Trial Outcomes & Findings for Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (NCT NCT01075516)
NCT ID: NCT01075516
Last Updated: 2021-03-03
Results Overview
Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective.
Recruitment status
COMPLETED
Target enrollment
209 participants
Primary outcome timeframe
12 months follow-up
Results posted on
2021-03-03
Participant Flow
The sample size defined at least 100 pts per arm. The protocol allows few patients over in each of the 2 arms.
Participant milestones
| Measure |
Standard Follow Up
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
102
|
|
Overall Study
COMPLETED
|
89
|
86
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
| Measure |
Standard Follow Up
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Overall Study
Death
|
5
|
9
|
|
Overall Study
Lost to Follow-up
|
10
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Follow-Up
n=107 Participants
Implantable cardioverter defibrillators (ICD) patients followed through periodic in-hospital visits
|
Remote Follow-Up
n=102 Participants
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
69.7 years
STANDARD_DEVIATION 10.2 • n=102 Participants
|
69.3 years
STANDARD_DEVIATION 10.8 • n=209 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=107 Participants
|
16 Participants
n=102 Participants
|
31 Participants
n=209 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=107 Participants
|
86 Participants
n=102 Participants
|
178 Participants
n=209 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
107 participants
n=107 Participants
|
102 participants
n=102 Participants
|
209 participants
n=209 Participants
|
|
Implant Indication
Primary Prevention
|
83 Participants
n=107 Participants
|
82 Participants
n=102 Participants
|
165 Participants
n=209 Participants
|
|
Implant Indication
Secondary Precention
|
24 Participants
n=107 Participants
|
20 Participants
n=102 Participants
|
44 Participants
n=209 Participants
|
|
New York Heart Association (NYHA)
I
|
25 participants
n=107 Participants
|
30 participants
n=102 Participants
|
55 participants
n=209 Participants
|
|
New York Heart Association (NYHA)
II
|
51 participants
n=107 Participants
|
33 participants
n=102 Participants
|
84 participants
n=209 Participants
|
|
New York Heart Association (NYHA)
III
|
28 participants
n=107 Participants
|
38 participants
n=102 Participants
|
66 participants
n=209 Participants
|
|
New York Heart Association (NYHA)
IV
|
3 participants
n=107 Participants
|
1 participants
n=102 Participants
|
4 participants
n=209 Participants
|
|
ejection fraction (EF)%
|
32.2 percentage of blood
STANDARD_DEVIATION 10.6 • n=107 Participants
|
31.8 percentage of blood
STANDARD_DEVIATION 9.6 • n=102 Participants
|
32.0 percentage of blood
STANDARD_DEVIATION 10.1 • n=209 Participants
|
PRIMARY outcome
Timeframe: 12 months follow-upCosts analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective.
Outcome measures
| Measure |
Standard Follow Up
n=89 Participants
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
n=86 Participants
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Economic Impact of Remote Monitoring on Hospitals and Patients
|
1044.89 Euro (€)
Standard Deviation 1990.47
|
482.87 Euro (€)
Standard Deviation 2488.10
|
SECONDARY outcome
Timeframe: 1 yearComparison of Cardiovascular Hospitalizations costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow-up
Outcome measures
| Measure |
Standard Follow Up
n=89 Participants
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
n=86 Participants
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)
|
886.67 Euro (€)
Standard Deviation 1979.13
|
432.34 Euro (€)
Standard Deviation 2487.86
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: The clinical benefit for patients were evaluated through EQ-5D questionnaire. The results of the questionnaire were used to measure the quality-adjusted life years (QALY). It was considered costs and EQ-5D values only for the patients alive who completed the questionnaires (87 SC and 79 RM).
Evaluation of patient quality of life through Quality of Life (EQ-5D) questionnaire during follow up with/without using Merlin@Home system. Utility (patients' preferences) and Quality-adjusted life-year (QALY) scales were used. QALYs were based on utility, the EuroQoL EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (both ranges from 0 to 1). High score means better outcomes. One quality-adjusted life-year (QALY) is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).
