Lotus vs Sapien 3, different mechanisms with similar results

The new generation devices for transfemoral transcatheter aortic valve replacement have been optimized to improve valve position and reduce residual aortic regurgitation.  

This study compared 30 day, 12 month and 24 month outcomes of the repositionable, Lotus valve, with controlled mechanical expansion, and the balloon-expandable valve Edwards Sapien 3.

Primary end point was all cause mortality and disabling stroke at 12 months.

Between 2014 and 2016, 537 were enrolled in one center; 202 of these patients received the Lotus valve, and 335 the Sapien 3.

Also read: “Lotus Valve performance in relation to pacemaker implantation in Post-TAVR Patients”.

No patients presented post-TAVR moderate or severe aortic regurgitation. Mild regurgitation rate was lower with the Lotus repositionable valve, while pacemaker implantation rate was significantly lower with Sapien 3 (36.1% vs 14.9%, p<0.01).

Safety end point at 30 days resulted 7.4% for both devices, with no differences in mortality (Lotus 1.9% vs. Sapien 3 1.8%; p=0.87), disabling stroke (Lotus 1.5% vs. Sapien 3 2.1%; p=0.62) or major vascular complications (Lotus 2.9% vs Sapien 3, 2.4%; p=0.69).

After adjusting by propensity score, there were no differences in primary end point at 12 months (Lotus 15.5% vs. Sapien 3 18.6%; p=0.69) or 24 months (Lotus 21.9% vs. Sapien 3 26.4%; p=0.49).

Conclusion

Transcatheter aortic valve replacement with Lotus and Sapien 3 saw similar outcomes both at short term and at 2 year follow up. The study only show differences in pacemaker need, which was significantly lower with the balloon expandable valve.

Discussion

Both kinds of valves were specifically designed to reduce paravalvular leak. The Sapien 3 valve has an external skirt in the distal end of the stent to fill the gaps and facilitate crossing the native valve and the balloon catheter when deploying the transcatheter heart valve. 

To solve this problem, the Lotus uses two strategies: on one hand, its repositionable, which enables going up or down a few millimeters to improve the leak; on the other hand, it has Adaptive Seal technology, which is a polyurethane sealing outer layer that fills the gaps (a solution similar to the Sapien 3 outer skirt). The absence of moderate or severe paravalvular leak in 573 patients proves the specific design for this problem, fulfills its purpose.

The need of pacemaker was the only difference found, and it was twice as much for the Lotus valve. It remains unclear whether this need is associated to adverse events, but with TAVR being used in younger, lower risk populations, this could undermine the Lotus efficacy.

Original Title: Outcome with the Repositionable and Retrievable Boston Scientific Lotus Valve Compared with the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement.

Reference: Julia Seeger et al. Circ Cardiovasc Interv. 2017;10:e004670.

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