Cardiac Arrythmias, Cardiac Event, Left Ventricular Dysfunction, Sudden Cardiac Death
Conditions
Brief summary
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
Detailed description
LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF \<30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF \< 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.
Interventions
A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention
Sponsors
Zoll Medical Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients receiving a LifeVest prescription in clinical routine for the following indications: 1. implantable cardiac defibrillator (ICD) removal due to cardiac device infections, 2. a bridge to heart transplantation, 3. in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF \<30%), 4. a recent coronary revascularization with LV dysfunction (LVEF \< 30%). * Patients who have given their consent to participate.
Exclusion criteria
\- There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Not Receiving Appropriate Shocks When Necessary | from start to end of WCD use (3 months typical prescription) | While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence. |
| Appropriate Shock Events Per Patient | start to end of WCD use (3 months typical prescription) | Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered. |
| Inappropriate Shock Events Per Patient | from start to end of WCD use (3 months typical prescription) | Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Relative to Health State | Time of enrollment | Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life. Agreement score according to 5-point Likert scale (lower is better): 1. = Strongly Agree 2. = Agree 3. = Neither Agree nor Disagree 4. = Disagree 5. = Strongly Disagree |
| Survival During WCD Use | from start to end of WCD use (3 months typical prescription) | The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest |
Other
| Measure | Time frame | Description |
|---|---|---|
| Causes of Mortality | Duration of prescribed device use, up to 3 months. | Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular. |
| Deaths While Wearing the WCD | Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication. | Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes. |
Countries
France
Participant flow
Recruitment details
All LifeVest users completing use between May 2014 and December 2016 were approached for retrospective enrollment. All patients prescribed a LifeVest January 2017 through March 2018 were approached for prospective enrollment. Recruitment took place in France at 88 cardiology centers.
Participants by arm
| Arm | Count |
|---|---|
| All LifeVest Users Patients who were prescribed and used a LifeVest in France
Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention | 1,157 |
| Total | 1,157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data not available. | 7 |
Baseline characteristics
| Characteristic | All LifeVest Users | — |
|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 11.5 | — |
| BMI | 26.2 kilograms per meter squared STANDARD_DEVIATION 5 | — |
| Enrollment type Prospective enrollment | 529 Participants | — |
| Enrollment type Retrospective enrollment | 628 Participants | — |
| Indication for use Bridge to heart transplant | 88 Participants | — |
| Indication for use Early after coronary revascularization with LVEF 30% or less | 303 Participants | — |
| Indication for use Early after myocardial infarction with LVEF 30% or less | 647 Participants | — |
| Indication for use ICD extraction due to infection | 119 Participants | — |
| LVEF (3 groups) <30% | 751 Participants | — |
| LVEF (3 groups) ≥30% and <35% | 251 Participants | — |
| LVEF (3 groups) ≥35% | 147 Participants | — |
| LVEF (4 groups) ≤25% | 577 Participants | — |
| LVEF (4 groups) >25% and ≤35% | 483 Participants | — |
| LVEF (4 groups) >35% and ≤45% | 48 Participants | — |
| LVEF (4 groups) >45% | 41 Participants | — |
| NYHA class Class I | 140 Participants | — |
| NYHA class Class II | 320 Participants | — |
| NYHA class Class III | 238 Participants | — |
| NYHA class Class IV | 99 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Resting HR | 80.0 beats per minute STANDARD_DEVIATION 17.6 | — |
| Sex: Female, Male Female | 183 Participants | — |
| Sex: Female, Male Male | 974 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 1,157 |
| other Total, other adverse events | 0 / 1,157 |
| serious Total, serious adverse events | 6 / 1,157 |
Outcome results
Primary
Appropriate Shock Events Per Patient
Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered.
Time frame: start to end of WCD use (3 months typical prescription)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All LifeVest Users | Appropriate Shock Events Per Patient | Patients not shocked for VT or VF | 1139 Participants |
| All LifeVest Users | Appropriate Shock Events Per Patient | Patients with 1 appropriate shock event | 17 Participants |
| All LifeVest Users | Appropriate Shock Events Per Patient | Patients with 2 appropriate shock events | 1 Participants |
95% CI: [6.3, 8.7]
Primary
Inappropriate Shock Events Per Patient
Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.
Time frame: from start to end of WCD use (3 months typical prescription)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All LifeVest Users | Inappropriate Shock Events Per Patient | Patients without inappropriate shock events | 1149 Participants |
| All LifeVest Users | Inappropriate Shock Events Per Patient | Patients with 1 inappropriate shock event | 8 Participants |
95% CI: [1.9, 4.4]
Primary
Risk of Not Receiving Appropriate Shocks When Necessary
While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.
