ICDs for Heart FailureICDs for Heart Failure

Derek T. ConnellyDerek T. ConnellyPresident - Heart Rhythm UKPresident - Heart Rhythm UK

Consultant Cardiologist - Glasgow Royal InfirmaryConsultant Cardiologist - Glasgow Royal Infirmary

September 2005 September 2005

ICD TechnologyICD Technology

1989 2004 Weight 250 g 80 g

Implant site Abdominal Pectoral Leads Epicardial Endocardial

Implant time 4 hours 40 mins Implant

mortality 4-6% < 1%

Post-op stay 7-10 days 1 day

ICD TechnologyICD Technology

1989 2004

Battery life 2 years 7-9 years

Pacing None DDDR, + LV

Tachy detection Rate Rate, onset, stability, atrial rate

morphology Tachy Rx Shock Shock, pacing

Diagnostics Limited Extensive

ICD Trials:ICD Trials:“Secondary prevention”“Secondary prevention”

Randomised Trials of ICD TherapyRandomised Trials of ICD Therapy

““Secondary prevention” - patients who Secondary prevention” - patients who have had sustained VT or VFhave had sustained VT or VF

Antiarrhythmics versus Implantable Antiarrhythmics versus Implantable Defibrillator (AVID) - 1997Defibrillator (AVID) - 1997

Cardiac Arrest Study Hamburg (CASH) - Cardiac Arrest Study Hamburg (CASH) - 20002000

Canadian Implantable Defibrillator Study Canadian Implantable Defibrillator Study (CIDS) - 2000(CIDS) - 2000

Antiarrhythmics Versus Implantable Antiarrhythmics Versus Implantable Defibrillator (AVID)Defibrillator (AVID)

6000 patients screened, 1016 randomised6000 patients screened, 1016 randomised Mean age 65, 79% male, mean LVEF 31%Mean age 65, 79% male, mean LVEF 31% Inclusion arrhythmia:Inclusion arrhythmia:

• Ventricular fibrillationVentricular fibrillation 45%45%• Ventricular tachycardia with syncope Ventricular tachycardia with syncope 21%21%• Symptomatic VT with LVEF <40%Symptomatic VT with LVEF <40% 34%34%

ICD in 507, Antiarrhythmic drugs in 509 ICD in 507, Antiarrhythmic drugs in 509

N Engl J MedN Engl J Med 1997; 337: 1576-83 1997; 337: 1576-83

N Engl J Med 1997; 337: 1576-83

N Engl J Med 1997; 337: 1576-83

AVID subgroups

S J Connolly, Eur Heart J 2000; 21:2071-8

Meta-analysis - ICD v Amiodarone

S J Connolly, Eur Heart J 2000; 21:2071-8

Meta-analysis - ICD v Amiodarone

ICD Trials:ICD Trials:“Primary prevention” “Primary prevention”

Randomised Trials of ICD TherapyRandomised Trials of ICD Therapy

““Primary prevention” - patients who have Primary prevention” - patients who have not yet had VT or VF, but are thought to not yet had VT or VF, but are thought to be at high riskbe at high risk

Multicenter Automatic Defibrillator Multicenter Automatic Defibrillator Implantation Trial (MADIT) -1996Implantation Trial (MADIT) -1996

Multicenter UnSustained Tachycardia Trial Multicenter UnSustained Tachycardia Trial (MUSTT) - 1999(MUSTT) - 1999

MADIT 2 – 2002MADIT 2 – 2002 COMPANION – 2004COMPANION – 2004 SCD-HeFT - 2004SCD-HeFT - 2004

Studies of Non-Sustained VTStudies of Non-Sustained VT in pts with CAD, poor LV, inducible sustained VTin pts with CAD, poor LV, inducible sustained VT

Multicenter Automatic Defibrillator Multicenter Automatic Defibrillator Implantation Trial (MADIT)Implantation Trial (MADIT)• Hypothesis that survival with ICD is better than Hypothesis that survival with ICD is better than

with antiarrhythmic drugs when VT cannot be with antiarrhythmic drugs when VT cannot be suppressed by IV procainamidesuppressed by IV procainamide

Multicenter UnSustained Tachycardia Trial Multicenter UnSustained Tachycardia Trial (MUSTT)(MUSTT)• Hypothesis that survival with EP guided Rx Hypothesis that survival with EP guided Rx

