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Introduction
Cerebral hemorrhage is one of the most common neurological diseases. With the growing ageing population in China, the incidence of cerebral hemorrhage has increased yearly1. The incidence of intracerebral hemorrhage is 12-15/100,000 person/year. In Western countries, intracerebral hemorrhage accounts for approximately 15% of all strokes and 10-30% of all hospitalized stroke patients. The proportion of intracerebral hemorrhage is higher in China, accounting for 18.8-47.6% of stroke incidences2. It is characterized by critical onset, rapid development, and high mortality. Hypertension, hyperlipidemia and smoking are common risk factors for cerebral haemorrhage3. Patients with cerebral hemorrhage often suffer from disability, aphasia and other complications, which not only decrease their safety but also impose a significant burden on their families and society4. At present, minimally invasive surgery, craniotomy, conservative treatment, and drug therapy are mainly used to treat the disease in clinical practice, but different treatment methods have different levels of clinical efficacy. For example, the risk of a brain tissue injury during a craniotomy is significant, as is the risk of serious brain edema, and the mortality rate is also high5. Surgical treatment mainly includes craniotomy drilling hematoma aspiration, stereotactic hematoma evacuation and endoscopic and computed tomography (CT) intracerebral hematoma evacuation6. Minimally invasive stereotactic puncture evacuation of an intracranial hematoma is a new surgical method that combines stereotactic surgery with the minimally invasive evacuation of an intracranial hematoma. It establishes a brain coordinate system according to the principle of stereotactic geometric coordinates and installs a directional instrument on the patient’s skull to achieve accurate localization of target lesions7. This method has to date been widely used in clinical practice. In this paper, evidence-based medicine was used to strictly evaluate and analyze existing literature reports, and the clinical efficacy, postoperative neurological deficits, activities of daily living (ADL), the incidence of complications and mortality of minimally invasive stereotactic puncture evacuation of intracranial hematoma and traditional craniotomy in the treatment of patients with cerebral hemorrhage were evaluated.
Materials and methods
Search strategy
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidebook, a systematic literature search of the PubMed, MEDLINE, Web of Science, China National Knowledge Infrastructure, Wanfang and China Science and Technology Journal databases was performed from January 2010 to December 2021. A search strategy combining subject headings and free words was used. The search terms included cerebral hemorrhage, cerebellar hemorrhage, intracerebral hemorrhage, ICH, stereotactic minimally invasive, minimal surgical procedures, frameless stereotactic, intracranial puncture, burr hole drainage, keyhole, and craniotomy surgery. To avoid literature omission, we searched manually, reading the relevant systematic reviews to obtain related target literature on stereotactic hematoma evacuation and craniotomy hematoma evacuation in the treatment of patients with cerebral hemorrhage.
Inclusion and exclusion criteria
The study’s inclusion criteria were as follows: (1) Chinese and English studies published in peer-reviewed journals; (2) randomized controlled trial or observational studies; (3) study participants aged ≥ 18 years; (4) patients with a cerebral hemorrhage or those diagnosed with a cerebral hemorrhage using a brain CT scan met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Cerebral Haemorrhage (2019)8; (5) the location of bruises were in the basal ganglia, suprauli, frontal lobe and occipital lobe, using minimally invasive stereotactic puncture; and (6) the case data in the literature were complete, and the main outcome measures included the overall clinical response rate, length of hospital stay, post-operative neurological deficit evaluation, postoperative ADL and the incidence of complications and mortality.
The study’s exclusion criteria were as follows: (1) patients who had other causes of bleeding, including bleeding due to vascular abnormalities, for example, tumor bleeding, vascular malformations, aneurysms or vascular amyloidosis; (2) conference articles, systematic reviews and other types of literature; (3) articles with insufficient outcome information to extract data; and (4) articles that had been repeatedly published or were not available in full.
Study selection and data extraction
Two researchers independently screened the literature, performing preliminary screening using titles and abstracts and then reading the full text according to the inclusion and exclusion criteria for the secondary screening. When inconsistent opinions were encountered, the opinions of a third researcher were solicited and discussed to reach a unified agreement. After the literature screening, data extraction was performed independently by two researchers, and the extracted contents included the name of the first author, nationality and year of publication, the type of study, total sample size, hematoma evacuation time or hematoma elimination rate, operation time, length of hospital stay, post-operative neurological deficit evaluation, post-operative ADL, and any incidence of complications.
