device therapy in congestive heart failure teresa menendez hood, m.d., f.a.c.c

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

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

Device Therapy in Congestive Device Therapy in Congestive Heart FailureHeart Failure

Teresa Menendez Hood, M.D., F.A.C.C.

Page 2: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Congestive Heart FailureCongestive Heart Failure

400,000 5.0 million 250,000

Annual Incidence

Heart Failure Prevalence

Annual Mortality

U.S.

Up to 30 % of CHF patients have an IVCD (80% with a LBBB) Up to 30 % of CHF patients have an IVCD (80% with a LBBB) which has been linked to increases in mortality and morbidity.which has been linked to increases in mortality and morbidity.

CHF is the leading cause hospitalizations in the US and uses up 5% of CHF is the leading cause hospitalizations in the US and uses up 5% of the health care costs (1999 stats)the health care costs (1999 stats)

1-2% of the population and 6% of the population >65 1-2% of the population and 6% of the population >65 Prevalence is on the rise.Prevalence is on the rise.

Page 3: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Class I

Asymptomatic heart failure

ejection fraction (EF) <40%

Class II

Mild symptomatic heart failurewith ordinary

exertion

Class IV

Symptomatic heart failure

at rest

Class III

Moderatesymptomatic heart failure

with less thanordinary exertion

NYHA Class-evaluates the disability NYHA Class-evaluates the disability imposed on the patientimposed on the patient

The FDA and the ACC/AHA Guidelines have The FDA and the ACC/AHA Guidelines have approved biventricular pacing for class 3 and 4.approved biventricular pacing for class 3 and 4.

Page 4: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Leading Causes of Death in the Leading Causes of Death in the U.S.U.S.

National Vital Statistics Report. Oct. 12, 2001;49(11).MMWR. State-specific mortality from sudden cardiac death – US 1999. Feb 15, 2002;51:123-126.

0% 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)

Page 5: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

17

8

20

15

9

19

76

4

11

0

10

20

30

CHF-STAT GESICA SOLVD V-HeFT I MERIT-HF CIBIS-II CARVEDILOL-US

Con

trol

Gro

up M

orta

lity

Total Mortality

Sudden Death

Total Mortality ~15-40%; SCD accounts for ~50% of the total deaths.

12 months 16 months41.4 months 27 months 13 months45 months 6 months

SCD Rates in CHF Patients with LV SCD Rates in CHF Patients with LV DysfunctionDysfunction

Page 6: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

60%

70%

80%

90%

100%

0 60 120 180 240 300 360

Days

Cu

mu

lati

ve S

urv

ival

Duration (msec)

<90

90 120

120 170

170 220

• QRS duration is an independent predictor of mortality (>140 ms)

• Other factors are: age, creatinine, EF, and HR

.

-

-

-

QRS

-

-

-

>220

SCD in Heart FailureSCD in Heart Failure

Page 7: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Degree of SCD risk by classDegree 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%50 to 80% of the deaths are of the deaths are SuddenSudden 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 Up to 50% of the deaths are SuddenSudden Mortality in NYHA class IV is 30 to 70%Mortality in NYHA class IV is 30 to 70%

5 to 30% of deaths are 5 to 30% of deaths are SuddenSudden

SCD in Heart FailureSCD in Heart Failure

Page 8: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Right Ventricular PacingRight Ventricular Pacing

RV apex pacing is harmful in patients with RV apex pacing is harmful in patients with LV dysfunctionLV dysfunction

““Paced” LBBBPaced” LBBB Abnormal LV activationAbnormal LV activation Reduced stroke volume Reduced stroke volume

Page 9: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

RV pacingRV pacing

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

Page 10: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

MADIT II: ComplicationsMADIT II: ComplicationsNew or Worsening HFNew or Worsening HF

14.9%

19.9%

0.00%

10.00%

20.00%

Conventional Therapy ICD Therapy

(p= 0.09)

N= 490 N= 742

•RV pacing causes ventricular RV pacing causes ventricular dysynchrony and may lead to dysynchrony and may lead to worsening HF.worsening HF.

