Preclinical Feasibility and Patency Analyses of a New Distal Coronary Connector: The ELANA Heart Bypass

Abstract

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.

Preclinical Comparison of Distal Off-Pump Anastomotic Remodeling: Hand-Sewn Versus ELANA Heart Bypass

“…Our recent study demonstrated preclinical feasibility of the ELANA Heart Bypass technique (V2 prototype) up to 6 months of follow-up; however, the anastomotic leakage rate after construction was unacceptable. 6 The current study supports technical perioperative feasibility of the new V3 prototype and a reduced rate of anastomotic leakage. More important, the anastomotic remodeling was evaluated with regard to the conventional hand-sewn anastomosis.…”

“…Surgery, anastomotic construction, transit time flow measurements, and coronary angiography were performed according to our previously published protocol and article. 5 , 6 The ELANA Heart Bypass was constructed in compliance with its instructions for use, creating a 0-degree side-to-side anastomosis (i.e., functional end-to-side). The hand-sewn anastomoses were constructed 0-degree end-to-side.…”

“…From these perspectives, the ELANA Heart Bypass technique has been developed. 5 , 6 This technique enables a sutureless distal anastomosis in off-pump CABG by connecting donor graft and coronary artery per implant clip and performing arteriotomy thereafter per excimer (contact) laser. Whereas the technique was originally described for neurosurgical approaches, the first cardiovascular prototypes suited large caliber coronary arteries (3.0 mm).…”

“… 5 We previously confirmed the feasibility and patency of the ELANA Heart Bypass in 6-month follow-up in a porcine model. 6 …”

“…5 We previously confirmed the feasibility and patency of the ELANA Heart Bypass in 6-month follow-up in a porcine model. 6 Notwithstanding the foreseen assets from standardization and simplification, the ELANA anastomotic construction completely differs from the conventional hand-sewn technique. The ELANA anastomosis configures a side-to-side adventitia-adventitia apposition and introduces foreign material in the form of intraluminal titanium pins.…”