Top

Journal of Interventional Cardiac Electrophysiology

Published in:

01-08-2012 | PERSPECTIVES

Electrical devices for left ventricular dysfunction and heart failure: do we need revised guidelines?

Authors: Maya Guglin, S. Serge Barold

Published in: Journal of Interventional Cardiac Electrophysiology | Issue 2/2012

Abstract

Three recent trials have demonstrated the benefit of cardiac resynchronization therapy (CRT) in the New York Heart Association (NYHA) class II patients with heart failure (HF) with ischemic or nonischemic cardiomyopathy as well as in NYHA class I (asymptomatic) patients mostly with ischemic cardiomyopathy. Earlier intervention with CRT in asymptomatic or minimally symptomatic patients improves survival and reduces HF hospitalizations. The reduction or the prevention of HF hospitalizations is of paramount importance because the HF episodes seem to alter the natural history of disease and are associated with deterioration of left ventricular (LV) function and a marked increase in mortality. The CRT benefit is greatest in patients with a QRS ≥150 ms. At this time, it would seem prudent to consider CRT-D (D = ICD) therapy for class I NYHA patients with a QRS ≥150 ms and an LV ejection fraction ≤30% regardless of etiology. Although the data for NYHA class I patients with nonischemic cardiomyopathy are scanty, the recommendation for class I patients is justified because CRT achieves a much greater degree of LV reverse remodeling in nonischemic compared to ischemic patients. With regard to lone ICDs, there is no evidence that they prevent sudden cardiac death more efficiently in symptomatic than in asymptomatic patients. Cardiomyopathy should be the primary target for device therapy regardless of symptoms for both CRT and lone ICD therapy. New guidelines are needed to address the role of CRT in hospitalized NYHA class IV HF patients or those who depend on inotropic therapy or an LV assist device because randomized CRT trials have not included these patients. CRT in these patients remains controversial. The mortality of such patients even with CRT is very high despite the occasional positive response. The role of CRT in patients waiting for cardiac transplantation also needs guidelines. With the expansion of CRT indications to minimally symptomatic or asymptomatic patients, the benefit of device therapy must be carefully weighed against the potential risk of lifelong device complications.

Hunt, S. A., Abraham, W. T., Chin, M. H., Feldman, A. M., Francis, G. S., Ganiats, T. G., et al. (2009). 2009 Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults. A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation. Journal of the American College of Cardiology, 53(15), e1–e902.PubMedCrossRef

Lindenfeld, J., Albert, N. M., Boehmer, J. P., Collins, S. P., Ezekowitz, J. A., Givertz, M. M., et al. (2010). HFSA 2010 comprehensive heart failure practice guideline. Journal of Cardiac Failure, 16(6), e1–e194.PubMedCrossRef

Dickstein, K., Cohen-Solal, A., Filippatos, G., McMurray, J. J., Ponikowski, P., Poole-Wilson, P. A., et al. (2008). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). European Heart Journal, 29(19), 2388–2442.PubMedCrossRef

Yu, C. M., Bleeker, G. B., Fung, J. W., Schalij, M. J., Zhang, Q., van der Wall, E. E., et al. (2005). Left ventricular reverse remodeling but not clinical improvement predicts long-term survival after cardiac resynchronization therapy. Circulation, 112(11), 1580–1586.PubMedCrossRef

St John Sutton, M., Ghio, S., Plappert, T., Tavazzi, L., Scelsi, L., REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group, et al. (2009). Cardiac resynchronization induces major structural and functional reverse remodeling in patients with New York Heart Association class I/II heart failure. Circulation, 120(19), 858–865.CrossRef

Cleland, J. G., Daubert, J. C., Erdmann, E., Freemantle, N., Gras, D., Kappenberger, L., et al. (2005). The effect of cardiac resynchronization on morbidity and mortality in heart failure. The New England Journal of Medicine, 352(15), 1539–1549.PubMedCrossRef

