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. 2023 Aug;16(4):916-926.
doi: 10.1007/s12265-023-10367-9. Epub 2023 Mar 21.

Evaluating the Arteriotomy Size of a New Sutureless Coronary Anastomosis Using a Finite Volume Approach

Affiliations

Evaluating the Arteriotomy Size of a New Sutureless Coronary Anastomosis Using a Finite Volume Approach

Hanneke Crielaard et al. J Cardiovasc Transl Res. 2023 Aug.

Abstract

Objectives: The ELANA® Heart Bypass creates a standardized sutureless anastomosis. Hereby, we investigate the influence of arteriotomy and graft size on coronary hemodynamics.

Methods: A computational fluid dynamics (CFD) model was developed. Arteriotomy size (standard 1.43 mm2; varied 0.94 - 3.6 mm2) and graft diameter (standard 2.5 mm; varied 1.5 - 5.0 mm) were independent parameters. Outcome parameters were coronary pressure and flow, and fractional flow reserve (FFR).

Results: The current size ELANA (arteriotomy 1.43 mm2) presented an estimated FFR 0.65 (39 mL/min). Enlarging arteriotomy increased FFR, coronary pressure, and flow. All reached a maximum once the arteriotomy (2.80 mm2) surpassed the coronary cross-sectional area (2.69 mm2, i.e. 1.85 mm diameter), presenting an estimated FFR 0.75 (46 mL/min). Increasing graft diameter was positively related to FFR, coronary pressure, and flow.

Conclusion: The ratio between the required minimal coronary diameter for application and the ELANA arteriotomy size effectuates a pressure drop that could be clinically relevant. Additional research and eventual lengthening of the anastomosis is advised.

Keywords: Computational fluid dynamics; Coronary artery bypass grafting; Fractional flow reserve; Sutureless coronary anastomoses.

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Conflict of interest statement

The PhD-fellowship of Marieke Hoogewerf is partially funded by AMT Medical Research B.V. Bart P. van Putte and Pieter A. Doevendans are consultant with AMT Medical B.V. David Stecher is registered co-inventor of patents regarding the ELANA technique, without financial benefits. All other authors declared no conflict of interest. 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.

Figures

Fig. 1
Fig. 1
The ELANA Heart Bypass technique. The upper fork of the ELANA Heart Clip is inserted into the lumen of the graft (a). The ELANA Heart Laser Catheter is introduced via the distal free end of the graft, into the connector, and is perpendicularly fixated by the ELANA Heart Fixation Device. The arteriotomy is lasered per excimer laser (b). The lower fork is opened and inserted into the lumen of the coronary artery, while the upper fork and ELANA Heart Fixation Device maintain compression on the graft ensuring proper positioning of the graft and ELANA Heart Laser Catheter (c). The ELANA Heart Clip is closed and the arteriotomy in the coronary wall is lasered. The ELANA Heart Fixation Device is removed and the ELANA Heart Laser Catheter is retracted, retracting the lasered piece of coronary artery wall per vacuum (d). A hemoclip is placed at the distal end of the graft. The ELANA Heart Clip serves as an implant (e)
Fig. 2
Fig. 2
ELANA Heart Bypass anastomosis. The titanium ELANA Heart Clip connects graft and coronary artery by the intraluminal positioned pins; 0-degree, side-to-side, in adventitia-adventitia apposition. To indicate part of the geometry sources, we depict three transverse H&E stained sections of the situation directly postoperative in a porcine LIMA-LAD ELANA anastomosis; LIMA is depicted above, LAD below [7]. Middle black squares are the titanium pins of upper and lower forks (yellow in the simulation below), and lateral black rectangles are the ring for lateral compression (grey in the simulation below). The distal end of the graft is occluded by a hemostatic clip and thus forms a functional end-to-side anastomosis. The ELANA anastomosis is oval-shaped. Anastomotic toe/outflow (a), mid-anastomosis (b), anastomotic heel/inflow (c)
Fig. 3
Fig. 3
Schematic overview of the most important features of the numerical model. 3D fluid geometry of the ELANA Heart Bypass anastomosis, including the graft (a). The effect of changing one of the geometry parameters (increase in graft diameter) on the geometry (b). Overview of the various boundary conditions of the model (c)
Fig. 4
Fig. 4
Pressure in graft and coronary artery for the ELANA anastomosis. The two defined pressure drops are depicted. The bottom image presents the enlargement, with a focus on the anastomosis, of the total simulation presented above. Arteriotomy size = 1.43 mm2, graft diameter = 2.5 mm, coronary diameter = 1.85 mm
Fig. 5
Fig. 5
Results of the pressure drop (a), FFR (b), and hyperemic flow (c) for a range of arteriotomy sizes. Graft diameter = 2.5 mm, coronary diameter = 1.85 mm
Fig. 6
Fig. 6
Results of the pressure drop (a), FFR (b), and hyperemic flow (c) for a range of graft diameters. Arteriotomy = 1.43 mm2, coronary diameter = 1.85 mm

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