Prospective clinical trial of robotically assisted endoscopic coronary grafting with 1-year follow-up

OBJECTIVE: To follow up in prospective fashion patients with coronary artery anastomoses completed endoscopically with robotic assistance. The robotic system was evaluated for safety and its effectiveness in completing microsurgical coronary anastomoses. SUMMARY BACKGROUND DATA: Recently there has been an interest in using robotics and computers to enhance the surgeon's ability to perform endoscopic cardiac surgery. This interest has stemmed from the rapid advancement of technology and the desire to make cardiac surgery less invasive. Using traditional endoscopic instruments, it has not been possible to perform coronary surgery. METHODS: Nineteen patients underwent robotically assisted endoscopic coronary artery bypass grafting of the left internal thoracic artery (LITA) to the left anterior descending artery (LAD). Two robotic instruments and one endoscopic camera were placed through three 5-mm ports. A robotic system was used to construct the LITA-LAD anastomosis. All other required grafts were completed by conventional techniques. RESULTS: Seventeen LITA-LAD grafts (89%) had adequate intraoperative flow. The mean LITA-LAD graft flow was 38.5 +/- 5 mL/min. At 8 weeks, LITA-LAD grafts were assessed by angiography and showed 100% patency with thrombolysis in myocardial infarction (TIMI) I flow. At a mean follow-up of 17 +/- 4.2 months, all patients were NYHA class I and there were no adverse cardiac events. CONCLUSIONS: The results from the first prospective clinical trial of robotically assisted endoscopic coronary bypass surgery in the United States showed favorable short-term outcomes with no adverse events. Robotic assistance is an enabling technology allowing the performance of endoscopic coronary anastomoses.     

Robotically assisted coronary artery bypass grafting: a prospective single center clinical trial.

AIM: This prospective study was performed as a Phase 1 Food and Drug Administration clinical trial to assess the safety and feasibility of robotically assisted coronary artery bypass grafting (CABG). METHODS: Eighteen patients undergoing elective CABG were enrolled in this study. Full sternotomy was performed in 17 of 18 patients, while cardiopulmonary bypass and cardioplegic arrest was used in all cases. Robotically assisted CABG of the left internal thoracic artery (LITA) to the left anterior descending artery (LAD) was performed through three ports using a robotically assisted microsurgical system. Conventional techniques were used to perform all other grafts. Blood flow in the LITA graft was measured in the operating room, and when necessary, angiography was performed. Six weeks after the operation, all patients underwent selective coronary angiography of the LITA graft. RESULTS: Robotically assisted coronary artery anastomoses were successfully completed in all patients. Blood flow through the LITA graft was adequate in 16 of 18 patients (89%). The two inadequate grafts were revised successfully by hand. Six weeks after the operation, angiography demonstrated a graft patency of 100% (13 of 13). Mean follow-up has been over 190 days. All patients remain New York Heart Association Angina Class I. CONCLUSION: Robotic assistance represents an enabling technology that may allow the surgeon to perform endoscopic coronary artery anastomoses. Further clinical trials are needed to explore the clinical potential and value of robotically assisted CABG.     

Robotic totally endoscopic coronary artery bypass: program development and learning curve issues

BACKGROUND: The introduction of new procedures in heart surgery is a critical phase that includes learning curves and the risk of increased mortality or morbidity. Totally endoscopic coronary artery bypass grafting using robotic techniques represents such an innovative procedure. The aim of this report is to demonstrate the safe introduction of totally endoscopic coronary artery bypass grafting using a stepwise and modular approach. METHODS: From June 2001 until December 2002, 50 procedures were performed using the da Vinci telemanipulator system. After baseline training the following procedure modules were carried out in a stepwise manner: robotically assisted endoscopic left internal thoracic artery harvesting and completion of the procedure as conventional coronary artery bypass grafting, minimally invasive direct coronary artery bypass, or off-pump coronary artery bypass (n = 19), robotically assisted suturing of left internal thoracic artery to left anterior descending anastomoses during conventional coronary artery bypass grafting (n = 15), totally endoscopic coronary artery bypass grafting on the arrested heart using remote access perfusion and aortic endocclusion coronary bypass grafting (n = 15). One patient was excluded intraoperatively from a robotic procedure due to pleural adhesions. RESULTS: A significant learning curve was observed for left internal thoracic artery takedown time, y(min) = 181 - 39 x ln(x) (x = procedure number) (P <.001), and total operative time in totally endoscopic coronary artery bypass grafting, y(min) = 595 - 87 x ln(x) x = (procedure number) (P =.028). The conversion rate in totally endoscopic coronary artery bypass grafting was 2/15. Intensive care unit stay correlated significantly with total operative time (r =.427, P =.002). There was no hospital mortality. CONCLUSION: Totally endoscopic coronary artery bypass grafting can be safely implemented into a heart surgery program. Learning curves are steep for robotic left internal thoracic artery takedown and for performance of totally endoscopic coronary artery bypass grafting. Long operative times translate into prolonged intensive care unit stay in specific cases but not into increased mortality.     