• Intrinsic ventricular activation is Intrinsic ventricular activation is better for ICD patients with left better for ICD patients with left ventricular dysfunction who do not ventricular dysfunction who do not “need” pacing.“need” pacing.

•<<10% of ICD patients have a Class I 10% of ICD patients have a Class I pacing indication at the time of pacing indication at the time of implant.implant.

•Physicians, when appropriate, Physicians, when appropriate, should consider programming of should consider programming of ICDs to avoid frequent RV pacing.ICDs to avoid frequent RV pacing.

Page 11: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

ICD indication but ICD indication but nono indication for a indication for a pacemakerpacemaker

Ef < 40%Ef < 40% DDDR @ 70BPM DDDR @ 70BPM

versus VVI 40 BPMversus VVI 40 BPM

DAVID — Dual Chamber and VVI DAVID — Dual Chamber and VVI Implantable Defibrillator TrialImplantable Defibrillator Trial

Page 12: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

TheThe ConceptConcept

In In mostmost patients with an IVCD (QRS > 130 ms) , the patients with an IVCD (QRS > 130 ms) , the presence of atrial-biventricular (RV + LV) pacing presence of atrial-biventricular (RV + LV) pacing will provide early stimulation to an otherwise late will provide early stimulation to an otherwise late segment of electrical activation in the LV.segment of electrical activation in the LV.

This This shouldshould translate into an increase in the EF, translate into an increase in the EF, decrease of the LV dimension, improvement in the decrease of the LV dimension, improvement in the QOL and NYHA class. QOL and NYHA class.

This This maymay translate into an decrease in CHF translate into an decrease in CHF exacerbations , hospitalizations and a decrease in exacerbations , hospitalizations and a decrease in mortality.mortality.

Page 13: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The ProofThe Proof

1994–1997: Mechanistic and both short- and 1994–1997: Mechanistic and both short- and longer-term longer-term observationalobservational studies. Studies initially studies. Studies initially used epicardial leads placed by thoracotomy or used epicardial leads placed by thoracotomy or thorascope. thorascope. The first BiV pacer was implanted in 1994The first BiV pacer was implanted in 1994

1998–1999: 1998–1999: Randomized, controlled studiesRandomized, controlled studies to to assess exercise capacity, functional status, and assess exercise capacity, functional status, and quality of life.quality of life. There was development of transvenous leads via the There was development of transvenous leads via the

coronary sinus in to get to the LV.coronary sinus in to get to the LV.

Cohen TJ, Klein J. J Inva2002;14:48-53.

Page 14: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The ProofThe Proof

2000–2005: Randomized, controlled trials to assess 2000–2005: Randomized, controlled trials to assess combined combined mortality and CHF hospitalizationmortality and CHF hospitalization. Also . Also evaluated the evaluated the combined combined benefit of ICD’s with CRT.benefit of ICD’s with CRT.

Future: Identify patients who will benefit from CRT along Future: Identify patients who will benefit from CRT along with the QRS duration.This will use echocardiographic with the QRS duration.This will use echocardiographic markers of asynchrony. markers of asynchrony. 20% of patients do not respond to therapy in clinical trials with a 20% of patients do not respond to therapy in clinical trials with a

wide QRS and 50% patients with a narrow QRS/CHF have wide QRS and 50% patients with a narrow QRS/CHF have asynchrony on echo and may benefit from this therapy.asynchrony on echo and may benefit from this therapy.

If the QRS is < 150 then the chances of responding to BiVP is If the QRS is < 150 then the chances of responding to BiVP is ~5%. It will be in this patient group of QRS of 120-150 ms where ~5%. It will be in this patient group of QRS of 120-150 ms where preselection of responders will be preselection of responders will be mostmost valuable. valuable.

Page 15: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The Cardiac The Cardiac Resynchronization Resynchronization

Clinical TrialsClinical Trials

PATH-CHF, MUSTIC, MIRACLE, PATH-CHF, MUSTIC, MIRACLE, COMPANION, and CARE-HF*COMPANION, and CARE-HF*

*This is not a complete list of all the CRT trials and the dates given are *This is not a complete list of all the CRT trials and the dates given are when the trial results were published.when the trial results were published.

