Current Spine Intervention Innovations

[Michael Barraza]
I want to ask you about your new book. It's titled Vertebral Augmentation: The Comprehensive Guide to Vertebroplasty, Kyphoplasty and Implant Augmentation. It was published in March, and our listeners can find it on Amazon and Theme.com. How did you put this together and how is this different from standard textbooks on the topic?

[Douglas Beall]
I put it together by doing years of education. We teach people vertebral augmentation techniques, and I've done it for a long time...For teaching curriculum, you have the approaches, and you have vertebroplasty, balloons, implants. You have the usual, typical stuff. You have the prevalence, but what you don't have is questions like how much cement should I put in the vertebral body? I see the patient back. They still have pain. Now what? When should I really choose kyphoplasty versus a vertebroplasty, or does it matter? I try to reduce the height and re-establish, but does that really matter? When should we treat people? Why should we brace people? What data is there behind that, and so forth… The answers to all of these questions, I comprised little Power Points, and I put them in a big file. For every question somebody had, I would shoot them a Power Point like with here's the answer and here's the evidence behind it. By doing that time and time again, there's a grouping of about 25 or 30 questions that are common focuses that are the typical ones that people always ask about. For years, I would just keep up with the literature and every time I found something interesting, ground-breaking or earth-shattering, I would absolutely add it, and I would maintain the evidence and maintain the story in that Power Point… I essentially took those Power Points and made them into a book. This is the real how-to. Hopefully, the Vertebral Augmentation Comprehensive Guide, will answer every question that you have. It even has a chapter of the Masters of Vertebral Augmentation. I put stuff in here that has not been published. For example, thoracic pain after fixing mid-thoracic fractures. A guy named Fergus McKiernan described it originally as postural fatigue syndrome, and I want to credit him for that, but he never published it. He never wrote about it. We have a whole chapter in there about postural fatigue syndrome… It's not an exhaustive resource. It's a book that, if you're really interested in upping your game and doing the best possible augmentation, being the best at it, this is your book. It'll tell you exactly how to do that. It'll give you tips and tricks, most of which are in the literature, some of which is not.

[Michael Barraza]
It's got stuff on RF ablation and dorsal root ganglion stimulation. It's deeply comprehensive.

[Douglas Beall]
I made the decision to resurrect a fellowship training program and to start posting these things [on social media]. I've been pleasantly surprised. They've been very well-received. I get the occasional blowback from spine surgeons and some of the other people that say we shouldn't be doing it. One of the other reasons to investigate, to be all in, for research and Level 1 data is because you can respond to that by saying, "You shouldn't really rely on your non-randomized, non-placebo control study of your own opinion, because we've got data that says that what we're doing here in this particular case is not only better than the traditional thing. It's a lot better.” For example, fusion for disabled discogenic back pain. A good to excellent surgical outcome is 33% reduction in pain, which is crazy.

[Michael Barraza]
Doug, what advice do you have for interventionalists out there who are looking to learn procedures like spinous process augmentation or the basivertebral nerve ablation?

[Douglas Beall]
The first thing I'd like them to know is that it's not that hard. It's really easy to do these things. Spinous process augmentation is done in concert with putting in interspinous decompression spacers. Subsidence of the implant into the spinous process will cause symptom recurrence, so I learned this technique from a guy named Luigi Manfré. His Italian practice is in Sicily. First time I saw it, I thought, "That looks like something that would really work," because early on doing X-stops, interspinous decompression spacers that were done open, I had a problem with subsidence. I would say we have a problem with subsidence. I'd get very little uptake on this, but later, we knew that to be the case. Luigi did a paper of 688 patients, 256 people did not have spinous process augmentation. The rest did, and used symptom recurrence. That's it, just symptom recurrence as the only method of measurement. He found symptom recurrence in 11.3% of the ones that did not have spinous process augmentation and less than 1% in the ones that did.

[Michael Barraza]
Wow.

[Douglas Beall]
Yeah, and this came out this last year. Once it came out, you take one look at the paper and you're like, "Yeah, of course. Duh," as my daughter says with an eye roll. It should make sense. For spinous process augmentation, I developed a kit because we don't really have anything formal made for it. We just cobble things together. I used to use a 14-gauge Bonopty and some verticum 2 cement. Now we actually have a kit that we made through a company called IZIO with a 13-gauge needle that has a ruler lock on it and some plastic 1cc syringes that are easy to control. You don't need that much cement. You need it to be cheap, and you need it to be effective. This is something that's very easy to learn, super easy. It's right up there with basivertebral nerve ablation. Compared with stable discogenic back pain treated with fusion, it's about 50/50, 50% of the people improve and 50% don't improve or get worse. It takes 12 weeks to recover from. You're not yourself again for a year. As I mentioned, the pain reduction is less than optimal. What I didn't mention is about one in five patients will have additional surgery within four years. That's based on the Vermola data. Compare that with basivertebral nerve ablation, which has about a 70% to 75% response rate. On the average, they reduce their pain about 75% and it appears to be durable or permanent. You do that, similar to a vertebral augmentation technique. It's not even an incision big enough, you get a suture or staple. It's no comparison for efficacy, no comparison for durability and level of invasiveness. Anybody that does augmentation can do basivertebral nerve ablation. It's just a matter of targeting and bone. It's really simple. The difference between RF ablation in-bone and outside of the bone is it appears that the nerve doesn't grow back, which is a good thing.