Quality evaluation
Two researchers independently performed the quality evaluation of the included literature. In case of disagreement, the opinion of a third researcher was solicited and discussed to reach a unified agreement. Randomized controlled trials were evaluated according to the Cochrane Handbook for Systematic Reviews 5.1.09. This included the generation of random sequences, allocation concealment, the blinding of study participants and implementers, the blinding of outcome assessors, completeness of the outcome data and selective reporting of the study results and other sources of bias; each was evaluated as “low,” “unclear” or “high” risk.
Statistical analysis
The Revman 5.3 software was used for statistical analysis. The effect size of measurement data was expressed as an odds ratio (OR), and the enumeration data were expressed as the standardized mean difference (SMD). Both indicators were used to estimate the interval range of the effect size with a 95% confidence interval (CI). If the original literature only provided median and range data; these were transformed into mean and standard deviation using a formula and included in the analysis. A heterogeneity evaluation was used to determine the size of heterogeneity using the I2 test; if I2 < 50% or p > 0.1, the included literature was considered homogeneous, and the Mantel-Haenszel was used for analysis assuming a fixed effect model. If I2 > 50% or p ≤ 0.1, the included studies were considered heterogeneous, and the DerSimonian-Laird random effect model was used for analysis. If the heterogeneity was large, sensitivity analysis or subgroup analysis was used to explore the source of heterogeneity. The test level of the meta-analysis was set as alpha = 0.05.
Results
Literature search results
A total of 384 relevant literature papers were retrieved for the current study. After the systematic search and screening of Chinese and English databases, 15 literature studies that met the criteria were finally included10-24. A flowchart of the literature retrieval and screening processes is shown in figure 1.
Basic characteristics of included studies and literature quality evaluation
Five studies were published from 2005 to 2015, and 10 were published from 2016 to 2021. Fifteen studies were from China, and they were all were randomized controlled studies. The total sample size of the 15 studies was 1312, with 673 in the experiment group and 639 in the control group. There were three high-quality, nine medium-quality and three low-quality articles. All of the randomized controlled trials stated that the principle of “randomization” had been followed, with one article not specifying a randomization scheme10 and two articles not elaborating on neurological deficit scoring criteria8,12. These were evaluated as low-quality articles. The basic characteristics and quality evaluation of the included articles are shown in table 1.
Table 1 Basic characteristics of included studies and literature quality evaluation table
| Included articles | Publication Year | Published country | Study type | Sample Size | Surgical method | Outcome Measures | Literature quality evaluation grade | ||
|---|---|---|---|---|---|---|---|---|---|
| Experimental group | Control group | Experimental group | Control group | ||||||
| Huang Xiantuan | 2019 | China | Randomized controlled trial | 40 | 40 | Stereotactic minimally invasive puncture intracranial hematoma removal | Drug therapy | ①② | Middle |
| Ma Xiankun et al. | 2012 | China | Randomized controlled trial | 28 | 27 | Frameless stereotactic hematoma evacuation | Craniotomy | ③⑥ | Middle |
| Gao Jianguo, et al. | 2005 | China | Randomized controlled trial | 82 | 60 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ①⑤⑥ | Low |
| Song Anjun et al. | 2016 | China | Randomized controlled trial | 30 | 30 | Stereotactic minimally invasive puncture intracranial hematoma removal | Drug therapy | Middle | |
| Wang Hong et al. | 2020 | China | Randomized controlled trial | 36 | 36 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ⑤② | Low |
| Yang Lichao et al. | 2017 | China | Randomized controlled trial | 16 | 16 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ②③④ | Middle |
| Li Liang et al. | 2020 | China | Randomized controlled trial | 40 | 40 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ④⑤② | Middle |
| Zheng Jianghuan et al. | 2013 | China | Randomized controlled trial | 60 | 60 | Stereotactic minimally invasive puncture intracranial hematoma removal | Expectant treatment | ②⑤ | Low |
| Fu Qiang et al. | 2021 | China | Randomized controlled trial | 30 | 30 | Stereotactic minimally invasive puncture intracranial hematoma removal (Improved-soft channel) | Craniotomy | ①②④⑤ | Middle |
| Wang Junfeng et al. | 2019 | China | Randomized controlled trial | 82 | 82 | Stereotactic minimally invasive puncture intracranial hematoma removal (Improved-soft channel) | Expectant treatment | ①⑤ | Middle |
