Abstract
OBJECTIVE:
This study aims to compare the curative effect of different treatment methods of hypertensive putamen hemorrhage, in order to determine an ideal method of treatment; and to explore the curative effect of the application of soft channel technology-minimally invasive liquefaction and drainage of intracerebral hematoma in the treatment of hypertensive putamen hemorrhage.
METHODS:
Patients with hypertensive cerebral hemorrhage, who were treated in our hospital from January 2015 to January 2016, were included into this study. Patients were divided into three groups: minimally invasive drainage group, internal medical treatment group and craniotomy group. In the minimally invasive drainage group, puncture aspiration and drainage were performed according to different hematoma conditions detected in brain CT, the frontal approach was selected for putamen and intracerebral hemorrhage, and drainage was reserved until the hematoma disappeared in CT detection. Drug therapy was dominated in the internal medical treatment group, while surgery under general anesthesia was performed to remove the hematoma in the craniotomy group.
RESULTS:
Post-treatment neurological function defect scores in minimally invasive drainage group and internal medical group were 16.14
CONCLUSION:
Clinical observation and following-up results revealed that minimally invasive drainage treatment was superior to internal medical treatment and craniotomy.
Keywords
Ke-Shan Liang and Jian Ding contributed equally.
Hypertensive cerebral hemorrhage is a common clinical disease, and a common late complication in patients with hypertension. The mortality of this disease, which occurs within 30 days after onset, is 33.3% to 50.6% [1, 2]; and 41% of survivors have a disability [3]. Furthermore, this disease is characterized by acute onset and high mortality and disability rates, which seriously threatens the life of a patient [4]. It was found in a study that the annual incidence of hypertensive cerebral hemorrhage was (1–35)/100 thousands, accounting for approximately 20%–30% of stroke patients in Asia. It was also found that both its incidence and mortality rate ranked first in patients with stroke in Asia, and its incidence continuous to increase annually with the trend of population aging [5]. The main etiologies of the disease include the formation of microaneurysm and basal ganglia cerebral arteries, which weakens the membrane structure in the middle layer of the external membrane and the cerebral artery wall, and the spasm of cerebral arterioles caused by cerebral arterioles fibrinoid necrosis. All these result to mechanical pressure changes of hematoma in brain tissues [6, 7, 8]. The traditional treatment was dominated internal medical expectant therapy. However, this method is relatively passive and depends on the patient’s own absorption of hematoma. In addition, the course of disease is long, mortality rate and disability rate are higher, the mortality rate of drug treatment falls between 70% and 80% before the application of CT, and the burden on patients is increased [9, 10, 11]. Removal of hematoma with surgical craniotomy is another way to treat hypertensive intracerebral hemorrhage. However, this method has disadvantages of large trauma, poor tolerance of patients, as well as having a narrow spectrum of indications, poor prognosis, and high cost; limiting its applications. Therefore, in recent years, studies on the application of the minimally invasive evacuation of intracranial hematoma for hypertensive intracerebral hemorrhage have increased [12]. It was found in a study that the application of minimally invasive intracranial hematoma evacuation in the treatment of hypertensive intracerebral hemorrhage has great value, with advantages of simple operation, minimal trauma, high efficiency, short operation time, safety and reliability, and its capability of effectively improving the nerve function of patients with hypertensive cerebral hemorrhage. Therefore, it is an effective method in the treatment of hypertensive cerebral hemorrhage [13, 14, 15]. In order to better carry out the work of hypertensive cerebral hemorrhage treatment in clinic and further confirm the effective treatment method of hypertensive cerebral hemorrhage, minimally invasive intracranial hematoma evacuation was performed in 180 cases of patients with hypertensive putaminal hemorrhage from January 2015 to January 2016; and the results were compared with that from patients who underwent internal medical treatment and craniotomy. These results are reported as follows.
