General introduction 11 1.2 Evaluation of complication rates in device therapy Cardiac implantable electronic devices (CIED) are used to treat impulse and conduction abnormalities, ventricular arrhythmias and heart failure. CIEDs include pacemakers, ICDs, cardiac resynchronization therapy (CRT). Furthermore, diagnostic CIEDs like implantable loop recorders are used to detect the cause of unexplained syncope. Many new innovations have been introduced in the past decade and include subcutaneous ICDs, leadless pacemakers, and conduction system pacing to achieve CRT (11, 12). Growing numbers of pacemaker and ICD implantations can be observed due to increasing life expectancy and growing age of the population (11, 12). This can also be observed in the Netherlands, with 14,570 pacemaker interventions in 2022. However, the number of ICD interventions has remained stable with 5,664 ICD interventions in 2022, with up to 40% for secondary prevention (13). The indications for a pacemaker most commonly are sinus node dysfunction and high-degree atrioventricular block. Over 80% of implanted pacemakers are in patients >65 years of age. An ICD is usually indicated in patients for secondary prevention of sudden cardiac death, or for primary prevention in heart failure patients with a left ventricular ejection fraction of ≤35% (12). Finally, CRT therapy is indicated in patients with chronic heart failure with severe LV dysfunction and left bundle branch block (LBBB). By correcting the electromechanical desynchrony caused by LBBB, positive LV remodelling is possible. This has resulted in significant improvement in morbidity and mortality in patients with heart failure and LBBB (11). Both pacemakers and ICDs are considered low-risk procedures, but unfortunately are still associated with complications such as bleeding, infection and lead dislocation (11, 12). To minimize risks, preventive measures such as antibiotics prophylaxis, experienced and certified staff, sterile environment, periprocedural haemostatic agents, antibacterial envelopes and post-procedural pressure bandages are essential (14). Prevention of pocket hematoma is important and this also requires meticulous attention to modifiable risk factors, including older age, renal failure, congestive heart failure, low operator experience, concomitant antiplatelet therapy, device replacement, lead revision, and heparin bridging (15, 16). Periprocedural oral anticoagulation is associated with a higher likelihood for pocket hematoma (17). 1
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