Device profile of the SAPIEN 3 transcatheter heart valve in low-risk patients with aortic stenosis: overview of its safety and efficacy.

Abstract

INTRODUCTION:

Transcatheter aortic valve replacement (TAVR) has become a treatment of reference for patients with symptomatic severe aortic stenosis, and the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems are two of the most broadly used worldwide. Lately, TAVR has progressively expanded toward the treatment of low-risk patients.

AREAS COVERED:

In this review we aimed to describe the main characteristics of the SAPIEN 3 valve, and to delineate the main clinical findings regarding the safety and efficacy associated with this THV system in low-risk patients undergoing TAVR.

EXPERT OPINION:

The approval of THV systems for use in low-risk patients has been a significant step forward in expanding current TAVR indications. Along with procedural refinement and growing operator experience, device iterations implemented in new-generation THV systems have played a vital role in the successful spread of TAVR. The availability of SAPIEN 3 represented an inflection point, as it allows for a predictable positioning and safer navigability while dramatically decreasing the rate of residual paravalvular leakage compared to previous balloon-expandable systems. However, some unresolved issues remain like the relatively high rates of conduction disturbances and the uncertainty about valve performance in the long-term. Future studies are warranted.

• Authors: Alberto Alperi, Jules Mesnier, Vassili Panagides, Josep Rodés-Cabau
• Journal: Expert review of medical devices (Expert Rev Med Devices) Vol. 18 Issue 9 Pg. 815-821 (Sep 2021) ISSN: 1745-2422 [Electronic] England
• PMID: 34404298 (Publication Type: Journal Article, Review)

Topics

• Aortic Valve (surgery)
• Aortic Valve Stenosis (surgery)
• Heart Valve Prosthesis
• Humans
• Prosthesis Design
• Transcatheter Aortic Valve Replacement (adverse effects)
• Treatment Outcome