Floseal only versus in combination in spine surgery: a comparative, retrospective hospital database evaluation of clinical and healthcare resource outcomes

Hosp Pract (1995). 2018 Oct;46(4):189-196. doi: 10.1080/21548331.2018.1498279. Epub 2018 Jul 23.

Abstract

Objective: Flowable agents such as FlosealĀ® (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.

Keywords: Floseal; hemostasis; hemostatic matrix; resource use; total spine.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Blood Loss, Surgical / prevention & control*
  • Blood Loss, Surgical / statistics & numerical data
  • Blood Transfusion / statistics & numerical data*
  • Databases, Factual
  • Female
  • Gelatin Sponge, Absorbable / therapeutic use*
  • Hemostatics / therapeutic use*
  • Humans
  • Length of Stay / statistics & numerical data*
  • Male
  • Operative Time
  • Outcome and Process Assessment, Health Care / statistics & numerical data
  • Patient Discharge / statistics & numerical data
  • Regression Analysis
  • Retrospective Studies
  • Spine / surgery*
  • United States

Substances

  • FloSeal Matrix
  • Hemostatics