Declaration of conflict of interest. None

Transcription

1 Declaration of conflict of interest None

2 Implantable cardioverter-defibrillator in patients with Chagas cardiomyopathy. Can we extrapolate results from the big trials? Dr. Santiago Nava Townsend National Institute of Cardiology Ignacio Chávez México City

3 CCM is a major cause of Morbidity in Latin America. Produces life threatening ventricular arrhythmias Ventricular conduction defects Scarring and fibrosis (apical aneurisms) SCD is the principal cause of death (55-65% of deaths). Incidence is estimated in 24 per 1000 pts/yr.

4 Facts ICD therapy reduces all cause mortality in pts with high risk of arrhythmic death. Secondary prevention of SCD in general, is accepted as a Class I indication. Thus ICD seems a very attractive therapy for primary and secondary prevention of SD in patients with Chagas disease.

5 n (%) x DE +/- Hombres 30(47.6) Mujeres 33(52.4) Edad promedio Fracción de Expulsión Diámetro Diastólico VI Diámetro Sistólico VI Aneurisma 6 (10) Extrasístoles Ventriculares 26(41) Fibrilación Auricular. 5(8) TVMS 17(27) TVMnS 14(22) Bloqueo AV 14(22) Trastornos H-P 49(77) Marcapaso 8(13) Taquicardia Ventricular en pacientes con Enfermedad de Chagas. Experiencia del Instituto Nacional de Cardiología Ignacio Chávez. Nava T. et al Con Taquicardia Sostenida S/TVMS P TVMSRIHH TVMSRD sup TVMSRD inf Total Hombres (n) ns Mujeres (n) ns Edad promedio ns Aneurisma (n) ns EV (n) FE promedio ns DDVI promedio ns DSVI promedio ns

6 Kaplan-Meier estimates for survival stratified for: no nonsustained ventricular tachycardia (NSVT) and no left ventricular (LV) dysfunction (group A): either NSVT or LV dysfunction (group B); and NSVT and LV dysfunction (group C) Rassi, A. et al. Circulation 2007;115:

7 Proposed algorithm to guide mortality risk assessment and therapeutic decision-making in patients with Chagas disease Rassi, A. et al. Circulation 2007;115:

8 Muratore C et al. PACE 1997; 20: Reported NO differences in outcomes in pts with ICD and Chagas vs Ischemic Cardiopathy. Martinelli Filho M et al. PACE 2000; 23: 1944 At 2 years, the cumulative probability of lifethreatening VA nonoccurrence was 0 in the Chagas' heart disease group versus 40% up to 55 months of follow-up in the non- Chagas disease group (P = ).

9 Appropriate shocks in 30 to 60%. 70% Supraventricular arrhythmias. 30% FV; 30 % TV. 60% Shocks, 60% ATP. 34% Mortality Probability of NO Therapy 9% per year 15% Arrhythmic storm Muratore CA. Europace. 2009;11: Cardinalli- Neto et al. J Cardiovasc Electrophysiol. 2007;18: Pacing Clin Electrophysiol. 2006; 29:

10 Muratore CA et al. Europace 2009; 11: ICD therapy provides protection by effectively terminating life-threatening arrhythmias in patients with Chagas' disease. This is especially so when patients receive the device for secondary prevention.

11 Marilelli M, et al. Am J Cardiol 2012; Jun 20 (Epub ahead of print). ICD efficacy in 2 nd : 116 pts, 42% EF, 7.1% annual mortality rate. 50% appr shocks, 11% inappropriate. Low EF and FNYHA III predictors of worst prognosis. Low cumulative RV pacing predictor of better outcome. Di Toro D, et al. Pacing Clin Electrophysiol 2011; 34: pts. 1 a P and 2 nd P. 60 yo, 40% EF, 10% one year mortality Age and LVEF predictors of mortality.

12 So is it the same? There are no randomized prospective evaluation of the safety and efficacy of ICD in CCM Only registries or small series of consecutive pts.

