BB&T Contributing Writer

CHICAGO — At the annual postgraduate course in Advanced Gynecologic Surgery sponsored by the Society of Gynecologic Surgeons (SGS) and Dartmouth Hitchcock Continuing Education in Health Sciences (Lebanon, New Hampshire), topics ranged from laparoscopic approaches for treating pelvic organ prolapse, to robotic applications in gynecologic surgery along with updates on current surgical clinical trials.

Dee Fenner, MD, Director of Gynecology, University of Michigan (Ann Arbor, Michigan) presented “Robotic Applications in Gynecologic Surgery,“ as a review of the use of robotic assistance in gynecologic surgery to date. In her opinion, robotic assistance is of value in complex procedures where lots of suturing is required such as prostatectomies, myomectomies, sacrocolpopexy, gastric bypass, cardiac valves, pancreatic surgery and radical hysterectomy with node dissection. She cautioned however, “You can't start up a robotic program on your own. You need a partner to be willing to do it with you and to share in the learning process.“ Even when the decision to add a robot to your hospital has been made, Intuitive Surgical (Sunnyvale, California) the only company offering a surgical robot (the da Vinci system) at this time has their own set of requirements to determine whether or not they will place a robot in a hospital. A commitment to perform the next 20 surgeries robotically as well as a minimum volume of at least 10 procedures on the robot over twelve months seems to be the going criteria. Although some of the benefits of using the robot may appear obvious, such as decreased surgeon morbidity, Fenner stated that not all of the patient benefits have been clinically proven (see Table 1). Early published studies show improved outcomes for the robot compared to open surgery, but laparoscopic surgery comparison was not part of the equation; in other words, they were not comparing apples to apples. In general, these retrospective studies comparing open gynecologic surgery to robot-assisted laparoscopic surgery has shown that the OR time is longer but blood loss is less and length of stay (LOS) is about half of open surgery. This latter fact is what contributed to Fenner's hospital to purchase the robot since “It's all about the beds'“ she said, “the hospital ROI increases when you can get the patients out of the beds sooner.“

There seems to be a reluctance on behalf of the gynecologists to use the robot routinely. One influence hospitals have used to encourage gynecologists to use the robot is to offer the gynecologist “free“ time on the robot if the hospital has already made the investment and there is available time on the robot. “In that case, if you can get equal or better outcomes using the robot and do not have to incorporate the cost (into your equation), it makes sense to go ahead and use it,“ said Fenner. Other surgeons here said that they have experienced pressure from their hospital to use the robot so that the hospital can advertise it for use in gynecology. Another surgeon mentioned that a potential patient made the decision to select a robot-using gynecologist over a non-user.

At an initial cost on average of $1.5 million dollars (an additional $500,000 for the teaching module), along with longer OR times, required robot disposable instruments, and annual service contracts from 1% to 3% of the purchase price, the robot is not contributing to keeping healthcare costs down. In spite of the increased cost, robot sales remain robust with penetration now even in rural small community hospitals. A new competitor for Intuitive is on the horizon to enter the U.S. market in the next year or two. Titan Medical (Toronto) has introduced its Amadeus Surgical Robot and is touting superior navigation and positioning, communications and vision. While Intuitive has a head start of more than 1400 units in place, there is plenty of room for Titan, as the projected global market is about 6,000 robots ($3.4 billion) and there are no other direct competitors. It will be interesting to see what happens to pricing with another robot on the market.

While the main driver for robot placements seems to be as a marketing tool, fresh clinical toe-to-toe comparisons against laparoscopic surgery are now being published. In the September issue of Obstetrics & Gynecology, Jason C. Barnett, MD, Duke University Hospital (Durham, North Carolina) authored “Cost Comparison Among Robotic, Laparoscopic, and Open Hysterectomy for Endometrial Cancer.“ In his study, he compared the costs associated with robotic, laparoscopic, and open hysterectomy for the treatment of endometrial cancer. In the model that included inpatient hospital costs, robotic expenses, lost wages and caregiver costs, they found that the average cost for a laparoscopic procedure was $10,128, for robotic was $11,726, and for open was $12,847. The open abdominal surgery patients stayed longer in the hospital and had a longer time for recovery (return to work) that accounted for the increased cost. In the two other models he studied — one that excluded lost wages and caregiver costs, and one that excluded the initial purchase of the robot — laparoscopic surgery without using the robot was again the least costly. He concluded, “Laparoscopy is the least expensive surgical approach for the treatment of endometrial cancer.“

Another comparative study was done at the Cleveland Clinic (Cleveland) and presented this past August at the American Urogynecology Society (AUGS; Washington) annual meeting, but has not yet been published. In that study, they found that the robotic surgery was more costly than laparoscopic surgery, with similar outcomes, said Fenner.

In a climate of healthcare cost containment, it seems amusing to find the most expensive technology being employed for the sake of marketing the hospital to potential patients. However, hospitals are convinced that if they do not have a robot they will lose their patient base. The numbers prove this true: the volume of oncologic gynecology procedures using the robot has doubled over the past two years. While hysterectomies may not be the most cost-effective procedure performed on the robot, their numbers are declining rapidly due to the advances made with endometrial ablation for dysfunctional uterine bleeding, and uterine fibroid embolization for fibroids. Where the robot adds value is for cancer surgery and other complicated procedures requiring a lot of suturing, and it appears that that is where the robot is heading in gynecology.

