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Comparison of Craniotomy and Stereotactic Aspiration Plus Thrombolysis in Isolated Capsulo-Ganglionic Hematoma: A Retrospective Analyses
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0028-3886.344635
Keywords: Basal ganglia hematoma, capsulo-ganglionic hematoma, ICH, intracerebral hematoma, stereotactic aspiration
Hypertension is a pandemic affecting nearly 1.28 billion people globally. One in every four males and one in every five females are hypertensive.[1] In India, the prevalence rates vary from 25 to 30% and are responsible for nearly half of all strokes.[2],[3],[4] The cumulative incidence of stroke range is 105–152/100,000 persons/year in India, and 10–20% of all strokes are hemorrhagic.[5] With these estimates, in a country of 1.38 billion people, nearly 2–3 lakhs suffer from Intra-cerebral hemorrhage (ICH) every year. Globally, >5 million people suffer from hemorrhagic stroke.[6] With such an enormous disease burden, management issues are still debatable and far from ideal. Although STICH-1 and 2 trials did not show significant advantages of early surgery over best medical management, decision making in ICH is dynamic over a timeline and depends upon the clinical status and radiological findings. It is worth notable that 26% of patients in STICH-1 and 21% in STICH-2 trials crossed over to the surgical arm due to neurological deterioration.[7],[8] Recently, a meta-analysis of pooled data of STICH-1 and 2 subjects had shown that surgical interventions might not be beneficial in extremes of Glasgow Coma Scale (GCS) score but do have the edge over medical treatment in GCS 10-13.[9] The outcome of these trials suggests that there are subsets of patients who may benefit from surgery in reducing mortality at the cost of morbidity. The tested interventions for hematoma evacuation are craniotomy, endoscopy, and stereotactic aspiration plus thrombolysis. In both STICH trials, the most commonly adopted surgical procedure was craniotomy, which does not address the outcome of minimally invasive procedures. Recent meta-analysis had shown the benefit of minimally invasive surgery over conventional treatment in select patients of supratentorial ICH.[10],[11] This study aims to compare the outcomes of two techniques of hematoma evacuation (Craniotomy and Stereotactic Aspiration plus thrombolysis) in capsule-ganglionic locations.
We conducted a retrospective data analysis from January 2015–December 2019 (5 years), recorded the follow-up in Jan–Feb 2021, and obtained consent. Medical and radiological data were analyzed. We designed the inclusion criteria to keep the uniformity of the ICH score of 2 in both treatment arms.[12] The Inclusion criteria were – patients operated for Capsule-Ganglionic hypertensive hematomas, Glasgow Coma Scale (GCS) at presentation 5-12, hematoma volume ≥30 ml, no concomitant IVH, age <80 years, no coagulopathy, and with a minimal follow-up of 1 year. All patients received anti-hypertensive agents, Mannitol and Lasix, Tranexamic acid, and intensive care as part of medical management. This study included 16 variables - Age, Gender, Hematoma side (Left/Right), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at presentation, Preoperative Glasgow Coma Scale (GCS), Preoperative hematoma volume, Surgical method, Postoperative hematoma volume, Number of full days on the ventilator (Ventilator Days), ICU stay, hospital stay, surgical site infection (SSI)/Meningitis, number of Re-bleed, Modified Ranking Score (MRS) at last follow-up, and Follow-up duration. We dichotomized GCS into Group-A (GCS 5-8) and Group-B (GCS 9-12). Percentage of hematoma reduction by any of the surgical methods was categorized into Group 1 (>75% reduction), Group 2 (51-75% reduction), Group 3 (26-50% reduction), and Group 4 (≤25% reduction). Outcomes were assessed in terms of surgical parameters, intensive care parameters, and neurological parameters. MRS scores were categorized into two groups considering different criteria proposed in the literature.