Pocket related complications in 163 patients receiving anticoagulation or dual antiplatelet therapy: D-Stat Hemostat versus standard of care.

BACKGROUND

Pocket hematoma is a common complication after cardiac rhythm device implantation (CRDI) in patients receiving anticoagulation or dual antiplatelet therapy (DAPT). We sought to assess the safety and effectiveness of D-Stat Flowable Hemostat ([D-Stat]-a mixture of thrombin and collagen) in these patients.

METHODS

We conducted a prospective case control study and enrolled all patients admitted for CRDI receiving anticoagulation or DAPT. Participants received either D-Stat into the pectoral pocket as an adjunct to standard of care versus the standard of care (UC) alone. The primary endpoint was a composite of hematoma needing evacuation, and pocket infection.

RESULTS

We included a total of 163 patients (mean age 72 ± 8 years). 119 (73%) were male. 82 patients (50%) received D-stat and 81 (50%) usual care; 82 patients (50%) were treated with anticoagulation, 62 patients (38%) received DAPT, and 19 patients (12%) both. The primary endpoint occurred in 12/82 patients from the D-Stat group and 3/81 patients of the control group (14.6% versus 3.7%; p=0.03). The use of D-Stat tended for a higher incidence of pocket hematoma requiring evacuation (8.5% versus 2.4%; p=0.12), and an increased rate of pocket infections (6.1% versus 1.2%; p=0.21). Postoperative Immunoglobulin E levels (86 ± 147 IU/ml (D-Stat) versus 120 ± 231 IU/ml (UC)) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus UC: 14 mg/l) were similar in both groups (p=0.26 and p=0.4, respectively).

CONCLUSIONS

Administration of D-Stat does not decrease the frequency of clinically relevant pocket hematomas. The observed rate of pocket infections in the D-Stat group is a matter of concern.