Evo Terra (Host): This is Check-up Chat with EvergreenHealth. I'm Evo Terra, and I'm joined today by Annie Wong, a licensed occupational therapist, and a neurologist, Dr. Sheila Smith, for a discussion about transforming post-stroke care with Vivistim. Dr. Smith, Annie, welcome to the show.

Annie Wong: Thank you.

Sheila Smith, MD: Thank you. Thanks for having us.

Host: So Dr. Smith, I'll start with you. What is Vivistim, and how does it work?

Sheila Smith, MD: So, Vivistim is a vagal nerve stimulator. Vagal nerve stimulators have been around for quite some time. They've been used for epilepsy and depression treatment. Vivistim is a very specific type of vagal nerve stimulator that was developed for stroke patients who have paralysis of an arm that has persisted after their stroke.

And how the device works is that the device is implanted in the chest wall, and there's a lead that connects to the vagus nerve, which runs in the neck. And by stimulating the vagus nerve, signals are sent to the brain, which then lead to an increase in neurotransmitter release. And what scientists have discovered is that when you stimulate the vagus nerve and there's neurotransmitter release, that doesn't necessarily help stroke patients.

However, if you pair that with intense occupational therapy, that the two of those things together help increase motor pathways after stroke. So, how that works is that an occupational therapist will deliver stimulation through the device while a patient's doing repetitive motor task. And that leads to encoding in the brain in the motor pathways and what we call an increase in neuroplasticity, which is an increase in synapses in the brain. So, there's actually reorganization of motor pathways by pairing these two things together.

Host: Quite interesting. The fact that you do this while there's an occupational therapist, and which is why we have Annie on the show as well. So, maybe, Annie, jumping in here to you, what does that look like when you're working with the neurosurgeon? What's going on with you and the patient?

Annie Wong: I'll first back up and say that, traditionally, from OT's standpoint, we would have patients engage in repetitive motion and repetitive tasks to stimulate neuroplasticity in the brain, kind of like what Dr. Smith was just saying. But that initiation activation of movements, it triggers a chemical process within the brain to just help strengthen those nerves to sync up, which strengthens the pathway from the brain to that hemiparetic part of the body, therefore increasing function.

And also, depending if the patient's appropriate, sometimes we use Kinesio tape, sometimes we use NMES or like a magic vibrating massager over the targeted group of muscles that we are working on to try to encourage movement. And all these are very helpful, and this is like our traditional way of doing therapy for stroke patients.

However, with the incorporation of the vagus nerve stimulator implant, the biggest change is that the rate of progress and functional movement is considerably expedited. So, you know, in terms of what happens logistically in an OT session, like we continue with engaging patients in repetitive movements and tasks.

Again, we can use the Kinesio tape, the NMES, and the magic wand vibrator massager over the target group of muscles. The only difference in the actual session is that us OTs will have this little clicker button that delivers those electrical stimulations to the vagus nerve when the patient initiates a movement. So, it's very paired, just as what Dr. Smith had mentioned.

Host: So Dr. Smith, I know that we have had post-stroke treatments for a long time now. Vivistim is something new. How is it different than what has been offered to patients before?

Sheila Smith, MD: It's the first implantable neurostimulator device. So currently, occupational therapists will do repetitive tasks with patients, and we know that high-frequency repetitive tasks do work, and they do help with neuroplasticity, which again, is reorganization of motor pathways and increasing those connections in the brain. But this device pairs the neurostimulation with those repetitive tasks to reinforce those motor pathways even more. So, the other devices on the market currently are external devices, but this is the first implantable one.

Host: So, implantable means someone's got to put it in. So, how invasive is the surgery to get that implantation?

Sheila Smith, MD: Yeah, that's a great question. So, one of our neurosurgeons places a device. There's a battery pack that is placed on the anterior chest wall, kind of behind the pectoral muscles, and it's attached to a lead, and that lead is wrapped around the vagus nerve. We each have two vagus nerves, one on each side. They wrap it around the left-sided vagus nerve, and that battery pack in the chest has a battery life of about five years. So when the surgeon implants the device, they have to obviously take the patient to the operating room. It's usually a same-day surgical procedure, but it is an invasive procedure. They have to make an incision in the neck, and they do have to do what we call a neck dissection, which means they have to move some tissue out of the way to get to that vagus nerve. Most patients are able to go home same-day surgery, but we do have to worry about the usual potential complications of any surgical procedure, which includes bleeding and infection.

