Editor’s Corner: The Watchman Story

What grabs our attention? A good story. 

The Watchman device, approved by the FDA on March 13, 2015, for percutaneous closure of the left atrial appendage (LAA), has been in limbo for a decade. Notably, the PROTECT AF pivotal trial began in 2005, the same year the device was approved for use in Europe. Watchman’s journeysince then has involved many delays and much discussion.

Between PROTECT AF, PREVAIL, and 2 continued access registries, there have been more than 2,400 patients studied and nearly 6,000 person-years of follow-up, as well as millions of dollars spent. Prior to US approval, Watchman was commercially available in 74 countries worldwide.

Still, with all the hesitancy expressed at the 3 FDA advisory panel meetings, I would have bet money against it being sold in the United States. Good thing I didn’t. Now that the Watchman story—at least regarding approval—has reached its end, where are we?

The world is a very different place than it was when Watchman started out. As of now, the device is only cleared for use in patients who are suitable for warfarin, are at high embolic risk, and have reason to consider a warfarin alternative. Novel oral anticoagulants may be a cost-effective alternative, and additional LAA closure devices are on the horizon in the United States and are already being sold elsewhere. There is clearly much discussion left to be had.

All this noise stands in contrast to the quiet reaction that many studies inspire, as evidenced by a paper released online March 26 ahead of print in Circulation.

“Nearly half of all peer-reviewed articles published in cardiovascular journals are poorly cited 5 years after publication, and many are not cited at all,” Harlan M. Krumholz, MD, SM, of Yale-New Haven Hospital (New Haven, CT), and colleagues report. At the same time, they note, the number of articles and journals in the field has grown in recent years.

Yet an accompanying editorial by Jeffrey M. Drazen, MD, editor-in-chief of the New England Journal of Medicine, asks whether being noticed is what matters most.

“My conclusion is that citations may be a surrogate for community interest, but they are not a surrogate for science well done,” he writes, concluding, “Before we decide that an endeavor is unworthy of the time and resources it consumed because others have not quickly taken note of it in a publication, we should take a careful look at its intrinsic worth.”

As news editor of TCTMD, I am constantly aware of my limited capacity to keep up with the deluge of research studies. I, like all of us following developments in cardiovascular medicine, must choose where to direct my attention. To the most engaging story? Or to findings that can guide patient care? Knowing where to focus can be difficult, but it is a worthy endeavor.