The clinical effectiveness and cost-effectiveness of cardiac resynchronisation (biventricular pacing) for heart failure: Systematic review and economic model

Health Technology Assessment

Volumn 11, Issue 47, 2007, Pages

  Fox, M ^a,b   Mealing, S ^a,b   Anderson, R ^a,b   Dean, J ^c   Stein, K ^a,b   Price, A ^d   Taylor, R S ^a,b  

^a UNIVERSITY OF EXETER   (United Kingdom)

^b UNIVERSITY OF PLYMOUTH   (United Kingdom)

^c ROYAL DEVON AND EXETER NHS FOUNDATION TRUST   (United Kingdom)

^d UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOGRAPHY; CARDIAC RESYNCHRONIZATION THERAPY; CARDIOMYOPATHY; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COHORT ANALYSIS; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; ECHOCARDIOGRAPHY; ELECTROCARDIOGRAM; GENERAL CONDITION IMPROVEMENT; HEALTH CARE COST; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART EJECTION FRACTION; HEART FAILURE; HOSPITALIZATION; HUMAN; INTERNAL VALIDITY; META ANALYSIS; METHODOLOGY; MORTALITY; MYOCARDITIS; QRS COMPLEX; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; REVIEW; RISK FACTOR; RISK REDUCTION; SENSITIVITY ANALYSIS; SUDDEN DEATH; SURVIVAL RATE; SYNCOPE; SYSTEMATIC REVIEW; SYSTOLIC DYSFUNCTION; ARTIFICIAL HEART PACEMAKER; BIOMEDICAL TECHNOLOGY ASSESSMENT; CLASSIFICATION; ECONOMICS; HEART PACING; HEART VENTRICLE FUNCTION; STATISTICAL MODEL; SUDDEN CARDIAC DEATH; TREATMENT OUTCOME;

CARDIAC PACING, ARTIFICIAL; COST-BENEFIT ANALYSIS; DEATH, SUDDEN, CARDIAC; HEART FAILURE; HUMANS; MODELS, ECONOMIC; PACEMAKER, ARTIFICIAL; TECHNOLOGY ASSESSMENT, BIOMEDICAL; TREATMENT OUTCOME; VENTRICULAR DYSFUNCTION;

EID: 38049133948     PISSN: 13665278     EISSN: None     Source Type: Journal    
DOI: 10.3310/hta11470     Document Type: Review

References (152)

1. Davies M, Hobbs F, Davis R, Kenkre J, Roalfe AK, Hare R, et al. Prevalence of left-ventricular systolic dysfunction and heart failure in the Echocardiographic Heart of England Screening study: a population based study. Lancet 2001; 358:439-44.
2. McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart 2000; 83:596-602.
3. Coats AJS. Oxford textbook of medicine. 4th ed. Oxford: Oxford University Press; 2003.
4. Fox KF, Cowie MR, Wood DA, Coats AJS, Gibbs JSR, Underwood SR, et al. Coronary artery disease as the cause of incident heart failure in the population. Eur Heart J 2001;22:228-36.
5. NICE. Chronic heart failure. NICE Guideline No. 5. London: National Institute for Health and Clinical Excellence; 2003.
6. Abraham WT, Fisher WG, Smith AL, DeLurgio DB, Leon AR, Loh E, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346:1845-53.
7. Kerwin WF, Botvinick EH, O'Connell JW, Merrick SH, DeMarco T, Chatterjee K, et al. Ventricular contraction abnormalities in dilated cardiomyopathy: effect of biventricular pacing to correct interventricular dyssynchrony. J Am Coll Cardiol 2000; 35:1221-7.
8. Manolis AS. Cardiac resynchronization therapy in congestive heart failure: Ready for prime time? Heart Rhythm 2004;1:355-63.
9. Cowie MR, Wood DA, Coats AJS, Thompson SG, Suresh V, Poole-Wilson PA, et al. Survival of patients with a new diagnosis of heart failure: a population based study. Heart 2000;83:505-10.
10. Delise P, Sciarra L. The problem of sudden death in heart failure. Ital Heart J 2005;6(Suppl 1): 24S-33S.
11. British Heart Foundation. Mortality from heart failure. URL: http://www.heartstats.org/datapage.asp?id=752. Accessed 10 January 2006.
