Key result
Transcatheter aortic valve replacement using the Lotus valve in high-risk patients with severe aortic stenosis resulted in 98.7% procedural success and 2.7% all-cause mortality at 30 days.
Why the study?
Does transcatheter aortic valve replacement with the Lotus Valve system improve procedural and 30-day mortality in high-risk symptomatic patients with severe aortic stenosis?
Observational (n=225)
Yes
Does transcatheter aortic valve replacement with the Lotus Valve system improve procedural and 30-day mortality in high-risk symptomatic patients with severe aortic stenosis?
TAVR with the Lotus valve in high-risk patients with severe aortic stenosis demonstrated excellent procedural success and low 30-day mortality, though it was associated with a high rate of new permanent pacemaker implantation.
Lotus TAVR feasible with low 30-day mortality in high-risk AS; leaves open randomized comparisons for safety and pacemaker risk.
OBJECTIVES: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. BACKGROUND: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. METHODS: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. CONCLUSIONS: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients.
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Montone et al. (2017) conducted an observational in severe aortic stenosis (n=225). Transcatheter aortic valve replacement with Lotus Valve was evaluated on procedural and 30-day mortality. Transcatheter aortic valve replacement using the Lotus valve in high-risk patients with severe aortic stenosis resulted in 98.7% procedural success and 2.7% all-cause mortality at 30 days.
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