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............................................................................................................................................................................. 25 implantations.429 Data from a large national quality assurance programme for pacemakers and CRT-P showed that the annual hospital implantation volume was inversely related to complication rates, with the greatest difference observed between the lowest (1- 50 implantations/year) and the second lowest quintile (5190 implantations/year).699 Furthermore, emergency and out-of-hours procedures are associated with increased complication rates.354 These data clearly suggest that CIED procedures should be performed by operators and centres with a sufficient procedural volume.

10.2 Specific complications

10.2.1 Lead complications Pacemaker leads are a frequent source of complications due to dislodgement, insulation defects, lead fractures, and sensing or threshold problems. In a Danish cohort, lead-related interventions (2.4%) were the most common major complication.354 LV leads have a particular propensity for complications such as dislodgement and coronary vein dissection or perforation.700 In a nationwide registry, LV leads (4.3%) were more commonly associated with complications compared with RA leads (2.3%) and RV leads (2.2%).429 A CRT device (OR 3.3) and passive fixation RA lead (OR 2.2) were the most important risk predictors.

A meta-analysis of 25 CRT trials noted mechanical complications in 3.2% (including coronary sinus dissection or perforation, pericardial effusion or tamponade, pneumothorax, and haemothorax), other lead problems in 6.2%, and infections in 1.4%. Peri-implantation deaths occurred in 0.3%.369

10.2.2 Haematoma Pocket haematoma is a frequent complication (2.19.5%), which can usually be managed conservatively. Evacuation, required in 0.32% of cases, is associated with an 15 times increased risk of infection.639 Moreover, patients developing pocket haematoma stay in hospital longer and have a higher in-hospital mortality rate (2.0% vs. 0.7%).724 Hence, appropriate precautions are critical, and reoperation should be limited to patients with severe pain, persistent bleeding, distension of the suture line, and imminent skin necrosis. Many haematomas can be avoided by careful haemostasis and optimal management of antiplatelet and anticoagulant drugs.

10.2.3 Infection Infection is one of the most worrying CIED complications, causing significant morbidity, mortality, and healthcare costs.725,726 Infection rates are higher with device replacement or upgrade procedures,695 as well as CRT or ICD implants compared with simple pacemaker implantation.727 Olsen et al.702 reported the lifetime risk of system infection in patients with: a pacemaker (1.19%), ICD (1.91%), CRT-P (2.18%), and CRT-D (3.35%). Specifically, patients undergoing reoperations, those with a previous device-related infection, men, and younger patients had a significantly higher risk of infection. Similar findings have been reported in a large cohort of patients receiving an ICD, with infection rates of 1.4% for single, 1.5% for dual, and 2.0% for biventricular ICDs.728 In addition, early reintervention (OR 2.70), previous valvular surgery (OR 1.53), reimplantation (OR 1.35), renal failure on dialysis (OR 1.34), chronic lung disease (OR 1.22), cerebrovascular disease (OR 1.17), and warfarin use (OR 1.16) were associated with an increased risk of infection.702 Infections also occur more frequently with use of temporary pacing or other procedures before implantation (OR 2.5 and 5.8, respectively), early reinterventions (OR 15), and lack of antibiotic prophylaxis (OR 2.5).639,729 Further comprehensive information on how to prevent, diagnose, and treat CIED infections has been provided in a recent EHRA consensus document.642

10.2.4 Tricuspid valve interference CIED leads may interfere with tricuspid valve function intraoperatively by causing damage to the tricuspid valve leaflets or the subvalvular apparatus, or chronically after operation or lead extraction. This damage has been linked to haemodynamic deterioration and an adverse clinical outcome.730 In fact, moderate to severe tricuspid regurgitation is generally associated with excess mortality731,732 and occurs at a significantly higher rate in CIED patients.733 The prevalence of significant tricuspid regurgitation (defined as grade 2 or above) following CIED implantation varies between 10% and 39%. Most studies attribute a greater harm with ICD leads and in the

Table 12 Complications of pacemaker and cardiac resynchronization therapy implantation

Incidence of complications after CIED therapy % Lead-related reintervention354,639,690,692,695,700,701 (including dislodgement, malposition, subclavian crush syndrome, etc.) 1.05.9 CIED-related infections, <12 months354,639,641,645,685,695,702 0.71.7

Superficial infection354 1.2 Pocket infections354 0.4 Systemic infections354 0.5 CIED-related infections, >12 months702709 1.14.6

Pocket infections702 1.3 Systemic infections702,705 0.51.2 Pneumothorax354,658,690,692,700,701,707 0.52.2 Haemothorax695 0.1 Brachial plexus injury695 <0.1 Cardiac perforation354,663,690,692,695 0.30.7 Coronary sinus dissection/perforation710,288 0.72.1 Revision due to pain/discomfort354,690 0.10.4 Diaphragmatic stimulation requiring reintervention711,712,665,713 0.55 Haematoma354,639,650,652,654,690,700,714,715 2.15.3 Tricuspid regurgitation716718 515 Pacemaker syndrome146,701,719 120 Generator/lead problem354,639,690 0.11.5 Deep venous thrombosis (acute or chronic)354,720,721 0.12.6 Any complication354,639,690,692,695,707,722,723 515 Mortality (<30 days)354,694 0.81.4 CIED = cardiovascular implantable electronic device. ESC 2021 Downloaded from academic.oup.com/eurheartj/article/42/35/3427/6358547 by guest on 07 October 2026