Real-time technical support for guiding remotely ICD/CRT-D implantation

Abstract

Background: In the electrophysiologic (EP) lab, technical support for implantable cardioverter/defibrillators (ICD) and cardiac resynchronization therapy (CRT-D) procedures is often limited by the availability and costs of field clinical specialist (FCS) bioengineers.

Methods: This study explores the viability of using remote support through an internet-based platform for ICD and CRT-D implantation procedures, aiming to enhance efficiency and overcome geographical or pandemic-related barriers. After preclinical phases, thirty patients underwent ICD/CRT-D guided either remotely or with on-site FCS implantation at two primary cardiac care centers, with ten procedures guided remotely and twenty cases with on-site FCS.

Results: All procedures in both study arms were successfully completed (100% of cases). Procedural time was shorter in the telemedicine group (P = 0.031). Although fluoroscopic time was slightly reduced in the remote guided group, the difference did not reach statistical significance (P = 0.5). No major adverse events occurred.

Conclusion: The study demonstrates the feasibility of remotely supported ICD and CRT-D implantation procedures.

Keywords: device; electrophysiology; heart failure; remote monitoring; technical support; telemedicine.

Figure 1

Remote FCS ysupport system setup. Representative pictures of remotely-driven procedures steps: (A) device interrogation and programming in a previously implanted patient; (B) external simulator displaying cardiac arrhythmias analyzed both in- and out-side the EP lab; (C) audio/video consolle set-up for remote guidance; (D) phantom covered by sterile drape; (E) physician operating in the EP lab while receiving instructions by the engineer at the computer; (F) rotating camera for focusing and zooming unlimited times in order to allow remotely-guided devices implantation.

Figure 2

Total procedure length according to typology of cardiac implantable electronic devices. Box plots compare EP lab occupancy times (in minutes) between two groups: procedures with a biomedical engineer either physically on-site (N = 20) or providing remote telemedicine support (N = 10) during transvenous implantable cardioverter/defibrillator procedures (TV-ICD, 5 vs. 3), cardiac resynchronization therapy with defibrillators (CRT-D, 3 vs. 3), and subcutaneous ICD (S-ICD, 12 vs. 4). The EP lab occupancy time is longer for the onsite group, whereas the remote group shows shorter and more consistent occupancy times, suggesting greater efficiency with remote support. List of abbreviations: CRT-D, cardiac resynchronization therapy with defibrillator; EP lab, electrophysiology laboratory; ICD, implantable cardioverter defibrillator; S-ICD, subcutaneous; TV-ICD, transvenous implantable cardioverter defibrillator.

Figure 3

Fluoroscopy time and radiation exposure deriving from standard approach and from telemedicine-driven implantation. The box plots compare fluoroscopy times (in minutes) between two groups: cases with a biomedical engineer either physically on-site or providing remote telemedicine support. The interventions include transvenous implantable cardioverter-defibrillators (TV-ICD, 5 on-site vs. 3 remote), cardiac resynchronization therapy with defibrillators (CRT-D, 3 on-site vs. 3 remote), and subcutaneous ICDs (S-ICD, 12 on-site vs. 4 remote). The onsite group shows longer fluoroscopy times, while remote group has shorter and more consistent times. List of abbreviations: CRT-D, cardiac resynchronization therapy with defibrillator; ICD, implantable cardioverter defibrillator; S-ICD, subcutaneous implantable cardioverter defibrillator; TV-ICD, transvenous implantable cardioverter defibrillator.