Mid‐term outcome in patients with bicuspid aortic valve stenosis following transcatheter aortic valve replacement with a current generation device: A multicenter study

Abstract

Objectives: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve.Background: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce. Methods:We collected baseline characteristics, procedural data, 30-day and midterm clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve.Results: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of allcause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%.Conclusions: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.aortic valve disease percutaneous intervention, paravalvular leak, structural heart disease intervention, transcatheter valve implantation Transcatheter aortic valve replacement (TAVR) has emerged as the preferred treatment modality for many patients with severe aortic stenosis (AS). 1-6 However, the great majority of data demonstrating efficacy and safety of TAVR derives from patients with tricuspid aortic valve morphology. Treatment of bicuspid aortic valve (BAV) disease with TAVR remains controversial. 7 BAV is a heritable defect found in 0.5-2% of the population. [8][9][10] Due to younger age at presentation and anatomical complexity, bicuspid AS has been excluded from major randomized trials comparing TAVR to surgical aortic valve replacement (SAVR). However, 2-6% of patients in large clinical registries have bicuspid AS. 11,12 Anatomical challenges associated with BAV include larger aortic annuli, severe and asymmetric leaflet and annular calcification, altered geometry, and dilation of the ascending aorta. 9,[13][14][15] In 2010, the first series of patients with BAV treated with early TAVR devices confirmed feasibility. 16 Typically, residual aortic regurgitation (AR) and periprocedural complications have been more common in patients with bicuspid AS undergoing TAVR. [16][17][18][19] However, this data is based on observational studies, in most of which, early generation devices were used. Perlman et al 20 demonstrated favorable periprocedural and 30-day outcomes in patients with BAV undergoing TAVR with the SAPIEN 3 valve, suggesting superior results with newergeneration devices. Subsequently, Yoon et al demonstrated improved procedural outcomes with the SAPIEN 3 val...

Long-Term Mortality After TAVI for Bicuspid vs. Tricuspid Aortic Stenosis: A Propensity-Matched Multicentre Cohort Study

“…In the hallmark trial with the third-generation balloon-expandable Edward Sapien 3 valve, the incidence of moderate-to-severe PVL was dramatically reduced compared to older generation valves, with the caveats of relatively high 30day mortality rate (3.9%), new pacemaker requirement (23.5%), and asymmetrical valve deployment (38%) (22). However, recent large-scale registry-based analyses of patients treated with Edward Sapien 3 valve did not confirm the initial concerns, showing comparable rates of procedural complications in bicuspid and tricuspid AS patients, and similar 1-year rates of stroke and all-cause mortality (11,23). Similarly, the procedural and 1-year outcomes of TAVI with new-generation self-expanding Evolut R or Evolut PRO valves were similar in patients with BAV and TAV (24).…”

Ten-year experience with transcatheter aortic valve implantation in bicuspid aortic valve: lessons learned and future perspectives

“…Nevertheless, 2 large studies proved that nowadays life expectancy of BAV patients does not differ from the general population [5,6]. Similarly, recent multicenter registry-based studies indicate that patients with BAV stenosis have similar TAVI outcomes as patients with TAV stenosis [7][8][9][10]. With over 150 TAVI procedures in BAV since 2009 and more than 10 years of follow-up, our institution has developed substantial expertise with this patient population.…”

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview

“…As mentioned above, the introduction of the new-generation THVs improved the device success rate in BAV similarly to TAV. 3,[5][6][7]9,13,14,16,[19][20][21][22][23][24][25][26][27][28][29] With regard to THV choice in bicuspid anatomy, in the BEAT registry (Balloon Versus Self-Expandable Valve for the Treatment of Bicuspid Aortic Valve Stenosis), the balloon-expandable Sapien 3 (Edwards Lifesciences) THV had higher residual gradients and a trend towards higher rates of annular rupture, while the self-expanding CoreValve Evolut R/PRO (Medtronic) valves had higher rates of moderate or severe PVL. 20 Granted that, in the absence of randomized comparisons among different types of THVs in BAV (Table ), a definitive recommendation on the preferable THV cannot be formulated.…”