Robotic totally endoscopic triple coronary artery bypass grafting on the arrested heart: report of the first successful clinical case

Robotic technology enables "port only" totally endoscopic coronary artery bypass grafting (TECAB). During early procedure development only single bypass grafts were feasible. Because current referral practice for coronary bypass surgery mostly includes multivessel disease, performance of multiple endoscopic bypass grafts is desirable. We report a case in which a patient received a right internal mammary artery bypass graft to the left anterior descending artery and a left internal mammary artery jump graft to 2 obtuse marginal branches. The procedure was performed through 5 ports on the arrested heart using the daVinci S robotic surgical system. This is the first reported triple bypass grafting procedure using an arrested heart approach.     

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.     

机器人非体外循环冠状动脉旁路移植术

目的 总结使用da Vinci S机器人系统完成的微创机器人非体外循环冠状动脉旁路移植术(CABG)的技术特点和临床效果.方法 2007年4月至2008年12月,共有56例患者接受微创机器人非体外循环CABG.所有患者术前均有心绞痛症状,冠状动脉造影显示严重的前降支病变,10例患者合并有回旋支或右冠状动脉病变.其中25例患者有心肌梗死病史.心功能(NYHA分级)Ⅱ级45例,Ⅲ级11例,平均射血分数为57%±11%.所有患者肺功能良好,无胸膜炎和左侧胸腔手术史.术前常规行64排CT检查双侧胸廓内动脉(ITA)的解剖情况.共采用三种术式:(1)机器人单侧或双侧ITA游离并同期小切口非体外循环CABG;(2)全机器人非体外循环CABG;(3)对合并有回旋支或右冠状动脉局限性狭窄的患者,接受上述两种术式的一种后行分站式支架置入杂交术.行单支或多支CABG时于左侧胸壁第4肋间做长6 cm的小切121,直视、心脏跳动下行ITA和前降支的吻合;行全机器人非体外循环CABG时无需胸壁切口.术后以冠状动脉造影或64排CT评估桥血管的通畅性,并进行随访.结果 所有患者成功接受了上述手术.术中平均ITA桥血流量为(23.2±16.7)mL/min,无中转开放手术和手术死亡.ITA移植到前降支53例,双支桥3例,其中10例患者旁路移植后接受了回旋支或右冠状动脉的支架植入杂交术.术后复查未见桥血管狭窄或闭塞.结论 微创机器人非体外循环CABG手术效果确实、可靠,不破坏胸腔骨性结构、创伤小,是微创CABG的发展方向之一.     

Robotic totally endoscopic coronary artery bypass and catheter based coronary intervention in one operative session

A 56-year-old male patient underwent robotically assisted totally endoscopic left internal mammary artery (LIMA) to left anterior descending artery (LAD) grafting. After protamine administration complete heart block developed in the patient. On intraoperative angiography the LIMA to LAD graft was perfectly patent but an acute occlusion of the right coronary artery (RCA) was noted. We performed an immediate on table percutaneous coronary angioplasty and stent placement to the RCA. The heart regained sinus rhythm and the wall motion abnormalities on the back wall of the heart resolved. No clinical symptoms indicating ongoing myocardial ischemia were noted postoperatively. This case demonstrates that a hybrid procedure of robotic totally endoscopic coronary artery bypass grafting and catheter based coronary intervention is feasible in one simultaneous session.     

Total endoscopic off-pump coronary artery bypass grafting

Two cases of totally endoscopic off-pump coronary artery bypass grafting (TECAB) of the left internal thoracic artery to the left anterior descending artery using the da Vincitrade mark telemanipulation system (Intuitive Surgical, Mountain View, CA) are described. A new articulating endoscopic stabilizer with cleats was developed to enable endoscopic anchoring of silastic vessel loops for vascular occlusion. Newly created attachments for irrigation and suction, along with active robotic enhanced assistance by a second surgical console, permitted our group to perform for the first time a truly endoscopic bypass grafting without any thoracotomy.     

