Atrial Fibrillation
Conditions
Brief summary
Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units.
Detailed description
Even with its increasing popularity and use, the impact of ICMs on AF (atrial fibrillation) management is still being determined and can even be conflicting. Furthermore, the use of ICM is dependent on physician preference. It is hypothesized that dynamic monitoring with ICMs is superior to conventional methods and should be used for all patients with AF. Thus, it aimed to measure the outcomes of using ICM versus more traditional approaches in patients with AF.
Interventions
OTHERNo intervention or administration will be performed due to the observational nature of the study
Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
Sponsors
Kansas City Heart Rhythm Research Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years of age * Present for management of AF * ICM is inserted at the discretion of the treating physician
Exclusion criteria
* Patients \< 18 years of age * Presence of a permanent pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy * Unable to tolerate ICM or traditional monitoring with ECG, Holter, or MCOT monitoring * Unable to tolerate AAD, OAC, and CA as part of AF standard of care * ICM inserted for cryptogenic stroke or syncope * Was not followed \> 12 months * CA performed for AF before ICM implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Freedom From AF, OAC and AAD Use | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. | Number of patients with freedom from AF, OAC and AAD Use after 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes in Participants With ICM and Non-ICM Participants | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. | Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months |
| Total CV-related Hospital Stay Duration, Days | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. | — |
Countries
United States
Participant flow
Recruitment details
598 patients, with 299 in the non-ICM and ICM groups, respectively were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Participants With ICM Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management. | 299 |
| Non-ICM Participants Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management. | 299 |
| Total | 598 |
Baseline characteristics
| Characteristic | Participants With ICM | Non-ICM Participants | Total |
|---|---|---|---|
| Age, Continuous | 72.3 Years STANDARD_DEVIATION 7.6 | 72.3 Years STANDARD_DEVIATION 7.6 | 72.3 Years STANDARD_DEVIATION 10.75 |
| Baseline AAD Use | 120 Participants | 101 Participants | 221 Participants |
| Compensated heart failure (EF <35%) | 18 Participants | 18 Participants | 36 Participants |
| Coronary artery disease | 50 Participants | 70 Participants | 120 Participants |
| Parosysmal Atrial Fibrillation | 171 Participants | 234 Participants | 405 Participants |
| Persistent Atrial Fibrillation | 128 Participants | 65 Participants | 193 Participants |
| Race/Ethnicity, Customized African American | 37 Participants | 35 Participants | 72 Participants |
| Race/Ethnicity, Customized Caucacian | 251 Participants | 258 Participants | 509 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Female | 79 Participants | 57 Participants | 136 Participants |
| Sex: Female, Male Male | 220 Participants | 242 Participants | 462 Participants |
| Stroke / TIA | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 2 / 299 | 9 / 299 |
| serious Total, serious adverse events | 7 / 299 | 24 / 299 |
Outcome results
Primary
Number of Patients With Freedom From AF, OAC and AAD Use
Number of patients with freedom from AF, OAC and AAD Use after 12 months
Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With ICM | Number of Patients With Freedom From AF, OAC and AAD Use | Number of patients with freedom from AF | 257 Participants |
| Participants With ICM | Number of Patients With Freedom From AF, OAC and AAD Use | Number of patients with freedom from OAC use | 208 Participants |
| Participants With ICM | Number of Patients With Freedom From AF, OAC and AAD Use | Number of patients with freedom from AAD use | 230 Participants |
| Non-ICM Participants | Number of Patients With Freedom From AF, OAC and AAD Use | Number of patients with freedom from AF | 185 Participants |
| Non-ICM Participants | Number of Patients With Freedom From AF, OAC and AAD Use | Number of patients with freedom from OAC use | 118 Participants |
| Non-ICM Participants | Number of Patients With Freedom From AF, OAC and AAD Use | Number of patients with freedom from AAD use | 109 Participants |
Secondary
Clinical Outcomes in Participants With ICM and Non-ICM Participants
Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months
Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With ICM | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Access to EP | 299 Participants |
| Participants With ICM | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Attempted Rhythm Control With AAD | 299 Participants |
| Participants With ICM | Clinical Outcomes in Participants With ICM and Non-ICM Participants | OAC Compliance | 233 Participants |
| Participants With ICM | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Initial Ablation | 275 Participants |
| Non-ICM Participants | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Initial Ablation | 185 Participants |
| Non-ICM Participants | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Access to EP | 180 Participants |
| Non-ICM Participants | Clinical Outcomes in Participants With ICM and Non-ICM Participants | OAC Compliance | 216 Participants |
| Non-ICM Participants | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Attempted Rhythm Control With AAD | 189 Participants |
Secondary
Total CV-related Hospital Stay Duration, Days
Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With ICM | Total CV-related Hospital Stay Duration, Days | 3.5 Days | Standard Deviation 1.9 |
| Non-ICM Participants | Total CV-related Hospital Stay Duration, Days | 7.4 Days | Standard Deviation 5.3 |