Purpose: The aim of this study was to evaluate the feasibility of the Heartstring hemostatic seal system for proximal anastomoses without the need for aortic side clamping in off-pump coronary artery bypass surgery .
Material And Methods: Between May and November 2003, 50 proximal bypass anastomoses were performed with the Heartstring device in 29 consecutive patients (21 men, 8 women) with calcified aorta (assessed by transesophageal echocardiography/digital palpation). Mean patient age was 68 +/- 7 years. A mean of 1.7 anastomoses per patient was performed. Bypass patency was assessed by intraoperative flow measurements. Neurological outcome was graded in 4 severities.
Results: The learning curve was completed after deployment of approximately 10 devices. Crack of the seal prior to deployment occurred in 8 cases. No conversion to conventional side clamping was needed. No accidental stitching of the seal or wrapping of the suture around the seal stem occurred. Slight diffuse bleeding occurred with arterial pressure under 65 mm Hg. Bypass graft flow was 53.7 +/- 23.9 L/min. No perioperative ischemic events occurred, and there were no postoperative neurological complications.
Conclusions: Proximal bypass aortic anastomoses can be performed safely without side clamping using the Heartstring hemostatic seal system. Anastomoses can be completed with no foreign material (stent) remaining.
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