Next-Generation TAVR in Bicuspid Aortic Valve Stenosis
What are the results of transcatheter aortic valve replacement (TAVR) using a SAPIEN 3 valve in bicuspid aortic stenosis (AS)?
Baseline characteristics, procedural data, and 30-day clinical follow-up findings were retrospectively collected from eight centers in Europe and Canada that had performed TAVR using the SAPIEN 3 valve (Edwards Lifesciences) among patients with bicuspid AS.
A total of 51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation aortic regurgitation (AR) was none/trivial in 63% and mild in 37%; there were no cases of moderate or severe AR. At 30-day follow-up, there were two deaths (3.9%), two major vascular complications, and 12 patients (23.5%) required pacemaker implantation.
TAVR in bicuspid AS using a SAPIEN 3 device was feasible and effective, with favorable valve performance and no cases of moderate or severe AR.
The presence of a bicuspid aortic valve is considered a relative contraindication to TAVR, limited by higher rates of significant paravalvular AR among patients with bicuspid rather than tricuspid AS. The SAPIEN 3 device incorporates an outer fabric seal intended to prevent or reduce the severity of paravalvular AR. This multicenter but relatively small, retrospective report suggests that the device may be suitable at least for some patients with bicuspid valve and severe AS. Only 6 of 51 patients had a Sievers type 0 bicuspid valve (two symmetrical leaflets and no raphe [J Thorac Cardiovasc Surg 2007;133:1226-33]), the group that is probably at greatest risk of paravalvular AR; perhaps limiting these findings to patients with a type 1 (one raphe) or functional bicuspid valve (degeneration and commissural fusion of a congenitally trileaflet valve). Valve calcification still is required, so results should not be extrapolated to patients with bicuspid aortic valve and dominant AR as an indication for intervention.
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