Transcript Document

Minimally Invasive
Surgery
+
rt-PA for ICH Evacuation
SURGICAL TRAINING
Protocol Overview
Objectives
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Overview of MISTIE 3
Major Findings: MISTIE 2
Key Elements of Procedures
Minimally Invasive Procedure
Considerations
Overview
• Phase III: Efficacy and Safety
• Combination MIS and Clot Lysis w/rt-PA to remove ICH
• 500 Patients
• 1:1 Adaptive randomization
• 250 Surgical vs 250 Medical Management
• Funding: NIH/NINDS
Overview (cont)
• Performed by qualified neurosurgeon
• Performed in OR (preferred)
• Also in procedural CT/MRI scanner or ICU
• Use introducer and catheter (commercially suitable kit is
available)
• Aspiration with 10 ml syringe
• Antibiotic coverage
Qualified Surgeon
3 Phases
• Pre-Qualification: Everyone must participate , Letter of
Attestation
• Have performed 3 prior image-guided or stereotactic catheter
aspiration or placement procedures
• Have current privileges to perform these procedures at institution
• Qualification w/Probation: Must have satisfactorily performed
one MISTIE procedure for ICH in which catheter placement is
reviewed by Surgical Center and Reading Center prior to or
during this trial
• M2 Veterans – you can get credit
• New to MISTIE –
• Need to be proctored on site or tele-proctored for your first case*
• Proctor must be Fully Qualified MISTIE surgeon
Qualified Surgeon
3 Phases (cont)
• Full Qualification: Must have satisfactorily performed
three MISTIE procedure for ICH in which catheter placement
is reviewed by Surgical Center and Reading Center prior to or
during this trial
• We anticipate all surgeons will pass through this phase
• Recognize review of catheter placement is part of protocol and is
an ongoing activity
• Take Home Message: After first 3 successful MISTIE
procedures, you will reach Full Qualification status.
• Additional Training: Surgeon’s Webinar once/month
• One-time mandatory course for those not able to attend
Investigator Meeting. Set up by Coordinating Center.
Qualified Surgeon
“To Do List”
• Letter of Attestation
• Send Letter of Attestation regarding performance and privileges
• Credit for Prior MISTIE Procedures
• MISTIE II surgeons may request that images be pulled from their
M2 cases for review.
• Reading Center is also pulling Veteran M2 scans for Surgical
Center review.
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Will notify site coordinators of individual surgeons’ status
• Non-M2 surgeons who have performed off-label MISTIE
procedures may send those images for review.
• SEND YOUR LETTER, CASES , REQUEST MISTIE II CASES to
either of Surgical Center Coordinators:
• Agnieszka Stadnik , [email protected]
• Lynn Money, [email protected]
M3 Inclusion Criteria
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Age 18-80
GCS </=14 or NIHSS >/= 6
Spontaneous supratentorial ICH >/= 30cc
Sx < 24 hrs prior to Dx CT (unknown time of Sx onset is
exclusionary)
• Intention to initiate surgery within 72 hrs after Dx CT
• 1st dose can be given within 76 hrs of Dx CT
Inclusion Criteria (cont)
• Stable clot on 6-hour stability scan (within 5cc from diagnostic
to stability scan)
• (A*B*C)/2 method
• SBP < 180mm HG sustained for 6 hrs recorded closest to time
of randomization
• Historical Rankin score of 0 or 1
