ICDs in Chagas heart disease: the standard treatment for secondary

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ICDs in Chagas heart disease: the standard treatment for secondary prevention of sudden death Marco Paulo Tomaz Barbosa

Volume 15, Issue 9

, Manoel Otávio da Costa Rocha, Federico Lombardi, Antonio Luiz Pinho Ribeiro

EP Europace, Volume 15, Issue 9, 1 September 2013, Pages 1383–1384, https://doi.org/10.1093/europace/eut123 Published: 21 May 2013

September 2013

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1

We appreciate the critical reading of our article by Anis Rassi, Jr and Anis Rassi, but we disagree with them. Secondary prevention

References

studies have shown striking survival benefit with implantable cardioverter-defibrillator (ICD), irrespective of the aetiology of the cardiac disease,

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2–6

with 50% reduction in sudden cardiac death and 28% reduction in mortality from all causes (absolute reduction of

3.5% per year). This benefit, observed in randomized clinical trials (RCTs), was confirmed and extended in observational studies, including populations different from original trials.

6,7

Our results suggest secondary prevention with ICD can be more useful in patients with Chagas disease (ChD) than other 8

cardiopathies, due to the high arrhythmogenic profile of the former. Indeed, we found that ChD increased by 2.2 times the chance of patients receiving an ICD appropriate therapy and that ChD was the only independent predictor of combined outcome death or appropriate therapy in this sample. Moreover, we have previously demonstrated that Chagas cardiomyopathy was associated with 9

poorer survival compared with idiopathic disease, further suggesting that the benefit of ICD implantation could be higher in ChD than in other cardiopathies. About the three specific comments by Rassi Jr and Rassi, two of them are directly related to the composition of our study population. We studied consecutive patients referred to university hospital mainly from a state-wide emergency care system, most of them resuscitated from cardiac arrest. Moreover, we followed the current guidelines for implantation of ICD developed by Brazilian Health Ministry, which restricts the indication for well-selected cases for secondary prevention. However, the cohort profile of our study sample was not significantly different from that included in both RCTs and observational studies for secondary prevention. The reported all-cause mortality rate in our study (12.3%, median follow-up: 8.7 months) is slightly higher than that observed in the AVID 10

trial (10.7% in 1 year), but lower than the mortality rate of patients documented in other observational studies in Latin America. 13

11–

The mean left ventricular ejection fraction (LVEF) of our sample (37%) was also quite similar to the value reported from the meta6

analysis of the three major clinical trials that demonstrated the benefit of ICD for secondary prevention (34%). Although, as claimed by Rassi Jr and Rassi, this meta-analyses suggested that the benefit of the secondary prevention was restricted to patients with lower LVEF, it must be recalled that this conclusion arose from a post hoc subgroup analysis of these studies, thus considerably reducing the strength of this statement. Finally, the suggestion that a ‘RCT comparing ICD with amiodarone is urgently needed’ for secondary prevention of sudden death in 14

ChD cardiomyopathy is not supported by current evidence. Studies conducted in patients with dilated cardiomyopathy showed no reduction in overall mortality with the use of amiodarone, in spite of a modest reduction in the incidence of sudden and cardiovascular 15

death, but revealed a two- and five-fold increase risk of pulmonary and thyroid toxicity. The lack of effect on global mortality by 15

amiodarone was evident in both ischaemic and non-ischaemic cardiomyopathies. Thus, an RCT comparing ICD, an effective treatment that reduces overall mortality in a wide range of situations of high risk of sudden death, with amiodarone, which had not proved to reduce global mortality, could lead to unjustified loss of lives, is dubious and, probably, unethical. Conflict of interest: none declared.

