Use of a Topical Thrombin-Based Hemostatic Agent in Shoulder Arthroplasty
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.
We also found no significant increase in adverse events related to use of the hemostatic agent. Complications of particular concern would include wound complications, deep prosthesis infection, and systemic thromboembolic disease (eg, myocardial infarction, stroke, DVT, pulmonary embolus). There were no statistical differences in major and minor complications between the groups and no identifiable complications related to the hemostatic agent used.
Our results should be viewed in light of study limitations. First, with this retrospective study, we relied heavily on the accuracy of computer-based patient documentation. In addition, blood loss estimates are imperfect regardless of measurement technique. Intraoperative EBL is often determined by the surgeon and is highly variable, and autologous blood collection does not account for blood lost in operative sponges, instruments, and irrigation. To minimize this issue, we tried to assess perioperative blood loss through multiple data points, including intraoperative EBL, autologous blood returned during surgery, drain output, transfusion rates, and HBL calculations. Also, blood transfusion criteria depend on the physician’s clinical assessment and decision making, as well as patient condition, which could certainly add variability to the transfusion rate between groups. Another limitation is that the procedures studied were not homogeneous, and including primary and revision anatomical and reverse shoulder arthroplasties may have added variability to the results. In this single-surgeon study, however, we were able to ensure that the same standard techniques and hemostasis were applied in all procedures. Last, given the relatively small sample used, more patients may be needed to reveal a significant and clinically relevant difference in blood loss.
Conclusion
Perioperative blood loss poses serious risks to patient health. In light of the varying findings in the literature and the cost of transfusions and blood loss management products, use of these hemostatic agents remains controversial. In the present study, we found no significant difference in perioperative blood loss or transfusion rates with use of a hemostatic agent during shoulder arthroplasty. Therefore, we cannot conclude that this agent is effective for blood loss management in shoulder arthroplasty. Highly powered prospective studies are needed to confirm our findings.
