Key result
Lotus TAVR reduces mild PVL ~35% vs Sapien 3 but increases pacemaker and cerebrovascular events.
Why the study?
Frequent paravalvular leak was the main concern with early-generation TAVR devices, prompting technological improvements and the need to compare outcomes of next-generation Lotus and Sapien 3 devices for severe native valve stenosis.
Does TAVR with the Lotus valve compared to the Sapien 3 valve improve procedural, clinical, and functional outcomes in patients with severe native valve stenosis?
Meta-Analysis (n=1,974)
Does TAVR with the Lotus valve compared to the Sapien 3 valve improve procedural, clinical, and functional outcomes in patients with severe native valve stenosis?
Compared to the Sapien 3 valve, the Lotus valve for TAVR reduces mild paravalvular leak but significantly increases the risk of permanent pacemaker implantation and cerebrovascular events.
Answers are grounded in this paper and cite their sources.
Lotus valve raises pacemaker and cerebrovascular risks despite lower leak rates; challenges its preference over Sapien 3 in TAVR.
BACKGROUND: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements. Current systematic review and meta-analysis sought to compare outcomes of TAVR for severe native valve stenosis with next-generation devices: Lotus and Sapien 3. METHODS: Electronic databases were screened for studies comparing outcomes of TAVR with Lotus and Sapien 3. In a random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. RESULTS: Sapien 3 N=1,974) met inclusion criteria. No differences were observed regarding composite endpoints-device success and early safety. Similarly, 30-day mortality, major vascular complications, acute kidney injury and serious bleeding events were similar with both devices. Lotus valve demonstrated 35% reduction of the risk for mild PVL: risk ratio (RR) 0.65, 95% confidence interval (CI): 0.49-0.85, P=0.002; but there were no statistical differences with regard to moderate/severe PVL (RR 0.56, 95% CI: 0.18-1.77, P=0.320). Lotus valves produced significantly higher mean transaortic gradients: mean difference (MD) 0.88 mmHg, 95% CI, 0.24-1.53 mmHg, P=0.007; however, without translation into higher rate of prosthesis-patient mismatch (RR 1.10, 95% CI: 0.82-1.47, P=0.540). As compared to Sapien 3, Lotus device placement was associated with significantly higher rate of permanent pacemaker implantation (RR 2.30, 95% CI: 1.95-2.71, P<0.00001) and cerebrovascular events (RR 1.76, 95% CI: 1.03-2.99, P=0.040). CONCLUSIONS: Lotus valve, as compared with Sapien 3, was associated with lower risk for PVL but higher risk for permanent pacemaker implantation and cerebrovascular events.
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Gozdek et al. (2020) conducted a meta-analysis in severe native valve stenosis (n=1,974). Lotus prosthetic valve vs. Sapien 3 prosthetic valve was evaluated on mild paravalvular leak (PVL) (RR 0.65, 95% CI 0.49-0.85, p=0.002). TAVR with the Lotus valve compared to Sapien 3 reduced the risk of mild paravalvular leak (RR 0.65; 95% CI 0.49-0.85) but increased permanent pacemaker implantation and cerebrovascular events.
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