Hospitals considering buying another surgical robot might think twice in light of study findings showing that for its primary use—hysterectomies for benign disease like fibroids—the robot offers no better outcomes compared with traditional laparoscopic hysterectomies, but costs $2,189 more per patient.
That's according to research by Jason D. Wright, MD, of Columbia University College of Physicians and Surgeons and colleagues, which is published in the Journal of the American Medical Association.
Wright drew conclusions from an analysis of 264,758 hysterectomy procedures chronicled by the Premier database of 441 participating hospitals. The files include information from all payers between 2007 and 2010.
"The robot was introduced for prostatectomy years ago, but slowly diffused into other procedures" like hysterectomy, Wright says. "But the problem is we don't have a lot of data comparing outcomes in patients who underwent these procedures robotically versus other methods. This is really the first large study that compares them."
Other than cost, the only difference was that patients who underwent laparoscopic hysterectomy were slightly more likely to have a greater than two-day length of stay—one or two days more—than patients who underwent surgery with the robot. Infection rates, intraoperative injuries, reoperations, and transfusions were all essentially the same for either procedure.
The volume of robotic hysterectomy procedures in the United States has grown from 140,000 da Vinci cases in 2011 to 176,000 in 2012, according to a spokeswoman for Intuitive Surgical Inc., which makes the most commonly sold surgical robot, da Vinci. Most, 138,000, were related to non-cancerous conditions addressed in Wright's report.
The volume of robot surgery for hysterectomies now greatly exceeds that for prostate cancer, for which the da Vinci treated 88,000 U.S. patients last year.
Frank Loffer, MD, medical director of the American Association of Gynecologic Laparoscopists and a gynecologic surgeon at the University of Arizona, applauded the paper and suggested it should raise more questions for women choosing between types of hysterectomies, especially when they are led to believe the robot offers a better option.
"Mainly this is marketing on the part of hospitals and physicians, persuading patients to come in fixed on the idea, saying 'I want the latest; I want a robotic procedure, and if you don't do it I'm going to go to the guy next door.' Robotics is the latest and robotics is sexy," Loffer says. A position paper published by the AAGL this month calls for more research comparing the two hysterectomy procedures.
But Myriam Curet, MD, chief medical advisor at Intuitive and a consulting professor at Stanford University disagrees with Wright's report.
She says hysterectomies with da Vinci robot allow many women to opt for minimally invasive surgery instead of undergoing an open abdominal hysterectomy, or laparotomy, which requires a large abdominal incision, their only other choice. That's because many doctors around the country have not been trained in traditional laparoscopic techniques, which require more training, or just prefer doing procedures with the robot.
"Even after 20 years of laparotomies, only 25% to 30% of women are able to have a laparoscopic hysterectomy because there are limitations in doing that procedure...There's a complex learning curve to get past."
Additionally, she said, some morbidly obese patients are unsuitable for traditional laparoscopic procedures, but can more easily undergo the operation using the robot.
Lastly, she disputed Wright's conclusion that the robot is more expensive than traditional laparoscopy.
"There have been other studies that looked at lap versus the robot, and they found decreased readmission rates, decreased in some complications, decreases in pain scores and quicker recovery" with robots compared with traditional laparoscopy.
Wright says that though laparoscopic surgery has been around since the 1990s, "the uptake has been relatively slow." But once the da Vinci robot was introduced in 2005, the percentage of women who underwent abdominal hysterectomy began to drop. For some reason, the number of surgeons willing to perform the procedure less-expensively, with traditional laparoscopic techniques, never really took off.
Wright says that because of the number of patients in his analysis, his report might change the conversation between gynecologic surgeons and their patients. "It's reassuring because for both procedures, for lap and robotic hysterectomy, the complication rate was low for both operations."
Intuitive says some 1,871 da Vinci robots are now in use in U.S. hospitals, where they are approved by the U.S. Food and Drug Administration for otolaryngologic and thoracoscopic procedures in addition to gynecologic and urologic surgery. The robots are also used for cholecystectomy, gastric bypass, and mitral valve repair. Prices ranges from $1.2 million to $2.2 million per machine.
An accompanying editorial by Joel Weissman, PhD and Michael Zinner, MD, of Brigham and Women's Hospital in Boston, said hospitals and doctors need to keep better registry data, because robotic surgery may prove more "valuable for subgroups of patients with select comorbidities or anatomy."
Nevertheless, they criticize the "commercialization of this technology, which has raised eyebrows in the media and elsewhere" for taking direct-to-consumer marketing "to a higher level with advanced campaigns not only by industry but also by surgeons and the hospitals that own the machines."
When what is being advertised "is of questionable advantage, direct-to-consumer promotion may only fuel unnecessary utilization," they wrote. "Consumer advertising of expensive devices should be subjected to the same scrutiny as that of new and expensive medications."