Tuesday, January 6, 2015

robot for surgical procedures approved by FDA

Clinical Application and Data

Several robotic systems are currently approved by the FDA for specific surgical procedures. As mentioned previously, ROBODOC is used to precisely core out the femur in hip replacement surgery. Computer Motion Inc. of Goleta, CA, has 2 systems on the market. One, called AESOP, is a voice-controlled endoscope with 7 degrees of freedom. This system can be used in any laparoscopic procedure to enhance the surgeon’s ability to control a stable image. 

The Zeus system and the Da Vinci system have been used by a variety of disciplines for laparoscopic surgeries, including cholecystectomies, mitral valve repairs, radical prostatectomies, reversal of tubal ligations, in addition to many gastrointestinal surgeries, nephrectomies, and kidney transplants. 

The number and types of surgeries being performed with robots is increasing rapidly as more institutions acquire these systems. Perhaps the most notable use of these systems, however, is in totally endoscopic coronary artery grafting, a procedure formerly outside the limitations of laparoscopic technology.

The amount of data being generated on robotic surgery is growing rapidly, and the early data are promising. Many studies have evaluated the feasibility of robot-assisted surgery. One study by Cadiere et al evaluated the feasibility of robotic laparoscopic surgery on 146 patients. Procedures performed with a Da Vinci robot included 39 antireflux procedures, 48 cholecystectomies, 28 tubal reanastomoses, 10 gastroplasties for obesity, 3 inguinal hernia repairs, 3 intrarectal procedures, 2 hysterectomies, 2 cardiac procedures, 2 prostatectomies, 2 artiovenous fistulas, 1 lumbar sympathectomy, 1 appendectomy, 1 laryngeal exploration, 1 varicocele ligation, 1 endometriosis cure, and 1 neosalpingostomy. 

This study found robotic laparoscopic surgery to be feasible. They also found the robot to be most useful in intra-abdominal microsurgery or for manipulations in very small spaces. They reported no robot related morbidity. 

Another study by Falcone et al tested the feasibility of robot-assisted laparoscopic microsurgical tubal anastomosis. In this study, 10 patients who had previously undergone tubal sterilization underwent tubal reanastomosis. 

They found that the 19 tubes were reanastomosed successfully and 17 of the 19 were still patent 6 weeks postoperatively. There have been 5 pregnancies in this group so far. Margossian and Falcone also studied the feasibility of robotic surgery in complex gynecologic surgeries in pigs. In this study, 10 pigs underwent adnexal surgery or hysterectomy using the Zeus robotic system. 

They found that robotic surgery is safe and feasible for complex gynecologic surgeries. In yet another study by Marescaux et al, the safety and feasibility of telerobotic laparoscopic cholecystectomy was tested in a prospective study of 25 patients undergoing the procedure. Twenty-four of the 25 laparoscopic cholecystectomies were performed successfully, and one was converted to a traditional laparoscopic procedure. 

This study concluded that robotic laparoscopic cholecystectomy is safe and feasible. Another study by Abbou et al found telerobotic laparoscopic radical prostatectomy to be feasible and safe with dramatically enhanced dexterity.

One of the areas where robotic surgery is transforming medicine the most and one of the areas generating the most excitement is minimally invasive cardiac surgery. Several groups have been developing robotic procedures that expand laparoscopic techniques into this previously unexplored territory with encouraging results. Prasad et al successfully constructed left internal thoracic artery (LITA) to left anterior descending (LAD) artery anastomoses on 17 of 19 patients with the use of a robotic system. 

They conclude that robotically assisted endoscopic coronary bypass surgery showed favorable short-term outcomes with no adverse events and found robotic assistance is an enabling technology that allows surgeons to perform endoscopic coronary anastomoses. Damiano et al conducted a multicenter clinical trial of robotically assisted coronary artery bypass grafting. In this study 32 patients scheduled for primary coronary surgery underwent endoscopic anastomosis of the LITA to LAD. Two-month follow-up revealed a graft patency of 93%. This study concluded that robotic assisted coronary bypass grafting is feasible. In another study, Mohr et al used the Da Vinci system to perform coronary artery bypass grafting on 131 patients and mitral valve repair on 17 patients. They used the robot to perform left internal thoracic artery takedown, LITA-LAD anastomosis in standard sternotomy bypass, and total endoscopic coronary artery bypass grafting LITA-LAD anastomosis on the arrested heart and the beating heart. They found that robotic systems could be used safely in selected patients to perform endoscopic cardiac surgery. Internal thoracic artery takedown is an effective modality, and total endoscopic bypass on an arrested heart is feasible but does not offer a major benefit to the minimally invasive direct approach because cardiopulmonary bypass is still required. Their study suggests that robotic systems have not yet advanced far enough to perform endoscopic closed chest beating heart bypass grafting despite some technical success in 2 of 8 patients. In addition, robotic endoscopic mitral valve repair was successful in 14 of 17 patients. In contrast, several groups in Europe have successfully performed closed-chest, off-pump coronary artery bypass grafting using an endoscopic stabilizer. Kappert and Cichon et al performed 37 off-pump totally endoscopic coronary artery bypass (TECAB) on a beating heart with the Da Vinci system and an endoscopic stabilizer. In this series, they reported a 3.4% rate of conversion to median sternotomy. They concluded that their results promote optimism about further development of TECAB. Another study by Boehm and Reichenspurner et al using a similar stabilizer with the Zeus system had similar results and conclusions about TECAB. Interestingly, a study by Cisowski and Drzewiecki in Poland compared percutaneous stenting with endoscopic coronary artery bypass grafting in patients with single-vessel disease. In this series of 100 patients percutaneous stenting resulted in restenosis in 6% and 12% at 1 and 6 months, respectively, compared with 2% at 6 months in the endoscopic bypass group.

Another use for robotic systems being investigated is pediatric laparoscopic surgery. Currently, laparoscopic pediatric surgery is limited by an inability to perform precise anastomoses of 2 to 15 millimeters. Although laparoscopic techniques may be used to treat infants with intestinal atresia, choledochal cysts, biliary atresia, and esophageal atresia, it is not the standard approach because of the technical difficulties. To evaluate the feasibility of robotic systems in pediatric minimally invasive surgery, Hollands and Dixey developed a study where enteroenterostomy, hepaticojejunostomy, and portoentorostomy were performed on piglets. They found all the procedure to be technically feasible with the Zeus robotic system. The study concludes that robotic-assisted laparoscopic techniques are technically feasible in pediatric surgery and may be of benefit in treating various disorders in term and preterm infants. More recently, Hollands and Dixey devised a study using 10 piglets to develop the procedure and evaluate the feasibility of performing a robot-assisted esophagoesophagostomy. In this study, robot-assisted and thoracoscopic approaches were evaluated and compared for leak, narrowing, caliber, mucosal approximation, as well as anesthesia, operative, anastomotic, and robotic set-up times. They found that the robot-assisted approach is feasible. They also discerned no statistically significant difference between the 2 approaches based on the above variables.

Despite many studies showing the feasibility of robotic surgery, there is still much to be desired. More high-quality clinical trials need to be performed and much more experience needs to be obtained before the full potential of these systems can be realized.

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