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

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 in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.

Study Overview

• Status: Completed
• Conditions: Aneurysm, Brain; Cardiac Pacing, Artificial; Arteriovenous Malformations, Cerebral
• Intervention / Treatment: Procedure: Rapid ventricular pacing; Procedure: No rapid ventricular pacing

Detailed Description

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 in 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. The investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging, brain oxygenation (Sct O₂) evaluated by near-infrared spectroscopy 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, Sct O2 (3) and troponin levels (4) both markers for ischemia damage.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cerebral aneurysm surgery with RVP; Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. 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 will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. During surgery subjects allocated in this study arm will undergo RVP.	Procedure: Rapid ventricular pacing; 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 in 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
Active Comparator: Craniotomy without RVP; Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. 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 will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. No rapid ventricular pacing is applied perioperatively.	Procedure: No rapid ventricular pacing; No rapid ventricular pacing is applied perioperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near infrared spectroscopy	Near infrared spectroscopy measures brain oxygenation (Sct O2), a decrease of more than 10% of the initial Sct O2 or lower than 60% during pacing will be considered as a possible risk of cerebral ischaemia.	During surgery
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 6,12 and 24 hours after start surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic resonance imaging	Magnetic Resonance Imaging 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
Occurence of arrhythmias	Any disturbances of the normal rhythmic beating of the heart or myocardial contraction.	During surgery

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Vera Saldien, MD, University Hospital, Antwerp; Principal Investigator: Tomas Menovsky, MD, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): June 12, 2022
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Nervous System Malformations; Intracranial Arterial Diseases; Vascular Malformations; Central Nervous System Vascular Malformations; Aneurysm; Intracranial Aneurysm; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: 17/16/205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No