title: Perioperative management of antithrombotic treatment during implantation or revision of cardiac implantable electronic devices: the European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI).
abstract: The European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI) was a prospective European survey of consecutive adults who had undergone implantation/surgical revision of a cardiac implantable electronic device (CIED) on chronic antithrombotic therapy (enrolment March-June 2015). The aim of the survey was to investigate perioperative treatment with oral anticoagulants and antiplatelets in CIED implantation or surgical revision and to determine the incidence of complications, including clinically significant pocket haematomas. Information on antithrombotic therapy before and after surgery and bleeding and thromboembolic complications occurring after the intervention was collected at first follow-up. The study population comprised 723 patients (66.7% men, 76.9% aged ≥66 years). Antithrombotic treatment was continued during surgery in 489 (67.6%) patients; 6 (0.8%) had their treatment definitively stopped; 46 (6.4%) were switched to another antithrombotic therapy. Heparin bridging was used in 55 out of 154 (35.8%) patients when interrupting vitamin K antagonist (VKA) treatment. Non-vitamin K oral anticoagulant (NOAC) treatment was interrupted in 88.7% of patients, with heparin bridging in 25.6%, but accounted for only 25.3% of the oral anticoagulants used. A total of 108 complications were observed in 98 patients. No intracranial haemorrhage or embolic events were observed. Chronic NOAC treatment before surgery was associated with lower rates of minor pocket haematoma (1.4%; P= 0.042) vs. dual antiplatelet therapy (13.0%), VKA (11.4%), VKA + antiplatelet (9.2%), or NOAC + antiplatelet (7.7%). Similar results were observed for bleeding complications (P= 0.028). Perioperative management of patients undergoing CIED implantation/surgical revision while on chronic antithrombotic therapy varies, with evidence of a disparity between guideline recommendations and practice patterns in Europe. Haemorrhagic complications were significantly less frequent in patients treated with NOACs. Despite this, the incidence of severe pocket haematomas was low.
authors.affiliation: Department of Cardiology, University Hospital La Timone, Marseilles, France jean-claude.deharo@ap-hm.fr.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Deharo
authors.affiliation: Department of Cardiology, Institution of Medical Science, Uppsala University, Uppsala, Sweden.
authors.forename: Elena
authors.initials: E
authors.lastname: Sciaraffia
authors.affiliation: Department of Cardiology, University Hospital Pontchaillou, CIC-IT 804, INSERM 1099, Rennes, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Leclercq
authors.affiliation: Department of Cardiology, GHI Le Raincy-Montfermeil, Montfermeil, France.
authors.forename: Walid
authors.initials: W
authors.lastname: Amara
authors.affiliation: Department of Electrophysiology, University Leipzig - Heart Center, Leipzig, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Doering
authors.affiliation: 2nd Cardiology Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Maria G
authors.initials: MG
authors.lastname: Bongiorni
authors.affiliation: Department of Heart Disease, Haukeland University Hospital, Bergen, Norway Department of Clinical Science, University of Bergen, Bergen, Norway.
authors.forename: Jian
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Electrophysiology, University Leipzig - Heart Center, Leipzig, Germany.
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Dagres
authors.affiliation: Department of Cardiology, MedizinischeKlinik I, Ludwig-Maximilians-Universität, Campus Großhadern, Marchioninistrasse 15, München 81377, Germany.
authors.forename: Heidi
authors.initials: H
authors.lastname: Estner
authors.affiliation: Department of Cardiology, AF Study group, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Torben B
authors.initials: TB
authors.lastname: Larsen
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Jens B
authors.initials: JB
authors.lastname: Johansen
authors.affiliation: School of Medicine, Belgrade University, Cardiology Clinic, Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Tatjana S
authors.initials: TS
authors.lastname: Potpara
authors.affiliation: Division of Cardiology, University Hospital S. Maria della Misericordia, IRCAB Foundation Udine, Udine, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Proclemer
authors.affiliation: Department of Cardiology, Maastricht University Medical Centre and Cardiovascular Research Institute, Maastricht PO Box 5800, The Netherlands.
authors.forename: Laurent
authors.initials: L
authors.lastname: Pison
authors.affiliation: Department of Cardiology, University Hospital La Timone, Marseilles, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Brunet
authors.affiliation: Department of Cardiology, Institution of Medical Science, Uppsala University, Uppsala, Sweden.
authors.forename: Carina
authors.initials: C
authors.lastname: Blomström-Lundqvist
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D005060:Europe; D005260:Female; D006406:Hematoma / Q000453:epidemiology* / Q000209:etiology; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects* / Q000145:classification; D059035:Perioperative Period; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D012086:Reoperation; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000925:Anticoagulants
keywords: Antiplatelet; Antithrombotic therapy; Bleeding; Cardiac implantable electronic device; EHRA survey; Non-vitamin K oral anticoagulants; Pocket haematoma; Warfarin