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Updated: May 23, 2026
Evaluation of a Novel Laser-assisted Coronary Anastomotic Connector - the Trinity Clip - in a Porcine Off-pump Bypass Model
Published on: November 24, 2014
Early patency evaluation of new distal anastomotic device in internal mammary artery grafts using computed tomography
Husam H Balkhy1, L Samuel Wann, Susan Arnsdorf
1From the Department of Cardiac Surgery, Wisconsin Heart Hospital, Milwaukee, WI USA.
Insights
Automated surgical stapling devices offer a safe and effective alternative for creating coronary artery bypass grafts. These devices demonstrate excellent short-to-midterm graft patency, potentially improving future sternal-sparing cardiac surgeries.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Imaging Technology
Background:
- Traditional coronary artery bypass grafting (CABG) relies on manual suturing techniques.
- Automated anastomotic devices, such as C-Port xA and Flex A, offer reproducible and compliant connections.
- Multidetector computed tomography (CT) is a validated method for assessing coronary artery bypass graft patency.
Purpose of the Study:
- To evaluate the safety and efficacy of automated anastomotic devices for internal mammary artery (IMA) to coronary artery connections.
- To assess the short-term and mid-term patency rates of grafts created with these devices.
- To explore the role of multidetector CT in evaluating these grafts.
Main Methods:
- A study included the first 24 patients undergoing IMA anastomosis with automated devices (C-Port xA or Flex A).
- Twenty-five IMA grafts were created during off-pump CABG via sternotomy.
- Graft patency was assessed using 64-slice multidetector CT at 30 days (10 grafts) and 90 days (15 grafts).
Main Results:
- No device failures occurred during the procedures.
- There were no perioperative strokes, myocardial infarctions, or deaths.
- All 10 grafts examined at 30 days were patent; one of 15 grafts examined at 90 days was occluded.
Conclusions:
- The C-Port xA and Flex A devices are safe and effective for creating IMA-to-coronary artery anastomoses in CABG.
- These automated devices achieve excellent short-to-midterm graft patency.
- Further long-term studies are warranted, with implications for sternal-sparing CABG approaches.
Introduction:
: Traditional coronary artery bypass grafting is performed using a hand sewn technique. The C-Port xA and Flex A anastomotic stapling devices (Cardica Inc., Redwood City, CA) were cleared by the Food and Drug Administration for use in distal coronary anastomoses in November 2006 and April 2007, respectively. They provide the ability to create a compliant, consistently reproducible, and automated anastomosis. Multidetector computed tomography (CT) has been shown to be effective in evaluating coronary artery bypass graft patency.
Methods:
: The first 24 patients to undergo internal mammary artery (IMA) anastomosis using the automated device in our practice were included in the study. Twenty-five IMA grafts (24 left IMA and 1 right IMA) were created using the C-Port xA or Flex A anastomotic device as part of multivessel off-pump coronary revascularization by sternotomy. Graft patency was evaluated at 30 days in the first 10 grafts and at 90 days in the next 15 grafts using multidetector (64 slice) CT.
Results:
: There were no device failures. There were no perioperative strokes, myocardial infarctions, or deaths. All 10 IMA grafts evaluated at 30 days were patent using multidetector CT. One of the 15 IMA grafts studied at 90 days was occluded using multidetector computed tomography.
Conclusions:
: The C-Port xA and Flex A distal anastomotic devices provided a safe and effective means to create a left IMA-left anterior descending artery anastomoses in coronary bypass surgery with excellent short to midterm patency in this early experience. Long-term follow-up is warranted. These findings will have important implications for future sternal sparing coronary bypass surgery.
