Transcatheter Aortic Valve Implantation in the Era After Commercialization

Abstract

Transcatheter, transarterial aortic valve implantation (TAVI) is a revolutionary approach for the treatment of aortic valve stenosis, a lingering but malignant disease characterized by a long, symptom-free latency period but a high rate of death after the onset of symptoms.1,2 Introduced only recently in 2002,3 TAVI has entered the clinical arena in an unprecedented fashion. Offering for the first time a definite, catheter-based treatment option for nonsurgical and high-risk patients with symptomatic severe aortic stenosis, TAVI has been adopted rapidly in Europe despite the absence of data in larger patient populations and the lack of randomized studies. Initial first-in-humans feasibility and safety studies had been conducted by expert operators in highly specialized centers and selected patient groups in Europe and Canada that demonstrated a remarkable clinical success, but also unanticipated problems.4,–,7 However, the significant clinical benefit in the high-risk elderly patient population, for whom few options were available previously, led to a unique dissemination of TAVI, especially after Conformite Europeenne (CE) approval of the balloon-expandable Edwards SAPIEN (Edwards Lifesciences Inc, Irvine, CA) and the self-expandable Medtronic CoreValve (Medtronic, Inc, Minneapolis, MN) prosthesis in 2007. To date, more than 10 000 TAVI procedures have been performed worldwide with these devices, and the number of procedures is increasing continuously. Article see p 299 With this transfer into the real world, the value of TAVI in daily clinical practice now must be demonstrated. Randomized controlled clinical trials are the “gold standard” for evaluation of treatment effectiveness, providing the highest-quality data and evidence. The Placement of Aortic Transcatheter Valves (PARTNER) trial,8 conducted mainly at US centers, is the first prospective, multicenter, randomized controlled clinical trial in the setting of TAVI to evaluate the safety and effectiveness of transfemoral and transapical TAVI with the SAPIEN …