12. Cowie MR, Wood DA, Coats AJ, Thompson SG, Poole-Wilson PA, Suresh V, et al. Incidence and aetiology of heart failure; a population-based study. Eur Heart J 1999;20:421-8.
13. Petersen S, Rayner M, Wolstenholme J. Coronary heart disease statistics: heart failure supplement. London: British Heart Foundation; 2002.
14. European Society of Cardiology. URL: http://www.escardio.org. Accessed 12 January 2006.
15. British Heart Foundation. Incidence of heart failure. URL: www.heartstats.org/datapage.asp?id=1116. Accessed 12 January 2006.
16. Stewart S, Jenkins A, Buchan S, McGuire A, Capewell S, McMurray JJ. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail 2002;4:361-71.
17. Bentkover JD, Stewart EJ, Ignaszewski A, Lepage S, Liu P, Cooper J. New technologies and potential cost savings related to morbidity and mortality reduction in Class III/IV heart failure patients in Canada. Int J Cardiol 2003;88:33-41.
18. National Horizon Scanning Centre. Atriobiventricular pacing in severe heart failure. Birmingham: University of Birmingham; 2001.
19. National Horizon Scanning Centre. Update: Biventricular pacing (cardiac resynchronisation) for heart failure. Birmingham: University of Birmingham; 2003.
20. McAlister FA, Tu JV, Newman A, Lee DS, Kimber S, Cujec B, et al. How many patients with heart failure are eligible for cardiac resynchronization? Insights from two prospective cohorts. Eur Heart J 2006;27:323-9.
21. Royal College of General Practitioners, Office of Population Censuses and Surveys and Department of Health. Morbidity statistics from general practice - fourth national study 1991/92. London: HMSO; 1995.
22. Mair FS, Crowley TS, Bundred PE. Prevalence, aetiology and management of heart failure in general practice. Br J Gen Pract 1996; 46:77-9.
23. Office for National Statistics. Key health statistics from general practice. London: The Stationery Office; 2000.
24. Lyons RA, Perry HM, Littlepage BN. Evidence for the validity of the Short-form 36 Questionnaire SF-36 in an elderly population. Age Ageing 1994; 23:182-4.
25. Hobbs F, Kenkre J, Roalfe AK, Davis RC, Hare R, Davies MK. Impact of heart failure and left ventricular systolic dysfunction on quality of life. Eur Heart J 2002;23:1867-76.
26. Juenger J, Schellberg D, Kraemer S, Haunstetter A, Zugck C, Herzog W, et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart 2002; 87:235-41.
27. Leidy NK, Rentz AM, Zyczynski TM. Evaluating health-related quality-of-life outcomes in patients with congestive heart failure: a review of recent randomized controlled trials. PharmacoEconomics 1999;15:19-46.
28. Lee WC, Chavez YE, Baker T, Luce BR. Economic burden of heart failure: a summary of recent literature. Heart Lung 2004;33:362-71.
29. McMurray J, Hart W, Rhodes G. An evaluation of the cost of heart failure to the National Health Service in the UK. Br J Med Econ 1993; 6:99-110.
30. British Heart Foundation. Costs of heart failure to the NHS, 2000, UK. URL: www.heartstats.org. Accessed 3 March 2006.
31. Jong P, Vowinckel E, Liu PP, Gong Y, Tu JV. Prognosis and determinants of survival in patients newly hospitalized for heart failure: a population-based study. Arch Intern Med 2002;162:1689-94.
32. Berry C, Murdoch DR, McMurray JJV. Economics of chronic heart failure. Eur J Heart Fail 2001;3:283-91.
33. Enright P. The six-minute walk test. Respir Care 2003; 48:783-5.
34. Demers C, McKelvie RS, Negassa A, Yusuf S. RESOLVD Pilot Study Investigation. Reliability, validity, and responsiveness of the six-minute walk test in patients with heart failure. Am Heart J 2001; 142:698-703.
35. Troughton RW, Frampton CM, Yandle TG, Espiner EA, Nicholls MG, Richards AM. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet 2000; 355:1126-30.
36. Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Committee to revise the 1995 Guidelines for the Evaluation and Management of Heart Failure. J Am Coll Cardiol 2001;38:2101-13.
37. Bennett J, Riegel B, Bittner V, Nichols J. Validity and reliability of the NYHA classes for measuring research outcomes in patients with cardiac disease. Heart Lung 2002;31:262-70.
