Da Vinci Robot Surgical Risks Detailed

When something goes wrong after robotic surgery with the da Vinci surgical system, it's most likely due to co-morbidities in certain patients that make the procedure riskier, not flaws in the robot's technology itself, according to a study of 884 surgeries published this week in the Archives of Surgery.

"After reviewing all these cases, we can say for sure that there is no specific morbidity connected with the robot by itself, and that its mechanical failure is very, very rare," says lead author Pier C. Giulianotti, MD, of the Division of General and Minimally Invasive Surgery at the University of Illinois at Chicago. "We can now say that the morbidity and mortality that occurred in these patients was connected to the risk factors in the patients."

The authors wrote that by understanding which patients are at greater risk for robotic surgery complications, surgeons eventually can develop a scoring system to measure quality of care among providers and hospitals.

The authors determined that among these 884 robotic surgeries, the need to resort to non-robotic surgery techniques because of unanticipated complications was 2%; the re-operation rate was 2.4%; the mortality rate was .5%; the overall postoperative was 16.7%; and the mean length of stay was 4.5 days.  Giulianotti says that all the 884 procedures were done with the da Vinci system, and were assessed for complications that occurred within 30 days of hospital discharge.

Giulianotti emphasized that robotic surgery is, across the board, "clearly superior" than procedures done with open incisions or laparoscopy. "You don't leave big scars and adhesions, you have less post-operative pain, recovery times are shorter, and infection rates almost non-existent."

Risk Factors
But there were certain factors that predicted an increased rate of mortality and other complications, including having a body mass index less than 30, patient's age 70 or older, and several factors related to a diagnosis of malignant disease such as blood loss, and need for transfusion. The BMI under 30 was attributed, in part, to nutritional issues resulting from metastatic disease.

Performing more advanced types of procedures, such as a liver resection, removal of parts or all of the pancreas, and lung resection and kidney transplantation, were also associated with higher complication rates. 

Procedures associated with intermediate risk and having lower complication rates, were listed as living donor nephrectomies, bariatric procedures, esophageal hernia repairs, endocrine operations such as thyroidectomies, colorectal resections, splenectomies, thymectomies, and gynecological procedures.

Basic, or lowest-risk procedures were identified as gall bladder surgeries, hernia repairs, and biopsies.

Training Important
However, because there are complication rates and a risk of mortality with robotic surgery, it's important that surgeons who use the robot have appropriate experience and training, Giulianotti says.

"Unfortunately, there are institutions that are using the robot just because they want to be in the newspaper and want to advertise (that they have the latest technology)," although sometimes their surgeons are not sufficiently trained on the device. "The procedure ends up taking longer because people don't know exactly what to do, and this is connected to bad training."

Longer procedure times mean more anesthesiology and greater risk.

Giulianotti says that the study points to the need for hospital medical staffs to make sure surgeons are adequately trained and credentialed before granting staff privileges for robotic surgery.

"I think the surgical community and associations should work to clearly evaluate the standards, which are the guidelines for proctoring, teaching and training for giving privileges," to perform robotic surgery in hospitals, he says.

At the University of Illinois, he says, "We never let an inexperienced surgeon operate alone (with the da Vinci) without guidance or proctorship."

Da Vinci surgical robots have become ubiquitous in U.S. hospitals, with about 1,500 now operating just in the United States.  But their rapid adoption has raised questions about whether they are really superior to other surgical methods such as laparotomy or an open surgery.

They are expensive, costing an estimated $3.5 million over a five-year period. And their comparative effectiveness over other surgical procedures has not been well documented.

In a January report, the ECRI Institute noted that in the midst of the growth of these devices, "questions remain about clinician learning curves, what the ideal training program is, how many procedures are needed to maintain proficiency and what criteria hospitals should use to credential surgeons using these systems."

Proponents of robotic surgery state that the benefits this technology offers, including improved visualization, precision, and dexterity for the surgeon, make these systems well worth the added cost incurred to implement and maintain them," the ECRI report said.

"While this may be true, the real unanswered questions are how much value they add and, more importantly, how and when will they definitively improve patient care and long-term outcomes?"