| Huang Lihua | 2015 | China | Randomized controlled trial | 25 | 25 | Stereotactic minimally invasive puncture intracranial hematoma removal (Improved-soft channel) | Craniotomy | ⑤⑥③ | Middle |
| Lin Xiaoqiang et al. | 2018 | China | Randomized controlled trial | 33 | 31 | Stereotactic minimally invasive puncture intracranial hematoma removal | Expectant treatment | ①②④ | High |
| Ma Xiaoqiang et al. | 2021 | China | Randomized controlled trial | 32 | 30 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ③ | Middle |
| Zhou et al. | 2011 | China | Randomized controlled trial | 64 | 58 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ②④⑥ | High |
| Jing et al. | 2021 | China | Randomized controlled trial | 75 | 74 | Stereotactic minimally invasive puncture intracranial hematoma removal | Craniotomy | ②③④⑥ | High |
① Hospital stay (d) ② Postoperative neurological deficit score ③ Postoperative activities of daily living score ④ Incidence rate of complications (%) ⑤ Effective rate ⑥ Mortality rate
Meta-analysis results of the primary outcome measures
THE CLINICAL EFFICACY OF MINIMALLY INVASIVE STEREOTACTIC PUNCTURE EVACUATION OF INTRACRANIAL HEMATOMA IN THE TREATMENT OF PATIENTS WITH CEREBRAL HEMORRHAGE
A total of eight literature papers compared the clinical efficacy of minimally invasive stereotactic puncture evacuation of intracranial hematoma (experiment group) with traditional craniotomy or treatment methods in the treatment of patients with cerebral hemorrhage (control group). The heterogeneity evaluation indicated homogeneity across studies (I2 = 0%, p = 0.55); therefore, the fixed effects model was used to calculate the pooled statistics. The meta-analysis showed that minimally invasive stereotactic puncture evacuation of intracranial hematoma had a higher overall clinical response rate in patients with cerebral hemorrhage compared with traditional craniotomy or treatment, with a pooled effect size of OR = 4.84 (95% CI: 3.30, 7.10, p < 0.00001) as shown in figure 2.
THE EFFECT OF MINIMALLY INVASIVE STEREOTACTIC PUNCTURE EVACUATION OF INTRACRANIAL HEMATOMA ON NEUROLOGICAL DEFICITS IN PATIENTS WITH CEREBRAL HEMORRHAGE
Twelve articles compared the effect of minimally invasive stereotactic puncture evacuation of intracranial hematoma (experiment group) with traditional craniotomy or treatment methods (control group) concerning the degree of neurological deficits in patients with cerebral hemorrhage. The heterogeneity evaluation indicated a high degree of heterogeneity among studies (I2 = 98%, p < 0.00001); accordingly, the random effects model was used to calculate the pooled statistics. The meta-analysis showed that patients with cerebral hemorrhage who had been treated with minimally invasive stereotactic puncture intracranial hematoma evacuation had a lower degree of post-operative neurological deficits compared with a craniotomy or treatment modalities used in the control group (SMD = –0.32, 95% CI: –1.33, 0.70), but the difference between the experiment and control groups was not statistically significant (p = 0.054) as shown in figure 3.
The sensitivity analysis showed that, after removing three studies that scored neurological deficits using the Glasgow Outcome Scale13,19,21, heterogeneity among the included studies was reduced by 1%, but the difference between the experiment and control groups remained statistically insignificant (SMD = –0.99, 95% CI: –2.03, 0.06, p = 0.06).
THE EFFECT OF MINIMALLY INVASIVE STEREOTACTIC PUNCTURE EVACUATION OF INTRACRANIAL HEMATOMA ON HOSPITAL STAYS IN PATIENTS WITH CEREBRAL HEMORRHAGE
Five articles compared the effect of minimally invasive stereotactic puncture evacuation of intracranial hematoma (experiment group) with traditional craniotomy or treatment methods (control group) concerning the length of hospital stay among patients with cerebral hemorrhage. The heterogeneity evaluation showed a high degree of heterogeneity among studies (I2 = 97%, p < 0.00001); therefore, the random effects model was used to calculate the pooled statistics. The meta-analysis showed that minimally invasive stereotactic puncture evacuation of intracranial hematoma could significantly shorten the length of hospital stay for patients with cerebral hemorrhage, compared with craniotomy or treatment modalities used in the control group (SMD = –2.53, 95% CI: –3.95, –1.11, p = 0.0005) as shown in figure 4. After excluding one study19, the sensitivity analysis showed that heterogeneity among the included studies had been reduced by 2%, and minimally invasive stereotactic puncture evacuation of intracranial hematoma could still significantly shorten the length of intensive care unit (ICU) stay for patients with cerebral hemorrhage (SMD = –1.70, 95% CI: –2.83, –0.56, p = 0.003).