Data and methods
Clinical data
All patients were admitted in our hospital, and provided a detailed disease history and underwent brain CT examination. The volume of hematoma (excluding the hematocele in the ventricle and subarachnoid) was calculated using the Tada formula (long axis value
Minimally invasive drainage group: A total of 180 cases were enrolled, which comprised of 106 male cases and 74 female cases. The age of these patients ranged between 34–92 years old, with an average age of 60.1
Internal medical treatment group: A total of 120 cases were enrolled, which comprised of 76 male cases and 44 female cases; and the average age of these patients was 62.1
Craniotomy group: A total of 60 cases were enrolled, which comprised of 38 male cases and 22 females case; and the average age of these patients was 59.8
Methods
The timing of minimally invasive surgery
For patients in these present groups, the time was within three hours to seven days from onset to the operation. Among these patients, 36 patients were in the super early stage of within less than or equal to six hours, 87 cases were in the acute stage of within 7–24 hours, 42 cases were in the early stage of within 24–72 hours, 15 cases were in delayed stage of within more than three days.
Minimally invasive drainage procedure
Local infiltration anesthesia was adopted. (1) For putaminal hemorrhage, the appropriate scan level was selected according to the sectional anatomy of the brain CT, the puncture point was marked at the forehead, and the puncture was performed parallel to the scanning plane under the guidance of CT detection, which was conducive to accurate positioning. The position and direction of the puncture were selected according to the shape of the hematoma, in order to not only thoroughly remove the hematoma, but also to reduce trauma. (2) For a kidney shaped, fusiform putaminal hematoma, the soft passage for drainage was established at the approach of the forehead along the maximal long axis of the hematoma. (3) For spherical-like putaminal hemorrhage, a temporal approach was established through the center of the circle of the maximum CT level of the hematoma. (4) The special catheter of the internal cranial hematoma drainage was made of quality silicone materials with scale, which had two side holes at the blind end with a diameter of 3–5 mm and a length of 20 cm. The special cranial outer drainage device can prevent the backflow of the drainage device, and partially adjust the pressure in the hematoma cavity (the disposable cranial outer drainage device was manufactured by Shandongdazheng Medical Products Co. Ltd.). (5) Routine preoperative preparation was performed to the patients. Intravenous injection of diazepam could be given to the irritable patients. After skin disinfection and local anesthesia, the puncture depth of the special cranial cone was set (with the intention of not stabbing and wounding the brain tissue or blood vessel during puncturing through the skull); and the skull and dura were consecutively penetrated through. The puncture was performed according to the detected direction and depth with a silicone drainage tube (used for minimally invasion) with stylet. The drainage tube was placed at the distal of the hematoma cavity along the point and direction of the puncture, with a distance of 0.5–1.0 cm to the wall of hematoma. Through the “expansion” of the compressed brain tissue and the extrusion of the hematoma liquefied by urokinase during resetting, the old hemorrhage was discharged out of the skull along the side holes of the drainage tube, which made the evacuation of hematoma and brain tissue resetting synchronous. Therefore, pneumocrania was avoided, which was caused by sharply reduced intracranial pressure that resulted from the one-time evacuation of hematoma performed in traditional craniotomy and small bone window microsurgery. The hematoma was aspirated slowly, and washed with normal saline after dozens of milliliters of old blood or bloody cerebrospinal fluids were non-resistantly aspirated using a 5-ml syringe, and 0.05% norepinephrine or reptilase (saline dilution) were irrigated into the tube to stanch the bleeding for patients who had intraoperative secondary intracerebral hemorrhage. The drainage tube was fixed on the scalp and connected to an extracranial disposable drainage device that has a three-way valve on the tail end for controlling drainage pressure. The drainage device was placed 0–10 cm higher than the position of the external ear hole on the head of the patients. (6) Then, 20 thousand to 10,000 thousand units of urokinase dissolved in 2–5 ml of normal saline were injected through the three-way valve to liquefy the clot, once to twice per day. The three-way valve was opened for drainage after closing for 2–3 hours. Then, a brain CT review was performed, and changes in the hematoma were continuously observed. The tube was closed for 24 hours if the hematoma and the cerebroventricular hematocele basically disappeared, the circulation of cerebrospinal fluid was smooth, the cerebroventricular drainage fluid was clear. The drainage tube can be pulled out if no obvious headache or increased intracranial pressure were found in the patients. For the 180 patients with putamen hemorrhage and 22 patients who were combined with ventricular casting or obstructive hydrocephalus, external drainage of internal liquefaction on the affected lateral ventricle was performed at the same time; and unilateral ventricle with more volumes of hematocele were selected. The puncture point was selected at the intersection of 1.5–2.5 cm to the sagittal line of the forehead (or determined according to the results of preoperative or intraoperative brain CT) and 8 cm above the eyebrow. The direction was along the plane that constitute the connected line of two external ear canals and the puncture point, and was parallel to the sagittal plane of the forehead. A soft, high quality special silicone rubber hose with a round blunt head and multi-side holes (with an internal diameter of 2.5–3.2 mm) was imported into the unilateral ventricle, and a disposable external craniocerebral drainage device was connected at the outer side, with the liquefaction drainage similar to that described above. Drug treatment was dominated in the internal medical treatment group. The hematoma was surgically removed under general anesthesia in the craniotomy group, supporting therapies for the reduction of intracranial pressure, adjustment of blood pressure, and infection and complication preventive and symptomatic therapies were given.
