Original Research

Use of a Topical Thrombin-Based Hemostatic Agent in Shoulder Arthroplasty

Am J Orthop. 2015 August;44(8):E262-E267

References

1. Millett PJ, Porramatikul M, Chen N, Zurakowski D, Warner JJ. Analysis of transfusion predictors in shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(6):1223-1230.

2. Hardy JC, Hung M, Snow BJ, et al. Blood transfusion associated with shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(2):233-239.

3. Gruson KI, Accousti KJ, Parsons BO, Pillai G, Flatow EL. Transfusion after shoulder arthroplasty: an analysis of rates and risk factors. J Shoulder Elbow Surg. 2009;18(2):225-230.

4. Schumer RA, Chae JS, Markert RJ, Sprott D, Crosby LA. Predicting transfusion in shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(1):91-96.

5. Sperling JW, Duncan SF, Cofield RH, Schleck CD, Harmsen WS. Incidence and risk factors for blood transfusion in shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(6):599-601.

6. Ahmadi S, Lawrence TM, Sahota S, et al. The incidence and risk factors for blood transfusion in revision shoulder arthroplasty: our institution’s experience and review of the literature. J Shoulder Elbow Surg. 2014;23(1):43-48.

7. National Heart, Lung, and Blood Institute. What are the risks of a blood transfusion? http://www.nhlbi.nih.gov/health/health-topics/topics/bt/risks.html. Published January 30, 2012. Accessed June 24, 2015.

8. Bracale U, Rovani M, Picardo A, et al. Beneficial effects of fibrin glue (Quixil) versus Lichtenstein conventional technique in inguinal hernia repair: a randomized clinical trial. Hernia. 2014;18(2):185-192.

9. Gazzeri R, Galarza M, Alfier A. Safety biocompatibility of gelatin hemostatic matrix (Floseal and Surgiflo) in neurosurgical procedures. Surg Technol Int. 2012;22:49-54.

10. Krishnan S, Conner TM, Leslie R, Stemkowski S, Shander A. Choice of hemostatic agent and hospital length of stay in cardiovascular surgery. Semin Cardiothorac Vasc Anesth. 2009;13(4):225-230.

11. Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999;81(11):1580-1588.

12. Wang GJ, Goldthwaite CA Jr, Burks S, Crawford R, Spotnitz WD; Orthopaedic Investigators Group. Fibrin sealant reduces perioperative blood loss in total hip replacement. J Long Term Eff Med Implants. 2003;13(5):399-411.

13. Kim HJ, Fraser MR, Kahn B, Lyman S, Figgie MP. The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012;94(13):1160-1165.

14. Massin P, Scemama C, Jeanrot C, Boyer P. Does fibrin sealant use in total knee replacement reduce transfusion rates? A non-randomised comparative study. Orthop Traumatol Surg Res. 2012;98(2):180-185.

15. Wang GJ, Hungerford DS, Savory CG, et al. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001;83(10):1503-1505.

16. Surgiflo Hemostatic Matrix Kit [package insert]. Somerville, NJ: Ethicon; 2012.

17. Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003;90(5):596-599.

18. Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962;51(2):224-232.

19. Faris PM, Spence RK, Larholt KM, Sampson AR, Frei D. The predictive power of baseline hemoglobin for transfusion risk in surgery patients. Orthopedics. 1999;22(1 suppl):s135-s140.

20. Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1647-1654.

21. Murphy P, Heal JM, Blumberg N. Infection or suspected infection after hip replacement surgery with autologous or homologous blood transfusions. Transfusion. 1991;31(3):212-217.

22. Thomas D, Wareham K, Cohen D, Hutchings H. Autologous blood transfusion in total knee replacement surgery. Br J Anaesth. 2001;86(5):669-673.

23. Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010;50(4):753-765.

24. Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009;17(12):727-736.

Patient electronic medical records were reviewed for demographic information, including age, sex, height, weight, comorbidities, American Society of Anesthesiologists (ASA) physical status, and preoperative anticoagulation use. Anesthesia records were reviewed for intraoperative estimated blood loss (EBL) and intraoperative autologous blood return (Cell Saver, Haemonetics). Patient laboratory results were reviewed for preoperative and postoperative hemoglobin (Hb) and hematocrit levels. Electronic medical records were also reviewed for incidence of transfusion and any major or minor complications occurring within 90 days of the procedure. All data were collected and reviewed under the approval of the human investigations committee at our institution.