Page 16: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Cumulative Enrollment in Cardiac Cumulative Enrollment in Cardiac Resynchronization Randomized Resynchronization Randomized

TrialsTrials

0

1000

2000

3000

4000

1999 2000 2001 2002 2003 2004 2005

Results Presented

Cum

ulat

ive

Pati

ents

PATH CHF

MUSTIC SR

MUSTIC AF

MIRACLE

CONTAK CD

MIRACLE ICD

PATH CHF II

COMPANION

MIRACLE ICD II

CARE HF

Page 17: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

This was the This was the first multicenter trialfirst multicenter trial and used the standard endocardial and used the standard endocardial RV lead and an RV lead and an epicardialepicardial LV lead via thoracotomy or thorascope LV lead via thoracotomy or thorascope

Single blinded RCTSingle blinded RCT 53 centers in 53 centers in EuropeEurope 41 41 patientspatients

PATH-CHF: 1999PATH-CHF: 1999Pacing Therapy for Congestive Heart Failure

Page 18: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Acute hemodynamic testing

Randomization 1:1

Best single chamber CRT

Best mode

No CRT

4 weeks

8 weeks

One year

NYHA class III-IVDCM

QRS > 120 msPR>150

No CRT

Implant

CRT Best single chamber12 weeks

PATH-CHFPATH-CHF

Page 19: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

PATH-CHFPATH-CHF

Primary endpointsPrimary endpoints Peak VO2Peak VO2 Six-minute walk distanceSix-minute walk distance

Secondary endpointsSecondary endpoints Minnesota Living with Heart Failure score (QOL)Minnesota Living with Heart Failure score (QOL) NYHA classNYHA class EFEF Trend towards decrease in HospitalizationsTrend towards decrease in Hospitalizations

Acute hemodynamic testing revealed that the lateral and Acute hemodynamic testing revealed that the lateral and posterolateral walls were the best target sites.posterolateral walls were the best target sites. The best responders were those with QRS>150 , long PR and dP/dt < 700 The best responders were those with QRS>150 , long PR and dP/dt < 700

mm Hg/smm Hg/s

Page 20: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

MUSTIC: 2001MUSTIC: 2001Multicenter Stimulation in CMMulticenter Stimulation in CM

European study with 67 patientsEuropean study with 67 patients QRS>150, CHF, EF <35%QRS>150, CHF, EF <35% BiVP versus backup VVI pacing at 40 BPMBiVP versus backup VVI pacing at 40 BPM Increase in 6 minute walk time , QOL and Peak VO2 Increase in 6 minute walk time , QOL and Peak VO2

with BiVP and persisted for up to 12 monthswith BiVP and persisted for up to 12 months 60% decrease in CHF hospitalizations 60% decrease in CHF hospitalizations First to use endocardial LV leadsFirst to use endocardial LV leads via the CS via the CS No significant change in mortality, but a trend No significant change in mortality, but a trend

towards an improvement.towards an improvement. Acute hemodynamic studies showed the Acute hemodynamic studies showed the mid lateral mid lateral

wallwall to be the best site to be the best site

Page 21: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

MIRACLE:2002MIRACLE:2002Multi-center In Sync Randomized Clinical Multi-center In Sync Randomized Clinical

Evaluation TrialEvaluation Trial

Double blinded RCTDouble blinded RCT FirstFirst US trial US trial Class 3 or 4, on OPT, QRS >130 ms, EF<35%Class 3 or 4, on OPT, QRS >130 ms, EF<35% Enrollment of 453 patientsEnrollment of 453 patients

Page 22: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

MIRACLEMIRACLENYHA class III-IVLVEDD > 60 mmQRS > 130 ms

Stable 3 month regimen of beta-blocker/ACE inhibitorEF < 35%

Randomization

CRT on

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

Page 23: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Nonresponders:Nonresponders: older, ischemic CM, no MR, QRS<150 older, ischemic CM, no MR, QRS<150Responders: Responders: had shorter duration on CHF and longer QRS>155 had shorter duration on CHF and longer QRS>155

MIRACLEMIRACLE

39%39%34%34%

27%27%

67%67%

17%17% 16%16%

0%0%

20%20%

40%40%

60%60%

ImprovedImproved No ChangeNo Change WorsenedWorsened

Pro

port

ion

Pro

port

ion

Control N=225Control N=225 CRT N=228CRT N=228

P < 0.001P < 0.001

Page 24: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

MIRACLEMIRACLE

There was a decrease in hospitalizations of 50% at 6 months There was a decrease in hospitalizations of 50% at 6 months and a and a trend towardstrend towards a decrease in mortality. a decrease in mortality.

