Update on PFO Study

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Dr. Doug Ebersole

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As many of you know, Dr. Petar Denoble and I have been running a DAN sponsored study of PFO. I thought I'd update everyone on what we do and don't know about PFOs and diving.


First of all, PFOs are very common -- occurring in about 25% of the population. Secondly, they DO increase the risk of DCS -- probably by about 5 fold. Now, while that sounds impressive at first glance, you need to look at the ABSOLUTE risk of DCS. The best data we have is on recreational diving where the incidence of DCS is about 2 per 10,000 dives. Therefore, recreational divers with PFO probably have a risk of about 10 per 10,000 dives or 1 per 1000 dives (0.1%).


While PFO closure is a relatively minor procedure, the complication rate is in the range of 1-2% with complications ranging from minor things like palpitations and minor bleeding to severe problems like erosion of the device, device embolism, need for emergent surgery, etc.


Clearly, it doesn't make sense for someone who has never had a DCS event and has a risk of DCS of 0.1% to have a procedure that has a complication rate of 1-2% (10-20 times higher!). However, for divers that have had recurrent "unexpected" DCS, especially if they are technical or professional divers, closure may be a good alternative.


With this in mind, we developed a research protocol with the first enrollment about 3 years ago. We are looking for about 100 patients with DCS and a known PFO -- regardless of whether or not they elected to have it closed. We have enrolled 58 patients so far and have a mean follow-up of two years.


Preliminary findings suggest, as one would expect, more aggressive or frequent divers are more likely to opt for closure of their PFO while those that only do the occasional recreational dives are more likely to opt for conservative therapy.


Addiditonally, one of our co-investigators, Derrick Covington, will be reporting an abstract at next month's UHMS meeting that shows divers tend to change their diving styles once the diagnosis of PFO and DCS is made, regardless of whether or not their PFO was closed. Divers with uncomplicated closure did more dives afterwards while a number of them did fewer due to either closure complications or concomitant disease. Some divers with PFO who chose not to close but dive conservatively did more dives but used more nitrox and limited their depth and time.


In follow-up, three subjects have reported DCS events -- two with skin bends and one with spinal DCS. Obviously, these numbers are too small to make any conclusions, but we continue to follow the participants and are actively recruiting.


If you or any of your diving friends are interested in participating or simply learning more about the study, follow this link:


Diving Medical Research Projects ? DAN | Divers Alert Network


Thanks!
Doug


Douglas Ebersole, MD
Interventional Cardiology, Watson Clinic LLP
Lakeland, Florida
 
Fascinating study, Doug... thanks for the update!

Here's my story from last October: http://www.rothschilddesign.com/dcs

Since then, I have continued to dive actively, maybe a bit more conservatively (staying further away from NDLs, 5 minute safety stops, etc..). I was thinking about doing technical training this year. No symptoms since then. I don't consider this a truly "undeserved" hit, even though I didn't go past NDLs, etc... due to the details of the profile, but I guess that's up for discussion.

Do you think that I should be evaluated for a PFO? My guess is that I would probably opt to not close it and keep diving as I have been since the accident unless there was a good argument for doing otherwise. I know that this is controversial.

Best,

Mike
 
Thanks for the update Doug!
 
Doug, were the three subjects who developed DCS people who had had closures, or people who continued to dive with open PFOs?
 
Doug,

Thank you for both conducting this study and updating us on it! Best of luck!

Cheers,
 
Mike -- if you would not opt for closure or change your level of conservatism with diving based on whether or not you have a PFO, I would not recommend looking for one.

Lynn -- one event (skin bends) was in the closure group and two events in the "no closure" group. As you well know, while interesting, there is absolutely no statistical power to this information!
 
No, no power at all . . . but it's intriguing that you had a skin bends case in the closure group.
 
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