Abstract 3027: The Pocket Protector Study: Use of D-Stat® Flowable Hemostat in Pulse Generator Pectoral Pockets Reduces the Rate of Clinically Relevant Hematomas
Background: Patients who are anti-coagulated following pulse generator implantation have a 20% risk of hematoma development in the pre-pectoral pocket. In general, hematomas are correlated with patient discomfort & pain, lead to increased risk of infections, & may require surgical drainage leading to longer hospitalization.
Objectives: This investigation was conducted to evaluate safety & effectiveness associated with use of D-Stat® Flowable Hemostat following implantation of a pulse generator compared to standard of care. Safety endpoint evaluated the incidence of major study-related adverse events & effectiveness endpoint evaluated the incidence rate of clinically significant hematomas. Clinically relevant hematoma was defined as alteration in the standard of care.
Methods: Two hundred sixty nine anticoagulated patients were enrolled at ten sites & followed through 8 weeks post-procedure. Patients undergoing implantation were randomized to either D-Stat Flowable Hemostat or standard of care.
Results: No statistical differences were observed in the baseline demographics between treatment groups. The D-Stat Flowable group presented with 65.4% males compared to 71.4% in the control group. Mean age was 73.3 years in the D-Stat Flowable group vs 72.2 years in the control group. Pulse generator distribution between the study groups was 54.4% pacemakers & 45.5% ICDs in the D-Stat Flowable group vs 54.9% pacemakers & 45.1% ICDs in the control group. The safety of the D-Stat Flowable was successfully demonstrated as the incidence rate of major complications experienced in both groups (D-Stat Flowable: 21.3%; Control: 27.8%) was equivalent (p value 0.0008). The effectiveness of D-Stat Flowable was successfully demonstrated as the overall rate of clinically relevant hematomas experienced in the D-Stat Flowable group (11.8%) was significantly less than that of the control group (22.6%) (p-value 0.0231).
Conclusions: The findings from this investigation demonstrate the use of D-Stat Flowable within the pre-pectoral pocket in anti-coagulated patient population undergoing placement of a pulse generator is safe and effective. Use of D-Stat Flowable resulted in a 48% reduction in the rate of clinically relevant hematomas in the target population.