Sapien 3 versus Sapien XT prosthetic valves in transcatheter aortic valve implantation: A meta-analysis.

OBJECTIVES

The S3 prosthetic valve was introduced to overcome several issues with its predecessor, the SXT, in transcatheter aortic valve implantation (TAVI), however, the clinical outcomes of this new model are not clearly defined. We performed a meta-analysis to compare the outcomes in Sapien 3 (S3) and Sapien XT (SXT) recipients.

METHODS

A literature search through PUBMED and EMBASE was conducted. Articles that included at least one of the clinical outcomes of interest were included in the meta-analysis: moderate to severe paravalvular regurgitation (PVR), permanent pacemaker implantation (PPI), major vascular complications (MVC), cerebrovascular events (stroke and transient ischemic attack) (CVE), failure rate of device implantation, life-threatening, disabling or major bleeding, need for post-dilation and early all-cause-mortality.

RESULTS

A total of 9 observational cohort studies were included. S3 was implanted in 945 and SXT in 1553 patients. S3 was associated with a lower incidence of moderate to severe PVR (1.6% vs 6.9%, p<0.0001), lower MVC (5.1% vs 8.9%, p=0.01) and less serious bleeding (8.1% vs 15.2%, p=0.003) compared to the SXT. Device deployment failure rate was lower in the S3 (1.2% vs 5.9%, p=0.004) and the S3 required less post-dilation (16.9% vs 26.9%, p=0.05). Rates of CVE, perioperative mortality and PPI were similar between the two valves.

CONCLUSIONS

Implantation of the S3 prosthetic valve results in lower rates of moderate to severe PVR, MVC, post-dilation and serious bleeding however it does not improve on the SXT in terms of CVE, PPI and early mortality.