In 1958, the world's first patient was implanted with a pacemaker.It brought numerous benefits, the most important of which was increased survival. Since then, pacemaker technology has evolved with the development of improved device longevity, by including a high-energy density battery and utilising high impedance, low threshold leads. Implantable pulse generators (IPGs) for cardiac arrhythmias are now a proven and widely used treatment method. A worldwide cardiac pacing and implantable cardioverter-defibrillator (ICD) survey found that in 2009 there were over 700,000 new implants, with the majority of these implants being performed in the US and Europe, but the greatest growth occurring in Asia.
1Despite new developments in pacemaker technology, there is still a high incidence of pacemaker-related complications.2 A large prospective multicentre study found that after two months 12 % of patients present with acute complications (see Figure 1).3 Chronic complications subsequently occur in 10 % of patients. Most of these complications are related to the lead or the surgical pocket created to hold the pacemaker.Local pocket-related complications include haematoma, wound pain, decreased mobility, pocket erosion and infection. Pocket infection can be a serious complication, which occurs in 0.5-1.5 % of implants, but has a mortality of 10 %. Staphylococcus aureus is the main source of infection and is becoming increasingly antibiotic resistant. Pocket haematoma is also a relatively common complication. It is usually benign and treated conservatively but sometimes requires repeated surgery, which can be a major issue in patients who use anticoagulant drugs. 4,5 However, the greatest potential for a complication in a pacemaker procedure is related to the lead. The overall incidence of clinical problems related to the lead is around 8 %.6 Mechanical failure and lead dislodgement are relatively common complications.
AbstractPacemaker technologies have advanced dramatically over the decades since they were first introduced, and every year many thousands of new implants are performed worldwide. However, there continues to be a high incidence of acute and chronic complications, most of which are linked to the lead or the surgical pocket created to hold the device. A leadless pacemaker offers the possibility of bypassing these complications, but requires a catheter-based delivery system and a means of retrieval at the end of the device's life, as well as a way of repositioning to achieve satisfactory pacing thresholds and R waves, a communication system and low peak energy requirements.A completely self-contained leadless pacemaker has recently been developed, and its key characteristics are discussed, along with the results of an efficacy and safety trial in an animal model. The results of the LEADLESS study, the first human trial to look at safety and feasibility of the leadless device, are discussed and the possible implications for future clinical practice examined.
KeywordsLeadless pacemaker, cardiac arrhythmias, pacemak...