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Device Therapy in Heart Failure Teresa M. Menendez Hood, M.D., F.A.C.C.

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Presentation on theme: "Device Therapy in Heart Failure Teresa M. Menendez Hood, M.D., F.A.C.C."— Presentation transcript:

1 Device Therapy in Heart Failure Teresa M. Menendez Hood, M.D., F.A.C.C.

2 Heart Failure 400, million 250,000 Annual Incidence Heart Failure Prevalence Annual Mortality U.S. Up to 30 % of HF patients have an IVCD (80% with a LBBB) which has been linked to increases in mortality and morbidity. Up to 30 % of HF patients have an IVCD (80% with a LBBB) which has been linked to increases in mortality and morbidity. HF is the leading cause of hospitalizations in the US and uses up 5% of the health care costs HF is the leading cause of hospitalizations in the US and uses up 5% of the health care costs 2% of the population and 6% of the population >65 2% of the population and 6% of the population >65 Prevalence is on the rise. Prevalence is on the rise.

3 Heart Failure Background At Risk for Heart Failure Heart Failure Stage A At high risk of HF but without structural heart disease or HF symptoms Stage C Structural heart disease with prior or current HF symptoms Stage B Structural heart disease but without signs or symptoms of HF Stage D Refractory HF requiring specialized interventions

4 Class I Asymptomatic heart failure ejection fraction (EF) <40% Class II Mild symptomatic heart failure with ordinary exertion Class IV Symptomatic heart failure at rest Class III Moderate symptomatic heart failure with less than ordinary exertion NYHA Class-evaluates the disability imposed on the patient who already has structural heart disease

5 Stages of Heart Failure

6 Leading Causes of Death in the U.S. National Vital Statistics Report. Oct. 12, 2001;49(11). MMWR. State-specific mortality from sudden cardiac death – US Feb 15, 2002;51: %5%10%15%20%25% Septicemia Nephritis Alzheimer’s Disease Influenza/pneumonia Diabetes Accidents/injuries Chronic lower respiratory diseases Cerebrovascular disease Other cardiac causes All cancers You must combine deaths from all cancers to outnumber the deaths from SCA each year. All other causes Sudden cardiac arrest (SCA)

7 SCD accounts for ~50% of the total deaths. 12 months16 months41.4 months27 months 13 months45 months6 months SCD Rates in CHF Patients with LV Dysfunction

8 60% 70% 80% 90% 100% Days Cumulative Survival Duration (msec) < QRS duration is an independent predictor of mortality (>140 ms) Other factors are: age, creatinine, EF, and HR QRS >220 SCD in Heart Failure

9 Degree of SCD risk by class Degree of SCD risk by class Mortality in NYHA class II is 5 to 15% Mortality in NYHA class II is 5 to 15% 50 to 80% of the deaths are Sudden 50 to 80% of the deaths are Sudden Mortality in NYHA class III is 20 to 50% Mortality in NYHA class III is 20 to 50% Up to 50% of the deaths are Sudden Up to 50% of the deaths are Sudden Mortality in NYHA class IV is 30 to 70% Mortality in NYHA class IV is 30 to 70% 5 to 30% of deaths are Sudden (more deaths from pump failure) 5 to 30% of deaths are Sudden (more deaths from pump failure) SCD in Heart Failure

10 Right Ventricular Pacing RV apex pacing is harmful in patients with LV dysfunction. Became evident in multiple pacer and ICD trials that it increases HF by producing a “paced” LBBB. RV apex pacing is harmful in patients with LV dysfunction. Became evident in multiple pacer and ICD trials that it increases HF by producing a “paced” LBBB. Abnormal LV activation Abnormal LV activation Reduced stroke volume Reduced stroke volume

11 Detrimental RV pacing MADIT II (2002) had a survival benefit with the ICD but in a subgroup analysis, there was an increase in heart failure morbidity (more hospitalizations) felt due to forced RV pacing compared to controls in which no pacing was present. MADIT II (2002) had a survival benefit with the ICD but in a subgroup analysis, there was an increase in heart failure morbidity (more hospitalizations) felt due to forced RV pacing compared to controls in which no pacing was present.

