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........................................................................................... Based on data from surgical and intravascular catheter procedures, skin antisepsis should be performed using chlorhexidinealcohol instead of povidone-iodinealcohol.647,648 In a large RCT comprising 2546 patients, chlorhexidinealcohol was associated with a lower incidence of short-term intravascular catheter-related infections (HR 0.15, 95% CI 0.05 - 0.41; P = 0.0002).647

9.4 Management of anticoagulation

It is well known that the development of a pocket haematoma after the implantation of a pacemaker system significantly increases the risk for subsequent pocket infection.641,643,649 The Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL) proved that a clinically significant pocket haematoma is an independent risk factor for subsequent device infection (HR 7.7, 95% CI 2.920.5; P < 0.0001).649 Therefore, it is of utmost importance to take all steps to avoid post-operative pocket haematoma. Heparin bridging for pacemaker implantation in patients anticoagulated with a vitamin K antagonist leads to a significant 4.6-fold increase in post-operative pocket haematoma compared with a continued warfarin strategy.650 International normalized ratio tapering and temporary shifting of dual antiplatelet to single antiplatelet administration may significantly reduce the haematoma and infection rate by 75% and 74%, respectively, compared with heparin bridging.651 Regarding non-vitamin K antagonist oral anticoagulants, the Randomized Controlled Trial of Continued Versus Interrupted Direct Oral Anti-Coagulant at the Time of Device Surgery (BRUISE CONTROL-2) was stopped prematurely due to futility because the event rate was far lower than anticipated; however, it suggested that, depending on the clinical scenario and concomitant antiplatelet therapy, either stopping or continuing non-vitamin K antagonist oral anticoagulants might be reasonable at the time of device implantation.652

Patients on dual antiplatelet therapy have a significantly increased risk of post-operative pocket haematoma compared with patients treated with aspirin alone or without antiplatelet therapy. In such cases, P2Y12 receptor inhibitors should be discontinued for 37 days (according to the specific drug) before the procedure where possible and based on an individualized risk assessment.638,653,654 For more details on the management of anticoagulation in the pacemaker procedure, refer to Table 11.

9.5 Venous access

Transvenous lead implantation for pacemaker implantation is commonly performed by venous access via the cephalic, subclavian, or axillary vein. In the case of clinical signs of venous occlusion of the subclavian vein or the innominate vein, pre-operative imaging (venography or chest CT scan) may be useful in planning venous access or an alternative access ahead of the procedure. In the case of impossible superior venous access, appropriate, alternative approaches may be transfemoral lead implantation, or implantation of a leadless device or epicardial leads. When using the Seldinger technique, there is a risk of a pneumothorax, haemothorax, inadvertent arterial puncture, and injury to the brachial plexus during venous puncture of the subclavian vein and (less so) the axillary vein. These risks are avoidable by using the cephalic vein approach, which allows venous insertion of leads under direct vision. Subclavian vein access is associated with a 7.8-fold

Table 11 Management of anticoagulation in pacemaker procedures

Dual antiplatelet therapy655,656 NOAC652 VKA650 OAC 1 antiplatelet657

Thrombotic risk after PCI Intermediate or low

>1 month PCI >6 months acute coronary

syndrome at index PCI High <1 month PCI

<6 months acute coronary

syndrome at index PCI

Low procedural bleeding risk First implant Continue aspirin AND

Discontinue P2Y12 inhibitors: Ticagrelor at least 3 days before surgery Clopidogrel at least 5 days before surgery Prasugrel at least 7 days before surgery Elective surgery: Consider

postponement Otherwise:

• Continue aspirin • Continue P2Y12 inhibitor Continue or interrupt as

per operator preference. If interruption, then based on CrCl and specific NOAC Continuea Continue OAC (VKAa or

NOAC). Discontinue antiplatelet per patient-specific

risk/benefit analysis

High procedural bleeding risk Device exchange, upgrade/ revision procedure Continue aspirin AND

Discontinue P2Y12 inhibitors: Ticagrelor at least 3

days before surgery, Clopidogrel at least 5 days before surgery, Prasugrel at least 7 days before surgery.

Bridging with GP IIb/IIIa

inhibitors

CrCl = creatinine clearance; GP = glycoprotein; NOAC = non-vitamin K antagonist oral anticoagulant; OAC = oral anticoagulant; PCI = percutaneous coronary intervention; VKA = vitamin K antagonist. aTarget international normalized ratio within therapeutic range. ESC 2021 Downloaded from academic.oup.com/eurheartj/article/42/35/3427/6358547 by guest on 07 October 2026