Hemoglobin loss and hidden blood loss (HBL) were calculated as described by Good and colleagues.¹⁷ Total Hb loss was estimated using the total blood volume formula described by Nadler and colleagues.¹⁸ Difference between preoperative Hb level and final Hb level recorded during hospital stay was corrected for units of blood transfused (estimate, 52 g of Hb per unit). Hemoglobin loss was then used to calculate total blood loss, and total drain output was added to total blood loss to determine HBL. These formulas were used:

Hb_loss = Blood Volume (L) × [Hb_initial (g/L) – Hb_final (g/L)] + Hb_transfused

Total Blood Loss (mL) = 1000 × Hb_loss/Hb_initial

HBL (mL) = Total Blood Loss (mL) + Total Drain Output (mL)

All statistical analyses were performed using SPSS Statistics Version 20 (IBM). A Shapiro-Wilk test was used to test for normality. All variables collected were compared between the experimental and control cohorts. For continuous variables, independent t test was used to compare normal data, and the Mann-Whitney rank sum test was used for non-normal data. Categorical variables were compared with the Fisher exact test for 2×2 tables and with the χ² test for larger tables. In all tests, P < .05 was considered statistically significant.

Results

The experimental and control cohorts were demographically similar with respect to age, sex, body mass index (BMI), ASA status, and home anticoagulation treatment (Table 1). Patients who received preoperative anticoagulation therapy were evenly distributed between the 2 patient groups (P = .745). Thirty-five patients in the experimental group and 39 in the control group were taking aspirin. In addition, in the experimental group, 5 patients were taking warfarin, 4 clopidogrel, 1 dabigatran, and 1 prasugrel. In the control group, 6 patients were taking warfarin, 3 clopidogrel, 2 dabigatran, and 1 rivaroxaban. Type of arthroplasty (primary anatomical, primary reverse, revision shoulder arthroplasty) was also evenly distributed (P = .256), and operative time did not vary significantly between cohorts (P = .518).

Markers of operative blood loss were also compared between patient groups (Table 2). There was no significant difference in intraoperative EBL or cell saver volume between cohorts (Ps = .301 and .800). Drain output on PODs 1 and 2 did not differ between cohorts (Ps = .789 and .777); the same was true for total postoperative drain output (P = .906). Hemoglobin levels did vary significantly between groups before surgery (P = .002) and on PODs 1 and 2 (Ps = .027 and .005), with the experimental group having a lower mean Hb level at each time point. Mean Hb loss, however, did not vary significantly (P = .253). There was also no difference in HBL between cohorts (P = .601), the calculation of which accounts for patient height and weight, Hb loss, and transfusions. The incidence of transfusion was 25% in the experimental group and 20% in the control group—not a statistically significant difference (P = .407). Mean (SD) number of transfused units of packed red blood cells was 0.54 (1.05) in the experimental group and 0.40 (0.91) in the control group—again, not a statistically significant difference (P = .377).

Preoperative Hb level under 13 g/dL has been reported as a risk factor for transfusion after surgery.¹⁹ To account for the significantly lower Hb level in the experimental group, we examined the incidence of transfusion in patients with preoperative Hb levels above and below this cutoff. Among patients with preoperative Hb levels under 13 g/dL, transfusion incidence was 45.8% (experimental group) and 42.9% (control group) (P > .99); among those with preoperative Hb levels above 13 g/dL, transfusion incidence was 7.7% (experimental) and 11.1% (control) (P = .760).

To account for reportedly higher blood loss and transfusion rates in revision cases,^1,2,20 we stratified our data by primary and revision cases, comparing them within the entire patient cohort and comparing the experimental and control groups within these subsets. Tables 3 and 4 list the results. Revision cases had more EBL (P < .001), autologous blood return (P < .001), drain output on POD 1 (P = .025), and total drain output (P = .002). There was no significant difference in transfusion rate between primary (22.2%) and revision (27.3%) cases (P = .505) or when the experimental and control groups were compared within primary and revision subsets. Among primary cases, transfusion rates were 23% (experimental) and 21.2% (control) (P = .853); among revision cases, rates were 35% (experimental) and 15% (control) (P = .263). Revisions showed a significant (P = .043) difference in HBL between the experimental and control groups, with more blood loss in the experimental group. EBL and autologous blood return were equivocal. Hb levels and drain outputs were statistically different only for POD 2, but there was no difference between overall Hb loss or total drain outputs. Among primary cases, no parameters of blood loss were statistically significantly different. The significantly lower preoperative and postoperative Hb levels were again seen in the experimental group.