Regarding DBS trend

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Aldertonghen

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At our program during a DBS surgery we use MER to guide placement, however, I was told that many institutions simply use imaging (which is slowly getting better) and skip MER to save time. Also heard that at some institutions the MER is being done by APPs so that institutions can have neurologists see more patients in the clinic instead. What direction are we headed?

In addition, with ongoing closed loop trials (ADAPT-PD)- does anyone feel that DBS programming after the initial visit would sort of become redundant, only requiring follow up programming visits if things are horribly wrong? I just would like to gather what everyone’s thought process was on the direction DBS is headed towards and the role neurologists will play.

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From my limited OR experience, MER is not something a neurologist needs to be around for. I would rather spend my time outside of the OR. I know some places require a neurologist to be there.

We're probably still a short number of years away from adaptive DBS. I, for one, look forward to adaptive DBS and won't mind that it will take away from programming. That's assuming that the DBS electrophysiologic biomarkers pan out; the Boston Scientific rep was adamant they would not -- I disagree, and I also wonder how necessary kinetic biomarkers (wearable devices) will be. Regardless, there are a lot of patients who have non-adaptive DBS that will need programming for the next 20 to 30 years. It is really an exciting time for PD treatment, but I do worry about the impact of socioeconomic status on one's ability to achieve these treatments. Lastly, I have seen places that exclusively use DBS reps to program and places that have hired APPs whose job is dedicated to DBS programming.
 
MER guided placement is still the gold standard, and image-guided approaches are primarily used for efficiency, not for quality. The factory-style surgical groups that push image-guided placement do so based on some very underpowered studies showing non-inferiority of outcomes and anatomical placement at the group level. However, as anyone who has been in the OR a lot can tell you, there are plenty of times where the anatomical placement of an electrode looks great, but MER and intraoperative testing reveals it to be suboptimal. Subsequent adjustments sometimes look less accurate from a pure imaging standpoint, but produce better functional effects. A pretty decent proportion of patients would receive leads that look great on post-op imaging but which are not ideal from an electrophysiology standpoint with asleep DBS (i.e. https://www.sciencedirect.com/science/article/abs/pii/S187887501932248X).

That's not to say that asleep DBS doesn't have its place. A lot of generalized dystonia patients could never handle an awake case, and there are a decent number of PD and ET patients whose anxiety would make an awake OR situation... unpredictable. In those cases, the option to use an asleep procedure, with the informed consent that there is a risk that the placement may not be quite as "individualized" to their neurophysiology, is a nice thing to have, especially with modern directional DBS to tweak the effective placement in programming clinic. However, I would never send my family member to be treated at a DBS center that is only doing asleep cases. Not only does this leave out the possibility of a better placement with MER and exam guidance, it speaks to the values and approach of the center that's made that decision.

As far as programming, I think most high volume DBS centers are integrating APPs into the programming in some sense. Where I trained, programming was done mostly by nurses (not even NPs until after my fellowship) who had literally decades of experience programming many cases per day. Where I am now, I do more of the initial programming and more difficult cases, but APPs definitely offload at least half of our programming followups. I find it necessary to give those with less than 10 years of experience a clear plan to follow, but it's really not hard to bump amplitude by 0.1-0.2 mA in response to an increase in tremor. In the ET patients in particular, however, it's often necessary to keep a close eye as distinguishing ataxia from tremor can be difficult for a non-neurologist.

I really have less optimism about closed-loop DBS than most people. The extreme focus on beta-band optimization in these trials seems to work in some patients and not others. I saw several posters at MDS this year from Japanese groups that are already using closed-loop systems in clinic, and the takeaway was that you really can't rely on it to do your job for you, as in a pretty decent portion of patients (IIRC 20-30%) it successfully suppressed the beta band, but the patient was left woefully undertreated until manual increases were implemented. I don't know if this is because we need a more comprehensive understanding of PD electrophysiology, or because there's a variability in this EP signature based on implantation error, or because the entire concept of recording only from the same place we are stimulating is fundamentally flawed. Probably all 3 to some extent. My sense is that once we get it running, it will act more like the extra patient parameters we give to allow patients to turn their amplitude up or down a few clicks - not a replacement for experienced DBS programmers.
 
