Device Therapy in Heart Failure

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

Heart Failure Prevalence
Annual Incidence Heart Failure Prevalence Annual Mortality 5.0 million 400,000 250,000 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. 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 Prevalence is on the rise.

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

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

Stages of Heart Failure

Leading Causes of Death in the U.S.
Septicemia Nephritis You must combine deaths from all cancers to outnumber the deaths from SCA each year. Alzheimer’s Disease Influenza/pneumonia Diabetes Accidents/injuries Chronic lower respiratory diseases Cerebrovascular disease Other cardiac causes Sudden cardiac arrest (SCA) Sudden cardiac death is the 2nd leading cause of death after all cancers combined. Death from cardiac causes accounted for 30.3% of all deaths (National Vital Stats). Sudden cardiac death represents 63% of all cardiac deaths. (Mortality and Morbidity Weekly Review (MMWR), Feb 15, 2002) Therefore SCA accounts for 19.1% of deaths, more than all other causes except all cancers combined. All other causes All cancers 0% 5% 10% 15% 20% 25% National Vital Statistics Report. Oct. 12, 2001;49(11). MMWR. State-specific mortality from sudden cardiac death – US Feb 15, 2002;51:

SCD Rates in CHF Patients with LV Dysfunction
CHF-STAT: Singh SN, et al. Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia. N Engl J Med 1995; 333: GESICA: Doval, HC. Lancet SOLVD: Cooper H, et al. Dirueticsand Risk of Arrhythmic Death in Patients with Left Ventricularl Dysfunction. Circulation ; 100: V-HEFT I: Goldman S, Johnson G, Cohn JN, Cintron G, Smith R, Francis G. Mechanism of death in heart failure. The Vasodilator-Heart Failure Trials. The V-HeFT VA Cooperative Studies Group. Circulation Jun;87(6 Suppl):VI24-31 MERIT-HF: Effect of metoprolol CR/XL in chronic heart failure: metoprolol CR/XL randomized intervention trial in Congestive Heart Failure (MERIT-HF). Lancet 1999; 353: CIBIS II: The Cardiac Insufficiency Bisoprolol Study II (CIBIS II): a randomized trial. THE LANCET: 353: 9-13. CARVEDILOL-US: The Effect of Carvedilol on Morbidity and Mortality in Patients with Chronic Heart Failure. N Engl J Med 1996; 334: 45 months 13 months 41.4 months 27 months 12 months 16 months 6 months SCD accounts for ~50% of the total deaths.

SCD in Heart Failure QRS duration is an independent predictor of mortality (>140 ms) Other factors are: age, creatinine, EF, and HR QRS 100% Duration (msec) 90% <90 90 - - 120 Cumulative Survival 80% 120 - - 170 170 - - 220 70% >220 60% 60 120 180 240 300 360 Days .

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

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. Abnormal LV activation Reduced stroke volume

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: Complications New or 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. <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. (p= 0.09) N= 490 N= 742 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.

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

Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial : 2007 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) ― 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

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. 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.

The Proof 1994 –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 1998 –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. Cohen TJ, Klein J. J Inva2002;14:48-53. References: Cohen TJ, Klein J. Cardiac resynchronization therapy for treatment of heart failure. J Invas Cardiol. 2002;14:48-53. Foster AH, Gold MR, McLaughlin JS. Acute hemodynamic effects of atrio-biventricular pacing in humans. Ann Thorac Surg. 1995;59: Saxon LA, Boehmer JP, Hummels H, et al, for the VIGOR CHF and VENTAK CHF Investigators. Biventricular pacing in patients with congestive heart failure: two prospective randomized trials. Am J Cardiol. 1999;83:120D-124D. Abraham WT. Cardiac resynchronization therapy: a review of clinical trials and criteria for identifying the appropriate patient. Rev Cardiovasc Med. 2003;4(suppl 2):S31-S37. Gras D, Cazeau S, Mabo P, et al. A long-term benefit of cardiac resynchronization in heart failure patients: The 12-month results of the InSync Trial. J Am Coll Cardiol. 2000;35:230A.

The Proof 2000 – 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. 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.

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.

Cumulative Enrollment in Cardiac Resynchronization Randomized Trials
Main purpose: Show that a large number of patients have been studied in completed and ongoing randomized controlled studies of CRT. Use in conjunction with previous slide. Key messages: Over 3000 patients have been enrolled in randomized controlled clinical trials presented to date. When CARE-HF, another landmark trial assessing mortality and hospitalization, is reported, close to 4,000 patients will have been studied.