(with ICD for drug failures) is better than (with ICD for drug failures) is better than controlscontrols

Multicenter Automatic Defibrillator Multicenter Automatic Defibrillator Implantation Trial (MADIT)Implantation Trial (MADIT)

Post - MI patients with asymptomatic Post - MI patients with asymptomatic non-sustained VT and LVEF non-sustained VT and LVEF << 35%; age 35%; age 25 - 8025 - 80

Sustained VT reproducibly inducible at Sustained VT reproducibly inducible at EPS and not suppressible with IV EPS and not suppressible with IV procainamideprocainamide

Randomised to antiarrhythmic drugs or Randomised to antiarrhythmic drugs or ICDICD

Moss et alMoss et al N Engl J Med N Engl J Med 1996; 1996; 335335: 2933-40: 2933-40

MADIT - Results

Moss et al N Engl J Med 1996; 335: 2933-40

MUSTT ProtocolMUSTT Protocol

N o A A d ru g s

E P S -ve

F /U on d ru g

D ru g resp on d ers

IC D

N on -resp on d ers

E P G u id ed R x N o A A d ru g s

E P S + ve

B ase lin e E P S + S A E C G

MUSTT ResultsMUSTT Results

2202 pts with NSVT studied, 767 inducible, 2202 pts with NSVT studied, 767 inducible, 704 pts randomised704 pts randomised• 351 EP guided Rx, 353 no antiarrhythmic Rx351 EP guided Rx, 353 no antiarrhythmic Rx• 40% on 40% on -blockers, 75% on ACE inhibitors-blockers, 75% on ACE inhibitors

158 pts (45%) on antiarrhythmic drugs158 pts (45%) on antiarrhythmic drugs• Class I 26%, amio 10%, sotlol 9%Class I 26%, amio 10%, sotlol 9%

161 pts (46%) had ICD161 pts (46%) had ICD

Buxton et al Buxton et al N Engl J MedN Engl J Med 1999; 1999; 341341: 1882-90: 1882-90

MUSTT ResultsMUSTT Results

5 year mortality 24% in pts with ICD, 5 year mortality 24% in pts with ICD, 55% in those without (p<0.001)55% in those without (p<0.001)• antiarrhythmic drugs had no effect on antiarrhythmic drugs had no effect on

mortalitymortality Relative risk of total mortality in ICD Relative risk of total mortality in ICD

treated patients was 0.40 (95% CI treated patients was 0.40 (95% CI 0.27-0.59)0.27-0.59)

Buxton et al Buxton et al N Engl J MedN Engl J Med 1999; 1999; 341341: 1882-90: 1882-90

MUSTT - Results

Buxton et al. N Engl J Med 1999 ;341:1882-90

UK ICD GuidelinesUK ICD Guidelines

‘‘Secondary Prevention’:Secondary Prevention’:• Cardiac arrest due to VT or VFCardiac arrest due to VT or VF• Spontaneous sustained VT with syncope Spontaneous sustained VT with syncope

or significant haemodynamic or significant haemodynamic compromisecompromise

• Sustained VT with poor ejection fraction Sustained VT with poor ejection fraction (<35%), NYHA Class (<35%), NYHA Class >> 3 3

www.nice.org.ukwww.nice.org.uk September 2000 September 2000

UK ICD GuidelinesUK ICD Guidelines

‘‘Primary Prevention’:Primary Prevention’:• Previous MI and all of the following:Previous MI and all of the following:

Non-sustained VT on 24 hour ECG monitoringNon-sustained VT on 24 hour ECG monitoring Inducible VT on electrophysiological testingInducible VT on electrophysiological testing LV ejection fraction < 35%, NYHA Class LV ejection fraction < 35%, NYHA Class >> 3 3

• A familial condition with a high risk of A familial condition with a high risk of sudden death, e.g. Long QT, HOCM, sudden death, e.g. Long QT, HOCM, Brugada syndrome, ARVD, repaired Brugada syndrome, ARVD, repaired tetralogy of Fallottetralogy of Fallot

www.nice.org.ukwww.nice.org.uk September 2000 September 2000

NICE ICD GuidelinesNICE ICD GuidelinesAdditional RecommendationsAdditional Recommendations

Protocols for the implantation of ICDs Protocols for the implantation of ICDs should be developed, to include:should be developed, to include:• early referral of appropriate patientsearly referral of appropriate patients• rapid decision making and implantationrapid decision making and implantation• conscious sedation rather than GAconscious sedation rather than GA• rehabilitative approach to after-care, including rehabilitative approach to after-care, including

psychological preparation for living with ICDpsychological preparation for living with ICD• early dischargeearly discharge• efficient and comprehensive follow-upefficient and comprehensive follow-up

ICD Trials: Why is the benefit greater in ICD Trials: Why is the benefit greater in “Primary Prevention” studies?“Primary Prevention” studies?