[13] Conventionally, MRS of 0-2 was considered a good outcome, and a score of 3-6 was considered a poor outcome. As per the MISTIE trial, 0-3 MRS was considered a good outcome, and 4-6 was considered a poor outcome. Statistical analysis was done on software JASP (version 0.14.1, Amsterdam). Continuous and categorical variables were expressed as mean ± SD. Chi-square and Fisher's exact test was used for categorical variables. Continuous variables were analyzed by independent t-test and Mann-Whitney U tests. Step-wise logistic regression was applied to observe the influence of variables on outcome. Two-tailed P values were considered statistically significant at P < 0.05. Surgical technique After a standard-sized (nearly 15 X 12 cm) craniotomy, the hematoma was removed, mostly through the middle frontal gyrus under the microscope. We were conservative for hematoma removal on the insular side to avoid bleeding encounters with lenticulostriate arteries. The technique of stereotactic aspiration was mostly as per MISTIE protocol.[14] The “Leksell stereotactic frame” was applied under local anesthesia, and along the X, Y, and Z-axis, calculations were done on the CT console. The catheter tip was targeted to the hematoma's posterior-most end along the longest axis through the center. We used commercially available external ventricular drain (EVD) as a drainage catheter. The catheter position was clinically confirmed by gravity drainage with dark-colored blood at the tip. The catheter was tunneled subcutaneously for 5 cm or more and fixed. No attempt was made during surgery to aspirate the hematoma. All patients were subjected to an immediate CT scan for radiological confirmation. Alteplase 1 mg diluted in 2-ml normal saline was installed, and the catheter was closed with a three-way stop-cock connected to a drainage bag. After 1 hour, gravity drainage was allowed. A total of nine doses were used at 8-hour intervals. A follow-up CT scan was done on postoperative day three. The protocol for catheter removal was either hematoma size <15 ml and reduction in midline shift. In cases of significant residual hematoma, additional doses were installed for two more days. The stereotactic aspiration group required additional steps like a navigation CT after applying frame, repeated installation of Alteplase, drainage of hematoma, and mobilization for CT scans with EVD in situ.
A total of 201 patients met the inclusion criteria. A total of 38 patients were excluded (27-did not complete treatment and left against medical advice and 11 were lost on follow-up). The final analysis included 173 patients (90 in the craniotomy group and 83 in the stereotactic aspiration group). Both groups had no statistical difference in terms of age, gender, SBP, DBP, side of hematoma, preoperative GCS, GCS groups, and preoperative hematoma volume (P > 0.5). The overall mean follow-up was 39.89 ± 18.85 (range 12–72) months. Follow-up was significantly lower (P < 0.001) in the stereotactic aspiration group than in the craniotomy group (25.59 ± 10.80 vs. 53.08 ± 14.58 months) [Table 1].
There was no significant difference in residual hematoma volumes, reduction category, SSI/Meningitis, and the chance of re-bleed among both treatment arms in terms of surgical performance (P > 0.05). A total of 6/83 (7.22%) patients required Alteplase installation for >3 days. The number of days on ventilation, ICU stay, and hospital stay was significantly higher in the craniotomy group (P < 0.001) [Table 1]. A total of 4/83 patients re-bleed in the stereotactic aspiration group. Two of these patients underwent craniotomy, and one survived with MRS 4. Two of the re-bleeds deteriorated to poor GCS beyond rescue. The mean MRS was significantly lower (P 0.01) in the stereotactic aspiration group (3.25 ± 1.60) as compared to the craniotomy group (3.86 ± 1.56). A significantly higher number of patients (P 0.02) in the stereotactic aspiration group achieved a good MRS score (0-2). Similarly, when MRS was grouped according to the MISTIE trial, the stereotactic aspiration group had a significantly higher number of good outcome (MRS 0-3) patients (P 0.01). The overall case-fatality rate was 38/173 (21.96%), in the craniotomy group 24/90 (26.66%), and in the stereotactic aspiration group 14/83 (16.86%), but this difference was not significant (P 0.12) [Table 1]. Twenty-two patients died in the hospital, whereas 16 were dead on follow-up. The primary reasons for in-hospital deaths were SSI/Meningitis in nine, re-bleed in six, and multi-organ dysfunction in seven cases. When both surgical methods were compared in terms of the hematoma side, on the left side, there was no significant difference in neurological outcome (P 0.33 or 0.13). On the right side, stereotactic aspiration has a significantly superior edge over craniotomy (P 0.03 or 0.04) [Table 2].
