DOI: https://doi.org/10.21203/rs.3.rs-1542034/v1
Aims: To compare Endoscopic Surgery and Robot CAS-R-2 drainage for surgical treatment of basal ganglia hypertensive intracerebral hemorrhage.
Methods: Fifty consecutive basal ganglia hemorrhage patients were reviewed retrospectively. The primary and secondary outcomes were 6-months mortality and 6-months modified Rankin Scale score, which were assessed by a multivariate logistic regression mode.
Results: Compared with the Robot CAS-R-2 group, the 6-month prognosis was significantly higher in the endoscopic evacuation group (OR 5.912, 95% CI 1.014-34.459). Preoperative hematoma volume (OR = 0.931, 95% CI 0.875-0.990) and IVH (OR = 0.578, 95% CI0.396-0.844) were independent predictors for 6-month prognosis. No significant difference in the mortality was found in the two groups (OR 0.501, 95% CI 0.192-1.308).
Conclusion: Endoscopic hematoma removal significantly improved the 6-month prognosis compared with the drainage of hematoma under Robot CAS-R-2.
Hypertensive intracranial hemorrhage (HICH) is a common neurological disorder with a poor prognosis and outcome, with an estimated mortality rate of > 30% within the initial 30 days and the vast majority of survivors being disabled at 6 months.[1] Moreover, HICH in thalamus and basal ganglia account for the majority. Evacuation of these hematomas by craniotomy is generally considered controversial because of the high rates of mortality and morbidity observed after this procedure and, Currently, with the development of micro neurosurgery, intraoperative neuro-physiological monitoring, and neuron navigation make surgical treatment of HICH easier and safer[2, 3].which had a higher evacuation rate, lower risk of complications, and shorter operation time compared with those that underwent a craniotomy or stereotactic aspiration[4] .
The surgery for endoscopic evacuation of hematomas using a transparent sheath was first described by TETSUHIRO NISHIHARA et al. [5]in 2000.In 2004, Chen et al. reported that a frontal approach can facilitate optimal evacuation of putamina hemorrhage, Which the hematoma evacuation rate was more than 90% (median 93%) with the frontal approach and 84% with the temporal approach. [6]Up to 2016, Phase II of the Minimally Invasive Surgery with thrombolysis for ICH Evacuation (MISTIE) trial showed an endoscopic evacuation arm of MISTIE II, called the intraoperative stereotactic computed tomography-guided MIS (ICES), showed the safety and effectiveness of the chronic neurological outcome.[2]Meanwhile, After the MISTIE III Paul Vespa et al. argue that for moderate to large intracerebral hemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral hemorrhage.[7] Currently, there are few studies comparing the effects of Endoscopic minimally invasive surgery and intraoperative stereotactic computed tomography-guided MIS or Robot CAS-R-2 drainage with urokinase.
In the present study, the records of ICH basal ganglia patients in Shanghai Sixth People's Hospital between June 2017 to May 2021 were reviewed. Finally, a retrospective analysis of the 6-months clinical outcomes was conducted in patients with hemorrhage volume ≥ 30ml. The long-term effects of the surgical technique, including Robot CAS-R-2 and Endoscopic Surgery, were evaluated.
Fifty patients with basal ganglia HICH who underwent endoscopic hematoma evacuation or Robot CAS-R-2 drainage with urokinase in Shanghai Sixth People's Hospital between June 2017 to May 2021 were retrospectively analyzed. The preoperative and postoperative treatments, including blood pressure management, were identical for all patients. Blood pressure was controlled under 140 mmHg.
(1)Patients who met the diagnostic criteria of basal ganglia intracerebral hemorrhage and had surgical indications ; (2) Glasgow Coma Scale (GCS) score 》5; (3) Patients and their families agreed to this study and cooperated with postoperative follow-up;(4) Patients` brain CT with hematoma volume > 30 mL .
(1) ICHs due to tumor, trauma, aneurysm, arteriovenous malformation, and hemorrhage after infarction; (2) Age > 79; (3) Thalamic hemorrhage that was diagnosed as the hematoma mainly located medial side of the internal capsule and extended to the brain stem was also excluded. Patients with intraventricular hematoma that caused hydrocephalus were excluded;(4) Patient's important data was lost or lost follow-up.
