A Multicenter Prospective Randomized Trial of a 2nd Generation Anastomotic Device in Coronary Artery Bypass Surgery
Lars Wiklund3, Marek Setina2, Robert J. Cusimano1, Katherine Tsang1, Terrence M. Yau1; 1Division of Cardiovascular Surgery, Toronto General Hospital, Toronto, ON, Canada; 2University Hospital FN Motol, Prague, Czech Republic; 3Sahlgrenska University Hospital, Gothenburg, Sweden
Comment on this Abstract
Objective: We performed a prospective randomized trial to evaluate the clinical and angiographic outcomes of a 2nd generation anastomotic device used for saphenous vein grafts.
Methods: This multinational randomized trial was performed at 3 centers from August 2003 to December 2004. Patients undergoing elective isolated CABG with at least 2 saphenous vein grafts were consented.
Intraoperatively, the proximal vein graft segments were sized and appropriate sizes of a second-generation aortic connector system (St. Jude Medical) were recorded. The proximal anastomoses were then randomized, within each patient, to be constructed by the connector or by suture. Each patient was randomized to receive at least one connector study graft and one sutured study graft.
Patient demographics, intraoperative data, hospital outcomes and followup data were collected. One-year study graft patency was evaluated by coronary angiography, MRI or CT, and analyzed on an intent-to-treat basis.
Results: 151 patients (65±9 yrs, 87% male) who met inclusion/exclusion criteria and were enrolled into the study were analyzed. 489 grafts were constructed (3.2±0.5 grafts per patient), including 327 vein grafts randomized to the connector (N=162) or suture (N=165). There were 140 LITA grafts and 22 vein grafts which were not randomized (some patients had 3 or more vein grafts, but only 2 vein grafts were randomized). In 162 connector grafts, 151 devices were successfully implanted. 11 devices had technical issues requiring explantation. A second device was used in 6 of these grafts, and the other 5 were sutured.
There were 2 early (≤ 30 days) deaths and 1 late death. At 1 year, patients reported a mean CCS angina class of 1.01±0.2.
Patency was evaluated in 120 patients (81%) with 260 study grafts. 74 patients with 161 grafts were evaluated by coronary angiography, 31 patients with 69 grafts by MRI and 15 patients with 30 grafts by CT. The mean interval from surgery to angiographic/MRI/CT follow-up was 418±83 days.
The one-year patency rate for study grafts constructed with the anastomotic connector was 92.2% (118/128), and for hand-sutured grafts was 91.7% (121/132).
Conclusion: This prospective multicenter randomized controlled trial demonstrated good in-hospital and late clinical outcomes and excellent one-year patency for vein grafts constructed both by the St. Jude Medical second generation aortic connector system and hand-sutured grafts. The patency of the connector grafts did not differ from that of the hand-sutured grafts.
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