ABSTRACT
Purpose: Prophylactic use of lung sealants among patients undergoing thoracic resection has been reported for the management of intraoperative air leaks and is associated with a lower incidence of prolonged air leak (PAL) and a shorter length of stay (LOS). This study estimated the incremental economic and clinical burden of PAL among patients with lung sealants used during thoracic resection in the United States. Patients and Methods: This retrospective analysis examined hospital data (Premier Healthcare Database) for adults (age ≥18 years) with inpatient thoracic resection between October 2015 - March 2021 (first admission=index) and lung sealant used during their procedure. Follow-up extended through 90 days post-discharge. Patients were grouped by presence/absence of PAL (ie, diagnosis of post-procedural air leak or post-procedural pneumothorax with associated LOS exceeding 5 days). Outcomes included intensive care unit (ICU) days, total index hospital costs, all-cause 30-, 60-, and 90-day readmission, discharge status, and in-hospital mortality. Generalized linear models quantified associations between PAL and outcomes, accounting for hospital-level clustering, and patient, procedure, and hospital/provider characteristics. Results: Among the 9727 patients included for study (51.0% female, 83.9% white, mean age 66 years), 12.5% had PAL, which was associated with significant incremental increases in ICU days (0.93 days, p<0.001) and total hospital cost ($11,119, p<0.001). PAL also decreased the likelihood of discharge to home (from 91.3% to 88.1%, p<0.001) and increased the risk of readmission within 30, 60, and 90 days by up to 34.0% (from 9.3% to 12.6%;11.7% to 15.4%;13.6% to 17.2%, respectively), all p<0.01. Absolute risk of mortality was low, but two times higher in patients with PAL versus those without PAL (2.4% vs 1.1%, p=0.001). Conclusion: This analysis demonstrates that despite the prophylactic use of lung sealants, PAL continues to put a burden on the healthcare system, highlighting an unmet need for improved sealant technology.
ABSTRACT
BACKGROUND: Evidence comparing fibrin sealants (FSs) in surgery are limited. This study evaluated the efficacy and safety of FSs, and manual compression in peripheral vascular surgery. METHODS: A systematic review of randomized trials was conducted in Medline, Embase, and Cochrane databases within the last 15 years. Data were available to conduct a network meta-analysis (NMA) in peripheral vascular surgery. Fibrin sealant treatment arms were further broken-down and assessed by clotting time (i.e., 2-min [2C] or 1-min [1C]). The primary efficacy outcome was the proportion of patients achieving hemostasis by 4 min (T4). Treatment-related serious and non-serious adverse events (AEs) were qualitatively assessed. RESULTS: Five studies (n = 693), were included in the NMA. Results predicted VISTASEAL 2C, followed by EVICEL 1C, had the highest probability of achieving T4. Compared with manual compression, significant improvements in T4 were found with VISTASEAL 2C (relative risk [RR] = 2.67, 95% CrI: 2.13-3.34), EVICEL 1C (RR = 2.58, 95% CrI: 2.04-3.23), VISTASEAL 1C (RR = 2.00, 95% CrI: 1.45-2.65), and TISSEEL 2C (RR = 1.99, 95% CrI: 1.48-2.60). TISSEEL 1C was not significantly different than manual compression (RR = 1.40, 95% CrI: 0.70-2.33). Among FSs, VISTASEAL 2C was associated with a significant improvements in T4 compared with VISTASEAL 1C (RR = 1.33, 95% CrI: 1.02-1.82), TISSEEL 2C (RR = 1.34, 95% CrI: 1.05-1.77), and TISSEEL 1C (RR = 1.90, 95% CrI: 1.18-3.74). Treatment-related serious and non-serious AE rates were typically lower than 2%. CONCLUSIONS: In peripheral vascular surgeries, VISTASEAL 2C and EVICEL 1C were shown to have the highest probabilities for achieving rapid hemostasis among the treatments compared. Future studies should expand networks across surgery types as data become available.
ABSTRACT
Hemostasis products, such as SURGICEL®, have been increasingly used across a wide variety of surgical procedures to mitigate bleeding-related risks and complications. This retrospective observational study described the utilization pattern of the SURGICEL® family of oxidized regenerated cellulose products (SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL SNoW®) in a large, vertically integrated healthcare system, by utilizing electronic medical records (EMR) extracted from August 2013 through June 2015 at Henry Ford Health System (HFHS). Descriptive measurements were compared between SURGICEL® ORIGINAL and advanced SURGICEL® products (SURGICEL® FIBRILLAR™ and SURGICEL SNoW®) for pooled common surgical procedures. Among 1471 patients, 450 received SURGICEL® ORIGINAL, and 1021 received advanced SURGICEL® products. A significantly greater proportion of patients given advanced SURGICEL® products had comorbidities (91.0% vs 85.6%, p=.0024), prior bleeding conditions (49.9% vs 30.9%, p<.0001), and prior use of anticoagulants (27.7% vs 5.3%, p<.0001). Advanced SURGICEL® products were more likely to be used in coronary artery bypass grafting (13.7% vs 1.6%, p<.0001). Among a sub-set of 1420 patients with complete package size information (988 Advanced and 432 ORIGINAL), significantly fewer mean normalized units of Advanced SURGICEL® were used per patient case (3.9 vs 5.5, p<.0001). Despite Advanced SURGICEL® products being utilized in higher risk bleeding situations compared to cases where SURGICEL® ORIGINAL was utilized, fewer overall normalized units of Advanced SURGICEL® were required per patient case. Further research is needed to investigate the implications of topical hemostat use in continuous oozing bleeding situations on outcomes, hospital costs, and resources.