The variables for good (MRS 0-2 or MRS 0-3) and poor outcome (MRS 3-6 or MRS 4-6) were analyzed. Patients with good outcomes had a hematoma on the right side (P < 0.001), had significantly lower DBP (P 0.04 or 0.03), higher GCS at presentation (P < 0.001), were in better GCS group–B (P < 0.001), smaller preoperative hematoma volume (P < 0.001 or 0.002), and underwent stereotactic aspiration of the hematoma (P 0.02 or 0.01) [Table 3]. [Figure 1] depicts the MRS score achieved among groups (method, side of hematoma, and GCS groups).
Analyzing these factors in step-wise logistic regression analysis, DBP, and preoperative hematoma volume failed to sustain their significance in determining outcomes. The significant parameters predicting the poor outcome (MRS 3-6) were GCS 5-8 (Odds Ratio (OR) 2.38), Left side hematoma (OR 1.75), and craniotomy as a method of removal of hematoma (OR 1.70). Similar observations were made when the poor outcome is considered as MRS 4-6 (GCS 5-8: OR 2.64, Left side: OR 2.27, and Craniotomy: OR 1.79) [Figure 2].
Cerebral compliance is the capability of the brain to buffer an increased intracranial volume without a significant rise in ICP. As the volume–pressure relationship is not linear, after a period of spatial compensation, ICP rises exponentially. The pressure–volume index (PVI) is the volume required to raise the ICP by a factor of 10, and in the normal adult brain, it varies as 22–30 ml.[15],[16] Thus, it is reasonable to believe that patients with large hematoma who show signs of raised ICP or impending herniation may have better survival rates than medical management alone.[17] Hematoma removal also has potential advantages to ameliorate the risk of secondary brain insult by reducing blood products' toxic effects, reducing peri-hematoma edema, and ischemia due to mass effect.[18],[19],[20],[21] Our stereotactic aspiration technique is adapted from the MISTIE trial.[22] Unlike MISTIE, we perform the procedure under local anesthesia with sedation and do not aspirate hematoma. We believe that in intraoperative hematoma aspiration followed by passing of soft catheter along the track created by rigid cannula (MISTIE technique), the catheter may get off-target due to softness and at times give the impression of mal-position on subsequent CT. We use an EVD catheter with a stylet instead of a rigid cannula, which gives us an advantage of leaving the catheter in situ in one attempt. To achieve the best engagement in hematoma in the anterior–posterior axis, we prefer to perform burr hole as frontal as possible, at times even slightly anterior to the hairline. In this scenario, we use a transverse incision along Langer's line. Our catheter tip targets the posterior-most point of hematoma, as in the postoperative period, the patient lies supine, and liquefied hematoma keeps on falling into the cavity due to gravity. As we do not aspirate hematoma, our technique is more of a “Stereotactic Drainage” rather than a “Stereotactic Aspiration.” Representative images of select cases are showcased in [Figure 3].
In contrast to other studies, we set the inclusion criteria to keep the uniformity of the ICH score of 2, thereby eliminating the potential confounding factors for the outcome. We compared outcomes between the sides of hematoma [Table 4]. We also evaluated care parameters like ventilator days, ICU stays, and hospital stays, which were significantly shorter in the stereotactic aspiration group. The likely reason is that a set of patients in GCS >8 in the stereotactic aspiration group never required intubation and general anesthesia, as the procedure can be safely performed under local anesthesia and sedation. It reduces the overall cost of treatment, as also shown by Hattori et al.[23] in their randomized study.
