Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers. This study explores feasibility of remotely supported implantations through an internet based platform, aiming at enhancing efficiency and overcoming geographical or pandemic related barriers. The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients, compared to 20 procedures with FCS on site. Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS. Finally, this study demonstrates the safety after testing at one year of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
30
Interventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory
Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
"Magna Graecia" University of Catanzaro
Catanzaro, Italy
Percentage of Participants With Interventional Procedures Successfully Completed
Investigators are going demonstrate the feasibility of cardiology interventional procedures using a proctoring system, comparing them to on site operations carried out by a biomedical engineer. For this purpose engineers develop a system for remote technical support with dedicated computer room, multimedia information system and multi angles cameras, located at the boarders of the electrophysiology lab. In the preclinical step phantom are used for approaching all types of materials and equipment that are going to be used in interventional procedures. Each procedure is considered complete and feasible when the measurements of the electronic parameters of all implanted leads are optimal, in particular, when the pacing function was effective (pacing threshold less than 1 Volt @ 0.5 millisecond).
Time frame: From enrollment to the end of treatment at 12 months
Mean Pacing Threshold at 12-Month Follow-Up
The outcome assesses the mean pacing threshold at 12-month follow-up, used as an indicator of long-term electrical stability of implanted cardiac leads. Stable pacing thresholds suggest proper lead function and adequate myocardial contact over time.
Time frame: 12-month follow-up visit
Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance
Fluoroscopy time (FT), expressed in minutes, is used as a surrogate measure of procedural efficiency and radiation exposure. The FT corresponds to the skin-to-skin time and is recorded from the beginning of X-ray emission to the end of the cardiac device implantation procedure. Data are compared between two groups: procedures performed with onsite presence of the biomedical engineer and those executed with remote technical assistance through the telemedicine support system.
Time frame: During the interventional procedure up to 2 hours
Electrophysiology Laboratory Occupancy
Investigators determined the duration of interventional procedures in minutes and compared this result both for standard and telemedicine driven approach.
Time frame: The time in minutes during procedure
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