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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-paced | Sham Comparator |
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| Paced | Experimental | The patient is randomized to the order of measurements taken, and serves as his own control.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right ventricular epicardial pacing | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular systolic dyssynchrony index (SDI) | For each segment of 16 segments excluding the apical cap in a standard 17-segment model, the time to reach regional minimal volume is calculated as a fraction of the total cardiac cycle (RR interval) and expressed as a percentage.10 The standard deviation of these measurements is defined as the SDI. Three-dimensional SDI is therefore the dispersion time to reach the minimum systolic volume (as recommended). | Intraoperative, end of cardiac surgery (duration 10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular volumes and ejection fraction | We will obtain a full volume 3D dataset and obtain end diastolic (EDV) and end systolic volume (ESV). By subtracting ESV from EDV we will obtain the ejection fraction (EF). | Intraoperative, end of cardiac surgery (duration 10 minutes) |
| LVOT blood flow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Flier, MD MSc | London Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital - London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20946287 | Background | 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. | |
| 16087800 |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| D000098523 | Device Lead Extraction |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
| D020878 | Device Removal |
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Sequence of measurements, during sinus rhythm and during pacing is randomized.
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| cardiac surgery | Procedure | Elective cardiac surgery, with use of cardiopulmonary bypass. |
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| 3D TEE | Device | Intraoperatively, all patients will be monitored by means of TEE |
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| Pacemaker lead | Device | All patients will have a epicardial pacemaker lead in situ. |
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As a surrogate for cardiac output we will obtain the velocity time integral (VTI) across the left ventricular outflow tract (LVOT) |
| Intraoperative, end of cardiac surgery (duration 10 minutes) |
| Presence and severity of mitral regurgitation | From midesophageal position we will perform a transesophageal echocardiography (TEE) study to interrogate the mitral valve for the presence and severity of mitral regurgitation. | Intraoperative, end of cardiac surgery (duration 10 minutes) |
| 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. |
| 24521215 | Background | 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. |
| 15620924 | Background | 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. |