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Medical Faculty of Oporto University Biostathistic and Medical Informatics Department

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  1. Medical Faculty of Oporto UniversityBiostathistic and Medical Informatics Department Introduction to Medicine – 1st Year 2005/2006 Head teacher: Prof. Dr. Altamiro da Costa Pereira Supervisor: Dr. Filipa Almeida

  2. 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?

  3. 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) • Braunwald, et al . A textbook of Cardiovascular Medicine. Elsevier Saunders, 7th Ed, 509-539 • Hunt S et al. ACC/AHA 2005 Guidiline for the Diagnosis and MAnagement of CHF in the adult. JACC 2005; 38: 134-213 • Swedberg K et al. Guidelines for the diagnosis and treatment of Chronic Heart Failure. Eur. Heart J 2005; 26: 1115-1140

  4. 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

  5. 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

  6. 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) • Ho K et al. The epidemiology of heart failure: the Framingham Study. JACC 1993; 22: 6-21 • Louis A et al. A systematic review of telemonitoring for the management of heart failure. Eur J Heart Failure 2003; 5: 583-590 • American Heart Association. Heart disease and stroke statistics: 2005 update. Dallas; American Heart Association

  7. 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

  8. 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 disease-management programs: • Intensive patient education • Encouragement of patients to be more aggressive in their care • Close monitoring of patients • Careful review of medication • Swedberg K et al. Guidelines for the diagnosis and treatment of Chronic Heart Failure. Eur. Heart J 2005; 26: 1115-1140 • Rich M et al. A multipledisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. NEJM 1995; 333:1190-95

  9. 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. • Philbin F. Comprehensive multidisciplinary programs for management of patients with congestive heart failure. JGIM 1999; 14: 130-35 • West J. A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. Am J Cardiolog 1997; 79: 58-63 • Shah N et al. Prevention of hospitalizations for heart failure with na interactive home monitoring program. Am heart J1998; 135: 373-8

  10. 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.

  11. 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

  12. 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

  13. 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]

  14. 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

  15. Methods 1st phase – initial exclusion Performed by 3 groups with 3 reviewers each EXCLUSION CRITERIA Articles not evaluating the advantages of ambulatory or clinical monitoring Those which don’t mention the methods used and results Those which only present results about costs Clinical cases Drugs specific treatment or other factors’ influence Only data acquisition Articles comparing ambulatory and hospital monitoring Ventricular therapeutical Articles not written in Portuguese, English, French and Spanish Supportive-educative intervention and technologies in improving heart failure-related self-care behaviour

  16. 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 • Clinical trials of patients with heart failure using ambulatory monitoring • Comparison between home and usual monitoring or between clinical and usual monitoring • Studies about blood pressure, heart rate and oximetry monitoring • Those which mention the quality of life of patients with heart failure

  17. Methods • Endpoints definition: • Primary: • Mortality and readmission rate • Secondary: • Evaluation of quality of life • Data analyses: • Data base construction in SPSS 13.0 • Data analyses on RevMan 4.2 • Significance level – 0.05

  18. 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)

  19. Methods Articles’ Selection Flowchart

  20. Results

  21. Results Data extraction – Baseline studies’ characteristics

  22. Results Data extraction – Baseline studies’ characteristics

  23. 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).

  24. Results • Primary endpoints: (Global rates) • Hospital readmission • Global cardiac mortality

  25. 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

  26. vs Home monitoring Total number of patients – 1405 Mean follow up time – 382 days vs Daily clinics Total number of patients – 1108 Mean follow up time – 285 days Results Usual care

  27. Mortality : Home monitoring vs Usual Care Results • 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.

  28. Mortality: Daily clinics vs Usual Care Results • 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.

  29. Readmissions: Home monitoring vs Usual Care Results • We did not found statistical differences between the RR of readmissions in home monitoring and usual care. • Only two studies included this primary outcome.

  30. Readmissions: Daily clinics vs Usual Care Results • 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.

  31. Results Concordance Analysis Inter-reviewers reproductability tests: exclusion and inclusion phase Shoukri M.M., Edge V.L. Statistical Methods for Health Sciences 1996

  32. 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.

  33. 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.

  34. 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

  35. THE END Joana Rocha Joana Gomes Joana Lima Joana M. Barros Joana Neves Sofia Coutinho Maria Liberal Joana A. Barros Joana Silva Filipe Puga Cristiana Fernandes TURMA 11