216-42: Interim Analysis of the Prospective, Randomized Study Evaluating the Effects of an Adjunctive Application of PerClot® Polysaccharide Hemostatic System When Used During Device Implantation

Abstract

Purpose of the study: Pocket hematoma is a common complication after implantation or generator change (GC) of cardiac rhythm devices (CRD) in patients receiving oral anticoagulation (OAC) or dual antiplatelet therapy (DAPT). The aim of this study was to evaluate the safety and effectiveness of PerClotw in these patients. Method used: PerClotw is a hemostatic medical device composed of absorbable polysaccharide particles. In this prospective 1:1 randomized post‐market study we will include consecutively 150 patients admitted for implantation or GC of CRD receiving OAC and/or DAPT. Primary endpoint is a composite of hematoma and pocket infection. All patients receiving DAPT continue their medication. The maximum duration of NOAC withhold is 36 hours. Patients receiving Phenprocoumon continue the medication with a target INR of 2.0‐2.5. No bridging with heparin is done. Summary of results: In the interim analysis 46 patients were included (mean age 73 + 11 years). 34 (74%) were male. 24 patients (52%) received PerClotw and 22 (48%) standard of care. 35 patients (76%) were treated with anticoagulation alone (15 (32%) Phenprocoumon, 10 (22%) Apixaban, 6 (13%) Dabigatran, Rivaroxaban 4 (9%)), 12 patients (26%) received DAPT, and 1 patient (2%) a triple therapy. Patients were comparable with regard to age (72 + 11 years vs 76 + 10 years; p = 0.5), CHA2DS2VASc (3.5 + 1.6 vs 4.0 + 1.3; p = 0.31) and HASBLEDScore (2.0 + 1.0 vs 2.0 + 0.8; p = 0.99). Patients did not differ with regard to CRD type or procedure type. There was no difference between OAC or DAPT between the two groups. The use of PerClotw tended for a higher incidence of hematoma (5 (20.8%) versus 0 (0%), p = 0.050) and postoperative fever (6 (25.0%) versus 0 (0%); p = 0.02). Postoperative inflammation parameters were higher in PerClotw Group (C‐Reactive Protein (CRP) 66.3 + 52.6 mg/l vs 25.3 + 18.7; p = 0.002; white blood count 13.7 + 4.1/n:l vs 8.8 + 2.8/nl; p , 0.001). Reoperation because of hematoma or pocket infection was not necessary in any patient. Conclusion: Administration of PerClotw does not decrease the frequency of clinically detectable pocket hematoma. The observed rate of fever and inflammation parameters in the PerClotw Group was significantly higher, although no clinical signs of infection could be observed. Device explantation was not necessary in any patient.