TY - JOUR
T1 - Preclinical Comparison of Distal Off-Pump Anastomotic Remodeling
T2 - Hand-Sewn Versus ELANA Heart Bypass
AU - Stecher, David
AU - Hoogewerf, Marieke
AU - van Putte, Bart P.
AU - Osman, Shadan
AU - Doevendans, Pieter A.
AU - Tulleken, Cornelis
AU - van Herwerden, Lex
AU - Pasterkamp, Gerard
AU - Buijsrogge, Marc P.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the EuroTransBio grant (ETB110014).
Funding Information:
We acknowledge the constructive contributions of Martijn van Nieuwburg, Evelyn Velema, Grace Croft, Joyce Visser, Marlijn Jansen, Cees Verlaan, and colleagues from the Utrecht University Central Animal Facilities for their support and care for the animals and experiments; Noortje van den Dungen, Arjen Schoneveld, and Petra van der Kraak for their support for processing the samples for histology; and Glenn Bronkers, Niklank Noest, Rik Mansvelt Beck, Sander van Thoor, and other colleagues of Corvasco Medical and ELANA B.V., and the Brain Technology Institute, for their technical support. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the EuroTransBio grant (ETB110014).
Publisher Copyright:
© The Author(s) 2022.
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - OPCAB
KW - coronary artery bypass grafting
KW - coronary connector
KW - coronary revascularization
KW - sutureless anastomosis
UR - https://www.scopus.com/pages/publications/85126631989
U2 - 10.1177/15569845221079606
DO - 10.1177/15569845221079606
M3 - Article
C2 - 35297703
SN - 1556-9845
VL - 17
SP - 111
EP - 118
JO - INNOVATIONS: TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY
JF - INNOVATIONS: TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY
IS - 2
ER -