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Episode 105: MASTER CLASS - Surgical Management of ICH

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Contributors

  • Stephan A. Mayer, MD, FCCM

    William T. Gossett Endowed Chair of Neurology
    Henry Ford Health System
    Stephan Mayer is Chair of Neurology for the Henry Ford Health System in Detroit. He previously served as director of Neurocritical Care for the Mount Sinai Health System in New York and director of the Neurological Intensive Care Unit at Columbia University College of Physicians and Surgeons in New York. Dr Mayer earned his medical degree from Cornell University Medical College. He completed a residency in neurology and a fellowship in critical care neurology at the Neurological Institute of New York, Columbia-Presbyterian Medical Center. He is board certified in neurology and a founding member and past president of the Neurocritical Care Society. Dr Mayer has published more than 230 original research articles, 180 review articles, and 340 abstracts, and he has written 7 books, and co-edited the most recent edition of Merritt’s Textbook of Neurology. He was principal investigator of the FAST Trial, a worldwide multicenter clinical trial evaluating ultra-early hemostatic therapy for brain hemorrhage, and he served as principal investigator of the NIH-funded New York Presbyterian Hospital hub of the Neurological Emergencies Treatment Trials (NETT) network. His work in helping victims of severe brain injury has been featured in The Wall Street Journal and the book Cheating Death by CNN medical correspondent Dr Sanjay Gupta.

  • Jon Rosenberg, MD

    Jon Rosenberg is an Assistant Professor of Neurology and Neurosurgery at Westchester Medical Center New York Medical College and Associate Program Director of the Neurocritical Care Fellowship at Westchester Medical Center. 

  • Christopher Kellner, MD

  1. 00:00:20
    Hi, everyone. I'm Dr. Stefan Mayer.
  2. 00:00:23
    I'm professor of neurology neurosurgery
  3. 00:00:25
    at New York Medical College in New York.
  4. 00:00:28
    John Rosenberg, assistant professor of
  5. 00:00:30
    neurology neurosurgery. What's just the
  6. 00:00:32
    medical center of New York Medical
  7. 00:00:33
    College in New York? And we're here
  8. 00:00:36
    today with Dr. Christopher Kellner.
  9. 00:00:39
    Chris Kellner is a pioneer in minimally
  10. 00:00:42
    invasive surgery for interest cerebral
  11. 00:00:44
    hemorrhage. And we're going to pick his
  12. 00:00:45
    brain today about where the field is now
  13. 00:00:48
    and where he thinks it's going to be
  14. 00:00:49
    going. Dr. Kellner is associate
  15. 00:00:53
    professor. Is that true, Chris?
  16. 00:00:57
    Assisted for now, associates in the
  17. 00:00:58
    works. Okay. Up and coming associate
  18. 00:01:02
    professor at the ICON School of Medicine
  19. 00:01:05
    in Mount Sinai. And he's based in Mount
  20. 00:01:07
    Sinai West Hospital in Midtown Manhattan,
  21. 00:01:10
    which is actually a kind of very unique
  22. 00:01:12
    practice setting. It's a hub for
  23. 00:01:15
    interest-rebral hemorrhage for your
  24. 00:01:16
    system. Isn't that true, Chris?
  25. 00:01:20
    Yes, it is. We have done our best to
  26. 00:01:22
    build an interest liberal hemorrhage
  27. 00:01:23
    center at one of our major hospitals in
  28. 00:01:26
    the middle, right in the middle of the
  29. 00:01:27
    city. Super cool. So welcome back to
  30. 00:01:30
    the podcast, Chris. It's good to see
  31. 00:01:33
    you. So, you know, for many of our
  32. 00:01:35
    listeners are kind of at different
  33. 00:01:37
    levels of training and new to the
  34. 00:01:38
    subject. Let me set the stage for us.
  35. 00:01:40
    Tell us a little bit about the, you
  36. 00:01:41
    know, where the field was of a
  37. 00:01:44
    minimally invasive, how the field
  38. 00:01:45
    started with maybe the misty trial,
  39. 00:01:47
    minimally invasive surgery for ICU
  40. 00:01:51
    evacuation and then taking that, maybe
  41. 00:01:53
    the lessons we learned and what the next
  42. 00:01:55
    steps were after
  43. 00:01:58
    that. Thanks a lot, John. And thank
  44. 00:01:58
    you, Stefan, for inviting me here to
  45. 00:02:00
    speak on a topic that I'm very
  46. 00:02:02
    passionate about. So happy to talk all
  47. 00:02:04
    day about this topic. Well, let me
  48. 00:02:08
    start by saying how I came into this and
  49. 00:02:12
    kind of how, why I've been focusing on
  50. 00:02:14
    this. And when I was in my fellowship
  51. 00:02:17
    at Mount Sinai as an endovascular.
