medical faculty of oporto university biostathistic and medical informatics department

Ambulatory Monitoring for Heart Failure Patients – A systematic Review

Medical Faculty of Oporto Medical Faculty of Oporto

UniversityUniversity Biostathistic and Medical Informatics Biostathistic and Medical Informatics

DepartmentDepartmentIntroduction to MedicineIntroduction to Medicine – 1st – 1st

YearYear

2005/20062005/2006

Head teacher: Prof. Dr. Altamiro da Costa Head teacher: Prof. Dr. Altamiro da Costa PereiraPereira

Supervisor: Dr. Filipa AlmeidaSupervisor: Dr. Filipa Almeida


Ambulatory Monitoring for Ambulatory Monitoring for Heart Failure PatientsHeart Failure Patients – a – a

Systematic ReviewSystematic Review

Does especial monitoring, at home or at daily clinics, bring more advantages than the usual clinical care?


IntroductionIntroduction• 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


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:Definition of Heart Failure:

Symptoms of heart failure: Breathlessness

(also called dyspnea)Fatigue, limit exercise

toleranceAnkle swelling, fluid , fluid

retentionretention

Objective evidence of cardiac dysfunction

Response to treatment directed towards heart failure

Definition of Heart Failure:

4. Denolin H, Kuhn H, Krayenbuehl HP et al. The definition of heart failure. Eur Heart J 1983; 4: 445-448


Aetiology of heart failure

Coronary artery diseaseCoronary artery disease High blood pressure (hypertension)High blood pressure (hypertension) Valve abnormalitiesValve abnormalities Cardiomyopathy Cardiomyopathy (heart muscle disease)(heart muscle disease)

DilatedDilated HypertrophicHypertrophic RestrictiveRestrictive

Rhythm disturbancesRhythm disturbances IdiopathicIdiopathic

Is the principal complication of all forms Is the principal complication of all forms of heart diseaseof 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


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)

Prevalence and Incidence

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


TreatmentTreatment

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


TreatmentTreatment

Most patients have multiple Most patients have multiple

medical, social and behavioral medical, social and behavioral

challenges, and effective care challenges, and effective care

requires a multidisciplinary requires a multidisciplinary

systems. (11)systems. (11)

There are a lot of HF disease-There are a lot of HF disease-

management programs:management programs:

Intensive patient educationIntensive patient education

Encouragement of patients to be Encouragement of patients to be

more aggressive in their caremore aggressive in their care

Close monitoring of patients Close monitoring of patients

Careful review of medication 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

There are a lot of drugs that can be used in the treatment of There are a lot of drugs that can be used in the treatment of HF, such as:HF, such as: (10)(10)


Importance of the studyImportance of the study

There are a lot of scientific studies being performed about There are a lot of scientific studies being performed about

home monitoring of heart failure patients; (12)home monitoring of heart failure patients; (12)

The home monitoring or the daily clinics monitoring of The home monitoring or the daily clinics monitoring of

such patients is extremely time and resources consuming; such patients is extremely time and resources consuming;

(13)(13)

It is important to evaluate the actual benefit of such It is important to evaluate the actual benefit of such

programs when considering the usual primary outcomes programs when considering the usual primary outcomes

such as mortality and readmission rates;such as mortality and readmission rates; (14)(14)

We intend to compare to most frequent disease-We intend to compare to most frequent disease-

management programs vs standard care published, and management programs vs standard care published, and

establish the importance of these programs in the establish the importance of these programs in the

treatment and follow-up of chronic heart failure patients. 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


Objective of the Study Objective of the Study

To perform a systematic review on To perform a systematic review on ambulatory monitoring, at home ambulatory monitoring, at home or at daily clinics, for heart failure or at daily clinics, for heart failure patients in order to find out if patients in order to find out if there are additional advantages in there are additional advantages in comparison with the usual clinical comparison with the usual clinical care.care.


MethodsMethodsSystematic review searching in medical

databases: PubMed’s Cochrane’s online database.

Searching criteria: from the earliest article available

until the March 2006.

Limits Humans


MethodsMethods

Mesh termsMesh terms Heart Failure, Congestive; Monitoring,

Ambulatory; Telemedicine; Outpatient Clinical, Hospital; Self Care; Heart-Assist Devices

KeywordsKeywords Chronic Heart Failure; Heart Insufficiency;

Cardiac Insufficiency; Cardiac Failure; Home Monitoring; Self monitoring; Telemonitoring ; Home care; Outpatient management; Heart Failure clinics


"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]

Pubmed’s Query


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


EXCLUSION CRITERIA1. 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

1st phase – initial exclusion

Performed by 3 groups with 3 reviewers each

MethodsMethods


INCLUSION CRITERIA1. 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

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

MethodsMethods


MethodsMethods Endpoints definition:Endpoints definition:

• Primary:Primary:• Mortality and readmission rate Mortality and readmission rate

• Secondary:Secondary:• Evaluation of quality of lifeEvaluation of quality of life

Data analyses:Data analyses:• Data base construction in SPSS 13.0Data base construction in SPSS 13.0• Data analyses on RevMan 4.2Data analyses on RevMan 4.2

Significance level – Significance level – 0.050.05


MethodsMethods

Quality criteriaQuality criteria

Type of study (clinical trials)Type of study (clinical trials)

Type of intervention Type of intervention

Definition of methods and detail resultsDefinition of methods and detail results

Definition of primary endpoints (mortality and Definition of primary endpoints (mortality and readmission rates) readmission rates)


MethoMethodsds

Articles’ Articles’ SelectioSelectio

n n FlowchaFlowcha

rtrt

Start

Query Pubmed Query Cochrane

831 artilcles found

54 artilcles found

Reading Title and abstract by 3

reviewers

Reading Title abstract by 3 reviewers

Excluded?

