Two 2008 Studies Provide Data on Robotic Surgery Complications
MIRA 2008
Two large studies indicate equipment malfunctions occur and provide data on robotic surgery complications
By John J. Otrompke, JD
Two large studies released at MIRA 2008 provide data on Da Vinci equipment malfunctions, and indicate that complications from robotic surgery with the da Vinci decrease when the surgery is performed in a high-volume institution or a center of excellence. Nonetheless, the presenter of the studies called for surgeons who experience complications or equipment failure to register their results with a download from the device.
“Every surgeon should register errors when they occur,” said Dr. Kenneth Palmer, MD, a resident at Florida Hospital Celebration Health, who presented the two studies at MIRA. The studies were noteworthy for their size, as the first, ‘Robotic Equipment Malfunction During Robotic Prostatectomy: A Multi-Institutional Study,’ involved 11 institutions and a total case volume of 8,240.
The second study, ‘Intra Operative Complications During Robotic Assisted Laparoscopic Prostatectomy,’ involved 1,256 consecutive cases at Ohio State University.
The twelve institutions in the first study, regarding device malfunctions, included Vanderbilt University, the Prostate Cancer Center of Austin, Texas, Cornell and Ohio State Universities, and others, according to Palmer.
“With the Da Vinci robot, the computer board can go wrong, or there can be problems with the arms or with the optics,” said Palmer, noting that the carbon dioxide which is normally used to inflate the patient’s abdomen can also prevent camera fogging. “Defaults can be overridden, and the procedure can be converted to either laparoscopic or open surgery. Most critical failures can be identified before the procedure, because the Da Vinci performs a self-test. It all depends on the volume of the center or the experience of the surgeon,” Palmer added.
Of more than 8,000 Da Vinci prostatectomies performed in the study, critical failure occurred in 0.4% of the cases, leading to 23 cancellations, one laparascopic conversion, and eight open conversions. Recoverable failure occurred in 1.5% of cases, according to the abstract.
Medical complications were slightly more common, however. According to the second study, complications occurred in 64 out of 1,256 cases, or just over 5.1%. However, there was no mortality or immediate return for second procedure associated with these complications. The study involved a follow-up of 19.7 months.
The complications included four blood transfusions, four myocardial infarctions, and two lymphoceles, among others.
As with equipment problems, complications appeared to decrease with the experience of the center and surgeons.
Other doctors on the study included Dr. Vipul Patel, MD, founder of the Global Robotics Institute, which is hosting its third annual World Robotic Urology Symposium in Orlando, March 17-19 (see calendar). The studies were on-going, Palmer said.
Another study released by Palmer, Vatel and colleagues at MIRA 2008, ‘Robotic Assisted Laparascopic Radical Prostatectomy: Perioperative Outcomes of 1,500 Patients,’ reported positive results in 1,500 consecutive prostatectomy cases.
Two large studies indicate equipment malfunctions occur and provide data on robotic surgery complications
By John J. Otrompke, JD
Two large studies released at MIRA 2008 provide data on Da Vinci equipment malfunctions, and indicate that complications from robotic surgery with the da Vinci decrease when the surgery is performed in a high-volume institution or a center of excellence. Nonetheless, the presenter of the studies called for surgeons who experience complications or equipment failure to register their results with a download from the device.
“Every surgeon should register errors when they occur,” said Dr. Kenneth Palmer, MD, a resident at Florida Hospital Celebration Health, who presented the two studies at MIRA. The studies were noteworthy for their size, as the first, ‘Robotic Equipment Malfunction During Robotic Prostatectomy: A Multi-Institutional Study,’ involved 11 institutions and a total case volume of 8,240.
The second study, ‘Intra Operative Complications During Robotic Assisted Laparoscopic Prostatectomy,’ involved 1,256 consecutive cases at Ohio State University.
The twelve institutions in the first study, regarding device malfunctions, included Vanderbilt University, the Prostate Cancer Center of Austin, Texas, Cornell and Ohio State Universities, and others, according to Palmer.
“With the Da Vinci robot, the computer board can go wrong, or there can be problems with the arms or with the optics,” said Palmer, noting that the carbon dioxide which is normally used to inflate the patient’s abdomen can also prevent camera fogging. “Defaults can be overridden, and the procedure can be converted to either laparoscopic or open surgery. Most critical failures can be identified before the procedure, because the Da Vinci performs a self-test. It all depends on the volume of the center or the experience of the surgeon,” Palmer added.
Of more than 8,000 Da Vinci prostatectomies performed in the study, critical failure occurred in 0.4% of the cases, leading to 23 cancellations, one laparascopic conversion, and eight open conversions. Recoverable failure occurred in 1.5% of cases, according to the abstract.
Medical complications were slightly more common, however. According to the second study, complications occurred in 64 out of 1,256 cases, or just over 5.1%. However, there was no mortality or immediate return for second procedure associated with these complications. The study involved a follow-up of 19.7 months.
The complications included four blood transfusions, four myocardial infarctions, and two lymphoceles, among others.
As with equipment problems, complications appeared to decrease with the experience of the center and surgeons.
Other doctors on the study included Dr. Vipul Patel, MD, founder of the Global Robotics Institute, which is hosting its third annual World Robotic Urology Symposium in Orlando, March 17-19 (see calendar). The studies were on-going, Palmer said.
Another study released by Palmer, Vatel and colleagues at MIRA 2008, ‘Robotic Assisted Laparascopic Radical Prostatectomy: Perioperative Outcomes of 1,500 Patients,’ reported positive results in 1,500 consecutive prostatectomy cases.
posted by John J. Otrompke | 8:04 AM
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