38. Rector TS, Kubo SH, Cohn JN. Patients' self assessment of their congestive heart failure. Part 2: content, reliability and validity of a new measure, The Minnesota Living with Heart Failure Questionnaire. Heart Fail 1987;3:198-209.
39. Rector TS. A conceptual model of the quality of life in relation to heart failure. J Card Fail 2005; 11:173-6.
40. Piano MR. Alcoholic cardiomyopathy:incidence, clinical characteristics, and pathophysiology. Chest 2002;121:1638-50.
41. Dracup K, Baker DW, Dunbar SB, Dacey RA, Brooks NH, Johnson JC. Management of heart failure II. Counseling, education, and lifestyle modifications. JAMA 1994;272:1442-6.
42. Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, et al. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005). Eur Heart J 2005; 26:1115-40.
43. Breithardt O, Claus P, Sutherland G. Do we understand who benefits from resynchronisation therapy? Eur Heart J 2004;25:535-6.
44. NICE. Arrhythmia - implantable cardioverter defibrillators (ICDs). NICE Technology Appraisal Guidance No. 95. London: National Institute for Health and Clinical Excellence; 2006.
45. Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult. A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (writing committee to update the 2001 guidelines for the evaluation and management of heart failure). J Am Coll Cardiol 2005; 46(6):e1-82.
46. Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2001;38:2101-13.
47. Porciani MC, Dondina C, Macioce R, Demarchi G, Pieragnoli P, Musilli N, et al. Echocardiographic examination of atrioventricular and interventricular delay optimization in cardiac resynchronization therapy. Am J Cardiol 2005; 95:1108-10.
48. Jarcho JA. Resynchronizing ventricular contraction in heart failure. N Engl J Med 2005;352:1594-7.
49. McAlister FA, Ezekowitz JA, Wiebe N, Rowe B, Spooner C, Crumley E, et al. Systematic review: cardiac resynchronization in patients with symptomatic heart failure. Ann Intern Med 2004; 141:381-90.
50. Sanders GD, Hlatky MA, Owens DK. Cost-effectiveness of implantable cardioverter-defibrillators. N Engl J Med 2005;353:1471-80.
51. Birnie D, Soucie LP, Smith S, Tang ASL. Effects of cardiac resynchronisation on maximal and submaximal exercise performance in advanced heart failure patients with conduction abnormality. Heart 2001;86:703-4.
52. Khand AU, Gemmell I, Rankin AC, Cleland JG. Clinical events leading to the progression of heart failure: insights from a national database of hospital discharges. Eur Heart J 2001;22:153-64.
53. Fauchier L, Poret P, Robin I, de Labriolle A, Giraudeau C, Cosnay P, et al. Different criteria of cardiac resynchronization therapy and their prognostic value for worsening heart failure or major arrhythmic events in patients with idiopathic dilated cardiomyopathy. Am J Cardiol 2006;97:393-9.
54. Cleland JGF, Goode K, Khaleva O, Khan N. How many patients need cardiac resynchronization therapy? Eur Heart J 2006;27:251-2.
55. NHS. National Pacing Database, Implantable Cardiac Defibrillators and Cardiac Ablations, Annual Report 2004. URL: www.icservices.nhs.uk/ ncasp/pages/audit_topics/chd/pacdata-old.asp. Accessed 14 March 2006.
56. Department of Health. National Schedule of Reference Costs 2005. Leeds: Department of Health; 2005.
57. Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J 1992; 124:1017-25.
58. Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53-72.
59. NICE. Implantable cardioverter defibrillators for arrhythmias (review of existing guidance no. 11). London: National Institute for Health and Clinical Excellence; 2005.
60. NHS Centre for Reviews and Dissemination. Undertaking systematic reviews of research on effectiveness. 2nd ed. York: NHS Centre for Reviews and Dissemination; 2001.
61. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, et al. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUORUM statement. Lancet 1999; 354:1896-900.
62. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 1998;17:2815-34.
63. Egger M, Smith GD, Phillips AN. Meta-analysis principles and procedures. BMJ 1997;315:1-14.
64. Higgins J, Thompson S, Deeks J, Altman D. Statistical heterogeneity in systematic reviews of clinical trials: a critical appraisal of guidelines and practice. J Health Serv Res Policy 2002; 7:51-61.
