Medical Devices: Evidence and Research (Mar 2021)
Association of Complications with Healthcare Utilization and Hospital-Borne Costs Among Patients Undergoing Open Low Anterior Resection Using Curved Cutter Staplers
Abstract
Pragya Rai,1 Stephen S Johnston,1 Rusha Chaudhuri,2 Elena Naoumtchik,3 Esther Pollack3 1Epidemiology Medical Devices, Johnson & Johnson, New Brunswick, NJ, USA; 2Decision Science, MuSigma, Bengaluru, Karnataka, India; 3Health Economics and Market Access, Ethicon, Somerville, NJ, USACorrespondence: Pragya RaiReal World Data Analytics and Research, Epidemiology, Medical Devices, Johnson & Johnson, 410 George Street, New Brunswick, NJ, USATel +1 404 234 5433Email [email protected]: 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.Keywords: anastomotic leak, bleeding, costs, contour curved stapler, radial reload, rectal resection