3D Echocardiographic Assessment of Epicardial Pacing After Cardiopulmonary Bypass.

NCT ID: NCT02842762

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2018-08-31

Brief Summary

This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the operating room in cardiac surgical patients. Each patient will serve as his own control, following a paired design.

Detailed Description

Cardiac surgical patients sometimes require temporary pacing wires to optimize cardiac function during weaning from cardiopulmonary bypass (CPB), and/or to treat hemodynamically significant brady-arrhythmias. The available patient series report that 8.6% to 23.9% of patient undergoing coronary artery bypass grafting (CABG) or valve surgery require temporary pacing at some time after CPB. The site of pacemaker wire placement seems to be a crucial determinant of cardiac output. In non-surgical patients isolated right ventricular (RV) pacing seems to induce electromechanical dyssynchrony of the RV and the left ventricle (LV). A normal ventricle in sinus rhythm displays a simultaneous contraction of all segments of the heart, so that regional minimal volume (i.e. maximal contraction) will occur at the same time. Isolated RV pacing seems to result in a left bundle branch type electrical activation sequence, with delayed contraction of some of the segments. The LV, but not the RV, seems to negatively affected by this state of dyssynchrony, resulting in decreased cardiac output. In surgical patients however, there is not such data available yet. Since isolated RV epicardial wire placement is still widely practiced in cardiac surgery, and in our own institution, we would like to study the effect of RV pacing on LV synchrony and LV output.

Again from studies in non-surgical patients receiving resynchronization therapy, we know that real-time three-dimensional (3D) echocardiography is very useful to pick up subtle changes in LV synchrony and thereby guide synchronization of ventricular contraction. However, to date the usefulness of real-time 3D echocardiography to guide pacemaker therapy in cardiac surgery is unknown. In the present feasibility study in cardiac surgical patients, we want to investigate the acute effects of isolated RV pacing on LV synchrony, and LV output.

Conditions

Disorder of Pacing Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Non-paced

• cardiac surgery
• 3D TEE measurements of systolic dyssynchrony
• right ventricular epicardial pacemaker lead (off)

Group Type: SHAM_COMPARATOR

cardiac surgery

Intervention Type: PROCEDURE

Elective cardiac surgery, with use of cardiopulmonary bypass.

3D TEE

Intervention Type: DEVICE

Intraoperatively, all patients will be monitored by means of TEE

Pacemaker lead

Intervention Type: DEVICE

All patients will have a epicardial pacemaker lead in situ.

Paced

The patient is randomized to the order of measurements taken, and serves as his own control.

• cardiac surgery
• 3D TEE measurements of systolic dyssynchrony
• right ventricular epicardial pacemaker lead (on)

Group Type: EXPERIMENTAL

Right ventricular epicardial pacing

Intervention Type: DEVICE

The patient's own heart rate at that moment will be the starting point for the study. Right ventricle pacing will be instituted by selecting a rate that is 5 beats above the patient's own heart rate. We will use a stepwise approach where we increase the pacermaker's rate with steps of 5 beats until we have 100% capture of the pacemaker beats. After waiting for at least one minute of pacing we will obtain a set of measurements.

cardiac surgery

Intervention Type: PROCEDURE

Elective cardiac surgery, with use of cardiopulmonary bypass.

3D TEE

Intervention Type: DEVICE

Intraoperatively, all patients will be monitored by means of TEE

Pacemaker lead

Intervention Type: DEVICE

All patients will have a epicardial pacemaker lead in situ.

Interventions

Right ventricular epicardial pacing

The patient's own heart rate at that moment will be the starting point for the study. Right ventricle pacing will be instituted by selecting a rate that is 5 beats above the patient's own heart rate. We will use a stepwise approach where we increase the pacermaker's rate with steps of 5 beats until we have 100% capture of the pacemaker beats. After waiting for at least one minute of pacing we will obtain a set of measurements.

Intervention Type: DEVICE

cardiac surgery

Elective cardiac surgery, with use of cardiopulmonary bypass.

Intervention Type: PROCEDURE

3D TEE

Intraoperatively, all patients will be monitored by means of TEE

Intervention Type: DEVICE

Pacemaker lead

All patients will have a epicardial pacemaker lead in situ.

Intervention Type: DEVICE

Other Intervention Names

three-dimensional transesophageal echocardiography

Eligibility Criteria

Inclusion Criteria

• Adult patient scheduled to undergo elective cardiac surgery by means of full sternotomy and use of cardiopulmonary bypass
• Preoperative moderate to good LV function, ejection fraction > 30%
• Age > 18 yrs. old
• Preoperative sinus rhythm
• Pacemaker lead inserted by cardiac surgeon during surgery
• Underlying sinus rhythm after cardiopulmonary bypass before the end of surgery
• Able to understand written and verbal patient information
• Signed informed consent

Exclusion Criteria

• Emergency cardiac surgery
• Minimally invasive surgery
• Contraindication to TEE
• Redo surgery
• Hemodynamic instability after CPB (late exclusion criterium)
• No pacemaker lead inserted by cardiac surgeon (late exclusion criterium)
• No sinus rhythm during chest closure towards the end of surgery (late exclusion criterium)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzanne Flier, MD

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Flier, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suzanne Flier, MD MSc

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Center

Locations

University Hospital - London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

References

Wolber T, Haegeli L, Huerlimann D, Brunckhorst C, Luscher TF, Duru F. Altered left ventricular contraction pattern during right ventricular pacing: assessment using real-time three-dimensional echocardiography. Pacing Clin Electrophysiol. 2011 Jan;34(1):76-81. doi: 10.1111/j.1540-8159.2010.02908.x. Epub 2010 Oct 14.

Reference Type: BACKGROUND

PMID: 20946287 (View on PubMed)

Kapetanakis S, Kearney MT, Siva A, Gall N, Cooklin M, Monaghan MJ. Real-time three-dimensional echocardiography: a novel technique to quantify global left ventricular mechanical dyssynchrony. Circulation. 2005 Aug 16;112(7):992-1000. doi: 10.1161/CIRCULATIONAHA.104.474445. Epub 2005 Aug 8.

Reference Type: BACKGROUND

PMID: 16087800 (View on PubMed)

Alwaqfi NR, Ibrahim KS, Khader YS, Baker AA. Predictors of temporary epicardial pacing wires use after valve surgery. J Cardiothorac Surg. 2014 Feb 12;9:33. doi: 10.1186/1749-8090-9-33.

Reference Type: BACKGROUND

PMID: 24521215 (View on PubMed)

Bethea BT, Salazar JD, Grega MA, Doty JR, Fitton TP, Alejo DE, Borowicz LM Jr, Gott VL, Sussman MS, Baumgartner WA. Determining the utility of temporary pacing wires after coronary artery bypass surgery. Ann Thorac Surg. 2005 Jan;79(1):104-7. doi: 10.1016/j.athoracsur.2004.06.087.

Reference Type: BACKGROUND

PMID: 15620924 (View on PubMed)

Other Identifiers

108176

Identifier Type: -

Identifier Source: org_study_id