Six-Month Healing of the Nonocclusive Coronary Anastomotic Connector in an Off-Pump Porcine Bypass Model

Stecher, David; Agostoni, Pierfrancesco; Pasterkamp, Gérard; Hoefer, Imo E.; Herwerden, Lex A. van; Buijsrogge, Marc P.

doi:10.1097/imi.0000000000000055

Cited by 7 publications

(9 citation statements)

References 12 publications

(7 reference statements)

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“…Following successful testing on large caliber arteries (3.0 mm outer diameter [OD]), this new downsized connector enables a standardized distal anastomosis (1.6 to 1.9 mm OD) for off-pump CABG (OPCAB). 6 - 8 Our previous studies demonstrated the feasibility of the ELANA Heart Bypass in OPCAB and minimally invasive direct CABG models. 9 , 10 However, follow-up data comparing the ELANA Heart Bypass to the hand-sewn, have not been provided yet.…”

Section: Introductionmentioning

confidence: 99%

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

Stecher

Hoogewerf

Bronkers³

et al. 2021

Innovations�(Phila)

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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.

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Section: Introductionmentioning

confidence: 99%

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

Stecher

Hoogewerf

Bronkers³

et al. 2021

Innovations�(Phila)

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“…C = connector; RITA = right internal thoracic artery; RCA = right coronary artery. (B) A detailed SEM image at the level of the fork of the connector demonstrating complete coverage with endothelium (2,080X magnification), at 6-month followup 6,7 .…”

Section: Representative Resultsmentioning

confidence: 99%

“…. (A) An OCT image at 6-month follow-up, transverse section, mid-anastomosis 7 . Note: the OCT wire is visible in the lumen.…”

Section: Representative Resultsmentioning

confidence: 99%

“…In addition, the antiplatelet regimen is in anticipation of the blood-exposed nonintimal surface of the anastomosis (BENIS). In our previous study, we showed that the anastomotic nonintimal surface of a predecessor coronary connector completely endothelialized after 10 days 6,7 . The role for antiplatelet therapy in clinics, using this connector, should be based on the rate of endothelialization.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, in a porcine open sternotomy OPCAB model, proper healing with minimal intimal hyperplasia was found at the long-term 6,7 . dissection of the coronary artery, in such a way a hemoclip can completely ligate the coronary artery.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of a Novel Laser-assisted Coronary Anastomotic Connector - the Trinity Clip - in a Porcine Off-pump Bypass Model

Stecher¹,

Bronkers²,

Noest³

et al. 2014

JoVE

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To simplify and facilitate beating heart (i.e., off-pump), minimally invasive coronary artery bypass surgery, a new coronary anastomotic connector, the Trinity Clip, is developed based on the excimer laser-assisted nonocclusive anastomosis technique. The Trinity Clip connector enables simplified, sutureless, and nonocclusive connection of the graft to the coronary artery, and an excimer laser catheter laser-punches the opening of the anastomosis. Consequently, owing to the complete nonocclusive anastomosis construction, coronary conditioning (i.e., occluding or shunting) is not necessary, in contrast to the conventional anastomotic technique, hence simplifying the off-pump bypass procedure. Prior to clinical application in coronary artery bypass grafting, the safety and quality of this novel connector will be evaluated in a long-term experimental porcine off-pump coronary artery bypass (OPCAB) study. In this paper, we describe how to evaluate the coronary anastomosis in the porcine OPCAB model using various techniques to assess its quality. Representative results are summarized and visually demonstrated.

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The Sutureless Excimer Laser Anastomosis Clip Pilot Study: a feasibility and safety study

Zwan

Gortzak²,

Boer³

et al. 2022

Acta Neurochir

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Background The excimer laser-assisted non-occlusive anastomosis (ELANA) bypass technique may have the advantage of its non-occlusive design in the treatment of last-resort cases where endovascular treatment or direct clipping is considered to be unsafe. However, the technique remains technically challenging. Therefore, a sutureless ELANA Clip device (SEcl) was developed to simplify the technique avoiding tedious anastomosis stitching in depth. The present study investigates the clinical feasibility and safety of the SEcl technique. Methods Three patients with complex and large aneurysms in the anterior circulation were selected after multidisciplinary consensus that the aneurysms were too complex for endovascular or direct clipping treatment options. Bypass surgery was considered as a last-resort treatment option, and after preoperative evaluation and informed consent, SEcl bypass surgery was performed. Applicability, technical aspects and patient outcomes are assessed. Results All aneurysms were excluded from the circulation. The creation of the intracranial anastomosis was easier and faster. No device-related serious adverse events were encountered, and all outcomes were favorable (one patient stable Modified Rankin Scale, two patients improved). Conclusion The SEcl anastomosis technique is feasible and, considering the severity of the disease, relatively safe. It can be considered a treatment option in very difficult-to treat last-resort aneurysm cases. From this study, further developments in minimizing clip size and application in cardiac surgery are initiated.

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Six-Month Healing of the Nonocclusive Coronary Anastomotic Connector in an Off-Pump Porcine Bypass Model

Cited by 7 publications

References 12 publications

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

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

Evaluation of a Novel Laser-assisted Coronary Anastomotic Connector - the Trinity Clip - in a Porcine Off-pump Bypass Model

The Sutureless Excimer Laser Anastomosis Clip Pilot Study: a feasibility and safety study

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