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| Name | Class |
|---|---|
| Aalborg University | OTHER |
| Medistim ASA | INDUSTRY |
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The aim of this study is to evaluate whether use of the echoclip device (an ultrasound transducer positioning device which can stabilize the involved part of the myocardium on the beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass surgery will be included in the study in order to evaluate if the surgeons can visualize the coronary anastomoses before closure of the sternum. Ultrasonograpic pictures will be analyzed directly peroperatively and electronically post-operatively in order to evaluate if selected areas of the anastomoses can be visualized. Use of the echoclip devise will be considered a success if at least 80% of the anastomoses can be visualized.
The technical quality of coronary artery bypass anastomoses during coronary artery bypass grafting is often evaluated by measuring flow rate in grafts using transit time flowmetry. Unfortunately, flow rate and flow waveform are poor indicators of the anatomy of anastomoses. A better way to evaluate the anatomy of an anastomosis is 3-dimensional imaging. Three problems must be overcome in performing epicardial echocardiography on the beating heart:
The investigators designed an ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg, Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging. The present study is a feasibility study with the aim to evaluate if the echoclip device facilitates imaging of coronary bypass anastomoses during coronary artery bypass surgery in humans to the same degree as was shown in animal studies. Ultrasonography will be used for visualizing all coronary anastomoses during 100 elective low-risk (logistic II EuroSCORE <6) on-pump coronary artery bypass procedures. It will be registered if the heel, the central portion and the toe of the anastomosis can be visualized in end-to-side and side-to-side anastomoses.Use of the echoclip devise will be considered a success if at least 80% of all parts of the anastomoses can be visualized either directly or by electronic reading using a special developed algorithm that may identify the inner border of the anastomoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echoclip device | Experimental | Ultrasonography using the echoclip device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echoclip | Device | An ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg,Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging will be used for visualising the coronary bypass anastomoses during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of periferal coronary artery bypass anastomotic structures | Ultrasonographic images of periferal coronary artery bypass anastomoses will be studied in order to evaluate if the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) can be visualized directly on the screen using the echoclip device. | Peroperative |
| Measure | Description | Time Frame |
|---|---|---|
| Automatic quality control of periferal coronary artery bypass anastomotic structures | To quantify the anastomotic quality from epicardial utrasound images obtained peroperative, the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) will be meassured using an automatic anastomosis segmentation algorithm to extract the area of the anastomotic structures. The ultrasound images obtained peroperative will be analyzed in the Laboratory when 50 patients and 100 patients have been included in the study, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan J Andreasen, MD, PhD | Aalborg University Hospital and Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21168035 | Result | Staalsen NH, Kjaergaard B, Andreasen JJ. A new technique facilitating intraoperative, high-frequency echocardiography of coronary bypass graft anastomoses. J Thorac Cardiovasc Surg. 2011 Jan;141(1):295-6. doi: 10.1016/j.jtcvs.2009.11.074. No abstract available. | |
| 39762954 | Derived | Jorgensen AS, Andersen MS, Ostergaard LR, Schmidt SE, Nohr D, Andreasen JJ. A laboratory feasibility study using a computer algorithm for anastomosis segmentation of epicardial ultrasonography images from distal coronary artery bypass anastomoses. J Cardiothorac Surg. 2025 Jan 6;20(1):34. doi: 10.1186/s13019-024-03187-8. |
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Individual participant data are available for Monitor
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Peroperative |
| 31915030 | Derived | Andreasen JJ, Nohr D, Jorgensen AS, Haahr PE. Peroperative epicardial ultrasonography of distal coronary artery bypass graft anastomoses using a stabilizing device. A feasibility study. J Cardiothorac Surg. 2020 Jan 8;15(1):3. doi: 10.1186/s13019-020-1057-x. |
| 30866994 | Derived | Andreasen JJ, Nohr D, Jorgensen AS. A case report on epicardial ultrasonography of coronary anastomoses using a stabilizing device without the use of ultrasound gel. J Cardiothorac Surg. 2019 Mar 13;14(1):59. doi: 10.1186/s13019-019-0882-2. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |