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2 Minimally Invasive Intracerebral Hemorrhage Removal
37
Stereotactic Evacuation withThrombolysis
The rst major trial to evaluate the effect of stereotactic hematoma aspiration in conjunction with direct thrombolysis was the
SICHPA trial (Stereotactic Treatment of Intracerebral Hematoma
by Means of a Plasminogen Activator) in 2003 [10]. This trial
compared stereotactic hematoma evacuation with urokinase to the
best medical management. A catheter was inserted stereotactically and serially infused with urokinase to drain the hematoma
over 48hours. Seventy-one patients were randomly assigned to
the surgical or nonsurgical groups. While there was no signicant
difference in mortality between the surgical and nonsurgical
groups (56% vs 59%, respectively), there was a signicant
decrease in hematoma volume in the surgical arm over 7 days
[10].
In the MISTIE trials (Minimally Invasive Surgery with
Thrombolysis in Intracerebral hemorrhage Evacuation), surgical
stereotactic hematoma evacuation with recombinant tissue plasminogen activator (rtPA) was compared to medical management.
For their surgical technique, a sheath was stereotactically passed
through a burr hole into the middle of the hematoma, and manual
aspiration is performed. A catheter is then left behind in place of
the sheath. The drainage catheter remains and periodic injection
of alteplase is performed. Clot burden is assessed with daily CT
scans, and injections continue until up to nine injections have
been performed or the ICH volume is less than 15cm3 [1, 11].
MISTIE-I (2008) provided hope for MIS treatment, as there
was a signicant increase in clot resolution compared to medical
management, although it was only a phase 1 trial [11]. MISTIE-II
(2016) was a multicenter phase II randomized trial comparing stereotactic aspiration with thrombolysis to conservative medical
management in 96 patients and primarily focused on safety outcomes. There was no signicant difference in the primary outcomes of 30-day mortality, periprocedural mortality, symptomatic
bleeding, and infection leading them to conclude that MIS with
alteplase was a safe technique [11].
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J. Jestus et al.
MISTIE-III (2019) was a multicenter, blinded endpoint randomized controlled trial conducted in 506 patients. This efcacy
study showed a decrease in length of hospital stay and mortality
after 1year compared to medical management with no signicant
difference in mRS at 1 year. However, for those patients who
achieved a reduction in hematoma volume less than 15mL, there
was a signicant improvement in mRS at 1year [12]. Other trials
of stereotactic aspiration with thrombolysis rarely demonstrated
any positive effects; this in tandem with the exploratory nature of
the MISTIE trials suggests a continued need to evaluate other surgical modalities [1].
Endoport-Mediated Evacuation
For this technique, a small craniotomy and dural opening is performed. An endoport along with its obturator is inserted into the
hematoma. The obturator is removed, and hematoma evacuation
is then performed with a microsurgical approach or with a handpiece allowing for suction, irrigation, and coagulation of vessels
for hemostasis. The endoport is removed at the conclusion of the
case [1]. Many different clinical studies have been conducted to
evaluate an endoport-mediated system for ICH evacuation with
the potential benets including less tissue damage, better access
and visualization for deep ICH, and potentially faster evacuation
times.
The Early Minimally-Invasive Removal of ICH (ENRICH)
trial is a recently resulted trial evaluating endoport-mediated
hematoma evacuation using the BrainPath and Myriad devices.
Prior to ENRICH, there have been small retrospective studies of
endoport-mediated evacuation, although the results of those studies are inconclusive given that they either did not compare their
experimental group to a control, had relatively small series of
patients [13–15], or demonstrated poor functional outcomes [16].
They did, however, demonstrate potential positive outcomes in
terms of the reduction of hematoma volume using an endoportmediated evacuation system [13–15].The ENRICH trial published
results with Bayesian analysis showing a posterior probability of
2 Minimally Invasive Intracerebral Hemorrhage Removal
39
superiority of surgery over medical management of 0.981. This
was based off of a utility-weighted modied Rankin scale (uwmRS) of 0.458 for the surgery group and 0.374 for the control
group. While ICH in the general population is predominantly
located within the basal ganglia, the trial ratio was roughly 70/30
lobar to basal ganglia because of an adaptive trial design. Anterior
basal ganglia hemorrhages were dropped from enrollment when
an interim analysis showed that the trial was unlikely to prove an
effect with hemorrhages of that location. Therefore, the positivity
of the trail overall was carried by the lobar hemorrhages. Nevertheless, ENRICH represents the rst large, randomized controlled
trial showing positive results for surgical intervention in ICH [17].
Endoscope-Assisted Evacuation
In this technique, an endoscope is combined with an aspiration
cannula through an access sheath to remove the ICH via a small
craniectomy. The endoscope provides visualization, while the
cannula allows for aspiration and irrigation of the hematoma. This
technique also allows for the coagulation of vessels for hemostasis. A drainage catheter can be left in the cavity as needed [1].
