While this year's American College of Cardiology (ACC) conference didn?t pack the late breaking clinical trial firepower of years past, the expectation was that the PREVAIL trial results of Boston Scientific's Watchman endovascular left atrial appendage (LAA) closure device were going to be the one late breaker to watch, and it definitely was. Saturday morning's presentation was the perfect setting for the unveiling of the PREVAIL results. The room was packed?in fact, it was standing room only as conference goers worked through their morning coffee listening to Larry King, trademark suspenders and all, give an acceptance speech after receiving the first CardioSmart Patient Advocacy Award for his years of raising awareness of heart disease. With his speech ending on a high note, the PREVAIL results were to be next?but what followed surprised the room, as the announcement came of a broken embargo and the resulting pulling of the presentation of the PREVAIL results, leading to not so much a gasp, but definitely a murmur of ?They can do that??.
Thankfully physicians are largely iPhone users and have switched away from smartphones with keyboards, saving the room from the chorus of key clacking as the news was spread. As a testament of how social media has entered the conference scene, the #ACC13 hashtag was flooded with PREVAIL results news and speculation as to what had occurred. I was pretty happy for the speed of light internet response because it gave me the chance to grab another coffee while following the reaction on my phone. For a great recap of what occurred and some more detailed information you should check out the story by Forbes contributor Larry Husten
The Watchman device was supposed to be one of the bright spots for a company that has not had the best run as of late, but a simple mistake of forgetting to account for different time zones has resulted in a PR snafu for Boston Scientific. The mixed results of the PREVAIL trial
, meeting 2 of the 3 primary clinical end points, are not going to help the perception of this device in the minds of physicians who attended ACC looking to hear the informed discussion of those said results. Attendees I spoke with were disappointed that they did not get to see the results presented, and they hoped to hear discussion on the usefulness of this device in the future. Some understood the decision to pull the trial results by the ACC, though others wished that the results had still been presented because it was set up as the premier trial at the conference.
Will this snafu limit the adoption of the Watchman device in the US? Definitely an interesting question, but FDA approval is the next big step before we see how physicians react to the device.