To simplify and facilitate beating heart (i.e., off-pump), minimally invasive coronary artery bypass surgery, a new coronary anastomotic connector, the Trinity Clip, is developed based on the excimer laser-assisted nonocclusive anastomosis technique. The Trinity Clip connector enables simplified, sutureless, and nonocclusive connection of the graft to the coronary artery, and an excimer laser catheter laser-punches the opening of the anastomosis. Consequently, owing to the complete nonocclusive anastomosis construction, coronary conditioning (i.e., occluding or shunting) is not necessary, in contrast to the conventional anastomotic technique, hence simplifying the off-pump bypass procedure. Prior to clinical application in coronary artery bypass grafting, the safety and quality of this novel connector will be evaluated in a long-term experimental porcine off-pump coronary artery bypass (OPCAB) study. In this paper, we describe how to evaluate the coronary anastomosis in the porcine OPCAB model using various techniques to assess its quality. Representative results are summarized and visually demonstrated.
The results of the present study have demonstrated that the Excimer laser-assisted nonocclusive anastomotic connector is safe and reliable and can be efficiently applied in an acute rabbit abdominal aortic bypass model. Provided the limitations can be addressed, this easy-to-use and nonocclusive technique has the potential to facilitate minimally invasive coronary bypass surgery.
The new nonocclusive coronary connector is easy to use, and the long-term results suggest favorable healing and remodeling in the porcine model. After downsizing, this anastomotic device, with its emphasis on zero ischemia and simplified prebounding of vessel walls, has intrinsic potential for minimally invasive off-pump coronary artery bypass surgery.
Objective This pilot study evaluates the anastomotic healing of the Excimer Laser Assisted Nonocclusive Anastomosis coronary connector at 6 months in a porcine off-pump coronary artery bypass (OPCAB) model. Methods Left internal thoracic artery to left anterior descending coronary artery bypass in two animals and left internal thoracic artery to left anterior descending coronary artery and right internal thoracic artery to right coronary artery bypasses in one animal were evaluated intraoperatively and at 6 months. The anastomoses (n = 4) were examined by angiography, intravascular ultrasound, optical coherence tomography, scanning electron microscopy, and histology. Results At follow-up, all anastomoses (n = 4) were fully patent (FitzGibbon grade A). Scanning electron microscopy demonstrated complete endothelial coverage of the anastomotic surface, and histology showed minimal streamlining intimal hyperplasia. The in vivo intravascular ultrasound and optical coherence tomography acquisitions confirmed histologic findings. Optical coherence tomography demonstrated 0.06-mm intimal coverage of the intraluminal part of the connector along the full circumference of the anastomosis. Conclusions In this pilot study, the Excimer Laser Assisted Non-occlusive Anastomosis coronary connector showed an excellent healing response on the long-term in the porcine OPCAB model. Hence, this new concept might be a potential alternative to hand-sutured anastomosis in (minimally invasive) OPCAB surgery.
Objective This preclinical study determines the feasibility and 6-month patency rates of a new distal coronary connector, the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) Heart Bypass. Methods Twenty Dutch Landrace pigs received either a hand-sewn ( n = 8) or an ELANA ( n = 12) left internal thoracic artery to left anterior descending artery anastomosis, using off-pump coronary artery bypass grafting. Six-month patency rates were demonstrated by coronary angiography and histological evaluation. Throughout, procedural details and complication rates were collected. Results The ELANA Heart Bypass demonstrated 0% mortality and complication rates during follow-up. It was demonstrated feasible, with comparable perioperative flow measurements (ELANA vs hand-sewn, median [min to max], 24 [14 to 28] vs 17 [12 to 31] mL/min; P = 0.601) and fast construction times (3 [3 to 7] vs 31 [26 to 37] min; P < 0.001). Yet, an extra hemostatic stitch was needed in 25% of the ELANA versus 12.5% of the hand-sewn anastomoses. The 6-month patency rate of the ELANA Heart Bypass was 83.3% versus 100% in hand-sewn anastomoses. The 2 occluded ELANA-anastomoses were defined model-based errors. Conclusions The ELANA Heart Bypass facilitates a sutureless distal coronary anastomosis. A design change is suggested to improve hemostasis and will be evaluated in future translational studies. This new technique is a potential alternative to hand-sewn anastomoses in (minimally invasive) coronary surgery.
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