Auer et al. conducted a randomized controlled study in 100
patients with spontaneous supratentorial ICH and compared
endoscopic hematoma evacuation with medical management.
Patients in the surgical arm demonstrated signicantly lower mortality rates at 6months (30% vs 70%) and signicant neurological
functional improvement; however, it should be noted that the surgical outcome of those patients suffering a thalamic ICH was no
different from those managed conservatively [18]. Other retrospective endoscopic studies generally demonstrated some benet
to this technique over medical management (e.g., lower rebleeding rate, decreased mortality, lower mRS score, improved functional outcomes, and/or greater evacuation percentages) [18–23].
In addition, two recent meta-analyses of this technique have been
conducted which also demonstrate benet [24, 25].
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J. Jestus et al.
The Intraoperative Stereotactic Computed TomographyGuided Endoscopic Surgery (ICES) for Brain Hemorrhage was a
multicenter, randomized controlled trial which compared endoscopic hematoma evacuation to medical management. In this trial,
20 enrolled subjects were randomized into a surgical (n=14) and
control (n=6) group. In addition, 36 subjects from the medical
arm of the MISTIE trials were prospectively added to the control
group for analysis. Their data suggests that endoscopic hematoma
evacuation may improve functional outcomes, as the percentage
of subjects with a mRS<4 at 1year was 42.9% and 23.7% for the
surgical and control groups, respectively. However, with a high
p-value (p= 0.19), these results are inconclusive. A large-scale
clinical trial will need to be conducted to demonstrate true efcacy of endoscopic hematoma evacuation, as many of the aforementioned studies were conducted retrospectively or have small
sample sizes.
Adjunctive Aspiration Devices
An adjunctive aspiration device functions similarly to an
endoscope- assisted technique but with enhanced control over
aspiration strength, potentially decreasing inadvertent damage to
the adjacent normal brain parenchyma while enabling more thorough clot removal [1, 26]. These systems use an endoscope working channel for irrigation and another channel for a tool that
combines aspiration and agitation of the clot. The Apollo system
(Penumbra Inc., Alameda, California) is a low-prole system that
consists of an aspiration wand which vibrates and softens the clot
preventing the cannula from obstructing. The Artemis system
(Penumbra Inc., Alameda, California) is the second-generation
system.The set up for such a procedure requires neuronavigation,
the endoscope and monitor, basic surgical instruments and the
Artemis device with suction. Imaging is usually performed to
check hematoma evacuation prior to closure, which generally
requires angio equipment, a portable CT scanner or a burr hole
2 Minimally Invasive Intracerebral Hemorrhage Removal
41
ultrasound probe.Figure 2.1 shows an example of this procedure
set up in the angiogram suite.In Fig.2.2, the surgeon holds the
endoscope and the aspiration device.The authors’ preference is to
have the assistance hold the endoscope sheath rather than staple it
to the scalp, so that it can be manipulated as needed throughout
the procedure. An example of the endoscope view during hematoma evacuation is shown in Fig.2.3.
The Stereotactic ICH Underwater Blood Aspiration (SCUBA)
method, using the Apollo system, was described by Kellner etal.
The SCUBA technique occurs in two stages. In the rst stage, the
endoscope and adjunctive aspiration device are inserted, and
high-power suction is applied at the depth of the hematoma. The
endoscope and adjunctive aspiration device are then pulled back
until it is at the proximal end of the hematoma. The suction is then
decreased, and the irrigation is increased in order to expand the
Fig. 2.1 Room set up for endoscopic assisted MIS ICH evacuation. This
example is set up in the angiogram suite, demonstrating the endoscope tower,
standard angiogram equipment and surgical back table. The stealth machine
is also in-room, situated behind the camera in this instance
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J. Jestus et al.
Fig. 2.2 View of the surgeon controlling both the aspiration device and the
endoscope. In this situation, an assistant would control the depth of the
sheath. The author’s preference is for the surgeon to control both the endoscope and the sheath, with the resident or assistant controlling the aspiration
device
cavity allowing for direct visualization and exploration of the cavity to allow for further clot evacuation as well as hemostasis. This
second phase also helps to reduce trauma to cavity walls. The
endoscope is then removed [1, 27].
2 Minimally Invasive Intracerebral Hemorrhage Removal
43
Fig. 2.3 Endoscope view during clot aspiration. In general, keeping the
aspiration device advanced a clear distance out through the endoscope will
help to keep the lens of the endoscope clean and maintain visualization. The
authors also nd that the 30 degree scope is not only manageable but may be
easier in this regard.
Spiotta etal. reported on a multicenter initial experience utilizing the Apollo system in 29 patients demonstrating a signicant
reduction in hematoma size postoperatively [28]. Goyal et al.
reported a case-control study of 19 patients who underwent MIS
using the Apollo system of basal ganglia ICH.This interventional
cohort was then matched to 54 conservatively managed patients.
