Key points

Introduction

Robotic-assisted laparoscopic surgery (RALS) has evolved since its inception in 1985 to its current state in the form of the da Vinci surgical system (Intuitive Surgical, Sunnyvale, California). Following receipt of US Food and Drug Administration approval in 2000 for adult and pediatric surgeries, utilization has increased ahead of empirical evidence demonstrating superiority over conventional surgical approaches. The technology offers advantages of a 3-dimensional view of the operative field, absence of a fulcrum effect, 7° versus 4° of freedom of movement compared with conventional laparoscopy with ‘wristed’ instruments that facilitate intracorporeal suturing, elimination of surgeon tremor, and ergonomic benefits, hastening the learning curve for open surgeons transitioning to minimally invasive surgery. Additional advantages over open surgery include smaller incisions, reduced intraoperative blood loss due to carbon dioxide insufflation, decreased postoperative pain, and shorter hospital lengths of stay (LOS) and convalescence. Disadvantages of RALS include relatively longer operative times, absence of tactile feedback, and instrument collisions when traversing broader operative fields.

Since the introduction of the da Vinci system, most cases are now dedicated toward urology and urologic oncology procedures. With more than 1400 robotic surgical systems installed in US hospitals, with some having up to 5 systems, and the number of robotic systems in other countries doubling from 200 to 400 between 2007 and 2009, RALS has been rapidly adopted in the absence of overwhelming evidence demonstrating superior outcomes compared with laparoscopic and open surgery. Further, direct-to-consumer advertising has resulted in heightened patient demand for RALS, particularly for radical prostatectomy. However, men who underwent radical prostatectomy with RALS versus open surgery were more likely to be diagnosed with incontinence and erectile dysfunction, and more likely to experience treatment regret. Regarding utilization of pharmacotherapy for erectile dysfunction following treatment for localized prostate cancer, men undergoing minimally invasive surgery including RALS were more likely to use pharmacotherapy after treatment. Moreover, patients were more likely to be regretful and dissatisfied, possibly because of greater expectation of an innovative procedure with less counseling on adverse effects. It has been suggested that urologists carefully portray the risks and benefits of new technologies during preoperative counseling to minimize regret and maximize satisfaction. However, more recent analysis demonstrates that robotic-assisted versus open radical prostatectomy is associated with fewer positive surgical margins and less use of radiation or androgen deprivation therapy within 2 years of surgery, suggesting better cancer control outcomes. As such, further comparative effectiveness research is needed to identify determinants of appropriate dissemination of robotic surgery.

Introduction

Robotic-assisted laparoscopic surgery (RALS) has evolved since its inception in 1985 to its current state in the form of the da Vinci surgical system (Intuitive Surgical, Sunnyvale, California). Following receipt of US Food and Drug Administration approval in 2000 for adult and pediatric surgeries, utilization has increased ahead of empirical evidence demonstrating superiority over conventional surgical approaches. The technology offers advantages of a 3-dimensional view of the operative field, absence of a fulcrum effect, 7° versus 4° of freedom of movement compared with conventional laparoscopy with ‘wristed’ instruments that facilitate intracorporeal suturing, elimination of surgeon tremor, and ergonomic benefits, hastening the learning curve for open surgeons transitioning to minimally invasive surgery. Additional advantages over open surgery include smaller incisions, reduced intraoperative blood loss due to carbon dioxide insufflation, decreased postoperative pain, and shorter hospital lengths of stay (LOS) and convalescence. Disadvantages of RALS include relatively longer operative times, absence of tactile feedback, and instrument collisions when traversing broader operative fields.

Since the introduction of the da Vinci system, most cases are now dedicated toward urology and urologic oncology procedures. With more than 1400 robotic surgical systems installed in US hospitals, with some having up to 5 systems, and the number of robotic systems in other countries doubling from 200 to 400 between 2007 and 2009, RALS has been rapidly adopted in the absence of overwhelming evidence demonstrating superior outcomes compared with laparoscopic and open surgery. Further, direct-to-consumer advertising has resulted in heightened patient demand for RALS, particularly for radical prostatectomy. However, men who underwent radical prostatectomy with RALS versus open surgery were more likely to be diagnosed with incontinence and erectile dysfunction, and more likely to experience treatment regret. Regarding utilization of pharmacotherapy for erectile dysfunction following treatment for localized prostate cancer, men undergoing minimally invasive surgery including RALS were more likely to use pharmacotherapy after treatment. Moreover, patients were more likely to be regretful and dissatisfied, possibly because of greater expectation of an innovative procedure with less counseling on adverse effects. It has been suggested that urologists carefully portray the risks and benefits of new technologies during preoperative counseling to minimize regret and maximize satisfaction. However, more recent analysis demonstrates that robotic-assisted versus open radical prostatectomy is associated with fewer positive surgical margins and less use of radiation or androgen deprivation therapy within 2 years of surgery, suggesting better cancer control outcomes. As such, further comparative effectiveness research is needed to identify determinants of appropriate dissemination of robotic surgery.

Consequences of rapid adoption of robotic surgery

Many patients intuitively perceived minimally invasive approaches as reducing complications compared with conventional surgery. Patients prefer these approaches, especially RALS, because of smaller incisions requiring fewer analgesics and shorter hospital stays, even at a greater cost to the health system. The cosmetic appeal of multiple small incisions versus a single incision is one of personal preference. With rapid adoption, prolonged learning curves, and varying hospital accreditation practices for attaining RALS privileges, there may come unforeseen risks. For example, the rapid adoption of laparoscopic cholecystectomy in the 1990s resulted in a spike in biliary tract injuries from 1500 to 4000 per year. Well-designed studies comparing surgical approaches are sparse, and most studies are comprised of single-surgeon series that may not be generalizable to other practice settings.

