1. Terapias Inapropriadas de los Desfibriladores Automaticos Implantables Dr. Humberto Castro Villacorta . Cardiología Clínica y Electrofisiología Cardiaca Clínica de Electrofisiología y Estimulación Cardiaca Hospital de Especialidades CMNT1 León, Guanajuato. ¿Como evitarlo?
5. DAI : No está exentos de problemas. Alter et al., PACE 2005 440 pacientes con DAI Pts. (%); (Seguimiento: 46 37 meses) Complicaciones relacionados al DAI Dispositivo (Falla de la bateria, recall ,etc.) 6 Electrodo (Ruptura o fractura , etc.) 12 Descargas Inapropiadas ( Fa, sinusal, TSV, Sobresensado,etc.) 12 Implante (Infección,, trombosis, Problemas en el hombro, etc) 10
6. DAI : No está exentos de problemas. Complicaciones Post implante (100 pacientes-año) 1. Malfuncionamiento del dispositivo 1.4% (1.2 to 1.6 IC 95%). 2. Problemas del electrodo 1.5% (1.3 a 1.8 IC 95%). 3. Infecciòn 0.6% (0.5 a 0.8 IC 95%) 4. Descargas inapropiadas 19.1% (16.5 a 22.0 IC95%) en ensayos clinicos. 4.9% (CI, 4.5 to 5.3) en estudios observacionales. Ezekowitz et al. Ann Intern Med. 2007;147:251-262 . Bri g nole M. Europace 2009;0:eup174v1
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8. Terapia Inapropiada Descargas Pero……… de cada 10 descargas ¿Cuantos te gustaria tener? 9 descargas inapropiadas entregadas: Dolorosos o angustiantes Pero estas vivo para contarlo. ó 1 descarga inapropiada retenida : Fatal?
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12. Predictores de Terapias Inapropiadas (IST) Rinaldi CA e al Heart 2004; 90: 330-331 * p<0.001, ** p<0.05, *** p<0.05
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20. Sobresensado Estudio retrospectivo de 518 pacientes se observo 7.3% de sobresensado y consecuentemente con descargas inapropiadas en un 2.3% Rauwolf et al. Europace 2007; 9; 1041–1047
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29. Estudio PREPARE (Primary Prevention Parameters Evaluation) Estudio prospectivo controlado de 700 pacientes Reducción de terapias para : 1. Evitar la detección TV lenta. 2. Evitar la detección de TVNS. 3. Evitar la detección de TSPV como TV/FV. 4. Terapia para TVR. 5. La primera descarga de alto voltaje. Wilkoff B et al. J Am Coll Cardiol 2008; 52:541-50.
30. Detección de TV/FV PR Logic ON : FA/FLU, Taq Sinusal ( 1:1 VT-ST = 66% ) or Limite de TSPV = 200 lpm Wilkoff B et al. J Am Coll Cardiol 2008; 52:541-50. Detección FC Latidos detectados Terapias FV ON > 250 lpm 30 de 40 30-35 J TVR Via FV 182-250 lpm (30 de 40) 1 seq ATP, 30-35J TV 167-181 lpm 32 Ninguna
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32. EMPIRIC Wilkoff BL, et al, Heart Rhythm Society 2005;2:1034-1037. Sterns LD, et al, Heart Rhythm. 2005;2(1S):S126. Objetivo Primario: Evaluar las descargas apropiadas para TV/FV y TSPV Prevención Secundaria: TV (espontanea, sostenida) FV (espontanea, sostenida) Síncope Prevención Primaria: CAD, Disfunción del VI, EFF+ CAD, Disfunción del VI, EFF-/no realizado Otros 51.7% 26.7% 10.6% 14.4% 48.3% 23.8% 17.5% 7.0% 55.8% 25.7% 13.0% 17.1% 44.2% 22.2% 16.0% 5.9% Empiric (N = 445) Tailored (N = 455)
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34. EMPIRIC PR Logic® Detection On: AF/Afl, Sinus Tach (1:1 VT-ST = 66%), SVT Limit = 300 ms Burst ATP: 8 intervals, R-S1 = 88%, 20 ms decrement Ramp ATP: 8 intervals, R-S1 = 81%, 10 ms decrement Wilkoff BL, et al, Heart Rhythm Society 2005;2:1034-1037. Sterns LD, et al, Heart Rhythm. 2005;2(1S):S126. Morgan JM, et al. Current Controlled Trials in Cardiovascular Medicine 2004, 5:12, Zona Detección Intervalo/FC Latidos de Detección Terapias FV On 300 ms (> 200 bpm) 18 of 24 30 J x 6 TVR Via VF 240 ms (201 – 250 bpm) NA Burst (1), 30 J x 5 TV On ≥ 400ms (≤ 150 – 200 bpm) 16 Burst (2), Ramp (1), 20J, 30 J x 3 Ambos Brazos Cambios durante el seguimiento si está justificado.