Cleland, J. G., Freemantle, N., Daubert, J. C., Toff, W. D., Leisch, F., & Tavazzi, L. (2008). Long-term effect of cardiac resynchronisation in patients reporting mild symptoms of heart failure: a report from the CARE-HF study. Heart, 94(3), 278–283.PubMedCrossRef

Castel, M. A., Magnani, S., Mont, L., Roig, E., Tamborero, D., Méndez-Zurita, F., et al. (2010). Survival in New York Heart Association class IV heart failure patients treated with cardiac resynchronization therapy compared with patients on optimal pharmacological treatment. Europace, 12(8), 1136–1140.PubMedCrossRef

Linde, C., Abraham, W. T., Gold, M. R., Daubert, C., & REVERSE Study Group. (2010). Cardiac resynchronization therapy in asymptomatic or mildly symptomatic heart failure patients in relation to etiology: results from the REVERSE (Resynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study. Journal of the American College of Cardiology, 56(22), 1826–1831.PubMedCrossRef

10.

Moss, A. J., Hall, W. J., Cannom, D. S., Klein, H., Brown, M. W., MADIT-CRT Trial Investigators, et al. (2009). Cardiac-resynchronization therapy for the prevention of heart-failure events. New England Journal of Medicine, 361(14), 1329–1338.PubMedCrossRef

11.

van Bommel, R. J., van Rijnsoever, E., Borleffs, C. J., Delgado, V., Marsan, N. A., Bertinim, M., et al. (2010). Effect of cardiac resynchronization therapy in patients with New York Heart Association functional class IV heart failure. The American Journal of Cardiology, 106(8), 1146–1151.PubMedCrossRef

12.

Khoo, M., Kelly, P. A., & Lindenfeld, J. (2009). Cardiac resynchronization therapy in NYHA class IV heart failure. Current Cardiology Reports, 11(3), 175–183.PubMedCrossRef

13.

Herweg, B., Ilercil, A., Cutro, R., Dewhurst, R., Krishnan, S., Weston, M., et al. (2007). Cardiac resynchronization therapy in patients with end-stage inotrope-dependent class IV heart failure. The American Journal of Cardiology, 100(1), 90–93.PubMedCrossRef

14.

Lindenfeld, J., Feldman, A. M., Saxon, L., Boehmer, J., Carson, P., Ghali, J. K., et al. (2007). Effects of cardiac resynchronization therapy with or without a defibrillator on survival and hospitalizations in patients with New York Heart Association class IV heart failure. Circulation, 115(2), 204–212.PubMedCrossRef

15.

Theodorakis, G., Katsiki, S.A., Livanis, E., Kostopoulou, A., Adamopoulos, S., Tsiapras, D., et al. (2011). Long term effects of cardiac resynchronization therapy in non-ambulatory NYHA IV heart failure patients. Pacing and Clinical Electrophysiology. doi:10.1111/j.1540-8159.2011.03205.x.

16.

Muratsu, J., Hara, M., Mizote, I., Asano, Y., Sakata, Y., Saito, S., et al. (2011). The impact of cardiac resynchronization therapy in an end-stage heartfailure patient with a left ventricular assist device as a bridge to recovery. International Heart Journal, 52(4), 246–17.PubMedCrossRef

17.

Nishimura, T., & Kyo, S. (2010). Triple-site pacing: a new supported therapy approach for bridge to recovery with a left ventricular assist system in a patient with idiopathic dilated cardiomyopathy. Journal of Artificial Organs, 13(1), 54–57.PubMedCrossRef

18.

Keilegavlen, H., Nordrehaug, J. E., Faerestrand, S., Fanebust, R., Pettersen, R., Haaverstad, R., et al. (2010). Treatment of cardiogenic shock with left ventricular assist device combined with cardiac resynchronization therapy: a case report. Journal of Cardiothoracic Surgery, 5, 54.PubMedCrossRef

19.

