Why the study?
Data on whether different TAVR devices and delivery approaches achieve equally favorable outcomes when performed by a single heart team are scarce.
Do different TAVR devices (Medtronic CoreValve, Lotus, or SAPIEN XT) result in different rates of mortality, MI, or stroke at 180 days in patients with severe aortic stenosis?
Cohort (n=231)
No
Do different TAVR devices (Medtronic CoreValve, Lotus, or SAPIEN XT) result in different rates of mortality, MI, or stroke at 180 days in patients with severe aortic stenosis?
In a single-center retrospective cohort, TAVR using Medtronic CoreValve, Lotus, or SAPIEN XT devices yielded similar 30- and 180-day clinical outcomes for severe aortic stenosis.
Should not yet change TAVR device selection; leaves open need for randomized head-to-head comparisons.
BACKGROUND: Data on whether different transcatheter aortic valve replacement (TAVR) devices and delivery approaches can achieve equally favorable outcomes when performed by a single heart team are scarce. We sought to compare the performance and short-term outcomes of three different TAVR devices-self-expanding Medtronic CoreValve (MCV), mechanically expanded Lotus valve, and balloon-expandable Edwards SAPIEN XT (SXT)-for the treatment of severe aortic stenosis (AS) in a single large-volume center in Taiwan. METHODS: We retrospectively reviewed consecutive patients who underwent TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria. The composite primary endpoint was combined all-cause mortality, myocardial infarction (MI), or disabling stroke within 180 days. RESULTS: A total of 231 patients (MCV n=112, Lotus n=18, and SXT n=101) were included. The device and procedural success rates were similar among all three TAVR devices. At 30 days, there was no significant difference in all-cause mortality, cardiovascular mortality, periprocedural MI, stroke, major vascular complications, life-threatening bleeding, acute kidney injury (AKI, stage 2/3), or VARC-2 composite early safety endpoints. There was no difference among groups in the rate of primary endpoint within 180 days. Lack of procedural success, presence of acute coronary occlusion during TAVR, and presence of AKI (stage 3) after TAVR were independent predictors of adverse outcomes. CONCLUSION: TAVR using MCV, Lotus, or SXT was associated with similar 30- and 180-day clinical outcomes. The presence of periprocedural complications was one of the main determinants of short-term adverse outcomes.
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Tzeng et al. (2019) conducted a cohort in severe aortic stenosis (n=231). Transcatheter aortic valve replacement (Medtronic CoreValve, Lotus valve, or Edwards SAPIEN XT) vs. Comparison among the three devices was evaluated on Composite of all-cause mortality, myocardial infarction, or disabling stroke within 180 days.
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