Abstract
Despite continuous technological developments, transvenous pacemakers (PM) are still associated with significant immediate and long-term complications, mostly lead or pocket-related. Recent technological advances brought to the introduction in clinical practice of leadless PM for selected cohort of patients. These miniaturize devices are implanted through the femoral vein and advanced to the right ventricle, without leaving leads in place. Lack of upper extremity vascular access and/or high infective risk in patients requiring VVI pacing are the most common indications to leadless PM. The recently introduced MICRA AV leadless PM also allows ventricular synchronization through mechanical sensing of atrial contraction waves, thus solving the problem of AV synchronization. This review will discuss and summarize available clinical evidence on leadless PM, their performance compared to transvenous devices, current applications and future perspectives.
Highlights
Transvenous pacemakers (PM) are well-known devices for the treatment of bradyarrhythmias, providing over one million people worldwide every year with life-saving pacing [1].despite continuous technological developments, transvenous PM are still associated with significant complications, mostly lead or pocket related
Seven patients who had been implanted with the device had an unexpected battery failure that resulted in abrupt loss of pacing and communication; immediate replacement of the Nanostim with a traditional device was required in PM-dependent patients
The major complication rate trended lower in the Micra Post Approval Registry (PAR) than in the investigational device exemption (IDE) study (hazard ratio 0.71; 95% Confidence Interval (CI) 0.44–1.1; p = 0.160) while there was a 63% lower risk of major complications in the Micra PAR compared to the historical cohort of transvenous PM
Summary
Transvenous pacemakers (PM) are well-known devices for the treatment of bradyarrhythmias, providing over one million people worldwide every year with life-saving pacing [1]. Immediate and short-term complication rates can be as high as 12% These short-term complications are mainly represented by pocket hematoma, pneumothorax, cardiac tamponade lead dislodgement [2,3]. The incidence of long-term complications such as tricuspid regurgitation, venous obstruction, lead fractures, insulation failure and device related infection is around 9% [3]; notably, transvenous lead-related endocarditis has been linked to higher mortality risk ranging from 12% to 31% [5]. In a Danish Cohort of patients followed from 1982 to 2018, overall risk of infection was low in PM implantations but considerably higher in Cardiac Resynchronization Therapy (CRT) systems and after reinterventions [6]. The FOLLOW-PACE multicentre cohort study aimed to identify patients more prone to complications and possible predisposing factors, but it still remains challenging to recognize high risk individuals [3]. This review will discuss and summarize available clinical evidence on leadless pacemakers, their performance compared to transvenous devices, current indications and future perspectives
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