Feasibility of intraventricular nicardipine prolonged release implants in patients following aneurysmal subarachnoid haemorrhage

Br J Neurosurg. 2011 Dec;25(6):677-83. doi: 10.3109/02688697.2010.548878. Epub 2011 Feb 23.

Abstract

Objective: Intracisternal nicardipine prolonged release implants (NPRI) have been shown to be effective in the prophylaxis of cerebral vasospasm (VS). However, they cannot be used in patients following coil occlusion of the aneurysm. As a certain dissemination of nicardipine within the cerebrospinal fluid (CSF) has been described, we examined the feasibility of intraventricular use of NPRI in patients that underwent clip and coil occlusion of their aneurysms following aneurysmal subarachnoid haemorrhage (aSAH). By comparison with an historical control group, an estimation of their effectivity in regard to angiographic vasospasm and the development of cerebral infarction has been performed.

Methods: Thirty-one patients suffering from aSAH were prospectively included in this trial. Study participants received prior to clipping (n = 17) or coiling (n = 14) 6 (n = 15) or 10 NPRI (n = 16) into the lateral ventricles. Physiological data were collected, proximal and global VS were determined using pre-operative and day 8 ± 1 angiography, and incidence of hydrocephalus and VS related infarcts were evaluated and compared to a historical control group consisting of 16 operated patients without NPRI implantation.

Results: Intraventricular NPRI were tolerated well. There were no adverse side effects detectable, physiological variables such as heart rate (HR), mean arterial blood pressure (MAP), intracranial pressure (ICP) and electrolytes showed no difference compared to control. There was no difference in the proportion of patients that required CSF shunting. A significant positive angiographic effect could only be observed in clipped patients (proximal vessel diameters: control, 80 ± 30%; NPRI 90 ± 24%; incidence of moderate/severe global VS: control, 73%; NPRI, 41%).

Conclusions: The use of intraventricular NPRI seems to be safe and tolerated well. There is preliminary evidence for effectivity on angiographic VS for clipped patients only. A further increase of the effective dose might also exert efficacy in the subset of patients following coil occlusion.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Angiography, Digital Subtraction
  • Brain Infarction / diagnostic imaging
  • Brain Infarction / epidemiology
  • Cerebral Ventricles / blood supply
  • Delayed-Action Preparations / administration & dosage
  • Delayed-Action Preparations / therapeutic use
  • Drainage / methods
  • Drug Implants
  • Feasibility Studies
  • Female
  • Humans
  • Hydrocephalus / epidemiology
  • Hydrocephalus / therapy
  • Male
  • Middle Aged
  • Nicardipine / administration & dosage
  • Nicardipine / therapeutic use*
  • Prospective Studies
  • Subarachnoid Hemorrhage / complications
  • Subarachnoid Hemorrhage / drug therapy*
  • Subarachnoid Hemorrhage / surgery
  • Treatment Outcome
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / therapeutic use*
  • Vasospasm, Intracranial / diagnostic imaging
  • Vasospasm, Intracranial / etiology
  • Vasospasm, Intracranial / prevention & control*

Substances

  • Delayed-Action Preparations
  • Drug Implants
  • Vasodilator Agents
  • Nicardipine