My wife was coiled for a 6 mm ruptured aneurysm. At the 6 month check-up it had compacted, so the good doctor added coils and a stent. It was wonderful compared to the original experience. She spent the night in CCU and walked out the next day when I came to pick her up. At 18 months the check-up revealed the repair to be perfect. That's our experience, and, even though conditions may be a bit different for everyone, I hope it encourages you to go ahead and have done whatever is necessary.
hi! I think we have veered off course here, numbers mean nothing to me, 10 percent 20 or 25, we are all unique so my advice is to not waste a bunch of time with numbers games, there are dozens of variables with sah emergencys such as the scale of severity they grade you in-I forget the name, I was level 5 the worst and location and ease of operation etc etc, anyway to answer the authors concerns--yes mine needed recoiling, thank God it was 100% occluded! It was very scary post op waking up on cloud nine with 3 or 4 nurses trying to stop the bleeding, I was on Coumadin blood thinner that is why- i'm sure that wont happen to you! tc let us know please~~
Hi Laura, I havent been on this site in a year or so, but recently have been developing new neuro symptons, so felt the need to come back to this site. I read your story. I am a white, female 52 year old. My first aneursym ruptured when i was 40 yrs old. They did an emergency crainotomy and clipped it. It was a right communicationg aneursym. 6 months later they were doing a routine angio ( I had to have angio’s every 6 months for four years for routine checks) and they found another aneursym but this time, it was a left communicating aneursym. it was small, but the kicker was that is was a mirror image of the first one on the right (guess that is a big deal) and the aneursym had a “small neck”. So they sent me to a big medical institution and I was scheduled for a coiling. Long story short, the coiling didnt work. they kept on trying to get into the aneursym but had difficulties because “of the neck”. They ruptured this aneurysm while i was in the o.r. and the coil is still imbedded inside my aneursym and laying against my left optic nerve. The recovery on that one was long. I began to have crippling headaches, every day, all the time. Soooo, a year later I had a third surgery, this time it was another crainotomy that my original neurosurgeon performed. He tried to get the coil out, but couldnt, because of too much scars and adhesions. So, he had to leave the coil inside my aneursym and clipped it in two different spots. I had three surgeries in 3 years, my road to recovery was a long one, I suffered a stroke 5 years ago and had to learn to walk and talk again…but why I am writing you is because I survived everything! I still have daily headaches, which can be pretty bad, and I have decreased cognitive skills, language confusion etc… But, please…remember Life Can Always Be A Struggle, but people like us can and do survive. Have Faith, trust your doctor, say a prayer and continue on…Hope this helps. Michelle McClay
Hi Laura,
My aneurism ruptured and was coiled in Jan. 2014. It was 4" long and in the middle of my forehead. I was in ICU for 2 weeks and in re-Hab for 3 weeks. Six months after that I was scheduled to have a Flow Diverter (looks like a tiny slinky) inserted in the artery that runs perpendicular to the aneurism. I had to go on Plavix (blood thinner) 4 days before this procedure and stay on it for 6 months when they would do an angiogram. The Flow Diverter strengthens the walls of the artery and keeps it open so the blood will flow through it more easily and not want to go back to its old habits of leaking into the aneurism. It went smoothly. I had my angiogram on Tuesday to make sure everything was healing the way it was supposed to and that nothing was leaking or thinning out. It was successful…everything was OK thank goodness and I don’t have to take the Plavix any longer. I will need a follow up angiogram in another six months. I hope this is helpful.
My coils in my ruptured aneurysm compacted. Had to go back and add more.this was after 1.5yrs. My unruptured aneurysm didn’t need any new ones. I went back to work full time after a few months of part time work. Overall I am very blessed. If we have to go back & add more I look at it like I do car maintenance. At50,000 miles you have to have something.
tj1 .... re: discussion...
The following are approved stents by the FDA code/numbering...easy to search just starting with the first number...
H020002; H050001; H060001; and the most recent P100018 ...
There nay be more or less as I type this... If search the first ...it will take us to the FDA site...and, which will open up one after another by year, etc...The first one: H020002 is the Neuroform 2 from 2002...
Perhaps some or all have been discontinued by the FDA...but I do not think so...as they appear the same on the FDA site... there is also a neuroform 3 or some such...
Frankly, I am not confident that all were for cerebral implants...for aneurysm treatment...however, I can assure you neuroform 2 is the main used on me...multiple times...in a very short time frame...
tj1 said:
Why not start a new discussion. I'll see if I can help there is only one stent device currently FDA approved in the US. That may be why the coding is complicated. A lot is off label or adapted by aggresive and inovative surgeons.
pat.om@frontier.com said:Rugel...thank you for sharing this...I was coiled and stented off-label and off-record...except for billing and certain angio images...
Of the greatest interest/concern of mine...on coils/stents...are the applications to and the review/approval of the FDA on these devices...because they do not address the arterial access, arteries with tortuous turns and more...More recently (apx April) the voluntary recalls of some stent (PED?) and a retrieval device...Of those, I do not recall ever having been explained to a patient during the recommended procedures...and, the potential need for what may be retrieved...
If anyone has had information provided on this, it would be great if they share it here for others...
Even in the voluntary recall data, there was no definitive explanation...including the CPT (current procedural terminology) used for the billing... I attempted finding it on the AMA CPT site and I could not put in the right "keywords"...to secure the CPT code...presuming there is one..
I have no expertise...lots of experiences...including...coils/stents definitely take more f/u than the usual open surgery/clip...