13 There is evidence questioning the ICD in CCM. Cardinalli-Neto et al. J Cardiovasc Electrofhysiol. 2007; 18: pts: 34% Mortality, 93% due to pomp failure Number of Shock per pt. Only independent predictor of mortality. Proarrhythmia due to VD pacing?, Shocks Cardiac function?? The most relevant clinical question is whether in a given condition the ICD reduces all cause mortality with an acceptable risk of complications and adverse effects compared with best medical therapy Anis Rassi. J Cardiovasc Electrophysiol. 2007; 18: 1241

14 Nava et al 38 61±1.3 68% 38±2.7 ICD+Amio 26% AS 45% Anis Rassi. J Cardiovasc Electrophysiol. 2007; 18: 1241

15 Primary Prevention Secondary Prevention R.B. Bestetti, A. Cardinalli-Neto / International Journal of Cardiology 2008; 131 : 9 17

16 CCM and ICD CCM and ICD in Mexico: 21 pts, 63% men, mean age 61 y/o. EF 30 ± % Secondary prevention (93% MVT) 15/21 pts had appropriate therapy. 246 episodes overall (1 61 episodes p/p) Arrhythmic storm in 42.9% Flores J. Nava S. et al. Arch Cardiol Mex. 2009; 79:263

17 Determinants of Arrhythmic Storm in Patients with CCM and ICD Flores J. Nava S. et al. Arch Cardiol Mex. 2009; 79:263 Cardiopatía Chagásica Crónica con TE (n=9) sin TE (n=12) P Edad NS Masculino 6 (46.2%) 7 (53.8%) NS Comorbilidades DM 1 (11.11%) 2 (16.6%) NS HAS 2 (22.2%) 2 (16.6%) NS Dislipidemia 2 (22.2%) 0 NS Tabaquismo AS is more frequent 3 (33.3%) in patients 4 (33.3%) with: NS Prevención Secundaria 8 (88.8%) 7 (58.3%) NS EF below 35% Tratamiento Médico Digitálico NYHA FC III/IV 8 (88.8%) 6 (50%) Diuréticos 8 (88.8%) 10 (83.3%) NS Lack of BB therapy IECAs 6 (66.6%) 11 (91.6%) NS Beta-bloq. 5 (55.5%) 12 (100%) 0.01 Estatina 0 0 NS Amiodarona 9 (100%) 11 (91.6%) NS FEVI Promedio 27.11% (+-3.6) 33% (+-3.51) NS FEVI <35% 8 (88.8%) 6 (50%) CF III-IV NYHA 6 (66.6%) 1 (8.3%) 0.01

18 Variable Chagas 38 CAD 38 Valor p Age ± ± 1.38 t=.231 TV CL µ ± DE ± ± t = QRS (ms) ± ± t = EF (%) ± ± 1.8 t =.596 LVDD(mm) ± ± 1.2 t = st Event (months) 3.25 ± ± 1.43 t = No of VT events Median 3 (min 1, max 8) Median 1 Min 1, max 4 ) U =.142 Sincope 15 (39) 4 (11) SD 5 (13 ) 6 (16) MVT 31 ( 81) 24 (63) 0.1 NYHA I 21 (55) 21 (55) II 14 (37) 10 ( 26) III 4 (10) 5 (13) IV 0 1 (3) NSVT( Holter) 29 ( 76) 22 (58) 0.003

19 Variable Chagas Isquémicos N (%) N (%) Valor p Modo de estimulación VVI 15 ( 40) 27 ( 71) DDD 22 ( 57) 7 ( 18) Biventricular 1 (3) 4 (11) Eventos detectados post implante de DAI 26 (68) 11 (29) Frecuencia de detección de la taquicardia TV1 ( < 160 lpm) TV2 ( 161 a 200 lpm) FV (> 200 lpm) 1 (3) 18 (47) 7 (18) 3 (8) 6 (16) 2 (5) Tormenta arrítmica 17 (45) 4 ( 11 ) Hospitalización por falla cardiaca 9 (23) 3 (8) Muerte 10 (26) 9 (24) 0.553

20 Observations: 80% had combined therapy (ATP + Shock) Only 20% responded to ATP alone. Some represent well tolerated VT s Nº of VT zones Increase number of Shocks? Deterioration of EF due to Shocks? Mortality 26%. No arrhythmic deaths 60% associated to CHF. 22% Mortality with AS vs 25% w/o AS.

21 Monomorphic Ventricular Tachycardia in patients With Chagasic Cardiomyopathy.

22 Monomorphic Ventricular Tachycardia in patients With Chagasic Cardiomyopathy.

23 Conclusions ICD indication in CCM should not be extrapolated from results of randomized studies obtained in patients with other conditions. Arrhythmic profile in CCM is different. High density of VT may emerge as a serious problem increasing de % of Arrhythmic storm. Frequent appropriate shocks may result in myocardial damage.

24 ICD persist as an attractive option in patients with CCM and unstable VT/VF or high risk evaluation for SCD. Indications should be made in individual basis. Randomized trials of adequate size comparing ICD with placebo or amiodarone will be able to identify the most appropriate management strategy in patients with CCM.