All other primary and secondary endpoints were met: 6 minute All other primary and secondary endpoints were met: 6 minute walk time, peak Vo2, QOL, EF , NYHA class, LVEDDwalk time, peak Vo2, QOL, EF , NYHA class, LVEDD

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

Page 25: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

FDA ApprovalFDA Approval

The first CRT device was The first CRT device was approved by the FDA in approved by the FDA in

September 2001September 2001 . .

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

20022002 . .

Page 26: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

MADIT 1 MADIT 1 19961996 required a positive EP studyrequired a positive EP study

MUSTTMUSTT 1999 required a positive EP study1999 required a positive EP study

Madit 2Madit 2 20022002 prior MI (ischemic cardiomyopathy) and prior MI (ischemic cardiomyopathy) and EF<30% (no EP study required) ;60% had CHF and 50% EF<30% (no EP study required) ;60% had CHF and 50% had QRS > 120 ms; resulted in a 31% decrease risk of had QRS > 120 ms; resulted in a 31% decrease risk of death and halted prematurely due to the positive effect of death and halted prematurely due to the positive effect of the ICD: resulted in the FDA approving the ICD for the ICD: resulted in the FDA approving the ICD for primary prevention this patient population, but only those primary prevention this patient population, but only those with a QRS > 120 ms.with a QRS > 120 ms.

The primary ICD prevention trialsThe primary ICD prevention trials

Page 27: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The primary ICD prevention trialThe primary ICD prevention trial

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

Page 28: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

ACC/AHA/NASPE ACC/AHA/NASPE 20022002 Indications for Indications for Cardiac Resynchronization TherapyCardiac Resynchronization Therapy

Class II a ( Level A) IndicationClass II a ( Level A) Indication for Biventricular Pacing in for Biventricular Pacing in Dilated CardiomyopathyDilated Cardiomyopathy

Biventricular pacing in medically refractory, Biventricular pacing in medically refractory, symptomatic NYHA Class III/IV patients with symptomatic NYHA Class III/IV patients with idiopathic dilated or ischemic cardiomyopathy, idiopathic dilated or ischemic cardiomyopathy, prolonged QRS interval (prolonged QRS interval (130 msec), LV end diastolic 130 msec), LV end diastolic diameter diameter 55mm, and LVEF 55mm, and LVEF 35% 35%

Page 29: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

COMPANION:2004COMPANION:2004

• OPT1

• OPT

• CRT+

2

• OPT

• CRT-D+

2

Randomization

Comparison of Medical Therapy, Pacing and

Defibrillation in Heart Failure

Page 30: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

COMPANIONCOMPANION Enrolled 1520 patients class 3 and 4, QRS >120msEnrolled 1520 patients class 3 and 4, QRS >120ms Primary endpointPrimary endpoint: death or hospitalization for any cause: death or hospitalization for any cause CRT CRT metmet the primary endpoints and the CRT +/- ICD the primary endpoints and the CRT +/- ICD

significantly reduces mortalitysignificantly reduces mortality This was the This was the first to show mortality benefitfirst to show mortality benefit from CRT from CRT

alonealone Showed that patients with CRT also benefit from ICD therapyShowed that patients with CRT also benefit from ICD therapy

OPT had SCD in OPT had SCD in 36%,36%, 23%23% in CRT and in CRT and 2.9%2.9% in CRT+ICD in CRT+ICD

Page 31: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

• CRT arm had 20% reduction in mortality and CRT arm had 20% reduction in mortality and hospitalization over OPT arm but it was not statistically hospitalization over OPT arm but it was not statistically significantsignificant

• Significant reduction in CRT-ICD arm of 40% for Significant reduction in CRT-ICD arm of 40% for mortality over OPT arm (19% in OPT and 11% in CRT-mortality over OPT arm (19% in OPT and 11% in CRT-ICD group)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 monthsMean follow up was 16 months

