Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve
Introduction
Transcatheter aortic valve implantation (TAVI) with first generation transcatheter valves for treatment of severe aortic stenosis in patients with increased surgical risk resulted in similar [1] or significantly lower rates of one-year mortality [2] compared with surgical aortic valve replacement. Both, for the balloon-expandable Edwards Sapien valve and the self-expandable CoreValve, the occurrence of paravalvular aortic regurgitation was significantly higher with the transcatheter approach compared with the surgical replacement [2], [3]. Long-term follow-up showed that even mild paravalvular regurgitation was associated with increased late mortality with the balloon-expandable Edwards Sapien valve [3]. Second generation TAVI devices such as the balloon-expandable Edwards Sapien 3 or the repositionable Lotus Valve were designed to minimize the risk for paravalvular aortic regurgitation [5], [6]. An elimination of paravalvular aortic regurgitation could translate into a further reduction of mortality in patients undergoing TAVI. We compared the repositionable Lotus Valve and the balloon-expandable Edwards Sapien 3 valve in patients undergoing TAVI for severe aortic stenosis with respect to post-procedural paravalvular regurgitation and clinical outcome.
Section snippets
Patient population
We included patients with severe aortic stenosis defined as having an aortic valve area (AVA) of 1 cm2 or less or an indexed AVA of 0.6 cm2/m2 or less in combination with the presence of clinical symptoms that are defined as New York Heart Association (NYHA) functional class 2 or more. Furthermore patients had a high risk of surgical aortic valve replacement defined as a Society of Thoracic Surgeons score of ≥ 8%, a logistic EuroSCORE ≥ 15%, contraindications to conventional surgical valve
Results
Between January and June 2014 patients (N = 78) were treated with the repositionable Lotus valve (N = 26) or the Edwards Sapien 3 valve (N = 52). Baseline characteristics were comparable between groups (Table 1). Hemodynamic severity of aortic stenosis assessed by echocardiography or cardiac catheterization was similar between the groups (Table 2). Pre-procedural moderate or severe aortic insufficiency was present in 15% of patients in the Lotus group and 17% of patients in the Edwards Sapien 3
Discussion
TAVI with the repositionable Lotus valve and the balloon-expandable Edwards Sapien 3 valve resulted in similar acute and 30 day outcome. In both groups there was no post-procedural moderate or severe paravalvular aortic regurgitation. The rate of mild aortic regurgitation was low in both groups. The need for permanent pacemaker implantation was higher with the Lotus compared with the Edwards Sapien 3 valve.
The risk for post-procedural aortic regurgitation with first generation TAVI devices was
Conclusion
TAVI with the repositionable Lotus Valve System and the balloon-expandable Edwards Sapien 3 reduced the risk for moderate or severe paravalvular aortic regurgitation. Both second-generation TAVI devices were associated with a lower rate for mild aortic regurgitation compared with first generation transcatheter valves. Device success according to VARC was similar between both groups while the need for permanent pacemaker was significantly higher with the Lotus valve.
Conflict of interest
The authors report no relationships that could be construed as a conflict of interest.
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