Germany & Dr. Bierstedt for Cervical ADR?

[Stonewall_Boris]

Originally Posted by NJ Gene

U.S. Docs have quite a few options. They just don't have the ability to use the M6 yet. Btw, just because I've ruled out Bierstedt doesn't mean I've ruled out of other surgeons in Europe. I was impressed with Dr. Bertagnoli, who told me I only needed one level of ADR when other surgeons (both in the U.S. and Europe) suggested that I need two. I have no expectation of insurance covering this. If it does, it will be a pleasant surprise.

Hi NJ,

It's good that you are narrowing your doctor choices, it is part of the process.
Best wishes.

[LauraB]

There has been quite a lengthy and productive conversation going on here, and I thought I may just chime in for a moment.

The most important factor in making your decision is not only the research you have conducted, but the "gut" feeling you have when you feel you have made the right decision. All of the surgeons you have inquired about are highly qualified and experienced in multi-level ADR surgical placements, unlike the US. Like you, I needed to have intervention on several levels and fusion was my only option. I have a relative that opted for this situation and is facing paralysis unfortunately - only due to continued degenerative disease forced upon the adjacent levels. In some cases, it really is the only option, but why stop there if there are possibilities of repair and regaining mobility.

My experience: I had contacted Dr. Bertagnoli due to my initial research and his extensive and lengthy expertise in ADR placement. I didn't know at the time that he had a business relationship with ProDisc; making it a conflict to use M6 (ProDisc has several patent lawsuits against M6; mostly as a deterent for FDA approval - these lawsuits have been determined unfounded and dismissed). In my opinion, the M6 was the only device I would have considered.

Post Surgery: I have 3 levels replaced from C4-C7. Other than my scar, no one can tell that I have "metal" parts. I don't feel any different; other than normal now. I have resumed all my loved sports once again; even did a cartwheel when my students all passed their math test - I am in my 50's.
In regard to insurance coverage, Dr. Bierstedt had supplied me with detailed information regarding his exam, determination of intervention, and prognosis. I submitted everything through my insurance and within 4/5 months, I was reimbursed - COMPLETELY. The travel expenses were a medical deduction on my tax return. It can be done!

My advice is to make sure you choose a surgeon who is free to make the best possible choice for YOU. You should consider someone who has the ability to use the best device that will give you the best surgical outcome, and not confined by political/financial regulations (not necessarily healthful).
An M6 can be replaced if a failure was to occur. This is not the case with the ProDisc. Fusion is the only option after that.

Please...no offense to anyone who has had success with other options. I only have the M6 and I feel it was a Godsend that I had discovered it; along with this support group. I am a success story and grateful everyday to have my life back. I can't help but share my compelling urge to praise not only the device, but Dr. Bierstedt, as well for giving me back my life.

[Cynlite]

Laura, thank you for chiming in and sharing your experience! I so appreciate a well thought out post from someone who has also had to make this decision and done the research. Also, I just want to say how sorry I am for your relative and his/her fusion failure. I've been avoiding the fusion surgery for many years and am so hopeful that I am a success story with ADR. Sadly, I read or hear about so many fusion failures all the time. I wonder how many are truly successful? My gut has always told me that fusion was not the way to go for me.

I'm amazed that you got your insurance to pay for your surgery! If you don't mind sharing, which insurance company did this for you? I believe you stated that your insurance would only cover fusion in the U.S. Is that correct?

I think that surgery in Europe may end up winning this battle in my head mostly because of the surgeons' experience there and secondly because of the technology available there. (I'm meeting with a top notch neurosurgeon on Monday in the U.S. so, I'll see how I feel after that experience. I'm not highly optimistic based on my past experience but, I'll see.) I'm wondering, did you pay for business class air fare to avoid the discomfort of flying? My flight would be around 16 hours to Germany and that just sounds like misery to me. I've already flown many four hour domestic flights after surgery and that was not very comfortable. People kept bumping into me and that was pretty unnerving since I was so protective of my body at the time. It's so hard to get comfortable in an airline seat. The difference is that in my case it was several days after surgery whereas with Dr. Bierstedt, it would be two weeks later. Deciding to go to Europe is a huge financial cost but, really how do you put a price on being out of pain and the chance of living life again?

Initially, I thought the M6-C was the best cervical device out there. Now, I'm trying to sort out if the Mobi-C is equally as good. The M6-C is self restraining and therefore protects the facet joints better over time. The Mobi-C may have a lower HO rate. (Perhaps I'm just reaching because of insurance reasons.) That is the question I'm trying to get sorted out in my mind. There is a slim chance I can get my insurance to cover the Mobi-C here in the U.S. so, if it is as good or better in my body, there is that to consider. Lastly, the Mobi-C does not have a keel whereas the M6-C does have a keel. If a revision surgery is necessary, it is easier if the disc does not have a keel.

