Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study.
Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study. Patients with complex UIA were prospectively enrolled and the safety and efficacy of RVP were evaluated recording cardiovascular events and outcome of the patients as well as the amount of aneurysm occlusion after the surgical clip-reconstruction procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms
Goethe University Hospital
Frankfurt am Main, Germany
RECRUITINGmodified Rankin scale
Time frame: 6 months
Efficacy of flow reduction and improvement of clip application
Efficacy of flow reduction (failure rate of pacing; measuring of heart rate and blood pressure). Also improvement of clip application: performing surgeon has to complete a questionnaire.
Time frame: intraoperatively
safety of pacing catheter
Complications during insertion, positioning, application (intraoperatively) and removal of pacing catheter (postoperatively on ICU). Anesthesiologist has to complete a questionnaire.
Time frame: intraoperatively upt o 24 hours after operation
Cardiovascular events
All cardiovascular events will be documented (like arrhythmias etc.). Also preoperative heart values (of Troponin T, CK, CK-MB) and values after operation and one day after operation will be documented and afterwards analyzed. Reference values (05/2016): CK \<190 U/l; CK-MB \<24 U/l; Troponin T \<14pg/ml Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment were documented and analyzed.
Time frame: intraoperatively upt o 24 hours after operation
occlusion rate of aneurysm
Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping.
Time frame: 1 week after operation
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