This article forms part of a Point/Counterpoint discussion on robotic surgery.
The shorter length-of-stay and decreased transfusion rates could lead to decreased perioperative costs of robotic procedures, but, if so, the differences are not sufficient for robotic technology to provide overall savings. 13–18 The initial trials for robotic cystectomy have demonstrated similar results, but long-term outcomes are still largely unknown, and further investigation is required. By increasing the share of nephron-sparing procedures for surgical extirpation of renal masses, robot-assisted partial nephrectomy (RAPN) is likely to confer increased value, compared with nonrobotic surgery.19 Although robotic surgery has experienced huge growth, the evidence that it meets the objectives of adding value to health care for all procedures is not convincing. Instead, robotic surgery might add value only in select cases (such as partial nephrectomy), and its use in other situations could place a large cost burden on society.
Robotic surgery in urological oncology: patient care or market share? Deborah R. Kaye, Jeffrey K. Mullins, H. Ballentine Carter and Trinity J. Bivalacqua Abstract | Surgical robotic use has grown exponentially in spite of limited or uncertain benefits and large costs. In certain situations, adoption of robotic technology provides value to patients and society. In other cases, however, the robot provides little or no increase in surgical quality, with increased expense, and, therefore, does not add value to health care. The surgical robot is expensive to purchase, maintain and operate, and can contribute to increased consumerism in relation to surgical procedures, and increased reliance on the technology, thus driving future increases in health-care expenditure. Given the current need for budget constraints, the cost-effectiveness of specific procedures must be evaluated. The surgical robot should be used when cost-effective, but traditional open and laparoscopic techniques also need to be continually fostered. Kaye, D. R. et al. Nat. Rev. Urol. 12, 55–60 (2015); published online 23 December 2014; doi:10.1038/nrurol.2014.339
Use of the surgical robot has seen exponential growth in spite of uncertain or limited benefits. From 2007 to 2010, the number of robotic surgeries worldwide nearly tripled, and da Vinci®robot installation increased by 75% in the USA.1 According to an estimate based on the Nationwide Inpatient Sample, minimally invasive radical prostatectomy (MIRP) accounted for 5.6% of all prostatectomies in 2005, increasing to 60% in 2009, and the robotic technology is associated with excess spending of greater than US$4 million per year nationally.2–5 Although some benefits have been achieved in short-term outcomes for robot-assisted prostatectomy (shorter hospital stays, decreased blood loss and decreased postoperative complications), quality-of-life data are mixed, no differences have been observed in oncologic outcomes and costs are substantial.6–8 Patients who undergo robot-assisted radical prostatectomy (RARP) are more likely to be dis satisfied with their outcomes than patients who undergo an open radical prostatectomy (ORP).9,10 However, although robotic technology offers limited benefits for radical prostatectomy and uncertain benefits for Competing interests The authors declare no competing interests.
radical cystectomy, it probably facilitates nephron-sparing surgery for treatment of kidney cancer. Although the benefits are moderate, costs associated with robotic surgery are great. In 2007, Barbash et al.1 demonstrated that, on average, the additional variable expenses associated with robot-assisted approaches were $1,600 (a 6% increase) per procedure compared with open surgery, rising to $3,200 (a 13% increase) if the price of the robot was taken into consideration. The authors further concluded that, if robotic technology completely replaced traditional surgery, nearly $2.5 billion would be added to health-care costs.1 This estimate includes the cost of the technology, but does not include expenses incurred as a result of unnecessary procedures.11 Value in health care is defined as health outcome per dollar spent. 12 In order for a technology to add value to the healthcare system, it needs to either improve outcomes or be associated with decreased expenditure. Few studies have shown any differences in outcomes for robotic prostatectomy that would translate into substantial savings. However, it should be noted that some of the series compare early experience in robotic surgery with more mature experience in open surgery.
