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.

Interrupted versus uninterrupted novel oral anticoagulant peri‐implantation of cardiac device: A single‐center randomized prospective pilot trial

“…In a subgroup of patients undergoing CIED surgery in the RE‐LY trial, interruption of dabigatran was associated with similar incidence of pocket hematoma compared with interruption of warfarin . Routine discontinuation of NOAC therapy is currently a common practice in most centers, and was demonstrated by the recent European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS‐PREDI) in which NOAC therapy was interrupted in 88.7% of patients before CIED implant . Jennings et al.…”

“…Moreover, pocket hematomas often result in prolonged interruption of anticoagulation, and a consequently increased risk of thrombotic events. Pocket hematomas are also associated with a 7‐fold higher risk of device infection, which carries a significantly higher risk of morbidity and mortality . Implantation of a CIED without interruption of NOAC therapy may reduce the risk of thromboembolic events in those with underlying atrial fibrillation.…”

“…Pocket hematomas are also associated with a 7-fold higher risk of device infection, which carries a significantly higher risk of morbidity and mortality. 12,17,18 The main limitation of this pilot study is the limited number of patients and the single-center design. This trial is underpowered to detect bleeding difference in the two groups.…”

Oral anticoagulation management in patients with atrial fibrillation undergoing cardiac implantable electronic device implantation

“…It is of interest to compare the patterns of anticoagulation management we observed in our large North American AF registry with recent observational data from Europe. The European Snapshot Survey on Procedural Routines for Electronic Device Implantation examined patterns of anticoagulation management in 723 patients undergoing CIED implantation in 2015 . European providers were more likely to continue oral anticoagulation (67% vs 35% in ORBIT‐AF).…”

Underrecognized entity of the transient rise in the atrial capture threshold early after dual‐chamber pacemaker implantation

“…Standard implantation techniques were applied in all patients . A passive or active fixation lead was used in 182 patients (77%) and 57 patients (24%), respectively.…”