In AVID, CASH and CIDS, the main entry In AVID, CASH and CIDS, the main entry criterion was ventricular arrhythmiacriterion was ventricular arrhythmia• Some patients had preserved LV functionSome patients had preserved LV function• Mortality reduction with ICD 28% overallMortality reduction with ICD 28% overall• Mortality reduction 34% in patients with LVEF Mortality reduction 34% in patients with LVEF <<

35% 35% In MADIT and MUSTT, the main entry In MADIT and MUSTT, the main entry

criterion was poor LV functioncriterion was poor LV function• LVEF LVEF <<35% in MADIT, 35% in MADIT, <<40% in MUSTT40% in MUSTT• Mortality reduction with ICD 54 - 60%Mortality reduction with ICD 54 - 60%• Heterogeneity in antiarrhythmic drug useHeterogeneity in antiarrhythmic drug use

Who benefits most from ICDs?Who benefits most from ICDs?

1990’s1990’s Patients at highest Patients at highest

risk of sudden death risk of sudden death are those with are those with ventricular ventricular arrhythmias arrhythmias (spontaneous or (spontaneous or induced)induced)

The ICD is a The ICD is a treatment for treatment for ventricular ventricular arrhythmiasarrhythmias

2000’s2000’s Patients at highest Patients at highest

risk of sudden death risk of sudden death are those with heart are those with heart failure due to poor failure due to poor LV systolic functionLV systolic function

The ICD is a The ICD is a treatment for treatment for heart failureheart failure

MADIT-2MADIT-2 Post MI, LVEF Post MI, LVEF < < 30%30% ICD or controlICD or control Post - randomisation: non-invasive Post - randomisation: non-invasive

markers, EP studymarkers, EP study Primary end-point total mortality; Primary end-point total mortality;

secondary: QOL, costsecondary: QOL, cost Target enrolment 1200 patientsTarget enrolment 1200 patients

Klein et al Klein et al Am J CardiolAm J Cardiol 1999; 1999; 8383: 91D-97D: 91D-97D

MADIT-2MADIT-2 Study terminated November 20, 2001Study terminated November 20, 2001 1232 patients randomised1232 patients randomised

• 742 defibrillator, 490 conventional 742 defibrillator, 490 conventional Mean follow-up 20 months (range 6 days - Mean follow-up 20 months (range 6 days -

53 months53 months 105 deaths in ICD group (14.2%)105 deaths in ICD group (14.2%) 97 deaths in conventional group (19.8%)97 deaths in conventional group (19.8%) 31% reduction in risk of death with ICD31% reduction in risk of death with ICD

Moss et al Moss et al New Engl J MedNew Engl J Med 2002; 2002; 346346: 877-883: 877-883

MADIT-2MADIT-2Concomitant therapiesConcomitant therapies

ACE inhibitors used in 70%ACE inhibitors used in 70% blockers used in 70%blockers used in 70% Statins used in 68%Statins used in 68% 57% had previously had CABG57% had previously had CABG 44% had previously had PTCA44% had previously had PTCA

• MADIT-2 targeted patients who were MADIT-2 targeted patients who were considered suitable for CABG / PTCAconsidered suitable for CABG / PTCA

• Benefit of ICD is over & above benefit Benefit of ICD is over & above benefit from revascularisationfrom revascularisation

MADIT II Results

Moss et al New Engl J Med 2002; 346: 877-883

MADIT-2MADIT-2Subgroup analyses and additional testsSubgroup analyses and additional tests Heart rate variability (several Heart rate variability (several

parameters), signal averaged ECG - parameters), signal averaged ECG - not usefulnot useful

