Use of MPH hemostatic powder for electrophysiology device implantation reduces postoperative rates of pocket hematoma and infection

Abstract

Background: Surgical site bleeding and infection are potential complications after electrophysiology (EP) device implantation procedures. To date, there is a wide variety of tools for management of intraoperative bleeding but it still remains unclear what methods are preferred.

Objective: The aim of our study is to compare the rate of complications in patients who underwent cardiac implantable electronic device (CIED) implantation utilizing MPH hemostatic powder to the rate of complications in those patients who underwent standard procedure protocol without MPH hemostatic powder.

Methods: In our study, a new plant-derived microporous polysaccharide hemostatic powder (Arista) was used. A total of 283 consecutive patients were retrospectively studied to assess the rate of complications in patients who underwent CIED implantation with MPH hemostatic powder (n = 77, MPH hemostatic powder) and without (n = 206, no MPH hemostatic powder). Patients were followed for 12 months.

Results: The MPH hemostatic powder group of patients had a lower complication rate when compared to no MPH hemostatic powder, 0.3% vs. 1.7% (p < .05), respectively. The rate of device implantation site MPH hematoma in the MPH hemostatic powder group was 0.4%, versus 0.9% in the other group. There were no postoperative infections in the MPH hemostatic powder group versus 3.2% infections in the other group. The main predictor of increased risk of post-procedural complication was the usage of anticoagulation with a hazard ration of 2.7.

Conclusion: Using MPH hemostatic powder for post-procedural hemostasis was shown to result in a significant reduction in the rate of overall post-procedural complications (a composite endpoint of hematoma and infections), and a trend in reduction of the infections rates and device implantation site hematoma rates.

Keywords:

• Pocket hematoma
• cardiac implantable electronic device
• cardiac device infection
• hemostatic agent

Transparency

Declaration of funding

This manuscript was not funded.

Author contributions: E.F.A., H.N., O.R.: involved in conception and design; E.F.A., O.R., C.K.P., J.B., P.B., J.E.A., P.A., N.S.: involved in analysis and interpretation of the data; E.F.A., O.R.: involved in the drafting of the paper; E.F.A., D.M., O.R.: revising the article critically; E.F.A., D.M., O.R.: the final approval of the version to be published. All authors agree to be accountable for all aspects of the work.

Declaration of financial/other relationships

E.F.A. has disclosed that after presentation of the study at HRS in 2016 he became a speaker for Arista. O.R., P.A., N.S., C.K.P., H.N., J.B., P.B., J.E.A. and D.M. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

None reported.

Notes

* Arista – plant based hemostatic powder derived from purified plant starch, containing microporous polysaccharide hemospheres.