The Laser-Assisted Coronary Anastomotic Connector - The Trinity Clip - in a Preclinical Safety Study
David Stecher1, Glenn Bronkers2, Cornelis A.F. Tulleken1, Imo E. Hoefer1, Lex A. van Herwerden1, Gerard Pasterkamp1, Marc P. Buijsrogge1.
1University Medical Center Utrecht, Utrecht, Netherlands, 2Corvasco Medical b.v., Utrecht, Netherlands.
OBJECTIVE: A facilitated construction of a coronary anastomosis is key toward expansion of less invasive bypass surgery. This preclinical safety study evaluated a laser-assisted, nonocclusive connector - the Trinity Clip - on small caliber coronary arteries in a porcine off-pump bypass model.
METHODS: In 58 pigs, 33 left internal thoracic to left anterior descending coronary (1.6-1.9 mm outer diameter) artery anastomoses were facilitated by the connector, and 25 were hand-sutured. To assess anastomotic healing and patency, the anastomoses were evaluated at the short- (intraoperative and 4, 10, 14, 35 days) and long-term (90 and 180 days) follow-up, and were examined by flow measurements, angiography, histology, and scanning electron microscopy.
RESULTS: A faster construction time was found (P<0.01) and hemostasis tended to be better (94% versus 80%, respectively; P=0.11) in the connector compared to the hand-sutured group. Long-term follow-up showed 100% (14/14) patency in the hand-sutured compared to 82% (18/22) in the connector group (P=0.12; long-term patency was 92% [12/13] before a connector design change halfway the study). The patent facilitated-anastomoses showed less intimal hyperplasia formation compared to the hand-sutured (0.08 ± 0.06 versus 0.26 ± 0.07 mm, respectively; P<0.01).
CONCLUSIONS: This study demonstrated the feasibility of the connector to facilitate off-pump CABG on small caliber arteries. Patency rates were inferior, however, were related to a design change halfway the study. Provided the technical limitations can be addressed, the presented concept of nonocclusive simplified anastomosis construction could fill the missing link toward expansion of minimally invasive CABG.
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