Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. 


BACKGROUND: Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known.

METHODS: In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients’ assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment.

RESULTS: A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration.

CONCLUSIONS: Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages.

Incidence of and risk factors for superior facet violation in minimally invasive versus open pedicle screw placement during transforaminal lumbar interbody fusion: a comparative analysis.


 

 

A reported risk factor for adjacent-segment disease is injury to the superior facet joint from pedicle screw placement. Given that the facet joint is not typically visualized during percutaneous pedicle screw insertion, there is a concern for increased facet violation (FV) in minimally invasive fusion procedures. The purpose of this study was to analyze and compare the incidence of FV among patients undergoing minimally invasive transforaminal lumbar interbody fusion (MITLIF) and open transforaminal lumbar interbody fusion (TLIF). The impact of O-arm navigation compared with traditional fluoroscopy on FV in MITLIF is also assessed, as are risk factors for FV.

Methods

The authors identified a consecutive population of patients who underwent MITLIF with percutaneous pedicle screw placement, as well as a matched cohort of patients who underwent open TLIF. Postoperative CT imaging was assessed to determine intraarticular FV due to pedicle screw placement. Patients were stratified into minimally invasive and open TLIF groups. Within the MITLIF group, the authors performed a subanalysis of image guidance methods used in cases of FV. Two-tailed Student t-test, ANOVA, chi-square testing, and logistic regression were used for statistical analysis.

Results

A total of 282 patients were identified, with a total of 564 superior pedicle screw placements. The MITLIF group consisted of 142 patients with 284 screw insertions. The open TLIF group consisted of 140 patients with 280 screw insertions. Overall, 21 (7.4%) of 282 patients experienced FV. A total of 21 screws violated a facet joint for a screw-based FV rate of 3.7% (21 of 564 screws). There were no significant differences between the MITLIF and open TLIF groups in the percentage of patients with FV (6.3% vs 8.6%) and or the percentage of screws with FV (3.2% vs 4.3%) (p = 0.475 and p = 0.484, respectively). Further stratifying the MI group into O-arm navigation and fluoroscopic guidance subgroups, the patient-based rates of FV were 10.8% (4 of 37 patients) and 4.8% (5 of 105 patients), respectively, and the screw-based rates of FV were 5.4% (4 of 74 screws) and 2.4% (5 of 210 screws), respectively. There was no significant difference between the subgroups with respect to patient-based or screw-based FV rates (p = 0.375 and p = 0.442, respectively). The O-arm group had a significantly higher body mass index (BMI) (p = 0.021). BMI greater than 29.9 was independently associated with higher FV (OR 2.36, 95% CI 1.65–8.53, p = 0.039).

Conclusions

The findings suggest that minimally invasive pedicle screw placement is not associated with higher rates of FV. Overall violation rates were similar in MITLIF and open TLIF. Higher BMI, however, was a risk factor for increased FV. The use of O-arm fluoroscopy with computer-assisted guidance did not significantly decrease the rate of FV.

Source: Journal of Neurosurgery