EndoscopyImage-guided endoscopic evacuation of spontaneous intracerebral hemorrhage☆
Introduction
Spontaneous ICH is a devastating disease with historically poor outcomes. Medical management of these patients results in unacceptable morbidity and mortality. Only 48% to 65% of ICH victims are alive at 1-month follow-up, and only 10% of these patients are living independently [4], [5], [6], [9]. The natural course of acute ICH is not static [10]. After initial irreversible tissue injury is suffered near the hemorrhage nidus, a progressive cascade of elevated local pressures, edema, and excitotoxicity causes additional secondary injury to surrounding brain [12], [16], [17]. Much of this secondary process is thought to be attributable to the mass effect of the new hemorrhage, as well as the toxicity associated with hematoma decomposition and release of inflammatory and free radical mediators.
As a result, there has been great interest in the potential benefits of acute hematoma evacuation. In the United States, more than 7000 patients with ICH undergo evacuation procedures each year [8]. This enthusiasm has been tempered by the lack of supportive clinical data. The efficacy of surgical evacuation was most recently studied in the iSTICH [11]. This large multicenter, international randomized trial evaluated the efficacy of early (<24 hours after randomization) surgical therapy vs best medical management in the treatment of spontaneous ICHs. Although this study has received criticism for the subjectivity of its inclusion criteria, frequency of treatment group crossover, and diversity of surgical approaches, it remains the most powerful study of hematoma evacuation to date. This trial corroborated the results of prior smaller studies that failed to show a survival or morbidity benefit of conventional surgery.
The surprising failure of conventional hematoma evacuation may be attributable to the type of surgical approach. Although standard open craniotomy is routinely effective in complete hematoma evacuation and maintenance of hemostasis, the approach commonly causes damage to uninjured brain overlying the hematoma. Minimally invasive surgical strategies have been devised to minimize this risk. The safety of image-guided and frameless stereotactic procedures has been reported in numerous small trials [7], [15]. These approaches commonly necessitate use of thrombolytic therapy and require increased evacuation times. Furthermore, these methods are limited in their ability to achieve hemostasis and completely evacuate the hematoma.
Despite the success of early studies, endoscopic assisted evacuation of ICH has received little attention as a minimally invasive technique. The endoscopic approach has been shown to be effective in achieving immediate and complete hematoma evacuation [2], [14]. This technique also has the benefit of improved visualization and hemostasis with electric cautery [13]. Auer et al [1] have published the most promising surgical data related to ICH evacuation. They have reported a significant survival benefit of endoscopic evacuation over medical therapy with hematomas greater than 50 mL. Although there was no improvement in mortality with smaller lesions, patients undergoing endoscopic evacuation were more likely to have a favorable functional recovery at 6 months.
The lack of an effective surgical treatment for ICH, despite the persistence of a sound pathophysiologic argument for hematoma evacuation, has led us to initiate a single-center, randomized, controlled trial of acute endoscopic assisted hematoma evacuation. This phase 2 study, comparing image-guided endoscopic evacuation vs aggressive medical management, was designed to assess the feasibility and potential benefit of this minimally invasive technique. The percent volume of evacuated hematoma at 24 hours was set as the primary efficacy outcome measure. The rate of rehemorrhage, deterioration of the GCS by 2 points during the ICU stay, and fall in the NIHSS by 4 points at 30 days was used to determine the safety of endoscopic evacuation. This manuscript will report the current safety and efficacy data of this ongoing trial and investigate the technical challenges associated with this minimally invasive approach.
Section snippets
Methods
The University of California Institutional Review Board approved this study. Subjects were considered for enrollment if they presented to University of California, Los Angeles Medical Center within 24 hours of onset of symptoms for acute ICH. Patients were eligible for the study if they were 18 years or older, had an ICH volume above 15 mL, and had significant neurological symptoms resulting from the acute hematoma. Patients with a GCS score below 5, posterior fossa hemorrhage, ICH secondary to
Results
Thirty-four total patients were screened for enrollment. Twenty-four patients did not meet inclusion criteria with stroke subtype [6], lesion size [4], and preclusive admission GCS [4] being the most common limiting factors. Three patients were not enrolled because of refusal of consent by the legally authorized patient representative. One additional patient was randomized to the surgical arm (case 6) and required emergent conventional craniotomy as a result of brain herniation and clinical
Discussion
In this study, we demonstrated that image guided endoscopic evacuation of primary ICH is feasible and safe. The primary results were the following. (1) The mean reduction in hematoma volume was 80% ± 13%. (2) The 90-day mortality rate in the surgical group was less than half of that in the medical management group. (3) Endoscopic evacuation can be accomplished safely with minimal risk of clinical deterioration or hemorrhagic expansion. (4) Technical efficacy was assessed and needed improvements
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This work was supported by a grant from the Division of Extramural Research of the National Institutes of Health: P50-NS044378 (Alger, Vespa, Martin, Kidwell).