PFO Patients, be cautious what to EXPECT from RESPECT Clinical Trial

The PFO chatter around TCT may indeed be a bit more popular this week than in previous years, but RESPECT will only get PFO closure back to “base camp” at best if the results show promise.

-DP Dansereau, Know-Stroke.org

I am remided of the “base camp” reference made for PFO closure that stuck in my brain from the First Annual PFO Summit back in September 2010 in Washington DC. I would of preferred to use a running analogy myself, perhaps a marathon vs. a sprint, but I’ll explain the reference to climbing in this post.

Background:

During Session #3 of the First PFO Summit Regulatory, Reimbursement, and Device Industry Topics were presented.

Billy Dunn, MD of the FDA gave a brief overview of the Neurology perspective of stroke and PFO closure.

Will PFO Closure make it Back to “Base CAMP” after the Respect Clinical Trial Data is Presented?- Know-Stroke.org

In one of Dr. Dunn’s slides (snagged from my camera here) entitled “Where do we go?” he mentioned we were still at base camp if we put it in climbing terms in route to the top of Mt. Everest. I believe Dr. Dunn was suggesting at the time the path remaining towards identifying PFO as something other than a coincidental finding in the heart instead of a possible pathological risk for stroke was still a long way off. Dr. Dunn did disclose at the start of his talk that his position at the FDA was related to the drug side of the stroke equation, or I assume he meant the medical management end of stroke prevention/treatment. Anyway, with that in mind, even with positive RESPECT outcomes, the results reported this week may only give us PFOers a little more oxygen to start the climb again. Closure 1 certainly emptied our oxygen tanks and perhaps we’ll breathe a little easier now but please be cautious and don’t EXPECT too much from RESPECT.

It is too bad we are not allowed to make these videos available because several presenters would not sign off on the video release. The best I can do for you for now is show you a shot I took from my phone of “base camp”. Hope we all don’t run out of oxygen before we reach the Summit (or can afford another PFO Summit) as we do sometimes have issues with hypoxia you know.

David Dansereau for KNOW-STROKE.ORG