65. Der Simonson R, Laird N. Meta analysis in clinical trials. Control Clin Trials 1986;7:177-88.
66. Freemantle N, Tharmanathan P, Calvert MJ, Abraham WT, Ghosh J, Cleland JGF. Cardiac resynchronisation for patients with heart failure due to left ventricular systolic dysfunction - a systematic review and meta-analysis. Eur J Heart Fail 2006;8:433-40.
67. Pichon-Riviere A, Augustovski F, Regueiro A. Cardiac resynchronizatian therapy: biventricular or three chamber pacemaker. Ciudad de Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS); 2003.
68. Bradley DJ, Bradley EA, Baughman KL, Berger RD, Calkins H, Goodman SN, et al. Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. JAMA 2003;289:730-40.
69. Abdulla J, Haarbo J, Køber L, Torp-Pedersen C. Impact of Implantable Defibrillators and resynchronization therapy on outcome in patients with left ventricular dysfunction - a meta-analysis. Cardiology 2006; 106:249-55.
70. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points. Eur J Heart Fail 2001;3:481-9.
71. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005; 352:1539-49.
72. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al. Baseline characteristics of patients recruited into the CARE-HF study. Eur J Heart Fail 2005;7:205-14.
73. Cleland JG, Ghosh J, Freemantle N, Kaye GC, Nasir M, Clark AL, et al. Clinical trials update and cumulative meta-analyses from the American College of Cardiology: WATCH, SCD-HeFT, DINAMIT, CASINO, INSPIRE, STRATUS-US, RIO-Lipids and cardiac resynchronisation therapy in heart failure. EX I. Eur J Heart Fail 2004; 6:501-8.
74. Cleland JG, Tavazzi L, Freemantle N. New results from the CARE-HF Programme. European Society of Cardiology Congress Reports; 2005. http://www.escardio.org/knowledge/congresses/CongressReports/clinical/ 2005/cleland.htm. Accessed 14 March 2006.
75. Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail 2000;6:276-85.
76. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004;350: 2140-50.
77. Carson P, Anand I, O'Connor C, Jaski B, Steinberg J, Lwin A, et al. Mode of death in advanced heart failure - the Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure (COMPANION) trial. J Am Coll Cardiol 2005;46:2329-34.
78. FDA. Summary of safety and effectiveness. P010012/SO26. Washington, DC: US Food and Drug Administration; 2004. URL: http://www.fda.gov/cdrh/pdf/P010012S026.html. Accessed April 2007.
79. Saxon LA, Boehmer JP, Hummel J, Kacet S, De MT, Naccarelli G, et al. Biventricular pacing in patients with congestive heart failure: two prospective randomized trials. The VIGOR CHF and VENTAK CHF Investigators. Am J Cardiol 1999;83(5B):120D-123D.
80. Lozano I, Bocchiardo M, Achtelik M, Gaita F, Trappe HJ, Daoud E, et al. Impact of biventricular pacing on mortality in a randomized crossover study of patients with heart failure and ventricular arrhythmias. Pacing Clin Electrophysiol 2000; 23(11 Pt 2):1711-12.
81. Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, et al. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol 2003; 42:1454-9.
82. Knight BP, Desai A, Coman J, Faddis M, Yong P. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol 2004; 44:72-7.
83. FDA. Summary of safety and effectiveness. P010012. Washington, DC: US Food and Drug Administration; 2002. URL: http://www.fda.gov/cdrh/pdf/ P010012b.pdf. Accessed April 2007.
84. Abraham WT, Fisher WG, Smith AL, DeLurgio DB, Loh E, Kocovic DZ, et al. Multicenter InSync randomized clinical evaluation (MIRACLE): results of a randomized, double-blind, controlled trial to assess cardiac resynchronization therapy in heart failure patients (abstract). Circulation 2001; 104:II-618.
85. Aranda JM Jr, Conti JB, Johnson JW, Petersen-Stejskal S, Curtis AB. Cardiac resynchronization therapy in patients with heart failure and conduction abnormalities other than left bundle-branch block: analysis of the Multicenter InSync Randomized Clinical Evaluation (MIRACLE). Clin Cardiol 2004;27:678-82.
86. Leon AR, Abraham WT, Curtis AB, Daubert JP, Fisher WG, Gurley J, et al. Safety of transvenous cardiac resynchronization system implantation in patients with chronic heart failure - combined results of over 2,000 patients from a multicenter study program. J Am Coll Cardiol 2005;46:2348-56.
