Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain

Study Overview
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Brief Summary
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Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.

Detailed Description
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Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both markers for ischemia damage.

Official Title
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Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain

Conditions
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Cardiac Pacing, Artificial, Aneurysm, Brain, Arteriovenous Malformations, Cerebral

Intervention / Treatment
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* Procedure: Rapid ventricular pacing (RVP)
* Procedure: No rapid ventricular pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria elective cerebral aneurysm clipping surgery arteriovenous malformation surgery craniotomy American Society of Anesthesiologists 1,2 and 3 Exclusion Criteria: cardiac abnormalities coronary heart disease valvular heart disease pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerebral aneurysm surgery with RVP<br>During surgery patients allocated to this group will undergo RVP. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared. | Procedure: Rapid ventricular pacing (RVP)<br>* Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.<br>|
| Craniotomy without RVP<br>No rapid ventricular pacing is applied during surgery. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared. | Procedure: No rapid ventricular pacing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline) | For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively | A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 24 hours up to 60 hours after start surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic resonance imaging or computed tomography | Magnetic resonance imaging or computed tomography of the brain pre-and postoperatively is used as standard of care. To screen for RVP induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on)and fossa posterior will be evaluated. | Preoperative and within 1 week post surgery |