The superiority and efficacy of stereotactic aspiration over conventional craniotomy had been proved in the various meta-analyses.[30],[31],[32] This technique has even been used effectively in cerebellar hemorrhage.[33] Although craniotomy reduces ICP immediately at the cost of cortical damage, stereotactic aspiration does it slowly over a period. In hematomas having liquefied clots, even a considerable amount of blood gets drained out in the first 24 hours. Another advantage is that the catheter also drains a fair amount of CSF from sulcal spaces (evident as increased drain output), further reducing the ICP. If required, the catheter itself can be used to monitor ICP.[34] Like in some studies, we did not find any significant difference in the chance of re-bleed between both methods.[25],[26],[29] On the contrary, an increased risk of re-bleed was seen after craniotomy in other studies.[24],[28] While open surgery has a chance to achieve hemostasis immediately, we prefer to stay conservative for maximum possible safe removal towards the insular side to avoid inadvertent bleeding encounters with lenticulostriate branches. We believe that the aim of surgery should be to reduce ICP rather than having a clean scan. In the stereotactic aspiration technique, a gradual reduction in hematoma volume occurs, therefore maintaining the tamponade-induced hemostasis. For similar reasons, we avoid aspiration and prefer gravity drainage. As open surgery for deep-seated hematoma incorporates traversing through undamaged white matter fibers, the trends of minimally invasive surgeries are on the rise. Cho et al.[35] compared endoscopic, stereotactic, and craniotomy methods for hematoma removal and concluded that both endoscopic and stereotactic methods are equivalent in performance and better than craniotomy. In contrast, recently, in 2019, a meta-analysis of RCT comparing endoscopic surgery and craniotomy showed lower complication rates with endoscopy, but no superior advantage in morbidity rates.[36] Katsuki et al.[37] in 2020 reported similar observations. Compared to endoscopic procedures, stereotactic aspiration is even less invasive, and their safety and outcome have been proven in MISTIE trials. Initial results were encouraging but failed to show functional improvement in 1 year over medical management.[14],[22] In MISTIE-III, 44.17% of stereotactic aspiration patients achieved a good outcome (MRS 0-3) in comparison to 60.24% in our study. At 1 year, the case-fatality rate in MISTIE-III was 19%, whereas it was 16.86% at a mean follow-up of 25.59 months in our stereotactic cohort. These differences can be explained as the MISTIE cohort included basal ganglia along with lobar hematomas, patients of all GCS, with IVH, and on anticoagulant/anti-platelet drugs.[22] Patients after stereotactic aspiration also get benefits in terms of improved activities of daily living.[38] MRS or extended Glasgow outcome score is mostly used for outcome assessment, which basically evaluates the patient's functional independence. As most capsulo-ganglionic bleeds induce primary and secondary white matter injury to the eloquent brain,[39] no modality is likely to restore neurological status to pre-event level, and some residual deficit with impaired functional independence is expected. Moreover, aphasia in the left side hematoma is a major influential factor for MRS. These patients land up mostly in MRS grade 3 or more; therefore, judging treatment outcomes by these scoring scales is harsh. An inter-observer variation is another inherent limitation in the evaluation of MRS.[40] Researchers are in a constant endeavor to develop better scales.[41] The follow-up in the present study is longer than in other published studies. It was significantly shorter in the stereotactic aspiration group as this procedure was adopted in the latter half of the study period, and more patients in the latter half were subjected to stereotactic aspiration than craniotomy. With longer follow-up in the stereotactic aspiration group equivalent to the craniotomy group, the outcomes of stereotactic aspiration have the potential chance to improve further.
The results of our study suggest that the invasiveness of the procedure affects the outcomes. Stereotactic hematoma aspiration plus thrombolysis is a safe and effective technique for hematoma evacuation. Its surgical performance is equivalent to conventional craniotomy and has the edge in terms of fewer ventilator days, ICU stays, and hospital stays, reducing the overall cost of treatment. The neurological outcomes after stereotactic aspirations are superior to craniotomy. Acknowledgments We are extremely grateful to Dr. Shahwar Alam, Dr. Vikrant Tamrakar, Dr. Rahul Kulkarni, Mr. Hemlal Sahu, and Ms. Rosy Kaur for data collection and conducting follow-up of patients. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]
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