Computer-assisted endoscopic coronary artery bypass anastomoses: a chronic animal study.

BACKGROUND: With traditional instruments, endoscopic coronary artery bypass grafting (ECABG) has not been possible. This study was designed to determine the feasibility of using a robotically-assisted microsurgical system to perform ECABG in a chronic animal model. METHODS: Nine calves were placed on cardiopulmonary bypass after harvesting the left internal mammary artery (LIMA). Subxiphoid endoscopic ports (2 instrument, 1 camera) were placed, and a robotic system was used to perform ECABG between the LIMA and left anterior descending coronary artery. LIMA graft flow (LIMAQ) was measured. Animals were sacrificed at 1 month, and hearts underwent angiographic and histologic analyses. RESULTS: Acute graft patency was 89% (8/9). Two animals died suddenly within the first 48 hours. There was no significant difference in mean acute and chronic (n = 6) LIMAQ (40.9+/-4.7 and 38.5+/-5.0 ml/min, respectively). Survivors had an angiographic patency rate of 100% (6/6), confirmed by histology. CONCLUSIONS: This study shows that ECABG is feasible in a chronic animal model with excellent results.     

Benefits accruing to grafting of the right internal thoracic artery to the left anterior descending artery in coronary artery bypass grafting.

OBJECTIVES: We have investigated the effects and outcome from grafting the right internal thoracic artery to the left anterior descending artery in coronary artery bypass grafting. METHODS: We analyzed the findings in 185 patients who underwent coronary artery bypass grafting involving right internal thoracic artery-left anterior descending artery bypass. The survival rate, cardiac events related to the right internal thoracic artery-left anterior descending artery graft, and graft patency were investigated. In cardiac catheterization, the production of nitric oxide from the endothelium of the internal thoracic artery was measured as the plasma nitrite and nitrate levels by the Griess reaction. The reactions to acetylcholine infusion (5 micrograms) in the right internal thoracic artery (n = 4) were compared to those in the left internal thoracic artery (n = 9) grafts. RESULTS: The hospital mortality rate was 0.5%. The actuarial survival rate at 11 years after operation was 98.81%. The rate of freedom from cardiac events at 11 years after operation was 92.08%. The rate of patency of the right internal thoracic artery-left anterior descending artery was 97.0% in 133 patients. Nitric oxide production was calculated as (total nitrite plus nitrate production in response to stimulation by acetylcholine-total nitrite plus nitrate level before acetylcholine load)/(total nitrite plus nitrate level before acetylcholine load). There was no significant difference in changes in plasma concentration in response to acetylcholine stimulation between the right internal thoracic artery-left anterior descending artery and left internal thoracic artery-left anterior descending artery groups (20 +/- 29% versus 5 +/- 10%). CONCLUSIONS: The right internal thoracic artery-left anterior descending artery grafts exhibited good patency and release of nitric oxide in response to acetylcholine loading, similar to left internal thoracic artery-left anterior descending artery grafts.     

Benefits accruing to grafting of the right internal thoracic artery to the left anterior descending artery in coronary artery bypass grafting

Objectives: We have investigated the effects and outcome from grafting the right internal thoracic artery to the left anterior descending artery in coronary artery bypass grafting.Methods: We analyzed the findings in 185 patients who underwent coronary artery bypass grafting involving right internal thoracic artery-left anterior descending artery bypass. The survival rate, cardiac events related to the right internal thoracic artery-left anterior descending artery graft, and graft patency were investigated. In cardiac catheterization, the production of nitric oxide from the endothelium of the internal thoracic artery was measured as the plasma nitrite and nitrate levels by the Griess reaction. The reactions to acetylcholine infusion (5 μg) in the right internal thoracic artery (n = 4) were compared to those in the left internal thoracic artery (n = 9) grafts.Results: The hospital mortality rate was 0.5%. The actuarial survival rate at 11 years after operation was 98.81%. The rate of freedom from cardiac events at 11 years after operation was 92.08%. The rate of patency of the right internal thoracic artery-left anterior descending artery was 97.0% in 133 patients. Nitric oxide production was calculated as (total nitrite plus nitrate production in response to stimulation by acetylcholine-total nitrite plus nitrate level before acetylcholine load) / (total nitrite plus nitrate level before acetylcholine load). There was no significant difference in changes in plasma concentration in response to acetylcholine stimulation between the right internal thoracic artery-left anterior descending artery and left internal thoracic artery-left anterior descending artery groups (20 ± 29% versus 5 ± 10%).Conclusions: The right internal thoracic artery-left anterior descending artery grafts exhibited good patency and release of nitric oxide in response to acetylcholine loading, similar to left internal thoracic artery-left anterior descending artery grafts.     

