Clinical Use Of Remote Programming In Follow-up Of Cardiovascular Implantable Electronic Devices

Background:The current situation of postoperative follow-up of cardiovascular implantable electronic devices(CIED)is severe.In-person evaluation(IPE)is the most dominant follow-up mode,but the overall compliance is poor.Both patient factors and objective environmental factors show some influence on the frequency of follow-up.Patient factors include distance between patient residence and follow-up clinic,transportation for follow-up,patients’ awareness of the importance of their own diseases and equipment,time post-CIED implantation,and so on.Objective environmental factors include the limited and unevenly distributed follow-up resources,and so on.Remote monitoring(RM)has emerged as a tool to be a new standard of care for patients with CIED in Europe and America and other developed countries and regions.It has clinical benefits such as reducing the number of IPE and earlier detection of device-related adverse events.However,it is not widely used in China and device specialists can not adjust parameters of CIED through RM.Therefore,we propose an innovative tool,remote programming,to provide a solution to address the predicament of IPE and further improve the quality of follow-up management.Objectives:Our study intended to analyze the compliance with IPE and related factors of noncompliance with IPE.And we evaluated the safety and effectiveness of remote programming in follow-up by observing the process of remote programming of CIED patients during in-office visits.Methods:Patients who traveled to 8 general hospitals in Sichuan province to undergo follow-up from February 2021 to February 2022 were included.Their compliance of IPE was investigated and a logistic regression model was used to determine the independent influencing factors of noncompliance.Professionals from CIED Remote Follow-up Center of The Third People’s Hospital of Chengdu conducted remote interrogation,lead parameter testing and individualized parameter modifications of CIED through 5G-cloud technology support platform(5G-CTP).The alert messages,the process of testing and programming of CIED,and communication issues including whether the picture of the remote site was frozen or the connection was disconnected,and whether any adverse events occurred were analyzed.Questionnaires were conducted to investigate the acceptance and satisfaction for remote programming of patients and physicians who participated in the study.Results:A total of 255 CIED patients for follow-up were included in the study.The average age was 74.1 years old,and the proportion of men was 45.5%.The proportion of pacemaker(PM),implantable cardioverter defibrillator(ICD)and cardiac resynchronization therapy pacemaker/defibrillator(CRT-P/CRT-D)patients were 88.6%(226 patients),5.9%(15 patients)and 5.5%(14 patients),respectively.The indications for CIED implantation were sinus node dysfunction(93 patients,36.5%),high-degree atrioventricular block(109 patients,42.7%),primary prevention of sudden cardiac death(12 patients,4.7%),secondary prevention of sudden cardiac death(7 patients,2.7%)and other causes(34 patients,13.3%),respectively.None of the CIED patients were enrolled in RM services.The overall compliance with IPE was 63.9%.Factors including age(each 1-year increase)[OR 1.038,95%CI(1.008-1.069),P=0.011]and time post-CIED implantation longer than 30 months[OR 1.786,95%CI(1.038-3.071),P=0.036)]were statistically significant independent predictors of noncompliance.All the devices were successfully interrogated,tested and programmed.A total number of alert messages was 88 times.The most common alert messages in PM,ICD and CRT were pacemaker-mediated tachycardia(29/226),high percentage of ventricular pacing(7/15)and low biventricular pacing percentage(4/14),respectively.According to clinical needs,the individualized reprogramming rate of devices was 37.6%(96/255).A total number of reprogramming was 166 times,including modifications on specialized functions(ACapTM Confirm,ventricular AutoCapture,and ventricular intrinsic preference)(54 times)and other device parameters(112 times).There were no communication problems and any adverse events occurred during remote programming.In the survey of acceptance and satisfaction of remote programming,the majority of patients(92.9%)and physicians(88.2%)were willing to continue to choose remote programming for further follow-up management.Conclusions:The overall compliance of IPE of CIED patients in this region needs to be improved.No adverse events occurred,and real-time device interrogation,lead parameters testing and device parameters optimization could be realized in the CIED remote programming process based on 5G-CTP.Therefore,the initial exploration of the application of remote programming in follow-up of CIED was safe,effective and feasible.However,a larger sample size and a more rigorous study protocol are needed to further verify its safety and reliability.A standardized operation process of remote programming is also needed to be established before widespread clinical application.