Initial experience with proximal anastomoses performed with a mechanical connector

Area of Science:

• Cardiovascular Surgery
• Medical Device Technology
• Surgical Innovation

Background:

• The Symmetry Bypass System Aortic Connector is a novel device designed for sutureless proximal anastomoses.
• It facilitates saphenous vein graft attachment to the aorta without the need for aortic clamping.
• This study reports the initial clinical experience with this innovative device.

Purpose of the Study:

• To evaluate the safety, reliability, and efficacy of the Symmetry Bypass System Aortic Connector in constructing sutureless proximal anastomoses.
• To assess the initial clinical outcomes of using this device in coronary artery bypass grafting procedures.
• To determine the learning curve and potential benefits of this novel surgical approach.

Main Methods:

• A total of 139 consecutive proximal anastomoses were performed in 67 patients over a 2-month period (May-July 2001).
• All procedures were conducted on a beating heart without cardiopulmonary bypass or aortic clamping.
• Intraoperative variables and postoperative results were prospectively collected and retrospectively analyzed.

Main Results:

• The device achieved a high technical success rate, with 138 out of 139 (99.3%) anastomoses successfully completed.
• Six anastomoses (4.3%) required additional sutures for leakage, and one required revision due to misdeployment.
• No operative mortality, perioperative myocardial infarction, or stroke occurred. Mean follow-up of 7 months showed 94.1% survival and 88.1% survival free of major adverse cardiac and cerebrovascular events (MACCE).

Conclusions:

• Initial clinical experience indicates that the sutureless proximal anastomosis using the mechanical connector is safe, reliable, and easy to use.
• A brief learning curve is associated with device loading and deployment, which improves with experience.
• Further benefits and efficacy will be assessed in an ongoing randomized study.