12 MADIT II: Complications New or Worsening HF (p= 0.09) N= 490 N= 742 RV pacing causes ventricular dysynchrony and may lead to worsening HF.RV pacing causes ventricular dysynchrony and may lead to worsening HF. Intrinsic ventricular activation is better for ICD patients with left ventricular dysfunction who do not “need” pacing. Intrinsic ventricular activation is better for ICD patients with left ventricular dysfunction who do not “need” pacing. <10% of ICD patients have a Class I pacing indication at the time of implant…they do not NEED pacing.<10% of ICD patients have a Class I pacing indication at the time of implant…they do not NEED pacing. Physicians, when appropriate, should consider programming of ICDs to avoid frequent RV pacing.Physicians, when appropriate, should consider programming of ICDs to avoid frequent RV pacing.

13 ICD indication but no indication for a pacemaker ICD indication but no indication for a pacemaker EF < 40% EF < 40% 70BPM versus VVI 40 BPM 70BPM versus VVI 40 BPM DAVID — Dual Chamber and VVI Implantable Defibrillator Trial : 2002

14 Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial : patients with sinus-node disease, intact AV conduction and normal QRS interval 1065 patients with sinus-node disease, intact AV conduction and normal QRS interval Randomized to conventional dual-chamber pacing (n=535) or dual-chamber minimal ventricular pacing (n=530) Randomized to conventional dual-chamber pacing (n=535) or dual-chamber minimal ventricular pacing (n=530) ― study tests new pacing algorithm that avoids ventricular pacing except during periods of high-grade AV block With dual-chamber pacing, ↓ frequency RV pacing (9.1% vs. 99%; p<0.001) and 40% relative risk ↓ in incidence of persistent AF With dual-chamber pacing, ↓ frequency RV pacing (9.1% vs. 99%; p<0.001) and 40% relative risk ↓ in incidence of persistent AF

15 The Concept In most patients with an IVCD (QRS > 130 ms), the presence of atrial-biventricular (RV + LV) pacing will provide early stimulation to an otherwise late segment of electrical activation in the LV. In most patients with an IVCD (QRS > 130 ms), the presence of atrial-biventricular (RV + LV) pacing will provide early stimulation to an otherwise late segment of electrical activation in the LV. This should translate into an increase in the EF, decrease of the LV dimension, improvement in the QOL and NYHA class. This should translate into an increase in the EF, decrease of the LV dimension, improvement in the QOL and NYHA class. This may translate into an decrease in CHF exacerbations, hospitalizations and a decrease in mortality. This may translate into an decrease in CHF exacerbations, hospitalizations and a decrease in mortality.

16 The Proof 1994 –1997: Mechanistic and both short and longer term observational studies. Studies initially used epicardial leads placed by thoracotomy or thorascope –1997: Mechanistic and both short and longer term observational studies. Studies initially used epicardial leads placed by thoracotomy or thorascope. The first BiV pacer was implanted in 1994 The first BiV pacer was implanted in –1999: Randomized, controlled studies to assess exercise capacity, functional status, and quality of life –1999: Randomized, controlled studies to assess exercise capacity, functional status, and quality of life. There was development of transvenous leads via the coronary sinus in to get to the LV. There was development of transvenous leads via the coronary sinus in to get to the LV. Cohen TJ, Klein J. J Inva2002;14:48-53.

17 The Proof 2000 – 2006: Randomized, controlled trials to assess combined mortality and CHF hospitalization. Also evaluated the combined benefit of ICD’s with CRT – 2006: Randomized, controlled trials to assess combined mortality and CHF hospitalization. Also evaluated the combined benefit of ICD’s with CRT : Trials to identify patients who will benefit from CRT. This uses echocardiographic markers of dyssynchrony and the QRS measurement : Trials to identify patients who will benefit from CRT. This uses echocardiographic markers of dyssynchrony and the QRS measurement. 20% of patients do not respond to therapy in clinical trials with a wide QRS and 50% patients with a narrow QRS/CHF have dyssynchrony on echo and may benefit from this therapy. 20% of patients do not respond to therapy in clinical trials with a wide QRS and 50% patients with a narrow QRS/CHF have dyssynchrony on echo and may benefit from this therapy. If the QRS is < 150 ms, then the chance of responding to BiVP is ~5%. It will be in this patient group of QRS of ms where preselection of responders would be most valuable. If the QRS is < 150 ms, then the chance of responding to BiVP is ~5%. It will be in this patient group of QRS of ms where preselection of responders would be most valuable.

