An Increase in
Robotic Surgery AERs, the FDA Survey
Robotic technology
has gained popularity in various surgical specialties, including urology,
gynecology, thoracic surgery, general surgery, and head and neck surgery. The
da Vinci® Surgical System (Intuitive Surgical®; Sunnyvale, California) is the
only FDA-approved robotic system on the market. The system has now been
installed at more than 2000 hospitals around the world, according to Intuitive
Surgical. Between 2011 and 2012, the number of associated adverse event reports
(AERs) increased by 34%, from 211 to 282.[1] This has prompted the FDA to
survey robotics-using surgeons about their experiences. During that period, the
number of procedures performed with the da Vinci system increased by 26%, from
292,000 to 367,000.
AERs With Robotics:
Any Worse Than After Laparoscopy?
The robotic platform
is only 8 years old, so any surgeon who has used the device has, at most, only
8 years of experience, and so the rate of AERs in general still is likely to be
high.[2] Medscape interviewed Joseph Colella, MD, founder of the Clinical Robotic Surgery Association,
who believes that curves of adoption and adverse events that occur with
robotics, and that occurred with laparoscopic surgery, are very similar, if not
almost identical. As an example, he said, "One of the more commonly
reported errors with robotics is inappropriate arcing of a coagulation device,
where it injures a piece of intestine. Those same events happened and still
happen with laparoscopy." To date, studies comparing laparoscopy and
robotic procedures are of poor quality and suffer from significant
heterogeneity and control bias.[3]
What About Machine
Errors?
Recent studies[4,5] and
lawsuits involving microcracks in the insulation, which may cause burning, have
triggered questions about the safety of robotic surgery, which subsequently has
been covered in the popular media.[6] Dr. Colella believes that
machine errors are rare. "In my experience, I have never had the robot
malfunction in any way." A 2008 review looked at the FDA Manufacturer and
User Facility Device Experience (MAUDE) database, a valuable source of
information on adverse outcomes associated with devices.[7] It
reported an estimated rate of device malfunctions of 0.38%, and only a small
percentage of these were associated with patient injury.[8]
The robotic approach provides surgeons with
multiple advantages compared with open procedures and other minimally invasive
approached, notably a 3-dimensional perspective and improved dexterity and
precision.[9] Dr.
Colella described the advantages for the patient. “As a potential
patient, stop for a moment and put on the common-sense hat. Your surgeon
tells you that he can see 100% better in 3 dimensions, that he can sew better
and probably within 1-2 years he will be able to do every procedure though 1
incision. You can imagine that the sky is the limit in employing robotic
surgery. It’s an enabling technology. I firmly believe that we are
finding new and beneficial applications almost on a monthly basis.
There are also a
number of disadvantages.[9] Dr. Colella mentioned, “The
robotic visual field is somewhat smaller that the laparoscopic visual
field. However, you quickly adapt and know the limits of your vision or
the lack of them.” Training and experience typically resolve this
problem, and surgeons learn to compensate for loss of tactile and force
feedback. For surgeons in training, however, the latter challenge
increases the risk of rupturing sutures during knotting.
Is Insufficient
Training a Serious Problem With Robotic Surgery?
Intuitive Surgical
is currently facing various lawsuits involving improperly trained surgeons.[10] In
a Medscape interview,
J. Kellogg Parsons, MD, Associate Professor of Surgery, Department of Urology,
Moores Cancer Center, University of California, San Diego, pointed out that
"there is no standardized process for credentialing, teaching, proctoring,
or obtaining hospital privileges for robotic-assisted surgery." Both the
Institute of Medicine and the FDA have recognized that the process by which new
devices enter into practice needs to be revised.[11,12]
Statement From James
T. Breeden, MD, President, ACOG
In March 2013, James
T. Breeden, MD, President of the American Congress of Obstetrics and Gynecology
(ACOG), issued a statement that recommended against using robotic
devices in routine gynecologic procedures.[13] A 2013 study
in JAMA reported
that the percentage of robotically assisted hysterectomies increased from 0.5%
in 2007 to 9.5% in 2010.[14] Three years after the first
robotically assisted hysterectomies were performed, the approach accounted for
22.4% of all hysterectomies where robotic surgery was available. Studies
suggest that robotic and laparoscopic hysterectomy have similar morbidity
profiles, but the use of robotics substantially increases costs.[9,15] In
the JAMA study, costs associated with
robotically assisted hysterectomy were $2189 more per case than for
laparoscopic hysterectomy.