Totally endoscopic quadruple coronary artery bypass grafting is feasible using robotic technology

Multivessel robotic totally endoscopic coronary artery bypass grafting is currently under development. Quadruple totally endoscopic coronary artery bypass has so far not been reported. A 75-year-old patient with multivessel coronary artery disease underwent daVinci Si-assisted completely endoscopic placement of a left internal mammary artery bypass to the left anterior descending artery and construction of a right internal mammary artery Y-graft off the left internal mammary artery to the posterior descending artery. The left internal mammary artery was also connected to a diagonal branch as a sequential graft. The obtuse marginal branch was revascularized using an endoscopically harvested vein graft originating from the left axillary artery.     

Facilitated endoscopic beating heart coronary artery bypass grafting using a magnetic coupling device

BACKGROUND: Suturing of a coronary anastomosis in totally endoscopic coronary artery bypass grafting on the beating heart is technically demanding. The potential benefits of the endoscopic Magnetic Vascular Positioner device (Ventrica, Inc, Fremont, Calif) to facilitate construction of a coronary anastomosis in a closed chest environment were evaluated. METHODS: Totally endoscopic coronary artery bypass grafting on the beating heart was performed in 8 foxhound-beagle inbred dogs with the da Vinci telemanipulation system (Intuitive Surgical, Mountain View, Calif). A prototype of the endoscopic Magnetic Vascular Positioner device was used to facilitate construction of the coronary anastomosis. One pair of magnets was inserted in the internal thoracic artery and left anterior descending artery using robotic instruments to guide and place the endoscopic delivery platform. All animals underwent angiography; gross inspection of the anastomotic site was performed after excision of the hearts. RESULTS: The procedure was accomplished in all animals in 169 minutes (155-190 minutes). Dissection of the left anterior descending coronary artery (6.5 minutes; 1-20 minutes), positioning of the stabilizer (8.5 minutes; 7-16 minutes), placement of occlusion tapes (6 minutes, 3-10 minutes), and arteriotomy 5.5 minutes (3-30 minutes) was achieved without problems. By use of the Magnetic Vascular Positioner device, the anastomosis at the graft site was performed with the graft still in situ. Except for 1 premature deployment, all other deployments were easily accomplished in 3 minutes (1-28 minutes). The following adverse events were encountered: bleeding from the right ventricle caused by occlusion tape (1), anastomotic leakage on reperfusion requiring repair stitches (2), and anastomotic occlusion as a result of thrombus (1). All except 1 animal with a patent graft and anastomosis survived the procedure. The overall patency was 7 of 8. DISCUSSION: The combination of robotic technology allowing for dexterous manipulation in a closed chest environment and a simple yet effective and timesaving technique for anastomotic coupling may facilitate beating heart totally endoscopic coronary artery bypass grafting.     

Reoperative coronary artery bypass grafting using a minimally invasive direct coronary artery bypass procedure

OBJECTIVE: Reoperative coronary artery bypass grafting with cardiopulmonary bypass tends to cause a higher mortality and morbidity than the primary operation. The purpose of this study was to discuss the effectiveness and safety of a minimally invasive coronary artery bypass procedure for patients who had previously undergone coronary artery bypass surgery. METHODS: We performed redo single coronary artery bypass grafting to the left anterior descending coronary artery in 9 patients and to the right coronary artery in 3 patients using minimally invasive cardiac surgery. The graft to the left anterior descending coronary artery was taken from the left internal thoracic artery in 5 patients, the right gastroepiploic artery in 3 patients, and from the saphenous vein in the other 1 patient. The graft to the right coronary artery was from the right gastroepiploic artery in all 3 patients. RESULTS: All grafts were patent. There was no major postoperative complication and no surgical or hospital death except one late death. CONCLUSIONS: In selected patients, we could safely and completely perform coronary artery bypass re-grafting to the left descending coronary artery or right coronary artery using a minimally invasive operation.     

