Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective.

BACKGROUND: Mastectomy or breast conserving surgery, both with axillary lymph node dissection, are common treatments for early-stage breast cancer. Monopolar electrocautery is typically used for both procedures, despite evidence of improved clinical outcomes with HARMONIC FOCUS™+. This analysis evaluated the budget impact of adopting HARMONIC FOCUS™+ versus monopolar electrocautery for patients undergoing these procedures from an Italian hospital perspective. METHODS: Total costs for an annual caseload of 100 patients undergoing mastectomy or breast conserving surgery, with axillary lymph node dissection, with either the intervention or comparator were calculated. Italian clinical and cost input data were utilised. The analysis included costs for the device, operating room time, postoperative length of stay, treating seroma and managing postoperative chest wall drainage. Deterministic and probabilistic sensitivity analyses assessed uncertainty of model input values. Two scenario analyses investigated the impact of conservative estimates of postoperative length of stay reduction and daily hospital cost on the simulated cost difference. RESULTS: HARMONIC FOCUS™+ achieves annual savings of EUR 100,043 compared with monopolar electrocautery, derived from lower costs for operating room time, postoperative length of stay and seroma and postoperative chest wall drainage management, offsetting the incremental device cost increase (EUR 43,268). Cost savings are maintained in scenario analyses and across all variations in parameters in deterministic sensitivity analysis, with postoperative hospital stay costs being key drivers of budget impact. The mean (interquartile range) cost savings with HARMONIC FOCUS™+ versus monopolar electrocautery in probabilistic sensitivity analysis are EUR 101,637 (EUR 64,390-137,093) with a 98% probability of being cost saving. CONCLUSIONS: The intervention demonstrates robust cost savings compared with monopolar electrocautery for mastectomy or breast conserving surgery, with axillary lymph node dissection, in an Italian hospital setting, and improved clinical and resource outcomes. These findings, with other clinical and cost analyses, support HARMONIC FOCUS™+ use in this setting.

In-hospital economic burden of anastomotic leakage after colorectal anastomosis surgery: a real-world cost analysis in Italy.

BACKGROUND: Anastomotic leakage (AL) is a severe complication of colorectal surgery. We aimed to quantify inpatient costs and key cost contributors associated with AL in a single Italian center. RESEARCH DESIGN AND METHODS: Electronic records for adults who had undergone colorectal surgery with anastomosis (January 2015 - December 2016), were retrospectively reviewed. Patients with AL were identified using clinical signs and/or imaging findings and/or intraoperative findings. Available data included patient, clinical, and procedural characteristics, healthcare resource utilization, and inpatient costs. Multivariate models were used to adjust for potential confounders. RESULTS: AL occurred in 12.3% of patients (N = 317). Mean adjusted inpatient cost was 108% higher (p < 0.001) for patients with AL versus no AL (€14,711; 95% CI: 12,113; 17,866 versus €7,089; 95% CI: 6,623; 7,587). Key cost contributors were ward stay, disposables, operating room, and hospital consultations. Mean losses (reimbursement minus costs) were €2,041/patient with AL. AL extended mean length of stay by 9 days and increased odds of reoperation and ICU stay (all p < 0.001). CONCLUSIONS: Patients with AL place considerable economic and resource burden on healthcare systems and hospital reimbursement rates do not cover treatment costs. This study highlights an unmet need for novel techniques to reduce the burden of AL.