87. Woo GW, Petersen-Stejskal S, Johnson JW, Conti JB, Aranda JA Jr, Curtis AB. Ventricular reverse remodeling and 6-month outcomes in patients receiving cardiac resynchronization therapy: analysis of the MIRACLE study. J Interv Card Electrophysiol 2005;12:107-13.
88. FDA. Summary of safety and effectiveness. P010015. Washington, DC: US Food and Drug Administration; 2001. URL: http://www.fda.gov/cdrh/pdf/ p010015.html. Accessed April 2007.
89. Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, et al. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med 2001;344:873-80.
90. Moher D, Schulz KF. Randomized controlled trials in cancer: improving the quality of their reports will also facilitate better conduct. Ann Oncol 1998; 9:483-7.
91. Roland M, Torgerson DJ. Understanding controlled trials: What are pragmatic trials? BMJ 1998;316:285.
92. Ontario Ministry of Health and Long-Term Care. Biventricular pacemaker. Toronto, ON: Ontario Ministry of Health and Long-Term Care; 2003.
93. Farris O, editor. Memorandum from the FDA to the authors of the COMPANION trial. P010012/026 (COMPANION). Washington, DC: US Food and Drug Administration; 2004.
94. Fernandez L, I, Higgins S, Escudier Villa JM, Niazi I, Toquero J, Yong P, et al. [Antitachycardia pacing efficacy significantly improves with cardiac resynchronization therapy]. Rev Esp Cardiol 2005; 58:1148-54 (in Spanish).
95. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Eggar M, Davey Smith G. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001;5(33).
96. Birnie DH, Tang AS. The problem of non-response to cardiac resynchronization therapy. Curr Opin Cardiol 2006;21:20-6.
97. Bleeker GB, Bax JJ, Fung JWH, van der Wall EE, Zhang Q, Schalij MJ, et al. Clinical versus echocardiographic parameters to assess response to cardiac resynchronization therapy. Am J Cardiol 2006;97:260-3.
98. Breithardt OA, Stellbrink C, Kramer AP, Sinha AM, Franke A, Salo R, et al. Echocardiographic quantification of left ventricular asynchrony predicts an acute hemodynamic benefit of cardiac resynchronization therapy. J Am Coll Cardiol 2002; 40:536-45.
99. Bax JI, van der Wall EE, Schalij MJ, Gottlieb SS, Fisher ML, Abraham WT. Cardiac resynchronization therapy for heart failure. N Engl J Med 2002;347:1803-4.
100. Molhoek SG, Bax JJ, Bleeker GB, Boersma E, Van EL, Steendijk P, et al. Comparison of response to cardiac resynchronization therapy in patients with sinus rhythm versus chronic atrial fibrillation. Am J Cardiol 2004;94:1506-9.
101. Leclercq C, Walker S, Linde C, Clementy J, Marshall AJ, Ritter P, et al. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. Eur Heart J 2002;23:1780-7.
102. Brignole M, Gammage M, Puggioni E, Alboni P, Raviele A, Sutton R, et al. Comparative assessment of right, left, and biventricular pacing in patients with permanent atrial fibrillation. Eur Heart J 2005;26:712-22.
103. Garrigue S, Bordachar P, Reuter S, Jais P, Kobeissi A, Gaggini G, et al. Comparison of permanent left ventricular and biventricular pacing in patients with heart failure and chronic atrial fibrillation: prospective haemodynamic study. Heart 2002;87:529-34.
104. Doshi RN, Daoud EG, Fellows C, Turk K, Duran A, Hamdan MH, et al. Left ventricular-based cardiac stimulation post AV nodal ablation evaluation (the PAVE study). J Cardiovasc Electrophysiol 2005; 16:1160-5.
105. Etienne Y, Mansourati J, Gilard M, Valls-Bertault V, Boschat J, Benditt DG, et al. Evaluation of left ventricular based pacing in patients with congestive heart failure and atrial fibrillation. Am J Cardiol 2002;83:1138-40.
106. Evers S, Goossens M, de Vet H, van Tulder M, Ament A. Criteria list for assessment of methodological quality of economic evaluations: consensus on health economic criteria. Int J Technol Assess Health Care 2005;21:240-54.
107. Weinstein MC, O'Brien B, HornbergerJ, Jackson J, Johannesson M, McCabe C, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices - Modeling Studies. Value Health 2003; 6:9-17.