• Negative pregnancy test
Exclusion Criteria
• Infratentorial hemorrhage
• IVH, even when EVD placed, does not necessarily represent an
exclusion*
• Thalamic bleeds w/ midbrain extension and 3rd nerve palsy or
dilated and NR pupils**
• Irreversible impaired brain stem function - GCS </= 4
• Ruptured aneurysm, AVM, vascular anomaly, Moyamoya
disease, tumor as source of hemorrhage
Exclusion Criteria (cont)
• Pts w/unstable mass or evolving intracranial compartment
syndrome
• PLT <100,000, INR > 1.4, or elevated PT/aPTT
• Irreversible coagulopathy or known clotting disorder either
due to medical condition or prior to randomization
• Inability to sustain INR < or = 1.4 using short- and long-acting
procoagulants (such as, but not limited to, NovoSeven, FFP
and/or Vitamin K)
• Pts requiring resumption of therapeutic anticoagulation within
30 days are excluded
Exclusion Criteria (cont)
• Use of Dabigatran (or other antithrombin drugs) prior to Sx
onset
• Internal bleeding, involving retroperitoneal sites or GI, GU or
respiratory tracts
• Superficial/surface bleeding (ie. venous cutdowns, arterial
punctures) or surgical site
• Positive urine/serum preg test in pre-menopausal female w/o
documented hx surgical sterilization
• Allergy/sensitivity to rt-PA
Exclusion Criteria (cont)
• Prior enrollment in the study
• Planned or simultaneous participation (b/w screen and Day
30) in another interventional trial
• Pts not expected to survive to day 365 visit due to comorbidities and/or are DNR/DNI status prior to randomization
• Any concurrent serious illness that would interfere w/safety
assessments*
• Pts with a mechanical valve
Exclusion Criteria (cont)
• Known risk for embolization*
• Any other condition that the investigator believes would pose
a significant hazard to the subject if the therapy were initiated
• Active drug/alcohol use or dependence that, in the opinion of
the site investigator, would interfere w/adherence to study
requirements
• In investigator’s opinion, pt is unstable and would benefit from
a specific intervention rather than supportive care plus/minus
MIS + rt-PA
• Inability/unwillingness of subject or legal guardian or
representative to give written, informed consent
M2 Results
1.The MIS procedure can reduce clot size safely without
increased mortality or morbidity
2.The reduction is associated with an estimate between 10% 14% improved outcome across multiple modified Rankin cut
points
3.The intervention is associated with shorter (39-day) hospital
stay and a $45,000 savings/patient
4.An estimate of 14% fewer patients reside in long-term nursing
facilities at 180 and 365 days post procedure.
M2 Surgical Results
• Optimal catheter placement within the clot is critical to
successful outcome
• Achieved by catheter trajectory planning
• Surgical Review Required
• Not required to follow Surgical Review Recommendation
• If disagreement, site NS must demonstrate rationale of his/her plan
Surgical Committee Roster
• Dan Hanley
• Mario Zuccarello
• Issam Awad
• Francois Aldrich
• Paul Camarata
• William Broaddus
• Neil Martin
• A. David Mendelow
• Sagi Harnoff
• Judy Huang
• Jean Louis Caron
• Robert Dodd
• Michael Rosenblum
Real Time Partnering
Provide guidance, share expertise, answer questions
(not to interfere with your patient care!)
