Minimally invasive puncture and drainage or patients with hypertensive spontaneous basal ganglia intracerebral hemorrhage: A prospective non-randomized comparative study of 198 cases

Background: The treatment of hypertensive spontaneous intracranial hemorrhage(ICH) is still controversial. The purpose of the present study was to investigate whether minimally invasive puncture and drainage(MIPD) could provide improved patient outcome compared with decompressive craniectomy(DC).Methods: Eligible, consecutive patients with ICH(≥30 ml, in basal ganglia, within 24 hours of ictus) were nonrandomly assigned to receive MIPD(group A) or to undergo DC(group B) hematoma evacuation. The primary outcome was death at 30 days after onset. Functional independence was assessed at 1 year using the Glasgow Outcome Scale(GOS, scores range from 1 to 5, score 1 indicating death, ≥4 indicating functional independence, with lower scores indicating greater disability). Results: A total of 198 patients met the per protocol analysis(84 cases in group A and 114 cases in group B), including 9 cases lost during follow-up(2 cases in group A and 7 cases in group B). For these 9 patients, their last observed data were used as their final results for intention-to-treat analysis. The mean age of all patients was 57.1 years(range of 31-95 years), and 114 patients were male. The initial Glasgow Coma Scale(GCS) score was 8.1±3.4, and the National Institutes of Health Stroke Scale(NIHSS) score was 20.8±5.3. The mean hematoma volume(HV) was 56.7±23.0 ml(range of 30-144 ml), and there was extended intraventricular hemorrhage(IVH) in 134 patients(67.7%). There were no significant intergroup differences in the above baseline data, except group A had a higher mean age(59.4±14.5years) than the mean age of group B(55.3±11.1 years, P=0.025). The total cumulative mortalities at 30 days and 1 year were 32.3% and 43.4%, respectively, and there were no significant differences between groups A and B(30 days: 27.4% vs. 36.0%, P=0.203; 1 year: 36.1% vs. 48.2%, P=0.112, respectively). However, the mortality for patients ≤60 years, NIHSS【15 or HV≤60 ml was significantly lower in group A than that in group B(all P【0.05). The total cumulative functional independence at 1 year was 26.8%, and the difference between group A(33/43, 39.3%) and group B(20/144, 17.5%) was significant(absolute difference 21.7%, odds ratio [OR] 0.329, 95% confidence interval [CI] 0.171 to 0.631, P=0.001). For patient with severe IVH, the 30 days and 1 year mortality rates were significant lower in group B than those in group A(P=0.025, P=0.036). However, the number of favorable outcomes had no significant difference between groups at 1 year post ictus. Multivariate logistic regression analysis showed that a favorable outcome after 1 year was associated with the difference in therapies(OR 0.280, 95% CI 0.104–0.752, P=0.012), age(OR 0.215, 95% CI 0.069–0.671, P=0.008), GCS(OR 1.187, 95% CI 1.010–1.395, P=0.037), HV(OR 0.943, 95% CI 0.906–0.982, P=0.005), IVH(OR 0.655, 95% CI 0.506–0.849, P=0.001) and PI(OR 0.211, 95% CI 0.071–0.624, P=0.001). Conclusions: Our results suggest that for patients with hypertensive spontaneous ICH(HV≥30 ml in basal ganglia), MIPD may be a more effective treatment than DC, as assessed by a higher rate of functional independence at 1 year after onset as well as reduced mortality in patients ≤60 years of age, NIHSS【15 or HV≤60 ml. For patients with HV 】60 ml, deep coma and severe IVH, the outcomes of the two therapies were similar.