EP study performed in those with ICDEP study performed in those with ICD• If EP +ve, more likely to get VTIf EP +ve, more likely to get VT• If EP -ve, more likely to get VF !If EP -ve, more likely to get VF !• Overall limited usefulnessOverall limited usefulness

QRS width - powerful predictor of QRS width - powerful predictor of benefit from ICDbenefit from ICD

Moss et al New Engl J Med 2002; 346: 877-883

MADIT II - Subgroup analysis

Bristow et al New Engl J Med 2004; 350: 2140

COMPANION Results

COMPANION Results

Bristow et al New Engl J Med 2004; 350: 2140

Bristow et al New Engl J Med 2004; 350: 2140

COMPANION Subgroups

Companion StudyCompanion Study

Biventricular pacing (Biventricular pacing (++ ICD) ICD)• Improves quality of lifeImproves quality of life• Improves 6-minute walk timeImproves 6-minute walk time• Reduces need for hospitalisation for Reduces need for hospitalisation for

heart failureheart failure• Improves NYHA functional classImproves NYHA functional class

MIRACLE ICD StudyMIRACLE ICD Study

Efficacy of antitachycardia pacingEfficacy of antitachycardia pacing

• 88% from RV (336 episodes) 88% from RV (336 episodes) • 95% from LV (658 episodes)95% from LV (658 episodes)

Sudden Cardiac Death in Heart Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)Failure Trial (SCD-HeFT)

2500 patients with symptomatic heart 2500 patients with symptomatic heart failure (NYHA 2-3) and LV ejection fraction failure (NYHA 2-3) and LV ejection fraction < 35%< 35%

50% ischaemic, 50% idiopathic DCM50% ischaemic, 50% idiopathic DCM Randomised to Randomised to

• No antiarrhythmic therapyNo antiarrhythmic therapy• AmiodaroneAmiodarone• ICDICD

5 year follow-up5 year follow-up Results presented March 2004Results presented March 2004

* Double-blind for drug therapy

Hypothesis and Primary Hypothesis and Primary EndpointEndpoint

To determine, by intention-to-treat To determine, by intention-to-treat analysis, if amiodarone or a analysis, if amiodarone or a conservatively programmed shock-conservatively programmed shock-only ICD reduces all-cause mortality only ICD reduces all-cause mortality compared to placebo* in patients with compared to placebo* in patients with either ischemic or non-ischemic NYHA either ischemic or non-ischemic NYHA Class II and III CHF and EF Class II and III CHF and EF << 35%. 35%.

Baseline Enrollment Baseline Enrollment CharacteristicsCharacteristics

AgeAge 60.1 yrs (51.7, 68.5)60.1 yrs (51.7, 68.5)median (25median (25thth, 75, 75thth percentiles) percentiles)

FemaleFemale 23%23% MinoritiesMinorities 23%23% Heart rateHeart rate 73 bpm (63, 84)73 bpm (63, 84) Blood pressureBlood pressure

• SystolicSystolic 118 mmHg (106, 130)118 mmHg (106, 130)

• DiastolicDiastolic 70 mmHg (62, 80) 70 mmHg (62, 80) WeightWeight 190 lbs (164, 219)190 lbs (164, 219)

Baseline Enrollment Baseline Enrollment CharacteristicsCharacteristics

CHF durationCHF duration 24.5 mo (8.1, 59.4)24.5 mo (8.1, 59.4) LV EFLV EF 25.0 (20.0, 30.025.0 (20.0, 30.0 NYHA II, IIINYHA II, III 70%, 30%70%, 30% Ischemic, non-ischemicIschemic, non-ischemic 52%, 48%52%, 48% 6 minute walk6 minute walk 1130 ft (840, 1360)1130 ft (840, 1360) DiabetesDiabetes 30%30% CABG and/or Perc. Revasc.CABG and/or Perc. Revasc. 37%37% H/O HypertensionH/O Hypertension 56%56% H/O HyperlipidemiaH/O Hyperlipidemia 53%53% H/O AFH/O AF 15%15% H/O NSVTH/O NSVT 23%23% ECG QRS duration msECG QRS duration ms 112 ms (96, 140), 41% 112 ms (96, 140), 41% >> 120 120

