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Transcatheter aortic valve implantation: efficacy, safety and mortality at 30-days to 1- year from a nationwide eight year registry
Advisor(s)
Abstract(s)
Background: Transcatheter aortic valve implantation (TAVI) is currently an established therapy in patients with
symptomatic severe aortic stenosis who are deemed inoperable or of very high surgical risk. Large population
registries provide invaluable real world data.
Purpose: To analyse the 30 days to 1year results of all TAVI procedures performed throughout 8 years in an
entire country.
Methods: Nationwide TAVI registry from 2007 to 2015. Endpoints were defined according to the Valve
Academic Research Consortium2. Longterm composite endpoints were clinical efficacy (after 30 days) and
timerelated valve safety. Other noncomposite enpoints, namely cardiovascular mortality and allcause
mortality were concomitantly assessed. For statistical analysis we used the univariate and multivariate Cox
regression and KaplanMeier Survival.
Results: 819 patients underwent TAVI (mean age 80±8 years, 47% male). The most common diagnosis was
aortic stenosis (94,7%), followed by bioprosthesis dysfunction (3,4%) and aortic disease (1,8%). Mean valve
area was 0,65±0,18 cm2
. The mean Euroscore II was 5,8±4,4 and the mean STS score was 6,6±5,8. 61% of
patients were considered highrisk and the remainder inoperable.
The implanted prosthesis was a Medtronic CoreValve® in 467 (57%) patients, an Edwards Sapien® model in
319 (39%) patients or another type in the remainder. The transfemoral route was used in 83% of cases, a
transapical approach in 11,8% a transaortic route in 1,7% and a subclavian approach in 3,2%. Device success
was achieved in 88,4% of patients.
Mean followup was 585±611 days. After implantation, 92% of patients were in NYHA functional class I or II.
Clinical efficacy (after 30 days) was 75%. Between 30 days and 1 year, allcause mortality was 11,8%
(cardiovascular mortality was 6,3%) and prosthesis dysfunction was 14,4%.
The variables associated with 30days to 1year mortality were age (p=0,042) STS mortality score (p=0.034),
nontransfemoral route (p=0.006), indication for TAVI other than aortic stenosis (p=0,015), chronic pulmonary
disease (p=0,036), chronic renal disease (p=0,043), acute kidney injury (p<0,001), NYHA class > II after
TAVI (p<0,001), stroke after TAVI (p=0,031), and hospital readmission (p<0,001).
Independent predictors of 30days to 1year mortality by multivariate Cox regression were hospital
readmission (HR 4,73; 95% CI 2,52–8,89; p<0,001) and indication for TAVI other than aortic stenosis (HR
2,64; 95% CI 1,03–6,78; p=0,043). By KaplanMeier analysis survival was significantly lower in both groups
(Log Rank 32,48 p<0,001 for the former; Log Rank 6,67 p=0,010 for the latter).
Conclusions: A nationwide TAVI registry demonstrated very good longterm results. Clinical efficacy was very
high and mortality low. The only independent predictors of non shortterm mortality (after 30 days) were
hospital readmission and TAVI for an indication other than aortic stenosis, such as aortic regurgitation.
Description
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016.
Keywords
Aortic disease
Pedagogical Context
Citation
European Heart Journal (2016) 37 (Abstract Supplement ), 418
Publisher
Oxford University Press