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.

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.