Defibrillators, Heart Failure, Telemedicine
Conditions
Keywords
electrophysiology, remote monitoring, technical support, device
Brief summary
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.
Interventions
OTHERinterventional cardiology procedures with proctoring system
Interventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory
OTHERinterventional cardiology procedures with engineer in the electrophysiology laboratory
Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
Sponsors
University of Calabria
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Interventional Procedures Successfully Completed | From enrollment to the end of treatment at 12 months | 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). |
| Mean Pacing Threshold at 12-Month Follow-Up | 12-month follow-up visit | 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. |
| Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance | During the interventional procedure up to 2 hours | 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. |
| Electrophysiology Laboratory Occupancy | The time in minutes during procedure | Investigators determined the duration of interventional procedures in minutes and compared this result both for standard and telemedicine driven approach. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional Cardiology Procedures With Engineer in Remote Support interventional cardiology procedures with proctoring system: Interventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory | 10 |
| Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory. | 20 |
| Total | 30 |
Baseline characteristics
| Characteristic | Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory | Total | Interventional Cardiology Procedures With Engineer in Remote Support |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 30 Participants | 10 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 11 | 64 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 30 Participants | 10 Participants |
| Region of Enrollment Italy | 20 Participants | 30 Participants | 10 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 21 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 20 |
| other Total, other adverse events | 0 / 10 | 0 / 20 |
| serious Total, serious adverse events | 0 / 10 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Cardiology Procedures With Engineer in Remote Support | Electrophysiology Laboratory Occupancy | 84 minutes | Standard Deviation 6.5 |
| Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory | Electrophysiology Laboratory Occupancy | 103 minutes | Standard Deviation 28 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Cardiology Procedures With Engineer in Remote Support | Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance | 6 minutes | Standard Deviation 4 |
| Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory | Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance | 8 minutes | Standard Deviation 8 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Cardiology Procedures With Engineer in Remote Support | Mean Pacing Threshold at 12-Month Follow-Up | 0.42 Volt | Standard Deviation 0.12 |
| Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory | Mean Pacing Threshold at 12-Month Follow-Up | 0.42 Volt | Standard Deviation 0.098 |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Cardiology Procedures With Engineer in Remote Support | Percentage of Participants With Interventional Procedures Successfully Completed | 10 Participants |
| Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory | Percentage of Participants With Interventional Procedures Successfully Completed | 20 Participants |