Se siguen las Guías en la prevención primaria de

MS Concepción Moro

Medicina USA 2009 NEJM

Muerte Súbita en Cardiopatía Isquémica

Estudios randomizados con DAI en Prevención Primaria de MS

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac

Rhythm Abnormalities

May 2008

Class I Benefit >>> Risk

Procedure/ Treatment SHOULD be performed/ administered

Class IIa Benefit >> RiskAdditional studies with focused objectives needed

IT IS REASONABLE to perform procedure/administer treatment

Class IIb Benefit ≥ RiskAdditional studies with broad objectives needed; Additional registry data would be helpful

Procedure/Treatment MAY BE CONSIDERED

Class III Risk ≥ BenefitNo additional studies needed

Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL

Level A: Data derived from multiple randomized clinical trials or meta-analyses Multiple populations evaluated;

Level B: Data derived from a single randomized trial or nonrandomized studies Limited populations evaluated

Level C: Only consensus of experts opinion, case studies, or standard of care Very limited populations evaluated

Applying Classification of Recommendations and Level of Evidence

Level of Evidence:

ICD therapy is indicated in patients with LVEF less than or equal to 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III.

ICD therapy is indicated in patients with nonischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III.

ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than or equal to 30%, and are in NYHA functional Class I.

ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF less than or equal to 40%, and inducible VF or sustained VT at electrophysiological study.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.

Implantable Cardioverter-Defibrillators

ICD implantation is reasonable for patients with HCM who have 1 or more major† risk factors for SCD.

ICD implantation is reasonable for the prevention of SCD in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) who have 1 or more risk factors for SCD.

ICD implantation is reasonable to reduce SCD in patients with long-QT syndrome who are experiencing syncope and/or VT while receiving beta blockers.

All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.

† See Section 3.2.4, “Hypertrophic Cardiomyopathy,” in the full-text guidelines for definition of major risk factors.

I IIaIIbIII

I IIaIIbIII

I IIaIIbIII

Implantable Cardioverter-Defibrillators

ICD implantation is reasonable for nonhospitalized patients awaiting transplantation.

ICD implantation is reasonable for patients with Brugada syndrome who have had syncope.

ICD implantation is reasonable for patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest.

ICD implantation is reasonable for patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers.

ICD implantation is reasonable for patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas disease.

I IIaIIbIII

I IIaIIbIII

I IIaIIbIII

I IIaIIbIII

I IIaIIbIII

Implantable Cardioverter-Defibrillators

ICD therapy may be considered in patients with nonischemic heart disease who have an LVEF of less than or equal to 35% and who are in NYHA functional Class I.

ICD therapy may be considered for patients with long-QT syndrome and risk factors for SCD.

ICD therapy may be considered in patients with syncope and advanced structural heart disease in whom thorough invasive and noninvasive investigations have failed to define a cause.

ICD therapy may be considered in patients with a familial cardiomyopathy associated with sudden death.

ICD therapy may be considered in patients with LV noncompaction.

III IIaIIaIIa IIbIIbIIbIIIIIIIIIIII IIaIIaIIa IIbIIbIIbIIIIIIIIIIII IIaIIaIIa IIbIIbIIbIIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

I IIaIIbIII

I IIaIIbIII

I IIaIIbIII

I IIaIIbIII

Implantable Cardioverter-Defibrillators

1.- Alta eficacia en prevención de MS.

2.- Tratamientos combinados:

* Bradi-taquiarritmias

* Arritmias supra/ventriculares

* IC y arritmias ventriculares...

3.- Implantación fácil. Morbilidad 4%

1.- Tx no curativo.

2.- Más del 50% de los pacientes precisan FAA.

3.- Descargas inapropiadas (arritmias supra, interferencias, rotura de cable...)

4.- Vida limitada de cables y batería del generador.

5.- Coste elevado dispositivo

Desfibrilador Desfibrilador Automático Implantable

Implantes por millon por comunidad autónoma

49,6

76,4

105,2

53,4

8373,4

65,1

88,2

44,7

62,673,5 76,8 81

70,9

56

71,1

51,8

14,3

0,0

20,0

40,0

60,0

80,0

100,0

120,0

Implante DAI en España. Ultima publicación Registro Nacional 2008

Implantes DAI /millón habitantes. Datos Europeos

Implant rates per million, high power(2006-2007)

Source: Eucomed

Avg = 189

Avg = 160

USAGermany

ItalyNetherlands

DenmarkAustria

Western EuropeIreland

BelgiumSwitzerland

FranceFinland

SwedenUK

NorwayPortugal

Spain

0 100 200 300 400 500 600 700

ICD CRT-D 2007 WE Average 2006 WE Average

Las guías pueden

incumplirse por exceso

o por defecto.

• Variaciones en la determinación FEVI.• No existe la misma evidencia del

efecto DAI en mujeres.• ¿Como valorar el riesgo competitivo

entre MS y muerte por ICC ?. • ¿ Edad > 75 años ?.

Prevención Primaria

Myerburg R.NEJM 2008;359:2245

FEVI en Estudios de PP sobre DAI

Mortalidad total en el MADIT II

Hazard Ratios and 95 Percent Confidence

Intervals for

Death from Any Cause in the

Defibrillator Group vs Conventional Medical

Therapy,

according to Selected Clinical Characteristics.

Moss AJ et al. MADIT II. NEJM 2002;346; 877-883

Factores que refuerzan la indicación de DAI

• Seguimos las Guias. ¿Cual de ellas?.• Las variaciones en Implantacion DAI

regionales y nacionales se deben a la distinta Interpretación de las Indicaciones de tipo Clase IIB.

• Se cumplen las guías en algunos puntos por exceso y en otros por defecto.

Prevención Primaria

• Mujer de 45 años, portadora de una mutación en el gen de la desmoplakina.

• Hermano con MS a los 35 años.• Dos miembros en la familia materna con la

mutación identificada llevan DAI.• Asintomática.• ECG anormal con T negativas sobre VI.• EV frecuentes en el Holter. No TVs.• ECO y RMN normal.

Caso clínico

Indicación IIb. Evidencia C

• Varón de 62 años. IM extenso hace 10 años . • FEVI <36%.• Clase Funcional I.• EV frecuentes en Holter con parejas y algunos

tripletes.• QRS con duración 110 mseg. • EEF: TV/FV no inducibles.

Caso clínico

Indicación IA, Evidencia A, si FEVI <35% y CF II ó FEVI <30% CF I

Sí.Antes quisiera consultar otro médico.

Ud. necesita un DAI.

¿Algún deseo antes

del implante?

• Interpretación variable de las DISTINTAS guías. Unica explicación de las diferencias en Nº Implantes de DAI y de DAI-CRT.

• Son necesarios más estudios randomizados en diferentes cohortes poblacionales. Los registros no aportan suficiente nivel de evidencia.

• Son necesarios nuevos marcadores de MS.

Prevención Primaria.