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Increased costs associated with the use of robotics are derived from a combination of greater procedural expenses (both fixed and variable) per operation, and the use of advanced technologies to conduct operations in patients who are least likely to benefit from surgical intervention.11 Fixed costs are associated with purchasing and maintaining the robot, the use of disposable equipment and base operating-room costs. Variable costs include those associated with the length of a procedure (such as staffing and operating-room expenses), hospital length-of-stay, transfusion requirements, complications, convalescence, time required off work, additional procedures and medications. Konety et al.18 demonstrated that the median cost of a complication after cystectomy is $15,000, and that every complication, except for a haematoma, significantly increases hospital costs and length-of-stay. Robotic surgery has high fixed outlays and, therefore, must have substantially lower variable charges to provide overall savings. A monopoly currently exists in the market for the supply of surgical robots, whereas competition might result in a fall in the fixed costs. Savings have yet to be realized for most procedures, even in the most experienced centres of robotic surgery.13–18 VOLUME 12 | JANUARY 2015 | 55
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PERSPECTIVES Even when procedural costs are similar, increased use of unnecessary procedures places a cost burden on society. Perceived differences in postoperative recovery and outcomes drive increased demand from patients for robotic surgery rather than for alternative surgical or nonsurgical options, active surveillance or watchful waiting. Since 2005, the prostatectomy rate has increased despite a decrease in the incidence of prostate cancer.1,20 Much of this increase has involved patients >65 years old, who, in 2007, were 14% more likely to undergo surgery than their counterparts 3 years earlier, suggesting that the availability of robotic technology has created excess demand for surgery, when nonoperative management could have had equivalent or better outcomes. 1,20 Treatment with advanced technologies, including RARP, has increased among those least likely to benefit.11
Use of the surgical robot has seen exponential growth in spite of uncertain or limited benefits
Factors such as improved visibility of the surgical site, surgeon comfort, instrument stability and precision combined with a good range of motion and a shorter learning curve than for laparoscopic surgery have led to the adoption of robotic surgery. However, societal effects, and more specifically, directto-patient marketing and media coverage have also had a critical role.21 Direct-topatient marketing leads to increased spending on pharmaceutical and medical services and perceptions of improved performance with robotic surgery, even though the advertising claims might be unsubstantiated.21–25 In a study of direct-to-patient marketing for RARP, Mirkin et al.26 found that many advertisements claimed benefits that were not supported by the literature, and that 42% of websites failed to mention any possible complications. 26 Not only has this marketing strategy for robotic surgery been pervasive, but widespread media coverage of RARP has added to consumerism and increased demand from patients for the new technology.21 By contrast, partial nephrectomies are likely to be underutilized for extirpation of renal masses, and robotic technology enables increased adoption of this technique.19,27,28 More surgeons are now performing minimally invasive partial nephrectomy than 56 | JANUARY 2015 | VOLUME 12
before the introduction of the surgical robot, possibly owing to the shorter learning curve associated with the robot-assisted technique, compared with laparoscopy.19 Compared with radical nephrectomy, preservation of renal parenchyma might provide cost savings because of a decrease in the morbidity that is associated with chronic kidney disease, reduced risk of metachronous recurrences, improvement in many health-related quality- of-life (HRQOL) domains and improved survival.19,27,29–33 Using linked data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) programme and the Centers for Medicare and Medicaid Services (CMS), Miller and colleagues 34 demonstrated that surgeon preferences have greater influence over the type of renal oncologic surgery performed than patient or tumour characteristics. The authors argued that decreasing the adoption barriers to nephron-sparing and laparoscopic surgery is necessary to improve the care of patients with early-stage renal cancer.34 However, it is also important to avoid unnecessary use of robotic techniques in kidney surgery. Robot availability, practice patterns and consumerism can lead to an increase in the number of surgeries to remove small renal masses (SRMs), when observation might be a preferable option. Also, a surgeon with limited experience could be tempted by the availability of a surgical robot to perform a partial nephrectomy, or a robot-assisted total nephrectomy, when the patient might be better served by referral to a high-volume centre.
Outcomes of robotic surgery Prostatectomy Compared with open surgery, RARP has been associated with shorter lengths-ofstay, 14,35 decreased blood loss 14,35,36 and decreases in specific short-term complications, but increased operative times.35,37,38 Compared with ORP, RARP has been associ ated with an increased risk for any patient safety indicator, adverse patient safety events and decreased odds of mortality.3,39,40 The data are inconclusive for effects on erectile dysfunction and incontinence,35,36,41 as well as for cancer control.35,37,41–46 After performing a systematic review of the literature, Ahmed et al.14 concluded that minimally invasive urological surgery was associated with decreased length-of-stay and blood loss. Ficarra et al.35 performed a meta-analysis comparing ORP, laparoscopic radical prostatectomy (LRP) and RARP, and found no difference in positive
surgical margins (PSMs) between treatments (11–37% for ORP, 11–30% for LRP and 9.6–26% for RARP). Hu et al.41 compared ORP with MIRP, using SEER data from 2003 to 2007, and demonstrated that patients undergoing MIRP had a shorter length-of-stay, fewer postoperative respiratory complications and anastomotic strictures and fewer blood transfusions, but increased erectile dysfunction and urinary incontinence. No difference was found in the need for additional cancer therapies.41 Although the use of MIRP affects speci fic, short-term complication rates, it is not associated with decreased complication rates overall. Lowrance et al.37 showed that, compared with ORP, MIRP led to a shorter length-of-stay and fewer bladder-neck or urethral obstructions, but no difference in general, genitourinary or bowel complications, or in the need for postoperative androgen deprivation or radiation therapy. Using the Nationwide Inpatient Sample, Yu et al. 38 demonstrated that RARP and LRP resulted in decreased wound and vascular complications, but no differences in overall complication rates, when compared with ORP. Pierorazio et al.47 found that, when compared with ORP and LRP, RARP was more commonly associated with complications causing patients to be off the clinical care pathway (experiencing a complication). In a study comparing ORP with RARP in the modern era (defined by the authors as being after October 2008), when the surgical robot is widely used, and learning curves have theoretically been passed, Gandaglia et al.2 demonstrated that overall 30-day and 90-day complication rates for the two approaches were comparable, but RARP was associated with a higher probability of genitourinary complications.
