North American Spine Review: 0% Chance of Worsening-Really Guys?
I met with a long-time patient this past week who is an insurance agent who loves acrobatics. She is one of those few patients who I thought could benefit from disc bulge surgery on her neck, so I had given her a few referrals. She came back asking about a clinic I hadn’t heard of before and told me the most concerning thing I had heard in 26 years of practicing medicine. The physician’s office had told her that their minimally invasive spine surgery had never made anyone worse! Hence, I proceeded to write this North American Spine review for my patient.
This is a patient who is middle aged and still doing high level athletic things. When she doesn’t do these things, she’s fine and we’ve been able to help her arm and shoulder symptoms with various regenerative interventional orthopedic procedures. However, when she does what she wants, which is more than 99.99% of people her age, she gets arm symptoms from a combination of scoliosis and a bulging disc in her neck. Hence, I referred her to a surgeon we’ve worked with in California who does a true minimally invasive spine surgery using a scope. She came back with another clinic name, “North American Spine”. I had never heard of this clinic and wan’t really too focused on wanting to know too much about them until this very credible patient said something that sounded to my medical ear like “the sky is green”. She relayed that she had spoken with people at the doctor’s office several times and that they hold told her there was 0% chance of getting worse after the procedure. She hadn’t spoken to the doctor, as the clinic didn’t allow this to happen, but she wanted to know what I thought. It took me about a second to say, “There is no medical procedure ever devised by man that has a 0% complication or worsening rate!”
So who the heck is North American Spine and why would they tell an intelligent professional woman that there is no chance of her getting worse? It took me a few seconds through Google to find out the following:
1. There is no doctor to speak to at this “clinic” because the company is a marketing group of businessmen formed to sell procedures, collect the money, and then assign an unrelated doctor to do the procedure. Hence, she was never speaking to a doctor’s office.
2. The 0% chance of worsening has been disputed by multiple lawsuits against the company and it’s doctors. Patients have claimed that they not only got worse, but more significantly, that they have suffered paralysis and bowel and bladder problems. The Korean paper on the company web-site that reports on a case series of patients who had the company’s Accurascope procedure backs this up. The paper reported just under a 30% complication rate! This included new nerve symptoms down the leg, and foot drop that took 6 months to recover! In addition, one patient had a serious infection (meningitis) and 3 patients had other infections.
3. The procedure uses a scope to insert a catheter that can cut out or Laser out a disc bulge. The Korean research published on this technique on the company’s web-site (a case series of 109 patients) isn’t really consistent with the marketing on the front of the web-site, which touts an 82% “success rate”. This paper shows that around 2 years after the procedure, 32% rated their post-operative condition as “Excellent”, 24% as “Good”, 26% as “Fair”, and 18% as “Poor”. The marketing business guys didn’t report this as a physician would, that based on this data 58% (Excellent 32% + Good 26%) had a successful outcome, instead they added in the 26% of patients who reported their condition as “Fair” to get to 82%. Pretty sneaky, as any patient that tells me that did they “Fair” with their procedure I wouldn’t consider a success. So a procedure that works slightly better than 50/50 now looks like it’s a home run!
4. If we look at patient reported pain data from the Korean paper, this falls into line with the procedure success data. Pain before the procedure was 7.6 out of 10 and then 3.6/10 after the surgery. That’s on average about a 50% improvement in pain.
The upshot? So much for 0% worsening and complications! The Korean paper on the web-site shows that many patients experienced complications. It also shows that the results on the web-site were over-rated compared to the results found in the research paper listed on the site. More importantly, for my patient, the story told by the business guys trying to sell procedures to patients isn’t consistent with the medical reality described in the research. So would I recommend this procedure to the few patients every year we can’t help without surgery? Possibly, but here are my concerns:
1. The procedure looks like it may help some patients, but it has a complication rate like any medical procedure ever devised.
2. From speaking with my patient, the format of the company doesn’t allow you to know which doctor will be performing the procedure, only that your doctor will be “board certified”. Since that board certification is likely to be pain management, which as a base board has little to do with the Accurascope procedure, knowing the doctor and his or her experience level with the procedure is critical. This would extend to finding out about prior lawsuits for that provider. So without being able to speak to Dr. X and being able to research that physician before you commit, I would tell my patients to steer clear.