Does Robotics Have a Place in Transplantation?

[Clark]

http://onlinelibrary.wiley.com/doi/10.1111/ajt.12686/full

The AJT Report
Sue Pondrom
DOI: 10.1111/ajt.12686
American Journal of Transplantation
Volume 14, Issue 3, pages 499–500, March 2014

Does Robotics Have a Place in Transplantation?

As patient demand drives the sale of surgical robots, critics note safety concerns and underreported adverse events

Technology has a “wow” factor. Perhaps that's one reason why between 2007 and 2011, the number of procedures performed with the da Vinci robotic surgery system, manufactured by Intuitive Surgical, increased by more than 400% in the U.S. and by more than 300% internationally, while the number of da Vinci systems installed increased by 75% in the U.S. and doubled internationally.[1] Those hospitals that spent $1.5 million for a surgical robot have aggressively marketed its availability to a technology-hungry public.

However, it remains to be seen whether there is true added value for this device relative to the conventional approaches, either in terms of clinical outcomes or cost. Most importantly, concerns about robot safety have emerged from some, including the belief that system malfunctions, injuries and even deaths may be underreported, and have led some medical professionals to question use of the surgical robot (see “FDA Notes Increase in Adverse Events With Robotic Surgery,” next page).[1, 2] Marty Makary, MD, associate professor of surgery at Johns Hopkins Hospital in Baltimore, says that “in every example in healthcare, voluntary reporting inherently underrepresents the magnitude of complications,” with robotic surgery's haphazard system of collecting data being no different.

Nonetheless, with hospitals and doctors determinedly advertising the benefits of their new surgical robot, it shouldn't be surprising that this much hyped technology for prostatectomy and hysterectomy has now found its way into transplantation.

Transplant Professionals Weigh In
What happens today is that intense media coverage and marketing can often overshadow the readiness of new technology, says Göran B.G. Klintmalm, MD, PhD, chief and chairman of Baylor University's Annette C. and Harold C. Simmons Transplant Institute in Dallas. “Sometimes, as surgeons, we are not given the time and place, plus the peace and quiet, to develop a technique before it becomes more widely spread,” he adds.

Matthew G. Hartwig, MD, director of thoracic surgery at Duke University Health System in Durham, N.C., uses the da Vinci robot in a variety of thoracic procedures, but not for transplantation, which constitutes about one-half of his practice. “I don't think the technology is good enough yet to do it for a lung transplant operation,” he says. “A transplant is very dependent upon expeditious operating and minimizing ischemia times for the organs. The robot tends to require a bit more time.”

At the Medstar Georgetown Transplant Institute in Washington, D.C., executive director Thomas Fishbein, MD, says the benefit of robotic surgery is yet to be studied or proved. “Robots are of marketing value, but not necessarily of scientific or clinical value,” he says, adding that “the incision with robotic surgery needs to be as big as the organ being removed or put in. This requirement limits the ability of the robot to lead to minimal incision size and its utility.”

“At our institution, the robot is used by many specialties,” says H. Albin Gritsch, MD, a transplant surgeon at the University of California, Los Angeles. Regarding transplantation, he adds that “the disposable robotic instruments add a significant cost and an incision is still required to insert the graft. In the event of bleeding from the anastomosis or graft, it may be difficult to get good control robotically and I would anticipate a significant conversion rate.”

KEY POINTS
While the number of robotic surgical procedures is on the rise, some question their safety and the accuracy of adverse event reporting.
Robotic use in transplantation is still limited, and larger studies are needed to address its usefulness.
Donor Nephrectomies and Kidney Transplants
Dr. Klintmalm says he had been skeptical about robotic surgery, but changed his mind after watching a video of Enrico Benedetti, MD, performing a robotic donor nephrectomy. “Any surgeon with worth knows when you see someone who has knowledge, skill sets and artistic skill. I came away totally convinced. Use of this technology, however, has to be developed by those individuals with talent who can then teach others.”

Dr. Benedetti, head of the department of surgery at the University of Illinois in Chicago, and his team have performed more than 880 robotic donor nephrectomies since September 2000. “The main advantage we've found is [that] the learning curve is shorter than using the laparoscope. It's about 10 to 15 cases [with robotics] versus 70 to 80 to become proficient in laparoscopic donor nephrectomy.”

Additionally, Dr. Benedetti's group announced in the December 2013 issue of the American Journal of Transplantation that between June 2009 and December 2011, 39 obese patients underwent robotic transplantation at their center, with outcomes comparing favorably to conventional transplantation.[3]

In fact, a majority of his patients are obese, Dr. Benedetti says, noting that many have come to his institution after they've been denied access to donation or transplantation from other centers. Historically, obese patients have worse outcomes and are predisposed to wound infection. “Only one-third of transplant centers accept a BMI [body mass index] greater than 35. Almost nobody does BMI greater than 40,” he adds. “Unfortunately, a good segment of the dialysis population is obese, especially in the minority and female population. Therefore, these patients are denied access or wait two years longer than normal-weight patients.”

In a recent robotic surgery review article, Dr. Benedetti and his team noted that donor nephrectomy is particularly popular with healthy donors who desire reduced postoperative pain, faster recovery and minimized surgical incisions.[4] Further, they noted that, “based on the experience in our institution, we can state that robotic-assisted kidney transplantation for obese recipients is a safe and effective procedure.” However, they added that while robotic surgery is good for kidney transplantation, its use in pancreas and liver transplantation “has been extremely limited, and larger series are needed to address its usefulness in these settings.”

FDA NOTES INCREASE IN ADVERSE EVENTS WITH ROBOTIC SURGERY
Last year, the U.S. Food and Drug Administration (FDA) noted an increase in the number of medical device reports (MDRs) submitted for the da Vinci Surgical System. However, “the increase is consistent with an overall increase in MDR reports submitted to the FDA for a variety of products over the last several years,” says Jennifer Rodriguez, an FDA spokesperson.

“This increase may be due to a number of factors,” she adds, “including an increase in the number of devices being used or surgeries being conducted as well as an increase in awareness of how to report problems with a device to the FDA.”

In recent years, the FDA has sent warning letters to Intuitive Surgical, the da Vinci manufacturer, noting that in some cases the company hadn't adequately reported device corrections and patient adverse events. Rodriguez says the FDA cannot comment on the warning letter because it is an open matter.

In a separate issue, Intuitive Surgical issued an “urgent medical device recall” for the robotic arms of its da Vinci Surgical System in early December, 2013, noting that the arms could stall and seize up while performing delicate operations.

Dr. Hartwig says surgeons might be more comfortable with the robot in the future. “As the technology improves, eventually they'll come up with a platform and procedures that would be possible to do those sorts of finer work.” He thinks that robotics will become an “integral part” of most, if not all, of surgeries. “But that's many years in the future,” he adds.


References
1
Makary MA. The all-American robot. In: Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care. New York, NY: Bloomsbury Press 2012.
2
Cooper MA. Ibrahim, Lyu H, Makary MA, Underreporting of robotic surgery complications. J Healthc Qual. Published online August 2013. DOI: 10/1111/jhq.12036:
3
Oberholzer J, Giulianotti P, Danielson KK, Spaggiari M, Bejarano-Pineda L, Bianco F, et al. Minimally invasive robotic kidney transplantation for obese patients previously denied access to transplantation. Am J Transplant 2013; 13: 721–728.
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4
Tzetanov I, Bejarano-Pineda L, Giulianotti PC, Jeon H, Garcia-Roca R, Bianco F, et al. State of the art of robotic surgery in organ transplantation. World J Surg 2013; 37: 2791–2799.
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