Nishimura, M., Ogiwara, M., Ishikawa, M., Imanaka, K., Okamura, N., & Kato, M. (2005). Successful bridge to resynchronization therapy with a left ventricular assist system in a patient with idiopathic dilated cardiomyopathy. Journal of Artificial Organs, 8(3), 210–213.PubMedCrossRef

20.

Tang, A. S., Wells, G. A., Talajic, M., Arnold, M. O., Sheldon, R., Connolly, S., Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators, et al. (2010). Cardiac resynchronization therapy for mild-to-moderate heart failure. The New England Journal of Medicine, 363(25), 2385–2395.PubMedCrossRef

21.

Daubert, C., Gold, M. R., Abraham, W. T., Ghio, S., Hassager, C., REVERSE Study Group, et al. (2009). Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE(Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. Journal of the American College of Cardiology, 54(20), 1837–1846.PubMedCrossRef

22.

Linde, C., Abraham, W. T., Gold, M. R., St John Sutton, M., Ghio, S., REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group, et al. (2008). Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. Journal of the American College of Cardiology, 52(23), 1834–1843.PubMedCrossRef

23.

Gold, M. R., Linde, C., Abraham, W. T., Gardiwal, A., & Daubert, J. C. (2010). The impact of cardiac resynchronization therapy on the incidence of ventricular arrhythmias in mild heart failure. Heart Rhythm, 8(5), 679–684.PubMedCrossRef

24.

Goldenberg, I., Hall, W. J., Beck, C. A., Moss, A. J., Barsheshet, A., McNitt, S., et al. (2011). Reduction of the risk of recurring heart failure events with cardiac resynchronization therapy MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy). Journal of the American College of Cardiology, 58(7), 729–737.PubMedCrossRef

25.

Barsheshet, A., Wang, P. J., Moss, A. J., Solomon, S. D., Al-Ahmad, A., McNitt, S., et al. (2011). Reverse remodeling and the risk of ventricular tachyarrhythmias in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy). Journal of the American College of Cardiology, 57(24), 2416–2423.PubMedCrossRef

26.

Barsheshet, A., Goldenberg, I., Moss, A. J., Eldar, M., Huang, D. T., McNitt, S., et al. (2011). Response to preventive cardiac resynchronization therapy in patients with ischaemic and nonischaemic cardiomyopathy in MADIT-CRT. European Heart Journal, 32(13), 1622–1630.PubMedCrossRef

27.

Penn, J., Goldenberg, I., Moss, A. J., McNitt, S., Zareba, W., Klein, H. U., MADIT-CRT Trial investigators, et al. (2011). Improved outcome with preventive cardiac resynchronization therapy in the elderly: a MADIT-CRT substudy. Journal of Cardiovascular Electrophysiology, 22(8), 892–897.PubMedCrossRef

28.

Durante, A., Cianflone, D., & Camici, P. G. (2011). A critical reappraisal of differences in cardiac resynchronization therapy defibrillator effectiveness between men and women in the MADIT-CRT trial. Journal of the American College of Cardiology, 58(4), 442–443.PubMedCrossRef

29.

Buber, J., Klein, H., Moss, A.J., McNit,T.,S., Eldar, M., Padeletti, L., et al. (2011). Clinical course and outcome of patients enrolled in US and non-US centres in MADIT-CRT. European Heart Journal. 32(21):2697–704.

30.

Zareba, W., Klein, H., Cygankiewicz, I., Hall, W. J., McNitt, S., Brown, M., Investigators, M. A. D. I. T.-C. R. T., et al. (2011). Effectiveness of cardiac resynchronization therapy by QRS morphology in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Circulation, 123(10), 1061–1072.PubMedCrossRef

31.

