Coupler Study.

Rationale:

Coronary Artery ByPass Grafting (CABG) procedures are typically employed to achieve revascularization of the heart. Different conduits can be used for bypass grafting.

In the last two decades, the radial artery (RA) has emerged as a major alternative arterial conduit in preference to saphenous vein grafts or when traditional grafts are unsuitable or unavailable in coronary artery bypass grafting (CABG). However, to optimize the use of RA as a coronary bypass conduit, several technical considerations have been emphasized.

One technique, as performed in our hospital, is the use of extended radial artery conduit for revascularization, with the use of both the left internal thoracic artery (LITA) and the RA, with a hand sewn end-to-end anastomoses. Though disadvantages of conventional suturing techniques for end-to-end anastomoses are; intraluminal suture material in the anastomoses, time consuming, difficulties in vessel size mismatch corrections and surgeon dependent quality of the anastomotic configuration. A well known and well described anastomotic device, which is used extensively in plastic surgery (and standard practice for some plastic surgical procedures in our hospital) and neurosurgery to facilitate anastomoses; is the GEM Microvascular Anastomotic COUPLER System. The system is specifically designed for use in the anastomosis of veins and arteries in microsurgical procedures. The GEM COUPLER is intended for use with veins and arteries having an outside diameter no smaller than 0.8mm and no larger than 4.3mm and a wall thickness of 0.5mm or less.



Objective:

The purpose of this study is to demonstrate patency of the GEM COUPLER system to facilitate the LITA-RA end-to-end anastomosis in CABG procedures.



Study design:

Patients planned to undergo a CABG procedure and agree to participate in the study (signed informed consent) will be included for the study. The surgery will be a routine CABG procedure, performed with the routine Extended Radial Artery Conduit Technique and extension of the radial artery with GEM COUPLER System, and according to the standard hospital practice;

Post procedure , the patients will be treated according to the hospital standard practice. The patients will be asked to return to a follow up visits at 3 months post hospital discharge, at which time an ECG will be performed, and data on blood pressure, anginal status and anticoagulant medications will be collected. At the 3-month follow-up visit, also a Multislice Computed Tomography (MS – CT scan) will be performed and patency information will be recorded on the study vessel.

Use of the GEM microvascular anastomotic coupler is feasible in coronary artery bypass procedures with the extended radial artery technique and the coupler anastomoses is patent after 3 months.

N/A

Standard CABG procedure, with extended radial artery technique, with the radial-lita anastomoses facilitated with the GEM flow microvascular coupler.