18 The Cardiac Resynchronization Clinical Trials PATH-CHF, MUSTIC, MIRACLE, COMPANION, and CARE-HF* *This is not a complete list of all the CRT trials and the dates given are when the trial results were published.

19 Cumulative Enrollment in Cardiac Resynchronization Randomized Trials

20 This was the first multicenter trial and used the standard endocardial RV lead and an epicardial LV lead via thoracotomy or thorascope This was the first multicenter trial and used the standard endocardial RV lead and an epicardial LV lead via thoracotomy or thorascope Single blinded RCT Single blinded RCT 53 centers in Europe 53 centers in Europe 41 patients 41 patients PATH-CHF: 1999 Pacing Therapy for Congestive Heart Failure

21 PATH-CHF Primary endpoints Primary endpoints Peak VO2 Peak VO2 Six-minute walk distance Six-minute walk distance Secondary endpoints Secondary endpoints Minnesota Living with Heart Failure score (QOL) Minnesota Living with Heart Failure score (QOL) NYHA class NYHA class EF EF Trend towards decrease in Hospitalizations Trend towards decrease in Hospitalizations Acute hemodynamic testing revealed that the lateral and posterolateral walls were the best target sites. Acute hemodynamic testing revealed that the lateral and posterolateral walls were the best target sites. The best responders were those with QRS>150, long PR and dP/dt 150, long PR and dP/dt < 700 mm Hg/s

22 MUSTIC: 2001 Multicenter Stimulation in CM European study with 67 patients European study with 67 patients QRS>150, CHF, EF 150, CHF, EF <35% BiVP versus backup VVI pacing at 40 BPM BiVP versus backup VVI pacing at 40 BPM Increase in 6 minute walk time, QOL and Peak VO2 with BiVP and persisted for up to 12 months Increase in 6 minute walk time, QOL and Peak VO2 with BiVP and persisted for up to 12 months 60% decrease in CHF hospitalizations 60% decrease in CHF hospitalizations First to use endocardial LV leads via the CS First to use endocardial LV leads via the CS No significant change in mortality, but a trend towards an improvement. No significant change in mortality, but a trend towards an improvement. Acute hemodynamic studies showed the mid lateral wall to be the best site Acute hemodynamic studies showed the mid lateral wall to be the best site

23 MIRACLE:2002 Multi-center In Sync Randomized Clinical Evaluation Trial Double blinded RCT Double blinded RCT First US trial First US trial Class 3 or 4, on OPT, QRS >130 ms, EF 130 ms, EF<35% Enrollment of 453 patients Enrollment of 453 patients

24 MIRACLE NYHA class III-IV LVEDD > 60 mm QRS > 130 ms Stable 3 month regimen of beta-blocker/ACE inhibitor EF < 35% Randomization CRT on 1- and 3-month follow-up 6-month follow-up CRT off 1- and 3-month follow-up 6-month follow-up Long-term follow-up

25 Nonresponders: older, ischemic CM, no MR, QRS<150 Responders: had shorter duration on CHF and longer QRS>155 MIRACLE39% 34% 27% 67% 17% 16% 0% 20% 40% 60% Improved No Change Worsened Proportion Control N=225 CRT N=228 P < 0.001

26 MIRACLE There was a decrease in hospitalizations of 50% at 6 months and a trend towards a decrease in mortality. There was a decrease in hospitalizations of 50% at 6 months and a trend towards a decrease in mortality. All other primary and secondary endpoints were met: 6 minute walk time, peak Vo2, QOL, EF, NYHA class, LVEDD All other primary and secondary endpoints were met: 6 minute walk time, peak Vo2, QOL, EF, NYHA class, LVEDD Magnitude of improvement not influenced by degree of QRS shortening with BiVP (average in all was –20msec)

27 FDA Approval The first CRT device was approved by the FDA in September The first CRT device was approved by the FDA in September The first CRT with an ICD was approved by the FDA in The first CRT with an ICD was approved by the FDA in May May 2002.

