Download Ambulatory Monitoring for Heart Failure Patients – a Systematic

Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Medical Faculty of Oporto University
Biostathistic and Medical Informatics Department
Introduction to Medicine – 1st Year
2005/2006
Head teacher: Prof. Dr. Altamiro da Costa Pereira
Supervisor: Dr. Filipa Almeida
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Ambulatory Monitoring for Heart
Failure Patients – a Systematic Review
Does especial monitoring,
at home or at daily clinics,
bring more advantages than
the usual clinical care?
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Introduction
• Heart or cardiac failure (HF) is the pathophysiologic state in
which the heart is enable to pump blood at a rate
commensurate with the requirements of the metabolizing
tissues. (1)
• Complex clinical syndrome that can result from any structural
or functional cardiac disorders that impairs the ability of the
ventricle to fill with or eject blood. (2)
• Many definitions of CHF* exist, but only selective features of
this complex syndrome are highlighted. None is entirely
satisfactory. (3)
1.
Braunwald, et al . A textbook of Cardiovascular Medicine. Elsevier Saunders, 7th Ed, 509-539
2.
Hunt S et al. ACC/AHA 2005 Guidiline for the Diagnosis and MAnagement of CHF in the adult. JACC 2005; 38: 134-213
3.
Swedberg K et al. Guidelines for the diagnosis and treatment of Chronic Heart Failure. Eur. Heart J 2005; 26: 1115-1140
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Definition of Heart Failure:
A simple objective definition of CHF is currently impossible as there is no
cutoff value of cardiac or ventricular dysfunction or change in flow,
pressure, dimension, or volume that can be used reliably to identify
patients with heart failure. (4)
Definition of Heart Failure:
Symptoms of heart failure:
Breathlessness (also called dyspnea)
Fatigue, limit exercise tolerance
Ankle swelling, fluid retention
Objective evidence of cardiac dysfunction
Response to treatment directed towards heart failure
4. Denolin H, Kuhn H, Krayenbuehl HP et al. The definition of heart failure. Eur Heart J 1983; 4: 445-448
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Aetiology of heart failure

Coronary artery disease

High blood pressure (hypertension)

Valve abnormalities

Cardiomyopathy (heart muscle disease)

Dilated

Hypertrophic

Restrictive

Rhythm disturbances

Idiopathic
Is the principal complication of all forms of heart
disease
5. Cleland JG, Swedberg K, Follath F et al. The EuroHeart Failure survey programme-a survey on the quality of care among
patients with heart failure in Europe. Part 1: patients characteristics and diagnosis. Eur Heart J 2003; 24: 442-463
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Prevalence and Incidence

4,9 million persons in USA are being treated for heart failure; (6)

550.000 new cases diagnosed each year

10% of patients older than 75 years have heart failure

Heart failure is the most common cause of hospitalization due to
cardiovascular disease in patients over 65 years of age (7)

In USA between 1979 and 2000 the number of heart failure hospitalizations
rose from 377.000 to 999.000 (+165%)

The number of HF deaths has increased steadly despite advances in
treatment, in part because of increasing numbers of patients with heart
failure (8)
6.
Ho K et al. The epidemiology of heart failure: the Framingham Study. JACC 1993; 22: 6-21
7.
Louis A et al. A systematic review of telemonitoring for the management of heart failure. Eur J Heart Failure 2003; 5: 583-590
8.
American Heart Association. Heart disease and stroke statistics: 2005 update. Dallas; American Heart Association
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Treatment

The prevention of heart failure should always be a
primary objective (9)

Prevention of progression of heart failure

Maintain or improve the quality of life

Avoid re-admissions

Increase duration of life
9. Wilhelmsen L, Rosengren A, Eriksson H et al. Heart failure in the general population of men-morbidity, risk
factors and prognosis. J Intern Med 2001; 249: 253-261
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Treatment


There are a lot of drugs that can be used in the treatment of HF, such as: (10)
Most patients have multiple medical, social
and behavioral challenges, and effective
care requires a multidisciplinary systems.
(11)

There are a lot of HF diseasemanagement programs:

Intensive patient education

Encouragement of patients to be more
aggressive in their care

Close monitoring of patients

Careful review of medication
10.
Swedberg K et al. Guidelines for the diagnosis and treatment of Chronic Heart Failure. Eur. Heart J 2005; 26: 1115-1140
11.
Rich M et al. A multipledisciplinary intervention to prevent the readmission of elderly patients with congestive heart
failure. NEJM 1995; 333:1190-95
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Importance of the study

There are a lot of scientific studies being performed about home monitoring
of heart failure patients; (12)

The home monitoring or the daily clinics monitoring of such patients is
extremely time and resources consuming; (13)

It is important to evaluate the actual benefit of such programs when
considering the usual primary outcomes such as mortality and readmission
rates; (14)