Observation of the curative effect
The scoring of clinical neurological function defects were performed using traditional standards at admission and at two weeks after treatment [18]. Observational indexes include the state of consciousness, eye movement, facial paralysis, language ability, muscle strength of the shoulder joint of the upper limb, hand muscle strength, muscle strength of the lower limbs, and walking ability. Physical examinations were performed in detail both before and after treatment, and were scored in accordance with the standard listed above. Changes in the degree of neurological function deficits and mortality rate before and 15 days after treatment were evaluated. The evaluation criteria of efficacy were evaluated according to the “Score standards of stroke patients with clinical neurological deficits”. (1) Cured: the scores of the function deficits decreased by 91%–100%, and the level of disability was zero degree. (2) Significantly improved: the scores of function deficits decreased by 46%–90%, and the levels of disability were within 1–3 degrees. (3) Improved: the scores of the function deficits decreased by 18%–45%. (4) No changes: the scores of the function deficits decreased or increased less than 18%. (5) Deteriorated: the scores of the function deficits increased more than 18%. (6) Died. Total efficiency was calculated with cure, significant improvement and improvement. The discharged alive patients were followed-up (for three months to three years). These patients were divided into five levels and assessed according to their ability of daily life (ADL) [19]. ADL1: completely recovered to normal life; ADL2: life can be taken care of by themselves; ADL3: patients need help in daily life and can walk with support. ADL4: the patients were stay in bed with consciousness; ADL5: the patients were in vegetative state.
Statistical analysis
All the data were analyzed using SPSS13.0 software. Measurement data were expressed as
Ethics statement
This study was conducted in accordance with the declaration of Helsinki.
Comparison of the degrees of neurological function deficits in the three groups before and after treatment (
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Comparison of the degrees of neurological function deficits in the three groups before and after treatment (
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This study was conducted with approval from the Ethics Committee of Qilu Hospital of Shandong University and Brain Science Research Institute.
Written informed consent was obtained from all participants.
Comparison of clinical efficacy among these three groups
Comparison of the degrees of neurological function deficits in the three groups
As shown in Table 1, there was no statistical significance in the scores of the degree of neurological function deficits in patients in these three groups before treatment; and these scores of neurological function deficits were statistically significant in patients in the three groups after 15 day-treatment. Furthermore, the difference was also statistically significant in the comparison of the reduction degree of scores for neurological function deficits in patients in the three groups; and pairwise comparison between these two groups revealed that there was a statistical significant difference among these three groups.
Comparison of clinical efficacy among these three groups
As shown in Table 2, the difference was statistically significant when comparing the curative effect among the three groups (X2
Comparison of mortality at different time-points using minimally invasive surgery
Comparison of mortality at different time-points using minimally invasive surgery
As shown in Table 3, the difference was not statistically significant in terms of mortality at different time-points in the minimally invasive drainage group (X2
Brain CT evolutions in the three methods of treatment
The typical cases in the minimally invasive drainage group revealed that patients had putamen hemorrhage upon admission, the space occupying effect was caused by hematoma, the lateral ventricle was compressed and became narrow (Fig. 1A), the hematoma completely disappeared on the fourth day of treatment of minimally invasive suction drainage, the drainage tube was displayed and visible, and no obvious edema reaction was found in the bleeding area (Fig. 1B). The space occupying effect of the hematoma was found in the brain CT of the typical cases in the internal medical treatment group and craniotomy group (Fig. 1C and E), the hematoma did not decrease on the fourth day of internal medical treatment, and density was reduced around the hematoma (Fig. 1D); while residual hematocele remained in the hematoma cavity on the fourth day of craniotomy treatment, the edema was obvious in the operation area, and the damage on local brain tissues could be observed (Fig. 1F).