28 MADIT required a positive EP study;ischemics MADIT required a positive EP study;ischemics MUSTT 1999 required a positive EP study; ischemics; EF<40% MUSTT 1999 required a positive EP study; ischemics; EF<40% MADIT prior MI (ischemic cardiomyopathy) and EF 120 ms; resulted in a 31% decrease risk of death and halted prematurely due to the positive effect of the ICD: resulted in the FDA approving the ICD for primary prevention this patient population, but only those with a QRS > 120 ms. MADIT prior MI (ischemic cardiomyopathy) and EF 120 ms; resulted in a 31% decrease risk of death and halted prematurely due to the positive effect of the ICD: resulted in the FDA approving the ICD for primary prevention this patient population, but only those with a QRS > 120 ms. The Primary ICD Prevention Trials

29 SCD-Heft The SCD-Heft trial resulted in FDA approval of the ICD January 2005 in patients with CHF and EF<35 % that included both ischemic and nonischemic cardiomyopathy for primary prevention without a positive EP study or ventricular ectopy. No QRS cutoff was required. SCD-Heft The SCD-Heft trial resulted in FDA approval of the ICD January 2005 in patients with CHF and EF<35 % that included both ischemic and nonischemic cardiomyopathy for primary prevention without a positive EP study or ventricular ectopy. No QRS cutoff was required.

30 COMPANION:2004 OPT 1 CRT + 2 OPT CRT-D + 2 Randomization Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

31 COMPANION Enrolled 1520 patients class 3 and 4, QRS >120ms Enrolled 1520 patients class 3 and 4, QRS >120ms Primary endpoint: death or hospitalization for any cause Primary endpoint: death or hospitalization for any cause CRT met the primary endpoints and the CRT +/- ICD significantly reduces mortality CRT met the primary endpoints and the CRT +/- ICD significantly reduces mortality This was the first to show mortality benefit from CRT alone This was the first to show mortality benefit from CRT alone Showed that patients with CRT also benefit from ICD therapy Showed that patients with CRT also benefit from ICD therapy OPT had SCD in 36%, 23% in CRT and 3% in CRT+ICD OPT had SCD in 36%, 23% in CRT and 3% in CRT+ICD

32 CRT arm had 20% reduction in mortality and hospitalization over OPT arm but it was not statistically significant CRT arm had 20% reduction in mortality and hospitalization over OPT arm but it was not statistically significant Significant reduction in CRT-ICD arm of 40% for mortality over OPT arm (19% in OPT and 11% in CRT-ICD group) Significant reduction in CRT-ICD arm of 40% for mortality over OPT arm (19% in OPT and 11% in CRT-ICD group) Study was halted prematurely due to its positive benefit. Study was halted prematurely due to its positive benefit. Mean follow up was 16 months Mean follow up was 16 months COMPANION

33 CARE-HFCArdiac REsynchronization in Heart Failure 2005 The effect of cardiac resynchronization on morbidity and mortality in heart failure in 813 patients in Europe ( prospective multicenter RCT) with completed enrollment by 2002 The effect of cardiac resynchronization on morbidity and mortality in heart failure in 813 patients in Europe ( prospective multicenter RCT) with completed enrollment by 2002 Large patient size and length of trial (average follow up of 29 months) allowed ability to asses effects of CRT Large patient size and length of trial (average follow up of 29 months) allowed ability to asses effects of CRT Looked at CRT alone (no ICD) Looked at CRT alone (no ICD) Patients with class 3 or 4, EF 120 ms Patients with class 3 or 4, EF 120 ms There was a 37% reduced mortality or first hospitalization for a cardiac cause compared to OPT There was a 37% reduced mortality or first hospitalization for a cardiac cause compared to OPT