108. Calvert MJ, Freemantle N, Yao GQ, Cleland JGF, Billingham L, Daubert JC, et al. Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial. Eur Heart J 2005;26:2681-8.
109. Feldman AM, de Lissovoy G, Bristow MR, Saxon LA, De Marco T, Kass DA, et al. Cost effectiveness of cardiac resynchronization therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial. J Am Coll Cardiol 2005; 46:2311-21.
110. Feldman AM, de Lissovoy G, Bristow MR, Saxon LA, De Marco T, Kass DA, et al. Cost-effectiveness of cardiac-resynchronization therapy with and without a defibrillator in COMPANION heart failure patients. J Am Coll Cardiol 2005; 45:160A.
111. Banz K, Eucomed CRT Steering Committee. Cardiac resynchronization therapy (CRT) in heart failure - a model to assess the economic value of this new medical technology. Value Health 2005;8:128-39.
112. Nichol G, Kaul P, Huszti E, Bridges JF. Cost-effectiveness of cardiac resynchronization therapy in patients with symptomatic heart failure. Ann Intern Med 2004;141:343-51.
113. Fattore G, Landolina M, Bontempi L, Cacciatore G, Curnis A, Gulizia M, et al. [Economic impact of cardiac resynchronization therapy in patients with heart failure. Available evidence and evaluation of the CRT-Eucomed model for analysis of cost-effectiveness]. Ital Heart J Suppl 2005;6:796-803 (in Italian).
114. McAlister F, Ezekowitz J, Wiebe N, Rowe B, Spooner C, Crumley E. Cardiac resynchronization therapy for congestive heart failure. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2004.
115. Havranek E, McGovern K, Weinberger J, Brocato A, Lowes B, Abraham W. Patient preferences for heart failure treatment: utilities are valid measures of health-related quality of life in heart failure. J Card Fail 1999;5:85-91.
116. NICE. Guide to the methods of technology appraisal. London: National Institute for Clinical Excellence; 2004.
117. Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993;13:322-38.
118. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary (BNF). No. 51, March 2006. London: BMA and RPS; 2006.
119. Bryant J, Brodin H, Loveman E, Payne E, Clegg AJ. The clinical and cost-effectiveness of implantable cardioverter defibrillators: a systematic review. Health Technol Assess 2005;9(36).
120. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston: Little, Brown; 1991.
121. Cleland JGF, Daubert JC, Erdmann E, Freemantle N, Gras D. Kappenberger L, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the Cardiac Resynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J 2006; 27:1928-32.
122. Miller DK, Homan SM. Determining transition probabilities: confusion and suggestions. Med Decis Making 1994;14:52-8.
123. Shahar E, Lee S, Kim J, Duval S, Barber C, Luepker RV. Hospitalised heart failure: rates and long term mortality. J Card Fail 2004; 10:374-9.
124. Lee DS, Green LD, Liu PP, Dorian P, Newman DM, Grant FC. effectiveness of implantable defibrillators for preventing arrhythmic events and death: a meta-analysis. J Am Coll Cardiol 2003; 41:1573-82.
125. Ezekowitz JA, Armstrong PW, McAlister FA. Implantable cardioverter defibrillators in primary and secondary prevention: a systematic review of randomized controlled trials. Ann Intern Med 2003; 138:445-52.
126. Hussey JC, Bond ZC, Wallwork J. Long-term patient survival for heart transplant recipients in the UK. URL: www.uktransplant.org.uk/ukt/ statistics/. Accessed 14 May 2006.
127. Kirsch J, McGuire A. Establishing health state valuations for disease specific states: An example from heart disease. Health Econ 2000;9:149-58.
128. Calvert MJ, Freemantle N, Cleland JG. The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study. Eur J Heart Fail 2005; 7:243-51.
129. Lewis E, Johnson P, Johnson W, Collins C, Griffin L, Stevenson L. Preferences for quality of life or survival expressed by patients with heart failure. J Heart Lung Transplant 2001:20:1016-24.
130. Levy D, Kenchaiah S, Larson MG, Benjamin EJ, Kupka MJ, Ho KK, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med 2002;347:1397-402.
131. Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of uncertainty in cost-effectiveness analysis. Med Decis Making 1998; 18:S68-80.
132. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ 2001; 10:779-87.
133. Bax JJ, Bleeker GB, Marwick TH, Molhoek SG, Boersma E, Steendijk P, et al. Left ventricular dyssynchrony predicts response and prognosis after cardiac resynchronization therapy. J Am Coll Cardiol 2004; 44:1834-40.