THE EFFECT OF MINIMALLY INVASIVE STEREOTACTIC PUNCTURE EVACUATION OF INTRACRANIAL HEMATOMA ON THE ADL IN PATIENTS WITH CEREBRAL HEMORRHAGE
Five articles compared the effect of minimally invasive stereotactic puncture evacuation of intracranial hematoma (experiment group) with traditional craniotomy or treatment methods (control group) on the ADL of patients with cerebral hemorrhage. The heterogeneity evaluation showed good homogeneity among studies (I2 = 0%, p = 0.58); accordingly, the fixed effects model was used to calculate the combined statistics. Patients in the experiment group had significantly higher levels of post-operative ADL compared with patients in the control group (OR = 4.97, 95% CI: 2.48, 9.96, p < 0.0001) as shown in figure 5.
THE EFFECT OF MINIMALLY INVASIVE STEREOTACTIC PUNCTURE EVACUATION OF INTRACRANIAL HEMATOMA ON COMPLICATIONS FOR PATIENTS WITH CEREBRAL HEMORRHAGE
Six articles compared the effect of minimally invasive stereotactic puncture evacuation of intracranial hematoma (experiment group) with traditional craniotomy or treatment methods (control group) on complications for patients with cerebral hemorrhage. Because the heterogeneity evaluation showed low heterogeneity across studies (I2 = 11%, p = 0.35), the fixed effects model was used to calculate the pooled statistics. Compared with patients in the control group, patients treated with minimally invasive stereotactic puncture evacuation of intracranial hematoma had a lower incidence rate of postoperative complications (OR = 0.22, 95% CI: 0.13, 0.35), and the difference was statistically significant (p < 0.00001) as shown in figure 6.
THE EFFECT OF MINIMALLY INVASIVE STEREOTACTIC PUNCTURE EVACUATION OF INTRACRANIAL HEMATOMA ON MORTALITY AMONG PATIENTS WITH CEREBRAL HAEMORRHAGE
Five articles compared the effect of minimally invasive stereotactic puncture evacuation of intracranial hematoma (experiment group) with traditional craniotomy or treatment methods (control group) on the mortality of patients with cerebral hemorrhage. Because the heterogeneity evaluation showed low heterogeneity across studies (I2 = 24%, p = 0.26), the fixed effects model was used to calculate the pooled statistics. Compared with patients in the control group, patients treated with minimally invasive stereotactic puncture evacuation of intracranial hematoma had a lower mortality rate (OR = 0.28, 95% CI: 0.18, 0.46), and the difference was statistically significant (p < 0.00001) as shown in figure 7.
Discussion
In this research, 15 studies evaluating the clinical efficacy of minimally invasive stereotactic puncture evacuation of intracranial hematoma in the treatment of patients with cerebral hemorrhage were included by systematically searching Chinese and English databases. The results of this study are summarized below.
Minimally invasive stereotactic puncture evacuation of intracranial hematoma has a higher clinical efficacy
The results of this study showed that minimally invasive stereotactic puncture evacuation of intracranial hematoma in patients with cerebral hemorrhage had a higher overall clinical response rate compared with traditional craniotomy or treatment (OR = 4.84 [95% CI: 3.30, 7.10, p < 0.00001]). A traditional craniotomy is invasive, the treatment takes too long to ensure the required therapeutic effect and damage can occur to the patient’s brain tissue25. The CT-guided stereotactic minimally invasive technique has been widely used in clinical practice in recent years. Minimally invasive intracranial hematoma evacuation mainly uses biochemical and enzymatic techniques to liquefy the patient’s hematoma, as well as liquid jet positive pressure to comminute the hematoma, followed by impact, washing and drainage of the hematoma. This allows for completely removing the intracranial hematoma in a short time. Therefore, minimally invasive stereotactic puncture evacuation of intracranial hematoma has also been widely used26,27. The procedure has the following advantages: CT-guided directional operation avoids blind actions, can more accurately determine the location of the hematoma and can locate the patient’s bleeding and determine the surrounding tissue damage, thereby improving the success rate, accuracy, and safety of the puncture28. In addition, endoscopic assistance can make the surgical field clearer, allowing for the accurate and comprehensive detection and handling of intraluminal hematoma bleeding to facilitate its removal quickly and thoroughly29. Furthermore, the operation of the technique is simple and can be completed with only local anesthesia, causing less impact on the brain tissue; the drainage tube placement time is also short30.
