Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Real-world outcomes of hemostatic matrices in cardiac surgery.

OBJECTIVE: While hemostatic matrices are efficacious in achieving hemostasis, outcomes research is limited; therefore, this study analyzed clinical outcomes of flowable hemostatic matrices in a real-world cardiac surgical population. DESIGN: Retrospective database analysis of cardiac surgical cases from 2006 to 2012. SETTING: Data were extracted from Premier's United States (US) Perspective Database, developed for quality and utilization benchmarking and containing approximately 25% of US hospital discharges. PARTICIPANTS: Coronary artery bypass grafting (CABG), aortic, valve, or valvular with CABG surgery cases in which FLOSEAL or SURGIFLO was included. INTERVENTIONS: Three study groups were formed, given usage of hemostatic matrices: (1) FLOSEAL or SURGIFLO, exclusively; (2) FLOSEAL or SURGIFLO, with fibrin sealants, sealants, or powder hemostats; and (3) FLOSEAL or SURGIFLO, with nonflowable hemostats with or without thrombin. Outcomes included complications, transfusions, surgical revisions, mortality, length of stay (LOS) and surgery time. MEASUREMENTS AND MAIN RESULTS: Group A included 4,480 FLOSEAL and 326 SURGIFLO cases. Results suggested SURGIFLO cases were associated with significantly higher risk of multiple adverse outcomes, including major (odds Ratio [OR] 2.12; 95% CI 1.34-3.35; p = 0.001) and minor complications (OR 1.84; 95% CI 1.33-2.55; p<0.001); surgical revisions (OR 2.01; 95% CI 1.03- 3.94; p = 0.042); transfusions for any blood products (OR 4.90; 95% CI 3.50-6.87; p<0.001); and longer surgery times (adjusted mean difference = 64 minutes, p<0.001) than the FLOSEAL group. There were no significant differences in mortality and LOS. Results were similar in groups B and C. CONCLUSIONS: These retrospective outcomes suggested FLOSEAL was associated with fewer negative consequences than SURGIFLO in this surgical population.

An international consensus panel on the potential value of Digital Surgery.

OBJECTIVES: The use of digital technology in surgery is increasing rapidly, with a wide array of new applications from presurgical planning to postsurgical performance assessment. Understanding the clinical and economic value of these technologies is vital for making appropriate health policy and purchasing decisions. We explore the potential value of digital technologies in surgery and produce expert consensus on how to assess this value. DESIGN: A modified Delphi and consensus conference approach was adopted. Delphi rounds were used to generate priority topics and consensus statements for discussion. SETTING AND PARTICIPANTS: An international panel of 14 experts was assembled, representing relevant stakeholder groups: clinicians, health economists, health technology assessment experts, policy-makers and industry. PRIMARY AND SECONDARY OUTCOME MEASURES: A scoping questionnaire was used to generate research questions to be answered. A second questionnaire was used to rate the importance of these research questions. A final questionnaire was used to generate statements for discussion during three consensus conferences. After discussion, the panel voted on their level of agreement from 1 to 9; where 1=strongly disagree and 9=strongly agree. Consensus was defined as a mean level of agreement of >7. RESULTS: Four priority topics were identified: (1) how data are used in digital surgery, (2) the existing evidence base for digital surgical technologies, (3) how digital technologies may assist surgical training and education and (4) methods for the assessment of these technologies. Seven consensus statements were generated and refined, with the final level of consensus ranging from 7.1 to 8.6. CONCLUSION: Potential benefits of digital technologies in surgery include reducing unwarranted variation in surgical practice, increasing access to surgery and reducing health inequalities. Assessments to consider the value of the entire surgical ecosystem holistically are critical, especially as many digital technologies are likely to interact simultaneously in the operating theatre.

Comparison of complication and conversion rates between robotic-assisted and laparoscopic rectal resection for rectal cancer: which patients and providers could benefit most from robotic-assisted surgery?

AIMS: To compare (1) complication and (2) conversion rates to open surgery (OS) from laparoscopic surgery (LS) and robotic-assisted surgery (RA) for rectal cancer patients who underwent rectal resection. (3) To identify patient, physician, and hospital predictors of conversion. MATERIALS AND METHODS: A US-based database study was conducted utilizing the 2012-2014 Premier Healthcare Data, including rectal cancer patients ≥18 with rectal resection. ICD-9-CM diagnosis and procedural codes were utilized to identify surgical approaches, conversions to OS, and surgical complications. Propensity score matching on patient, surgeon, and hospital level characteristics was used to create comparable groups of RA\LS patients (n = 533 per group). Predictors of conversion from LS and RA to OS were identified with stepwise logistic regression in the unmatched sample. RESULTS: Post-match results suggested comparable perioperative complication rates (RA 29% vs LS 29%; p = .7784); whereas conversion rates to OS were 12% for RA vs 29% for LS (p < .0001). Colorectal surgeons (RA 9% vs LS 23%), general surgeons (RA 13% vs LS 35%), and smaller bed-size hospitals (RA 14% vs LS 33%) have reduced conversion rates for RA vs LS (p < .0001). Statistically significant predictors of conversion included LS, non-colorectal surgeon, and smaller bed-size hospitals. LIMITATIONS: Retrospective observational study limitations apply. Analysis of the hospital administrative database was subject to the data captured in the database and the accuracy of coding. Propensity score matching limitations apply. RA and LS groups were balanced with respect to measured patient, surgeon, and hospital characteristics. CONCLUSIONS: Compared to LS, RA offers a higher probability of completing a successful minimally invasive surgery for rectal cancer patients undergoing rectal resection without exacerbating complications. Male, obese, or moderately-to-severely ill patients had higher conversion rates. While colorectal surgeons had lower conversion rates from RA than LS, the reduction was magnified for general surgeons and smaller bed-size hospitals.