Although the benefits are moderate, costs associated with robotic surgery are great
Although studies generally indicate equivalent oncologic outcomes between techniques, some studies have found that oncologic efficacy is inferior with the robotic approach. Williams et al.44 demonstrated increased likelihood of PSMs with RARP compared with ORP, even when controlling for confounders. Park et al.48 also demonstrated an increased PSM rate with RARP compared with ORP in a single www.nature.com/nrurol
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PERSPECTIVES surgeon’s early experience, although after >500 cases the pT3 PSM rates became equivalent. Most of the studies that have compared RARP and ORP are based on single institution experiences, and many are biased in terms of patient selection.23,25 Prospective, randomized, controlled trials involving multiple surgeons are required to properly compare these techniques.
Partial nephrectomy Preservation of kidney function is important for protection from renal insufficiency and associated cardiovascular morbidity. Laparoscopic partial nephrectomy (LPN) is technically challenging, and minimally invasive surgery is more likely to be used for removal of SRMs at high-volume centres than at low-volume centres.27,28 However, the advent of robotic surgery has enabled partial nephrectomy to be performed by less-experienced surgeons. RAPN is associ ated with a shorter learning curve than LPN, and its introduction has contributed to an increase in the rate of nephron-sparing surgery.19 Deane et al.49 demonstrated that, after performing as few as 10 RAPNs, a surgeon experienced in open surgical techniques can attain the same outcomes as a surgeon with extensive laparoscopic experience. By comparison, >200 cases can be required to become fully experienced at LPN.50–52 Data from retrospective studies suggest that kidney preservation with partial nephrectomy for SRMs can increase overall survival, because of decreased rates of renal insufficiency and cardiovascular problems. 53–56 Using linked SEER–CMS data, Tan and colleagues30 demonstrated improved overall survival for Medicare patients treated with partial nephrectomy rather than radical nephrectomy for T1a lesions. By contrast, Lau et al.56 performed an analysis of radical nephrectomy versus partial nephrectomy in patients with a healthy contralateral kidney, and found no differences in survival. Even though the American Urological Association guidelines recommend partial nephrectomy for patients with stage T1 renal lesions, in 2000–2001 only 20% of renal tumours 2–4 cm in diameter were removed with partial nephrectomy, suggesting that this procedure was underutilized.27,28 Few studies have directly compared open partial nephrectomy (OPN) with RAPN. In an analysis of the Nationwide Inpatient Sample, Yu et al.38 demonstrated that RAPN is associated with decreased length-of-stay
…robotic surgery has enabled partial nephrectomy to be performed by less-experienced surgeons
and fewer genitourinary, wound and vascular complications, but no differences in overall complications or mortality. Other studies comparing OPN with LPN have demonstrated decreased blood loss, shorter hospital stays, decreased analgesia requirements and shorter convalescence with LPN.57,58 Postoperative complications might be greater in LPN compared with OPN, but 10-year oncologic outcomes for the two procedures are equivalent.58,59 Although technically challenging, LPN offers equivalent outcomes, and cost savings, compared with RAPN. 60–62 In a systematic review comparing RAPN with LPN, no differences were found in operative times, blood loss, conversion rates, compli cations, PSMs or hospital length-of-stay, although RAPN was associated with shorter warm ischaemia times.62
Cystectomy Compared with open radical cystectomy (ORC), robot-assisted radical cystec tomy (RARC) has demonstrated shorter hospital stays, decreased blood loss and faster return of bowel function, but also increased operative times, and equivalent short-term oncologic outcomes.63–66 These data must be interpreted cautiously, as selection bias could have a role in the findings, and oncologic outcomes can only be determined with long-term follow-up observation. Many of these RARCs were performed in high-volume surgical centres, where surgeons have generally completed the robotic surgery learning curve, and the maximal benefits of the robot can be realized. The findings might not apply to lower-volume centres, with less-experienced surgeons and care-coordination teams. The Southwest Oncology Group (SWOG) performed a randomized, controlled trial of ORC versus RARC. The trial was terminated prematurely, after the interim analysis demonstrated no difference in outcomes between the two surgical approaches.67 Nix et al.65 performed a single-centre, randomized, controlled trial of ORC versus RARC, and found no differences in PSMs, lymphnode yield, overall complication rate or hospital stay. Robotic cystectomy was associated with decreased blood loss, faster return of bowel function and decreased analgesia