Endoscopic Doppler for detecting vessels in closed chest bypass grafting

A new method of endoscopic ultrasonography during endoscopic bypass grafting is described. Using a 7.5 MHz ultrasonic catheter (AcuNav, Acuson, Mountain View, CA) that was introduced through a 5mm port and manipulated by robotically enhanced endoscopic instruments, detection of the internal thoracic artery (ITA) and the left anterior descending (LAD) artery was possible through layers of fat and muscle in a canine model.     

Reoperative minimally invasive axillocoronary artery bypass to the obtuse marginal branch

A 73-year-old man was admitted with unstable angina, having severe coronary artery disease involving 3 vessels. He had undergone coronary artery bypass grafting to the left anterior descending artery and the obtuse marginal branch using saphenous vein grafts in 1979. Computed tomography showed severe calcium deposition and atherosclerosis in the ascending and descending aorta. We conducted axillocoronary artery bypass to the obtuse marginal branch and left internal thoracic artery as an in situ graft to the left anterior descending artery without cardiopulmonary bypass. Grafts were satisfactory and clinical results good.     

Axillary-coronary sequential vein graft for total endoscopic triple coronary artery bypass

We describe using an axillary-coronary vein graft for robotically assisted, total endoscopic coronary artery bypass grafting. After constructing the proximal vein anastomosis to the left axillary artery under direct vision, the graft was brought into the thorax through a thoracostomy in the second left intercostal space. Under cardiopulmonary bypass with cardioplegic arrest, the distal anastomoses were completed using da Vinci (Intuitive, Sunnyvale, CA) robotic instrumentation through small portholes. This procedure marks a significant advancement in robotic total endoscopic revascularization by increasing the range of targets available for the total endoscopic approach, thereby enlarging the patient population suitable for robotic revascularization.     

Totally endoscopic coronary artery bypass grafting on the arrested heart

In the late 1990s, totally endoscopic coronary artery bypass grafting was successfully introduced into the heart surgery armamentarium using robotic techniques. Surgeons have applied the da Vinci telemanipulation system in order to develop completely endoscopic placement of internal mammary artery bypass grafts, mainly to the left anterior descending artery system. Multivessel procedures are currently under development. These operations can be carried out on the arrested heart using remote access perfusion and cardioplegic arrest via ascending aortic balloon occlusion. Another option is performing procedures on the beating heart using an endostablilizer and local coronary artery occlusion. In this review, the technique and specific aspects of the arrested heart version of totally endoscopic coronary artery bypass grafting are outlined.     

Aortic valve replacement in a patient with a patent internal thoracic artery graft

Myocardial protection in patients requiring a second open-heart surgical procedure after coronary artery bypass grafting, especially when there is a patent left internal thoracic artery graft to the left anterior descending coronary artery, remains controversial. We present the case of a patient in whom aortic valve replacement was undertaken 18 months after coronary artery revascularization. Unusual features included beating-heart aortic valve replacement with continuous retrograde coronary sinus perfusion and avoidance of dissection of the patent grafts, including the left internal thoracic artery and a saphenous vein graft.     

机器人微创非体外循环冠状动脉旁路移植术

目的 评价da Vincis机器人系统进行胸廓内动脉(IMA)游离、小切口非体外循环下冠状动脉旁路移植术的安全性和手术效果.方法 2007年1月到2011年3月,105例患者接受机器人IMA游离、小切口非体外循环下冠状动脉旁路移植术.其中男性77例,女性28例,年龄33～77岁,平均(59±10)岁.患者术前行64排CT检查评估IMA质量,2例患者左LIMA纤细或走行异常弃用.术者于操作台前、三维成像系统下遥控机器人游离IMA并完成动脉桥与靶血管的徒手吻合.其中4例患者旁路移植后接受了杂交技术于回旋支或右冠状动脉行支架植入术.术中均以超声血流检测仪测量桥血管的波形及血流.术后以冠状动脉造影或64排CT评估桥血管的通畅性,并进行随访.结果 所有患者成功接受上述手术,无手术死亡病例.术中平均IMA血管桥血流量为(21±13) ml/min.1例于术后第1天突发心跳骤停经抢救后痊愈,复查桥血管通畅.1例合并脑梗死患者术后肺部感染,痊愈后出院.其余患者无并发症发生.术中及术后出血少,术后恢复快.随访1～51个月,平均(30±12)个月.术后冠状动脉造影或64排CT复查未见桥血管狭窄或闭塞,心绞痛症状缓解.结论 机器人IMA游离、小切口非体外循环冠状动脉旁路移植术创伤小、疗效确切、安全性好,是微创冠状动脉再血管化的重要方向之一.