MISTIE III Surgical Summary & Lessons Learned Issam Awad, MD Lynn Money M. Delour Fam Agnieszka Stadnik MISTIE III Surgical Center

Surgical summary to date

Surgical Summary to Date –Cont’d Catheter Category Trajectory A Trajectory B Trajectory C Surgical cases that didn’t go to surgery 115 SURGICAL CASES 54 26 33 2 (1 pt herniated overnight before surgery, taken for crani; 1 pt improved overnight so surgeon didn’t take to surgery) 64 GOOD INITIAL 34 (63.0% of 54) 9 (34.6% of 26) 21 (63.6% of 33) 38 SUBOPTIMAL INITIAL 18 (34.6% of 54) (16 dosed; 1 replaced and dosed; 1 replaced & reached endpoint) 10 (38.5% of 26) (5 dosed; 4 replaced & dosed; 1 replaced & reached endpoint) 10 (30.3% of 33) (10 dosed) 11 POOR INITIAL 2 (3.7% of 54) (replaced and dosed) 7 (26.9% of 26)* (6 replaced & dosed) 2 (6.1% of 33) (replaced & dosed) 26 CATHETERS REPOSITIONED AFTER DOSING OR REPLACED 6 (1 replaced d/t dislodging by pt) 16 (includes 5 repositioned after dosing and 1 replaced after dosing d/t dislodging) 5 (includes 1 new catheter placed during dosing to better target remaining clot) % Evacuated 74.6 71.1 68.4 *One case, the site exhausted their resources and did not attempt to retarget the clot. One case, site did not obtain permission from family for second procedure to retarget clot.

Surgical Summary to Date- Cont’d Good Suboptimal Poor % Evacuated Pre-qualified (n=63) 37 (58.7% of 63) 18 (28.6% of 63) 8 (12.7% of 63) 71.8 Qualified w/ probation (n=26) 13 (50% of 26) 12 (46.2% of 26) 1(3.8% of 26) 68.3 Fully qualified (n=24) 14 (58.3% of 24) 9 (37.5% of 24) 1 (4.2% of 24) 76.4 Note: 2 cases did not go to surgery so not counted here

Trajectory pitfalls

Given location of ICH, determine optimal trajectory. B C

Trajectory A

Catheter too deep: can be due to image guidance issues or a new shape of clot after aspiration Too deep better than too shallow… Can always simply withdraw

Too shallow Be careful about pulling back too much when repositioning the catheter - Too deep is always better than too shallow

Too medial May be prevented by more lateral and larger burr holes May reflect post-aspiration clot May still be suitable for dosing if catheter perforations in contact with clot

Trajectory b

Too medial Image guidance by anterior surface landmarks often inaccurate for posterior trajectories Consider burr hole and angle of approach

Burr hole vs twist drill: Burr hole allows greater maneuverability and angles of freedom. Especially important for Trajectory B clots

Mode of insertion - Larger and more lateral burr holes Twist Drill Burr hole

Mode of insertion - Angles Twist drill Burr hole

Trajectory c

Too shallow

Trajectory C is often used with complex clot shapes and may complete dosing with multiple small satellite bleeds remaining

Good placement generally leads to good clearance

Image Guidance is Mandatory For both cannula and catheter 20 Image Guidance is Mandatory For both cannula and catheter Stereotactic CT Guided Navigation (passive catheter introducer or equivalent device) Real Time Image Guidance (Procedural CT, intraop imaging, etc)

Image guidance Use image guidance with the cannula (when used) AND with the catheter insertion Avoid errors due to “wiggle” and depth estimates

Real time image guidance Using real time image guidance, site was able to immediately retarget clot remaining after aspiration for optimal catheter placement and dosing

Summary of Safety Lessons Mentoring and guidance can help achieve good results despite initial technical errors Image guidance is mandatory for catheter and cannula Use fiducials for posterior approaches, to avoid navigation mishaps Larger (and more lateral) burr holes often allow more accurate placement Real time image guidance and intraoperative imaging can save the day

Additional considerations

Importance of etiology screening 54 y/o male History included HTN, diabetes, prior smoker, BP up to 250/115 on admission CTA done, read as negative PI stated CTA suggested suspicious etiology so scheduled cath angio Found AVM, pt screen failed Risk factors alone are not enough to exclude vascular etiology Dural Arteriovenous Fistula

Preoperative (craniectomy) CT ICP monitoring 48 y/o female Expansion of ICH from 47-59ml, stabilized Young patient with tight cranial vault, comatose, intubated. No ICP monitoring. CTA negative, cath angio not done 3 day delay in randomization d/t stabilization, etiology screening, team availability Herniation before going to surgery, taken to open surgery ICP monitoring was indicated if operation delayed, or if case randomized to medical. All patients should receive best medical therapy Stability CT 1 Stability CT 3 Preoperative (craniectomy) CT

Drainage issues Post-2 doses 76 y/o male History of HTN, hyperlipidemia, afib CTA, MRI negative Trajectory B approved, C was used suboptimal but acceptable placement 2nd catheter placed after 4 doses; further doses given Dosing issues throughout: catheter left clamped twice, not allowed to drain Scant drainage reported with last few doses Expansion of ICH after 8 doses Final doses should not have been given with scant drainage. Always troubleshoot catheter drainage/dosing configuration and restore drainage before dosing. Post-2nd catheter Post-8 doses

Consent for multiprocess intervention 78 y/o female Site had poor initial catheter placement Procedure done late at night in procedure room, decided to wait to replace until morning when would be in own OR In the morning, family refused repositioning Consent should be obtained upfront for multiprocess intervention and not a single catheter placement

IVH Considerations 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 Concern about increased risk of infection with multiple drains. We will monitor this and inform sites if we see any trends. Cases with casting, mass effect or shift from IVH are not included Cases with IVH and more than one EVD cannot be included

M3 EVD Placement and Eligibility Determination

MISTIE-3 Patient 6074: EVD for ICP Management ICH: 42.23 cc LLV: 2.16 cc RLV: 6.68 cc Total Ventricular Volume: 8.84 cc

EVD with IVH Mass Effect Screen Failure ICH Volume: 42 cc

Thank you!