Robotic Surgery for
Hysterectomy
In the ACOG
statement, Dr. Breeden said, "Patients should be advised that robotic
hysterectomy is best used for unusual and complex clinical conditions in which
improved outcomes over standard minimally invasive approaches have been
demonstrated." Some centers have reported shortened length of stay and
reduced pain, operative time, and blood loss with robotic compared with
nonrobotic hysterectomies, as well as fewer complications, but larger studies
are needed to confirm its value compared to other minimally invasive
procedures.[15-17]
Robotic Surgery in
Bariatrics
Robotic surgery is
showing promise in complex bariatric cases, including in the superobese.[18-20] Dr.
Colella reported that the bleeding rate approaches zero, the major complication
rate is less than 0.3%, and there have been no reported deaths. Stricture rates
are substantially reduced and the procedure requires fewer staples than does
laparoscopy. Dr. Colella added, "Robotics have lessened the need for pain
medication, which allows much quicker gastrointestinal recovery, which, in
turn, reduces the incidences of pneumonia and aspirations. It will be a
tremendous game changer when you can do robotic gastric bypass with a single
15-mm incision in a 600-lb patient, who goes home the next day." Robotically
assisted revision can be done safely but has a high postoperative complication
rate.[21]
Robotic Surgery for
Prostatectomy
The European
Association of Urology (EAU) has issued guidelines on robotic and single-site
surgery in urology,[22] which conclude: "Robot-assisted
urologic surgery is an emerging and safe technology for most urologic
operations." The evidence was best for prostatectomy. Nonetheless, the
guideline authors also note that the evidence to support EAU's conclusions was
generally poor and based on expert consensus. Even with prostatectomy, studies
are not showing better long-term effects on incontinence and erectile
dysfunction than with open prostatectomies. However, perioperative benefits
were generally confirmed.[23]
Other Procedures
Some studies have
found robotic surgeries to be beneficial for specific complex procedures,
including those for gastric cancer[24] and transoral surgeries.[25-27] A
study on gastrectomy, however, found higher rates of anastomotic leaks in both
robotic and laparoscopic surgery compared with the open procedure.[28] It
is still unclear whether robotic surgery has a superior advantage in most
general surgeries. In a recent analysis, the robotic approach appeared to be
cost-effective and as safe as nonrobotic surgery, except in cholecystectomy and
esophagogastric procedures.[29] Robotic surgery is being used
in many urologic procedures in addition to prostatectomy,[30] but,
as with other robotic procedures, even with its advantages cost remains an
issue.[31,32]
Cost and
Overmarketing: The Elephants in the Room
The major issue in
the use of robotics is the price. The machines themselves cost between $1.5 and
$2.2 million, and service contracts run from $160,000 to $170,000 per year.
Disposable instruments range from $600 to $1000, and each procedure can use 3-8
instruments. It is not yet known whether costs will be recouped downstream. An
analysis published in March reported that da Vinci surgeries add incremental
costs of 20% per procedure, which are absorbed by the hospitals.[3] There
is also some indication that hospitals overmarket their robotic capabilities.
In a 2011 study, investigators reported that 41% of hospital Websites described
their capabilities; clinical superiority was claimed on 86% of these sites, and
none mentioned risks.[33]
Competitors and
Future Robotics
At this time, there
is no competitor to the da Vinci robotic system, although systems are in
development in Canada, Europe, and Asia. Dr. Colella said, "Other
technologies are attempting to enter that space, but right now the barriers to
entry are very significant. Of course, it's inevitable that eventually there
will be competition."
References ...
“Robotic Surgery:
Too Much, Too Soon?” by Carol Packham & Steven Schwaitzberg, M.D., for MedScape on August 8, 2013
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