Serious complications from a PFO closure should be under 1% -- death, stroke, device embolization, late device erosion, etc. It is one of the easiest interventional procedures I do. It takes less than an hour and patients go home the same afternoon or the next morning. Bleeding complications at the groin site should be 1% or so. Then there can be "palpitations" or "fluttering" from skiiped beats, SVT, or atrial fibrillation which sometimes occurs during the first couple of weeks after the procedure and may require a couple of weeks of a beta blocker. Patients go home on a combination of aspirin and Plavix for 3-6 months, after which they can be stopped. Like I mentioned before, every patient and every case is different. You have to have a one-on-one discussion with them regarding risks and benefits so that they can decide what is the best decision for them.
There will never be a randomized double-blind placeobo-controlled trial for PFO closure versus conservative management for DCS. The population is too small and the "hard" endpoints too uncommon for anyone to justify the cost of such a study. You would need hundreds (if not thousands) randomized into each arm of the trial and would then need very accurate long term follow-up for at least 5 years (if not longer). That is never going to happen. That is not a criticism. Most of what we do in medicine is based on expert consensus and personal experience and not on randomized double-blind placebo-controlled trials. In cardiology, we are fortunate to have some very good randomized research studies to help us make decisions. However, PFO closure is not one of those areas.
Currently, Dr. Denoble at DAN and I are performing a prospective NON-randomized study to follow patients who have suffered DCS and have a documented PFO. There is no randomization -- the subjects decide what they want to do. Some opt to stop diving, some opt to dive more conservatively, and some opt to have the PFO closed. This presents an obvious bias to the results in that the patient groups may not be well matched. And indeed they are not in our study. The divers who chose to have the PFO closed tended to be more active divers, dove deeper or did technical diving, and did a great deal more dives in follow-up than the "conservative" arm. Despite this, at least in our early interim analysis at about 2 years of follow-up, the divers who underwent PFO closure had a much lower recurrence rate of DCS than did the conservative group -- despite deeper and more aggressive dives in the PFO group. This rate was about 5X lower in the PFO group compared to the conservative group or about what you would expect for divers with no PFO to begin with. This is NOT DEFINITIVE data, but is interesting and thought provoking. More info will follow once we have 5 year follow-up so stayed tuned.
Just my 2 cents as a CCR trimix instructor, cave diving, interventional cardiologist and DAN consultant. :)
