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By: Candace Stuart

The prevailing wisdom is that transcatheter aortic valve replacement (TAVR) will waltz into the intermediate-risk category and then skip over to low-risk patients with severe aortic stenosis. That is, if all goes well in two randomized, controlled clinical trials in the U.S. And valves prove durable. And clinical benefits remain. And costs come down. And payers are willing to pay.

Reason for optimism

There has been a lot to make TAVR’s proponents cheer in recent months. Five-year results from the pivotal PARTNER I trial (Placement of AoRTic TraNscathetER Valves Trial) gave inoperable patients treated with Edwards Lifesciences’ balloon-expandable Sapien valve the advantage over those who underwent standard treatment, with a risk of all-cause mortality at five years of 71...

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High costs and slow recruitment have hampered many a randomized controlled clinical trial in recent years.