COMPANIONCOMPANION

Page 32: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

CARE-HF : March 2005CARE-HF : March 2005

The effect of cardiac resynchronization on morbidity and The effect of cardiac resynchronization on morbidity and mortality in heart failure in 813 patients in Europe mortality in heart failure in 813 patients in Europe ( prospective multicenter RCT) with completed enrollment ( prospective multicenter RCT) with completed enrollment by 2002by 2002

Large patient size and length of trial (average follow up of Large patient size and length of trial (average follow up of 29 months29 months) allowed ability to asses effects of CRT) allowed ability to asses effects of CRT

Looked at CRT alone (Looked at CRT alone (no ICDno ICD)) Patients with class 3 or 4, EF < 35%, QRS >120 msPatients with class 3 or 4, EF < 35%, QRS >120 ms There was a There was a 37%37% reduced mortality reduced mortality oror first hospitalization first hospitalization

for a cardiac cause compared to OPT for a cardiac cause compared to OPT

Page 33: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

CARE-HFCARE-HF All endpoints were met : EF, NYHA, QOL, BNP, Echo and All endpoints were met : EF, NYHA, QOL, BNP, Echo and

hemodynamic parametershemodynamic parameters 33%33% of the deaths in the CRT group were due to SCD of the deaths in the CRT group were due to SCD For every 9 devices, one death and 3 hospitalizations were For every 9 devices, one death and 3 hospitalizations were

preventedprevented Echo criteria in patients with QRS Echo criteria in patients with QRS 120-149ms120-149ms to look for to look for

asynchrony (had to have 2 of 3)asynchrony (had to have 2 of 3) Aortic pre-ejection delay of > 140 ms ( onset of QRS to Aortic Aortic pre-ejection delay of > 140 ms ( onset of QRS to Aortic

ejection)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)

Page 34: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

RA AnatomyRA Anatomy

Page 35: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Anatomical ChallengesAnatomical Challenges

Enlarged right atriumEnlarged right atrium Abnormal CS locationAbnormal CS location Presence of valves in CSPresence of valves in CS Altered CS angulation Altered CS angulation Acute branch take offs Acute branch take offs Tortuous vessel anatomyTortuous vessel anatomy

Page 36: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

CRT Procedure and Device Related CRT Procedure and Device Related Risks relative to CS placementRisks relative to CS placement

CS lead dislogdement 8%CS lead dislogdement 8% CS dissection or perforation 5%CS dissection or perforation 5% Failure of lead placement 8%Failure of lead placement 8% Phrenic nerve stimulation 2%Phrenic nerve stimulation 2%

ALL other risks associated with pacer or ICD implantation ALL other risks associated with pacer or ICD implantation and anesthesia in these patients.and anesthesia in these patients.

Page 37: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

CS Leads CS Leads they now come in many shapes and sizes and the the they now come in many shapes and sizes and the the

OTW systemOTW system

Page 38: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Achieving Cardiac Achieving Cardiac ResynchronizationResynchronization

Goal: Atrial synchronous biventricular pacing

Transvenous approach for left ventricular lead via coronary sinus

Back-up epicardial approach

Right AtrialLead

Right VentricularLead

Left VentricularLead

Page 39: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

RAO is best to

distinguish BASE

position from APEX

BASE

APEX

Posterior

Anterior

Page 40: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

LAO is best to

distinguishLATERAL

position from

SEPTAL

ANTERIOR

INFERIOR

LATERAL

SEPTAL

Anterior

PosteriorLateral

Page 41: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

LAOLAO

Page 42: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The implantThe implant 3 separate sticks via Seldinger technique in the subclavian 3 separate sticks via Seldinger technique in the subclavian

vein -can be done from the right but it is more difficult.vein -can be done from the right but it is more difficult. Use standard peel back sheaths for the RA and RV leads Use standard peel back sheaths for the RA and RV leads The RV lead is positioned The RV lead is positioned first -first - could develop CHB or VT so could develop CHB or VT so

it is good to have this in (screw-in or tined)it is good to have this in (screw-in or tined) Advance the long guide sheath into the RA ( not to the CS)Advance the long guide sheath into the RA ( not to the CS) Advance a Coronary Sinus EP catheter via the long guide Advance a Coronary Sinus EP catheter via the long guide

sheath into the CS – the LAO is the best: point towards the sheath into the CS – the LAO is the best: point towards the spine.spine.