Time frame: from start to end of WCD use (3 months typical prescription)
Population: All recorded occurrences of VF or sustained VT (\>30 seconds)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All LifeVest Users | Risk of Not Receiving Appropriate Shocks When Necessary | Appropriate shock for VT/VF | 19 Recorded instances of VT/VF |
| All LifeVest Users | Risk of Not Receiving Appropriate Shocks When Necessary | Response buttons used for tolerated VT/VF | 15 Recorded instances of VT/VF |
| All LifeVest Users | Risk of Not Receiving Appropriate Shocks When Necessary | Sustained VT, self-terminated before shock | 8 Recorded instances of VT/VF |
Secondary
Quality of Life Relative to Health State
Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life. Agreement score according to 5-point Likert scale (lower is better): 1. = Strongly Agree 2. = Agree 3. = Neither Agree nor Disagree 4. = Disagree 5. = Strongly Disagree
Time frame: Time of enrollment
Population: Data was collected from prospectively enrolled subjects at selected sites. Not all sites participated in the quality of life surveys.~Responses were available from 246 of the 529 prospectively enrolled subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All LifeVest Users | Quality of Life Relative to Health State | The LifeVest gives me peace of mind | 1.96 units on a scale | Standard Deviation 0.9 |
| All LifeVest Users | Quality of Life Relative to Health State | I don't worry as much because I know the LifeVest is protecting me | 2.17 units on a scale | Standard Deviation 1 |
| All LifeVest Users | Quality of Life Relative to Health State | I sleep significantly better knowing I am protected by the LifeVest | 2.51 units on a scale | Standard Deviation 1.12 |
| All LifeVest Users | Quality of Life Relative to Health State | I feel more confident returning to my normal daily activities when wearing the LifeVest | 2.11 units on a scale | Standard Deviation 0.95 |
| All LifeVest Users | Quality of Life Relative to Health State | LifeVest has given me the confidence to perform exercise or cardiac rehabilitation | 2.35 units on a scale | Standard Deviation 1.03 |
| All LifeVest Users | Quality of Life Relative to Health State | Wearing the LifeVest makes me take my condition seriously | 1.66 units on a scale | Standard Deviation 0.9 |
| All LifeVest Users | Quality of Life Relative to Health State | I take significantly better care of myself since being prescribed the LifeVest | 2.14 units on a scale | Standard Deviation 1.06 |
| All LifeVest Users | Quality of Life Relative to Health State | I follow lifestyle modification recommendations from my physician | 1.56 units on a scale | Standard Deviation 0.68 |
| All LifeVest Users | Quality of Life Relative to Health State | I would recommend LifeVest to family or friends with a similar medical condition | 1.67 units on a scale | Standard Deviation 0.9 |
Secondary
Survival During WCD Use
The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest
Time frame: from start to end of WCD use (3 months typical prescription)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All LifeVest Users | Survival During WCD Use | Death after WCD wearing period | 1 Participants |
| All LifeVest Users | Survival During WCD Use | Survival to end of prescribed WCD use (WCD wearing period) | 1132 Participants |
| All LifeVest Users | Survival During WCD Use | Death during WCD wearing period | 25 Participants |
Other Pre-specified
Causes of Mortality
Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.
Time frame: Duration of prescribed device use, up to 3 months.
Population: Subjects who died during the device prescription period. The prescriptive period ranged from 1 to 3 months.~One death had no information recorded (retrospective group) and was labeled unknown.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All LifeVest Users | Causes of Mortality | Cardiac cause | 17 Participants |
| All LifeVest Users | Causes of Mortality | Vascular cause (includes stroke) | 1 Participants |
| All LifeVest Users | Causes of Mortality | Non-cardiovascular cause | 6 Participants |
| All LifeVest Users | Causes of Mortality | Unknown (no information available) | 1 Participants |
Other Pre-specified
Deaths While Wearing the WCD
Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes.
Time frame: Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All LifeVest Users | Deaths While Wearing the WCD | Arrhythmic cause: primary asystole | 0 Participants |
| All LifeVest Users | Deaths While Wearing the WCD | Arrhythmic cause: VF (includes electrical storm) | 2 Participants |
| All LifeVest Users | Deaths While Wearing the WCD | Non-arrhythmic cause | 7 Participants |