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requirement, but longer operating times. In a pilot, three-armed, randomized, controlled trial of ORC, laparoscopic radical cystectomy (LRC) and RARC, Gan et al.68 observed increased blood loss and lengthof-stay, and delayed return of bowel function for ORC, but shorter operative times compared with RARC and LRC. No other signifi cant differences were found for other clinical or pathological variables, or for physical, emotional or social function scores or sexual well-being. In an analysis of the Nationwide Inpatient Sample, comparing minimally invasive radical cystectomy with ORC, Cohen et al.66 observed a 30% decrease in the likelihood of a patient safety indicator with the minimally invasive approach, but no difference in mortality rates. Wang et al.64 reported that even though patients undergoing an open cystectomy had more extensive disease (extravesical disease and nodal metastasis), complication rates and short-term oncologic outcomes (number of PSMs and lymph nodes removed) were similar. Parekh et al. 63 also found no differences in short-term oncologic outcomes. Challacombe et al.69 observed more PSMs with minimally invasive cystectomy than with ORC for bulky disease. In addition, laparoscopy or robot use could potentially cause tumour seeding or impaired lymphatic venous flow, leading to unusual patterns of tumour recurrence.70
Costs of robotic surgery
The use of surgical robots has been associ ated with marginal clinical benefits, but great financial costs. Outcome and cost data are difficult to decipher. Most data are retrospective and lack uniformity, and they are often limited to single-surgeon or single-institution experience. Also, it is hard to assess the true cost of robotic technology as the costs are hidden. Reimbursement is often the same for robotic and open pro cedures, and so hospitals spread the additional expenses of robotic surgery across other associated procedures, which might not be directly related to the technology.1 Hospital volume, by virtue of economies of scale, centralization of services, experience and practice patterns, influences charges that are directly related to the robot, and those that are associated with postoperative pathways, hospital length-of-stay and complication rates. In order for a complete comparison to be performed, all fixed and variable expenses, including those associated with readmission and absence from work during convalescence, must be determined. VOLUME 12 | JANUARY 2015 | 57
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PERSPECTIVES Prostatectomy Several studies have compared the costs of MIRP and ORP, finding that although laparoscopic costs are similar to those of open surgery, robotic surgery is more expensive. Bolenz et al.13 determined that ORP was a less-costly surgical approach than LRP or RARP, with median direct costs of $4,437, $5,687 and $6,752, respectively. Increased operating-room and surgical expenses accounted for most of the differences. Initial and maintenance costs of the robot were not included in this evaluation. Ahmed et al.14 performed a systematic review of the literature and confirmed that RARP is the most expensive surgical modality, with costs of $2,000–$39,215, compared with $740– $29,771 for LRP and $1,870–$31,518 for ORP. Yu et al.38 performed a propensitymatched analysis and also demonstrated some short-term clinical benefits to robotic technology, but again, these differences were not sufficient to translate into financial savings. RARP had a mean adjusted cost $1,100 higher than ORP. Although increased hospital volume can decrease costs, even in the highest-volume centres, where the fixed charges associated with the surgical robot are more widely dispersed, and other fixed costs are decreased, RARP is still more expensive than ORP.16 Follow-up costs and those associated with postoperative complications are important considerations when evaluating the overall expense of a technology. By including all inpatient and postoperative costs for 1 year postoperatively, excluding the costs of other cancer therapies, Lowrance and colleagues71 demonstrated that MIRP was only 7.4% ($751) more expensive per procedure than ORP. However, this difference was still statistically significant. Kim et al.72 used the American Hospital Association Survey and the Nationwide Inpatient Sample to measure costs associated with a prostatectomy, including postoperative complications. They found that, although patients undergoing RARP were younger, had lower Elixhauser comorbidity indices, and were more likely to be operated on in high-volume centres, RARP was associated with higher hospitalization expenses compared with ORP (adjusted costs $11,032 versus $9,390).72 In the postdissemination era, when surgical robots are widespread, and many surgeons are trained in their use, Gandaglia et al.2 demonstrated that RARP had higher charges than ORP within 1 year from surgery ($13,395 versus $11,970, P