Fortunately, I am getting an opinion for Dr. Zeegers who uses both devices. In the end, I think I'll have to heavily lean on the surgeon's advice because getting a good fit is very important. I believe Dr. Bierstedt uses the M6-C more often than not and it is what he has recommended for me. I'm curious to find out what the other two surgeons recommend.

Thanks again for your thoughts!


Note re abstracts on HO. The authors discuss "Grade" and they discuss "Level." I cannot figure out what the differences are between these categories so, the numbers are not an apples to apples comparison. It is also unclear if using an NSAID after the surgery will help to stop the HO process.

Data "Dema" shared from Kinetics re HO at 24 months...see his prior post dated 3/20/2015:

Beaurain,
J. et al
Intermediate clinical and radiological results of
cervical TDR (Mobi-C) with up to 2 years follow-up.
Eur Spine J, 5/12/09
85 24 mo. 3.9% 7.9%
Quan, G. et
al
Eight-Year Clinical & Radiological Follow-up of the
Bryan Cervical Disc Arthroplasty. Spine, Vol. 36 No.
8, 2011
27 96 mo. 11% 22%
Combined M6-C Pilot & Registry: Germany, USA & Mexico
(Independent qualitative analysis by Medical Metrics, Houston, TX, USA)
122 24 mo. 14.6% 4.1%

Information from the Abstract that Cheryl posted confuses the understanding of HO rates even further:
http://orthopedicstemcellinstitute.c...tion_Techy.pdf

Results: Class I data from older FDA IDE studies indicates the incidence of grade- 3 and 4 HO:

1. in ProDisc-C to be 7% at 24 month and Level 4 only 8% at 48-month follow-up, 4% of any HO in Kineflex-C at 24 months.

2. The Bryan trial did not report on HO. PCM had 4.4% incidence of grade-3 or 4 HO at 24 month followup.

3. Prestige had zero anterior HO at 2 and 5 year follow-up.. Newer class I studies show a much higher rate of HO after CADR.

4. The Secure-C had 19.2% of grade 3 and 4 HO at 24 months.

5. The Mobi-C trial showed a 15.9% incidence of level 3 and 4 HO at 24 months.

6. A review of all available class II data (also newer studies) indicates ProDisc-C with 63% of either grade 3 or 4 HO at 4 years.

7. Mobi-C disc at two year FU: grade 3 – 3%, 4 – 6%;

8. M6 at two-year follow-up an HO incidence of 48%;

9. Bryan disc at one-year follow-up 17.8% of patients had some type of HO and 6.7 had grade-3 or 4.

10. One class III paper reported a comparison of three CADR with an HO incidence of Bryan disc 21%, Mobi-C 52.5% and ProDisc-C 71.4%

[Dema]

Laura, thanks for your insightful post, and noticed that you had 3 ADR's C4/C7, so did you replace the fusion at C5-C6 with an ADR?

Cynlite & Laura, given the similar cervical areas to me, please advise if you had/have pain in the back of the trapezius/shoulder (area where you shrug the shoulder)! My MRI shows 3 disc problems (C3-C6) with 2 levels (C4-C6) being a little worse than C3-C4. Some of the specialist are recommending 2 levels ADR, while some recommend 3 levels, and of course some say that surgery will not help me! So wanted to know which level is most likely causing the pain in that area, to help determine if I should do all 3 levels or just 2 levels!

Thanks & wish Cynlite will be providing good success posts like Laura soon.
Dema & Raouf

[Cynlite]

Dear Dema, oh how I wish I had answers for you. I think in the end, you have to go with that voice in your head that tells you what is right for you and go with the surgeon you trust. After that you have to just put your care in their hands and pray for the best.

There is the mechanical aspect to surgery and the creative aspect. I want a surgeon that can handle the unexpected and creatively solve the problems he encounters. When surgeons look at our images I have been told they are getting about 50 percent of the picture. I think that explains why we get different answers from them. I have tried hard to figure out what is causing my issues by how I responded to my prior treatments. I too am making an educated guess but, it's still a guess. I'm at a point where not having surgery is not an option so, I will move forward to a logical solution for me. With each additional level I think we add more risk and from my experience more pain in the recovery. I'd speak to all the surgeons and get their input on what would happen if you went with just two and ask them all about going with three levels. Record your conversations with them so you can listen to their answers. I think that will help you to figure out your puzzle.

[Dema]

Thanks Cynlite for the quick response, and pray that we all will be guided to the right course of treatment, and get significant pain relief and gain our lives back.
Best of luck,
Dema

[LauraB]

Insurance: I have BlueCrossBlueShield through a Union. Initially I was told that this was not a covered surgical intervention and was denied twice. I submitted all of my medical information, bills, wired funds, and statements from the US doctors regarding my condition as well as Dr. Bierstedt. I submitted all of the information and made several phone calls to inquire if they needed more information - I literally became a nuisance. From a business standpoint, this surgery was well below the cost of ANY US surgical procedure and I made sure they understood it.