Martin, D. T., McNitt, S., Nesto, R. W., Rutter, M. K., & Moss, A. J. (2011). Cardiac resynchronization therapy reduces the risk of cardiac events in patients with diabetes enrolled in the multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT-CRT). Circulation: Heart Failure, 4(3), 332–338.CrossRef

32.

Pouleur, A. C., Knappe, D., Shah, A. M., Uno, H., Bourgoun, M., Foster, E., MADIT-CRT Investigators, et al. (2011). Relationship between improvement in left ventricular dyssynchrony and contractile function and clinical outcome with cardiac resynchronization therapy: the MADIT-CRT trial. European Heart Journal, 32(14), 1720–1729.PubMedCrossRef

33.

Arshad, A., Moss, A. J., Foster, E., Padeletti, L., Barsheshet, A., Goldenberg, I., MADIT-CRT Executive Committee, et al. (2011). Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Trial). Journal of the American College of Cardiology, 57(7), 813–820.PubMedCrossRef

34.

Solomon, S. D., Foster, E., Bourgoun, M., Shah, A., Viloria, E., Brown, M. W., MADIT-CRT Investigators, et al. (2010). Effect of cardiac resynchronization therapy on reverse remodeling and relation to outcome: multicenter automatic defibrillator implantation trial: cardiac resynchronization therapy. Circulation, 122(10), 985–992.PubMedCrossRef

35.

Moss, A. J. (2010). Preventing heart failure and improving survival. The New England Journal of Medicine, 25, 2456–2457.CrossRef

36.

Tang, A. S., Wells, G. A., Arnold, M., Connolly, S., Hohnloser, S., & Nichol, G. (2009). Resynchronization/defibrillation for ambulatory heart failure trial: rationale and trial design. Current Opinion in Cardiology, 24(1), 1–8.PubMedCrossRef

37.

US Food and Drug Administration approves devices for heart failure patients. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226123.htm. Accessed 16 Sept 2010.

38.

Dickstein, K., Vardas, P. E., Auricchio, A., Daubert, J. C., Linde, C., & McMurray, J. (2010). 2010 Focused update of ESC guidelines on device therapy in heart failure: an update of the 2008 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. European Heart Journal, 31(21), 2677–2687.PubMedCrossRef

39.

Al-Majed, N. S., McAlister, F. A., Bakal, A., & Ezekowitz, J. A. (2011). Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart failure. Annals of Internal Medicine, 154(6), 401–412.PubMed

40.

Reynolds, C. R., & Gold, M. R. (2011). Cardiac resynchronization therapy for mild heart failure: the time has come. Circulation, 123(2), 195–202.PubMedCrossRef

41.

Tamburro, P., & Wilber, D. (1992). Sudden death in idiopathic dilated cardiomyopathy. American Heart Journal, 124(4), 1035–1045.PubMedCrossRef

42.

Grimm, W., & Maisch, B. (2002). Sudden cardiac death in dilated cardiomyopathy: therapeutic options. Herz, 27(8), 750–759.PubMedCrossRef

43.

Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., & Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. (2005). Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. The New England Journal of Medicine, 352(3), 225–237.PubMedCrossRef

44.

Epstein, A. E., DiMarco, J. P., Ellenbogen, K. A., Estes, N. A., 3rd, Freedman, R. A., Gettes, L. S., et al. (2008). ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. C5 Olshansky, B., Chung, M.,Pogwizd, S.M., Goldschlager,N. (2012). Arrhythmia essentials, Sudbury, Jones and Bartlett Learning, 266.

45.

Otterstad, J. E., Froeland, G., St John Sutton, M., & Holme, I. (1997). Accuracy and reproducibility of biplane two-dimensional echocardiographic measurements of left ventricular dimensions and function. European Heart Journal, 18(3), 507–513.PubMedCrossRef

46.

Bellenger, N. G., Burgess, M. I., Ray, S. G., Lahiri, A., Coats, A. J., Cleland, J. G., et al. (2000). Comparison of left ventricular ejection fraction and volumes in heart failure by echocardiography, radionuclide ventriculography and cardiovascular magnetic resonance; are they interchangeable? European Heart Journal, 21(16), 1387–1396.PubMedCrossRef

47.

