title: [Prevention of pocket-related complications following heart rhythm device implantation. D-Stat Hemostat™ versus vacuum drainage].
abstract: 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: Klinik für Kardiologie, Zentralklinik Bad Berka, Robert-Koch-Allee 9, 99437, Bad Berka, Deutschland, marc.ohlow@zentralklinik.de.
authors: Marc-Alexander
authors: MA
authors: Ohlow
authors: Björn
authors: B
authors: Buchter
authors: Michele
authors: M
authors: Brunelli
authors: Bernward
authors: B
authors: Lauer
authors: Matthias
authors: M
authors: Schreiber
authors: J Christoph
authors: JC
authors: Geller
mesh_terms: D000368:Aged; D005260:Female; D006406:Hematoma / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control*; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D016459:Prosthesis-Related Infections / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control*; D013396:Suction / Q000379:methods; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics
references: J Am Coll Cardiol. 2006 Jun 20;47(12):2493-7
references: 16781379
references: J Artif Organs. 2005;8(3):137-42
references: 16235029
references: Chest. 2004 Oct;126(4):1177-86
references: 15486380
references: Mem Acad Chir (Paris). 1954 Mar 24-Apr 7;80(12-14):394-6
references: 13176072
references: Patient Saf Surg. 2009 Sep 04;3(1):21
references: 19732447
references: J Interv Cardiol. 2008 Aug;21(4):337-41
references: 18564214
references: J Endod. 1985 Feb;11(2):75-83
references: 3855964
references: Vascular. 2008 Mar-Apr;16 Suppl 1:S29-36
references: 18544303
references: Infect Immun. 1978 Feb;19(2):443-9
references: 631883
references: Am J Obstet Gynecol. 2003 Jan;188(1):71-5
references: 12548198
references: Annu Rev Biophys Bioeng. 1974;3(0):231-53
references: 4607533
references: J Biomed Mater Res. 1986 Jan;20(1):109-20
references: 3949821
references: Europace. 2005 Jul;7(4):374-9
references: 15944096
references: Int J Cardiol. 2012 Sep 6;159(3):177-80
references: 21376404
references: Clin Orthop Relat Res. 1991 Mar;(264):232-4
references: 1997239
references: J Endod. 1986 Jul;12(7):289-92
references: 3461117
references: Unfallchirurgie. 1989 Feb;15(1):24-31
references: 2711525
references: Circulation. 2007 Sep 18;116(12):1349-55
references: 17724263
references: Dtsch Arztebl Int. 2011 May;108(21):372-9; quiz 380
references: 21691561
references: J Reprod Med. 2000 Apr;45(4):327-31
references: 10804490
references: Heart Rhythm. 2012 May;9(5):728-35
references: 22182495
references: Circulation. 2003 Oct 21;108(16):2015-31
references: 14568887