New and Need Info on 3 level ADR

[FS]

Hello,
I'm fairly new to this site, never posted before but have spent many hours reading, sympathizing and seeking information to make infomed decisions. I've been told that I need a 3 level lumbar fusion, L3-L4, L4-L5, L5-S1 for DDD/3 herniated discs and 3 nerves effaced/compressed. I left the doctor's office in tears the day he told me this was all he could do for me, but by the time I got home I decided that I would not allow someone to perform a surgery that would leave me with this kind of significant limitation for the rest of my life. (I'm still a young/fit forty something, ok, 52 year old woman trying to hang on to my mind and my humor) This is when I began my research. I have recently sent my MRI, CT/Myelogram films to Dr. Delamarter in California, Dr. Blumenthal in Texas and Dr. Bertagnoli in Germany. So far, I have only gotten a response from Dr. Blumenthal who says he needs a discogram of 4 discs (the 3 noted above + L2-L3)and dexascan before he can give me his recommendations. Hope to hear from the other two docs very soon. One question I have at this point, that I have not seen addressed is: if I were to have my surgery with Dr. B in Germany and for some reason needed some kind of revision, would a doctor in the US be willing to help me???? I realize that I am looking at MAJOR surgery at this point, unlike the discectomy on L5-S1 I had in 2006, and I am struggling with WHO is the best doctor for someone like me who needs multiple level solutions/ADR and would it be in my best LONG TERM interest to have surgery in Germany? Weighing options in pain is proving to be very difficult and any feedback/personal experience would be greatly appreciated.
Thanks,
FS, waiting for relief in Georgia

[Harrison]

Hi FS, welcome to our community. One thought for now -- it is quite possible that each one of these experienced doctors could give you a very different solution to your spine problem. It is wise for you to be proactive in that regard.

You've asked some tough questions, but folks that have worked through some of these challenges will hopefully chime in with their ideas and learnings.

I'll post again soon.

[Lisibug]

Hi FS. I'm sorry to hear you need surgery. You're checking out great docs. I looked into Dr. Delamarter too, but as my insurance wouldn't cover anything, he would have been more expensive than Dr. Bertagnoli - plus, Dr. Bertagnoli obviously has far more experience that Dr D with this particular surgery. Just to warn you - Dr. B's office takes awhile to get back to you - and Dr. Fenk-Mayer, Dr. B's right hand spine surgeon will get back to you. I liked her very much. I was thrilled with the care I received there and am happy with my results.

There is one other doc you may wish to consider - Dr. Zeegers, also in GY. I have heard recently that he is cheaper than Dr. B.

If your insurance will cover Dr. Delamarter, I have only heard good things about him and know people who have had surgery by him with very good result. A relative of mine had a 2 level ADR done by him two years ago (cervical) and is entirely pain free.

It's a tricky thing about the follow-up. For me, my NS here (he performed my fusion 2 years prior to my 3 level ADR at adjacent levels) said he'd see me in follow-up even though he doesn't perform these surgeries. However, if I had any problems, I'd go see Dr. Delamarter and pay out of pocket. That is what I've decided for myself. Not easy to work it all out, is it?

[FS]

Thank you Harrison and Lisa for your replies. Yes, I know I have some difficult decisions ahead of me. I too have read that Dr. Zeegers in Germany has quoted lower prices. I will be sending my films to him as well. I'm still waiting to find out about how my surgery will be paid for. This is a WC claim and my attorney does not think they would be willing to cover this surgery in the US, much less Germany, so I will asking for a settlement based on the costs of 3 level fusion, out of work for 1 year, the probability of subsequent surgeries and catastrophic consequences. Attorney thinks this this will add up to a pretty big claim and that it would be in their (WC) best interest to settle with me. In the event this doesn't happen, then I will ask them to consider ADR and will go from there... Just found out that in the mean time WC is asking for a 2nd opinion, but that this is routine because it is such a big claim. Not that I like cruel and unusual punisment, but I will be asking that the 2nd opinion doc do a discogram and dexascan so I will have these diagnostic tests that appear to be required by everyone. From everything I've read...not looking forward to the discogram at all. Thanks again for you feedback.
FS

[JudyW]

Just a quick note...mine was workers comp. and I got them to go for it. ADR Prodisc at L4-5. Of course mine is only one disc. Just FYI.

