Associate Director, MedTech Epidemiology and Real World Data Sciences Johnson & Johnson New Brunswick, United States
Background: Although prolonged air leak (PAL) is one of the most serious complications following thoracic resection, there is no current standard of care for prevention. Prophylactic use of lung sealants has been used in the management of intraoperative air leaks and are associated with a lower incidence of PAL and a shorter length of stay with lower hospital costs.
Objectives: To estimate the incremental economic and clinical burden of PAL among patients undergoing thoracic resection with evidence of lung sealant application using a large US healthcare database.
Methods: Retrospective analysis of hospital data from the US Premier Healthcare Database (PHD). Study subjects were age ≥18 years and had an inpatient hospital encounter for thoracic resection (lobectomy, segmentectomy, wedge resection) between October 1, 2015 and March 31, 2021 (first of such admissions=index). Patients were also required to have evidence of lung sealant use on the day of the procedure and their hospital must continue to contribute data to the PHD for at least 90 days post discharge. Patients were grouped by presence vs. absence of PAL, defined by a diagnosis of post procedural air leak or postprocedural pneumothorax with length of stay exceeding 5 days post thoracic resection. Outcomes included, intensive care unit (ICU) days, total hospital costs during index, discharge status to home (vs skilled nursing/other), all-cause 30-, 60-, and 90-day readmission, and death. Generalized linear models were used to examine the association of PAL with the outcomes, accounting for hospital-level clustering and adjusting for patient demographics and clinical characteristics (e.g., age, sex, race), procedural (e.g., surgery type, surgical approach, lobe location of resection), and hospital/provider characteristics (e.g., hospital bed size, teaching status, procedural volume, surgeon specialty).
Results: A total of 9,727 subjects were included for study: 51.0% females, 83.9% white, mean age of 66 years; 12.5% had PAL, which was associated with significant incremental increases in days spent in ICU (0.93 days, p< 0.001) and incremental total hospital cost ($11,119, p< 0.001). Having PAL significantly decreased the risk of being discharged to home by 3.6% (from 91.3% to 88.1%, p< 0.001) and significantly increased the risk of being readmitted at 30 days by 34.0% (from 9.3% to 12.6%) at 60 days by 31.2% (from 11.7% to 15.4%) and at 90 days by 26.4% (from 13.6% to 17.2%), all p< 0.01. Although the absolute risk of death was low, it was two times higher in patients with PAL versus those without PAL (2.4% vs. 1.1%, p=0.001).
Conclusions: This analysis demonstrates that PAL was associated with substantial patient clinical and economic burden despite prophylactic lung sealant use.
