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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3856_Библиотеки_им_академика_М_И_Перельмана.pdf
Minimally Invasive Intracerebral Hemorrhage Removal
JackJestus, DemiDawkins,
KennethMoore, AdamArthur,
andChristopherNickele
Introduction
Spontaneous intracerebral hemorrhage (ICH) represents up to
20% of all strokes and remains one of the most dangerous stroke
subsets, with high morbidity and mortality rates. Despite its severity, there is still no denitive treatment for this disease [1]. Care
can range from medical management to surgical evacuation or
decompression. The goal of surgery is generally to treat mass
effect and reduce elevated intracranial pressure (ICP) in addition
to preventing secondary neurological injury related to cerebral
edema [1, 2]. Applying the advancements in minimally invasive
2
J. Jestus
Neurosurgery, University of Tennessee Health Science Center,
Memphis, TN, USA
D. Dawkins
Neurosurgery, Semmes Murphey Clinic, Memphis, TN, United States
K. Moore · A. Arthur, · C. Nickele (*)
Neurosurgery, University of Tennessee Health Science Center,
Memphis, TN, USA
Neurosurgery, Semmes Murphey Clinic, Memphis, TN, United States
e-mail: cnickele@semmes-murphey.com
© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2025
E. Veznedaroglu (ed.), Advanced Technologies in Vascular
Neurosurgery, https://doi.org/10.1007/978-3-031-67492-1_2
27
28
J. Jestus et al.
surgery (MIS) to surgical treatment of ICH potentially allows for
safer hematoma evacuation with less risk of injury to the adjacent
normal brain parenchyma.
This chapter reviews the various treatment options for MIS
ICH evacuation and the associated literature. Table2.1 illustrates
a summary of some of the techniques discussed in this review and
their respective study results (Table2.1) [1].
STICH Trial
The STICH (Surgical Trial in Intracerebral Hemorrhage) trials
were some of the rst large-scale clinical trials to evaluate the
benets of surgical intervention with craniotomy and hematoma
evacuation compared to nonsurgical treatment for ICH [3, 4]. For
STICH I, 1033 patients with supratentorial ICH were randomized
to early surgery or initial conservative medical management.
Patients randomized to medical management could undergo surgery if needed after randomization, but results were analyzed on
intention-to-treat basis. Results were based on the Glasgow
Outcome Scale at a 6-month follow-up. There was not a signicant difference in neurological function at 6months between the
early intervention group and the initial medical therapy group.
While this trial seems to suggest that early surgical intervention
has no effect on the neurological outcome of the patient, subgroup
analysis did note improved outcomes when the hematoma is more
supercial [3]. STICH II then sought to demonstrate the benet of
hematoma evacuation for hematomas on the cortical surface, but
ultimately it failed [4].
There are many possible reasons why these trials likely did not
show any positive benet to using surgical treatment of ICH.One
reason is the rate of crossover from medical management to surgery in STICH I, which was 140 out of 530 patients (26%) randomized to initial medical management. STICH II had 62 patients
of 292 crossover from initial medical management to surgery
(21%). Another reason is the surgical technique utilized in the
study. New, less invasive surgical techniques continue to be considered to further elucidate the potential benet of surgery on ICH
2 Minimally Invasive Intracerebral Hemorrhage Removal
=23.13, p=0.0001)
a
Mortality:
Number of
subjects Results
195
42 centers
2
6.7% vs 8.8% (p=0.44) at 90days
Functional status:
Barthel Index (BI) increase at
90days (x
Rebleeding:
9.7% vs 5.0%, p=0.08
craniopuncture
vs 182
conservative
medical
management
in China
Mortality:
14.5% vs 25.0% (p=0.02) at
90days
Functional status:
159
craniopuncture
with urokinase
vs 145
22 centers
in China
=4.166, p=0.38)
2
Rebleeding:
8.8% vs 21.4%, p=0.002
no difference in BI at 90days
(x
Mortality:
craniotomy
18.9% vs 24.4% (p=0.39) at
365days
Functional status:
BI=79.5 vs 62 (p=0.01) at
craniopuncture
vs 78
craniotomy
29
365days
Rebleeding:
10.0% vs 15.4%, p=0.29
(continued)
Dates of
Completed
Table 2.1 Summary of research studies evaluated
enrollment Location
2003 to June
2004
or ongoing MIS technique
Completed Craniopuncture January
Study
Wang etal.