  52. 00:02:19
    neurosurgeon in 2015 to '17. Dr. Jay
  53. 00:02:23
    Mako and Josh Betterson and Stanley
  54. 00:02:26
    Turum, who's here in neurology at the
  55. 00:02:27
    time, and Stefan, I think you were
  56. 00:02:28
    here even at that time as well. People
  57. 00:02:31
    were inviting, started talking about
  58. 00:02:34
    setting up an intrasurable hemorrhage
  59. 00:02:35
    program that would focus on improving
  60. 00:02:38
    the care of these patients and
  61. 00:02:39
    centralize the patients at Mount Sinai
  62. 00:02:42
    West, which is one of our hospitals
  63. 00:02:44
    that has an NSICU and by focusing
  64. 00:02:50
    patients there, we were hoping that we
  65. 00:02:52
    would be able to improve the care for
  66. 00:02:53
    those
  67. 00:02:55
    patients by acclimatizing everyone to
  68. 00:02:56
    this patient population, the surgeons,
  69. 00:02:59
    but also the nurses and the ICU
  70. 00:03:00
    attendings and the physical therapists
  71. 00:03:02
    and the social workers, 'cause these
  72. 00:03:04
    are patients that have a very specific
  73. 00:03:06
    set of needs. And so by doing that, we
  74. 00:03:10
    were able to really increase the volume
  75. 00:03:13
    and centralize it all in one spot to
  76. 00:03:15
    maximize our learning over time and
  77. 00:03:18
    maximize the. efficacy of our protocols.
  78. 00:03:21
    And so we have created a policy where if
  79. 00:03:25
    an interval hemorrhage patient comes in
  80. 00:03:27
    to any Mount Sinai hospital or any of
  81. 00:03:28
    the affiliated hospitals or any refer
  82. 00:03:31
    any hospital, sometimes those can even
  83. 00:03:32
    be very far away. We'll send them to
  84. 00:03:35
    Mount Sinai West and then take care of
  85. 00:03:37
    them there. And part of that program
  86. 00:03:39
    has been trying to figure out if
  87. 00:03:41
    minimally invasive surgery is an
  88. 00:03:43
    effective treatment for these patients
  89. 00:03:44
    and what specific procedure we can do
  90. 00:03:47
    for them And so when I was hired, Dr.
  91. 00:03:50
    Mako asked me if I'd like to focus on
  92. 00:03:53
    this particular disease process. And of
  93. 00:03:56
    course, as a neurosurgeon, I said,
  94. 00:03:58
    well, what about what about aneurysms
  95. 00:03:59
    and what about AVMs? And he was like,
  96. 00:04:01
    I can't promise anything about those,
  97. 00:04:02
    but you can take care of all the ICHs.
  98. 00:04:04
    And so I took that eagerly as an
  99. 00:04:07
    opportunity to try to make a difference
  100. 00:04:10
    in a field where not a lot of people
  101. 00:04:12
    have focused on, at least from the
  102. 00:04:14
    neurosurgical perspective in the past.
  103. 00:04:18
    To answer your question more directly,
  104. 00:04:22
    how did this field start? I would say
  105. 00:04:24
    that it started a long, long time ago.
  106. 00:04:27
    Around the time I was born in 1980,
  107. 00:04:30
    early 80s, there were a bunch of
  108. 00:04:33
    studies looking at a MISTI-like approach
  109. 00:04:35
    and those studies paved the way for
  110. 00:04:38
    MISTI showing the safety or some early
  111. 00:04:41
    safety data on catheter placement with
  112. 00:04:43
    rhombolysis And in the early 80s, there
  113. 00:04:47
    were even endoscopic papers showing some
  114. 00:04:50
    early data and even a randomized
  115. 00:04:52
    clinical trial from Austria, our at all,
  116. 00:04:55
    showing safety and perhaps even a little
  117. 00:04:58
    bit of an efficacy signal in endoscopic
  118. 00:05:01
    evacuation for deep and low bar
  119. 00:05:03
    hemorrhages. And so those early papers
  120. 00:05:06
    paved the way for larger studies in the
  121. 00:05:09
    future. And I see it really as a
  122. 00:05:11
    parallel track a whole bunch of
  123. 00:05:13
    minimally invasive studies happened
  124. 00:05:15
    while also in parallel. a bunch of open
  125. 00:05:18
    studies where open, I mean, open
  126. 00:05:20
    craniotomy and evacuation under a
  127. 00:05:22
    microscope or surgeon's choice. And
  128. 00:05:24
    surgeon's choice often will be open
  129. 00:05:27
    craniotomy with loops, which are just,
  130. 00:05:29
    you know, glass, surgical glasses with
  131. 00:05:31
    some magnification or a microscope. And
  132. 00:05:34
    we know from those early studies that it
  133. 00:05:37
    did seem like there was a signal in the
  134. 00:05:39
    minimally invasive studies all the way
  135. 00:05:41
    up to the present day Although there was
  136. 00:05:44
    no really high quality study performed
  137. 00:05:47
    up until MISTI-3. And the studies in
  138. 00:05:51
    parallel occurring in open procedures
  139. 00:05:54
    all appeared to be negative over time.
  140. 00:05:56
    And so that included many early studies,
  141. 00:05:59
    B, and then stitch 1 and, of course,
  142. 00:06:02
    stitch 2, published in 2013. So really
  143. 00:06:05
    up until then, the open studies weren't
  144. 00:06:08
    working out overall, although there are
  145. 00:06:09
    a few little nuggets of information in
  146. 00:06:11
    the history you really dig into it.
  147. 00:06:14
    While in parallel the memory and days of
  148. 00:06:16
    studies, did seem to have some signal
  149. 00:06:18
    over time. And those little pieces of
  150. 00:06:21
    information that we learned that built
  151. 00:06:23
    the premise and foundation that MISTI-3
  152. 00:06:27
    was built on, and also Enrich, and
  153. 00:06:29
    also some of the other trials that are
  154. 00:06:31
    occurring right now.
