Ian Valerio, MD, Plastic and Reconstructive Surgeon, The Ohio State University Wexner Medical Center talks about TMR and how it helps amputees.
Interview conducted by Ivanhoe Broadcast News in March 2019.
What is TMR? And What does it stand for?
IAN VALERIO: Targeted muscle reinnervation, TMR, is a type of surgery in which a nerve is cut – for example, in an amputation we look for a target motor nerve and muscle surrounding the area where that nerve has been injured. We target a specific muscle, hence muscle, and then reinnervate by hooking the peripheral nerve up to the motor nerve. It sends new signals as the nerve regrows and thus reinnervates the muscle, hence targeted muscle reinnervation.
What does the rewiring of nerves do for a patient?
IAN VALERIO: Think of a case where an electrical wire is cut outside. If that electric wire falls down, it causes shock, burning sensations or elicits that type of reaction. You don’t want to touch a power line when it’s down because it can shock you or burn you. When we have a nerve that’s cut, it acts the same way. It can form a neuroma and cause a neuroma pain; that’s one type of pain. A second type of pain is a phantom limb pain which is often described as a burning, shocking type of sensation when a peripheral nerve or nerve in your arm or your lower extremity is cut. A third pain is called residual limb pain, which is pain in your amputation stump that can be caused by bone type pain, soft tissue type pain, or scar pain; but this also has some neuropathic or nerve related pain association with it. The fourth type of pain, which really isn’t a pain, is called phantom limb sensation. This is when a limb, such as the foot or the hand, has been amputated because of disease, such as cancer, trauma, congenital reasons, diabetes, or peripheral vascular disease. When patients lose a limb, they say, they still feel like they have their hand or foot. It doesn’t hurt, but it’s there. It doesn’t bother them; they just always feel it. We’re trying to prevent the first three things with targeted muscle reinnervation because we don’t want neuroma pain to come, so we want to prevent a neuroma formation, and we also want to prevent phantom limb pain, because it inhibits people’s ability to sleep and activities of daily living if they’re trying to function. Something that can also inhibit their ability is a prosthetic. Another byproduct of our surgery we’ve seen that we can reduce is residual limb pain, which allows for a patient not only to tolerate their prosthetic more but also have less pain and wear their prosthetic much longer than they could otherwise. This is what we’re trying to affect when we do the surgery.
With each of these cases, it seems like there’s a significant barrier, in terms of quality of life, towards recovery, isn’t there?
IAN VALERIO: There can be. If you look at the historical rates of phantom limb pain or residual limb pain in patients, it’s upwards of 76 percent of patients have those type of pains. That is important because it can be quite debilitating for these individuals as it inhibits their ability to use a prosthetic effectively or optimally; it causes them prolonged time outside of their prosthetic due to the fact that they can’t work because it aggravates them or up-regulates these pain problems. It can inhibit their ability to tolerate sleep or be able to have a good night’s sleep, and more importantly, it can cause them to need multiple different pain modality medications. This could be narcotics, neuro modulators such as gabapentin or lyrica, and or other type of medicines that can make them drowsier in an effort to help their pain. Unfortunately, the side effects of these medicines can actually be quite problematic.
Prior to this surgery, how did patients control that pain? How did they get around it?
IAN VALERIO: Oftentimes it’s a lot of poly pharmacy. There are other type of techniques, such as mirror therapy, physical therapy, rehabilitation measures, sometimes tens, which is a way that they can stimulate the nerves to hopefully reduce the nerve pain. Nerve blocks is another way that people have done it. Brain stimulators or spine stimulators – hopefully spinal cord stimulators to lessen the pain. These are all modalities that have been used, but what is not being talked about as much as what we’re really proposing here, is doing a peripheral nerve surgery at the initial index amputation to lessen the severity of pain and then be complementarily reduce their pain from 76 percent, as we talked about earlier, to what we’re seeing as less than 25 percent have. Neuroma pain, phantom limb pain, and/or residual limb pain after. In fact, neuroma pain is almost always cured by this surgery as long as you do this to the right nerves. Phantom limb pain has been reduced by more than half of the historical controls in all the research studies we have done. This is also the case for residual pain. Both types of pain have been measured and reduced by half.
How long and complicated is the surgery? And are there some patients for whom this is a better bet than others?
