No Safety Benefit Found in Use of Robot for Hysterectomy
Surgery to remove the uterus using a $1.5 million robot from Intuitive Surgical Inc. (ISRG) doesn’t reduce complications and may raise pneumonia risk compared with conventional less-invasive techniques, according to a second extensive study to find no added benefit from the devices.
Researchers examined data from about 16,000 women who had hysterectomies for benign conditions in 2009 and 2010. The robot operations cost hospitals $2,489 more per procedure with a similar complication rate as the standard practice of removing the uterus with minimally invasive equipment, according to the study released in the journal Obstetrics & Gynecology.
“Unfortunately, the greater costs associated with robotic-assisted hysterectomy were not reflected in improvement in outcomes,” said researchers at the University of Texas Southwestern Medical Center at Dallas.
The results released yesterday are from the second large-scale research published this year to find higher costs with no added benefit for robotic hysterectomy. In February, Bloomberg News reported that U.S. health regulators were surveying surgeons on the robots following a rise in reports that included as many as 70 deaths since 2009. In July, Sunnyvale, California-based Intuitive said sales growth slowed in the second quarter and that it had received a regulatory warning letter concerning reporting issues for the devices.
Intuitive fell less than 1 percent to $384.52 at 9:52 a.m. New York time. The shares have declined 33 percent since Feb. 27, the day before Bloomberg News reported the Food and Drug Administration survey of surgeons about the products.
The company’s da Vinci system, used in more than 1,300 hospitals, is its primary product. Revenue from the robot and related instruments and supplies generated $1.8 billion in 2012, Intuitive has reported.
In the study released yesterday, while patients who got robotic hysterectomies had a lower rate of needing blood transfusions, they had double the risk of getting pneumonia after the operation.
The pneumonia finding may be related to a trend toward a higher number of robotic hysterectomy patients needing intubation after their operation, the University of Texas Southwestern researchers wrote. Lengthy robotic operations with patients in steep head-down positions may result in fluid buildup in the airways, the authors suggested. The trend was not statistically meaningful.
The net result was no benefit in reducing complications for robotic surgery. The complication rate was 8.80 percent for robotic hysterectomy surgery and 8.85 percent for a standard minimally invasive hysterectomy, according to the study.
Intuitive Surgical, in an e-mail, said patients in the study getting robotic surgery tended to be older, heavier and had a higher rate of chronic conditions.
“Given these facts, it is likely that a substantial percentage of patients who received a robotic-assisted hysterectomy would have otherwise received an open hysterectomy,” Angela Wonson, a spokeswoman for the company, said in the e-mail.
In the study, which culled data from more than 800,000 hysterectomies, the complication comparison was based on a subset of patients with similar ages, obesity rates and health status.
With standard minimally invasive surgery, called laparoscopy, surgeons manipulate instruments through several tiny incisions in the abdomen while looking inside the patient through a camera called a laparoscope.
Robotic surgery is similar, except that the surgeon sits at a console a few feet away and maneuvers robotic arms while looking into a high-definition display. Unlike the standard equipment, the robotic instruments have wrists, potentially enabling finer control and movement.
In February, a study in the Journal of the American Medical Association found that robotic hysterectomies for benign conditions cost hospitals $2,189 more per procedure than the same surgery without the robot. That research, which looked at data from 441 hospitals from 2007 to 2010, showed complication rates were 5.5 percent for the robot surgery and 5.3 percent for a less invasive hysterectomy.
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