PFO closure options in US/offshore

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New Member

Date Joined Apr 2009
Total Posts : 9
   Posted 4/22/2009 5:19 PM (GMT -6)   
I had a stroke about a week ago and was told that I have a PFO. I'm still in the process of talking to various docs about what to do about it. From what I read, I really want to get it closed. I didn't get information about the size and other complications of the PFO because I didn't know they were relevant, but I'm going to get those from my cardio doc next week.

What is interesting is that percutaneous PFO closure seems to be very standard and routine in places like UK, Europe, Australia, etc. However, in the US it seems to be mired up in clinical trials. For instance with my health plan, Kaiser, I would have to get into a clinical trial to do the closure, at least for the percutaneous method of it. I'm not sure yet about other methods.

Has anybody gone offshore to do this? I filled out a form on a medical tourism site and now they're bugging me to have a consultation with a doctor in India. They look like they're competent.

I'm not saying I'm ready to jump into doing this offshore. It just seems odd that the surgery is available in so many places except the US. I wouldn't be adverse to paying for the the procedure in the US if my provider didn't cover it, but it seems difficult to get it done outside of a study in the US. Am I wrong?

Regular Member

Date Joined Dec 2008
Total Posts : 28
   Posted 4/28/2009 12:58 PM (GMT -6)   
You might get more information and replies here
Good luck

New Member

Date Joined Mar 2009
Total Posts : 1
   Posted 5/4/2009 6:15 PM (GMT -6)   
Where are you located? I thought the same things, before I did more research. Check out my story:

Regular Member

Date Joined Oct 2008
Total Posts : 113
   Posted 5/6/2009 6:36 PM (GMT -6)   
Great story.
Similar to many of ours.
Just a thought:  do you think you may want to put a link to this website on your blog?
You may help even more people than you could ever imagine...
By the way, my 6 month "birthday" was on April 24th, the day of your surgery.
I also celebrated.
I am also a proud card carrying member of the NMT implant club.
I have the CardioSEAL Occluder.
I am grateful everyday for doctors who listen!
Wishing you all the best...
Enjoy the rest of your life,

New Member

Date Joined Apr 2009
Total Posts : 9
   Posted 5/13/2009 3:38 PM (GMT -6)   
Thanks. It's been a bit of a learning process for me. It turns out that my HMO will do the surgery, but the surgeon is bugging me to get into a randomized trial instead of getting the surgery outright. When I sit down and think about it, I really can't tell you why, other than he doesn't believe the data for closure is there yet.

They want "randomized" trials. There's no such thing as random. The only true randomizer is God. For instance the sample pool for PFO closure trials are biased by at least 2 things:

1. More pathogenic PFOs are going to be closed outside of the trials. This will bias the data against PFO closure benefits.

2. The trials will do the procedure and the medical treatments for free. That means you're going to be selecting for people without insurance, which very likely increases the frequency of behavioral issues that contribute to strokes like drug users, smokers, etc. This will tend to increase the stroke risk on both sides, so instead of 1% versus 3%, a 300% benefit, you go to 5% versus 7%, only a 30% benefit.

Just a guess. I'm leaning towards the closure surgery.

New Member

Date Joined Apr 2009
Total Posts : 9
   Posted 5/13/2009 5:14 PM (GMT -6)   
Canucks1, I finally read your blog. Interesting story. It turns out we've had similar experiences with regards to docs bugging people to join clinical trials. It's interesting that there are even more experimental devices for PFO closure being testing in other countries right now. The following is what I've found. Apparently Cierra is out of business, though. Their trail was stopped because the device wasn't working.

Bioadsorbable device BioSTAR, NMT Medical
Self-expanding stent Coherex FlatStent Closure System
Suturing device HeartStich Suturing device

“No device” approach
RF-based thermal energy PFX TM Closure System, Cierra, Inc.
Radiofrequency Thermal Coaptation,
CoAptus Medical Corporation
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