34 CARE-HF All endpoints were met : EF, NYHA, QOL, BNP, Echo and hemodynamic parameters All endpoints were met : EF, NYHA, QOL, BNP, Echo and hemodynamic parameters 33% of the deaths in the CRT group were due to SCD 33% of the deaths in the CRT group were due to SCD For every 9 devices, one death and 3 hospitalizations were prevented For every 9 devices, one death and 3 hospitalizations were prevented Echo criteria in patients with QRS ms to look for dyssynchrony (had to have 2 of 3)…the “gray area group” Echo criteria in patients with QRS ms to look for dyssynchrony (had to have 2 of 3)…the “gray area group” Aortic pre-ejection delay of > 140 ms ( onset of QRS to Aortic ejection) Aortic pre-ejection delay of > 140 ms ( onset of QRS to Aortic ejection) Interventricular mechanical delay of >40 ms ( RV-LV) Interventricular mechanical delay of >40 ms ( RV-LV) Delayed activation of the postero-lateral LV wall (>50ms) Delayed activation of the postero-lateral LV wall (>50ms)

35 Primary Endpoint (All-cause Mortality or Unplanned Hosp. for Major CVS Event) CRT : 159 pts (39%) Medical Therapy CRT Number at risk HR 0.63 (95% CI 0.51 to 0.77) Event-free Survival Days P <.0001 Medical : 224 pts Therapy (55 %)

36 Conclusions Conclusive results from CARE-HF demonstrate that CRT should be considered as part of routine therapy for patients with moderate to severe HF due to LVSD with evidence (ECG supported by Echo) of cardiac dyssynchrony to*: Conclusive results from CARE-HF demonstrate that CRT should be considered as part of routine therapy for patients with moderate to severe HF due to LVSD with evidence (ECG supported by Echo) of cardiac dyssynchrony to*: Improve cardiac function and efficiency Improve cardiac function and efficiency Improve symptoms and QoL Improve symptoms and QoL Reduce morbidity Reduce morbidity Prolong survival Prolong survival These benefits are in addition to those of optimal pharmacological therapy (OPT) These benefits are in addition to those of optimal pharmacological therapy (OPT)

37 The Resynchronization Therapy in Normal QRS (RethinQ) Study 2007

38 Background Currently, indications for cardiac resynchronization therapy (CRT) include QRS duration > 120ms, LVEF 120ms, LVEF < 35% and NYHA Class III-IV. Class III-IV % of patients do not respond to CRT despite application of established selection criteria % of patients do not respond to CRT despite application of established selection criteria. Patients with normal conduction or a slightly prolonged QRS duration also exhibit mechanical abnormalities due to intraventricular dyssynchrony. Patients with normal conduction or a slightly prolonged QRS duration also exhibit mechanical abnormalities due to intraventricular dyssynchrony. Myocardial Tissue Doppler Imaging (TDI) allows both the velocity and timing of regional longitudinal motion to be measured. Myocardial Tissue Doppler Imaging (TDI) allows both the velocity and timing of regional longitudinal motion to be measured. LV dyssynchrony may also be useful in predicting the benefit of CRT before implantation of the pulse generator. LV dyssynchrony may also be useful in predicting the benefit of CRT before implantation of the pulse generator.

39 Hypothesis We hypothesized that patients with NYHA class III, left ventricular ejection fraction less than or equal to 35%, narrow QRS duration < 130 ms, and evidence of mechanical dyssynchrony on echocardiography may benefit from cardiac resynchronization therapy. We hypothesized that patients with NYHA class III, left ventricular ejection fraction less than or equal to 35%, narrow QRS duration < 130 ms, and evidence of mechanical dyssynchrony on echocardiography may benefit from cardiac resynchronization therapy.

40 Mechanical dyssynchrony considered present if either M-Mode - Septal posterior wall mechanical delay (SPWMD) ≥ 130 ms OR Tissue Doppler Imaging (TDI) of the basal ventricular segments in apical 4/2/3 chamber views - Septal to lateral delay ≥ 65ms OR - Antero-septal to posterior delay ≥ 65ms Echo Criteria for LV Dyssynchrony

41 Summary:RethinQ This prospective, multi-center, randomized trial was designed to evaluate the effectiveness of CRT therapy in a HF population with narrow QRS duration and evidence of mechanical dyssynchrony. This prospective, multi-center, randomized trial was designed to evaluate the effectiveness of CRT therapy in a HF population with narrow QRS duration and evidence of mechanical dyssynchrony. There was no statistical significant difference in the change in Peak VO 2 between the treatment and control group during cardiopulmonary exercise testing. There was no statistical significant difference in the change in Peak VO 2 between the treatment and control group during cardiopulmonary exercise testing. No improvement in other objective parameters including 6-minute walk test, LV reverse remodeling, and secondary endpoint - quality of life score. No improvement in other objective parameters including 6-minute walk test, LV reverse remodeling, and secondary endpoint - quality of life score.

