Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device

• ClinicalTrials.gov Identifier: NCT02919124
• Recruitment Status: Completed
• First Posted: September 29, 2016
• Last Update Posted: January 3, 2020
• Sponsor: Aalborg University Hospital
• Collaborators: Aalborg University; Medistim ASA
• Information provided by (Responsible Party): Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronary Arteriosclerosis	Device: Echoclip	Not Applicable

Detailed Description:

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:

1. The transducer must be kept in a steady position relative to the anastomosis for 5 to 10 cardiac cycles to minimize frame-rate variability.
2. Ultrasound gel must be kept in contact with the transducer and the region studied.
3. The transducer must not cause any deformation of the vessels.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: During Coronary Artery Bypass Surgery. A Feasibility Study.
• Study Start Date: September 2016
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Echoclip device; Ultrasonography using the echoclip device	Device: Echoclip; 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

Outcome Measures

Primary Outcome Measures :

1. Quality of periferal coronary artery bypass anastomotic structures [ Time Frame: Peroperative ]
   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.

Secondary Outcome Measures :

1. Automatic quality control of periferal coronary artery bypass anastomotic structures [ Time Frame: Peroperative ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Elective on-pump coronary artery bypass surgery
• Surgery planned to be performed by specialist in cardiac surgery.
• Logistic euroSCORE II <6%.
• Must be able to read and understand the Danish
• Written informed acceptance to participate

Exclusion Criteria:

• Planned off-pump surgery.
• Peroperativ conversion to off-pump surgery.
• Logistic EuroSCORE II ≥ 6.
• The patient do not understand written or spoken Danish.
• Surgery within 24 hours after admittance to hospital
• Patients in whom the surgeon wants to end the surgery in a hurry due to e.g. hemodynamic problems or peroperative complications.
• The surgeon is not a specialist in cardiac surgery, e.g. surgeon in training.
• Pregnant or brest feeding patient.
• No written acceptance to participate.

Contacts and Locations

Locations

Denmark

Aalborg University Hospital

Aalborg, Denmark, 9100

Sponsors and Collaborators

Aalborg University Hospital

Aalborg University

Medistim ASA

Investigators

• Principal Investigator: Jan J Andreasen, MD, PhD; Aalborg University Hospital and Aalborg University

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andreasen JJ, Nøhr D, Jørgensen 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.

Andreasen JJ, Nøhr D, Jørgensen 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.

• Responsible Party: Jan Jesper Andreasen, Professor, MD, PhD, Professor, consultant, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT02919124
• Other Study ID Numbers: 0089Y
• First Posted: September 29, 2016
• Last Update Posted: January 3, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data are available for Monitor

Keywords provided by Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital:

Coronary artery bypass grafting; Anastomosis; Ultrasonography

Additional relevant MeSH terms:

Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Heart Diseases