References 1 Rassi AJr, Rassi A. Another disappointing result with implantable cardioverter-defibrillator therapy in patients with Chagas disease, Europace , 2013, vol. 15 pg. 1383 Google Scholar

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2 Stevenson WG, Stevenson LW, Middlekauff HR, Saxon LA. Sudden death prevention in patients with advanced ventricular dysfunction, Circulation , 1993, vol. 88 (pg. 2953-61) https://doi.org/10.1161/01.CIR.88.6.2953 Google Scholar

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3 The Antiarrhythmics versus Implantable Defibrillators (AVID) InvestigatorsA comparison of antiarrhythmicdrug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias, N Engl J Med , 1997, vol. 337 (pg. 1576-84) https://doi.org/10.1056/NEJM199711273372202 CrossRef

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4 Connolly SJ, Gent M, Roberts RS, Dorian P, Roy D, Sheldon RS, et al. Canadian Implantable Defibrillator Study (CIDS): a randomized trial of the implantable cardioverter defibrillator against amiodarone, Circulation , 2000, vol. 101 (pg. 1297-302) https://doi.org/10.1161/01.CIR.101.11.1297 Google Scholar

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5 Kuck K-H, Cappato R, Siebels JJr, R√°ppel R. Investigators ftCRandomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH), Circulation , 2000, vol. 102 (pg. 748-54) https://doi.org/10.1161/01.CIR.102.7.748 Google Scholar

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6 Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck K-H, Zipes DP, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials, Eur Heart J , 2000, vol. 21 (pg. 2071-8) https://doi.org/10.1053/euhj.2000.2476 Google Scholar

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7 Ezekowitz JA, Rowe BH, Dryden DM, Hooton N, Vandermeer B, Spooner C, et al. Systematic review: implantable cardioverter defibrillators for adults with left ventricular systolic dysfunction, Ann Intern Med , 2007, vol. 147 (pg. 251-62) Google Scholar

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8 Barbosa MP, da Costa Rocha MO, de Oliveira AB, Lombardi F, Ribeiro AL. Efficacy and safety of implantable cardioverter-defibrillators in patients with Chagas disease, Europace , 2013, vol. 15 (pg. 957-62) Google Scholar

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9 Pereira Nunes Mdo C, Barbosa MM, Ribeiro AL, Amorim Fenelon LM, Rocha MO. Predictors of mortality in patients with dilated cardiomyopathy: relevance of Chagas disease as an etiological factor, Rev Esp Cardiol , 2010, vol. 63 (pg. 788-97) https://doi.org/10.1016/S0300-8932(10)70181-0 Google Scholar

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10 Raitt MH, Klein RC, Wyse DG, Wilkoff BL, Beckman K, Epstein AE, et al. Comparison of arrhythmia recurrence in patients presenting with ventricular fibrillation versus ventricular tachycardia in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial, Am J Cardiol , 2003, vol. 91 (pg. 812-6) https://doi.org/10.1016/S0002-9149(03)00015-8 Google Scholar

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11 Dubner S, Valero E, Pesce R, Zuelgaray JG, Mateos JC, Filho SG, et al. A Latin American registry of implantable cardioverter defibrillators: the ICD LABOR study, Ann Noninvasive Electrocardiol , 2005, vol. 10 (pg. 420-8) https://doi.org/10.1111/j.1542-474X.2005.00060.x Google Scholar

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12 Cardinalli-Neto A, Bestetti RB, Cordeiro JA, Rodrigues VC. Predictors of all-cause mortality for patients with chronic Chagas' heart disease receiving implantable cardioverter defibrillator therapy, J Cardiovasc Electrophysiol , 2008, vol. 19 (pg. 34-5) https://doi.org/10.1111/j.1540-8167.2008.01108.x Google Scholar

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13 Rabinovich R, Muratore C, Iglesias R, Gonzalez M, Daru V, Valentino M, et al. Time to first shock in implantable cardioverter defibrillator (ICD) patients with Chagas cardiomyopathy, Pacing Clin Electrophysiol , 1999, vol. 22 Pt 2(pg. 202-5) https://doi.org/10.1111/j.1540-8159.1999.tb00333.x Google Scholar

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14 Exner DV, Klein GJ. Do we need a randomized trial of defibrillator therapy in every subset of patients with increased risk of sudden death?, J Cardiovasc Electrophysiol , 2003, vol. 14 (pg. 574-7) https://doi.org/10.1046/j.1540-8167.2003.03081.x Google Scholar

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15 Piccini JP, Berger JS, O'Connor CM. Amiodarone for the prevention of sudden cardiac death: a metaanalysis of randomized controlled trials, Eur Heart J , 2009, vol. 30 (pg. 1245-53) https://doi.org/10.1093/eurheartj/ehp100 Google Scholar

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Issue Section: Letters to the Editor

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013. For permissions please email: [email protected]

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