Manuel G Ramirez1, Harel Deutsch2, Nitin Khanna3, Donald Cheatem1, Dongyan Yang1, Erik Kuntze1. 1. a Baxter Healthcare Corporation , Deerfield , IL , USA. 2. b Department of Neurosurgery , Rush University , Chicago , IL , USA. 3. c Department of Orthopedics , Indiana University School of Medicine , Munster , IN , USA.
Abstract
OBJECTIVE: Flowable agents such as Floseal® (F) are often reserved as adjuncts to non-flowable agents (i.e. gelatin (G) sponges and thrombin (T)) when bleeding is not sufficiently controlled. Based on their perceived positive impact, it is postulated that flowable agents alone may result in better clinical and resource utilization outcomes. Clinical and health-care utilization outcomes were compared in this retrospective analysis of spine surgery cases with charges for Floseal only (FO) and F + G/T. METHODS: The United States Premier Hospital Database was searched for adult spine surgeries performed between October 2010 and September 2015 with FO or F and G/T charges. To obtain an unbiased treatment estimate, 1:1 propensity-score matching was used to identify FO and F + G/T cohorts. The cohorts were compared for rates of intraoperative, perioperative, postoperative and transfusion; blood loss-related, serious and other complications; hospital length-of-stay (LOS), surgical time, and volume of hemostat charged. RESULTS: Among 40,335 spine surgeries, 15,105 FO and F + G/T matched pairs were compared. Significantly (p < 0.0001) lower percentages of FO than F + G/T cases received intraoperative (1.4% vs. 2.5%), perioperative (1.6% vs. 2.8%), postoperative (1.6% vs 3.0%), and any transfusion (2.3% vs. 4.3%). FO cases had significantly less blood loss complications than F + G/T cases (0.5% vs. 0.8%, p = 0.0022) and significantly (p < 0.0001) shorter hospital LOS (-0.45 days), surgical time (-39.0 min), and used less hemostat (-12.5 mL). CONCLUSIONS: Results from this observational hospital database analyses indicate that FO use in spine surgery is associated with lower blood transfusion use and blood loss complications compared to its use with adjunct non-flowable hemostatic agents. The shorter hospital stay, reduced surgical time, and less hemostat volume health-care utilization outcomes that favored FO versus combination use may translate to health system cost savings. Further validation of these findings using controlled clinical trials and cost-consequence studies is warranted. CLINICAL RELEVANCE: The use of flowable hemostatic agents alone may result in better clinical and possibly economic outcomes in spine surgery.
OBJECTIVE: Flowable agents such as Floseal® (F) are often reserved as adjuncts to non-flowable agents (i.e. gelatin (G) sponges and thrombin (T)) when bleeding is not sufficiently controlled. Based on their perceived positive impact, it is postulated that flowable agents alone may result in better clinical and resource utilization outcomes. Clinical and health-care utilization outcomes were compared in this retrospective analysis of spine surgery cases with charges for Floseal only (FO) and F + G/T. METHODS: The United States Premier Hospital Database was searched for adult spine surgeries performed between October 2010 and September 2015 with FO or F and G/T charges. To obtain an unbiased treatment estimate, 1:1 propensity-score matching was used to identify FO and F + G/T cohorts. The cohorts were compared for rates of intraoperative, perioperative, postoperative and transfusion; blood loss-related, serious and other complications; hospital length-of-stay (LOS), surgical time, and volume of hemostat charged. RESULTS: Among 40,335 spine surgeries, 15,105 FO and F + G/T matched pairs were compared. Significantly (p < 0.0001) lower percentages of FO than F + G/T cases received intraoperative (1.4% vs. 2.5%), perioperative (1.6% vs. 2.8%), postoperative (1.6% vs 3.0%), and any transfusion (2.3% vs. 4.3%). FO cases had significantly less blood loss complications than F + G/T cases (0.5% vs. 0.8%, p = 0.0022) and significantly (p < 0.0001) shorter hospital LOS (-0.45 days), surgical time (-39.0 min), and used less hemostat (-12.5 mL). CONCLUSIONS: Results from this observational hospital database analyses indicate that FO use in spine surgery is associated with lower blood transfusion use and blood loss complications compared to its use with adjunct non-flowable hemostatic agents. The shorter hospital stay, reduced surgical time, and less hemostat volume health-care utilization outcomes that favored FO versus combination use may translate to health system cost savings. Further validation of these findings using controlled clinical trials and cost-consequence studies is warranted. CLINICAL RELEVANCE: The use of flowable hemostatic agents alone may result in better clinical and possibly economic outcomes in spine surgery.
Entities:
Keywords:
Floseal; hemostasis; hemostatic matrix; resource use; total spine