I recently got diagnosed with a brain aneurysm that is 1 cm/1 cm/1.4 cm. I had an angiogram last week where my neurologist said that he thinks that the pipeline embolization will be my best bet. I am currently waiting to hear from him about where this might be possible, as I know that there are only currently about 10 centers that do the surgery. He said that my case has to go through an IRB (which I'm assuming is an Independent Review Board). Are any of you familiar with this? Have your cases had to be approved before your surgeries? Any information that you are familiar with would be so helpful to me since this is all so new to me. Because mine is in the front and the doctor said the worst place it could be, brain surgery would be the last resort for him since the possible effects it could have on my hearing, sight, etc. are a possibility. Anything you all can inform me on would be much appreciated!! Thanks!
Hi Joseph and welcome to BAF,
My annies, both in the internal carotid artery, both at the ophthalmic artery, right side 9mm and left side 3mm were not subject to an independent reivew board (I'm not really sure what that even means!). I had the pipeline on the 9mm back on June 8, 2011 and my surgeon is actually one of six doctors that are proctoring the surgery for the pipline!
I see that you joined the Pipeline Group and there you will find a ton of information regarding the pipeline.
For me, I received the PED because my 9mm annie had a wide mouth. My surgeon first attempted to coil my annie, but found that the coils would not stay because of the wide mouth. He then told me that clipping my annie was not an option as it was too close to the optic nerve and the chance of blinding me with clipping surgery was too high! My only other option was the pipeline! It saved my life!
So, on May 25, 2011 I was put on 81 mg aspirin and plavix and sent home. Ten days later, on June 8, 2011 I had the pipeline surgery. One night stay over in ICU and home the next day by noontime!!
I am still on the plavix and aspirin (my 6 month angio is next week) and will probably stop taking the plavix after the angio, but will be on the aspirin regimen the rest of my life.
Where exactly is your annie if you know?
Please keep us posted and I will keep you in my thoughts and prayers.
Linda
Hi Linda and thanks for replying. I am just trying to get as much information as I can. As far as this IRB goes, I don't know really anything either. My primary doctor and my neurologist spoke and the neuro told my MD that it was going before an IRB. I see that some people on here are getting approval for a pipeline and having it done rather quickly, although I've been reading that it's only done in around 10 centers around the country right now. I live in Orlando and it is not being done anywhere in FL. My neuro said I would have to travel for it. I know that Emory does it which would be the closest for me, I think. According to my reports, I have a 13-mm, fusiform, mid-basilar trunk aneurysm. He says that brain surgery would be my last resort. I am waiting for a call back from my doctor's office to find out more about my status and what this IRB is. I want to learn as much as possible about this procedure. Thank you for your information and for this forum.
Hi Joseph,
The pipeline is becoming more and more prevalent across the country as the fabulous doctors teach the procedure. Our PED Group started at 2 of us in AUgust and we are now 4 months later at 20 members!
It's hard to believe that Florida has no hospitals that are doing the PED surgery yet? Maybe it has to do with the location of your annie as the FDA approved the PED for annies in the internal carotid artery area? I'm pretty sure that there are more than 10 centers across the US that are doing the surgery especially since we have 20 membersin the PED group and I don't believe that any of us have had the surgery in the same hospital!
Please keep us posted on how you make out. I am extremely curious regding the IRB procedure down there in Florida!
Best wishes,
Linda
Linda,
Thanks so much for your input and support. As I get more updates, I will keep you posted. Waiting is the hardest part; it's very frustrating. It's nice to be able to read about different people's experiences and gain any information I can. I guess we're the lucky ones since we've found our aneurysms. Keep you posted!!
Thanks,
Joey
Hi Joey,
I live in Nashville and I found out that Vanderbilt is going through the first stages to begin using this procedure. You may want to contact to see if this could be an avenue for treatment. You may also want to check on Liquid embolization (onyx hd 500). That is the procedure that I had for my annie. I think it is performed in Florida. I just had my 6 month post op angiogram and the onyx is holding the annie together. It's like a glue...I have a glue ball in my head now...lol...
Waiting is the hardest part of this process..That is the beauty of the BAF and the support you have to help you and give you encouragement through those tough days. You are in the right place.
Hugs and Happy Holidays To You!
