BACKGROUND: Pocket hematoma is a common complication after heart rhythm device implantation (HRD) in patients receiving anticoagulation and/or dual antiplatelet therapy (DAPT). METHODS: We conducted a prospective case-control study and enrolled all patients admitted for HRD receiving anticoagulation or DAPT. Participants received D-Stat (a mixture of collagen and thrombin) into the pectoral pocket and were compared with an age- and gender-matched group receiving a vacuum drainage system. The primary endpoint was a composite of hematoma needing evacuation and pocket infection. RESULTS: We included a total of 164 patients (mean age 73 ± 10.7 years; 118 [72 %] men). In all, 82 patients (50 %) received D-stat and 82 (50 %) vacuum drainage. There were 83 (51 %) patients who were treated with anticoagulation, 69 (42 %) patients received DAPT, and 11 (7 %) patients both. The primary endpoint occurred in 14.5 % (12/82) of patients in the D-Stat group and 0 % (0/82) of patients in the drainage group (p < 0.01). The use of D-Stat solution was associated with an increased incidence of pocket hematoma requiring evacuation (8.5 % versus 0 %; p = 0.01), and tended to an increased rate of pocket infections (6.1 % versus 0 %; p = 0.06). Postoperative immunoglobulin E levels (106 ± 219 IU/ml [D-Stat] versus 117 ± 189 IU/ml [drainage]) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus drainage: ∆21 mg/l) were similar in both groups (p = 0.7 and p = 0.5, respectively). CONCLUSIONS: Administration of D-Stat solution is associated with a higher rate of pocket hematoma requiring reoperation in a high risk population receiving anticoagulation and/or DAPT. The observed rate of pocket infections in the D-Stat group is a matter of concern.
BACKGROUND: Pocket hematoma is a common complication after heart rhythm device implantation (HRD) in patients receiving anticoagulation and/or dual antiplatelet therapy (DAPT). METHODS: We conducted a prospective case-control study and enrolled all patients admitted for HRD receiving anticoagulation or DAPT. Participants received D-Stat (a mixture of collagen and thrombin) into the pectoral pocket and were compared with an age- and gender-matched group receiving a vacuum drainage system. The primary endpoint was a composite of hematoma needing evacuation and pocket infection. RESULTS: We included a total of 164 patients (mean age 73 ± 10.7 years; 118 [72 %] men). In all, 82 patients (50 %) received D-stat and 82 (50 %) vacuum drainage. There were 83 (51 %) patients who were treated with anticoagulation, 69 (42 %) patients received DAPT, and 11 (7 %) patients both. The primary endpoint occurred in 14.5 % (12/82) of patients in the D-Stat group and 0 % (0/82) of patients in the drainage group (p < 0.01). The use of D-Stat solution was associated with an increased incidence of pocket hematoma requiring evacuation (8.5 % versus 0 %; p = 0.01), and tended to an increased rate of pocket infections (6.1 % versus 0 %; p = 0.06). Postoperative immunoglobulin E levels (106 ± 219 IU/ml [D-Stat] versus 117 ± 189 IU/ml [drainage]) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus drainage: ∆21 mg/l) were similar in both groups (p = 0.7 and p = 0.5, respectively). CONCLUSIONS: Administration of D-Stat solution is associated with a higher rate of pocket hematoma requiring reoperation in a high risk population receiving anticoagulation and/or DAPT. The observed rate of pocket infections in the D-Stat group is a matter of concern.
Authors: Matthew R Reynolds; David J Cohen; Aaron D Kugelmass; Phillip P Brown; Edmund R Becker; Steven D Culler; April W Simon Journal: J Am Coll Cardiol Date: 2006-05-30 Impact factor: 24.094
Authors: Uwe K H Wiegand; Dominik LeJeune; Frank Boguschewski; Hendrik Bonnemeier; Frank Eberhardt; Heribert Schunkert; Frank Bode Journal: Chest Date: 2004-10 Impact factor: 9.410
Authors: Hubertus von Korn; Marc A Ohlow; Jiangtao Yu; Burkhard Huegl; Walter Schulte; Andreas Wagner; Kai Haberl; Stefan Gruene; Bernward Lauer Journal: J Interv Cardiol Date: 2008-06-28 Impact factor: 2.279