Novel Anastomotic Device for Distal Coronary Anastomosis: Preclinical Results From Swine Off-Pump Coronary Artery Bypass Model Yoshifumi Itoda, MD, PhD,

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Novel Anastomotic Device for Distal Coronary Anastomosis: Preclinical Results From Swine Off-Pump Coronary Artery Bypass Model Yoshifumi Itoda, MD, PhD, Nirmal Panthee, MD, PhD, Tsuruhito Tanaka, MD, Takehiro Ando, PhD, Ichiro Sakuma, PhD, Minoru Ono, MD, PhD The Annals of Thoracic Surgery Volume 101, Issue 2, Pages 736-741 (February 2016) DOI: 10.1016/j.athoracsur.2015.09.082 Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 1 A magnified image of the stainless steel mechanism shows the smooth surface of the mechanism. The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 2 Device design. (A) The anastomotic device is composed of a polypropylene suture and a stainless steel mechanism connected to a free end of suture. This mechanism can also prevent the suture from being pulled out at the start part of the anastomosis. (B) After conventional running suture, the surgeon passes the suture through either slot of the mechanism and pulls the suture. (C) Finally, the surgeon pinches the slots of the mechanism with a needle holder to fix the suture. (D) Completion of the anastomosis. The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 3 Both (A) left internal thoracic artery to left anterior descending artery and (B) right internal thoracic artery to right coronary artery anastomoses were demonstrated by angiography. These anastomoses show Fitzgibbon A grade (stenosis less than 50%). The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 4 Intimal hyperplasia was indicated as the ratio to the intimal elastic layer. Number of anastomoses is indicated at the bottom of the bar. In the device group (blue bars), attenuation of intimal hyperplasia was not obvious (p = 0.08), but a decreasing trend was observed at 6 months after operation. (Orange bars = control group.) The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 5 Histopathology. (A) Anastomotic site of the control group 1 month after surgery (Elastica-van Gieson stain; original magnification ×4). The left internal thoracic artery (LITA) to left anterior descending artery (LAD) anastomosis by conventional suture was sliced along the long axis. Proximal native left anterior descending artery was ligated. Sutures are observed at the toe and heel of the anastomosis (arrows). Around the suture, fibrosis is stained. Intimal hyperplasia is observed inside the intimal elastic layer (bidirectional arrow). (B) Anastomotic site of the device group 1 month after surgery (hematoxylin-eosin stain; original magnification ×20). A field around the stainless mechanism was magnified. The mechanism is indicated with an arrow. Around the mechanism, inflammatory cell infiltration is observed. The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 6 Inflammatory cell infiltration. (A) The number of lymphocytes achieved a peak at 1 month after surgery in both groups. An attenuation trend was observed in the device group (blue bars) in 6 months (p = 0.25). (Number of anastomoses is same as in Fig 4.) (B) The number of granulocytes increased 1 month after the surgery in the device group compared with the control group (orange bars), without statistical significance. Significant attenuation was observed 6 months after surgery in the device group (p < 0.05). (C) The number of macrophages also increased 1 month after the surgery in both groups and attenuated at 6 months in the device group (p < 0.05). The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions

Fig 7 Fibrosis. Less thickness of fibrosis was observed in the device group (blue bars) at 1 month after the surgery compared with the control group (orange bars), without statistical difference. Attenuation of fibrosis was not observed in the device group 1, 3, and 6 months after surgery. The Annals of Thoracic Surgery 2016 101, 736-741DOI: (10.1016/j.athoracsur.2015.09.082) Copyright © 2016 The Society of Thoracic Surgeons Terms and Conditions