IAN VALERIO: In terms of how the surgery works, if you take that analogy earlier when we talked about cutting a wire and the wire outside falls the ground making it an electrical wire, how do we control that situation? We take that wire, splice it to a new wire, re-bring its continuity or hook it back up, and therefore the electrical discharges don’t occur because they have somewhere to go; we’re delivering that energy or electricity down that cable and we’re hooking up that cable so it can go somewhere where it’s needed. This surgery is the same thing. We’re taking that cut peripheral nerve that now has nowhere to connect to; it’s basically transected. Bringing a new cable to hook the cables back up so it can conduct and cause a feedback circuit that tells us, I’m hurt, but I’m better than I was because I’m now fixed; this is how the surgery works. The length of surgery depends on the number of nerves you have to do this to in the limb, and it varies depending on if it’s a below knee versus above knee, transradial or forearm amputation versus transhumar, which is above elbow amputation. On average, the surgery can range anywhere from an hour to two hours, depending on how complex the injury pattern is in the patient. The other thing that we do is we avoid a second surgery potentially; if we wait and to do the TMR surgery until later on, which is how it was traditionally done, you have a second surgery, which results in a delay in the time it takes you to recover from surgery, as well as adds extra cost, to the patient, to the system and to the financial structure. If a patient waits, it also inhibits their ability use a prosthetic because they have to take a timeout while they get their second surgery.
Do you do the additional procedure at the time of the initial amputation?
IAN VALERIO: Yes, we do both. Our standard, when we can, is to do it at the time of amputation. However, sometimes that can’t be done. For example, if you have a bad infection, have bad soft tissue, or crush injury that has to declare itself, then I may elect to do it later on. We do know the earlier you get it done the better it is with regards to your pain scores. However even if you’ve had an amputation one, five, 10 years ago, it can still greatly reduce your phantom limb pain and your other pain scores. This information is in a few of the articles we recently.
Is there anyone for whom this wouldn’t work or is there a time frame?
IAN VALERIO: Not really a time frame. I’ve operated on someone whose amputation had been 20 years prior, and they still benefited from the surgery. However, their benefit is a little less; instead of the four-time improvement that we see with immediate TMR patient, it may be two times the improvement. If you wait, you don’t see quite the dramatic improvement you’ll see if you get it right away, but it’s still a significant enough improvement; 50 percent to 100 percent improvement, that patients will tell you they never regretted having this surgery even later on. Most people weren’t doing this surgery in the past, making this surgery not an option for patients that had amputations that were long ago; since this is a newer type of procedure that we’ve adopted. Nowadays this is an option for treating amputees. My hope is that all patients not only get the surgery that they need going forward, but even those that have had amputations that may need it now due to neuroma pain or ongoing pain problems, such as phantom limb pain or residual limb pain. I hope they will come to Ohio State or elsewhere to, of course, get these measures addressed.
Are you one of the few groups doing this now? Are you teaching? Is it spreading?
IAN VALERIO: Yes, to all of the above. There is a neuroma group and research group of ours that we’ve formed that’s a team doing TMR surgery or targeted muscle reinnervation for amputees. Walter Reed Bethesda and San Antonio Military Medical Center are two of the military facilities doing this. Northwestern University in Chicago, Massachusetts General Hospital, and Ohio State University are doing it as well. We are all in a collective, and we’ve agreed to share our information – open book – with regards to research and make sure we communicate with all these centers, and we’re the leading centers in this. However from this, we did two things. We also started forming satellite programs at different hospitals. Some of my graduates from our program here at Ohio State, have gone to Milwaukee, Texas, Florida, and other southern and western regions and started a program. It’s starting to expand now and evolve from what was learned here. The other thing we’ve done is, we recently started to do cadaver as well as live surgery generate demonstrations. I’ve had patients as well as providers from Australia, Britain, and Canada come here to Ohio State and learn these procedures from me. We are doing a formalized study that’s actually DOD sponsored at Northwestern, and I’m one of the instructors along with Greg Doumani in there. We have other people that are interested in learning this technique fly to Chicago, we do live surgery there and we do cadaver demonstrations as well. We’ve hit this from all ends; papers that we’re publishing as well as expanding with regards to our footprint with graduates from our programs and doing live demonstrations at the respective centers. Walter Reed does this, Northwestern does this, we do it here, and of course we have the formalized cadaver program.
