Background:
Current expert consensus recommends remote monitoring for cardiac implantable electronic devices, with at least annual in-office follow-up. We studied safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for 2 years.
Methods:
In Japan, consecutive pacemaker patients committed to remote monitoring were randomized to either RFU or conventional in-office follow-up (conventional follow-up) at twice yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after 2 years. The primary end point was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was noninferiority with 5% margin.
Results:
Of 1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (Conventional follow-up) patients reached either the primary end point or 24 months follow-up. The primary end point occurred in 10.9% and 11.8%, respectively (
P
=0.0012 for noninferiority). The median (interquartile range) number of in-office follow-ups was 0.50 (0.50–0.63) in RFU and 2.01 (1.93–2.05) in conventional follow-up per patient-year (
P
<0.001). Insurance claims for follow-ups and directly related diagnostic procedures were 18 800 Yen (16 500–20 700 Yen) in RFU and 21 400 Yen (16 700–25 900 Yen) in conventional follow-up (
P
<0.001). Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.
Conclusions:
Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption.
Registration:
URL:
https://clinicaltrials.gov
; Unique identifier: NCT01523704.
Patients with AS and preserved LVEF have impaired longitudinal strain and endocardial radial strain, although circumferential strain and epicardial radial strain are preserved. Despite preserved LVEF, endocardial radial strain was associated with AS severity.
Acute changes in FMR with preload alterations resulted from the transverse changes in MAA rather than the longitudinal changes in tethering-tenting of mitral geometry, and mitral annular deformation was determined by changes in LA volume. Preload reduction might help heart failure treatment through the reduction in FMR resulting from the decrease in LA and mitral annular size.
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