As far as my surgical procedure. I have an ADR at C4/5 and C6/7. I still have my fusion at C5/6 - which is no longer an issue. The two ADR's "sandwiching" it act like guardians. The dengeration is stopped both above and below. It was a remote thought that the plate and screws could have been removed during the surgery - just to eliminate the metal parts, but due to scar tissue growth, Dr. Bierstedt felt that it would have caused additional healing time and not necessary. He wasn't impressed with the placement of the plate - it was crooked, but wasn't going to cause any harm.
I am a perfect example of why you need to look beyond fusions. In my experience, my fusion at the time, stopped the initial pain and paralysis of my left arm. I didn't know any better, but was warned by others that I may be back in the same situation within a year or two - barely made it that long. Because of the restriction of movement at the fused level, the energy is diffused to the levels above and below. When I had my car accident, it was inevitable that those levels received a much higher level of force. Since the ADR can retain mobility, this is no longer an issue.
Prior to my surgery, my pain was inconsistent in its location and intensity. There were times I had stabbing, shocking pain in my shoulder blades or the back of my neck. I would lose feeling in my arms and fingers; sometimes down into my left leg. The headaches were the most grueling and eventually my undoing. The migraines became more intense and frequent; usually lasting 3/4 days with 1 to 2 day reprieve before it would restart. I was fearful that I couldn't last much longer.
I still have reminiscent pain once in awhile; probably sympathy pain (hah), but never at the level it was, and probably due to common muscle aches from movement I was unaccustomed to.
I hope both of you do have the success that I had - for me I still don't know if I'm completely pain free - I don't know what that is like since I do have a connective tissue disorder, but I am more active than I ever have been and enjoying life!
Lastly, Dr. Bierstedt wasn't sure if he could place an M6 at the C6/7 level due to the severe compression. He choices (prior to me going under) was to "pry" open the areas enought to fit the M6, replace the M6 with a MobiC due to the size configuration, or fuse - it nothing would fit. Even though there is a keel with the M6, it is not intrusive enough to replace, if necessary. Again, bone issues are part of that configuration regardless of the situation.

Good Health to you, Laura

[DrewDotNet]

Originally Posted by Cynlite

When surgeons look at our images I have been told they are getting about 50 percent of the picture. I think that explains why we get different answers from them.

In How Doctors Think, the author discusses this. For some conditions, radiologists looking at an MRI or X-Ray would later change their impression (if they re-examined the image) up to 8% of the time. A different radiologist might disagree up to 15% of the time. These phenomena are referred to as intra-observer and inter-observer variability. This is why a second opinion is so important, and multiple second opinions should always be sought, if time and resources permit.

Ironically, the author (a doctor himself), explains his biggest medical regret as a fusion he had done on his lower back. The book was written in 2007 - it would be interesting to know his opinions on ADR. I imagine he might be an advocate.

The bottom line: You can never guarantee a diagnosis or recommendation, you can just maximize the odds. As a patient, you ideally want 3-5 experts in agreement about your general treatment plan (though they may disagree on smaller issues).

[Cynlite]

DrewDotNet, thank you for your very insightful post! It really emphasizes how important it is to suck it up, deal with the pain and not go with the first surgeon that wants to do surgery on you. Easier said than done I certainly know. People have this blind faith in doctors that is often to their detriment. I just try not to be one of them! I think it's easy to fall into the trap. What has me concerned lately is the build up of scar tissue that does not show up on MRI's or X-Rays. I've had four minimally invasive surgeries on my neck already. I'm not sure if there is a scan out there that can help the surgeon to anticipate what he'll run into once he opens me up.

Laura, I so appreciate your posts! Reading your list of symptoms revealed so many similarities to my own experience. I still have not found a surgeon that will agree that my leg problems are related to my cervical spine. Also, I laughed when you said you became a nuisance to the insurance company. I KNOW HOW TO DO THAT! I also may hire an attorney if I'm not feeling up to the task. I'll cross that bridge when I get there. Your last comments about Dr. Bierstedt were interesting. I'm so glad he got the M6-C into your C6-7 level. Wow, that must have been unsettling going into the surgery and not knowing the expected outcome. I'm so glad that most of your pain issues have been resolved! It gives me hope.

Today is a big day for me. I finally have my appointment with the surgeon at the Barrow Institute in Phoenix. Hopefully, I'll report back with a positive experience!

[Cheryl0331]

Originally Posted by Cynlite

Not quite sure how to link people into threads yet. I just posted some information you might be interested in reading.

https://www.adrsupport.org/forums/f6...45/#post109613


Note to information in post above: I believe that surgery in the UK will be more expensive than Germany or Spain so, Dr. Dare will fall to the bottom of my list. He took over some of the patients for Dr. Nick Boeree who sadly passed in 2011 and was considered one of UK's finest.

yeah the exchange rate is not good USD to British Pound at the moment. The Euro is way better. It was 1.34 to 1.00 Euro last May and now it's 1.09.