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Evaluation of a Novel Laser-assisted Coronary Anastomotic Connector - the Trinity Clip - in a Porcine Off-pump Bypass Model
Published on: November 24, 2014
The Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) Anastomotic System surgical technique to construct
Sophie Beukers1, Stephan Jacobs2, Bart van Putte1,3
1Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
Insights
The Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) system offers a novel, sutureless approach for coronary artery bypass grafting (CABG). This case study demonstrates its feasibility for creating distal anastomoses on a beating heart, improving surgical outcomes.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Minimally Invasive Procedures
Background:
- Coronary artery disease (CAD) is a major global health concern.
- Coronary artery bypass grafting (CABG) is standard for complex multivessel disease.
- Minimally invasive CABG is limited by technical challenges in distal anastomosis.
Purpose of the Study:
- To evaluate the safety and effectiveness of the Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) system.
- To describe the use of the ELANA system for left internal thoracic artery (LITA) to left anterior descending (LAD) coronary artery anastomosis.
- To assess the feasibility of sutureless, non-occlusive coronary anastomosis on a beating heart.
Main Methods:
- A prospective study (SAFE-CAB trial) was conducted.
- The ELANA system was used for a LITA-to-LAD anastomosis in a patient with two-vessel CAD.
- The six-step ELANA technique was performed on the beating heart in a pump-assisted setting via median sternotomy.
Main Results:
- The ELANA-assisted anastomosis was completed in 20 minutes.
- Transit-time flow measurements indicated satisfactory graft function.
- Six-month follow-up angiography confirmed a patent and well-functioning anastomosis.
Conclusions:
- The ELANA system facilitates sutureless, non-occlusive coronary anastomosis.
- This technology shows feasibility for improving minimally invasive CABG.
- Further trials and device refinement are needed to determine broader clinical applicability.
Abstract:
Coronary artery disease remains a leading cause of morbidity and mortality worldwide. Although coronary artery bypass grafting (CABG) via median sternotomy is the standard treatment for complex multivessel disease, wider adoption of minimally invasive approaches has been limited by the technical difficulty of constructing distal coronary anastomoses on the beating heart. The Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) Anastomotic System is a novel sutureless connector designed to enable reproducible distal anastomoses without interruption of native coronary blood flow. As part of the SAFE-CAB trial, a prospective study evaluating the safety and effectiveness of the ELANA system, we describe the construction of a left internal thoracic artery (LITA) to left anterior descending coronary artery (LAD) anastomosis using this technology. The procedure was performed via median sternotomy in a 63-year-old male with stable angina and two-vessel coronary artery disease. The six-step ELANA technique was executed on the beating heart in a pump-assisted setting. The ELANA-assisted LITA-LAD anastomosis was completed in 20 min, contributing to a total operative time of 185 min. Transit-time flow measurements demonstrated satisfactory graft function, and postoperative recovery was uneventful. Six-month follow-up coronary angiography showed a patent and well-functioning anastomosis, as independently confirmed by cardiology and core laboratory assessment. This case illustrates the feasibility of sutureless, non-occlusive coronary anastomosis using the ELANA system. Ongoing trials and continued device refinement will determine its broader clinical applicability and possibilities in facilitating safe minimally invasive CABG.

