TY - JOUR
T1 - Preclinical Feasibility and Patency Analyses of a New Distal Coronary Connector: The ELANA Heart Bypass
AU - Stecher, David
AU - Hoogewerf, Marieke
AU - Bronkers, Glenn
AU - van Putte, Bart P.
AU - Doevendans, Pieter A.
AU - Tulleken, Cornelis A. F.
AU - van Herwerden, Lex
AU - Pasterkamp, Gerard
AU - Buijsrogge, Marc P.
N1 - Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This research was financially supported by the University Medical Center Utrecht and Corvasco Medical B.V. (the former company developing the ELANA Heart Bypass). David Stecher, Glenn Bronkers, and Cornelis A.F. Tulleken are registered as co-inventors of patents regarding the ELANA technique, without financial benefits. Cornelis A.F. Tulleken is founder of the ELANA technique. Marieke Hoogewerf and Glenn Bronkers are currently employed by AMT Medical Research B.V. All authors declare no competing financial interests and have nothing to disclose with regard to commercial support. The authors have performed a free and independent evaluation of this new technology and had full control of the design of the study, methods used, outcome parameters, analysis of data, and production of the written report.
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 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).
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).
Publisher Copyright:
© The Author(s) 2021.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3
Y1 - 2021/3
N2 - Objective: This preclinical study determines the feasibility and 6-month patency rates of a new distal coronary connector, the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) Heart Bypass. Methods: Twenty Dutch Landrace pigs received either a hand-sewn (n = 8) or an ELANA (n = 12) left internal thoracic artery to left anterior descending artery anastomosis, using off-pump coronary artery bypass grafting. Six-month patency rates were demonstrated by coronary angiography and histological evaluation. Throughout, procedural details and complication rates were collected. Results: The ELANA Heart Bypass demonstrated 0% mortality and complication rates during follow-up. It was demonstrated feasible, with comparable perioperative flow measurements (ELANA vs hand-sewn, median [min to max], 24 [14 to 28] vs 17 [12 to 31] mL/min; P = 0.601) and fast construction times (3 [3 to 7] vs 31 [26 to 37] min; P < 0.001). Yet, an extra hemostatic stitch was needed in 25% of the ELANA versus 12.5% of the hand-sewn anastomoses. The 6-month patency rate of the ELANA Heart Bypass was 83.3% versus 100% in hand-sewn anastomoses. The 2 occluded ELANA-anastomoses were defined model-based errors. Conclusions: The ELANA Heart Bypass facilitates a sutureless distal coronary anastomosis. A design change is suggested to improve hemostasis and will be evaluated in future translational studies. This new technique is a potential alternative to hand-sewn anastomoses in (minimally invasive) coronary surgery.
AB - Objective: This preclinical study determines the feasibility and 6-month patency rates of a new distal coronary connector, the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) Heart Bypass. Methods: Twenty Dutch Landrace pigs received either a hand-sewn (n = 8) or an ELANA (n = 12) left internal thoracic artery to left anterior descending artery anastomosis, using off-pump coronary artery bypass grafting. Six-month patency rates were demonstrated by coronary angiography and histological evaluation. Throughout, procedural details and complication rates were collected. Results: The ELANA Heart Bypass demonstrated 0% mortality and complication rates during follow-up. It was demonstrated feasible, with comparable perioperative flow measurements (ELANA vs hand-sewn, median [min to max], 24 [14 to 28] vs 17 [12 to 31] mL/min; P = 0.601) and fast construction times (3 [3 to 7] vs 31 [26 to 37] min; P < 0.001). Yet, an extra hemostatic stitch was needed in 25% of the ELANA versus 12.5% of the hand-sewn anastomoses. The 6-month patency rate of the ELANA Heart Bypass was 83.3% versus 100% in hand-sewn anastomoses. The 2 occluded ELANA-anastomoses were defined model-based errors. Conclusions: The ELANA Heart Bypass facilitates a sutureless distal coronary anastomosis. A design change is suggested to improve hemostasis and will be evaluated in future translational studies. This new technique is a potential alternative to hand-sewn anastomoses in (minimally invasive) coronary surgery.
KW - OPCAB
KW - coronary artery bypass grafting
KW - coronary connector
KW - coronary revascularization
KW - sutureless anastomosis
UR - https://www.scopus.com/pages/publications/85102181073
U2 - 10.1177/1556984521991519
DO - 10.1177/1556984521991519
M3 - Article
C2 - 33682510
SN - 1556-9845
VL - 16
SP - 163
EP - 168
JO - INNOVATIONS: TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY
JF - INNOVATIONS: TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY
IS - 2
ER -