Minimally invasive stereotactic puncture evacuation of intracranial hematoma has little effect on postoperative activities of daily life in patients with cerebral hemorrhage
The results of this study showed that the level of postoperative ADL was significantly higher in the experiment group compared with the control group (OR = 4.97, 95% CI: 2.48, 9.96, p < 0.0001). Activities of daily life are intuitive and effective indicators for evaluating prognosis. The meta-analysis showed that patients with cerebral hemorrhage, who had been treated with minimally invasive stereotactic puncture evacuation of intracranial hematoma, had a higher proportion of complete recovery of ADL within 3 months after surgery, compared with patients who had been treated with traditional treatments or craniotomy, with better postoperative ADL and an overall better prognosis. The possible reasons were analyzed as follows: Minimally invasive stereotactic puncture evacuation of intracranial hematoma minimized the surgical trauma of patients, for example, less damage to brain tissue and intracranial surrounding tissue than other surgical methods31. This surgical method was not strictly limited by age, condition or anesthesia, and could effectively drain the hematoma and shorten the surgical duration32.
Minimally invasive stereotactic puncture evacuation of intracranial hematoma in patients with cerebral hemorrhage has a lower incidence of complications and mortality
The results of this study showed that patients treated with minimally invasive stereotactic puncture evacuation of intracranial hematoma had a lower incidence of postoperative complications (OR = 0.22, 95% CI: 0.13, 0.35, p < 0.00001) and a lower mortality rate (OR = 0.28, 95% CI: 0.18, 0.46, p < 0.00001) compared with patients in the control group. Studies have shown that iatrogenic injury is more serious when performing a conventional craniotomy, and the incidence of long-term complications, such as post-operative mortality and secondary epilepsy, is relatively high33. This has the limitations of a long surgical procedure, possible severe trauma, and a high risk of anesthesia; accordingly, its prognosis and clinical efficacy are unsatisfactory34. Severe pulmonary infections, such as respiratory failure caused by severe pneumonia, epilepsy, and stress ulcers in the thalamus and brainstem are common postoperative complications among patients with cerebral haemorrhage35. Minimally invasive stereotactic puncture evacuation of intracranial hematoma can effectively reduce iatrogenic blood loss in patients with cerebral hemorrhage, quickly puncture the hematoma, aspirate the fluid part of cerebral hemorrhage and reduce intracranial pressure in a very short time. The residual semisolid hematoma is dissolved by a fibrinolytic solvent, the effect of early hematoma evacuation is achieved and the effect on brain tissue is reduced36. Accordingly, the risk factors of related complications are also effectively suppressed, thereby reducing the incidence of postoperative complications. In addition, the surgical process and time required to perform minimally invasive stereotactic puncture evacuation of intracranial hematoma are controllable. A routine post-operative CT scan re-examination can monitor the dynamic changes of residual hematoma volume to determine the dosage and frequency of urokinase injection and achieve the purpose of a maximum evacuation of hematoma fluid mass, significantly reducing the mortality of patients and improving their prognosis level37. Moreover, a stereotactic puncture is less cost prohibitive than traditional medical conservative treatment due to shorter stays in the ICU and a greater clinical effect38.
Conclusion
In summary, the meta-analysis results of this study showed that minimally invasive stereotactic puncture intracranial hematoma evacuation had higher clinical efficacy in the treatment of patients with cerebral hemorrhage, compared with traditional craniotomy or conservative treatment, which could improve the post-operative ADL and reduce the incidence of post-operative complications and mortality. However, the method’s effect on neurological deficits remains unclear, which may be because the scoring criteria used in each study have not yet been unified. The degree of neurological deficit is primarily evaluated using scales and lacks strong objectivity. Furthermore, the current authors did not collect information about the size of the hematomas that each study included. Conventionally, it has been established that patients who are eligible for the evacuation of these collections by the stereotactic method are those that present smaller bruises, but some studies did not provide this information. Therefore, it is still necessary to carry out a large sample, multicenter study in the future, using standardized, unified and scientific methods to evaluate the postoperative indicators among patients with cerebral hemorrhage, thereby further verifying the comprehensive efficacy of minimally invasive stereotactic puncture intracranial hematoma evacuation in the treatment of patients with cerebral hemorrhage.