42 Conclusion:RethinQ CRT did not improve Peak VO 2 during exercise in patients with NYHA Class III heart failure, QRS duration <130ms, EF ≤ 35% and mechanical dyssynchrony as specified in this trial. CRT did not improve Peak VO 2 during exercise in patients with NYHA Class III heart failure, QRS duration <130ms, EF ≤ 35% and mechanical dyssynchrony as specified in this trial. While there was a statistically significant improvement of NYHA class, a secondary endpoint, there was no improvement in quality- of-life, 6-minute walking test, or echocardiographic measures of reverse LV remodeling While there was a statistically significant improvement of NYHA class, a secondary endpoint, there was no improvement in quality- of-life, 6-minute walking test, or echocardiographic measures of reverse LV remodeling A subgroup of patients with QRS duration between A subgroup of patients with QRS duration between 120 ms and 130 ms demonstrated an improvement from CRT, however patients with QRS duration < 120 ms did not demonstrate improvement 120 ms and 130 ms demonstrated an improvement from CRT, however patients with QRS duration < 120 ms did not demonstrate improvement The subgroup of patients stratified on the basis of cardiomyopathy etiology did not demonstrate an improvement in peak VO2. The subgroup of patients stratified on the basis of cardiomyopathy etiology did not demonstrate an improvement in peak VO2.

43 PROSPECT TRIAL 5/2008 Predictors of response to CRT Predictors of response to CRT 53 centers worldwide, 426 patients 53 centers worldwide, 426 patients Patients had standard CRT indications (OMT, EF 130) Patients had standard CRT indications (OMT, EF 130) 12 ECHO parameters of dyssynchrony 12 ECHO parameters of dyssynchrony 69% of patients clinically improved and 56% showed a decrease in LVESV of >15% 69% of patients clinically improved and 56% showed a decrease in LVESV of >15% No single ECHO measure of dyssynchrony could help select responders to CRT No single ECHO measure of dyssynchrony could help select responders to CRT

44 RAO is best to distinguish BASE position from APEX BASE APEX Posterior Anterior

45 LAO is best to distinguish LATERAL position from SEPTAL ANTERIOR INFERIOR LATERALLATERAL SEPTALSEPTAL Anterior Posterior Lateral

46 LAO

47 The 3 levels of Dyssynchrony 1. Intraventricular dyssynchrony is best treated by placing the LV lead in the best anatomic location-usually the lateral or posterolateral (proven my multiple studies). Get the LV working. 2. Interventricular dyssynchrony is dealt with by adjusting the V-V interval. Get the RV and the LV to work together. 3. A-V dyssynchrony is dealt with by adjusting the A-V interval. Get the atria and the ventricles working together.

48 Change in LVEF [%] 2% 9% 0% 2% 4% 6% 8% 10% P= P=0.04 Change in LV End-systolic Volume [ml] Improvement Posterolateral or Lateral walls are the best with LBBB where the septum contracts first and then the lateral wall last. Posterolateral or Lateral walls are the best with LBBB where the septum contracts first and then the lateral wall last. Paced at any other LV site Paced at most mechanically delayed LV site

49 CRT and Tissue Doppler Imaging -a measure of intraventricular delay Measures dyssynchronous (delayed) contraction different areas of the ventricle Measure from the onset of the QRS to the peak systolic shortening of that segment Defined as a segment with > 50 ms delay: this indicates intraventricular delay or asynchrony by ECHO criteria Colors: green- yellow-red (the longest delay of >300 ms)

50 V-V Timing: synchronize the RV and the LV The best V-V setting by measuring the RVOT and LVOT via PW Doppler The best V-V setting by measuring the RVOT and LVOT via PW Doppler V-V above > 40 ms is considered abnormal V-V above > 40 ms is considered abnormal In normals, the RV will contract before the LV in the heart by -20 ms In normals, the RV will contract before the LV in the heart by -20 ms LV and RV have different outputs in the newer devices that allow sequential instead of simultaneous delivery of output and thus allow for this to be programmable. LV and RV have different outputs in the newer devices that allow sequential instead of simultaneous delivery of output and thus allow for this to be programmable.

