Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry.

BACKGROUND AND AIMS: Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. METHODS: All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models. RESULTS: 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6-64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%-5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR: .47, 95% CI: .36-.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%-6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001). CONCLUSIONS: Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.

The Use of Electrocardiogram Smartwatches in Patients with Cardiac Implantable Electrical Devices.

Unlimited access to ECGs using an over-the-counter smartwatch constitutes a real revolution for our discipline, and the application is rapidly expanding to include patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs) and implantable cardioverter defibrillators (ICDs). CIEDs require periodic evaluation and adjustment by healthcare professionals. In addition, implanted patients often present with symptoms that may be related to their PMs or ICDs. An ECG smartwatch could reveal information about device functioning, confirm normal device function, or aid in the case of device troubleshooting. In this review, we delve into the available evidence surrounding smartwatches with ECG registration and their integration into the care of patients with implanted pacemakers and ICDs. We explore safety considerations and the benefits and limitations associated with these wearables, drawing on relevant studies and case series from our own experience. By analyzing the current landscape of this emerging technology, we aim to provide a comprehensive overview that facilitates informed decision-making for both healthcare professionals and patients.

Current Role of Electrocardiographic Imaging in Patient Selection for Cardiac Resynchronization Therapy.

Cardiac resynchronization therapy (CRT) is a recognized therapy for heart failure with altered ejection fraction and abnormal left ventricular activation time. Since the introduction of the therapy, a 30% rate of non-responders is observed and unchanged. The 12-lead ECG remains the only recommended tool for patient selection to CRT. The 12-lead ECG is, however, limited in its inability to provide a precise pattern of regional electrical activity. Electrocardiographic imaging (ECGi) provides a non-invasive detailed mapping of cardiac activation and therefore appears as a promising tool for CRT candidates. The non-invasive ventricular activation maps acquired by ECGi have been primarily explored for the diagnosis and guidance of therapy in patients with atrial or ventricular tachyarrhythmia. However, the accuracy of the system in this field is lacking and needs further improvement before considering a clinical application. On the other hand, its use for patient selection for CRT is encouraging. In this review, we introduce the technical considerations and we describe how ECGi can precisely characterize ventricular activation, especially in patients with left bundle branch block, thus identifying the electrical substrate responsive to CRT.