Evaluation of the Edwards Lifesciences SAPIEN transcatheter heart valve

Abstract

Severe aortic stenosis is a common valvular disease and is associated with both morbidity and mortality. Surgical aortic valve replacement was the only available therapeutic option until technological advances allowed for the development of a transcatheter heart valve system. The first available THV was the Edwards SAPIEN. The merits of this system in terms of safety and efficacy were explored in the pivotal Placement of AoRTic TraNscathetER (PARTNER) randomized trial whose results then led to the approval of this device for commercial use in the US. The valve is now indicated for inoperable patients and may be considered an alternative for surgery for high-risk patients. Two successive models, the XT and more recently the S3, were developed with the intent to improve procedural outcomes. In this article, the SAPIEN transcatheter heart valve family is described in terms of technology, scientific data and future directions.

Keywords::

• aortic stenosis
• SAPIEN
• transcatheter aortic valve replacement

Financial & competing interests disclosure

R Waksman has received the following: speaker’s bureau fees: Boston Scientific, Medtronic, AstraZeneca, Biotronik and Abbott Vascular; non-royalty payments: Biotronik; research grants: Boston Scientific, Medtronic, Volcano, Lilly Daiichi Sanko, AstraZeneca and Abbott Vascular; and consultancy fees: Biotronik, Boston Scientific, Abbott Vascular, Volcano. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Aortic stenosis is one of the most common valvular diseases.

• Surgical aortic valve replacement used to be the standard of care for symptomatic patients with severe aortic stenosis.

• The SAPIEN transcatheter heart valve system was the first commercially available system to allow a less-invasive replacement of the aortic valve.

• The SAPIEN transcatheter heart valve includes bioprosthetic valve leaflets mounted on a stent. Prior to the procedure, the valve is crimped over a balloon and, thus, can be delivered via a transfemoral or transapical access port.

• Pivotal randomized clinical trials established the merits of this device in different patient subgroups.

• These trials have demonstrated superior outcome over standard therapy in inoperable patients and similar results compared to surgical aortic valve replacement in patients at high risk for surgery.

• The major adverse events are vascular complication, stroke and aortic regurgitation. The incidence of these is constantly decreasing.

• Since these initial trials, ample evidence has established the merits of this device and created a paradigm shift in the way aortic sclerosis is treated today.