51 AV Delay Optimization Methods 1. Electrocardiographic COMPANION trial method COMPANION trial method 2. Echocardiographic (combined) Aortic velocity time integral (VTI) methods Aortic velocity time integral (VTI) methods Mitral velocity Doppler methods:E and A waves Mitral velocity Doppler methods:E and A waves Ritter formula Ritter formula 3. Hemodynamic measurements Pulse pressure method Pulse pressure method dP/dt max method dP/dt max method

52 Cardiac Resynchronization Therapy in Patients With Severe Systolic Heart Failure:2008 Guidelines For patients who have left ventricular ejection fraction (LVEF) less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds, and sinus rhythm, cardiac resynchronization therapy (CRT) with or without an ICD is indicated for the treatment of New York Heart Association (NYHA) functional Class III or ambulatory Class IV heart failure symptoms on optimal recommended medical therapy. For patients who have LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds, and AF, CRT with or without an ICD is reasonable for the treatment of NYHA functional Class III or ambulatory Class IV heart failure symptoms on optimal recommended medical therapy. For patients with LVEF less than or equal to 35% with NYHA functional Class III or ambulatory Class IV symptoms who are receiving optimal recommended medical therapy and who have frequent dependence on ventricular pacing, CRT is reasonable. I IIaIIbIII

53 Cardiac Resynchronization Therapy in Patients With Severe Systolic Heart Failure : 2008 Guidelines For patients with LVEF less than or equal to 35% with NYHA functional Class I or II symptoms who are receiving optimal recommended medical therapy and who are undergoing implantation of a permanent pacemaker and/or ICD with anticipated frequent ventricular pacing, CRT may be considered. CRT is not indicated for asymptomatic patients with reduced LVEF in the absence of other indications for pacing. CRT is not indicated for patients whose functional status and life expectancy are limited predominantly by chronic noncardiac conditions.

54 Indications for ICD Therapy 2008

55 Implantable Cardioverter- Defibrillators ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study. 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.

56 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. 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

57 ICD implantation is reasonable for patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM. ICD implantation is reasonable for patients with sustained VT and normal or near-normal ventricular function. 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. I IIaIIbIII 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 I IIaIIbIII Implantable Cardioverter- Defibrillators

58 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 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

59 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. I IIaIIbIII I IIaIIbIII I IIaIIbIII I IIaIIbIII 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

60 ICD therapy is not indicated for patients who do not have a reasonable expectation of survival with an acceptable functional status for at least 1 year, even if they meet ICD implantation criteria specified in the Class I, IIa, and IIb recommendations above. ICD therapy is not indicated for patients with incessant VT or VF. ICD therapy is not indicated in patients with significant psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up. ICD therapy is not indicated for NYHA Class IV patients with drug-refractory congestive heart failure who are not candidates for cardiac transplantation or cardiac resynchronization therapy defibrillators (CRT-D). 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

61 ICD therapy is not indicated for syncope of undetermined cause in a patient without inducible ventricular tachyarrhythmias and without structural heart disease. ICD therapy is not indicated when VF or VT is amenable to surgical or catheter ablation (e.g., atrial arrhythmias associated with the Wolff-Parkinson-White syndrome, RV or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease). ICD therapy is not indicated for patients with ventricular tachyarrhythmias due to a completely reversible disorder in the absence of structural heart disease (e.g., electrolyte imbalance, drugs, or trauma). 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

62 Summary Large number of patients studied in multiple RCTs. Large number of patients studied in multiple RCTs. CRT improves quality of life, exercise capacity, functional capacity, EF, peak VO2. CRT improves quality of life, exercise capacity, functional capacity, EF, peak VO2. CRT reduces the risk of mortality, worsening HF, and hospitalizations for CHF. CRT reduces the risk of mortality, worsening HF, and hospitalizations for CHF. CRT + ICD significantly reduces risk of mortality. CRT + ICD significantly reduces risk of mortality.


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