Severe ostial saphenous vein graft disease leading to acute coronary syndromes following proximal aorto-saphenous anastomoses with the symmetry bypass connector device - Is it a suture device or a "Stent"?

The Symmetry Bypass Connector (St. Jude Medical, St. Paul, Minnesota) is a nitinol, star-shaped device that was designed to facilitate placement of sutureless aorto-saphenous anastomoses during off-pump coronary artery bypass graft surgery (CABG). Although the device is approved for clinical use in Europe and the U.S., its short- and long-term safety and efficacy are not established. We report on 5 of 121 patients undergoing CABG who presented with an acute coronary syndrome two to five months following placement of this device. In each patient, all saphenous vein grafts (SVGs) placed (n=11) with the device were totally occluded (n=6) or compromised by ostial stenoses (n=5). Treatment consisted of repeat CABG in one patient and percutaneous coronary intervention (PCI) in four patients with cutting balloon atherotomy and stenting. Following PCI, two of four patients presented again within two months with near-occlusive ostial restenosis in all stents placed. Intracoronary ultrasound showed severe neointimal hyperplasia, but only at the proximal interface of the device and stent. One patient was treated with brachytherapy in two SVGs but had a recurrence four months later and was treated with drug-eluting stents in both restenotic segments. Recalcitrant neointimal hyperplasia is postulated to be involved in the pathogenesis of anastomotic device stenosis, possibly similar to in-stent restenosis. Prospective randomized clinical trials are needed to assess the clinical safety and efficacy of this device. Pending such studies, consideration should be given in limiting its use to cases of unacceptably high risk of stroke during aortic cross-clamping. Dual antiplatelet agents, evaluation for ischemia, and close follow-up are warranted in patients that have already received the device.