Assessing New Technologies in Surgery: Case Example of Acute Primary Repair of the Thumb Ulnar Collateral Ligament.

PURPOSE: Health technology assessment provides a means to assess the technical properties, safety, efficacy, cost-effectiveness, and ethical/legal/social impact of a novel technology. An important component of health technology assessment is the cost-effectiveness analysis (CEA), which can be performed using model-based CEA. This study used the CEA model to compare the cost-effectiveness of a novel ligament augmentation device with the standard technique for primary repair of complete ulnar collateral ligament (UCL) tears. METHODS: A model was developed for complete UCL tear requiring acute surgical repair, comparing the cost-effectiveness of standard technique primary repair and repair using a ligament augmentation device from a societal perspective. Primary outcomes included quality-adjusted life years (QALYs), cost, net monetary benefit (NMB) and incremental NMB. A cost-effectiveness threshold of CAD $50,000/QALY was used to compare the 2 techniques. Sensitivity analyses were conducted to assess the parameter uncertainty, specifically the impact of device cost, time off work, probability of complication, and postoperative outcome. RESULTS: The NMB for the standard technique was CAD $42,598, and the NMB for repair using the ligament augmentation device was CAD $41,818. The standard technique was the preferred strategy for primary repair of complete UCL tears. One-way sensitivity analyses demonstrated that the ligament augmentation device became cost-effective if individuals return to work in <18 days (base case 23 days). The device was also favored when the cost was less than CAD $50 and the difference in time to return to work was at least 1 day. CONCLUSIONS: Our model demonstrates that there may be significant costs associated with the introduction of novel health technologies, and certain conditions, such as an earlier return to work, must be met for some devices to be a cost-effective option. This study provides an example of how model-based CEA is a useful tool to assess the cost-effectiveness of a novel device. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/Decision Analysis II.

Primary Non-refluxing Megaureter: Analysis of Risk Factors for Spontaneous Resolution and Surgical Intervention.

Background: The risk of febrile urinary tract infection (fUTI) in children with primary non-refluxing megaureter (PM) has been extensively studied in the literature, however, a paucity of information exists regarding risk factors for surgical intervention and spontaneous resolution. We sought to analyze data from our prospectively collected PM cohort to determine risk factors that would predict surgery and resolution in this population. Methods: Patients with PM were identified from our prospectively-collected prenatal hydronephrosis (HN) database from 2008 to 2017. Primary outcomes included surgical intervention and hydroureter resolution. Spontaneous resolution was defined as ureteral dilation <7 mm at last follow-up. Age at presentation, gender, development of fUTI, HN grade [low (SFU I/II) vs. high (SFU III/IV)], anteroposterior diameter (APD) measurements and ureteral diameter at baseline and last follow-up were recorded. Univariate and multivariable analyses (binary logistic and Cox regression) were performed. Results: Of 101 patients, 86 (85%) were male, and 80 (79%) had high grade HN. Median age at baseline and last follow-up were 2 (0-23) and 29 (2-107) months, respectively. Overall, 23 (23%) patients underwent surgery at a median age of 22 (3-35) months. Mean ureteral diameter was larger in surgical patients vs. those treated non-surgically (14 ± 4 vs.11 ± 3 mm; p < 0.01). Of the 78 (77%) non-surgical patients, 43(55%) showed resolution of their ureteral dilation at a median age of 24(4-56) months. Survival analysis demonstrated that 12 patients resolved by year 1, 22 by year 2, 30 by year 3, 40 by year 4, and 43 by year 5. However, when considering resolution as APD <10 mm, 62(79%) children resolved their HN by last follow-up (29 months). Univariate and multivariable analyses (Table 1) revealed that high-grade HN at baseline, development of fUTI, and ureteric dilation ≥14 mm were significant risk factors for surgical intervention. Cox regression (Figure 2) found that ureteral dilation <11 mm was the only independent risk factor significantly associated with PM resolution (Table 2). Conclusion: Patients with PM and high-grade HN, as well as individuals with ureteral dilation ≥14 mm and fUTI were more likely to undergo surgical intervention. Ureteral dilation <11 mm was the only independent risk factor significantly associated with spontaneous resolution of PM.