Key result
The SAPIEN 3 transcatheter heart valve decreases residual paravalvular leakage compared to previous balloon-expandable systems, though conduction disturbances and long-term durability remain concerns.
Why the study?
With transcatheter aortic valve replacement progressively expanding toward low-risk patients, this review describes the SAPIEN 3 valve characteristics and clinical safety and efficacy findings in this population.
The SAPIEN 3 THV system expands TAVR indications to low-risk patients with improved positioning and reduced paravalvular leakage, though conduction disturbances and long-term durability require further study.
Supports SAPIEN 3 evaluation in TAVR for lower leak rates; leaves conduction and durability concerns open for prospective trials.
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.
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Alperi et al. (2021) conducted a review in Symptomatic severe aortic stenosis in low-risk patients. SAPIEN 3 transcatheter heart valve vs. Previous balloon-expandable systems was evaluated. The SAPIEN 3 transcatheter heart valve decreases residual paravalvular leakage compared to previous balloon-expandable systems, though conduction disturbances and long-term durability remain concerns.
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