The Placement of Aortic Transcatheter Valve (PARTNER) Trial

The Placement of Aortic Transcatheter Valve (PARTNER) Trial is a very well-designed, meticulously executed, prospective randomized trial that demonstrated that transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve was superior to medical therapy in the treatment of inoperable patients with aortic stenosis (cohort B) and that it was not inferior to standard surgical aortic valve replacement in patients with advanced symptomatic aortic stenosis who are high risk for surgical therapy (cohort A).1,2 The trial involved both surgeons and cardiologists from the beginning. Every patient enrolled in the trial was discussed by conference call before enrollment was accepted. Enrolling sites were centers of excellence in surgical valve replacement and in interventional cardiology. The trial demonstrated a 20% survival advantage in the nonoperable cohort A patients at 1 year. This level of benefit is rare in medical device therapy. In the high-risk surgical patients, TAVR and surgical valve replacement each demonstrated equivalent 1-year mortality (TAVR, 24.2%; surgical aortic valve replacement, 26.8%) and equivalent 1-year relief of symptoms.2 The results of the trial led to approval by the Food and Drug Administration of the device for commercial use in inoperable patients. Use of the device in the United States for high-risk surgical patients is under consideration. This therapy is of great benefit to patients who are similar to those enrolled in the trial. Certainly, this is cause for celebration.The celebration associated with PARTNER is tempered by concerns, however. The procedure remains a major interventional undertaking requiring transit of large-bore catheters across often-diseased vascular structures and deployment of a valve with precision in carefully selected patients. Patients and families of inoperable patients seeking TAVR focus on the 20% 1-year survival benefit. Sometimes lost in their consideration is the fact that in this very ill group …