Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect

The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects.

All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.

Study Overview

• Status: Completed
• Conditions: Bundle-Branch Block; Heart Septal Defects, Ventricular
• Intervention / Treatment: Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing

Detailed Description

Right bundle branch block is an exceedingly frequent complication in heart surgery, and especially in patients who have undergone surgical closure of a ventricular septal defect which is the most common congenital heart disease. How this bundle branch block effects the right ventricle of the heart on a long-term basis for this group of patients, is still unknown.

As a part of a PhD-study we therefore will try to illustrate this by echocardiography, MRI, exercise testing and other investigations 15 to 20 years after the surgical procedure. The study population thus consists of three different groups: 1. Patients whom undergone surgical closure of ventricular septal defect without postoperative right bundle branch block, 2. VSD-operated patients with right bundle branch block and 3. Healthy controls with no significant medical issues matched on age and sex. By carrying out the tests mentioned the right ventricles systolic function, diastolic function, the patients maximal exercise capacity and a lot of other parameters will be evaluated in the three groups of patients and compared amongst each other. The perspective therefore is the ability to point out a specific group of patients with an inferior outcome and with a possible need for further intervention. An additional perspective is to increase the awareness of protecting the bundle branch during the operation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Aarhus University Hospital Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby

Exclusion Criteria:

• No chart to be found
• No EKG to be found
• Known bundle branch block prior to the surgery
• Other arrythmias
• Use of ventriculotomy
• Other disease than VSD
• Pacemaker or other metallic implants
• Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VSD, +Right bundle branch block; Patients undergone surgical closure of ventricular septal defect and have a postoperative right bundle branch block, about 20 patients	Procedure: Echocardiography at rest; Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.; Procedure: Echocardiography during exercise; TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.; Procedure: MRI at rest; Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.; Procedure: Exercise testing; Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
Experimental: VSD, -Right bundle branch block; Patients undergone surgical closure of ventricular septal defect and does not have a postoperative right bundle branch block, about 20 patients	Procedure: Echocardiography at rest; Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.; Procedure: Echocardiography during exercise; TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.; Procedure: MRI at rest; Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.; Procedure: Exercise testing; Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
Experimental: Control; Healthy control subjects, about 20 patients	Procedure: Echocardiography at rest; Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.; Procedure: Echocardiography during exercise; TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.; Procedure: MRI at rest; Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.; Procedure: Exercise testing; Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic function at rest measured by echocardiography	Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspidale valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.	All patients are tested only once about 20 years post to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal oxygen consumption during exercise	Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potentiel diffenrences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbondioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.	All patients are tested only once about 20 years post to surgery
Force-frequency-relation during exercise	TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.	All patients are tested only once about 20 years post to surgery
Diastolic function at rest measured by MRI	Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.	All patients are tested only once about 20 years post to surgery
Diastolic function at rest measured by echocardiography	Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspidale valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.	All patients are tested only once about 20 years post to surgery
Systolic function at rest measured by MRI	Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.	All patients are tested only once about 20 years post to surgery

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital Skejby
• Investigators: Study Chair: Vibeke Hjortdal, MD, DMSc, Prof., Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby; Study Director: Michael R. Schmidt, MD, PhD, Dept. of cardiology, Aarhus university hospital Skejby; Study Director: Steffen Ringgaard, Physics, PhD, Dept. MRI, Aarhus University Hospital Skejby; Study Director: Andrew Redington, MD, DMSc, Prof., Dept. of Cardiology, The Hospital for Sick Children, Toronto

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: MRI; Echocardiography; Exercise testing; Right bundle branch block; Ventricular septal defect
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Bundle-Branch Block; Heart Block; Heart Septal Defects; Heart Septal Defects, Ventricular
• Other Study ID Numbers: VSDRBBBB-RV