Purpose To estimate the cost impact of using the ECHELON CIRCULAR™ Powered Stapler (ECP) compared with manual circular staplers (standard of care, SOC) among patients undergoing colectomy procedures that involve left-sided anastomosis. Methods A US hospital-based budget impact model was developed to estimate the impact of ECP in reducing the surgical complication of anastomotic leak. The incremental acquisition cost of ECP vs SOC was compared to the net potential savings from reduced complication costs. The model was based on complication rates from a recently published matching-adjusted indirect comparison (MAIC) that compared clinical and healthcare utilization outcomes of patients using ECP with those of a propensity score-matched retrospective SOC control cohort from a real-world clinical practice population. The model assessed total cost, average length of stay (LOS), proportion of patients with a non-home discharge, and all-cause readmission. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were conducted to evaluate the robustness of the model assumptions and inputs. Results Despite a higher device cost of $412 for ECP compared with $298 for a manual stapler, annual savings due to avoided complications with ECP was $53,987 for anastomotic leak, assuming 100 procedures per year with each type of circular stapler. ECP also helped to avoid 27 LOS days, 0.38 readmissions and 0.22 non-home discharges. Sensitivity analyses around potential drivers of costs established the robustness of economic savings with the use of ECP – with annual savings being most impacted by the probability of anastomotic leak complication in the DSA. Conclusion This model demonstrates that among patients undergoing left-sided colectomy procedures, the incremental cost of using the ECHELON CIRCULAR™ Powered Stapler instead of a manual circular stapler was offset by the savings from lowered incidence and cost of management of anastomotic leaks in the hospital setting.

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Purpose The ability of curved cutter staplers (CCS) to conform to the complex anatomy of the rectum has led to their widespread use in open low anterior resection (LAR). We describe the incidence of complications and their association with healthcare utilization and hospital-borne costs among patients who underwent open LAR with CCS, with the intent to provide contextual epidemiologic and economic burden data for future evaluations of innovations that may lead to a reduced incidence of complications. Methods Retrospective cohort study using Premier Healthcare Database. Studied patients were ≥18 years who underwent inpatient open LAR with CCS between October 1, 2016 and March 30, 2020 (index admission). Complications of interest included anastomotic leak, bleeding, infection, transfusion, and device complications/adverse incidents during the index admission. Outcomes included index admission hospital length of stay (LOS), non-home discharge status, total operating room (OR) time, total hospital-borne costs, and all-cause readmissions within 30, 60, and 90 days post discharge from index admission. Multivariable regression models were used to compare outcomes between patients with vs without any complication of interest. Results The study included 618 patients with a mean age of 61 years, of whom 57% were males. The incidence proportion of any complication during the index admission for open LAR with CCS was 28% (95% CI: [23.9%, 31.0%], n=170). As compared with patients experiencing no complications, those with a complication had higher adjusted mean total hospital costs ($38,159 vs $22,303, p<0.001), non-home discharge status (21.8% vs 9.2%, p=0.004), mean LOS (13 days vs 6 days, p<0.001), and mean OR time (362 mins vs 291 mins, p<0.001). There were no significant differences in all-cause readmissions between patients with vs without complications. Conclusion Among patients undergoing open LAR with CCS, over a quarter of patients experienced a complication, resulting in a substantial burden to the healthcare system.

To describe an approach wherein high-dimensional hospital data can be used to identify generalizable risk factors for surgical complications for which there may be limited prior knowledge, as illustrated in the context of hemostasis-related complications (HRC). Patients and Methods: This was a retrospective study of the Premier Healthcare Database. Patients included for the study underwent video-assisted thoracoscopic lobectomy (VATL), laparoscopic right colectomy (LRC), or laparoscopic sleeve gastrectomy (LSG) on an inpatient setting between Oct-2015 and Feb-2020 (first = index). The outcome, HRC, comprised hemorrhage, control of bleeding, and acute posthemorrhagic anemia. For each cohort, a high-dimensional dataset (ie, comprising 1000s of candidate risk factors) was constructed using taxonomies from the Clinical Classification Software Refined (CCSR). Candidate risk factors were fed into logistic regression models with a 70%/30% train/test split for each cohort; clinically plausible risk factors that were consistently significant predictors of HRC across the 3 training models were then used in a final parsimonious model including sex, age, race, and payor; finally, the parsimonious model was applied to the test data to compare predicted risk with observed incidence of HRSC. Results:The study included 11,141 VATL, 20,156 LRC, and 121,547 LSG patients, in whom 7.5%, 7.8%, and 1.2% experienced HRSC, respectively. Ultimately, 6 clinically plausible CCSR categories were identified as being statistically significant predictors across all 3 cohorts (eg, coagulation and hemorrhagic disorders, malnutrition, alcohol-related disorders, among others). In the parsimonious model applied to the test data, the observed incidence of HRSC was substantially higher in the top quintile vs bottom quintile of predicted risk: LSG 2.05% vs 0.53%, LRC 13.30% vs 4.11%, VATS 12.49% vs 5.04%. Conclusion: High-dimensional real-world data can be useful to identify risk factors for outcomes that generalize across multiple cohorts. The risk factors identified herein should be considered for inclusion in future studies of hemostasis-related complications.

Purpose To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels. Patients and Methods Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups. Results After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI −3.2% to 2.5%], P =0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes. Conclusion Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.