Initial prospective multicenter clinical trial of robotically-assisted coronary artery bypass grafting.

BACKGROUND: This multicenter prospective trial was designed to assess the safety and efficacy of using a robotically-assisted microsurgical system to create endoscopic coronary anastomoses. METHODS: . Thirty-two patients scheduled for elective primary coronary surgery underwent endoscopic anastomosis of the left internal thoracic artery (LITA) to the left anterior descending (LAD) artery. Three thoracic ports (two for instruments and one for a camera) were placed, and a robotic system was used to perform the LITA-LAD graft. Conventional techniques were used to perform the other grafts. Thirty-one patients underwent median sternotomy and 1 patient underwent a limited anterior thoracotomy. RESULTS: . Graft flow was measured in the operating room and averaged 37 +/- 19 mL/min. Mean anastomosis time was 24 +/- 9 minutes. There were three intraoperative revisions (9%). Two were for inadequate flow and one for an inadvertent injury. Each of these grafts was successfully revised by hand. There were no technical failures of the robotic system. Average postoperative length of stay was 5.5 +/- 2.7 days. There were three reoperations for bleeding, but none of these were related to the LAD anastomosis. Two months following the operation, selective angiography revealed a graft patency of 93%. The patients have been followed for 16 +/- 4 months. CONCLUSIONS: This initial prospective multicenter trial documents the feasibility of robotically-assisted coronary bypass grafting. Further trials are warranted to establish the safety and efficacy of this new technology.

Initial United States clinical trial of robotically assisted endoscopic coronary artery bypass grafting.

OBJECTIVES: With traditional instruments, endoscopic coronary artery bypass grafting has not been possible. This study was designed to determine the clinical feasibility of using a robotically assisted microsurgical system to create endoscopic coronary anastomoses. METHODS AND RESULTS: Ten patients underwent endoscopic coronary artery bypass grafting of the left internal thoracic artery to the left anterior descending artery. Subxiphoid endoscopic ports (2 for instruments, 1 for a camera) were placed, and a robotic system was used to perform the left internal thoracic artery-left anterior descending artery bypass graft. Conventional techniques were used to perform the other grafts. Blood flow through the left internal thoracic artery graft was measured in the operating room and was adequate in 8 of 10 patients. The 2 inadequate grafts were revised successfully by hand. Six weeks after the operation, selective coronary angiography demonstrated a graft patency of 100% (8/8). There were no technical failures of the robotic system. The only postoperative complication was mediastinal hemorrhage in 1 patient. CONCLUSIONS: This pilot study demonstrates the feasibility of robotically assisted endoscopic coronary artery bypass grafting.

Endoscopic coronary artery bypass graft (ECABG) procedure with robotic assistance.

BACKGROUND: Technical details of the Robotically assisted endoscopic coronary artery bypass graft (ECABG) procedure on the cadaver model are reported. Moreover, this study will provide essential techniques, steps, and procedural development concepts necessary to introduce the ZEUS Robotic Surgical System (Computer Motion, Inc., Goleta, CA) into the human operating room. METHODS: Between August 1998 and March 1999, an ECABG procedure was performed on 10 cadaver torsos. The cadaver torso was placed in the left anterior oblique (LAO) position. The left and right internal mammary arteries (IMA) were taken down endoscopically. The ends of the IMA's were intracorporeally prepared. An upper partial sternotomy was demonstrated for perfusion cannulation and proximal anastomoses for multiple vessel revascularization. An arteriotomy was created with an endoscopic scalpel. The IMA was anastomosed to a chosen coronary using robotic assistance. The patency was verified by probing and injecting of methylene blue. RESULTS: Templates were developed to determine the placement of the robotic arms. Port templates were developed to both harvest the IMA's and perform the desired anastomoses. The following vessels were accessed through the developed port templates and retraction of the heart: left anterior descending (LAD), right coronary artery (RCA), diagonal (D(1)), obtuse marginal (OM(1) and OM(2)), and posterior descending artery (PDA). CONCLUSIONS: The use of robotic assistance during an ECABG procedure on a cadaver model is feasible. This study is a necessary and useful progression from the use of robotics in the animal lab to the use of robotics in the human operating room.