This series demonstrated a signicantly lower in-hospital mortality in the MIS group (28% vs 56%) [29].Figures 2.4a, b showpre-
44
ab
Fig. 2.4 (a) Head CT from a 48-year-old patient with a left external capsule
hemorrhage. The patient required intubation for somnolence/airway protection and required drips to control blood pressure. (b) Postop head CT from the
same patient after endoscopic-assisted MIS ICH evacuation. This was done
through a burr hole on the left forehead. The patient was able to be extubated
POD#1 and was transferred out of the ICU POD#3 once his blood pressure
was controlled without IV drips. There were no issues with cerebral edema
during his hospital stay
J. Jestus et al.
operative and postoperative CT scans for a patient with left side
anterior basal ganglia ICH that was evacuated using an endoscope
and adjunctive aspiration device via a burr hole placed on the left
forehead.
The ongoing trials for adjunctive aspiration devices are the
Minimally Invasive Endoscopic Surgery with Apollo in Patients
with Brain Hemorrhage (INVEST) study which is based in the
USA and the Dutch Intracerebral Hemorrhage Surgery Trial
(DIST) based in the Netherlands. The results of these studies are
not yet available.The Artemis in the Removal of Intracerebral
Hemorrhage (MIND) study stopped enrollment early after the
ENRICH trial results were released. This was done after
enrollment of 236 patients, with interim analysis prespecied at
an N of 200. The primary endpoint of the trial was mRS at 180
days and in this measure, the trial showed no difference between
2 Minimally Invasive Intracerebral Hemorrhage Removal
medical management and minimally invasive surgery (MIS) evacuation (OR 1.03; 96% CI, 0.62 to 1.72, P=0.452). However, the
trial did show reduced perihematomal edema and reduced ventilator dependence at 30 days as well as reduced serious adverse
events with MIS evacuation of ICH.It should be noted that MIND
patients were split roughly 70/30 with most patients having basal
ganglia hemorrhages, which is more reective of the general population and is the inverse of the patients enrolled in ENRICH.At
the time of this writing, the full results of the MIND trial are not
yet published.
45
Surgiscope
The Aurora Surgiscope System is a relatively newer instrument. It
is a single-use endoscope approved by the FDA in January of
2019. There are no published reports of techniques using this system yet. The Minimally Invasive Intracerebral Hemorrhage
Evacuation (MIRROR) and Ultra-Early, Minimally Invasive
Intracerebral Hemorrhage Evacuation Versus Standard Treatment
(EVACUATE) trials have recently begun enrolling patients and
should provide a better understanding around the efcacy of this
technique [1].
Other Techniques
Other techniques to improve hematoma evacuation, such as transcatheter sonothrombolysis, have been reported but are not common in clinical practice [30].
Operative Setting andIntraoperative Imaging
As the eld of neurointervention continues to expand, advancements in cone beam CT (CBCT) imaging have allowed for the
evacuation of ICH in a minimally invasive manner with the assistance of real-time image guidance, thereby increasing the extent
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J. Jestus et al.
of the initial clot removal [26]. Many institutions utilizing adjunctive aspiration devices use them in hybrid or intraoperative angiography suites where CBCT allows for immediate feedback on
the extent of hematoma evacuation.
Both the operating room and the angiography suite can be used
as the setting for MIS ICH evacuation. Each has its own positive
and negative considerations, but the key secondary decision is
which type of imaging will be used to assess the clot evacuation
mid-procedure. Given the subgroup analysis of MISTIE III showing that residual hematoma volume <15 cc may be associated
with improved mRS at 1year, it seems imperative that the clot
evacuation be assessed mid-procedure, so that continued efforts
can be made until that goal is reached. This is most commonly
done in the angiography suite with CBCT but can also be done
with a burr hole ultrasound (US) probe. In the operating room, the
US probe is clearly still an option, but CT is only feasible if the
institution possesses a portable CT technology, or the room is a
hybrid suite.
Conclusions
MIS techniques offer several promising options for treating spontaneous intracerebral hemorrhage, although there is not yet a clinical study that suggests a denitive surgical advantage or an
optimal surgical technique for treating this disease. There are,
however, several ongoing clinical trials that are researching different MIS-ICH evacuation techniques that should help provide clarity around the efcacy of certain techniques and hopefully patient
selection.
References
1. Musa MJ, Carpenter AB, Kellner C, Sigounas D, Godage I, Sengupta S,
etal. Minimally invasive intracerebral hemorrhage evacuation: a review.
Ann Biomed Eng. 2022;50:365–86.
2. Wu G, Li C, Wang L, Mao Y, Hong Z.Minimally invasive procedures for
evacuation of intracerebral hemorrhage reduces perihematomal glutamate content, blood-brain barrier permeability and brain edema in rabbits. Neurocrit Care. 2011;14:118–26.