European Heart Rhythm Association, Heart Rhythm Society, Zipes, D. P., Camm, A., Borggrefe, M., Buxton, A. E., Chaitman, B., Fromer, M., et al. (2006). ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). Circulation, 114(10), e385–e484.PubMedCrossRef

48.

Wells, G., Parkash, R., Healey, J. S., Talajic, M., Arnold, J. M., Sullivan, S., et al. (2011). Cardiac resynchronization therapy: a meta-analysis of randomized controlled trials. Canadian Medical Association Journal, 183(4), 421–429.PubMedCrossRef

49.

Santangeli, P., Di Biase, L., Pelargonio, G., Dello Russo, A., Casella, M., Bartoletti, S., et al. (2011). Cardiac resynchronization therapy in patients with mild heart failure: a systematic review and meta-analysis. Journal of Interventional Cardiac Electrophysiology, 32(2), 125–135.PubMedCrossRef

50.

Adabag, S., Roukoz, H., Anand, I. S., & Moss, A. J. (2011). Cardiac resynchronization therapy in patients with minimal heart failure a systematic review and meta-analysis. Journal of the American College of Cardiology, 58(9), 935–941.PubMedCrossRef

51.

Tu, R., Zhong, G., Zeng, Z., Wu, W., Wu, H., Cao, X., et al. (2011). Cardiac resynchronization therapy in patients with mild heart failure: a systematic review and meta-analysis of randomized controlled trials. Cardiovascular Drugs and Therapy, 25(4), 331–340.PubMedCrossRef

52.

Sze, E., Moss, A. J., McNitt, S., Barsheshet, A., Andrews, M. L., Zareba, W., Multicenter Automatic Defibrillator Implantation Trial-II Investigators, et al. (2010). Risk factors for recurrent heart failure events in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II). Journal of Cardiovascular Electrophysiology, 21(11), 1217–1223.PubMedCrossRef

53.

Strauss, D. G., Selvester, R. H., & Wagner, G. S. (2011). Defining left bundle branch block in the era of cardiac resynchronization therapy. The American Journal of Cardiology, 107(6), 927–934.PubMedCrossRef

54.

Sipahi, I., Carrigan, T. P., Rowland, D. Y., Stambler, B. S., & Fang, J. C. (2011). Impact of QRS duration on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. Archives of Internal Medicine, 171(16), 1454–1462.PubMedCrossRef

55.

Stavrakis, S., Lazzara, R., Thadan, I.U. (2011). The benefit of cardiac resynchronization therapy and QRS duration: a meta-analysis. Journal of Cardiovascular Electrophysiology. doi:10.1111/j.1540-8167.2011.02144.x.

Title: Electrical devices for left ventricular dysfunction and heart failure: do we need revised guidelines?
Authors: Maya Guglin
S. Serge Barold
Publication date: 01-08-2012
Publisher: Springer US
Published in: Journal of Interventional Cardiac Electrophysiology / Issue 2/2012
Print ISSN: 1383-875X
Electronic ISSN: 1572-8595
DOI: https://doi.org/10.1007/s10840-011-9639-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Electrical devices for left ventricular dysfunction and heart failure: do we need revised guidelines?

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 2/2012

Predictive value of left atrial volume measured by non-invasive cardiac imaging in the treatment of paroxysmal atrial fibrillation

Axillary sub-pectoral pulse generator pocket for lowering defibrillation threshold

Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis

Isoproterenol infusion increases level of consciousness during catheter ablation of atrial fibrillation

Trends in atrial fibrillation ablation: have we maximized the current paradigms?

Anatomical analysis of the left atrial appendage using segmented, three-dimensional cardiac CT: a comparison of patients with paroxysmal and persistent forms of atrial fibrillation