We intend to compare to most frequent disease-management programs vs
standard care published, and establish the importance of these programs in
the treatment and follow-up of chronic heart failure patients.
12.
Philbin F. Comprehensive multidisciplinary programs for management of patients with congestive heart failure. JGIM
1999; 14: 130-35
13.
West J. A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource
utilization. Am J Cardiolog 1997; 79: 58-63
14.
Shah N et al. Prevention of hospitalizations for heart failure with na interactive home monitoring program. Am heart
J1998; 135: 373-8
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Objective of the Study
To perform a systematic review on
ambulatory monitoring, at home or at
daily clinics, for heart failure patients in
order to find out if there are additional
advantages in comparison with the usual
clinical care.
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Methods
Systematic review searching in medical databases:

PubMed’s

Cochrane’s online database.
Searching criteria:

from the earliest article available until the March 2006.
Limits

Humans
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Methods
Mesh terms

Heart Failure, Congestive; Monitoring, Ambulatory;
Telemedicine; Outpatient Clinical, Hospital; Self Care;
Heart-Assist Devices
Keywords

Chronic Heart Failure; Heart Insufficiency; Cardiac
Insufficiency; Cardiac Failure; Home Monitoring; Self
monitoring; Telemonitoring ; Home care; Outpatient
management; Heart Failure clinics
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Pubmed’s Query
"Heart Failure, Congestive"[MeSH] OR "chronic heart failure" OR
"heart insufficiency" OR "cardiac insufficiency" OR “cardiac
failure”
AND
"Monitoring, Ambulatory"[MeSH] OR "home monitoring" OR
"self monitoring" OR “Telemedicine"[MeSH] OR “telemonitoring”
OR “home care” OR “outpatient management” OR “heart failure
clinics” OR "Outpatient Clinics, Hospital"[MeSH] OR "Self
Care"[MeSH]
NOT
letter OR review OR editorial OR meta-analysis OR "Heart-Assist
Devices"[MeSH]
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Cochrane’s Query
Heart Failure, Congestive OR chronic heart failure
OR heart insufficiency OR cardiac insufficiency
OR cardiac failure
AND
Monitoring, Ambulatory OR home monitoring OR
self monitoring OR Telemedicine OR
telemonitoring OR home care OR outpatient
management OR heart failure clinics OR
Outpatient Clinics, Hospital OR Self Care
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Methods
1st phase – initial exclusion
Performed by 3 groups with 3 reviewers each
EXCLUSION CRITERIA
1.
Articles not evaluating the advantages of ambulatory or clinical monitoring
2. Those which don’t mention the methods used and results
3. Those which only present results about costs
4. Clinical cases
5. Drugs specific treatment or other factors’ influence
6. Only data acquisition
7. Articles comparing ambulatory and hospital monitoring
8. Ventricular therapeutical
9. Articles not written in Portuguese, English, French and Spanish
10. Supportive-educative intervention and technologies in improving heart failure-related
self-care behaviour
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Methods
2nd phase – Inclusion of the articles
Performed by 3 groups with 3 reviewers each
The inclusion of the article was dependent on the approval of at
least 2 reviewers
INCLUSION CRITERIA
1. Clinical trials of patients with heart failure using ambulatory monitoring
2. Comparison between home and usual monitoring or between clinical and
usual monitoring
3. Studies about blood pressure, heart rate and oximetry monitoring
4. Those which mention the quality of life of patients with heart failure
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Methods

Endpoints definition:
•
Primary:
•
•
Secondary:
•

Evaluation of quality of life
Data analyses:
•
•

Mortality and readmission rate
Data base construction in SPSS 13.0
Data analyses on RevMan 4.2
Significance level – 0.05
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Methods
Quality criteria

Type of study (clinical trials)

Type of intervention

Definition of methods and detail results

Definition of primary endpoints (mortality and readmission rates)
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Start
Methods
Articles’
Selection
Flowchart
Yes
709
articles
excluded
Query Pubmed
Query Cochrane
831
artilcles
found
54 artilcles
found
Reading Title and
abstract by 3
reviewers
Reading Title abstract
by 3 reviewers
Excluded?
Excluded?
No
No
122
articles
included
13
articles
included
Yes
41
articles
excluded
135
articles
selected
40
articles
excluded
No
Reading 45
Abstracts by 3
reviewers
Reading 45
Abstracts by 3
reviewers
Reading 45
Abstracts by 3
reviewers
Included?
Included?
Included?
Yes
Yes
Yes
5 Articles
included or
in doubt
5 Articles
included or
in doubt
7 Articles
included or
in doubt
No
38
articles
excluded
40
articles
excluded
No
17 Articles
included or
in doubt
2 articles
excluded
No
Reading 8 Full
Articles by 3
reviewers
Reading 9 Full
Articles by 3
reviewers
Included?
Included?
Yes
Yes
6 articles
included
6 articles
included
Exclusion
Exclusion
No
3 articles
excluded
Exclusion
Re-read and
analyse, and
extract data from
for metanalysis
End
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Study phase
Number of Articles
Pubmed
Cochrane
Initial systematic
review
831
54
Exclusion phase
125
13
Inclusion phase
13
4
Included in the
systematic review
and meta-analysis
12
Reason for
exclusion
18 articles not
available
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Data extraction – Baseline studies’ characteristics
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Data extraction – Baseline studies’ characteristics
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results

