (40)
ABSTRACT
Background:
The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.
Methods:
The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.
Results:
Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47–1.07;
P
=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).
Conclusions:
The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
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