[8]
2003 to July
2005
Sun etal. [7] Completed Craniopuncture January
Zhou etal. [9] Completed Craniopuncture 2005–2008 China 90
30
a
Mortality:
Number of
subjects Results
36 surgical vs
13 centers
56% vs 59% (p=0.78) at 180days
Functional status:
no difference in likelihood of
mRS>4 (OR=0.52, p=0.38)
Rebleeding:
0% vs 22%, p=0.006
35 nonsurgical
in the
Netherlands
Mortality:
19% vs 26% (p=0.04) at 365days
Functional status:
no difference in mRS<4 at
365days (45% vs 41%, p=0.33)
255 MISTIE
vs 251
standard
medical care
84 centers:
Australia,
Canada,
China,
Germany,
Rebleeding:
Hungary,
2% vs 1%, p=0.32
Israel,
J. Jestus et al.
Spain, UK,
and USA
Dates of
enrollment Location
Completed
or ongoing MIS technique
Study
Table 2.1 (continued)
March 1996
to May 1999
evacuation with
thrombolysis
Completed Stereotactic
Stereotactic
Treatment of
Intracerebral
Hematoma by
Means of a
Plasminogen
Activator
(SICHPA)
December
2013 to
August 2017
evacuation with
thrombolysis
Completed Stereotactic
Minimally
Invasive
Surgery Plus
Rt-PA for
ICH
Evacuation
Phase 3
(MISTIE 3)
2 Minimally Invasive Intracerebral Hemorrhage Removal
a
31
(continued)
Study ongoing—N/A
Number of
subjects Results
Expected
enrollment:
300
36 centers
in the USA
Dates of
enrollment Location
December
2016 to
December
mediated
evacuation
Completed
or ongoing MIS technique
Ongoing Endoport-
2021
Mortality:
42% vs 70% (p<0.01) at 180days
Functional status:
signicant difference in “minimal
neurologic decit” at 180days
vs 50 medical
management
Austria 50 endoscope
June 1983 to
August 1986
assisted
evacuation
Completed Endoscope-
(40% vs 25%, p<0.05)
Rebleeding:
4% vs 30%, p<0.05
Mortality:
0% vs 7.1% (p=0.68)
14 surgical vs
four medical
29 centers:
Canada,
August 2005
to August
assisted
Completed Endoscope-
Functional status:
no difference in mRS<4 at
180days (42% vs 24%, p=0.19)
Rebleeding:
no rebleeding in either group
management
Germany,
USA, and
UK
2012
evacuation
Study
Early
Minimally
Invasive
Removal of
Intracerebral
Hemorrhage
(ENRICH)
Auer etal.
[18]
Intraoperative
Stereotactic
Computed
Tomography-
Guided
Endoscopic
Surgery
(ICES)
32
, p<0.001
3
J. Jestus et al.
a
Number of
subjects Results
29 Apollo Mortality:
Four
Dates of
enrollment Location
May 2014 to
13.8% (n=4)
Mean ICH volume reduction:
54.1±39.1%, p<0.001
centers:
USA
September
2014
aspiration device
Mortality:
28% vs 56%, p=0.041
Functional status:
no difference in mRS at discharge
18 surgical vs
54 medical
management
One center:
USA
July 2014 to
December
2017
aspiration device
vs 15cm
3
or 3months (p=0.407 and 0.521,
respectively)
Median ICH volume at 24hours:
40cm
Study ongoing—N/A
Estimated
enrollment: 50
Seven
centers in
June 2017 to
June 2021
aspiration device
USA
(Apollo)
Completed
or ongoing MIS technique
Study
Table 2.1 (continued)
Completed Adjunctive
Spiotta etal.
[28]
Completed Adjunctive
Goyal etal.
[29]
Ongoing Adjunctive
Minimally
Invasive
Endoscopic
Surgery with
Apollo in
Patients with
Brain
Hemorrhage
(INVEST)
2 Minimally Invasive Intracerebral Hemorrhage Removal
(continued)
a
33
Study ongoing—N/A
Number of
subjects Results
Estimated
enrollment:
500
20 locations
in Germany
and USA
Dates of
enrollment Location
February
2018 to July
2024
aspiration device
(Artemis)
Completed
or ongoing MIS technique
Ongoing Adjunctive
Study ongoing—N/A
Estimated
enrollment:
600
Ten centers
in the
Netherlands
November
2018–
present
aspiration device
(Artemis)
Ongoing Adjunctive
Study ongoing—N/A
Estimated
enrollment:
Two centers
in the USA
2020 to
Ongoing Surgiscope October
500
October
2028
Study
Artemis in the
Removal of
Intracerebral
Hemorrhage
(MIND)
Dutch
Intracerebral
Hemorrhage
Surgery Trial
(DIST)
Minimally
Invasive
Intracerebral
Hemorrhage
Evacuation
(MIRROR)