Followed-up comparative observation for hypertensive putamen hemorrhage survival patients in different groups
Followed-up comparative observation for hypertensive putamen hemorrhage survival patients in different groups
Brain CT evolutions in the minimally invasive drainage group. A: The space occupying effect of hematoma and the lateral ventricle was compressed and became narrow; B: The hematoma completely disappeared on the fourth day of treatment of minimally invasive suction drainage, the drainage tube was displayed and visible, and no obvious edema reaction was found in the bleeding area; C and E: The space occupying effect of the hematoma was found in the brain CT of the typical cases in the internal medical treatment group and craniotomy group; D: The hematoma did not decrease on the fourth day of internal medical treatment, and density was reduced around the hematoma; F: While residual hematocele remained in the hematoma cavity on the fourth day of craniotomy treatment, the edema was obvious in the operation area, and the damage on local brain tissues could be observed.
A total of 275 cases of discharged alive patients were followed-up for half a year, and the results are shown in Table 4. As shown in the table, there was a statistical significance when comparing the ADL grading of the survival patients in the three groups (X2
Discussion
The main purpose of hypertensive cerebral hemorrhage operation is not to stop the bleeding, but to remove the hematoma, relieve the pressure of the brain tissue, and reduce secondary damage. In the process of removing the hematoma, minimizing trauma to the brain tissue should be the premise. Therefore, in recent years, minimally traumatic or invasive treatment for cerebral hemorrhage has been considered an important method, which mainly includes: small bony window craniotomy microsurgery, neuro-endoscopic surgery, “keyhole” surgery, stereotactic surgery, cone cranial hematoma aspiration, as well as puncture drainage and liquefaction. In several former methods, a 2–4 cm bone window or bone flap opened in the skull was required to establish a channel, which relatively worsened the trauma to patients; and in the later two methods, a thin-wall steel tube with a diameter of 3–5 mm was placed in the cerebral hematoma to build a hard channel to remove the hemorrhage. These two methods still have some drawbacks. In terms of efficacy, occasional surgical procedures, the surgical approach and surgical skills often play a decisive role. No matter how “minimally invasive” the operation is, craniotomy still relatively causes large trauma on the brain tissue and body of patients; which largely offsets its advantage in the thorough removal of hematoma. However, it is worth to further explore how to avoid and prevent the risk and complications of the surgery itself, and improve its efficacy.
We found in clinical observations that the treatment effect was better when minimally invasive drainage was performed in the early stage of onset (6–12 hours after onset) in patients whose volume of bleeding met the need for the surgical removal of the hematoma. Furthermore, surgery should be performed as soon as possible for larger hematomas, in order to relieve the compression of hematomas to the surrounding tissues and the progressive destruction, avoid the occurrence of serious cerebral edema, and reduce the possibility of the formation of cerebral herniation. At the same time, the hematoma solidification degree is mild in the early stage, and is more conducive to be aspirated; which can improve the life quality of patients. In order to avoid the occurrence of re-bleeding in early drainage, the volume in the first aspiration should not be too much, aspiration speed should not be too fast, and the aspiration negative pressure should not be too large. Therefore, pressure in the hematoma cavity would change slowly, preventing the occurrence of re-bleeding. The aspiration volume is generally not more than 70% of the calculation amount. However, in conditions when the hematoma perforates through the lateral ventricle, it should be considered whether the aspiration was mixed with the cerebrospinal fluid. In the process of the operation, the puncture point and puncture plane should be accurately marked on the scalp according to the results of brain CT scanning to determine the puncture direction, and prevent false punctures. For the putamen hematoma, the volume and pressure of normal saline for washing after aspiration should not be too large, and the remaining blood clot dissolved by urokinase can drain and remove the hematoma smoothly. For the ventricular hematocele, it can be aspirated and drained as much as possible.
