The Hemodynamic Effect of Transient Epicardial Right Ventricular Pacing After Cardiopulmonary Bypass, Assessed by Real-time Three-dimensional Echocardiography.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Left ventricular systolic dyssynchrony index (SDI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Non-paced
- cardiac surgery
- 3D TEE measurements of systolic dyssynchrony
- right ventricular epicardial pacemaker lead (off)
干预措施: cardiac surgery (Procedure)
Non-paced
- cardiac surgery
- 3D TEE measurements of systolic dyssynchrony
- right ventricular epicardial pacemaker lead (off)
干预措施: 3D TEE (Device)
Non-paced
- cardiac surgery
- 3D TEE measurements of systolic dyssynchrony
- right ventricular epicardial pacemaker lead (off)
干预措施: Pacemaker lead (Device)
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)
干预措施: Right ventricular epicardial pacing (Device)
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)
干预措施: cardiac surgery (Procedure)
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)
干预措施: 3D TEE (Device)
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)
干预措施: Pacemaker lead (Device)
结局指标
主要结局
Left ventricular systolic dyssynchrony index (SDI)
时间窗: Intraoperative, end of cardiac surgery (duration 10 minutes)
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).
次要结局
- Ventricular volumes and ejection fraction(Intraoperative, end of cardiac surgery (duration 10 minutes))
- LVOT blood flow(Intraoperative, end of cardiac surgery (duration 10 minutes))
- Presence and severity of mitral regurgitation(Intraoperative, end of cardiac surgery (duration 10 minutes))
研究者
Suzanne Flier, MD
Assistant Professor
Lawson Health Research Institute