RALS was rapidly adopted for radical prostatectomy, and hospital acquisition led to the expansion of RALS for other procedures. A consequence of the rapid adoption of RALS resulted in certain professional organizations recommending against RALS as a preferred treatment option. For instance, robotic hysterectomy has become increasingly utilized with increased complications and costs over open surgery, so much that the American Society of Obstetrics and Gynecology no longer recommends RALS as a first-line surgical option.

A recent population-based comparative effectiveness study of RALS utilization, patterns of care, and costs resulted in several important findings that may provide some insight into lessons learned from the rapid adoption of RALS. First, racial, geographic, and hospital-based variations exist in patients undergoing RALS, with limited access to care for nonwhite patients. Several other studies have demonstrated similar heterogeneity in access to newer technology and therefore limit generalizability of outcomes. Second, higher-volume hospitals are more likely to offer RALS for procedures such as radical prostatectomy; however, they are less likely to offer it for other procedures such as cystectomy, owing to likely increased complexity of the latter procedure. Outcomes of robotic cystectomy are comparable to the open approach; however, prior comparative analyses are derived from high-volume open and robotic surgeons. Interestingly, robotic partial nephrectomy has become increasingly adopted over conventional laparoscopy, which had a prolonged learning curve and technical complexity that precluded universal adoption. A recent population-based study found robotic partial nephrectomy to result in fewer complications and shorter length of stay than either the laparoscopic or open approach. As newer technologies such as RALS become further adapted to more complex procedures, it is critical to understand the consequences of rapid adoption of RALS in order to avoid potential future pitfalls. Some been suggested that state-based certificates of need should be implemented to control RALS utilization and limit costs as they pertain to prostate cancer. However, state-based regulations were ineffective in constraining robotic surgery adoption and intensity-modulated radiation therapy, another controversial, high-cost prostate cancer treatment modality. As health care reform gets underway, one may expect similar constructs to be implemented in order to control RALS and health care costs while striving to improve patient outcomes.

The costs of robotic surgery

RALS has been consistently shown to be more costly than conventional laparoscopic or open surgery. Others have demonstrated RALS to be $1065 to $2315 higher in direct costs for radical prostatectomy and $535 to $1651 more for partial nephrectomy, despite purported cost savings associated with shorter LOS. In regards to radical cystectomy, where there has been conflicting evidence regarding LOS benefit, RALS was $3797 more costly, with $4326 higher 90-day median direct costs than open surgery. One study estimated that the incremental cost (without factoring in the purchase of the robotic surgical system) of RALS averages approximately $1600, or an additional 6% per case more than open surgery. Lower costs have been associated with higher RALS volume for radical prostatectomy compared with other procedures, consistent with a study demonstrating 68% lower charges for high- versus low-volume minimally invasive radical prostatectomy surgeons. When analyzing RALS costs as related to radical prostatectomy, the incremental cost when compared to open surgery doubles when factoring in the $1.75 million capital acquisition cost of the robotic surgical system. This projects to $2.5 billion in annual US health care expenditures if RALS universally replaces conventional surgical approaches. Considering medical devices are not subject to the same level of scrutiny compared with pharmaceuticals in demonstrating clinical effectiveness, the rapid adoption of new medical technologies such as RALS significantly contributes to spiraling health care costs. Pearson and Bach proposed a tiered payment system, whereby full reimbursement be rendered for therapies demonstrating superior outcomes to existing standards. Under this paradigm, in the absence of demonstrable cost-effectiveness, fiscal responsibility for the incremental cost of RALS shifts from insurers to patients, and may thus attenuate demand.

Provider factors associated with costs: room to improve

High-risk surgical procedures such as pancreatectomy and esophagectomy have decreased morbidity and mortality when performed in high-volume hospitals. Similarly, higher hospital volume is associated with decreased morbidity for colon and breast cancer surgeries. Additionally, hospital volume is inversely related to in-hospital mortality and LOS after radical prostatectomy. However, surgeon rather than hospital volume has been shown to be the primary determinant of radical prostatectomy outcomes, as intensive care admissions and lengths of hospitalization have declined over the past 20 years. Taking into account the previously mentioned changes in radical prostatectomy trends and outcomes, hospital and surgeon volumes have been analyzed to assess whether centralization may be beneficial to minimize morbidity, mortality, and health care costs. Given that most radical prostatectomies are performed by surgeons performing fewer than 10 cases a year, selective referral of radical prostatectomies to high-volume surgeons may be lead to significant cost savings, particularly with the reality of accountable care organizations looming on the horizon.

Several studies have analyzed radical prostatectomy provider effects on costs. Higher surgeon and hospital volumes have been associated with a reduction in radical prostatectomy costs. It has even been suggested that selective referral to high-volume surgeons at intermediate- and high-volume hospitals nationally would reduce health care costs by more than $28.7 million. This amount exceeds the $19 million the National Cancer Institute allocated to funding surgery-related research in 2010 for prostate cancer. Others have shown that higher surgeon volume is associated with lower hospital charges, suggesting that as radical prostatectomy surgeons gain experience, they become more efficient, and have better outcomes with lower costs.

Lastly, it has been documented that higher surgeon volume is associated with better perioperative outcomes, which may be the more important determinant to offset costs. Higher-volume hospitals tend to be academic medical centers with the mission of furthering research, education, and clinical care, accepting patients regardless of clinical presentation and financial risk. Thus, higher-volume hospitals may have better information technology, documentation, and compliance with reimbursement guidelines to offset potential financial risks.