Electronic Device Implantation Through Remote Guidance

Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures

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.

Inclusion Criteria:

• Patients over 18 years
• Patients under 85 years
• Patients already implanted with defibrillator and admitted to cardiology division for others invasive procedures
• Patients undergoing defibrillator or cardiac resynchronization therapy defibrillator implantation
• Patients who signed written informed consent

Exclusion Criteria:

• Pacemaker dependent patients
• Patients who underwent generator replacement procedures