Key result
ELANA bypass yields less intima hyperplasia but inferior patency versus hand-sewn anastomoses in a porcine model.
Why the study?
Because the sutureless ELANA Heart Bypass System construction differs from standard hand-sewn anastomosis, this study evaluated the process of anastomotic healing and remodeling.
Does the ELANA Heart Bypass System improve anastomotic remodeling and patency compared to hand-sewn anastomosis in a pig model of coronary bypass?
Does the ELANA Heart Bypass System improve anastomotic remodeling and patency compared to hand-sewn anastomosis in a pig model of coronary bypass?
Although the ELANA Heart Bypass System demonstrated reduced intima hyperplasia, its inferior patency compared to hand-sewn anastomosis in a pig model indicates that further prototype refinement is needed before clinical use.
Reduced hyperplasia with ELANA is encouraging; inferior patency in this animal study leaves open further prototype refinement before clinical testing.
Objective: The ELANA Heart Bypass System is a new sutureless technique for coronary anastomoses. A titanium clip connects the graft with the coronary artery, whereafter the arteriotomy is performed by excimer laser. Since this anastomotic construction evidently differs from the standard hand-sewn anastomosis, we aim to evaluate the process of anastomotic healing and remodeling. Methods: Preclinical evaluation of anastomotic remodeling in 42 pigs who underwent off-pump left internal mammary artery to left anterior descending artery anastomosis by either the ELANA Heart Bypass ( n = 24) or the hand-sewn ( n = 18) technique. Anastomotic remodeling was evaluated by scanning electron microscopy and histology in short-term follow-up intervals up to 3 months. Anastomotic patency is determined by coronary angiography at latest follow-up before termination. Results: The nonendothelial surface of both the ELANA and the hand-sewn anastomoses were covered with neointima from 14 days onwards. Only half the amount of intima hyperplasia was present in the anastomotic surface of the patent ELANA anastomosis, compared with the hand-sewn anastomosis (98 [48–1358] vs 218 [108–296] µm, P = 0.001). Yet patency of the ELANA was inferior to the hand-sewn anastomoses (79% vs 100%, P = 0.06). Conclusions: This study shows the technical perioperative feasibility of the ELANA Heart Bypass System. Although limited intima hyperplasia was observed, hand-sewn anastomoses had superior patency during follow-up. The results of this trial suggest that an additional study with a new prototype is required before clinical implementation.
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Stecher et al. (2022) studied Coronary anastomosis (n=42). ELANA Heart Bypass System vs. Hand-sewn anastomosis was evaluated on Anastomotic patency (p=0.06). The ELANA Heart Bypass System demonstrated less intima hyperplasia but inferior patency compared to hand-sewn anastomoses (79% vs 100%, P=0.06) in a preclinical porcine model.
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