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MER guided placement is still the gold standard, and image-guided approaches are primarily used for efficiency, not for quality. The factory-style surgical groups that push image-guided placement do so based on some very underpowered studies showing non-inferiority of outcomes and anatomical placement at the group level. However, as anyone who has been in the OR a lot can tell you, there are plenty of times where the anatomical placement of an electrode looks great, but MER and intraoperative testing reveals it to be suboptimal. Subsequent adjustments sometimes look less accurate from a pure imaging standpoint, but produce better functional effects. A pretty decent proportion of patients would receive leads that look great on post-op imaging but which are not ideal from an electrophysiology standpoint with asleep DBS (i.e. https://www.sciencedirect.com/science/article/abs/pii/S187887501932248X).

That's not to say that asleep DBS doesn't have its place. A lot of generalized dystonia patients could never handle an awake case, and there are a decent number of PD and ET patients whose anxiety would make an awake OR situation... unpredictable. In those cases, the option to use an asleep procedure, with the informed consent that there is a risk that the placement may not be quite as "individualized" to their neurophysiology, is a nice thing to have, especially with modern directional DBS to tweak the effective placement in programming clinic. However, I would never send my family member to be treated at a DBS center that is only doing asleep cases. Not only does this leave out the possibility of a better placement with MER and exam guidance, it speaks to the values and approach of the center that's made that decision.

As far as programming, I think most high volume DBS centers are integrating APPs into the programming in some sense. Where I trained, programming was done mostly by nurses (not even NPs until after my fellowship) who had literally decades of experience programming many cases per day. Where I am now, I do more of the initial programming and more difficult cases, but APPs definitely offload at least half of our programming followups. I find it necessary to give those with less than 10 years of experience a clear plan to follow, but it's really not hard to bump amplitude by 0.1-0.2 mA in response to an increase in tremor. In the ET patients in particular, however, it's often necessary to keep a close eye as distinguishing ataxia from tremor can be difficult for a non-neurologist.

I really have less optimism about closed-loop DBS than most people. The extreme focus on beta-band optimization in these trials seems to work in some patients and not others. I saw several posters at MDS this year from Japanese groups that are already using closed-loop systems in clinic, and the takeaway was that you really can't rely on it to do your job for you, as in a pretty decent portion of patients (IIRC 20-30%) it successfully suppressed the beta band, but the patient was left woefully undertreated until manual increases were implemented. I don't know if this is because we need a more comprehensive understanding of PD electrophysiology, or because there's a variability in this EP signature based on implantation error, or because the entire concept of recording only from the same place we are stimulating is fundamentally flawed. Probably all 3 to some extent. My sense is that once we get it running, it will act more like the extra patient parameters we give to allow patients to turn their amplitude up or down a few clicks - not a replacement for experienced DBS programmers.
Thank you for your insight! With current imaging I feel that MER is superior, but now we are starting to correlate MER findings with 7T MRI and computer generated sequences, and the differences are starting to get much smaller.

When it comes to MER, do you feel this has to be performed by a movement trained physician, or can it be delegated to APP/nurses/DBS reps as well?
 
Thank you for your insight! With current imaging I feel that MER is superior, but now we are starting to correlate MER findings with 7T MRI and computer generated sequences, and the differences are starting to get much smaller.

When it comes to MER, do you feel this has to be performed by a movement trained physician, or can it be delegated to APP/nurses/DBS reps as well?
Be cautious of justifying individual patient decisions based on correlative data. You may find a highly significant correlation between the functional target and an MRI-defined structure, but what about those 10 or 20 percent of patients at the outside edges of your scatter? I'm all for improving the imaging guidance we use to create surgical plans, but throwing away the other 2 frames of reference (MER and intraop testing) we use to optimize placement just because you think your imaging guidance and placement technique are infallible is classic neurosurgeon god-complex stuff.

As far as MER, there are a lot of places that leave this to reps, contracted neurophysiologist, etc. However those people aren't really doing all of the testing and mapping we do, they act more as a second pair of hands for the surgeon. The cognitive work of figuring out whether the placement is adequate and where to move the electrode is then left to the surgeon, and in my experience the functional neurosurgeons who really want to do this and can do this at a high level are in the minority. Even at big DBS centers a lot of neurosurgeons want a neurologist to tell them where to go and when a second pass is needed. The places I see non-neurologists doing MER are generally low volume academic DBS centers without a robust movement group, and private practice neurosurgical groups that are throwing some electrodes in and sending back to the neurologist for post-care. I've gotten a lot of "fix my DBS" consults with interesting electrode positions from both types of places.
 
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