Compared to the SAPIEN XT, the SAPIEN 3 prosthesis significantly reduced the incidence of more-than-mild post-TAVI aortic regurgitation (2.0% vs. 8.8%, p<0.01).
Cohort (n=454)
No
Does the third-generation S3 balloon-expandable prosthesis reduce post-TAVI aortic regurgitation compared to the second-generation SXT prosthesis in patients with symptomatic aortic stenosis?
The third-generation S3 balloon-expandable prosthesis significantly reduces post-TAVI aortic regurgitation compared to the second-generation SXT, though it is associated with a higher rate of new left bundle branch block.
Odds Ratio: 0.54 (95% CI 0.33–0.89)
Absolute Event Rate: 2% vs 8.8%
p-value: p=<0.01
AIMS: Our aim was to assess the incidence of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the second (SXT) versus third-generation (S3) balloon-expandable SAPIEN prosthesis in patients with symptomatic aortic stenosis (AS). METHODS AND RESULTS: Of 634 patients undergoing TAVI in our centre from May 2010 to July 2014, 354 were treated with the SXT and 100 with the S3 prosthesis. The primary outcome was the incidence of more-than-mild post-TAVI AR at discharge. Secondary outcomes were 30-day incidence of all-cause death, any bleeding complications and need for new pacemaker. The incidence of the primary outcome was 2.0% vs. 8.8%, p<0.01 with S3 compared to SXT, and S3 use was the only independent predictor of post-TAVI AR (odds ratio 0.54; 95% CI: 0.33 to 0.89). At 30 days, there were no differences in mortality (1.0% vs. 4.2%, p=0.13) and pacemaker rate (12.0% vs. 10.5%, p=0.59) between S3 and SXT. S3-treated patients less frequently had bleeding complications (24.0% vs. 41.8%, p<0.01) and more often had permanent new left bundle branch block (22.0% vs. 7.1%, p<0.001). CONCLUSIONS: Compared to the SXT, the use of the S3 prosthesis substantially reduces post-TAVI aortic regurgitation. Longer follow-up is needed to assess if this finding translates to better clinical outcomes.
Jochheim et al. (Mon,) conducted a cohort in Symptomatic aortic stenosis (n=454). SAPIEN 3 prosthesis vs. SAPIEN XT prosthesis was evaluated on More-than-mild post-TAVI aortic regurgitation at discharge (OR 0.54, 95% CI 0.33-0.89, p=<0.01). Compared to the SAPIEN XT, the SAPIEN 3 prosthesis significantly reduced the incidence of more-than-mild post-TAVI aortic regurgitation (2.0% vs. 8.8%, p<0.01).