Another contributing factor to robot-mania is that less-skilled surgeons perform better using the robot. Fenner referred to the fact that less experienced surgeons can improve their performance with the robot, “But they still need to know how to do the surgery.“

Update on Clinical Trials

Linda Brubaker, MD, Professor, Department of OB/Gyn & Urology, Loyola University (Chicago) provided her annual update on final results as well as progress in ongoing surgical trials. She reminded the audience of “the importance of negative findings“ as she began her discussion; along with advice not to worry about translating the bizarre acronyms for most of the trials. She advised the audience to “Go to clinicaltrials.gov for more information on any of the trials discussed“ (see Table 2).

As an example of a negative finding that has a positive spin, the SISTEr trial that was published in the New England Journal of Medicine in 2007 compared two procedures that were used for treating stress urinary incontinence (SUI). At the time the trial was initiated, the Burch surgical procedure had been the gold standard for treating stress urinary incontinence for the past 60 years. Since the time of the publication the vast majority of the market has switched to using mid-urethral slings, rendering the findings somewhat irrelevant for current practice. However, of key importance in that study was the finding that showed that there were no statistically significant associations between the results of urodynamic testing and surgical outcomes. This fact could translate into the elimination of a $700-$800 urodynamic study that has been considered to be the standard of care for years for patients seeking treatment for urinary incontinence. This study was just presented at the American Urology Association (Linthicum, Maryland) meeting in May and was the longest and largest cohort of women followed and assessed annually over 7 years. Although it appeared in this trial that urodynamic testing did not correlate to outcome, several surgeons here felt that there was other valuable information gathered from urodynamic testing.

In the TOMUS (Trial of Mid-Urethral Slings) study, retropubic slings by Gynecare (Somerville, New Jersey) were compared to transobturator slings made by either Gynecare or American Medical Systems (Minnetonka, Minnesota) in terms of costs, complications, side effects and efficacy. The surgeons were blinded to the urodynamic test results and the patients were blinded to the type of sling they received. At twelve months, there were no significant differences in objective or subjective cure rates, patient satisfaction, or impact on quality of life across the groups. The TOMUS two-year data will be available in the summer of 2011.

Another trial that will have results in summer 2011 is the VALUE study where women were randomized with uncomplicated primary stress incontinence to either basic office evaluation only or with basic office evaluation plus urodynamic testing in order to better determine the value (thus, the name of the trial) of performing urodynamic testing that has been the gold standard in diagnosing urinary incontinence for a long time.

Always interesting is the variety of newly discovered treatments for using Botox by Allergan (Irvine, California). In 2008 the RUBI trial was trying to determine the efficacy of botox injections in the bladder for treating urge incontinence. The high rate of patients who quit taking the prevailing treatment for urge incontinence, anti-cholingenerics, along with the cost of those meds (average $150/month) were the driving forces to try the botox alternative. The RUBI trial was discontinued due to a higher than expected rate of urinary retention, although primary results documented efficacy in 60% of the patients for at least 193 days. In the wake of the RUBI trial, the ABC trial was initiated. In this trial only half the amount of botox is being injected and the trial is enjoying a quick enrollment.

Dr. Brubaker outlined a number of other trials in progress and summarized the questions they intended to answer, asking all audience members to encourage their patients to enroll in trials (see Table 3). She concluded with her personal mantra, “A day without data is a day without sunshine.“ She also advises gynecologists to read the data on new products, not just their brochures, as it is her opinion that “The thicker the brochure for a product, the weaker the data.“

Bulking agent market shifts

Bulking agents, or injectable fillers much the same as those used to cosmetically treat facial wrinkles, have taken a far-second seat to synthetic slings in the armamentarium of tools used to treat stress urinary incontinence (SUI). According to the Millennium Research Group (Toronto), the bulking agent market is about $25.4 million and is expected to grow 2%. Originally targeted for use in treating intrinsic sphincter disease (ISD), a form of SUI, bulking agents are now often used for mixed SUI, as a touch up to a sling procedure, or for patients who cannot undergo a sling procedure. Only four companies serve this market (see Table 4) and the one with the largest market share — CR Bard (Murray Hill, New Jersey) — appears to be exiting this market in spring 2011 when the herd of bovine that have produced this collagen product die out. Second in market share of bulking agents is Durasphere by Coloplast (Minneapolis), a $2 billion company who just this past October purchased Mpathy (Raynham, Massachusetts) for $30 million cash. Mpathy is a synthetic mesh company designed specifically for use in female pelvic surgery and whose products will complement and expand Coloplast's current offering of products that treat POP (pelvic organ prolapse) and SUI. Durasphere has two delivery systems: transurethral, that urologists prefer; and peri-urethral that gynecologists prefer. Boston Scientific (Natick, Massachusetts) and Microplastique/Uroplasty (Minneapolis) also compete for market share of bulking agents. Microplastique developed a unique device to enable an easier, more complete injection, but some cost concerns about its $400 price tag has led them to also develop a conventional needle delivery system like the others that costs only $30 on average.