Original Research

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

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Shoulder arthroplasty is associated with significant blood loss, often requiring blood transfusion. Hemostatic agents are used in various surgical specialties to minimize blood loss, but to date few studies have examined their efficacy in shoulder arthroplasty.

We retrospectively reviewed 211 consecutive shoulder arthroplasty cases performed by a single surgeon. Our hypothesis was that patients treated with a topical thrombin prepared with a hemostatic matrix (Surgiflo) would have decreased perioperative blood loss. Patients with humeral fractures or preexisting blood disease were excluded. Control patients were managed December 2012 through April 2013. Study patients were managed May 2013 through August 2013 using the same surgical technique with the additional application of the hemostatic agent before closure. Charts were reviewed for demographics, estimated blood loss, drain output, transfusion rates, and complications. Hidden blood loss was calculated using a validated method.

There were no differences in estimated blood loss (P = .301), drain output (P = .906), or hidden blood loss (P = .601) between groups. There was no increased incidence of transfusion between study (25%) and control (20%) groups (P = .407). No increased complications resulted from use of the hemostatic agent (P = .764).

On the basis of these results, we cannot conclude that this topical hemostatic agent is effective as a blood loss management tool in shoulder arthroplasty.


 

References

Shoulder arthroplasty can be associated with significant perioperative blood loss, with the overall rate of postoperative allogeneic blood transfusion ranging from 7.4% to 43%.1-6 Blood transfusions are associated with a range of health risks.7 Soft-tissue dissection and cutting and reaming of bone surfaces can be sources of significant blood loss. Directly visualized sources of bleeding can be addressed using standard surgical hemostasis, including electrocautery, suture ligation, compression, and careful avoidance of vascular structures. However, difficult-to-visualize areas and bony sources of bleeding are more difficult to manage.

Numerous products for mitigating perioperative blood loss are commercially available. Topical hemostatic agents have been used in many surgical specialties, including orthopedic surgery, cardiothoracic surgery, neurosurgery, vascular surgery, and general surgery.8-10 In orthopedic surgery, use of topical thrombin- and fibrin-based products as hemostatic agents has been studied in knee and hip arthroplasty, with varying results.11-14 Early studies have shown reduced blood loss and postoperative transfusion rates with use of a fibrin sealant or fibrin tissue adhesive,11,12,15 whereas others have shown no significant benefit of using these hemostatic agents. Massin and colleagues14 found no difference in blood loss in the setting of total knee arthroplasty (TKA) with use of a fibrin sealant. In a 2012 prospective study, Kim and colleagues13 also showed no significant reduction in blood loss in patients treated with a topical thrombin-based hemostatic agent in TKA.

Surgiflo (Ethicon) is a hemostatic matrix that is combined with a topical human thrombin solution before sterile application. The matrix consists of an absorbable porcine gelatin powder that provides a structure for platelet adhesion and aggregation.16 When used in combination with thrombin, it aids in fibrin clot formation, leading to hemostasis of oozing blood and minor bleeding from small capillaries and venules. According to the manufacturer’s data, it can halt bleeding in less than 2 minutes and retains its efficacy for up to 8 hours.

To our knowledge, there are no reports of studies on use of topical fibrin- or thrombin-based hemostatic agents in shoulder arthroplasty. We conducted a study to investigate perioperative blood loss, transfusion rates, and complications during the hospital stays of patients who underwent shoulder arthroplasty and were treated with or without the Surgiflo topical hemostatic agent. Our hypothesis was that patients intraoperatively treated with this agent would have significantly less perioperative blood loss and lower transfusion rates without increased rates of in-hospital complications.

Patients and Methods

We retrospectively reviewed data from 211 consecutive shoulder arthroplasties performed by Dr. J. Michael Wiater between December 2012 and August 2013. All primary and revision anatomical and reverse total shoulder arthroplasty (TSA) procedures were included. Patients with a preoperative diagnosis of acute fracture, and patients with a diagnosis of any type of blood diathesis, including anemia and platelet disorders that lead to excessive clotting or bleeding, were excluded. Patients treated between May 2013 and August 2013 had the hemostatic matrix applied to the soft tissues before final wound closure. Chart review for any exclusion criteria left 102 patients in the experimental (hemostatic agent) group and 98 patients in the control group.

For all patients, any anticoagulation or anti-inflammatory medication was discontinued 1 week before the elective arthroplasty. An interscalene regional block combined with general anesthesia was used in all cases. All procedures were performed through a standard anterior deltopectoral approach. Patients in the experimental group had 10 mL of the hemostatic agent topically applied to the soft tissues of the wound before closure. Half the mixture (5 mL) was applied to the deep tissues of the axillary recess, subacromial, and joint spaces, and the other half was applied superficially after closure of the deltopectoral interval. A medium Hemovac (Zimmer) drain was used in all cases, with 1 tubing placed in the deep space and another between the deltoid and the skin, both draining to a single drain evacuator.

After surgery, all patients received deep venous thrombosis (DVT) prophylaxis consisting of 5000 units of subcutaneous unfractionated heparin every 8 hours until discharge, and then aspirin 325 mg twice daily for 2 weeks after discharge unless contraindicated. Any long-term anticoagulation therapy discontinued before surgery was resumed on postoperative day 2 (POD 2). All drains were removed on POD 2 unless they had more than 50 mL of output over an 8-hour period. Complete blood cell counts were collected for all patients before surgery and on PODs 1 and 2. Whether to transfuse blood was based on clinical judgment of severe or symptomatic acute blood loss anemia; however, no strict predetermined criteria were followed.

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