title: Feasibility of intraventricular nicardipine prolonged release implants in patients following aneurysmal subarachnoid haemorrhage.
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.
authors.affiliation: Department of Neurosurgery, University Hospital Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Germany. martin.barth@umm.de
authors.forename: Martin
authors.initials: M
authors.lastname: Barth
authors.forename: Pablo
authors.initials: P
authors.lastname: Pena
authors.forename: Marcel
authors.initials: M
authors.lastname: Seiz
authors.forename: Claudius
authors.initials: C
authors.lastname: Thomé
authors.forename: Elke
authors.initials: E
authors.lastname: Muench
authors.forename: Stephan
authors.initials: S
authors.lastname: Weidauer
authors.forename: Elke
authors.initials: E
authors.lastname: Hattingen
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Kasuya
authors.forename: Peter
authors.initials: P
authors.lastname: Schmiedek
mesh_terms: D000328:Adult; D000368:Aged; D015901:Angiography, Digital Subtraction; D020520:Brain Infarction / Q000000981:diagnostic imaging / Q000453:epidemiology; D002552:Cerebral Ventricles / Q000098:blood supply; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004322:Drainage / Q000379:methods; D004343:Drug Implants; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006849:Hydrocephalus / Q000453:epidemiology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009529:Nicardipine / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D020301:Vasospasm, Intracranial / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*
chemical_list: D003692:Delayed-Action Preparations; D004343:Drug Implants; D014665:Vasodilator Agents; D009529:Nicardipine