  155. 00:06:33
    Those studies were summarized in a few
  156. 00:06:36
    meta-analyses. One of them was by ZU et
  157. 00:06:39
    al, Z-H-O-U. And
  158. 00:06:42
    that was published in 2013. And then
  159. 00:06:44
    our group even did an update on that for
  160. 00:06:46
    the same methodology, looking at
  161. 00:06:48
    minimally-based of studies from 2000 and
  162. 00:06:51
    2018. And we have repeatedly shown, as
  163. 00:06:56
    medicine has shown, that it does seem
  164. 00:06:58
    like the minimally-based of procedures
  165. 00:06:59
    overall are working.
  166. 00:07:02
    And it's only now, recently, that
  167. 00:07:03
    we've got now, level 1 evidence to show
  168. 00:07:05
    that it does appear to be working in the
  169. 00:07:07
    cortical average group. And we eagerly
  170. 00:07:11
    await the results of the enriched study
  171. 00:07:13
    to show that specifically. but to talk
  172. 00:07:18
    about now more modern day, as in 2019,
  173. 00:07:23
    with the MISTI three results, I think
  174. 00:07:25
    everyone was excited for that trial to
  175. 00:07:27
    be positive. I think anyone who's done
  176. 00:07:28
    that procedure and cared for those
  177. 00:07:30
    patients have seen some really big wins
  178. 00:07:33
    with the MISTI procedure, and we were
  179. 00:07:35
    waiting to see which groups does it work
  180. 00:07:38
    in? Does it work in everybody? Does it
  181. 00:07:40
    work in the deep leads? And I thought
  182. 00:07:43
    that trial was probably going to be
  183. 00:07:44
    positive, and it was negative, but we
  184. 00:07:47
    know that there was a subgroup that was
  185. 00:07:50
    a pre-specified subgroup analysis in the
  186. 00:07:54
    intentioned to treat analysis, and by
  187. 00:07:56
    as treated
  188. 00:07:59
    analysis, that's the patients who met
  189. 00:08:01
    the surgical endpoint. So the intention
  190. 00:08:05
    to treat analysis of all patients
  191. 00:08:07
    enrolled in the surgical group and the
  192. 00:08:09
    medical group, that did not work out,
  193. 00:08:09
    and
  194. 00:08:12
    we know that that was a negative overall
  195. 00:08:14
    primary outcome results. but one of the
  196. 00:08:16
    secondary outcomes that everyone is
  197. 00:08:18
    focused on, the as treated analysis
  198. 00:08:20
    were about 60 of the patients who met
  199. 00:08:23
    the surgical goal of leaving no more
  200. 00:08:25
    than 15 CCs at the end of treatment,
  201. 00:08:27
    end of treatment not being the surgery
  202. 00:08:29
    itself, but being a combination of the
  203. 00:08:31
    surgery, plus the multiple days of
  204. 00:08:36
    thrombolysis, given regularly in the
  205. 00:08:38
    ICU, those patients who met that
  206. 00:08:41
    surgical endpoint, they did have a
  207. 00:08:45
    benefit overall at the one-year endpoint.
  208. 00:08:48
    And so that let us, yeah. Sorry, if
  209. 00:08:52
    you don't mind, break down for our
  210. 00:08:53
    listeners, because I'm not sure
  211. 00:08:55
    everyone listening is gonna really know
  212. 00:08:57
    what is domestic procedure and how does
  213. 00:09:00
    that differ from the kind of surgeries
  214. 00:09:02
    that you do and what was performed in
  215. 00:09:05
    Enrich with the end of the Skype program?
  216. 00:09:08
    Yeah, you got it. These are a few very
  217. 00:09:11
    different surgical approaches the same
  218. 00:09:12
    problem. The MISTI approach is When you
  219. 00:09:17
    stereotactically place an EVD catheter
  220. 00:09:20
    into the hematoma, so normally using
  221. 00:09:23
    stereotactic guidance in an operating
  222. 00:09:24
    room, you would be placing an EVD into
  223. 00:09:26
    the ventricle, and the computer would
  224. 00:09:28
    guide you into the ventricle showing you
  225. 00:09:30
    exactly where to go, what's your
  226. 00:09:32
    trajectory to take. In the MISTI
  227. 00:09:34
    procedure, you are very tactically
  228. 00:09:37
    placing the catheter into the hematoma
  229. 00:09:40
    along the long axis of the hematoma,
  230. 00:09:42
    and a lot of training went into how to
  231. 00:09:44
    do that in the correct way, and that
  232. 00:09:46
    was built off the evidence built in
  233. 00:09:49
    MISTI 2 and prior studies. And then you
  234. 00:09:52
    lightly aspirate whatever will come out
  235. 00:09:55
    easily at the moment of catheter
  236. 00:09:56
    placement, so there's some aspiration
  237. 00:09:58
    right right away that occurs. And then
  238. 00:10:01
    a repeat scan is performed to show that
  239. 00:10:04
    the catheter is in the correct position.