Outcome measures
| Measure |
Standard Follow Up
n=87 Participants
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
n=79 Participants
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Impact of Remote Monitoring on Patients' Quality of Life
Utility at baseline
|
0.8621 score on a scale
Standard Deviation 0.1853
|
0.8686 score on a scale
Standard Deviation 0.1342
|
|
Impact of Remote Monitoring on Patients' Quality of Life
Utility at 12 months
|
0.8463 score on a scale
Standard Deviation 0.1846
|
0.8703 score on a scale
Standard Deviation 0.1618
|
|
Impact of Remote Monitoring on Patients' Quality of Life
Quality Adjusted Life Years (Method 1)
|
0.8542 score on a scale
Standard Deviation 0.1689
|
0.8694 score on a scale
Standard Deviation 0.1329
|
Adverse Events
Standard Follow Up
Serious events: 21 serious events
Other events: 18 other events
Deaths: 0 deaths
Remote Follow Up
Serious events: 34 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Follow Up
n=107 participants at risk
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
n=102 participants at risk
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Heart Failure
|
7.5%
8/107 • Number of events 10
|
2.9%
3/102 • Number of events 3
|
|
General disorders
Cardiac Death
|
0.00%
0/107
|
2.9%
3/102 • Number of events 3
|
|
General disorders
Death
|
1.9%
2/107 • Number of events 2
|
2.0%
2/102 • Number of events 2
|
|
General disorders
Unknown cause of death
|
2.8%
3/107 • Number of events 3
|
3.9%
4/102 • Number of events 4
|
|
Injury, poisoning and procedural complications
Implant site infection
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pocket formation of decubitus
|
1.9%
2/107 • Number of events 2
|
2.0%
2/102 • Number of events 3
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic neoplasm
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.93%
1/107 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Product Issues
Device inappropriate shock delivery
|
0.93%
1/107 • Number of events 1
|
2.9%
3/102 • Number of events 4
|
|
Product Issues
Device stimulation issue
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Product Issues
Lead dislodgement
|
2.8%
3/107 • Number of events 3
|
5.9%
6/102 • Number of events 11
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/107
|
2.0%
2/102 • Number of events 2
|
|
Surgical and medical procedures
Cardioversion
|
2.8%
3/107 • Number of events 3
|
2.0%
2/102 • Number of events 2
|
|
Surgical and medical procedures
Hospitalization
|
1.9%
2/107 • Number of events 2
|
3.9%
4/102 • Number of events 5
|
|
Surgical and medical procedures
Medical device repositioning
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Surgical and medical procedures
Mitral Valve replacement
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Arterial disorder
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Vascular disorders
Peripheral ischemia
|
2.8%
3/107 • Number of events 3
|
0.00%
0/102
|
|
Vascular disorders
Syncope
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Surgical and medical procedures
Cardiovascular event prophylaxis
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Product Issues
Device malfunction
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Motor disfunction
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Immune system disorders
Colitis ulcerative
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Vascular disorders
Hemorrage
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
Other adverse events
| Measure |
Standard Follow Up
n=107 participants at risk
ICD patients followed through periodic in-hospital visits
|
Remote Follow Up
n=102 participants at risk
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Cardiac disorders
Atrial fibrillation
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Cardiac disorders
Heart Failure
|
2.8%
3/107 • Number of events 3
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.93%
1/107 • Number of events 1
|
0.00%
0/102
|
|
Eye disorders
Eye symptoms
|
1.9%
2/107 • Number of events 3
|
0.00%
0/102
|
|
Investigations
Blood pressure dicreased
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Product Issues
Device capturing issue
|
0.00%
0/107
|
2.0%
2/102 • Number of events 2
|
|
Product Issues
Device electrical impedence issue
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
|
Product Issues
Device inappropriate shock delivery
|
2.8%
3/107 • Number of events 4
|
0.00%
0/102
|
|
Product Issues
Device malfunction
|
0.93%
1/107 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Product Issues
Device pacing issue
|
3.7%
4/107 • Number of events 6
|
4.9%
5/102 • Number of events 5
|
|
Product Issues
Device stimulation issue
|
1.9%
2/107 • Number of events 4
|
2.0%
2/102 • Number of events 2
|
|
Product Issues
Device telemetry issue
|
0.00%
0/107
|
4.9%
5/102 • Number of events 5
|
|
Product Issues
Oversensing
|
1.9%
2/107 • Number of events 2
|
0.98%
1/102 • Number of events 1
|
|
Product Issues
Undersensing
|
0.00%
0/107
|
0.98%
1/102 • Number of events 1
|
Additional Information
Dr. Renato P. Ricci
Department of Cardiology, San Filippo Neri Hospital - Rome
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place