The system is mainly composed of five parts: computer-aided surgical planning system, positioning and navigation system, degree of freedom manipulator, operation platform locking control device, mark point identification and fixation. It mainly completes the functions of measuring target coordinates, planning puncture trajectory, navigation operation platform and so on. The actual positioning accuracy error of the robot system is about 1.0mm.
We followed the steps protocol that defined the surgical task and its endpoint (reduction of blood clot size to < 15 ml). Under general anesthesia, after the burr hole is placed, we use image guidance to drill through the burr hole or drill. We prefer to drill near the keyhole to reach the long axis of the hematoma. Hematoma aspiration was performed with a 10 ml hand-held syringe until the first resistance appeared. Then, under image guidance, the soft catheter was placed into the residual hematoma, a hole was dug under the skin, and connected to the three-way cock and closed drainage system. CT examination was performed after operation to confirm the position of soft catheter and the stability of residual hematoma and catheter bundle. If the catheter does not engage the hematoma, remove it and reposition it. After placing the catheter for 6 hours or more, we injected urokinase directly into the hematoma through the catheter (Urokinase was injected directly into the clot through the catheter, at 10,000–30,000 units in 2 mL followed by 3 mL flush every 24 h, for up to 3 days.). Discontinue when it is determined that the surgical target (residual hematoma) ≤ 15ml. (Fig. 1)
All surgery was performed under general anesthesia, the surgical technique was performed as previously reported by many neurosurgeons. A burr hole was made on the frontal region for a hematoma in the basal ganglia region or on the skull at the point nearest to the hematoma for a subcortical hematoma especially near the temp lobe or occipital region (Fig. 2). Whether external ventricular drainage was placed on the opposite side of the ventricular depends on the blood in the ventricle.
We collected medical history from the case system and telephone follow-up; age, sex, hematoma location, Glasgow Coma Scale (GCS) score, disease history, comorbidities, use of antithrombotic drugs. We also measured the hematoma volume and the hematoma removal rate from the head CT on admission and just after the operation. The hematoma volume was calculated by the ABC/2 method. To evaluate the outcomes, postoperative hematoma volume, hematoma removal rate, complications such as hydrocephalus, pulmonary infection, intracranial infection, rebleeding and modified Rankin Scale (mRS) 6 months after the operation were investigated from the medical records or by telephonic or personal interview.
Data analysis was performed with SPSS 26.0 software. Measurement data which did not exhibit normal distribution were subjected to the rank-sum test (Mann-Whitney U-test). Counting data were expressed as percentages. The Chi-square test and the Fisher exact probability method were used for comparisons among groups. Finally, those with differences in basic values and clinical prognosis were included in logical analysis. P-values less than 0.05 were considered statistically significant.
5.1. Baseline comparisons
There were no statistically significant differences in preoperative hematoma volume, previous history of liver and kidney diseases and so on, age, gender, preoperative GCS score, or among other parameters between the endoscopic and Robot CAS-R-2 groups (p>0.05) (Table I). While presence of IVH had significant differences in these two grows with the existence of intraventricular hemorrhage in endoscopic group was 14 (38.9%) and 10(71.4%) days in the group (p<0.05).
5.2. Comparison of Surgery Parameters and Complications
All patients in this retrospective study underwent surgery 6 hours after the onset of hypertensive intracerebral hemorrhage in the basal ganglia. And were admitted to ICU after operation. The average time staied in ICU of Endoscopic Surgery group and Robot CAS-R-2 group were 4.5 (11) days and 16.5 (12.75) days (P < 0.001). CT Reexamination on the first day after operation showed that the good hematoma clearance rate (>60%) of Endoscopic Surgery group was 27 (75) higher than that of Robot CAS-R-2 group 1 (7.1) (P < 0.001). For patients with intraventricular hemorrhage, extra ventricular drainage is necessary, and we will remove the drainage tube within 12 days after operation. However,, in the Robot CAS-R-2 group, 1 patient (7.1%) had postoperative rebleeding. In the endoscopic group, 4 cases (11.1%) had rebleeding on CT the second day after operation. There was also no significant difference in rebleeding between the two groups (P > 0.05). At the same time, during the follow-up of 3 months after operation, 5 cases (13.9%) in the Endoscopic Surgery group and 2 cases (14,3%) in the Robot CAS-R-2 group died of various complications (P > 0.05). However, there was no significant difference in the incidence of pulmonary infection, hydrocephalus or intracranial infection between Endoscopic Surgery group and Robot CAS-R-2 group (P > 0.05) (Table I).