  240. 00:10:07
    And then I don't remember all the
  241. 00:10:08
    details about exactly what the timing is
  242. 00:10:09
    of additional scans, but I think
  243. 00:10:11
    approximately six hours, another scan
  244. 00:10:13
    is done. And then TPA is given at that
  245. 00:10:16
    point, if that scan shows that there's
  246. 00:10:18
    been no new bleeding in the catheters in
  247. 00:10:20
    the right spot. Then TPA is given at
  248. 00:10:23
    regular intervals over a maximum of four
  249. 00:10:26
    days with repeat scans occurring. And
  250. 00:10:28
    so that's the MISTI procedure. And a
  251. 00:10:31
    SCOPIC is kind of the next level of
  252. 00:10:34
    invasiveness where the MISTI procedure
  253. 00:10:37
    is the diameter of the EVD catheter,
  254. 00:10:40
    which is
  255. 00:10:43
    two point something millimeters. The
  256. 00:10:46
    diameter of the sheath using endoscopic
  257. 00:10:48
    procedures is 63 millimeters. So it's a
  258. 00:10:51
    larger tract that you're making, but
  259. 00:10:53
    you're giving yourself direct access to
  260. 00:10:55
    the hematoma so that you can do a active
  261. 00:10:58
    evacuation. And by active evacuation,
  262. 00:11:01
    I mean, you're in there and you're
  263. 00:11:03
    actively aspirating the clot and you're
  264. 00:11:06
    working to remove all of it right up
  265. 00:11:07
    front So you've got a larger track to
  266. 00:11:11
    get in there. You're doing more work in
  267. 00:11:13
    the moment. And you're trying to create
  268. 00:11:15
    a good result with everything done right
  269. 00:11:17
    there You're not leaving a catheter in
  270. 00:11:19
    after you're not giving TPA after you're
  271. 00:11:21
    trying to do it all at once And so what
  272. 00:11:24
    you do in that case is you put a 63
  273. 00:11:26
    millimeter in stereotypically then you
  274. 00:11:29
    put in an endoscope and then down the
  275. 00:11:32
    endoscope you have a working channel and
  276. 00:11:34
    Through that working channel you're
  277. 00:11:36
    putting in an aspiration device And if
  278. 00:11:38
    you need to you can even put a cottery
  279. 00:11:40
    device down there So if you see
  280. 00:11:41
    something bleeding you can handle it and
  281. 00:11:43
    the really nice thing about that. It's
  282. 00:11:45
    different from misty is You don't need
  283. 00:11:48
    to screen the patient to make sure the
  284. 00:11:49
    human tone is stable You can go right in
  285. 00:11:52
    right away and if there's a spot sign on
  286. 00:11:54
    the CTA You can even target that
  287. 00:11:56
    stereotypically and try to go right to
  288. 00:11:57
    that and cauterize that right from the
  289. 00:11:59
    beginning So it gives you a broader set
  290. 00:12:02
    of patients to treat with the procedure
  291. 00:12:04
    and perhaps even mitigate Expansion of
  292. 00:12:06
    the human tone if you get in there
  293. 00:12:07
    quickly and address the bleeding.
  294. 00:12:12
    The next level of invasiveness is end to
  295. 00:12:14
    port, and that is a 15 centimeter port
  296. 00:12:19
    is the port that was used in Enrich.
  297. 00:12:22
    And so that's more than two times the
  298. 00:12:25
    diameter of the end to scope sheath.
  299. 00:12:28
    And what you're doing there is you're
  300. 00:12:30
    putting that port in. That procedure
  301. 00:12:32
    requires a small craniotomy. And then
  302. 00:12:35
    you get a microscope and do a circle
  303. 00:12:37
    dissection. So you split the sulcus,
  304. 00:12:39
    whatever sulcus you're on And then you
  305. 00:12:41
    place the endo port at the depth of the
  306. 00:12:44
    sulcus, they're tactically guided into
  307. 00:12:46
    the hematoma. And then you lock it in
  308. 00:12:48
    place. And with a bimanual dissection,
  309. 00:12:51
    you're using your left hand with a
  310. 00:12:52
    sucker in your right hand with the nico
  311. 00:12:54
    myriad aspirating cutting device or with
  312. 00:12:57
    a regular sucker or a bipolar if you
  313. 00:12:59
    need to stop something from bleeding.
  314. 00:13:00
    So the nice thing there is that you can
  315. 00:13:02
    work with both hands like you do in
  316. 00:13:04
    regular neurosurgeries. It requires a
  317. 00:13:06
    little less training than endoscopic and
  318. 00:13:09
    is easier to address bleeding. is
  319. 00:13:11
    you've got a regular bipolar bipolar.
  320. 00:13:14
    So that's kind of the summary of each of
  321. 00:13:15
    the procedures for those of us who are
  322. 00:13:17
    not surgeons, which I think is probably
  323. 00:13:18
    most of your audience.
  324. 00:13:21
    That was a fantastic - That's a great
  325. 00:13:23
    summary, really.
  326. 00:13:26
    Thank you so much. Okay, we'll come up.