• Two surgical teams – will rotate call 50-50 to cover all sites
worldwide 24/7
• Cincinnati
• Mario Zuccarello, MD
• Lynn Money, Coordinator
• Chicago
• Issam Awad, MD
• Agnieszka Stadnik and Michael Jesselson, Coordinators
Regional Surgical Monitors
• Europe
• David Mendelow
• Middle East
• Sagi Harnof
• Asia
• Craig Anderson
• North America
• Issam Awad
• Mario Zuccarello
Standardization
• Precision, Accuracy, Safety are NOT Negotiable
• Standardization of key elements
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Entry Point
Trajectory
Reposition
Removal of clot = Aspiration
• Stabilization
• Dosing
• Catheter removal
• Will later discuss where there is latitude
Trajectory Planning
ICH Categories
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Type A = Deep-seated occupying the anterior third of the
basal ganglia with typical “oval” shape (football shape)
Type B = Deep-seated occupying the posterior third of the
basal ganglia; the shape can range from more roundish to
elliptical
Type C = Superficial (lobar) with variable shape, but often
more spherical
“Type A” (anterior basal ganglia)
^ Entry point ^
^ Slice showing greatest cross section ^
^ Trajectory ^
“Type B” (posterior basal ganglia)
^ Entry point ^
^ Slice showing greatest cross section ^
^ Trajectory ^
“Type C” (lobar and/or superficial)
^ Entry point ^
^ Slice showing greatest cross section ^
^ Trajectory ^
Plan for Procedure and Surgical
Review
• Site NS will review 3D reconstruction of ICH on CT
• To determine burr hole location, catheter trajectory and
hematoma target
• Select representative slices reviewed for trajectory determination
• Site coordinator will upload full set of thin-slice (1mm) DICOM
images into EDC ASAP
• Site NS and coordinator complete Surg Review Form and
upload into EDC
Surgical Center Review
• SC review site’s plan within 3 hours
• Notify site and document in EDC agreement w/planned approach
• Or provide different recommendation
• Site NS not required to follow recommendation
• If disagreement, site neurosurgeon must state rationale for
his/her plan before using surgical plan different from that
proposed by the Surgical Center
After Procedure Completed
• After catheter placement, protocol calls for scan to check
catheter placement
• Send post procedure CT to SC to confirm placement—full
DICOMs
• Full DICOMs will be required, but for this particular scan, you will
be allowed to send jpegs for an initial, quick review
Before Performing MIS
• Coordinating Center approval of inclusion/exclusion criteria
• Reading Center confirmation of stability and volume
• Surgical Center input on trajectory
Summary
Checklist
• Confirm Inclusion/Exclusion Criteria met
• Surgical Plan Completed that includes:
• Entry Point
• Trajectory
• Target
• Communications with Surgical Center and Coordinating Center
• Upload DICOM images of each scan for review
• Select planned trajectory on surgery page
• Approval from Surgical Center
Summary Checklist (cont)
• Perform Procedure, leaving catheter open to drainage
• Repeat CT to confirm catheter placement
• Immediately after procedure
• Allow 6 hours for stabilization
• Begin dosing
• With each catheter adjustment/replacement, repeat the steps
on this slide*
Instructional
Surgical Presentation
Minimally Invasive
Surgery (MIS)
for
Intracerebral Clot Removal
Antibiotics
• Protocol states that it is up to local hospital protocol or 1 to 2G
Ancef IV
• To be given pre-operatively and every 8 hours following until
catheter is removed
Skin Incision
• Approx. 1 inch in length
Skin Retraction
• Allow for view of the
skull
Burr Hole Drilling
• Burr hole is made at the
appropriate site for the
planned trajectory
according to ICH Type
(A, B, or C)
Cannula Introduction
• Dura is opened with a small
incision
• 14 French Cannula illustrated
• It is placed with a single pass
into central core (2/3 of
overall hematoma diameter)
Inner Cannula Removal
• Carefully remove the
inner portion of the
cannula while allowing
the cannula to remain
within the intracerebral
clot
Hematoma Aspiration
• Using a 10 cc syringe
aspirate hematoma until
there is no longer a fluid
component of clot noted
in aspirate
• Continue aspiration until
surgeon appreciates
significant resistance
• Document aspirate volume
Catheter Insertion
• Pass soft catheter
through cannula into
the residual hematoma
Cannula Removal
• While removing cannula
ensure that soft
catheter remains within
residual hematoma
Catheter Tunneling
• Tunnel catheter
subcutaneously away
from the incision as is
standard practice
Skin Closure
• Suture the skin incision
Connect Catheter to Stopcock
• Connect soft catheter
to a three-way stopcock
and then to closed
drainage bag system
Closed Drainage System