Procedural volume, cost, and reimbursement of outpatient incisional hernia repair: implications for payers and providers.

OBJECTIVE: This analysis aimed to evaluate trends in volumes and costs of primary elective incisional ventral hernia repairs (IVHRs) and investigated potential cost implications of moving procedures from inpatient to outpatient settings. METHODS: A time series study was conducted using the Premier Hospital Perspective® Database (Premier database) for elective IVHR identified by International Classification of Diseases, Ninth revision, Clinical Modification codes. IVHR procedure volumes and costs were determined for inpatient, outpatient, minimally invasive surgery (MIS), and open procedures from January 2008-June 2015. Initial visit costs were inflation-adjusted to 2015 US dollars. Median costs were used to analyze variation by site of care and payer. Quantile regression on median costs was conducted in covariate-adjusted models. Cost impact of potential outpatient migration was estimated from a Medicare perspective. RESULTS: During the study period, the trend for outpatient procedures in obese and non-obese populations increased. Inpatient and outpatient MIS procedures experienced a steady growth in adoption over their open counterparts. Overall median costs increased over time, and inpatient costs were often double outpatient costs. An economic model demonstrated that a 5% shift of inpatient procedures to outpatient MIS procedures can have a cost surplus of ∼ US $1.8 million for provider or a cost-saving impact of US $1.7 million from the Centers for Medicare & Medicaid Services perspective. LIMITATIONS: The study was limited by information in the Premier database. No data were available for IVHR cases performed in free-standing ambulatory surgery centers or federal healthcare facilities. CONCLUSION: Volumes and costs of outpatient IVHRs and MIS procedures increased from January 2008-June 2015. Median costs were significantly higher for inpatients than outpatients, and the difference was particularly evident for obese patients. A substantial cost difference between inpatient and outpatient MIS cases indicated a financial benefit for shifting from inpatient to outpatient MIS.

Observational evaluation of outcomes and resource utilization from hemostatic matrices in spine surgery.

OBJECTIVE: Studies have indicated that outcomes may differ by choice of flowable hemostat, but there is limited evidence in spine surgery. The objective of this study was to conduct a comparison of outcomes following use of advanced flowable hemostatic matrices in a large spine surgery population. METHODS: This is an observational retrospective cohort analysis using Premier's US Perspective Hospital Database. Two commonly-used hemostatic matrices (Floseal and Surgiflo kitted with thrombin) were compared in cases categorized as either major or severe spine surgery. Outcomes included complications, blood product administration, hospital length of stay (LOS), surgery time, and amount of matrix used in surgery. RESULTS: Major spine surgery patients treated with Surgiflo were associated with increased risk of blood product transfusion (OR = 2.56, 95% CI = 1.79-3.65, p < 0.001), longer surgery time (+8.84 min, p < 0.0001), and increased product usage (+3.34 mL, p < 0.001), compared to Floseal; however, risk of complications and LOS did not differ by choice of matrix in this patient group. Severe spine surgery patients treated with Surgiflo were associated with longer surgical time (+26.9 min, p < 0.001) and increased product usage (+1.52 mL, p < 0.01), compared to Floseal; however, risk of complications, transfusion and LOS did not differ by choice of matrix in this patient group. LIMITATIONS: Inherent to limitations associated with database analysis, this study did not evaluate potential physician differences such as skill and experience, assess long-term outcomes, nor include cases with missing data. CONCLUSION: The results from this analysis indicated that surgery time, risk of blood transfusion, and amount of matrix used are greater with Surgiflo patients, compared to Floseal patients. Choice of matrix did not appear to impact hospital LOS or risk of surgical complications. Future research should evaluate the cost consequences of increased clinical and resource utilization by choice of hemostatic matrix in spine surgery.

Hospital economic impact from hemostatic matrix usage in cardiac surgery.

OBJECTIVE: Improved health outcomes can result in economic savings for hospitals and payers. While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated, evaluations of their economic benefit are limited. This study quantifies the cost consequences to hospitals, based on clinical outcomes, from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery. RESEARCH DESIGN AND METHODS: Applying clinical outcomes from a prospective randomized clinical trial, a cost consequence framework was utilized to model the economic impact of comparator groups. From that study, clinical outcomes were obtained and analyzed for a flowable hemostatic matrix (FLOSEAL, Baxter Healthcare Corporation) vs non-flowable topical hemostats (SURGICEL Nu-Knit, Ethicon-Johnson & Johnson; GELFOAM, Pfizer). Costing analyses focused on the following outcomes: complications, blood transfusions, surgical revisions, and operating room (OR) time. Cardiac surgery costs were analyzed and expressed in 2012 US dollars based on available literature searches and US data. Comparator group variability in cost consequences (i.e., cost savings) was calculated based on annualized impact and scenario testing. RESULTS: RESULTS suggest that if a flowable hemostatic matrix (rather than a non-flowable hemostat) was utilized exclusively in 600 mixed cardiac surgeries annually, a hospital could improve patient outcomes by a reduction of 33 major complications, 76 minor complications, 54 surgical revisions, 194 transfusions, and 242 h of OR time. These outcomes correspond to a net annualized cost consequence savings of $5.38 million, with complication avoidance as the largest contributor. CONCLUSIONS: This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents. These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix, rather than a non-flowable topical hemostat, in cardiac surgery.