  327. 00:13:27
    I think let's jump into your thoughts of
  328. 00:13:29
    how you approach an ICH, who you look
  329. 00:13:31
    to take,
  330. 00:13:34
    population, demographics, timing of
  331. 00:13:38
    surgery, location, what's your thought
  332. 00:13:41
    process when you're getting consulted
  333. 00:13:43
    about these patients? We've had an
  334. 00:13:45
    evolution in thinking over time, mostly
  335. 00:13:48
    around the timing and the requirements
  336. 00:13:50
    related to being eligible for the
  337. 00:13:52
    procedure. But let me go all the way
  338. 00:13:54
    back to right when we started the
  339. 00:13:55
    program back in 2016. And these were a
  340. 00:14:01
    set of criteria that we derived in a
  341. 00:14:04
    multidisciplinary group,
  342. 00:14:07
    the meta-analyses that had been
  343. 00:14:08
    performed at the time. We didn't have
  344. 00:14:10
    Enrich. We didn't even have Misty at
  345. 00:14:11
    that point. So we came up with our
  346. 00:14:15
    criteria from the prior meta-analyses.
  347. 00:14:18
    And so a minimum of 20 PCs as a low end,
  348. 00:14:24
    and then an NIH stroke scale of six or
  349. 00:14:26
    greater. And that's basically derived
  350. 00:14:29
    from the stroke literature, where if
  351. 00:14:31
    somebody's a low-an-edge stroke scale,
  352. 00:14:34
    they probably don't merit the procedure
  353. 00:14:35
    because of the risk of the procedure.
  354. 00:14:37
    And so we're using six. And then in
  355. 00:14:40
    terms of age, not having an upper age
  356. 00:14:43
    limit, but the procedure being based on
  357. 00:14:47
    the patient's baseline neurologically
  358. 00:14:49
    and what their wishes are, rather than
  359. 00:14:52
    saving an upper age limit. And then in
  360. 00:14:55
    terms of the size of
  361. 00:14:58
    the hematoma, no upper size limit.
  362. 00:14:59
    Just treating the patient if it seems
  363. 00:15:01
    like the right thing to do and seems
  364. 00:15:02
    like something feasible with a minimally
  365. 00:15:04
    invasive approach so no upper size limit.
  366. 00:15:07
    And then we have a screening procedure.
  367. 00:15:09
    So just like any stroke patient coming
  368. 00:15:11
    in, they get a CT and a CTA. And that
  369. 00:15:14
    CTA has to show no aneurysm and no
  370. 00:15:16
    vascular malformation. You can't do a
  371. 00:15:18
    minimally invasive procedure and risk
  372. 00:15:19
    getting into one of those. So we need a
  373. 00:15:21
    negative CTA. And then if there's any
  374. 00:15:23
    question on the CTA and abnormal vessel
  375. 00:15:26
    beyond a spot sign, or if the patient's
  376. 00:15:29
    young with no hypertension, then we'll
  377. 00:15:31
    do an angiogram to rule out a vascular
  378. 00:15:34
    malformation or an aneurysm And so
  379. 00:15:38
    that's the general criteria. And then
  380. 00:15:40
    in terms of timing, early on, we were
  381. 00:15:42
    doing them within 72 hours. And that's
  382. 00:15:45
    what a few of the studies that were
  383. 00:15:47
    derived around that time were using for
  384. 00:15:50
    enrollment in the studies. And so
  385. 00:15:52
    that's what that timing was based on.
  386. 00:15:55
    But over time, we've seen in our own
  387. 00:15:57
    data that it appears that the patients
  388. 00:15:58
    who are being treated earlier with this
  389. 00:16:00
    are getting, have a higher probability
  390. 00:16:03
    of a good outcome. And we even
  391. 00:16:04
    published that in stroke in 2000 20.
  392. 00:16:08
    And so what we'll do now and what we've
  393. 00:16:12
    been doing for a few years is we will
  394. 00:16:15
    treat these patients exactly like an
  395. 00:16:17
    ischemic stroke. If they have a CT and
  396. 00:16:19
    CTA
  397. 00:16:21
    showing an aspects 10 and an LBO, then
  398. 00:16:25
    they're going to the angiosweet and
  399. 00:16:26
    they're going to get a thrombectomy. If
  400. 00:16:28
    they have a large hemorrhage and they
  401. 00:16:32
    have a negative CTA, then they're going
  402. 00:16:35
    to the angiosweet and they're getting a
  403. 00:16:36
    minimally invasive evac. And so we have
  404. 00:16:39
    been doing that for a bit now, given
  405. 00:16:41
    our interpretation of the timing data,
  406. 00:16:44
    which is pretty robust in the literature
  407. 00:16:46
    now, which we summarized in a recent
  408. 00:16:48
    review. And so that in our own
  409. 00:16:50
    experience is very convincing that this
  410. 00:16:52
    is really a timing time-based effect and
  411. 00:16:56
    that we really feel strongly the earlier
  412. 00:16:58
    the better. And I'm really looking
  413. 00:17:01
    forward to getting a good data set of
  414. 00:17:02
    the zero to six hyper acute period
  415. 00:17:05
    because I think who knows how good you
  416. 00:17:08
    can get if you get into that window.
  417. 00:17:10
    There's not much data published on that,
  418. 00:17:12
    except for one case series out of Taiwan
  419. 00:17:14
    from 2011 where they treated 68 patients
  420. 00:17:18
    in the early time window and a large
  421. 00:17:21
    percentage of those were ultra early
  422. 00:17:23
    within four hours and they had extremely
  423. 00:17:24
    good outcomes in there. So hoping to
  424. 00:17:27
    repeat that experience and see how that
  425. 00:17:30
    works with endoscopic, with the
  426. 00:17:33
    endoscopic procedure we've been
  427. 00:17:34
    performing. So just to reiterate then,
  428. 00:17:36
    so do you have like no minimum time
  429. 00:17:40
    window? Do you wait for a stability
  430. 00:17:42
    scan? Or do you simply just go on the
  431. 00:17:45
    baseline, non-con?
