Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography. The CS1 system enables continuous, direct measurement of cardiac wall motion. This is achieved through use of temporary pacemaker wires incorporating a motion detector called an accelerometer. Use of TMEs during and after open-heart surgery is part of the normal clinical routine. Continuous monitoring of cardiac wall motion during and after surgery can quickly highlight the need for medical intervention with cardiac drugs and allow very early detection of potentially serious complications leading to abnormal cardiac wall motion. Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare.
Echocardiography is currently the most important and most widely used tool in cardiology besides electrocardiography (ECG). It is reliable for assessing all stages of cardiovascular disease, and it is commonly used to detect heart (cardiac) wall motion dysfunction during and after open-heart surgery. During open-heart surgery, transesophageal echocardiography (when the echocardiography sensor is introduced into the esophagus) is used to monitor cardiac wall motion at various time points during surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography (when the echocardiography sensor is placed on the chest wall). Use of the CS1 system enables continuous, direct measurements of cardiac wall motion. This is achieved through use of temporary pacemaker wires (also called temporary myocardial electrodes or TMEs) incorporating a motion detector called an accelerometer. Use of TMEs during and after open-heart surgery is part of the normal clinical routine. Continuous monitoring of cardiac wall motion during the surgery and the post-surgical recovery period can, for example, quickly highlight the need for medical intervention with cardiac drugs and allow very early detection of potentially serious complications such as ischemia (heart muscle is not receiving enough oxygen) and myocardial dysfunction (cardiac wall motion appears abnormal). The key feature of the CS1 system is that the cardiac wall motion activity registered by the novel TMEs incorporating the accelerometer are displayed visually on a standard medical monitor and synchronized with the patient's ECG data. These data can easily be viewed by medical staff to check if the patient's condition is satisfactory or whether medical intervention is needed. In the study, the CS1 system will be used in addition to the standard monitoring procedures that include ECG, blood pressures and intermittent echocardiography. Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
38
Placement of CS1, a temporary bipolar myocardial electrode (TME) with an integrated motion sensor (accelerometer), on the left ventricle and externalization of the associated leads through the chest wall during open-heart surgery. CS1 will remain in place for up to 7 days after surgery and closure of the chest wall.
Oslo University Hospital
Oslo, Norway
Change from Baseline Peak Systolic Velocity (PSV) after increasing heart rate by 25 percent
Correlation between relative changes in PSVs measured by CS1 and echocardiography
Time frame: After surgery: before extubation, while patient is in the intensive care unit (ICU)
Change from Baseline PSV after increasing heart rate by 25 percent
Correlation between relative changes in PSVs measured by CS1 and echocardiography
Time frame: After surgery: after extubation and removal of drains, before patient is transferred from ICU to general ward
Adverse Events
Incidence of non-serious and serious adverse events rated for causality
Time frame: Up to 30 days after surgery
Adverse Device Effects
Incidence of non-serious and serious adverse device-related effects
Time frame: Up to removal of device at a maximum of 7 days after surgery
Device Deficiencies
Incidence of device deficiencies
Time frame: Up to removal of device at a maximum of 7 days after surgery
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