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Clinical Trial
Journal Article
Multicenter Study
Results of the prospective multicenter trial of robotically assisted totally endoscopic coronary artery bypass grafting.
Annals of Thoracic Surgery 2006 May
BACKGROUND: Robotic technology has been proven safe and efficacious in the performance of mitral valve repair and atrial septal defect repair. This report describes a Food and Drug Administration-sanctioned multicenter study of the safety and efficacy of the da Vinci system (Intuitive Surgical, Inc, Mountain View, CA) for totally endoscopic coronary artery bypass (TECAB) surgery.
METHODS: Patients requiring left anterior descending (LAD) coronary artery revascularization were eligible. The procedure was performed with femoro-femoral cardiopulmonary bypass (CPB), endoaortic balloon occlusion, and thoracoscopy. All aspects of the procedure were performed with the robotic system, from internal mammary artery harvest to coronary anastomosis.
RESULTS: Ninety-eight patients requiring single-vessel LAD revascularization were enrolled at 12 centers. Thirteen patients (13%) were excluded intraoperatively (eg, failed femoral cannulation, inadequate working space). In 85 patients (69 men, age 58 +/- 10 years) who underwent TECAB, CPB time was 117 +/- 44 minutes, cross-clamp time was 71 +/- 26 minutes, and hospital length of stay was 5.1 +/- 3.4 days. There were five (6%) conversions to open techniques. There were no deaths or strokes, one early reintervention, and one myocardial infarction (1.5%). Three-month angiography was performed in 76 patients, revealing significant anastomotic stenoses (> 50%) or occlusions in 6 patients. Overall freedom from reintervention or angiographic failure was 91%.
CONCLUSIONS: Robotic TECAB was accomplished with no mortality, low morbidity, and angiographic patency and reintervention rates comparable with published data. Although the use of CPB was a limitation of the technique, this experience represents a step toward more advanced procedures, such as multivessel or off-pump TECAB.
METHODS: Patients requiring left anterior descending (LAD) coronary artery revascularization were eligible. The procedure was performed with femoro-femoral cardiopulmonary bypass (CPB), endoaortic balloon occlusion, and thoracoscopy. All aspects of the procedure were performed with the robotic system, from internal mammary artery harvest to coronary anastomosis.
RESULTS: Ninety-eight patients requiring single-vessel LAD revascularization were enrolled at 12 centers. Thirteen patients (13%) were excluded intraoperatively (eg, failed femoral cannulation, inadequate working space). In 85 patients (69 men, age 58 +/- 10 years) who underwent TECAB, CPB time was 117 +/- 44 minutes, cross-clamp time was 71 +/- 26 minutes, and hospital length of stay was 5.1 +/- 3.4 days. There were five (6%) conversions to open techniques. There were no deaths or strokes, one early reintervention, and one myocardial infarction (1.5%). Three-month angiography was performed in 76 patients, revealing significant anastomotic stenoses (> 50%) or occlusions in 6 patients. Overall freedom from reintervention or angiographic failure was 91%.
CONCLUSIONS: Robotic TECAB was accomplished with no mortality, low morbidity, and angiographic patency and reintervention rates comparable with published data. Although the use of CPB was a limitation of the technique, this experience represents a step toward more advanced procedures, such as multivessel or off-pump TECAB.
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