Abbott Structural Heart Program for Transcatheter Aortic Valve Implantation

Abstract

Although first-generation devices for transcatheter aortic valve implantation (TAVI) have achieved favorable results in terms of clinical outcomes and valve performance, complications such as valve malpositioning, paravalvular leak, and conduction disturbances requiring permanent pacemaker implantation have emerged as important limitations of this procedure. Partially offsetting these negative effects, the Abbott Structural Heart Portico™ TAVI device is fully re-sheathable, repositionable, and retrievable until deployed. The Abbott Structural Heart Portico™ TAVI system provides a safe and effective treatment for patients with severe, symptomatic aortic stenosis who are considered to be at high or extreme risk for surgical aortic valve replacement. Early clinical results with outcome up to 1-year post-TAVI have been reported in the literature from approximately 300 patients. Accounting for the inevitable learning curve effect associated with the use of a new device, relatively low rates of mortality, stroke, and other major adverse events were reported, compared with other self-expanding and balloon-expandable TAVI systems. The observed rates of early mortality as well as of disabling stroke are comparable with those reported from first- and second-generation TAVI systems, and 30-day mortality approaches the low procedural mortality rates reported for third-generation aortic valves implanted via transfemoral access. In the current chapter, we describe the properties of the valve system and the implantation techniques, summarize the experience and available data, and provide an outlook to future developments.