PATH-CHF: 1999 Pacing Therapy for Congestive Heart Failure
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 53 centers in Europe 41 patients

PATH-CHF Primary endpoints Secondary endpoints
Peak VO2 Six-minute walk distance Secondary endpoints Minnesota Living with Heart Failure score (QOL) NYHA class EF Trend towards decrease in Hospitalizations 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 < 700 mm Hg/s

MUSTIC: 2001 Multicenter Stimulation in CM
European study with 67 patients QRS>150, CHF, EF <35% 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 60% decrease in CHF hospitalizations First to use endocardial LV leads via the CS No significant change in mortality, but a trend towards an improvement. Acute hemodynamic studies showed the mid lateral wall to be the best site

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

Stable 3 month regimen of beta-blocker/ACE inhibitor
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 Long-term follow-up

MIRACLE P < 0.001 67% 39% 34% 27% 17% 16% 0% 20% 40% 60% Improved
Nonresponders: older, ischemic CM, no MR, QRS<150 Responders: had shorter duration on CHF and longer QRS>155 39% 34% 27% 67% 17% 16% 0% 20% 40% 60% Improved No Change Worsened Proportion Control N=225 CRT N=228 P < 0.001 This slide is from the MIRACLE slides distributed earlier but is placed here to support the previous slide. Key Point: 67% of the CRT patients showed improvement in their composite response at 6-months compared to 39% of the Control patients. The difference is statistically significant. Additional Information: Unlike previous endpoints reported that analyze only those patients completing the 6 month randomization period, this measure accounts for the status of all patients randomized. The Composite Response has emerged as an important secondary endpoint of this study. It is the only endpoint, other than mortality, that takes into account all 453 patients. A patient is defined as improved if they improved 1 or more functional classes (by blinded physician), or if they if the patient indicated a moderate or marked improvement in the patient global assessment score. With the global assessment, the patient answers how they felt since the InSync system was implanted. There are seven possible responses: Markedly Improved, Moderately Improved, Mild Improvement, No Change, Slightly Worse, Moderately Worse, Markedly Worse. A patient is said to have worsened if they died, were hospitalized for worsening heart failure since implant, if they crossover from their assigned group because of worsening heart failure, if they withdraw consent, if they had a worsening of NYHA Functional Class, or if they indicated a moderate/markedly worse ranking on the global assessment. A patient is said to have not changed if the improved or worsened conditions are not met. Reference: Packer M. Proposal for a new clinical endpoint to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail 2001;7:

MIRACLE 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 Magnitude of improvement not influenced by degree of QRS shortening with BiVP (average in all was –20msec)

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

The Primary ICD Prevention Trials
MADIT required a positive EP study;ischemics MUSTT required a positive EP study; ischemics; EF<40% MADIT prior MI (ischemic cardiomyopathy) and EF<30% (no EP study required) ;60% had CHF and 50% had QRS > 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
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.

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

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

COMPANION 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) Study was halted prematurely due to its positive benefit. Mean follow up was 16 months In summary, this therapy is intended for patients with symptomatic CHF and wide QRS. The VIGOR CHF, CONTAK TR and EASYTRAK lead are investigational devices for this study. The EASYTRAK coronary venous lead is used with CONTAK TR congestive heart failure device. BV therapy and the EASYTRAK transvenous lead are being evaluated in this study.

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 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) Patients with class 3 or 4, EF < 35%, QRS >120 ms There was a 37% reduced mortality or first hospitalization for a cardiac cause compared to OPT

CARE-HF All endpoints were met : EF, NYHA, QOL, BNP, Echo and hemodynamic parameters 33% of the deaths in the CRT group were due to SCD 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” Aortic pre-ejection delay of > 140 ms ( onset of QRS to Aortic ejection) Interventricular mechanical delay of >40 ms ( RV-LV) Delayed activation of the postero-lateral LV wall (>50ms)

Primary Endpoint (All-cause Mortality or Unplanned Hosp
Primary Endpoint (All-cause Mortality or Unplanned Hosp. for Major CVS Event) 3 48 118 232 292 404 Medical Therapy 7 68 166 273 323 409 CRT Number at risk 500 1000 1500 0.00 0.25 0.50 0.75 1.00 HR 0.63 (95% CI 0.51 to 0.77) Event-free Survival Days P < .0001 Medical : 224 pts Therapy (55 %) CRT : 159 pts (39%) Key Messages: The primary composite end-point (death or an unplanned hospitalization for a major cardiovascular event) was reduced substantially by CRT. There was no early hazard from device implantation. The curves began to separate within the first 90 days and remained separated during the follow up period. The absolute difference between the CRT and Medical Therapy arms in the percentage of patients reaching the primary endpoint during 29.5 months was 16%.

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*: Improve cardiac function and efficiency Improve symptoms and QoL Reduce morbidity Prolong survival These benefits are in addition to those of optimal pharmacological therapy (OPT) Key Messages: In conclusion, CARE-HF’s results show that CRT significantly reduces both morbidity and mortality in patients with symptomatic HF due to LV systolic dysfunction complicated by cardiac dyssynchrony. Calculations based on hazard ratios suggest that for every 9 devices implanted, 1 death and 3 hospitalizations for major cardiovascular events can be avoided. Symptoms significantly improved as well.