35. EMPIRIC : Descargas Favorece Empiric Favorece Tailored -20% 0% 20% 10% Margen de no inferioridad Diferencia de Descargas % % Descargas de verdaderos eventos de TV/FV o TSPV -10% Wilkoff BL, et al, Heart Rhythm Society 2005;2:1034-1037. Ritmo Empiric Tailored TV/FV 22.3% 28.7% TSPV 11.9% 26.1%
36. PREPARE EMPIRIC PR Logic® Detection On: AF/Afl, Sinus Tach (1:1 VT-ST = 66%), SVT Limit = 300 Mmg. Burst ATP: 8 intervals, R-S1 = 88%, 20 ms decrement Ramp ATP: 8 intervals, R-S1 = 81%, 10 ms decrement PR Logic ON: FA/FLU, Taq Sinusal (1:1 VT-ST = 66%) or Limite de TSPV = 200 lpm Prevención Primaria Prevención Secundaria Detección FC Latidos detectados Terapias FV ON > 250 lpm 30 de 40 30-35 J TVR Via FV 182-250 lpm (30 de 40) 1 seq ATP, 30-35J TV 167-181 lpm 32 Ninguna Zona Detección Intervalo/FC Latidos de Detección Terapias FV On 300 ms (> 200 bpm) 18 of 24 30 J x 6 TVR Via VF 240 ms (201 – 250 bpm) NA Burst (1), 30 J x 5 TV On ≥ 400ms (≤ 150 – 200 bpm) 16 Burst (2), Ramp (1), 20J, 30 J x 3
46. Otros tipos de Terapias Inapropiadas 1 Moss AJ. N Engl J Med . 2002;346:877-83. 2 The DAVID Trial Investigators. JAMA 2002; 288: 3115-3123. 3 Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Circulation . 2003 Jun 17;107(23):2932-7 4 Steinberg JS. Presented at the 24 th Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology, Late breaking Clinical Trials, Section 2; May 17, 2003. 1. Estimulaciòn del VD causa asincronia y empeoramiento de la falla cardiaca. 2,3,4 2. Mayor indidencia de FA. 3. Ritmo intrinseco es mejor que la estimulaciòn . 2,3 MADIT-II (p= 0.09) N= 490 N= 742 TX n =490 DAI n =742 Problemas del electrodos - 1.8% Infecciones no fatales - 0.7% Hospitalizacion por falla cardíaca 14.9% 19.9%
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Notas del editor
ICDs reduced all-cause mortality by 20% (95% CI, 10% to 29%) in the RCTs and by 46% (CI, 32% to 57%) in the observational studies.
Basic forms of therapy delivered by ICDs
CDI no están exentos de problemas Esta diapositiva ilustra las cuatro categorías principales de problemas relacionados con el dispositivo
Define inappropriate – to be sure that audience is correctly understanding the term
El dolor que produce una descarga no se relaciona con la enérgia suministrada. Múltiples descargas son relativamente comunes (10-20%).
Este es un aspecto interesante! Choques (apropiado, así como inapropiado) son marcadores de un peor pronóstico Relación de causalidad no está clara!