No

Yes

122 articles included

709 articles

excluded

Reading 45 Abstracts by 3

reviewers

Included?


reviewers

Included?

Yes

5 Articles included or

in doubt


in doubt

Yes

Excluded?

No

13 articles

included135

articles selected


reviewers

Included?


in doubt

41 articles

excluded

Yes

Yes

40 articles

excludedNo


in doubt

Reading 8 Full Articles by 3

reviewers

Reading 9 Full Articles by 3

reviewers

Included? Included?

No38

articles excluded

40 articles

excluded

No

3 articles excluded

No2 articles excluded

No

Re-read and analyse, and

extract data from for metanalysis

Exclusion Exclusion

End

Exclusion

6 articles included

6 articles included

Yes Yes


ResultsResults

Study Study phasephase

Number of ArticlesNumber of Articles Reason for Reason for exclusion exclusionPubmedPubmed CochraneCochrane

Initial systematic review

831831 5454

Exclusion phase 125125 1313Inclusion phase 1313 44 18 articles not 18 articles not

availableavailable

Included in the systematic review and meta-analysis

1212


ResultsResultsData extraction – Baseline studies’ characteristics


ResultsResults Type of study: Type of study:

12 Articles were clinical trials (n=12)12 Articles were clinical trials (n=12)

Comparison: Comparison:

7 Articles comparing home monitoring vs Usual Care7 Articles comparing home monitoring vs Usual Care

5 Articles comparing daily clinics vs Usual Care5 Articles comparing daily clinics vs Usual Care

Men rate in global population – 70%Men rate in global population – 70%

Men rate in control group – 70% (SD: 14%; m: 41%; M: 84%)Men rate in control group – 70% (SD: 14%; m: 41%; M: 84%)

Men rate in intervention group – 69% (SD: 17%; m: 32%; M: 93%)Men rate in intervention group – 69% (SD: 17%; m: 32%; M: 93%)

Mean age – 68 yearsMean age – 68 years

Mean follow up time (in days) – 341Mean follow up time (in days) – 341

These two populations (control and intervention groups) were These two populations (control and intervention groups) were

homogeneous concerning gender, age and heart failure degree homogeneous concerning gender, age and heart failure degree

(NYHA).(NYHA).


ResultsResults

Control group

Intervention Group

Readmission(%)

59 32

Mortality(%)

30 14

Primary endpoints: (Global rates)

1.Hospital readmission

2.Global cardiac mortality


ResultsResults

Secondary endpoint:Secondary endpoint:

Quality of lifeQuality of life• 4 articles did not study it4 articles did not study it• 3 articles didn’t have significant 3 articles didn’t have significant

differences between the intervention differences between the intervention and the control group and the control group

• 5 articles described a better quality of 5 articles described a better quality of life in the intervention grouplife in the intervention group


ResultsResults

vs Home monitoringvs Home monitoring

Total number of patients – 1405Total number of patients – 1405

Mean follow up time – 382 daysMean follow up time – 382 days

Control Control GroupGroup

InterventIntervention ion

GroupGroup

ReadmissiReadmission (%)on (%)

7070 3333

Mortality Mortality (%)(%)

3838 1818

vs Daily clinicsvs Daily clinics

Total number of patients – Total number of patients – 11081108

Mean follow up time – 285 daysMean follow up time – 285 days

Control Control GroupGroup

InterventiIntervention Groupon Group

ReadmissiReadmissionon

(%)(%)

5050 3131

Mortality Mortality (%)(%)

1818 99

Usual careUsual care


ResultsResultsMortality : Home monitoring vs Usual CareMortality : 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.

•


ResultsResultsMortality: Daily clinics vs Usual CareMortality: 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.


ResultsResultsReadmissions: Home monitoring vs Usual CareReadmissions: 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.


ResultsResultsReadmissions: Daily clinics vs Usual CareReadmissions: 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.


ResultsResults

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

Concordance Analysis

Inter-reviewers reproductability tests: exclusion and inclusion phase

Shoukri M.M., Edge V.L. Statistical Methods for Health Sciences 1996


ConclusionsConclusions As for the primary endpoint of mortality we found a statistical As for the primary endpoint of mortality we found a statistical

significant reduction in the group of patients submitted to home significant reduction in the group of patients submitted to home monitoring or daily clinics monitoring when compared to standard monitoring or daily clinics monitoring when compared to standard care. care.

Concerning the hospital readmission rate, there was a significant Concerning the hospital readmission rate, there was a significant reduction in the intervention group submitted to daily clinics reduction in the intervention group submitted to daily clinics monitoring when the follow up was less than a year.monitoring when the follow up was less than a year.

No statistical difference was found in patients submitted to daily No statistical difference was found in patients submitted to daily clinics monitoring followed for more than a year or for patients clinics monitoring followed for more than a year or for patients submitted to home monitoring. submitted to home monitoring.

Studies comparing daily clinics with home monitoring are needed to Studies comparing daily clinics with home monitoring are needed to establish what is the best home treatment for chronic heart failure establish what is the best home treatment for chronic heart failure patients.patients.


ConclusionsConclusions

LimitationsLimitations

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.


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