Key result
The SAPIEN 3 valve significantly reduced paravalvular leakage (5.58% vs 19.35%; OR 0.27, P=0.000) and 30-day mortality compared to the SAPIEN XT valve, though pacemaker implantation was higher.
Why the study?
Does the SAPIEN 3 valve improve clinical outcomes and reduce complications compared to the SAPIEN XT valve in patients undergoing TAVR?
Meta-Analysis (n=4,496)
Does the SAPIEN 3 valve improve clinical outcomes and reduce complications compared to the SAPIEN XT valve in patients undergoing TAVR?
Effect estimate: OR 0.27
Absolute Event Rate: 5.58% vs 19.35%
p-value: p=0.000
The SAPIEN 3 valve demonstrates superior safety and efficacy outcomes, including lower mortality and paravalvular leak, but a higher risk of permanent pacemaker implantation compared to the SAPIEN XT valve.
Supports SAPIEN 3 preference in TAVR for lower mortality and PVL; confirms benefits from prior trials despite higher pacemaker risk.
Objectives The SAPIEN 3 valve (S3V) was designed to overcome the shortcomings of its predecessor, the SAPIEN XT (SXT) valve. We conducted a meta‐analysis to compare their clinical outcomes and procedural characteristics. Methods PUBMED, EMBASE, and Cochrane CENTRAL were searched by two independent reviewers. The clinical outcomes of interest were paravalvular leakage (PVL), major vascular complications (MVC), bleeding, acute kidney injury (AKI), device success, need for post dilation all‐cause mortality and procedural details. Results Fifteen observational cohort studies were included in the analysis involving a total of 4,496 patients. Of these, 1,700 were S3V recipients and 2,796 were SXT recipients. The S3V group showed fewer complications compared to the SXT group with respect to PVL (5.58% vs. 19.35%, OR: 0.27, P : 0.000), MVC (4.07% vs. 9.13%, OR: 0.44, P : 0.002), bleeding (6.40% vs. 12.03%, OR: 0.50, P : 0.003), 30‐day mortality (3.29% vs. 5.68%, OR: 0.51, P : 0.000), and stroke (1.48% vs. 2.86%, OR: 0.49, P : 0.014). Device success was higher in the S3V (98.18% vs. 93.76%, OR: 3.14, P : 0.000). Cardiovascular mortality, myocardial infarction, AKI and post‐dilatation were not significantly different. Permanent pacemaker implantation (PPI) was higher in S3V recipients (13.29% vs. 9.23%, OR: 1.58, P : 0.000). Procedure time was shorter for the S3V (71.94 vs. 86.85, P : 0.016) and used less contrast volume (129.36 vs. 161.18, P : 0.049). Conclusions Patients receiving the S3V had lower risk of PVL, MVC, bleeding, mortality, and stroke. PPI was somewhat higher in the S3V group. S3V implantation was faster and used less contrast.
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Tummala et al. (2017) conducted a meta-analysis in Transcatheter aortic valve replacement (TAVR) (n=4,496). SAPIEN 3 valve (S3V) vs. SAPIEN XT (SXT) valve was evaluated on Paravalvular leakage (PVL) (OR 0.27, p=0.000). The SAPIEN 3 valve significantly reduced paravalvular leakage (5.58% vs 19.35%; OR 0.27, P=0.000) and 30-day mortality compared to the SAPIEN XT valve, though pacemaker implantation was higher.
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