[snapoutofit]

Hi FS,

Regarding your question about care after Dr. B. I am going to Dr. B in less than 3 weeks for a 2 level ADR. I have been unable to find a neurosurgeon here in CLT who is willing to follow up with me. In fact, the doctor who is considered "top" in this area and has been recommend to me by patients both on this site and off told me that "he was so good at what he does that he's too busy to follow other doctors patients". He didn't think I was making a bad decision by going to Dr. B but won't treat me afterwards.
Nonetheless, I'm going, hopefully to the best doctor in the world and won't need a neurosurgeon here. I just had to weigh the pros and cons and went with my gut. I am, however, scared to death as this point as this is our life savings and we cannot afford complications.

I just wanted to share my experience to let you know that your concerns about follow up care are extremely valid.

[FS]

Judy,thanks for the heads up on getting your ADR paid for by WC. Don't know if it's different from state to state, but I would bet CA is a bit more open minded and progressive on these kinds of things.

Thanks for your sharing Snapoutofit. I wish you the very best on your journey to Germany and in your recovery!! I hope to be able to join the ranks myself....
FS

[snapoutofit]

Your Welcome - if you have any questions feel free to PM me. I haven't been checking in as often. Now that I have made my decision I find it hard to read about the "cons" of my choice. Although I am well aware of the negatives and everyone is so supportive I've had to stay away a bit.

Good luck to you - I know how brutal the whole decision making process it, enough to make you insane. Or me anyway.

[Slackwater]

Originally posted by FS:
Hello, I'm fairly new to this site, never posted before but have spent many hours reading, sympathizing and seeking information to make infomed decisions.

I got home I decided that I would not allow someone to perform a surgery that would leave me with this kind of significant limitation for the rest of my life. This is when I began my research.

Agree, ADR may be an alternative. Your research will increase your confidence level in your decision process. You might be a combination of fusion L5/S1 & ADR L3/4, L4/5. Stay flexible on the options.

Results from Fusion or ADR vary from "success" in to "adverse events". Please read the below on multi-level ADR from the NASS annual meeting if you have time.

I reset my sights to be a datapoint in the continuum of outcomes over time. I reset my sights to a modestly positive outcome. That being said, I spoke with SimonW a two-level ADR patient, done Feb 2, 2007. He raced a sailboat out in the ocean April 2007 and I saw him racing again last weekend. He is a ~successful outcome.

Dr. Blumenthal who says he needs a discogram of 4 discs (the 3 noted above + L2-L3)and dexascan before he can give me his recommendations.

Get the Tests. Doctors are scientists who need the best data to make informed decisions.

if I were to have my surgery with Dr. B in Germany and for some reason needed some kind of revision, would a doctor in the US be willing to help me????

Valid Question. I ask myself the same question, but I don't know the answer.

Suggest ask the question of Dr. Bertagnoli's office, for a referral suggestion. You may be able to find an ADR surgeon in your region, possibly from the medical literature. Put your question in writing and send it to your regional ADR surgeon. Fax the question to the surgeons' offices. A possible(?) in Florida is the gentleman that initiated the Braun, Aesculap Implant Systems "activ-L" FDA clinical trial in Florida, Dr. Roland Garcia, at Aventura Hospital, FL and listed here. I think Dr. Garcia was also a contributor in the Charite FDA clinical trial. I am out of context with the region around Georgia (forget things, drugs, ...), but I recall Dr. Bitan / NY, does ADR surgeries. He is published so contact data is somewhat available.

ADR insurance coverage may/will influence your local orthosurgeons practice(s). No insurance payments, then maybe no local practice in ADR. Orthosurgeons are not likely to train and have #'s of cases if insurance does not cover the surgery. It's changing, but realistically, 3-level ADR coverage by an insurance company is pushing the limits. My insurance covers single level ADR only in their published coverage position and it still requires appeals; figured I will have to pay for it myself.

I thought a work-around might be getting a ProDisc in Europe as it is US FDA approved, but I do not have the great answer. Posed the same question to the best fusion surgeon I met with and he cautioned me about revision based on his fusion experiences. His surgical practice has a measurable number of fusion revisions. Aesculap "activ L" is an alternative with Dr. Zeegers in Germany and there is an "activ L" FDA Clinical trial going on now.

