L Wiklund1, L F Bonilla, E Berglin. 1. Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. lars.wiklund@medfak.gu.se
Abstract
OBJECTIVE: A new mechanical anastomotic device was evaluated, aiming at its future use in minimally invasive techniques or limited access surgery in patients undergoing coronary artery bypass grafting. METHODS:Between April and December 2002, a total of 60 patients scheduled for elective multivessel bypass grafting were randomly assigned. One vein graft-coronary artery anastomosis per patient was either performed with the St Jude Medical ATG coronary connector system (n = 30; St Jude Medical Inc, St Paul, Minn) or hand sewn (n = 30). Selective coronary angiography or coronary magnetic resonance imaging of the studied graft and vessel was included in the 6-month follow-up. RESULTS: Twenty-eight of the connectors were successfully implanted. Two patients were excluded from the study because of conversion to hand-sewn anastomoses. Six connector-made anastomoses were bleeding at the anastomotic site. At the time of follow-up (190 postoperative days), all control anastomoses and grafts were patent, whereas 26% of the connector anastomoses were occluded. One graft in each group was patent but with stenosis. CONCLUSION: The St Jude Medical ATG coronary connector system for distal anastomoses represents a new concept for sutureless anastomoses in cardiac surgery. This randomized, controlled study shows lower graft patency for anastomoses performed with the connector than for hand-sewn control anastomoses. It illustrates the importance of controlled studies when evaluating new technical equipment in medicine.
RCT Entities:
OBJECTIVE: A new mechanical anastomotic device was evaluated, aiming at its future use in minimally invasive techniques or limited access surgery in patients undergoing coronary artery bypass grafting. METHODS: Between April and December 2002, a total of 60 patients scheduled for elective multivessel bypass grafting were randomly assigned. One vein graft-coronary artery anastomosis per patient was either performed with the St Jude Medical ATG coronary connector system (n = 30; St Jude Medical Inc, St Paul, Minn) or hand sewn (n = 30). Selective coronary angiography or coronary magnetic resonance imaging of the studied graft and vessel was included in the 6-month follow-up. RESULTS: Twenty-eight of the connectors were successfully implanted. Two patients were excluded from the study because of conversion to hand-sewn anastomoses. Six connector-made anastomoses were bleeding at the anastomotic site. At the time of follow-up (190 postoperative days), all control anastomoses and grafts were patent, whereas 26% of the connector anastomoses were occluded. One graft in each group was patent but with stenosis. CONCLUSION: The St Jude Medical ATG coronary connector system for distal anastomoses represents a new concept for sutureless anastomoses in cardiac surgery. This randomized, controlled study shows lower graft patency for anastomoses performed with the connector than for hand-sewn control anastomoses. It illustrates the importance of controlled studies when evaluating new technical equipment in medicine.
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