Preliminary Clinical Experience with the Heartflo™ Anastomosis Device*

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Abstract
A clinical, prospective trial to evaluate a multi-suture anastomotic device (HeartfloTM) is currently underway. This new surgical tool can be used during CABG to perform end-to-side or side-to-side coronary arteries anastomoses with interrupted suture technique. This reports our interim preliminary clinical experience. Methods: From February to November 2000, we attempted 15 anastomoses with the multi-suture anastomotic device (Heartflo) in 11 patients with coronary artery disease. Results: 7 males, 4 females, mean age 64 ± 3 yrs received 15 anastomoses with the device. The target vessels were: 8 RCA, 3 LAD, 4 OM. Mean coronary diameter was 2 ± 0.3 mm. Grafts used were 14 saphenous veins and 1 IMA. 13/15 anastomoses were completed with the device. 5/13 required 0 - 1 additional stitches versus 8/13 requiring more due to inappropriate tissue capture on the native coronary side. Average time was 17.7 ± 2 min. In 2/15 cases, the procedure was converted to a traditional handsaw anastomosis. Postoperative CK movement without Q-wave in the EKG was observed in 1/11 patients. Conclusions: This device is a reliable instrument that provides reproducible coronary anastomoses with interrupted suture technique, although it also requires additional measures to improve tissue capture and process of handling sutures before extensive clinical application.

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