Advance the sheath while pulling back on the CS catheter to Advance the sheath while pulling back on the CS catheter to get the sheath into the CSget the sheath into the CS

Some would use dye at this point to look at the anatomy of the Some would use dye at this point to look at the anatomy of the CS and its branches CS and its branches

Page 43: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The implantThe implant Advance the CS lead with or without the OTW system and Advance the CS lead with or without the OTW system and

make sure you place it in a mid/lateral or posterolateral make sure you place it in a mid/lateral or posterolateral position. Never go where the LAD would be but where the position. Never go where the LAD would be but where the obtuse marginals would be. obtuse marginals would be.

Test the CS lead including at 10 volts for phrenic nerve Test the CS lead including at 10 volts for phrenic nerve stimulationstimulation

Pull back on the sheath until it is out of the OS, then peel it Pull back on the sheath until it is out of the OS, then peel it out with a retention guide wire in the CS-be careful about out with a retention guide wire in the CS-be careful about dislodgementdislodgement

Position the atrial lead in the RAA (screw-in or tined)Position the atrial lead in the RAA (screw-in or tined) Test the ICD with induction of VF twice separated by 3-5 Test the ICD with induction of VF twice separated by 3-5

minutes: can do at a later time if the time is > 4 hours or the minutes: can do at a later time if the time is > 4 hours or the patient has been unstable in any way. Always use a high patient has been unstable in any way. Always use a high energy device in these patients.energy device in these patients.

Page 44: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

The 3 levels of asynchronyThe 3 levels of asynchrony

1.1. IntraventricularIntraventricular asynchrony is best treated by asynchrony is best treated by placing the LV lead in the best anatomicplacing the LV lead in the best anatomic locationlocation-usually the lateral or posterolateral -usually the lateral or posterolateral (proven my multiple studies). Get the LV working.(proven my multiple studies). Get the LV working.

2.2. InterventricularInterventricular asynchrony is dealt with by asynchrony is dealt with by adjusting the adjusting the V-VV-V interval. Get the RV and the LV interval. Get the RV and the LV to work together.to work together.

3.3. A-V asynchronyA-V asynchrony is dealt with by adjusting the is dealt with by adjusting the A-VA-V interval. Get the atria and the ventricles working interval. Get the atria and the ventricles working together.together.

Page 45: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Change in LVEF [%]

2%

9%

0%

2%

4%

6%

8%

10%P=0.04

-9.2

-28.4

-30

-25

-20

-15

-10

-5

0

P=0.04

Change in LV End-systolic Volume [ml]

Imp

rov

em

en

t

Posterolateral or Lateral walls are the best with LBBB where Posterolateral or Lateral walls are the best with LBBB where the septum contracts first and then the lateral wall last.the septum contracts first and then the lateral wall last.

Paced at any other LV site

Paced at most mechanically delayed LV site

Page 46: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

CRT and Tissue Doppler Imaging -a measure of CRT and Tissue Doppler Imaging -a measure of intraventricular delayintraventricular delay

• Measures dyssynchronous (delayed) contraction patterns @ 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)

Page 47: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

AV Delay Optimization MethodsAV Delay Optimization Methods

1.1. ElectrocardiographicElectrocardiographic COMPANION trial methodCOMPANION trial method

2.2. Echocardiographic (combined)Echocardiographic (combined) Aortic velocity time integral (VTI) methodsAortic velocity time integral (VTI) methods Mitral velocity Doppler methods:E and A wavesMitral velocity Doppler methods:E and A waves Ritter formulaRitter formula

3.3. Hemodynamic measurements Hemodynamic measurements Pulse pressure methodPulse pressure method dP/dtdP/dtmaxmax method method

Page 48: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

COMPANION Method:COMPANION Method: QRS < 150 QRS < 150

Sensed AV Delay:

Intracardiac AV interval:AS to VS = 300 ms

Intrinsic QRS duration:QRS = 140 ms

Page 49: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

COMPANION Method: COMPANION Method: QRS >150 QRS >150

Sensed AV Delay:

Intracardiac AV interval:AS to VS = 240 ms

Intrinsic QRS duration:QRS = 180 ms

Page 50: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Aortic VTI Method Aortic VTI Method

Objective:Objective: Identify the AV Delay that yields the maximum cardiac output Identify the AV Delay that yields the maximum cardiac output

as determined by an aortic VTI measurementas determined by an aortic VTI measurement Procedure:Procedure:

Obtain continuous wave Doppler echo of aortic valve outflow Obtain continuous wave Doppler echo of aortic valve outflow to obtain VTI measurementto obtain VTI measurement

Record VTI values over a range of programmed AV Delays Record VTI values over a range of programmed AV Delays Program the AV Delay value that yields the maximum aortic Program the AV Delay value that yields the maximum aortic

VTIVTI

Page 51: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Mitral Velocity Doppler Echo Mitral Velocity Doppler Echo MethodMethod

Objective:Objective: Identify the AV Delay that maximizes LV filling using mitral velocity Identify the AV Delay that maximizes LV filling using mitral velocity

echocardiographic measurementsechocardiographic measurements11

Procedure #1: “A-wave cutoff”Procedure #1: “A-wave cutoff” Obtain transmitral Doppler echo at a “long” programmed AV Delay Obtain transmitral Doppler echo at a “long” programmed AV Delay

during ventricular pacingduring ventricular pacing Shorten the programmed AV Delay by 10-20 ms until the echo Doppler Shorten the programmed AV Delay by 10-20 ms until the echo Doppler

A-wave becomes truncated (A wave is atrial contraction)A-wave becomes truncated (A wave is atrial contraction) Lengthen the programmed AV Delay back to the value where there is no Lengthen the programmed AV Delay back to the value where there is no

A-wave cutoff. This timing should enable ventricular contraction to occur A-wave cutoff. This timing should enable ventricular contraction to occur just at the end of atrial systolejust at the end of atrial systole

Page 52: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

V-V Timing: synchronize the RV V-V Timing: synchronize the RV and the LVand the LV

The best V-V setting by measuring the RVOT and LVOT via The best V-V setting by measuring the RVOT and LVOT via PW DopplerPW Doppler

V-V above > 40 ms is considered abnormalV-V above > 40 ms is considered abnormal

In normals, the RV will contract before the LV in the heart In normals, the RV will contract before the LV in the heart by -20 msby -20 ms

LV and RV have different outputs in the newer devices that LV and RV have different outputs in the newer devices that allow allow sequentialsequential instead of instead of simultaneoussimultaneous delivery of output delivery of output and thus allow for this to be programmable.and thus allow for this to be programmable.

Page 53: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Therapy for Heart FailureTherapy for Heart Failure

EF <40%…then need to evaluate patient for EF <40%…then need to evaluate patient for etiologyetiology of cardiomyopathy and begin to of cardiomyopathy and begin to optimize medical optimize medical therapytherapy..

If the patient is Class 3 or 4 , has a QRS> 130 ms, has If the patient is Class 3 or 4 , has a QRS> 130 ms, has had a documented EF<35% for >9 months… then had a documented EF<35% for >9 months… then consider for CRT-ICD.consider for CRT-ICD.

Page 54: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Stages of Heart FailureStages of Heart Failure

Page 55: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

SummarySummary

Large number of patients studied in multiple RCTs.Large number of patients studied in multiple RCTs. CRT improves quality of life, exercise capacity, CRT improves quality of life, exercise capacity,

functional capacity, EF, peak VO2.functional capacity, EF, peak VO2. CRT reduces the risk of mortality, worsening HF, and CRT reduces the risk of mortality, worsening HF, and

hospitalizations for CHF.hospitalizations for CHF. CRT + ICD significantly reduces risk of mortality.CRT + ICD significantly reduces risk of mortality.

Page 56: Device Therapy in Congestive Heart Failure Teresa Menendez Hood, M.D., F.A.C.C

Thank youThank you

Any Questions?Any Questions?