Karen
To all, I am pleased, more than pleased, for you, that your neuro has the care to cover all this detail with you.
You can go to the fda site and secure info on the IRB; they ae supposed to be used for review / approval of devices that are used in different location/purpose than is approved by the FDA (a/k/a off-label) ...Because your doctor was grand (few and far between) in explaining to you that he was securing IRB...he will likely explain the rest when you visit w/him again.
Joey, I am a non-degreed / non-licensed survivor offering my opinion...because I have numerous off-label stents implanted that are also off-record of my treatments...however, "a picture is worth a thousand words", and yet, "one picture will not tell the full story." I also have some coils off-label by their location... From the contacts I have made over the years, mine is not at all unique...
Cherish the ethics of your doctor....it adds tremendously to your Merry Christmas and Happy New Year.
Pat
Hi Pat! My doctor did use the term "off-label" and I didn't know what he meant at the time. The IRB...is that a federal review board or one at a hospital? I haven't seen my neuro in 2 weeks so I don't know. Does the IRB make the decision as to whether I get this life-saving procedure done or not? I'm just confused and trying to learn what I can in the meantime. Thank you for what information you've offered. Any more information would be greatly appreciated!! Thanks so much!
Joe
Hi Joey,
http://en.wikipedia.org/wiki/Institutional_review_board
Here is wikipedia's explanation of an IRB that specifically mentions the FDA for approval of using devices on humans that are not FDA approved for specific uses (such as in your case). I am guessing that since your annie is not in the internal carotid area, which is where the FDA approved the PED for, that your doctor has to submit an application to this IRB so he can request a compassionate use approval -- thus allowing them to use the PED in an area outside of what the FDA has approved it for.
In other words, the FDA doesn't want you being used as a guinea pig for unrecognized used of any device that is going to be put into your body!!!!! In a way I guess it's a good thing that the government is actually looking out for you!
Hope this helps!
Linda
Linda,
Do you know how apt are they to approve these compassionate uses? So does my life hang in the balance of them approving me?
Thanks....Joe
Joey,
The only thing I do know about the compassionate use is that my doctor and his collegue both did the PED on a woman just prior to the FDA approval.
http://www.jeffersonhospital.org/The-Daily-Dose/a-pipeline-to-better-vision-and-health.aspx
This is an article that explains my surgeon, Dr. Pascal Jabbour and his collegue Dr. Gonzalez use of the PED for compassionate use.
Hope this helps!
Linda
Linda, you are great to bring this website on...the only part I had read is off the FDA site...I was a guinea-hog...nothing to do with Pipeline...
I understand that in certain emergencies, some decision may be made...that is then supposed to be reviewed by the IRB...
Off-label usage occurs frequently with prescription drugs tho the guidelines are diff than for devices.
Hi Joseph,
This is Giovanni, another PED recipient from Italy.
In my understanding the compassionate use stops after getting the Fda approval, which means the device
Should be used in the Country.
If I can help you more, let me know.
Take care of You.
Giovanni
Hi all! So I spoke with my physician's assistant yesterday who said that my neuro has been in contact with people at a hospital in Jacksonville (my wife thinks it's probably Shands) where my case is being reviewed. It is considered "off label" for me. I'm just waiting to hear now what will happen. He said it could take about a month before hearing anything but at least I know it's being worked on. I wish you all Happy Holidays!! Thanks a bunch for all of your input...it's greatly appreciated!!
Joe
Happy Holidays to you, too; please keep us updated. You are in our prayers.
Pa
Hi Joey,
you can find more information on the PED ( Pipeline Embolization Device ) in the Pipeline Group.
I had the PED in Italy on january,2010 ........so I'm quite an old recipient.
Go to the PED Group , and send me an invitation to it.
take care.
giovanni
Joey,
The FDA # on PED is P100018; just put that in browse it will take you to it...you may already have this off your group site.
Pat
Happy NEW YEAR,,,thanks for all your input , i value everyones thoughts and experiences.Now i just have to wait for approval which hopefully will be soon , staying positive is the hardest part and im doing my best . Thanks again Giovanni...................joey
Pat,
From your post, I ascertain that to be survivors, we need to be licensed. Where do we get licensed? (Boy, I am so proud that I am able to remember big words this morning!!).
Sherri
Ha, I just looked and it is past morning. At least I took my smart pill today.