Bottom Line: (02.03.08 add)
3-Level ADR will probably require FDA letter/release under compassionate use(?), I think.



================================================== ===================================

Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S

P115. Up to 5-year Prospective Results of 1, 2, and 3-Level Lumbar
Arthroplasty with the ProDisc-L Device at a Single Institute
Rick B. Delamarter, MD1, Hyun W. Bae, MD1, Lea Kanim, MA1, Michael
A. Kropf, MD1, Ben B. Pradhan, MD1; 1The Spine Institute at Santa
Monica, Santa Monica, CA, USA

BACKGROUND CONTEXT: Artificial discs have been approved by the
US FDA as an alternative to fusion in intractable degenerative disc disease.
The ProDisc-L is the only device designed and tested in the US
clinical trials for multi-level (1 and 2) degenerative disc disease. Understanding
the benefits of arthroplasty, it is even more advantageous over
fusion when it comes to treating multiple levels, since multi-level fusion
can be considerably more morbid and stiffening. 3-level lumbar arthroplasties
have also been performed under a ‘‘compassionate use’’ allowance
by the FDA.

PURPOSE: Longer term follow-up of multi-level lumbar disc replacement.

STUDY DESIGN/SETTING: Prospective single-center study.

PATIENT SAMPLE: Patients with lumbar arthroplasty at a single institute
with the ProDisc-L device.

OUTCOME MEASURES: Oswestry Disability Index, Visual Analog
Scale for pain, Visual Analog Scale for patient satisfaction, and flexionextension
range of motion.

METHODS: This is a prospective study of 252 patients with lumbar
arthroplasty at a single institute with the ProDisc-L device. There were
116 1-level, 109 2-level, and 27 3-level implantations. Follow-up is up
to 5 years now, and the results are reported in terms of Oswestry Disability
Index, Visual Analog Scale for pain, Visual Analog Scale for patient
satisfaction, and flexion-extension range of motion.

RESULTS: As reported in the past for earlier follow-up, the improvements
in disability, pain, and patient satisfaction continue to be maintained at final
follow-up for 1, 2 or 3-level disc replacements. VAS and ODI scores
are 50% or lower from preoperative values at 3 years and beyond for 1,
2 and 3-level ADRs. There is actually a trend to increased benefit after
multi-level arthroplasty, which correlates to increased preoperative disability.
There have been no device-related complications, although there have
been a handful of reoperations which will be illustrated. No adjacent segment
problems have been detected yet at 5 years.

CONCLUSIONS: The results indicate that lumbar arthroplasty with the
ProDisc-L device has shown significant benefits in pain and disability reduction,
is holding up to the test of the rigorous USFDA standards, and
holding up to the test of time thus far at about 5 years. Multi-level arthroplasty
has obvious advantages to multi-level fusion, and DDD is unfortunately
often not isolated to a single level at L4-5 or L5-S1. This device
appears to be well-suited for this scenario.

FDA DEVICE/DRUG STATUS: ProDisc-L: Approved for this indication.

[Lisibug]

You mentioned being nervous about the discogram. I had my 3 level cervical ADR performed in 3/07 by Dr. Bertagnoli and his team. I was scheduled for a discogram the day prior to the surgery. I was more nervous about the discogram than I was about the surgery because of all the horror stories I have heard. Well, 3 spine surgeons performed my discogram, Dr. Fenk-Mayer, whom I like tremendously, was the head surgeon. Apparently I have unusually strong shoulders and they spent about 1/2 hour pulling my arms and shoulders down and around to try to get to where Dr. F-M could get a clear shot at my C6-7 level. It didn't hurt and was kinda funny. Anyway, Dr. Minter(?) was pulling my arms down and Dr. F-M put the needle in. It hurt, I let out a moan, but within seconds the pain improved tremendously. Then she did the same thing at another level, same result. This was of course, all done under fluoroscopy. After that I went back to my room, not really much extra pain. About an hour later I got a rotten headache, which I was prone to anyway, and took my meds. I was very surprised that it was a much less traumatic experience than I expected. I think the skill of the surgeon(s) has a lot to do with it.

Just thought it might be good for you to hear a positive discogram story!

Most importantly, again, I wish you every success in finding a surgery and surgeon you feel comfortable with, resulting in a very positive outcome. Hope you end up feeling a whole lot better.