Host: And after the surgery is over and after, you've done the treatment here, Annie, I'll go to you. What's the follow-up? What's needed after all of this?

Annie Wong: Yeah. So, the follow-up is they will rest for I think about 10 days or so. And then, they will come to OT sessions. It is a six-week protocol three times a week, and each of those sessions are 90 minutes long. So, they're fairly long and intensive sessions. And we engage. We first of all ask patients, you know, what are their goals? What do they want to work on? And based on those goals, we kind of tailor the activities and the exercises, and those repetitive movements that ties into their function.

Host: And Dr. Smith, during these sessions, are you still active? Is it all on the occupational therapist? What's it like for the surgery side once a surgeon has implanted this device?

Sheila Smith, MD: So after the device is implanted and Annie and her team work with the patients, they're doing all the heavy lifting during that six weeks. So, patients come in, as Annie said, for intense sessions that are 90 minutes for six weeks long. After those sessions, the patients can then actually turn the device on and off themselves at home. They have a magnet that they swipe, and they can do home exercises then, and they are allowed to swipe it eight times per day. Each session is thirty minutes.

So after the intense occupational therapy sessions, they're actually doing work on their own at home, doing home exercises. But neurology is more involved upfront in screening patients and making sure that they really understand how the device works and setting expectations. But after the device is placed, they really follow up with occupational therapy the most.

Host: And, Annie, having done this for a while, what kind of improvements in their condition should patients be able to expect after that six weeks of intensive work with you?

Annie Wong: Yeah. So, it's really variable from patient to patient. The two patients that I've seen so far, they both have had high tone and just very limited range of motion. My first patient that I worked with, who was actually the first patient in the entire Northwest that has had this implant, he was able to bring his hand pretty much almost to his mouth. And so, he can actually bring a fork to his mouth, he can bring a cup to his mouth, and I worked with this man for two years prior before, and he could only get his hand up to, like, his belly button. I mean, the two years that I worked with him pre-Vivistim, pre-implant, Vivistim implant. And another huge thing is he was able to just relax his hand on command. And that is so huge because in that two years when I was working with him, it was a really, really tight fist, and prying open his hand every week was just so much effort. And so, just to see these two major improvements for him, it was mind-blowing.

And then, the second patient that I had, I think he's the third person that got implanted here in the Pacific Northwest. Again, tone, limited range of motion. He increased his function increased exponentially. I think it was like a 22-point improvement on the Fugl-Meyer assessment. But yeah, he is now able to target a door handle and open the door and open a jar. And, again, the whole, like, relaxing on command, because, again, his tone was so elevated prior to the implant.

So, it's just mind-blowing to see the improvements right before my eyes, felt right in my hands. And so, in terms of, like, how much do we expect to get back for each patient, it's going to be a little bit variable for each patient. But I just would say that the rate of improvement that I've seen, it blows my mind how much in a short amount of time we've been able to accomplish

Sheila Smith, MD: So, we've noticed improvements as well, and patients report that they're much happier after the device. They find that they can do little things, like Annie said, things that might not seem a huge gain, but they're able to use a limb more for their activities of daily living, and that's very impactful for them.

The device was developed for upper limb paralysis that's persistent after stroke. But interestingly, some patients actually notice improvement in other areas as well. One of my colleagues who has a patient that was implanted with the stimulator also noticed an improvement in the patient's speech, even though that's not what the device was approved for.

But this patient in particular already had problems with speech and upper limb paralysis. And so, when it was implanted and they went through the OT therapy sessions, there was an improvement in both deficits, which was really nice.

Host: So, I want to get to something you mentioned earlier, Dr. Smith, very briefly, and I want to talk about qualifications. You know, not every patient might be right for this. Not every stroke might be right for this. So, I'll let you begin the conversation and who's the right candidate?

Sheila Smith, MD: We would love to implant this device in more patients. But currently, the device has FDA approval for patients who have had an ischemic stroke and not a hemorrhagic stroke. So at this point in time, we can't offer it to patients who have had a hemorrhagic stroke.

And then, in terms of ischemic stroke, it's also FDA-approved for those who have had an ischemic stroke, but they have upper limb weakness that's still present, and the weakness has to have been present for six months or more.

So, it can't be someone who just had a stroke in under six months. Those patients still may get better on their own just with routine physical and occupational therapy. But if that paralysis is looking like it's becoming more chronic, then they might qualify for it.

