Abstract
Introduction
The DANISH trial raised doubts about the effectiveness of primary prevention of sudden cardiac death by ICD implantation among patients with non-ischemic heart failure. We sought to analyse data from the EVITA-HF registry to give an answer from real-world registry data to the DANISH trial.
Methods
1804 patients were identified from the EVITA-HF registry with chronic heart failure (CHF) due to ischemic or dilated heart disease and reduced left ventricular ejection fraction of ≤ 35%. The patients were divided into two groups: Patients with newly implanted cardioverter–defibrillator (ICD group; mean age 66 ± 12 years, 77% male) and without ICD (no-ICD group; mean age 66 ± 14 years, 77% male). The subgroups were compared with regard to mortality and predictive parameters affecting survival.
Results
Cardiovascular risk factors were similar among patients in the non-ICD group (n = 1473) compared to ICD group (n = 331). After 1-year follow-up patients with ischemic heart disease showed a significant improved survival in the ICD group compared to non-ICD group [92.1% vs. 80.6%, HR 0.37 (0.22–0.62)]. Patients with non-ischemic cardiomyopathy did not show a difference with regard to survival between the ICD and the non-ICD group [93.7% vs. 93.1%, HR 0.92 (0.43–1.97)]. The data were stable in a Cox-regression model.
Conclusion
In a real-world setting, no benefit was evident for patients with non-ischemic cardiomyopathy and reduced left ventricular ejection fraction by adding ICD therapy in a short-term follow-up of 12 months in contrast to patients with ischemic cardiomyopathy.
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Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekvål TM, Spaulding C, Van Veldhuisen DJ (2015) 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Eur Heart J 36(41):2793–2867
Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH (2005) Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators: amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 352:225–237
Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH (2004) Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 350:2151–2158
Boveda S, Narayanan K, Jacob S, Providencia R, Beganton F, Algalarrondo V, Defaye P, Perier MC, Sadoul N, Piot O, Klug D, Gras D, Fauchier L, Bordachar P, Babuty D, Deharo JC, Leclercq C, Marijon E; DAI-PP Investigators (2017) Temporal trends over a decade of defibrillator therapy for primary prevention in community practice. J Cardiovasc Electrophysiol 28(6):666–673. https://doi.org/10.1111/jce.13198
Køber L, Thune JJ, Nielsen JC, Haarbo J, Videbæk L, Korup E, Jensen G, Hildebrandt P, Steffensen FH, Bruun NE, Eiskjær H, Brandes A, Thøgersen AM, Gustafsson F, Egstrup K, Videbæk R, Hassager C, Svendsen JH, Høfsten DE, Torp-Pedersen C, Pehrson S, DANISH Investigators (2016) Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med 375(13):1221–1230
Shun-Shin MJ, Zheng SL, Cole GD, Howard JP, Whinnett ZI, Francis DP (2017) Implantable cardioverter defibrillators for primary prevention of death in left ventricular dysfunction with and without ischaemic heart disease: a meta-analysis of 8567 patients in the 11 trials. Eur Heart J. 38(22):1738–1746
Wolff G, Lin Y, Karathanos A, Brockmeyer M, Wolters S, Nowak B, Fürnkranz A, Makimoto H, Kelm M, Schulze V (2017) Implantable cardioverter/defibrillators for primary prevention in dilated cardiomyopathy post-DANISH: an updated meta-analysis and systematic review of randomized controlled trials. Clin Res Cardiol 106(7):501–513
Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NAM III, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W, for the MADIT-CRT Trial Investigators (2009) Cardiac-resynchronization therapy of the prevention of heart-failure events. N Engl J Med 361:1329–1338
Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L, for the Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators (2005) The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 352:1539–1549
Tang ASL, Wells G, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL, for the RAFT Investigators (2010) Cardiacresynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 363:2385–2395
Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML (2002) Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 346:877–883
Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM, Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators (2004) Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 350:2140–2150
Bilchick KC, Stukenborg GJ, Kamath S, Cheng A (2012) Prediction of mortality in clinical practice for medicare patients undergoing defibrillator implantation for primary prevention of sudden cardiac death. J Am Coll Cardiol 60(17):1647–1655
Amit G, Suleiman M, Konstantino Y, Luria D, Kazatsker M, Chetboun I, Haim M, Gavrielov-Yusim N, Goldenberg I, Glikson M, Israeli Working Group on Pacing and Electrophysiology (2014) Sex differences in implantable cardioverter-defibrillator implantation indications and outcomes: lessons from the Nationwide Israeli-ICD Registry. Europace. 16(8):1175–1180
Providência R, Boveda S, Lambiase P, Defaye P, Algalarrondo V, Sadoul N, Piot O, Klug D, Perier MC, Bouzeman A, Gras D, Fauchier L, Bordachar P, Babuty D, Deharo JC, Leclercq C, Marijon E, on behalf of the DAI-PP Investigators (2015) Prediction of nonarrhythmic mortality in primary prevention implantable cardioverter-defibrillator patients with ischemic and nonischemic cardiomyopathy. Am Coll Cardiol EP 1–2:29–37
Grett M, Christ M, Röing Gen Nölke JP, Trappe HJ (2017) ECG score to predict ICD therapies in patients with nonischemic cardiomyopathy and primary prophylactic CRT-D. Herzschrittmacherther Elektrophysiol. 28(1):48–53
Gao P, Yee R, Gula L, Krahn AD, Skanes A, Leong-Sit P, Klein GJ, Stirrat J, Fine N, Pallaveshi L, Wisenberg G, Thompson TR, Prato F, Drangova M, White JA (2012) Prediction of arrhythmic events in ischemic and dilated cardiomyopathy patients referred for implantable cardiac defibrillator: evaluation of multiple scar quantification measures for late gadolinium enhancement magnetic resonance imaging. Circ Cardiovasc Imaging 5(4):448–456
Solomon SD, Zile M, Pieske B, Voors A, Shah A, Kraigher-Krainer E, Shi V, Bransford T, Takeuchi M, Gong J, Lefkowitz M, Packer M, McMurray JJ (2012) Prospective comparison of ARNI with ARB on Management Of heart failUre with preserved ejectioN fracTion (PARAMOUNT) Investigators: the angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet 380(9851):1387–1395
Böhm M, Young R, Jhund PS, Solomon SD, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Packer M, McMurray JJ (2017) Systolic blood pressure, cardiovascular outcomes and efficacy and safety of sacubitril/valsartan (LCZ696) in patients with chronic heart failure and reduced ejection fraction: results from PARADIGM-HF. Eur Heart J 38(15):1132–1143
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Jilek, C., Lewalter, T., Pauschinger, M. et al. Cardioverter–defibrillator does not improve short-term survival among patients with non-ischemic cardiomyopathy and reduced left ventricular ejection fraction. Clin Res Cardiol 109, 115–123 (2020). https://doi.org/10.1007/s00392-019-01503-0
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DOI: https://doi.org/10.1007/s00392-019-01503-0