Louis P Perrault1, Michel Carrier2, Pierre Voisine3, Peter Skov Olsen4, Nicolas Noiseux2, Hugues Jeanmart5, Filippo Cardemartiri6, Dave Veerasingam7, Craig Brown8, Marie-Claude Guertin9, Vilas Satishchandran10, Tracy Goeken10, Maximilian Y Emmert11. 1. Department of Surgery, Montreal Heart Institute, Montréal, Québec, Canada. Electronic address: louis.perrault@icm-mhi.org. 2. Department of Surgery, Montreal Heart Institute, Montréal, Québec, Canada. 3. Institut Universitaire de Cardiologie et de Pneumologie, Québec City, Québec, Canada. 4. Rigshopitalet University of Copenhagen, Copenhagen, Denmark. 5. Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. 6. Department of Surgery, Montreal Heart Institute, Montréal, Québec, Canada; SDN IRCCS, Naples, Italy. 7. Galway University Hospital, Galway, Ireland. 8. New Brunswick Heart Centre, Saint John, New Brunswick, Canada. 9. Montreal Health Innovations Coordinating Center, Montreal, Québec, Canada. 10. Somahlution, Jupiter, Fla. 11. Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, Berlin, Germany; Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.
Abstract
OBJECTIVES: To assess the effect of DuraGraft (Somahlution Inc, Jupiter, Fla), an intraoperative graft treatment, on saphenous vein grafts in patients undergoing isolated coronary artery bypass grafting. METHODS:Within patients, 2 saphenous vein grafts were randomized to DuraGraft or heparinized saline. Multidetector computed tomography angiography at 1, 3, and 12 months assessed change in wall thickness (primary end point at 3 months), lumen diameter, and maximum narrowing for the whole graft and the proximal 5-cm segment. Safety end points included graft occlusion, death, myocardial infarction, and repeat revascularization. RESULTS: At 3 months, no significant changes were observed between DuraGraft- and saline-treated grafts (125 each) for wall thickness, lumen diameter, and maximum narrowing. At 12 months, DuraGraft-treated grafts demonstrated smaller mean wall thickness, overall (0.12 ± 0.06 vs 0.20 ± 0.31 mm; P = .02) and in the proximal segment (0.11 ± 0.03 vs 0.21 ± 0.33 mm; P = .01). Changes in wall thickness were greater in the proximal segment of saline-treated grafts (0.09 ± 0.29 vs 0.00 ± 0.03 mm; P = .04). Increase in maximum graft narrowing was larger in the proximal segment in the saline-treated grafts (4.7% ± 12.7% vs 0.2% ± 3.8%; P = .01). Nine DuraGraft and 11 saline grafts had occluded or thrombosed. One myocardial infarction was associated with a saline graft occlusion. No deaths or revascularizations were observed. CONCLUSIONS: DuraGraft demonstrated a favorable effect on wall thickness at 12 months, particularly in the proximal segment. Longer-term follow-up in larger studies is needed to evaluate the effect on clinical outcomes.
RCT Entities:
OBJECTIVES: To assess the effect of DuraGraft (Somahlution Inc, Jupiter, Fla), an intraoperative graft treatment, on saphenous vein grafts in patients undergoing isolated coronary artery bypass grafting. METHODS: Within patients, 2 saphenous vein grafts were randomized to DuraGraft or heparinized saline. Multidetector computed tomography angiography at 1, 3, and 12 months assessed change in wall thickness (primary end point at 3 months), lumen diameter, and maximum narrowing for the whole graft and the proximal 5-cm segment. Safety end points included graft occlusion, death, myocardial infarction, and repeat revascularization. RESULTS: At 3 months, no significant changes were observed between DuraGraft- and saline-treated grafts (125 each) for wall thickness, lumen diameter, and maximum narrowing. At 12 months, DuraGraft-treated grafts demonstrated smaller mean wall thickness, overall (0.12 ± 0.06 vs 0.20 ± 0.31 mm; P = .02) and in the proximal segment (0.11 ± 0.03 vs 0.21 ± 0.33 mm; P = .01). Changes in wall thickness were greater in the proximal segment of saline-treated grafts (0.09 ± 0.29 vs 0.00 ± 0.03 mm; P = .04). Increase in maximum graft narrowing was larger in the proximal segment in the saline-treated grafts (4.7% ± 12.7% vs 0.2% ± 3.8%; P = .01). Nine DuraGraft and 11 saline grafts had occluded or thrombosed. One myocardial infarction was associated with a saline graft occlusion. No deaths or revascularizations were observed. CONCLUSIONS: DuraGraft demonstrated a favorable effect on wall thickness at 12 months, particularly in the proximal segment. Longer-term follow-up in larger studies is needed to evaluate the effect on clinical outcomes.
Authors: Gábor Veres; Kálmán Benke; Roland Stengl; Yang Bai; Klára Aliz Stark; Alex Ali Sayour; Tamás Radovits; Sivakkanan Loganathan; Sevil Korkmaz-Icöz; Matthias Karck; Gábor Szabó Journal: Antioxidants (Basel) Date: 2022-01-18
Authors: Philipp Szalkiewicz; Maximilian Y Emmert; Paul P Heinisch; Zsuzsanna Arnold; Ingo Crailsheim; Markus Mach; Thomas Aschacher; Martin Grabenwöger; Bernhard Winkler Journal: Front Cardiovasc Med Date: 2022-07-28