  432. 00:17:48
    That's a great question. And for a few
  433. 00:17:51
    years early on, we were waiting for a
  434. 00:17:53
    stability scan because we were enrolling
  435. 00:17:56
    patients in a registry or a trial. It
  436. 00:17:59
    was a single-arm feasibility study
  437. 00:18:00
    called the Invest Registry and Trial.
  438. 00:18:02
    And that did require a stability scan
  439. 00:18:04
    initially until our own data and other
  440. 00:18:09
    people's data, so that you actually
  441. 00:18:12
    don't need to wait for a stability scan
  442. 00:18:13
    when you're doing an active evacuation
  443. 00:18:15
    in which you can reliably treat bleeding.
  444. 00:18:18
    So I would say that early on, before we
  445. 00:18:21
    knew that bleeding could be treated
  446. 00:18:23
    endoscopically or through an end-aport
  447. 00:18:25
    mediated approach and now a surgical
  448. 00:18:26
    scope approach, we were hesitant to
  449. 00:18:30
    rush in the patients that weren't stable
  450. 00:18:32
    for the head spot signs. But now I know
  451. 00:18:34
    that can be handled in every single case
  452. 00:18:36
    when you encounter bleeding. And so now
  453. 00:18:39
    we are not waiting for a stability scan.
  454. 00:18:40
    We're not waiting until the CTA clears
  455. 00:18:42
    up with no spot sign. But instead
  456. 00:18:44
    seeing that, those seeing expansion and
  457. 00:18:47
    seeing a spot sign and seeing an early
  458. 00:18:49
    patient as being an opportunity to get
  459. 00:18:52
    in there with an active approach and
  460. 00:18:54
    address the bleeding to prevent that
  461. 00:18:56
    expansion from happening. Great, let
  462. 00:18:59
    me ask you another question. And so as
  463. 00:19:02
    many real listeners, maybe not all will
  464. 00:19:04
    know Rich Tribe was recently published.
  465. 00:19:07
    and they took an interesting approach.
  466. 00:19:08
    They were looking at good sized ICHs,
  467. 00:19:12
    and they were initially randomizing the
  468. 00:19:14
    deep ones and low bar, and they had a
  469. 00:19:16
    pre-specified rule that they would do an
  470. 00:19:19
    interim analysis, and they basically
  471. 00:19:21
    stopped enrolling the deeper bleeds on
  472. 00:19:24
    the basis of futility. There simply
  473. 00:19:26
    wasn't enough signal. They went on,
  474. 00:19:28
    continued to randomize several hundred
  475. 00:19:31
    of the low bar bleeds, and when they
  476. 00:19:33
    broke the data set and stopped enrolling,
  477. 00:19:36
    there was a very nice shift towards
  478. 00:19:38
    better outcomes across the range of rank
  479. 00:19:40
    and functional outcome levels. Are you
  480. 00:19:43
    surprised at all by that finding?
  481. 00:19:46
    Because I'm pretty sure, remember,
  482. 00:19:48
    that you would go for like those 30 to
  483. 00:19:51
    40 ML put terminal bleeds and showed me
  484. 00:19:54
    some cases that we're getting good
  485. 00:19:57
    results. Some of them, I remember a
  486. 00:19:59
    conversation where the Hemi-Parrisis was
  487. 00:20:03
    much, much better, just 24 hours later.
  488. 00:20:06
    and you thought it was just reduction of
  489. 00:20:08
    wall tension on the capsule. So I'm
  490. 00:20:11
    curious to hear your thoughts about how
  491. 00:20:13
    that trial shook out and where you think
  492. 00:20:16
    it might be going. Are you still gonna
  493. 00:20:18
    be treating the deep leads now?
  494. 00:20:22
    Yeah, I think that that trial showed us
  495. 00:20:25
    what we saw in a signal for in stitch
  496. 00:20:28
    two and in stitch one, that lower
  497. 00:20:31
    hemorrhages seem like they respond a
  498. 00:20:33
    little bit more than basal ganglia
  499. 00:20:36
    Hemorrhages to surgical evacuation. And
  500. 00:20:39
    it's gonna be really interesting to see
  501. 00:20:42
    can we identify other factors in the
  502. 00:20:44
    basal ganglia of leads in the enriched
  503. 00:20:46
    data set that would give us a hint that
  504. 00:20:48
    that's why the procedure didn't work in
  505. 00:20:51
    those patients such as time to
  506. 00:20:52
    evacuation or evacuation percentage.