According to the cerebral anatomical hierarchy relationship and the experiences summed up in clinic, the approach from the forehead to the skull should be used for the putamen area. This approach can effectively bypass the important function area of the temporal top and the vascular distribution area. This would prevent damage to the central anterior gyrus neuron possibly caused by anatomical hierarchy, reduce the probability of bleeding at the puncture tract, and provide favorable conditions for the clinical neurological rehabilitation and reduction of sequelae. At the same time, since the forehead skin is thin, it is not easy to shift to block the puncture channel, and has more reference marks for positioning; which are accurate and convenient. Thus, this makes the puncture operation simple and easy to operate, post-operative drainage tube is easy to be fixed, and a variety of decubitus could be selected by the patients after operation; reducing the incidence of complications. The procedure of the frontal angle puncture of the lateral ventricle via the forehead to the cranium was also adopted in the drainage for the cerebral ventricle. In the process of minimally invasive surgery, moderate sedation, and maintaining a relatively higher intracranial pressure and lower blood pressure are conducive to hemostasis and the prevention of the re-expansion of hematoma, as well as the removal of hematoma. The application of mannitol, glycerol fructose, furosemide and diuretic drugs should be stopped or reduced at preoperation and post operation. If the condition of heart function is allowed, isotonic saline and hypotonic glucose solution could be moderately infused to increase blood volume and blood flow in brain tissues, in order to promote the secretion of cerebrospinal fluid and the resetting of compressed brain tissues, and accelerate the removal of the hematoma after liquefaction.
The difference was not significant in the score of clinical neurological function defect degree in the minimally invasive drainage group, internal medical treatment group and craniotomy group before treatment. However, the difference was significant after treatment; and it can be concluded that the treatment of minimally invasive drainage can quickly eliminate the hematoma and block the occurrence of a series of pathological changes after bleeding, in order to improve clinical neurological functions. From the condition of patients followed-up after discharge, there was a remarkable significance in ADL grading in survival patients in the three groups, the followed-up mortality in the minimally invasive drainage group was significantly lower than that in the internal medical treatment group and craniotomy group, and there was a significant difference among the three groups; indicating that the treatment of minimally invasive aspiration drainage can significantly improve long-term survival quality and survival rate due to the improved clinical neurological functions in the acute period.
It was found in the observation of brain CT changes in patients in the internal medical treatment group and minimally invasive drainage group that there was significant difference in the edema belt of perihematoma brain tissues between these two groups, in which there were obviously lower density changes in perihematoma brain tissues in the internal medical treatment group, while lower density changes in perihematoma brain tissues were very slight or even had no changes in the minimally invasive drainage group. This indicates that thrombin was released from the process of the blood clot formation. Furthermore, the free hemoglobin and its degradation products released from the process of erythrocatalysis can be quickly removed during minimally invasive treatment; and these substances are related to brain edema, blood-brain barrier damage and cytotoxicity [20]. Therefore, minimally invasive drainage treatment has played positive roles in alleviating brain edema and restoring the function of the nerve system.
In the conservative internal medical treatment, drugs were mainly applied in the prevention and treatment of intracranial hypertension and the resulting complications, and the hematoma was eliminated by self-absorption in patients. Therefore, the hematoma, the hematoma place occupying effect and the factors that cause the edema could not be eliminated as soon as possible. Thus, this kind of treatment is passive, and the curative effect is poor.
From the observations of comparisons in the cerebral CT of patients between the craniotomy group and minimally invasive drainage group, brain damage and edema changes in patients in the craniotomy group were significant, which had a great relationship with the local trauma caused during surgery; and there are also obvious differences between these two. Furthermore, craniotomy surgery was performed under general anesthesia, the incision was larger, the trauma was greater, the procedures were cumbersome, and the tolerance of patients was poor.
The treatment of hypertensive cerebral hemorrhage with the application of soft channel minimally invasive aspiration and drainage is operated under the guidance of CT, which is fast and easy. In addition, its preoperative preparation time is short, local injury is slight, and systemic tolerance of patient is good. All these can significantly improve clinical nerve function and the quality of life of patients. Therefore, it has superiority when compared with other methods.
Conflict of interest
None to report.
