The Nonocclusive Laser Assisted Anastomotic Connector: A Pilot Study in a Small Caliber Porcine Off-Pump Coronary Artery Bypass Model
David Stecher, Gerard Pasterkamp, Lex A. van Herwerden, Marc P. Buijsrogge.
University Medical Centre Utrecht, Utrecht, Netherlands.
OBJECTIVE: In this pilot study, the initial feasibility, patency, and anastomotic healing of the novel oval-shaped small caliber Trinity Clip, based on the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) technique, were assessed in the acute and mid-term follow-up in a small caliber porcine OPCAB model.
METHODS: The implantable connector is suitable for coronaries with a minimal diameter of 1.2 mm. Nonocclusively, the graft is connected to the coronary, and a laser opens the anastomosis. In the porcine model (n=5 pigs), LITA-to-LAD bypasses were evaluated by flow measurements intraoperatively (n=5) and at 5 hours (n=3), and by angiography and histology at 5 weeks (n=2) follow-up.
RESULTS: The Trinity Clip enabled fast (mean 3.2 ± 0.4 minutes) anastomotic construction without proximal snaring of the coronary, and in all anastomoses complete hemostasis was demonstrated. All anastomoses were fully patent with a FitzGibbon grade A at 5 weeks follow-up. The mean peak hyperemic flow response (peak flow [following 30 second-graft occlusion] divided by the baseline flow [23 ± 10 mL/min]) was 5.4 ± 0.9. At 5-weeks follow-up, streamlining neointima coverage of the connector was observed along the full circumference of the anastomosis.
CONCLUSIONS: The Trinity Clip is easy-to-use and feasible on clinically relevant small caliber coronary arteries in the porcine off-pump bypass model. Hence, this facilitated nonocclusive coronary anastomosis technique has potential for minimally invasive coronary bypass surgery. The safety and quality on the long-term will be assessed in a preclinical study prior to clinical testing.
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