  507. 00:20:56
    Maybe it's harder to completely evacuate
  508. 00:20:59
    the basal ganglia of leads with the end
  509. 00:21:00
    of port technique. I don't know, I'm
  510. 00:21:02
    really looking forward to seeing those
  511. 00:21:04
    multivariable multivariate analyses of
  512. 00:21:08
    each location. But I think that what
  513. 00:21:12
    I've heard some people say is that
  514. 00:21:14
    perhaps the deep leads require a less
  515. 00:21:18
    invasive approach. And some evidence
  516. 00:21:21
    supporting that thinking is, I believe
  517. 00:21:24
    there was not a location-based
  518. 00:21:26
    difference in the MISTI approach So the
  519. 00:21:29
    MISTI data had basal ganglia hemorrhages
  520. 00:21:32
    and cortical hemorrhages. And in
  521. 00:21:35
    that subgroup analysis, I was
  522. 00:21:37
    mentioning where 60 of the patients had
  523. 00:21:42
    less than 15 cc's that end the treatment,
  524. 00:21:44
    there was not a location-based effect in
  525. 00:21:46
    the MISTI procedure. In my knowledge,
  526. 00:21:48
    I haven't seen that subgroup analysis
  527. 00:21:51
    come out of that study. And so I would
  528. 00:21:53
    say that it seemed like in that subgroup
  529. 00:21:55
    analysis when less than 15 cc's was met
  530. 00:21:58
    in MISTI, it seemed like they had a
  531. 00:22:01
    good effect across locations. However,
  532. 00:22:04
    we didn't see a good effect across
  533. 00:22:06
    locations in Enrich, and so we really
  534. 00:22:08
    needed to dig in the data and see if
  535. 00:22:09
    there's any hint there of why, but it
  536. 00:22:11
    might be about the degree of
  537. 00:22:13
    invasiveness of the approach. So just
  538. 00:22:16
    two quick questions. Do you think it's
  539. 00:22:18
    possibly just a less disruptive, with
  540. 00:22:21
    you could have more destruction of the
  541. 00:22:23
    subcorical U fibers with a more invasive
  542. 00:22:25
    approach? Is that what you're saying,
  543. 00:22:27
    Chris? Certainly possible, right? You
  544. 00:22:29
    could lose an effect in some patients in
  545. 00:22:31
    which you have to travel across some
  546. 00:22:34
    degree of depth and some increased
  547. 00:22:37
    number of fibers to get to the lesion.
  548. 00:22:39
    So that's certainly is a possible
  549. 00:22:40
    explanation. Yeah,
  550. 00:22:44
    tell us a little bit about where you
  551. 00:22:44
    think the future of minimally invasive
  552. 00:22:46
    surgery is headed.
  553. 00:22:49
    I think we've got to take serious the
  554. 00:22:53
    pressing time effect and understand what
  555. 00:22:55
    the differential of time is.
  556. 00:22:59
    And we're gonna see that from the Enrich
  557. 00:23:00
    data. As the average data driven by
  558. 00:23:02
    those early evacuations, we don't know
  559. 00:23:04
    yet, we're waiting for that paper in
  560. 00:23:06
    that subject analysis. But I think
  561. 00:23:09
    we're moving towards a emergent
  562. 00:23:12
    procedure, and we're moving towards
  563. 00:23:15
    technological advancement in which we
  564. 00:23:17
    can reliably always get all the cloud
  565. 00:23:19
    out and always stop the bleeding early.
  566. 00:23:23
    I think once we've got all those things
  567. 00:23:24
    figured out, we're gonna have a strong
  568. 00:23:26
    treatment effect across locations
  569. 00:23:30
    I've been so impressed with what you've
  570. 00:23:32
    been able to do in your approach. How
  571. 00:23:35
    much penetration has this kind
  572. 00:23:39
    of aggressive use of minimally invasive
  573. 00:23:41
    surgery, and in particular in earlier
  574. 00:23:44
    timeframes? How much penetration have
  575. 00:23:46
    you seen across the United States so far?
  576. 00:23:48
    And how does that compare to, let's say,
  577. 00:23:50
    other parts of the world like Japan or
  578. 00:23:53
    Europe? My question, I feel very
  579. 00:23:56
    fortunate to be in an institution where
  580. 00:23:58
    there's a, their disciplinary
  581. 00:24:00
    collaboration, supporting this
  582. 00:24:04
    type of management of these patients,
  583. 00:24:06
    and that's not universal, obviously. I
  584. 00:24:10
    think that the penetration is low right
  585. 00:24:14
    now. I think a minority of centers,
  586. 00:24:16
    mostly academic centers, are performing
  587. 00:24:19
    minimally invasive surgery as a standard
  588. 00:24:21
    of care for any location. After the
  589. 00:24:23
    enriched data comes out, I'm sure
  590. 00:24:24
    that's going to increase significantly
  591. 00:24:26
    and there will be more cortical
  592. 00:24:28
    minimally invasive evacuation. So I
  593. 00:24:31
    think I would just say penetration is
  594. 00:24:33
    low at the moment and will increase
  595. 00:24:35
    significantly in the next few years as
  596. 00:24:37
    people start doing cortical minimally
  597. 00:24:38
    invasive as more of standard of care
  598. 00:24:41
    across institutions, academic and
  599. 00:24:43
    non-academic. But we do know that
  600. 00:24:47
    minimally invasive evacuation has been
  601. 00:24:49
    standard of care in numerous Asian
  602. 00:24:51
    countries for many, many years in some
  603. 00:24:53
    decades and even included in their
  604. 00:24:55
    guidelines. So I think we're sort of of
  605. 00:24:59
    catching up to the way this has been
  606. 00:25:02
    done in China, for example, doing
  607. 00:25:05
    cranial puncture and publishing a really
  608. 00:25:06
    strong randomized trial in 2008, and
  609. 00:25:10
    then in Japan doing endoscopic assist,
  610. 00:25:13
    or in the last few decades, and then
  611. 00:25:14
    Taiwan, I mentioned that paper,
  612. 00:25:16
    they're ultra early. Exactly what I'm
  613. 00:25:19
    trying to do here now was done there for
  614. 00:25:21
    many years and published in 2011, so
  615. 00:25:23
    that was quite a long time ago. And
  616. 00:25:26
    just to clarify for the audience,
  617. 00:25:28
    you're still doing your procedures now
  618. 00:25:30
    in the Interventional Suite, is that
  619. 00:25:31
    right? Yeah, we've found a good home
  620. 00:25:35
    in the Interventional Suite because we
  621. 00:25:36
    have multiple rooms under our control in
  622. 00:25:39
    Mount Sinai West, so there's always a
  623. 00:25:41
    place to go with the case. And we've
  624. 00:25:43
    got a really great combined team where
  625. 00:25:46
    the IR tech has taken leadership role in
  626. 00:25:49
    setting up the equipment in the room and
  627. 00:25:51
    helping manage the patient during these
  628. 00:25:53
    cases and the imaging during the cases.