How many patients do you think you’ve helped since 2015? How many surgeries have you done?
IAN VALERIO: For targeted muscle reinnervation, specifically, well over 100 now. I’ve done well over 200 in my total career, when you look at my military time as well as my time at Ohio State. In my overall career, I’ve done thousands of surgeries on many different patients because I have a very robust practice. However, when it comes to this specific surgery, at one time, when I started learning this procedure, there was less than a hundred done in the world. We’re probably looking at well over a few thousand done in the world now as we’ve gone and expanded this.
What kind of impact does this have on people’s lives? What difference is this making?
IAN VALERIO: I think a lot of our studies have shown the great reductions in pain these patients have, as well as, the increased use of their prosthetics that they’ve entertained, as well as going back to work. A number of our amputees, even those that were out of work for a while with pain control issues, went on to have this surgery and now they’re off pain medicines and back to work. It has been a huge success for a number of patients. On average, we see about 10 to 15 amputees a week that have had or are going to have the surgery, and the stories have all been very similar for those that have had the amputation longer than immediately. Those that get secondary TMR have been depressed, down on their luck, been shunted through a lot of different medical systems, saying there wasn’t much they could do to help them. When they find the solution – and if they’re a correct and applicable candidate – they greatly benefit. I saw seven or eight this morning that said, it’s changed my life completely, I’m not on narcotic meds anymore even though I was routinely on that, and I’m back to work or I’m looking for work or doing other things. To them, they’ve already met those criteria as well succeeded. One of the patients we’re going to see today is an immediate TMR patient. This patient actually had a trauma, had to lose a limb, and was elected to go TMR surgery at the time of amputation. What you’ll see is, within six to eight weeks they’re typically fully recovered and potentially back in society and interacting with less pain medicine requirements. What we’ve found is if you get TMR at the time of your amputation, at about three months, most patients are completely off narcotics, and at one year about 75 percent are on no medications – meaning no number of modulators – or narcotics. We did another recent study that’s yet to be published here, it states that about 40 percent of amputees are on narcotics and about 80 percent are on some type of modulator even up to 10 years after the amputation. We’re seeing much less rates than that long term.
You mentioned the patient we’re going to see, Emily. Can you tell us anything about her?
IAN VALERIO: Yes. She’s a young female that was in a bad car accident, she suffered a devastating injury to her left lower extremity, a crush injury, and it was deemed an un-limb salvageable type case. In other words, not able to save her foot. She underwent a below knee amputation and, of course, a very life changing event for her but she was pretty strong with regards to her recovery. She had a number of different things that she had to work through during her initial traumatic injury phase when she was in the hospital, and through that time that we talked with her, she ended up getting her prosthetic work done with Optimus prosthetics, which is one of the small local prosthetic manufacturers in the Ohio- Columbus, Ohio area. She’s been able now to recover and has been a big advocate and does a lot of amputee advocacy efforts for people in the area as well as nationally. More importantly, she’ll tell you that her pain has been dramatically affected by this and as they talk to patients that have had the surgery, they start to see the real impact it’s hard for them. I think that the story is, how can we actually go further? One of the things that I’ve heard is helping physicians and surgeons reach the next milestones or opportunities is this surgery. We are evolving the way we treat performative injuries so that we can get better outcomes and specifically reduce pain for these patients.
Is there anything I didn’t ask you that you would want people to know about this procedure and its benefits for patients?
IAN VALERIO: I saw Mr. H today he was a sarcoma cancer patient that had to undergo a fourth quarter amputation. He pulled me aside today, as well as Julie, my P.A, and said the remarkable thing about the surgery is I didn’t realize the impact that it would have to me even three years now after this. What he’s referring to is, he has no pain, he can wear an advanced bio prosthetic, and his prosthetic works better today than it did three years ago because, as that TMR has aged or matured with him, he learned how to control it even better. He said the other remarkable thing is because it’s taking away the phantom limb pain, he still has some phantom limb sensation which are remarkable as it can mirror his prosthetic arm as he uses it. He can actually now, when he grabs something, feel from improper substrate feedback, his hand that’s now missing but robotic, can feel some type of touch. I think that’s what he’s seeing is that not only is it helping with pain control, but he’s getting some feeling; a touch back that gives him that human nature or element back.
END OF INTERVIEW
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