Causes
La incidencia de los tres predictores de terapia de choque inapropiado (IST) Números citados son porcentajes de pre-existentes fibrilación auricular (FA), la coexistencia de una terapia adecuada, y la única cámara de la CIE (CIE SC)
Assessment of inappropriate shocks Illustrate the points that need to be covered
Assessment of inappropriate shocks Illustrate the points that need to be covered
Points in patient’s history
Assessment of inappropriate shocks Illustrate the points that need to be covered
Detailed evaluation of the diagnostics and EGMs stored within the device
Assessment of inappropriate shocks Illustrate the points that need to be covered
Detailed look at the way the device has been programmed
Assessment of inappropriate shocks Illustrate the points that need to be covered
Modification of parameters to eliminate inappropriate therapy Do not hesitate to call for help! Most companies have a 24 by 7 help line
Ventricular arrhythmias have been shown to be faster in primary prevention patients than in secondary prevention patients Mean VT rate of 200 bpm in primary prevention patients vs 153 bpm in secondary prevention patients
21-Prospective Randomized Multicenter Trial of Empirical Antitachycardia Pacing Versus Shocks for Spontaneous Rapid Ventricular Tachycardia in Patients With Implantable Cardioverter-Defibrillators Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) Trial Results Mark S. Wathen, MD; Paul J. DeGroot, MS; Michael O. Sweeney, MD; Alice J. Stark, RN, PhD; Mary F. Otterness, MS; Wayne O. Adkisson, MD; Robert C. Canby, MD; Koroush Khalighi, MD; Christian Machado, MD; Donald S. Rubenstein, MD, PhD; Kent J. Volosin, MD; for the PainFREE Rx II Investigators
A single empiric ATP attempt terminated 72% (adjusted) of Fast VTs. ATP did not increase negative outcomes in terms of acceleration, syncope and mortality. Patients treated by ATP have improved QoL score as compared to patients treated with shock. Investigators of the PainFREE Rx II trial recommend ATP as the preferred therapy for FVT in most ICD patients.
Painless therapy
ATP before charging in the VF zone available in BOSTON and biotronik ATP during charging availble in Medtronic
700 pts vs grupo control 691 ( 415 primary prevention patients from Miracle ICD and 276 from EMPIRIC). 38 Centers, US & Europe miracle and empiric October 2003 – May 2005 1 year follow-up Medtronic Marquis-based ICDs and leads Single, dual and
This slide shows some of the prescribed programming. The key parameters were focused on extending the VFNID to 30 of 40, providing therapy only for tachycardias faster than 182 bpm and providing ATP before shock up to 250 bpm. Available SVT rejection algorithms, PR Logic in Dual and triple chamber ICDs and Wavelet in single chamber ICDs, were applied up to 200 bpm.
Limitaciones del estudio Non-randomized trial Historical control cohort Differences in baseline characteristics between PREPARE group and controls Significant reductions for endpoints remain when adjusting for differences: Morbidity Index, Morbidity Tachycardia Index, and shocked episodes Percent of patients receiving an all-cause shock Percent of patients receiving an inappropriate
Estudio de 900 pacientes de 54 centros Programación a criterio del médico. TAILORED
Assessment of inappropriate shocks Illustrate the points that need to be covered
Assessment of inappropriate shocks Illustrate the points that need to be covered
Data transmission
This is an important question!
This is an important question!
RV lead was dislodeged into atrium and oversensed atrial events These were considered to be ventricular events and fulfilled the tachycardia detection Inappropriate shock (that was not synchronised) fell on the T wave and induced VF Patient could not be resucitated from VF even with external shocks! Electro del VD se disloco cayo dentro de la aurícula y sobresenso eventos auriculares Estos fueron considerados como eventos ventriculares y cumplió la detección de taquicardias Choques inapropiados (que no se sincronizó) cayó en la onda T y VF inducida Paciente no pudo ser resucitated de VF, incluso a los choques externos!
There was a strong trend towards increased CHF hospitalizations in the ICD group compared to the conventional group. This is an important finding that probably stems from the ICD programming. Dr. Moss in his September article article in JCE stated that there was a strong correlation of the CHF hospitalization rate with the level of RV pacing. In fact, most patients with dual-chamber devices had their ICD programmed DDD at 70 beats per minute. Thus, it appears that this side effect of ICD therapy seen in MADIT-II study could be prevented by a different programming approach. In fact, the SCD-HeFT study has used a proscribed programming approach aimed at minimizing RV pacing. Importantly, the increased CHF hospitalization rate in MADIT-II study should lead to a less favorable cost-effectiveness value for ICD therapy. Given the above discussion, this may not accurately reflect the true cost of ICD therapy.
Sensibilidad = capacidad de detectar TODAS las TV ! E specificidad = capacidad de rechazar las TSV’s Para maximizar la sensibilidad • Obtener los datos en modo Pasivo • Que exista una adecuada separacion entre las anchuras del ritmo sinusal y el de la esperada TV ! Para maximizar la especificidad • Obtener los datos en modo Pasivo • Ancho umbral > max. QRS durante Ritmo Sinusal