Laura… A correction to my previous reply. The Flow Diverter was put in THREE months after my original coiling. I said six months by mistake. Sorry
Thats why I wanted to start a new thread Those are all based on a 501 filing. You have had primarily Neuroform2, which has 2 connectors reducing open cells as you noted there is a neuro form3 which uses a braided system an most recently the neuroform ez, which uses a number of different systems. These are all mrketed by stryker. There are others but as far as the FDA is concerned all self expanding stents are the same. There are of course still the original balloon delivery stents which the complicatins of are still fouling the data, because they still have a place but really aren't a neuro product. There is the new wingform which is different but still only has a compassionate approval.
Stents are a lot like catsup, that if a doc gets a favorite it become his Hunts. The fact is Delmonte is different. But marketed differently so not as popular. The new neuroform ez will change a lot in thst it can be delivered by multiple catheters and is prticularly helpful for AVM. As far as the FDA is concerned its the sameo sameo, and approved it on a 501 application. 501 allows for generics. But then as far as thecFDA is concerned the clips used today are the same as they were in 1938.
pat.om@frontier.com said:
tj1 .... re: discussion...
The following are approved stents by the FDA code/numbering...easy to search just starting with the first number...
H020002; H050001; H060001; and the most recent P100018 ...
There nay be more or less as I type this... If search the first ...it will take us to the FDA site...and, which will open up one after another by year, etc...The first one: H020002 is the Neuroform 2 from 2002...
Perhaps some or all have been discontinued by the FDA...but I do not think so...as they appear the same on the FDA site... there is also a neuroform 3 or some such...
Frankly, I am not confident that all were for cerebral implants...for aneurysm treatment...however, I can assure you neuroform 2 is the main used on me...multiple times...in a very short time frame...
tj1 said:Why not start a new discussion. I'll see if I can help there is only one stent device currently FDA approved in the US. That may be why the coding is complicated. A lot is off label or adapted by aggresive and inovative surgeons.
pat.om@frontier.com said:Rugel...thank you for sharing this...I was coiled and stented off-label and off-record...except for billing and certain angio images...
Of the greatest interest/concern of mine...on coils/stents...are the applications to and the review/approval of the FDA on these devices...because they do not address the arterial access, arteries with tortuous turns and more...More recently (apx April) the voluntary recalls of some stent (PED?) and a retrieval device...Of those, I do not recall ever having been explained to a patient during the recommended procedures...and, the potential need for what may be retrieved...
If anyone has had information provided on this, it would be great if they share it here for others...
Even in the voluntary recall data, there was no definitive explanation...including the CPT (current procedural terminology) used for the billing... I attempted finding it on the AMA CPT site and I could not put in the right "keywords"...to secure the CPT code...presuming there is one..
I have no expertise...lots of experiences...including...coils/stents definitely take more f/u than the usual open surgery/clip...
Hi Laura I had a clipping so can't relate but I had mine done at Northwestern and I just love my Neurosurgeon, Dr. Bendok.
Hi Laura - I had a ruptured SAH in June 2005 and was coiled at that time. At that time I was told that I would need to have additional coils added in a couple of months. The physician said that he wanted to allow the coils to compact and then add more coils. In August 2005 the second surgery was completed. I have had follow-up angiograms but no more surgery. With the first surgery I was in the hospital for nearly a month. With the second surgery I was there for just 3 days. Good luck to you.
And as publications such as the Lancet and others say - The ISAT trial is fundamentally flawed and should no longer be relied upon to reflect accurate numbers. A lot of neurosurgeons have even gone as far as calling ISAT bad science.The numbers do not stack up as the ISAT said they did - too many patients were excluded from the trial, certain aneurysms were excluded and 77% of the results came from the UK, so it was more in line with a UK study.
Ask your neuro and they will tell you that whilst coiling has a faster recovery rate than clipping, the rate of reoccurance is a lot higher with coiling than with clipping.
See the Journal of Neurosurg. 2010 Oct;113(4):795-801 for an article that lends a whole new slant to ISAT numbers. Even they say it is flawed.
Exactly Liam.
I caution people about studies. They aren't proof of anything. They are nothing more than scientists having a discussion. As with any discussion some folks add moer to it than others. Most lay folk never read the meat just the conclusions and summaries. Ever study has inclusion and exclusion criteria. The ISAT isn't necessarily flawed its just so narrow, it isn't helpful.
soooo....studies can/may/do bring up new device marketing profit...
I do not believe the retrieval devices were noted in the studies...even the marketing data does not qualify what may need to be retrieved other than a "foreign body"...peripheral or neurovascular...???
Maybe I will find time/ability to go again review ISAT...
tj1 said:
Exactly Liam.
I caution people about studies. They aren't proof of anything. They are nothing more than scientists having a discussion. As with any discussion some folks add moer to it than others. Most lay folk never read the meat just the conclusions and summaries. Ever study has inclusion and exclusion criteria. The ISAT isn't necessarily flawed its just so narrow, it isn't helpful.
Thats correct. Every 501application requires a several studies. The companies pay for them and define the "rules"
Look at studies as being Little Jimmy making up the rules for his own game. He SHOULD be able to win. Remeber Every study begins with a hyothesis "What its going to proove" Sadly I have seen in some of our communities folks who don't read beyond that. And believe the study supports the hypothesis. Often they don't.
Many of theses studies are cohort studies and as such are purley linear. The range of sujects is ver narrow. Consequently, they can be misleading. For example the FDA approval of the neoruform is ONLY for wide neck annies. We know it is used more widley than that.
That is who my new Neurosurgeon is. I have only met with him once, but he is overseeing my MRA and performing my angiogram. From what I have heard, he is great and I am glad to have been recommended to him. Hoping to get the help I need!
harlylena said:
Hi Laura I had a clipping so can't relate but I had mine done at Northwestern and I just love my Neurosurgeon, Dr. Bendok.