The other important thing to know is that if patients have complete paralysis, meaning they can't move the limb at all, they are unfortunately not candidates for the device. Because if you remember earlier, we talked about the device has to be paired with motor movements of the arm.

And so if someone has no movement of that arm whatsoever, unfortunately the device at this point in time doesn't look like it would help those patients. So, we need them to be able to move that arm and hand a little bit in order to qualify.

There are some patients who have a lot of spasticity, which is really tightness or clenching of the muscles, as Annie mentioned earlier. And in those patients, sometimes we'll have our physiatry colleagues actually inject Botox into the muscles to help loosen them up, hoping that that will help the patients move the limb more. So, we do often try that before Annie and her team then do a motor assessment on the patient to see whether or not they qualify.

I will be honest that, from a neurology standpoint, I can't always tell if someone qualifies in clinic. So often, I'll evaluate the patient. If they have a lot of tightness of the muscle, I'll send them for Botox injections. And then after the Botox kicks in, I'll ask them to see Annie and her team and have her do the motor scale at that point in time.

Host: Excellent. Annie, talk about that, that final process, I guess, that you get to be the one that makes the final motion, but that's the way the system works. We're going to do it that way. How are you evaluating them?

Annie Wong: Yeah. So, regarding the identification process, you know, sometimes we'll get a referral from Dr. Smith or another neurologist. Sometimes from our own caseload, we'll see patients like, "Hmm, maybe they might be appropriate for this implant."

And what we'll do on our end for OT side, we will administer something called the Fugl-Meyer assessment. It's basically an assessment of the upper extremity for all these different movements, that the upper extremity can follow through. The protocol there is that, currently, the patients who score between 15 and 55 within this range would suggest that patients might be appropriate for the implant.

Of course, on my end, there's also a couple other things that I look into. I want to make sure, one, that the patients have a good activity tolerance. You know, it's a 90-minute session three times a week for six weeks. It can be exhausting. So, I want to make sure that patients have good energy, can tolerate this mentally, physically.

I want to make sure that the patients have good support at home and have access to coming into our clinic. It is three times a week, so they need to be able to have access to where we are. I also, am looking for if patients cognitively can understand, the instruction, the process, the protocol, and make sure that they are cognitively having that capability to engage in this program. So, they're just some extra tidbits from the OT side.

Host: Excellent. Annie, earlier you talked about some great improvements and outcomes that you have seen. any, any final thoughts from you on this procedure and process before I go to Dr. Smith?

Annie Wong: My first patient, I should probably give you the numbers on the Fugl-Meyer assessment. When I first assessed after we were done with the program, he had a seven-point improvement. So, that was patient number one. And then, my second patient, he had a 25-point improvement as I look in my notes.

What I would just say just across our Vivistim and patients at Evergreen, we've seen an average improvement of 13 points of improvement on the Fugl-Meyer assessment. And this is much higher than our national average. I believe our national average on the Fugl-Meyer is about like five- to six-point improvement.

So Evergreen, we have gotten a 13-point improvement. I'm just so proud of the work that we've put in and just the teamwork , and everyone's collaboration, that we've, yeah, been working together to make a difference.

Host: Very good. Dr. Smith, any final thoughts from you?

Sheila Smith, MD: Yeah. My hope is that this is just the beginning of many more devices and treatment options that we'll have to offer patients. I think it's really exciting to see our patients improve like Annie has alluded to. And hopefully, we'll be able to bring this device to more patients than we currently are.

But the majority of the patients who have the device implanted have been very happy with it. And as Annie said, we've had some patients that have had great improvement. There were small numbers of patients included in the research trials. So, the device manufacturers has a registry to follow patients that are implanted, currently, long term.

And so, as we follow more patients out, which we're doing to three years post-implant, we should have more data to be able to share with future patients

Host: Excellent. Dr. Smith, Annie, thank you for all of this information about Vivostim today

Annie Wong: Thank you so much for

Sheila Smith, MD: having us.

Yeah. Thank you so much.

Host: And if you'd like more information on stroke care or other services offered by EvergreenHealth, please visit us at evergreenhealth.com. And if you enjoyed this episode of our podcast, please share it on your social channels and check out the entire podcast library for topics of interest to you. And this has been Check-up Chat with EvergreenHealth. Thanks for watching.