Remote interrogation and reprogramming of CIEDs: a prospective, paired, self-controlled, non-inferiority, multicenter clinical trial — Acute phase results of the CIED-CARE study

Background

Remote interrogation and reprogramming of cardiac implantable electronic devices (CIEDs) could provide important clinical benefits, particularly in emergencies, for patients living far from CIED specialists or during periods requiring strict physical distancing. However, the non-inferiority of remote CIED management in terms of feasibility and safety compared with conventional in-office follow-up has not yet been validated.

Purpose

To determine the feasibility and safety of a customized 5G cloud-based follow-up platform for remote interrogation and reprogramming of CIEDs in a nationwide multicenter clinical trial.

Methods

The CIED-CARE study is an investigator-initiated, paired, self-controlled, non-inferiority, multicenter trial involving 13 tertiary hospitals in China. All patients were scheduled for standard follow-up visits at six key time points: immediately post-implantation, pre-discharge, and at 1 month, 1–3 months, 6 months, and 12 months post-implantation. To assess the performance of the 5G cloud-based platform, each scheduled visit incorporated a paired comparison of remote and in-office sessions. The order of the two sessions (remote-first vs. in-office-first) was randomly assigned at each visit. The remote session was conducted via the 5G cloud-based platform, while the conventional in-office session was performed face-to-face. The primary safety outcome was the incidence of any adverse events directly related to the device follow-up procedure. The primary efficiency outcome was parameter measurement consistency, defined as the concordance of key device parameters between the remote and in-office measurements. Secondary efficiency outcomes included the rate of parameter measurement consistency, parameter measurement time, and reprogramming completion rate.

Results

A total of 2085 paired visits were completed in 695 CIED patients during the acute phase (immediately post-implantation, pre-discharge, and 1 month post-implantation). The cohort included 502 pacemakers (72.2%), 103 ICDs (14.8%), 77 CRT-Ds (11.1%), and 13 CRT-Ps (1.9%).

No primary safety events occurred in either in-office or remote sessions. Linear regression and paired t-test demonstrated excellent consistency between the two approaches for parameter interrogation, including right atrial and right ventricular lead thresholds and impedances, as well as battery parameters such as current and magnet rate (Panel A-L). Interrogation and reprogramming time did not differ significantly between in-office and remote sessions (P = 0.159, Panel M and N).

Conclusions

The acute phase results of the CIED-CARE study demonstrated that remote interrogation and reprogramming of CIEDs via the 5G cloud-based platform are safe and feasible. This strategy may enhance health care access and provide a potential solution to the current predicament of routine in-office management of CIEDs.Consistency of CIED parameters