5.3. Prognostic Ratio
Good prognosis was observed in 20 cases (87%) in the endoscopy group and in 3 cases (13%) in the Robot CAS-R-2 group. This difference was statistically significant (Chi-square =4.726; p=0.03) (Table I).
Table I: Clinical baseline parameters and operation related results
|
Parameters |
|
NS(N=36) |
MIS (N=14) |
Z/χ2 P-value |
|
|
Age(year), mean±SD GCS score preoperative, (n, %) 5-12 13-15 Preoperative hematoma volume, M(IQR) Preoperative midline displacement, M(IQR) Intraventricular hemorrhage, (n, %) Existence Icu time of stay, M(IQR) Gender, n, %) Man Male Disease history, (n, %) Coronary heart disease Diabetes Nephropathy Hepatopathy Anticoagulant drugs EVD, (n, %) Evacuation rate, (n, %) ≤60% >60 Death, (n,%) Complications, (n,%) Hydrocephalus Pulmonary infection Intracranial infection Rebleeding, (n,%) mRS after 6 months, (n,%) Poor (≤ 2) Good (≥ 3) |
52.69±9.56
26(72.2) 10(27.8) 38.7(21.1) 5.45(5.45)
14(38.9) 4.5(11)
27(75) 9(25)
3 4 1 0 1 28(77.8) 36 9(25) 27(75) 5(13.9)
6(16.7) 8(22.2) 6(16.7) 4(11.1)
16(59.3) 20(87) |
55.07±14.56
11(78.6) 3(21.4) 32.275(14.32) 4.3(4.4)
10(71.4) 16.5(12.75)
8(57.1) 6(42.9)
0 2 0 0 0 8(57.1) 14 13(92.9) 1(7.1) 2(14.3)
1(7.7) 5(35.7) 1(7.1) 1(7.1)
11(40.7) 3(13) |
0.565 0.579 0.01 0.920
0.983 0.326 0.281 0.779 4.276 0.039
3.434 0.001 1.477 0.304
2.045 0.55 0.000 1 0.65 1
0.665 1 1.228 0.268
0.0 1.0
0.109. 0.741 0.381. 0.537 0.174. 0.676 0.0. 1.0 4.726 0.03 |
||
A multivariate logistic regression equation was constructed by including age (age by decade), GCS score, preoperative hematoma volume, operation mode, extra ventricular drainage, ventricular hemorrhage. The results showed that the amount of preoperative hematoma (or = 0.931, 95% CI 0.875-0.990, P < 0.05), the effect of surgical methods (or = 5.912, 95% CI 1.014-34.459, P < 0.05), the effect of preoperative intraventricular hemorrhage (or = 0.578, 95% CI 0.396-0.844, P < 0.05), had a statistically significant effect on the 6-month good prognosis. (Table II)
Table II: Multivariate Analysis of 6-Month Functional Out- come With Modeled Probability as mRS Score, 0–3 (Reference mRS Score, 4–6) and Age by Decade
|
Independent Variable |
OR |
95% CI |
P value |
|
Preoperative hematoma volume |
0.931 |
0.875–0.990 |
0.023 |
|
IVH |
0.578 |
0.396–0.844 |
0.002 |
|
Surgical way |
5.912 |
1.014–34.459 |
0.048 |
IVH indicates intraventricular hemorrhage; mRS, modified Rankin Scale; and OR, odds ratio.
Endoscopic Surgery is a promising new way of ICH treatment. At present, there are still clinical trials in progress. This study was the first to statistically analyze and compare the related characteristics of long-term functional improvement in patients treated with Endoscopic Surgery and Robot CAS-R-2 hematoma drainage. It was determined that Endoscopic Surgery, lack of IVH and amount of intracerebral hemorrhage were related to the improvement of prognosis, and the OA value was determined.