134. Fenwick E, Claxton K, Sculpher M, Briggs AH. Improving the efficiency and relevance of health technology assessment: the role of iterative decision analytic modelling. Centre for Health Economics (CHE) discussion paper. York: University of York Centre for Health Economics; 2000.
135. Felli JC, Hazen GB. Sensitivity analysis and the expected value of perfect information. Med Decis Making 1998;18:95-109.
136. Briggs AH, Claxton K, Sculpher M. Decision modelling for health economic evaluation. Oxford: Oxford University Press; 2006.
137. Briggs AH, Goeree R, Blackhouse G, O'Brien BJ. Probabilistic analysis of cost-effectiveness models: choosing between treatment strategies for gastroesophical reflux disease. Med Decis Making 2002; 22:290-308.
138. Levine PA, Kohanyi G. Malfunctions of implantable cardioverter defibrillators [author reply]. JAMA 2006;295:161-2.
139. Anil G, Donald H, Valentin F. Primary prophylaxis with the implantable cardioverter-defibrillator: the need for improved risk stratification. JAMA 2006; 294:958.
140. Desai AS, Fang JC, Maisel WH, Baughman KL. Implantable defibrillators for the prevention of mortality in patients with nonischemic cardiomyopathy: a meta-analysis of randomized controlled trials. JAMA 2004;292:2874-9.
141. Abraham WT, Young JB, Leon AR, Adler S, Bank AJ, Hall SA, et al. Effects of cardiac resynchronization on disease progression in patients with left ventricular systolic dysfunction, an indication for an implantable cardioverter-defibrillator, and mildly symptomatic chronic heart failure. Circulation 2004;110:2864-8.
142. Cleland JGF, Coletta AP, Lammiman M, Witte KK, Loh H, Nasir M, et al. Clinical trials update from the European Society of Cardiology meeting 2005: CARE-HF extension study, ESSENTIAL, CIBIS-III, S-ICD, ISSUE-2, STRIDE-2, SOFA, IMAGINE, PREAMI, SIRIUS-II and ACTIVE. Eur J Heart Fail 2005;7:1070-5.
143. Briggs A, Sculpher M, Dawson J, Fitzpatrick R, Murray D, Malchau H. Modelling the cost-effectiveness of primary hip replacement: how cost-effective is the Spectron compared to the Charnley prosthesis? Centre for Health Economics (CHE) technical paper 28. York: University of York Centre for Health Economics; 2003.
144. Yu CM, Abraham WT, Bax J, Chung E, Fedewa M, Ghio S, et al. Predictors of response to cardiac resynchronization therapy (PROSPECT) - study design. Am Heart J 2005;149:600-5.
145. Maisel W. Pacemaker and ICD generator reliability: meta-analysis of device. JAMA 2006; 295:1929-34.
146. Collett D. Parametric proportional hazards model. In Modelling survival data in medical research. 2nd ed. Boca Raton, FL: Chapman and Hall/CRC: 2003. pp. 151-93.
147. Curnis A, Caprari F, Mascioli G, Bontempi L, Scivales A, Biachetta F, et al. Biventricular cardiac resynchronization in moderate to severe heart failure: Analysis of hospital costs and clinical effectiveness (Brescia Study). Conference proceeding. 2003. New Advances in Heart Failure and Atrial Fibrillation. Mediterranean Cardiology Meeting.
148. Fantoni C, Kawabata M, Massaro R, Regoli F, Raffa S, Arora V, et al. Right and left ventricular activation sequence in patients with heart failure and right bundle branch block: a detailed analysis using three-dimensional non-fluoroscopic electroanatomic mapping system. J Cardiovasc Electrophysiol 2005;16:112-19.
149. Gasparini M, Mantica M, Galimberti P, Marconi M, Genovese L, Faletra F, et al. Beneficial effects of biventricular pacing in patients with a "narrow" QRS. Pacing Clin Electrophysiol 2003; 26(1 Pt 2): 169-74.
150. Auricchio A, Stellbrink C, Sack S, Block M, Vogt J, Bakker P, et al. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am Coll Cardiol 200;39:2026-33.
151. Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA 2003;289:2685-94.
152. Auricchio A, Stellbrink C, Butter C, Sack S, Vogt J, Misier AR, et al. Clinical efficacy of cardiac resynchronization therapy using left