Type of study:
12 Articles were clinical trials (n=12)

Comparison:
7 Articles comparing home monitoring vs Usual Care
5 Articles comparing daily clinics vs Usual Care

Men rate in global population – 70%

Men rate in control group – 70% (SD: 14%; m: 41%; M: 84%)

Men rate in intervention group – 69% (SD: 17%; m: 32%; M: 93%)

Mean age – 68 years

Mean follow up time (in days) – 341

These two populations (control and intervention groups) were homogeneous
concerning gender, age and heart failure degree (NYHA).
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Primary endpoints: (Global rates)
1. Hospital readmission
2. Global cardiac mortality
Control group
Intervention
Group
Readmission
(%)
59
32
Mortality
(%)
30
14
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Secondary endpoint:
Quality of life
• 4 articles did not study it
• 3 articles didn’t have significant differences between
the intervention and the control group
• 5 articles described a better quality of life in the
intervention group
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Usual care
vs Home monitoring
vs Daily clinics
Total number of patients – 1405
Total number of patients – 1108
Mean follow up time – 382 days
Mean follow up time – 285 days
Control
Group
Intervention
Group
Readmission
(%)
70
33
Mortality (%)
38
18
Control
Group
Intervention
Group
Readmission
(%)
50
31
Mortality (%)
18
9
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Mortality : Home monitoring vs Usual Care
• For a follow up time less than a year, home monitoring had a 26% RR reduction than
usual care.
• For a follow up time 1 year or more, the reduction in the RR for home monitoring was
higher (42% reduction).
• Globally the home monitoring patients had a 38% RR reduction in mortality than
those with usual care.
•
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Mortality: Daily clinics vs Usual Care
• For a follow up time less than a year, daily clinics had a 33% RR reduction than usual
care.
• For a follow up time 1 year or more, the reduction in the RR for daily clinics was
higher (62% reduction).
• Globally the daily clinics patients had a 45% RR reduction in mortality than those
with usual care.
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Readmissions: Home monitoring vs Usual Care
• We did not found statistical differences between the RR of readmissions in home
monitoring and usual care.
• Only two studies included this primary outcome.
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Readmissions: Daily clinics vs Usual Care
• For the follow up time less than one year the results showed that patients
monitored in daily clinics had a 33% RR reduction in hospital readmission
than those treated with usual care.
• For the follow up time over one year the results weren’t statistical
significant.
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Results
Concordance Analysis
Inter-reviewers reproductability tests: exclusion and inclusion phase
groups
reviewers
1
2
3
Total
1-2
0,400
0,814
0,475
0,565
1-3
0,533
0,566
0,317
0,471
2-3
0,229
0,743
0,520
0,498
Total
0,385
0,707
0,439
0,512
groups
reviewers
1
2
3
Total
1 – fd
0,861
0,814
0,660
0,772
2 – fd
0,533
1,00
0,834
0,795
3 – fd
0,667
0,743
0,710
0,707
Shoukri M.M., Edge V.L. Statistical Methods for Health Sciences 1996
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Conclusions

As for the primary endpoint of mortality we found a statistical significant
reduction in the group of patients submitted to home monitoring or daily
clinics monitoring when compared to standard care.

Concerning the hospital readmission rate, there was a significant reduction in
the intervention group submitted to daily clinics monitoring when the follow
up was less than a year.

No statistical difference was found in patients submitted to daily clinics
monitoring followed for more than a year or for patients submitted to home
monitoring.

Studies comparing daily clinics with home monitoring are needed to establish
what is the best home treatment for chronic heart failure patients.
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
Conclusions
Limitations
 Difficulty in the definition of the query.
 Reduced number of articles.
 Problems extracting row data from the clinical trials included
in meta-analysis.
 Restricted access to some of the articles selected.
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
WEB SITE PLAN
Homepage


Icons from:
FMUP
IM
Title
Class and Year
Sitemap link
Other Pages







Lateral menu always available with links such as homepage, introduction, objectives, methods,
results, discussion, conclusion, etc.
Title at top of page
Icons to change the page
Gantt chart and flowchart
When possible, make the site links visible
Data base
PDF of full article
Last Page


Identification of the authors with photographs, name and e-mail
Links to FMUP and IM
Web site
Ambulatory Monitoring for Heart Failure Patients – A systematic Review
THE END
TURMA 11