34
J. Jestus et al.
a
Study ongoing—N/A
Number of
subjects Results
Estimated
enrollment:
240
Two centers
in Australia
Dates of
enrollment Location
2020 to
December
Completed
or ongoing MIS technique
Ongoing Surgiscope September
2025
11% (n=1)
Functional status:
NIH Stroke Scale decreased from
17.6 to 8.5
Nine surgical Mortality:
One center:
USA
2008 to July
2009
Completed Sonothrombolysis November
Mean volume reduction at
24hours:
59±5% for ICH; 45.1±13% for
IVH
Study
Table 2.1 (continued)
Ultra-Early,
Minimally
Invasive
Intracerebral
Hemorrhage
Evacuation
Versus
Standard
Treatment
(EVACUATE)
Newell etal.
[30]
Results for each category correspond respectively to their distinguished order in the “Number of subjects” column
a
2 Minimally Invasive Intracerebral Hemorrhage Removal
treatment. It is hypothesized that MIS could reduce the damage to
surrounding brain tissue that likely occurred in this study population.
35
Animal Models ofMIS forICH Evacuation
Multiple animal models of ICH and minimally invasive evacuation have been developed which demonstrate decreased bloodbrain barrier (BBB) permeability and other markers of cerebral
tissue damage in animals that undergo minimally invasive evacuation of induced ICH when compared to control models that do
not undergo evacuation of an induced hemorrhage [2, 5]. The
authors of these studies suggest that reduction in these factors
may translate to decreased secondary cerebral edema and thus
decreased secondary neuronal injury. Studies such as these form
the basis of interest in minimally invasive surgical ICH evacuation.
Meta-Analysis ofMIS Trials
Scaggiante et al. conducted a meta-analysis of 2152 patients
enrolled in 15 randomized clinical trials for supratentorial spontaneous ICH treatment [6]. This study attempted to determine the
benets of MIS on ICH in addition to the effects of quick treatment (<24hours post-ictus) on neurological outcome. This study
was able to demonstrate a decrease in “moderate-to-severe” functional impairment and mortality at long-term follow-up compared
to conventional treatment. As well, they demonstrated that patients
who received ICH evacuation within 24hours (or within 72hours)
of ictus were more likely to achieve functional independence
when compared to patients treated outside of that timeframe. The
results of this study help strengthen the case for the further development of MIS-ICH techniques in an attempt to discover an effective treatment for this disease.
36
J. Jestus et al.
Review ofMIS Techniques
Craniopuncture
Craniopuncture remains the standard of care for ICH treatment in
China, although no large-scale clinical trials have taken place in
Europe or the USA. With this technique, a puncture needle is
drilled through the skull to the hematoma. The needle is then
attached to the skull, and hematoma evacuation is performed with
the assistance of a thrombolytic agent. The cannula is left in place,
and a thrombolytic agent is delivered to the hematoma every
6–12hours. The needle remains in situ for 3–5days [1].
Three major studies based in China have taken place to evaluate the effects of craniopuncture, and all three demonstrate some
evidence of benet compared to nonsurgical treatment [7–9].
Wang et al. reported a multicenter randomized controlled trial
comparing craniopuncture to medical management for treatment
of basal ganglia hemorrhages in 377 patients. This demonstrated
signicant early improvement in neurological function (at
2weeks) and signicantly lower proportion of patients with modied Rankin Scale (mRS) >2 at 3months but with no signicant
difference in mortality rates [8]. Sun et al. conducted a multicenter randomized controlled trial of 304 patients comparing craniopuncture to small craniotomy for evacuation of basal ganglia
hemorrhages. This study demonstrated no difference in neurological function or mRS between the two groups, but there was a
signicant decrease in mortality at 90days and rebleeding after
surgery in the craniopuncture group [7]. Finally, Zhou etal. conducted a single center randomized controlled trial of 168 patients
with basal ganglia or lobar hemorrhages comparing craniopuncture to craniotomy for hematoma evacuation. Their study demonstrated no signicant difference in rebleed rate or mortality but
did note signicant improvement in mRS at 1year [9]. This group
of studies inconsistently demonstrates benet in mortality,
rebleeding rate, and functional status, and only one study provides
comparison to medical management. No signicant studies utilizing craniopuncture have been conducted in the USA.