Although the surgery way, the presence of IVH and the hemorrhage volume had been previously reported to be related to the results of surgical trials,[8, 9] this study's the first time to use logical analysis to determine the independent correlation between Endoscopic Surgery and Robot CAS-R-2 hematoma drainage to compare long-term functional prognosis. The choice of surgery way showed that the probability of obtaining favorable results by choosing Endoscopic Surgery hematoma removal surgery was 5.912 times than that of Robot CAS-R-2 hematoma removal. In the surgical treatment of intracerebral hemorrhage, the choice of surgical method is still a controversial issue. Clinical trials have shown that stereotactic puncture and drainage has no obvious advantages compared with drug conservative treatment. However, these studies may be limited by various factors in the current research,[7] there are few studies comparing Endoscopic Surgery hematoma removal with stereotactic hematoma drainage and postoperative urokinase treatment, Tao Xiao et al. reported that endoscopic surgery potentially represented a beneficial surgical procedure for treatment of supratentorial spontaneous intracerebral hemorrhage. Which retrospectively analyzed 108 supratentorial intracerebral hemorrhage cases.[10] However, there was a lack of further logistic regression to eliminate potential basic data deviation.In2020, Hai Xiao Liu et al. had an retrospectively study showed that endoscopic evacuation significantly decreased the 6-months mortality in patients with hemorrhage ≥ 40 ml and GCS ≤ 8. While No significant difference in the neurological functional outcome was found in the stereotactic aspiration group (OR 0.501, 95% CI 0.192–1.308) and the craniotomy group (OR 0.774, 95% CI 0.257–2.335) compared with the endoscopic evacuation group. [11]There may be similar studies in the future to analyze patients with GCS > 8.
In our series, The average length of stay in ICU of Endoscopic Surgery group and Robot CAS-R-2 drainage group were 4.5 (11) days and 16.5 (12.75) days (P < 0.001). which had the same result with other researches.[8, 10] In the patients reviewed after operation, there was also significant statistical difference between the experimental group and the control group in the hematoma clearance rate > 60. CT Reexamination on the first day after operation showed that the good hematoma clearance rate of Endoscopic Surgery group was 27 (75%) higher than that of Robot CAS-R-2 treatment group 1 (7.1%) (P < 0.001). Although the control group will be treated with urokinase until the remaining hematoma is less than 15ml, there was still significant difference in the prognosis between the two groups. That’s why so many researchers said that clot size reduction to 15 mL or less was associated with better mRS scores at 365 days in patients who were stabilized.[7, 12] [13]
The present study has several limitations. Which is a single center, retrospective analysis that the possibility of selection bias cannot be excluded, and the potential methodological limitations might influence the results of the present study. For these reasons, we caution the universal application of these results and encourage further investigation of variables that impact outcome after endoscopic ICH evacuation.
Endoscopic hematoma removal significantly improved the 6-month prognosis compared with the Robot CAS-R-2. However, there was no significant difference in mortality. These preliminary results provide a basis of further large-scale prospective randomized studies.
Ethical Approval and Consent to participate: The human protocol was adhere to the principles of the Declaration of Helsinki .All participants were fully informed and signed written informed consent in this study.
Human and Animal Ethics: The human ethics approved by the Institutional Ethics Committee of The Affiliated Sixth People’s Hospital, Shanghai Jiaotong University. The animal ethics was not applicable.
Consent for publication: Not applicable.
Availability of supporting data: Data availability may be considered upon request.
Competing interests The authors declare no competing interests.
Funding: This work was supported by National Natural Science Foundation of China (82071404).
Authors' contributions: Conceptualization and Funding acquisition: XC; Data curation: LY, DZ, XC, YL, FW, AZ; Formal analysis: DZ, XC; Writing—original draft and review and editing: All authors. All authors read and approved the final manuscript.
Acknowledgements: Not applicable.
Authors' information
Dongdong Zou†, Xin Chen*,Pengqi Zhang ,Youming Lu, Aijun Zhang, Lei Yuan and Fance Wei
†Dongdong Zou is Correspondence: Master degree, resident. The research direction is the basic and clinical research of intracerebral hemorrhage and hydrocephalus.
*Xin Chen made the most contribute. MD, Chief physician.
we all come from Department of Neurosurgery, The Affiliated Sixth People’s Hospital, Shanghai Jiaotong University, NO. 600 Yishan Road, Shanghai 200233, China.