Clinical and procedural outcomes with the SAPIEN 3 versus the SAPIEN XT prosthetic valves in transcatheter aortic valve replacement: A systematic review and meta-analysis.

ABSTRACT

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.