  629. 00:25:56
    And then we've got a great IRR. We've
  630. 00:25:57
    got a great OR team coming down to
  631. 00:25:59
    provide the OR tech support and the
  632. 00:26:01
    nursing support. So I think having a
  633. 00:26:04
    great team, having a room available,
  634. 00:26:06
    and then finally having the ability to
  635. 00:26:09
    do an intraoperative CT right on the
  636. 00:26:11
    table and check how much is left. Have
  637. 00:26:13
    I met that 15 cc target? Or was there
  638. 00:26:17
    something unexpected that I didn't pick
  639. 00:26:19
    up on through the endoscope? About 20
  640. 00:26:22
    of the time I am going back in for a
  641. 00:26:24
    second pass is one way to think about it.
  642. 00:26:27
    You know, you do multiple passes in
  643. 00:26:28
    thrombectomy and minimally invasive ICH
  644. 00:26:30
    you do one pass. See how much of the
  645. 00:26:32
    human tummy you got out. Do a CAT scan
  646. 00:26:34
    quickly. Don't close anything but
  647. 00:26:36
    remove the device. Put a sterile towel
  648. 00:26:39
    over the field. Do that Dynasty T on
  649. 00:26:42
    the table and then review that,
  650. 00:26:44
    calculate the residual volume and see
  651. 00:26:46
    exactly where it is in 3D space and then
  652. 00:26:49
    go back in and target that if necessary.
  653. 00:26:51
    For me that happens about 20 of the time
  654. 00:26:53
    but I find that's extremely helpful. to
  655. 00:26:55
    know what I'm coming out of the room
  656. 00:26:56
    with and how safe I feel that patient is
  657. 00:26:59
    and I know that I can be done with the,
  658. 00:27:02
    I know that I'm completely done with the
  659. 00:27:04
    procedure. Are you pulling in and just
  660. 00:27:06
    go back at the scan and you'll just go
  661. 00:27:08
    right back in through the same
  662. 00:27:09
    trajectory? Yeah, you really can't go
  663. 00:27:13
    through a separate trajectory. You know,
  664. 00:27:16
    you've got the hematoma there and you
  665. 00:27:18
    just go through the same trajectory and
  666. 00:27:20
    then once you're in the hematoma space,
  667. 00:27:22
    the cavity, then you'll direct it
  668. 00:27:23
    towards the residual hematoma that you
  669. 00:27:25
    saw on the CAT scan. Got it. This was,
  670. 00:27:28
    thank you so much, Chris. This was
  671. 00:27:29
    fabulous. I think if I could summarize
  672. 00:27:31
    a little bit of a nugget of information
  673. 00:27:33
    of what you said in nugget of wisdom for
  674. 00:27:36
    our audience, it sounds like even at
  675. 00:27:38
    this point, the field of minimally
  676. 00:27:40
    invasive surgery for hematoma evacuation
  677. 00:27:42
    is quite young and you're most
  678. 00:27:45
    interested optimizing timing to surgery
  679. 00:27:49
    techniques for hematoma evacuation And
  680. 00:27:51
    less, less, you know, kind of less
  681. 00:27:54
    dogmatic about. location at this point,
  682. 00:27:56
    I think there's still a lot more to
  683. 00:27:57
    understand as our technology and as our
  684. 00:27:59
    throughput gets better. Is that a good
  685. 00:28:01
    summary of your approach? Yeah, yeah,
  686. 00:28:03
    great summary. I think we've seen some
  687. 00:28:05
    hints in the literature that this can
  688. 00:28:07
    work in deep lesions as well as in
  689. 00:28:09
    cortical lesions, and we've got to do
  690. 00:28:11
    all the things we know that make this
  691. 00:28:13
    procedure work, which is get in there
  692. 00:28:15
    early and get all the blood out.
  693. 00:28:18
    Great Okay, so wrapping up again,
  694. 00:28:21
    thanks so much to Dr. Chris Kellner
  695. 00:28:24
    from Mount Sinai School of Medicine and
  696. 00:28:27
    Mount Sinai West. Again, I'm Stefan
  697. 00:28:29
    Mayer, John Rosenberg, and we're
  698. 00:28:32
    signing off with the master class of the
  699. 00:28:37
    NCS iPod series. Take care, guys.
  700. 00:28:40
    Thank you so much.