Cardiac resynchronization therapy (CRT) in heart failure--a model to assess the economic value of this new medical technology.

OBJECTIVES This article describes the framework of a comprehensive European model developed to assess clinical and economic outcomes of cardiac resynchronization therapy (CRT) versus optimal pharmacological therapy (OPT) alone in patients with heart failure. METHODS The model structure is based on information obtained from the literature, expert opinion, and a European CRT Steering Committee. The decision-analysis tool allows a consideration of direct medical and indirect costs, and computes outcomes for distinctive periods of time up to 5 years. Qualitative data can also be entered for cost-utility analysis. Model input data for a preliminary economic appraisal of the economic value of CRT in Germany were obtained from clinical trials, experts, health statistics, and medical tariff lists. RESULTS The model offers comprehensive analysis capabilities and high flexibility so that it can easily be adapted to any European country or special setting. The illustrative analysis for Germany indicates that CRT is a cost-effective intervention. Although CRT is associated with average direct medical net costs of Euro 5880 per patient, this finding means that 22% of its upfront implantation cost is recouped already within 1 year because of significantly decreased hospitalizations. With 36,600 Euros the incremental cost per quality-adjusted life-year (QALY) gained is below the euro equivalent (41,300 Euros, 1 Euro = US1.21 dollars) of the commonly used threshold level of US50,000 dollars considered to represent cost-effectiveness. The sensitivity analysis showed these preliminary results to be fairly robust towards changes in key assumptions. CONCLUSIONS The European CRT model is an important tool to assess the economic value of CRT in patients with moderate to severe heart failure. In the light of the planned introduction of Diagnosis Related Group (DRG) based reimbursement in various European countries, the economic data generated by the model can play an important role in the decision-making process.

[1]  A. Hoes,et al.  Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. , 2005, European heart journal.

[2]  D. DeMets,et al.  Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. , 2004, The New England journal of medicine.

[3]  Manouche Tavakoli,et al.  Use of Quality Adjusted Life Years and Life Years Gained as Benchmarks in Economic Evaluations: A Critical Appraisal , 2004, Health care management science.

[4]  M. Cowie,et al.  New pacing technologies for heart failure , 2003, BMJ : British Medical Journal.

[5]  A. Ignaszewski,et al.  New technologies and potential cost savings related to morbidity and mortality reduction in Class III/IV heart failure patients in Canada. , 2003, International journal of cardiology.

[6]  Antonio Curnis,et al.  Valutazione economica della resincronizzazione cardiaca nei pazienti affetti da scompenso cardiaco moderato-avanzato , 2003 .

[7]  S. Goodman,et al.  Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. , 2003, JAMA.

[8]  D. Francis,et al.  Comparison of medical therapy, pacing and defibrillation in heart failure (COMPANION) trial terminated early; combined biventricular pacemaker-defibrillators reduce all-cause mortality and hospitalization. , 2003, International journal of cardiology.

[9]  D. DeMets,et al.  Effect of Carvedilol on the Morbidity of Patients With Severe Chronic Heart Failure: Results of the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study , 2002, Circulation.

[10]  Thomas Lavergne,et al.  Long-term benefits of biventricular pacing in congestive heart failure: results from the MUltisite STimulation in cardiomyopathy (MUSTIC) study. , 2002, Journal of the American College of Cardiology.

[11]  Stefan Sack,et al.  Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. , 2002, Journal of the American College of Cardiology.

[12]  D. Delurgio,et al.  Cardiac resynchronization in chronic heart failure. , 2002, The New England journal of medicine.

[13]  S G Thompson,et al.  Hospitalization of patients with heart failure: a population-based study. , 2002, European heart journal.

[14]  C. Leclercq,et al.  Cardiac resynchronization therapy in advanced heart failure the multicenter InSync clinical study ☆ , 2002, European journal of heart failure.

[15]  R. Ferrari,et al.  Neurohormonal modulation in chronic heart failure , 2002 .

[16]  K. Swedberg,et al.  Guidelines for the diagnosis and treatment of chronic heart failure. , 2001, European heart journal.

[17]  L. Stevenson,et al.  Preferences for quality of life or survival expressed by patients with heart failure. , 2001, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[18]  J. McMurray,et al.  Economics of chronic heart failure , 2001, European journal of heart failure.

[19]  P. Rickenbacher.  Herzinsuffizienz: Epidemiologie, Pathophysiologie , 2001 .

[20]  L. Rydén,et al.  Reduction of hospital days by biventricular pacing , 2000, European journal of heart failure.

[21]  H. Pürerfellner,et al.  Transvenous left ventricular lead implantation with the EASYTRAK lead system: the European experience. , 2000, The American journal of cardiology.

[22]  B. Pitt,et al.  The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart Failure , 2000 .

[23]  S G Thompson,et al.  Survival of patients with a new diagnosis of heart failure: a population based study , 2000, Heart.

[24]  B. Pitt,et al.  The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. , 1999, The New England journal of medicine.

[25]  J. Cleland,et al.  Is the prognosis of heart failure improving? , 1999, Journal of the American College of Cardiology.

[26]  P. Armstrong,et al.  Insights into the contemporary epidemiology and outpatient management of congestive heart failure. , 1999, American heart journal.

[27]  D E Grobbee,et al.  The epidemiology of heart failure. , 1997, European heart journal.

[28]  J. McMurray,et al.  Trends in hospitalization for heart failure in Scotland 1980-1990. , 1993, European heart journal.

[29]  K. Teo,et al.  Contemporary medical management of left ventricular dysfunction and congestive heart failure. , 1992, The Canadian journal of cardiology.

[30]  Wolfgang Kruse,et al.  Early Readmission of Elderly Patients with Congestive Heart Failure , 1991, Journal of the American Geriatrics Society.

[31]  P. Bernadet,et al.  Abnormal in Vivo Platelet Activation During Exercise in Patients with Effort Kyocardial Infarction and Normal Coronary Arteriogram , 1983 .

[32]  W. Kannel,et al.  The natural history of congestive heart failure: the Framingham study. , 1971, The New England journal of medicine.

[33]  A. Raviele,et al.  The InSync Italian Registry : analysis of clinical outcome and considerations on the selection of candidates to left ventricular resynchronization , 2000 .

[34]  M. Santini,et al.  Cardiac resynchronization: Materials, technique and results. The InSync Italian Registry , 2000 .

[35]  K. Swedberg,et al.  Effects of enalapril on long-term mortality in severe congestive heart failure. CONSENSUS Trial Group. , 1992, The American journal of cardiology.