Considerations for the Surgeon
Autonomy vs Standardization of
Surgical Elements
• We don’t want to restrict the procedure and how it’s done
• Each veteran MISTIE surgeon has their own technique, have to
allow for variation
• Variability could cause fewer complications but also may take
away generalizability
• Technical variations OK if goal is met
• Standardization of key elements
• Optimal catheter placement within the clot, for example, as we
have discussed
Feb 7, 2013
ISC 2013 Late Breaking News
50
Image Guidance is Mandatory
Stereotactic CT Guided
Navigation
(passive catheter introducer or
equivalent device)
Real Time Image
Guidance
(Procedural CT, intraop imaging, etc)
Acceptable
Image Guidance Modalities
• Image guidance restrictive in M2, now can have procedural CT
in OR, even in CT, with real-time guidance
• Must be flexible with image guidance issues
• There are 2 algorithms for catheter placement
• Stereotactic Image Guided using passive catheter introducer
• Real Time Image Guidance using CT
Stereotactic Image Guidance
• Create Burr Hole w/Drill
• Use cannula large enough to pass final catheter through (14 F,
16 F)
• Catheter inserted passively inside cannula which is then
removed
• To Reposition, must re-target clot with new cannula/catheter
Real Time CT
• May use twist hole
• May use Dandy needle or large soft catheter to aspirate clot*
• Insert soft catheter using planned trajectory
• To reposition
• Correct on the spot
• Check placement at completion of procedure
Repositioning or replacement
before dosing
• Reposition defined as:
• Partial removal or “pull back”
• Remove non-optimally placed catheter/replace using second MIS
procedure using same or different trajectory
• Complete replacement of the catheter is allowed if there is
disturbance by inadvertent catheter movement or partial clot
reduction
• In any subject, complete replacement to occur only once
• If after placement and subsequent CT you decide to reposition, you
do not need Surgical Center confirmation for your decision
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Only after you have your final placement do you need to submit
images for Surgical Center review (important to remember, you
need to submit images to the Surgical Center when you feel you
have the final position)
Repositioning or replacement
after dosing begun
• If dosing has begun, there is a different procedure for
repositioning/replacement
• You must wait at least 24 hours after the most recent dose
before manipulating the catheter
• You must repeat all stability protocols as if it were the original
catheter placement
• Post placement, must upload DICOMs showing final placement
• Obtain SC approval
• Wait 6 hours for stability before resuming dosing
Large Difficult Shapes
• Suggest 2 catheters from the beginning
• Each using a different trajectory
• Consult SC for issues regarding
• Catheter management
• Dosing considerations
• SC and CC will adjudicate such matters on a case by case basis
Figure 1. A, Shape (left) and density (right) categorical scales and (B) examples of
homogeneous, regular ICH (left) and heterogeneous, irregular ICH (right).
Barras C D et al. Stroke 2009;40:1325-1331
Copyright © American Heart Association
IVH
• IVH, even when EVD placed, does not necessarily represent an
exclusion
• Proceed with evaluation
• Send CT scans
• Case will be adjudicated by SC and CC
• Cases with IVH and more than one EVD cannot be included
• If your patient has more than one catheter, they should be
clearly labeled to ensure the study rt-PA is injected only into
the ICH
Helpful CPT Codes
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61781: Stereotactic image guidance
61156: Burr hole for ICH
61210: Placement of brain catheter
61070: Aspiration or injection through brain tubing
• Injection is standard
• Drug is research
Consideration of Surgical Endpoint
• We confirm we wish to leave the primary surgical endpoints
unchanged from the MISTIE Phase II study
• The goal is to decrease clot volume to 10-15 cc
Consideration of Surgical Endpoint
The MISTIE II multivariable outcome prediction model
demonstrates that the greater the removal of clot the greater
the benefit.
Animal models are consistent but have not been performed with
detailed dose injury studies.
Epidemiologic models of human outcome after ICH have
however confirmed volume severity relationships.
Thus our surgical endpoint is to decrease to 10-15 cc.
Consideration of Surgical Endpoint
The failure to reach 10-15cc is a practical matter.
As removal is limited when the catheter does not contact the
clot, the surgeon must be allowed to individualize the goal for
each patient's specific catheter situation.
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