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

Background Currently, indications for cardiac resynchronization therapy (CRT) include QRS duration > 120ms, LVEF < 35% and NYHA Class III-IV. 20-30% 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. 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. 38

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. 39

Echo Criteria for LV Dyssynchrony
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 - Antero-septal to posterior delay ≥ 65ms

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. There was no statistical significant difference in the change in Peak VO2 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 . 41

Conclusion:RethinQ CRT did not improve Peak VO2 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 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 The subgroup of patients stratified on the basis of cardiomyopathy etiology did not demonstrate an improvement in peak VO2. 42

PROSPECT TRIAL 5/2008 Predictors of response to CRT
53 centers worldwide, 426 patients Patients had standard CRT indications (OMT, EF < 35%, Class III-IV, QRS > 130) 12 ECHO parameters of dyssynchrony 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

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

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

The 3 levels of Dyssynchrony
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. Interventricular dyssynchrony is dealt with by adjusting the V-V interval. Get the RV and the LV to work together. A-V dyssynchrony is dealt with by adjusting the A-V interval. Get the atria and the ventricles working together.

End-systolic Volume [ml]
Posterolateral or Lateral walls are the best with LBBB where the septum contracts first and then the lateral wall last. Paced at most mechanically delayed LV site Paced at any other LV site 10% P=0.04 -5 8% 9% -9.2 -10 6% Improvement A study from Ansalone and colleagues demonstrated the importance of LV pacing site for CRT.1 Pre-implant, they determined the LV region with the greatest mechanical delay using tissue Doppler imaging, and then paced patients at either the most delayed site or any other LV site. The results showed patients paced at the site of greatest mechanical delay exhibited significantly greater improvement in ejection fraction and reverse remodeling (reduction in LV end-systolic volume) than patients receiving LV stimulation at other sites. 1Ansalone G, et.al. J Am Coll Cardiol. 2002;39: -15 4% -20 2% -25 -28.4 P=0.04 2% 0% -30 Change in LV End-systolic Volume [ml] Change in LVEF [%]

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) Tissue Doppler Imaging is an echo method that measures the velocity of blood flow and the dyssynchrony in the ventricles. TDI calculates the amount of delayed contraction at different areas within the heart. TDI determines regional and global LV function and tracks longitudinal motion amplitude in each myocardial segment during systole.

V-V Timing: synchronize the RV and the LV
The best V-V setting by measuring the RVOT and LVOT via PW Doppler V-V above > 40 ms is considered abnormal 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.

AV Delay Optimization Methods
Electrocardiographic COMPANION trial method Echocardiographic (combined) Aortic velocity time integral (VTI) methods Mitral velocity Doppler methods:E and A waves Ritter formula Hemodynamic measurements Pulse pressure method dP/dtmax method There are a number of methods for determining and optimizing the AV Delay for a HF patient with a CRT device. Methods fall into three main categories—simple ECG assessment, echocardiography measures, and direct hemodynamic measurements. It’s important to note that currently no one method has been identified as being the single best method for every patient. Each method has its advantages and limitations. Part of the challenge in using any of these methods is that, to date, no study has identified which specific aspect of an AV Delay’s effect (i.e., LV filling time, stroke volume, pulse pressure, etc.) is the best one to evaluate to ensure the AV Delay provides maximum CRT benefit. Additionally with each method, there are inherent errors associated with the method itself and errors associated with the physiologic variations during the testing that should also be considered when evaluating the optimal AV Delay. Thus, the physician must determine which method(s) may be best suited for his/her patients, keeping in mind the limitations of each method. The next few slides provide a high-level overview of the individual methods. It is not the intent to provide in-depth instruction or to recommend one method over another, but to provide familiarization.

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 IIa IIb III A I IIa IIb III B I IIa IIb III

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. I IIa IIb III C I IIa IIb III B I IIa IIb III C

Indications for ICD Therapy
2008

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. I IIa IIb III A I IIa IIb III B I IIa IIb III B 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.

IIa IIb III A 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. I IIa IIb III B I IIa IIb III A I IIa IIb III B 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.

IIa IIb III 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 IIa IIb III I IIa IIb III I IIa IIb III I IIa IIb III B 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.

IIa IIb III 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 IIa IIb III I IIa IIb III I IIa IIb III I IIa IIb III 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.

IIa IIb III 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 IIa IIb III B I IIa IIb III I IIa IIb III I IIa IIb III 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.

IIa IIb III C 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). I IIa IIb III C I IIa IIb III C I IIa IIb III C 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.

IIa IIb III C 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). I IIa IIb III C I IIa IIb III B 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.

Summary Large number of patients studied in multiple RCTs.
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 + ICD significantly reduces risk of mortality.

Device Therapy in Heart Failure

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