Temporal Trends in Transcatheter Aortic Valve Replacement in France
Key result
TAVR in 2013-2015 linked to ~47% lower 30-day mortality versus 2010-2012 alongside increased device success.
- P<0.001
- n=16,969
Why the study?
National data regarding TAVR procedural characteristics and clinical outcomes over time were limited.
Does transcatheter aortic valve replacement (TAVR) show improved procedural and clinical outcomes over time in patients with severe aortic stenosis?
Population
12,804 FRANCE TAVI and 4,165 FRANCE 2 registry patients undergoing TAVR across France
Comparison
TAVR procedures in FRANCE TAVI (2013-2015) vs FRANCE 2 (2010-2012)
Design
Nationwide prospective registry comparison
Follow-up
30-day
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“the two most widely used transcatheter heart valve designs may not achieve the same clinical outcomes. Overall, the present study strongly supports conducting a randomized trial in order to compare head-to-head the most recent iterations of self-expanding and balloon-expanding transcatheter heart valves on all-cause mortality.”
“perhaps there is an inherent difference between the TAVR valves. It may be incorrect to assume that there is a class effect.”
“a potential difference in mortality, but it's relatively small and it's not in a randomized trial. So I don't know that at this point this kind of data will switch people from self-expanding to balloon expandable devices alone, but one could consider it another factor.”
Implication
Provides real-world reassurance on the safety and procedural evolution of transcatheter aortic valve replacement; extends.
Key Points
- To evaluate nationwide procedural performance trends and clinical outcomes of transcatheter aortic valve replacement over a 6-year period.
- Interventional registry analysis comparing consecutive patients undergoing TAVR across 48 centers from 2013 to 2015 (FRANCE TAVI, N=12,804; NCT01777828) with a historical cohort across 34 centers from 2010 to 2012 (FRANCE 2, N=4,165) in France.
- Evaluated temporal changes in patient risk profiles (logistic EuroSCORE), procedural characteristics, device success, and clinical complication rates.
- Device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001), while baseline surgical risk decreased (median EuroSCORE: 18.4% vs. 15.0%; p < 0.001).
- In-hospital mortality decreased from 8.2% to 4.4% (p < 0.001) and 30-day mortality decreased from 10.1% to 5.4% (p < 0.001).
- Stroke and life-threatening complications such as annulus rupture remained stable, whereas cardiac tamponade and permanent pacemaker implantation rates significantly increased.
Study Design
Type
Cohort (n=16,969)
Multicenter
Yes
Structured PICO
Does transcatheter aortic valve replacement (TAVR) show improved procedural and clinical outcomes over time in patients with severe aortic stenosis?
P
Population
16,969 patients with severe aortic stenosis undergoing transcatheter aortic valve replacement in France, comparing outcomes from 2013-2015 versus 2010-2012.
E
Exposure
Transcatheter aortic valve replacement (TAVR) performed between 2013 and 2015 (FRANCE TAVI registry)
C
Comparator
Transcatheter aortic valve replacement (TAVR) performed between 2010 and 2012 (FRANCE 2 registry)
O
Outcome
Device success, in-hospital mortality, and 30-day mortalityhard clinical
Main Result
Absolute Event Rate: 5.4% vs 10.1%
p-value: p=<0.001
TAVR performance and short-term mortality improved significantly over a 6-year period in France, though rates of cardiac tamponade and pacemaker implantation increased.
Cite This Study
Belle et al. (2017) conducted a cohort in Severe aortic stenosis (n=16,969). TAVR between 2013-2015 (FRANCE TAVI) vs. TAVR between 2010-2012 (FRANCE 2) was evaluated on 30-day mortality (p=<0.001). TAVR performed in France between 2013-2015 was associated with lower 30-day mortality compared to 2010-2012 (5.4% vs. 10.1%; P<0.001), alongside increased device success.