Key result
Lotus valve matches DFM valve for 30-day device success but links to more pacemakers.
Why the study?
Second generation TAVI devices with full repositionability aim to reduce paravalvular leak and complications, but comparative data between Lotus and DFM valves are limited.
Does the Lotus valve compared to the DFM valve improve procedural and 30-day outcomes in patients with severe aortic stenosis undergoing TAVI?
Cohort (n=175)
No
Does the Lotus valve compared to the DFM valve improve procedural and 30-day outcomes in patients with severe aortic stenosis undergoing TAVI?
Absolute Event Rate: 95% vs 98.2%
p-value: p=0.89
Both Lotus and DFM valves offer excellent 30-day safety and efficacy, but the Lotus valve is associated with a significantly higher rate of new pacemaker implantation.
Warrants caution selecting Lotus over DFM for TAVI to limit pacemaker needs; leaves open confirmation in randomized trials.
BACKGROUND: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. OBJECTIVES: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices. METHODS AND RESULTS: 175 patients with severe aortic stenosis underwent transfemoral TAVI with the Lotus (n = 60) and DFM (n = 115) valve. Baseline clinical characteristics did not differ between the two groups. All devices were successfully implanted, with one case of valve embolization in the Lotus group. Device success (95 vs. 98.2%, P = 0.89), VARC-defined combined safety (90 vs. 93%, P = 0.48), and clinical efficacy (86.7 vs. 90.4%, P = 0.65) rates at 30-days were similar between Lotus and DFM groups. There was no severe PVL; one patient in both Lotus and DFM group developed moderate PVL after the procedure. The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3 vs. 11.2%, P < 0.001) and a lower mean aortic gradient (9.4 ± 5 vs. 12.3 ± 5, P < 0.001) at 30-days as compared with the DFM valve. CONCLUSIONS: In this single-center, retrospective analysis, both Lotus and DFM devices demonstrated excellent device success, safety and efficacy at 30-day follow-up. The DFM valve was associated with minimally higher transvalvular gradients but lower new pacemaker implantation rates when compared to the Lotus valve.
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Giannini et al. (2017) conducted a cohort in severe aortic stenosis (n=175). Lotus valve vs. Direct Flow Medical (DFM) valve was evaluated on Device success at 30 days (p=0.89). Transfemoral TAVI with the Lotus valve demonstrated similar 30-day device success (95% vs 98.2%, P=0.89) compared to the DFM valve, but was associated with a higher rate of new pacemakers.
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