Transfemoral aortic valve implantation with new-generation devices: the repositionable Lotus vs. the balloon-expandable Edwards Sapien 3 valve
Key result
Lotus valve matches ES3 in device success but triples new pacemaker risk in TAVI.
- P=0.09
- n=315
Why the study?
New-generation transcatheter heart valves have been developed to reduce complications of TAVI, but comparative data between the repositionable Lotus and balloon-expandable Edwards Sapien 3 valves were lacking.
Does transfemoral TAVI with the Lotus valve compared to the Edwards Sapien 3 valve improve procedural and 30-day outcomes in patients with severe symptomatic aortic stenosis?
Population
315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI from two Italian registries
Comparison
Transfemoral TAVI with Lotus valve vs Edwards Sapien 3 valve
Design
Propensity-matched cohort study
Follow-up
30 days
Authors
Discussion
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Member takes
Implication
Lotus valve associated with higher pacemaker risk; should not yet change practice and leaves open need for randomized confirmation.
Study Design
Type
Cohort (n=315)
Multicenter
Yes
Structured PICO
Does transfemoral TAVI with the Lotus valve compared to the Edwards Sapien 3 valve improve procedural and 30-day outcomes in patients with severe symptomatic aortic stenosis?
P
Population
315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 valves, with 93 propensity-matched pairs evaluated at 30 days.
E
Exposure
Transfemoral TAVI with the repositionable Boston Scientific Lotus valve
C
Comparator
Transfemoral TAVI with the balloon-expandable Edwards Sapien 3 (ES3) valve
O
Outcome
Procedural and 30-day outcomes evaluated according to Valve Academic Research Consortium-2 definition (including device success, paravalvular leak, all-cause mortality, disabling stroke, and new pacemaker implantation)composite
Main Result
Absolute Event Rate: 97.8% vs 98.9%
p-value: p=0.09
Both Lotus and ES3 valves provide high device success and low paravalvular leak rates in TAVI, though the Lotus valve is associated with a significantly higher risk of new pacemaker implantation.
Cite This Study
Fovino et al. (2018) conducted a cohort in severe symptomatic aortic stenosis (n=315). Boston Scientific Lotus transcatheter heart valve vs. Edwards Sapien 3 (ES3) transcatheter heart valve was evaluated on Device success (Valve Academic Research Consortium-2 definition) (p=0.09). Transfemoral TAVI with the Lotus valve showed comparable device success to the ES3 valve (97.8% vs 98.9%, P=0.09) but a higher risk of new pacemaker implantation (31.7% vs 10.5%, P<0.001).