Background MedicationsBackground Medications

BaselineBaseline Last follow-upLast follow-up

ACE InhibitorACE Inhibitor 85%85% 72%72%

ACE Inhibitor or ARBACE Inhibitor or ARB 96%96% 87%87%

Beta-blockerBeta-blocker 69%69% 78%78%

SpironolactoneSpironolactone 19%19% 31%31%

Loop diureticsLoop diuretics 82%82% 80%80%

AspirinAspirin 56%56% 55%55%

StatinStatin 38%38% 47%47%Median follow-up 45.5 months

Mortality by Intention-to-TreatMortality by Intention-to-Treat

0.4

0.3

0.2

0.1

0

Mo

rtal

ity

0 6 12 18 24 30 36 42 48 54 60

Months of follow-up

Amiodarone

ICD Therapy

Placebo

• Median follow-up: 45.5 mo (34.8, 55.2)• Vital status known on 100% of 2,521 patients

36.1%7.2%/year

Mortality by Intention-to-TreatMortality by Intention-to-Treat

0.4

0.3

0.2

0.1

0

Mo

rtal

ity

0 6 12 18 24 30 36 42 48 54 60

Months of follow-up

Amiodarone

ICD Therapy

Placebo

HR 97.5% Cl P-ValueAmiodarone vs. Placebo 1.06 0.86, 1.30 0.529

Amiodarone vs. PlaceboAmiodarone vs. PlaceboHazard RatiosHazard Ratios

Patient Group N HR 97.5% Cl

All Patients 1692 1.06 0.86, 1.30

NYHA Class Class II 1195 0.85 0.65, 1.11Class III 497 1.44 1.05, 1.97

CHF Etiology Ischemic 879 1.05 0.81, 1.36Non-Ischemic 813 1.07 0.76, 1.51

0.5 1 2 4

Additional Subgroups:Additional Subgroups: Amiodarone vs. Placebo Amiodarone vs. Placebo

Patient Group N HR 97.5% Cl

Gender Female 398 1.17 0.72, 1.90Male 1294 1.04 0.83, 1.30

LVEF <30% 1407 1.04 0.84, 1.29> 30% 285 1.24 0.66, 2.31

Age < 65 1119 1.00 0.76, 1.32> 65 573 1.13 0.83, 1.52

QRS Duration < 120 ms 999 1.06 0.80, 1.41> 120 ms 692 1.05 0.78, 1.41

Race White 1292 1.06 0.84, 1.34Non-White 400 1.08 0.71, 1.62

Enrolling Country U.S. 1534 1.07 0.86, 1.32Non-U.S. 158 0.98 0.52, 1.84

Beta Blocker Yes 1162 1.10 0.85, 1.42No 530 0.98 0.69, 1.38

Diabetes Yes 514 1.20 0.87, 1.65No 1178 1.00 0.77, 1.30

0.5 1 2 4

Mortality by Intention-to-TreatMortality by Intention-to-Treat

0.4

0.3

0.2

0.1

0

Mo

rtal

ity

0 6 12 18 24 30 36 42 48 54 60

Months of follow-up

Amiodarone

ICD Therapy

Placebo

HR 97.5% Cl P-ValueAmiodarone vs. Placebo 1.06 0.86, 1.30 0.529ICD Therapy vs. Placebo 0.77 0.62, 0.96 0.007

ICD vs. PlaceboICD vs. PlaceboHazard RatiosHazard Ratios

Patient Group N HR 97.5% Cl

All Patients 1676 0.77 0.62, 0.96

NYHA Class Class II 1160 0.54 0.40, 0.74Class III 516 1.16 0.84, 1.61

CHF Etiology Ischemic 884 0.79 0.60, 1.04Non-Ischemic 792 0.73 0.50, 1.04

0.25 0.5 1 2

Additional Subgroups:Additional Subgroups: ICD vs. Placebo ICD vs. Placebo

Patient Group N HR 97.5% Cl

Gender Female 382 0.96 0.58, 1.61Male 1294 0.73 0.57, 0.93

LVEF <30% 1390 0.73 0.57, 0.92> 30% 285 1.08 0.57, 2.07

Age < 65 1098 0.68 0.50, 0.93> 65 578 0.86 0.62, 1.18

QRS Duration < 120 ms 977 0.84 0.62, 1.14> 120 ms 699 0.67 0.49, 0.93

Race White 1283 0.78 0.61, 1.00Non-White 393 0.75 0.48, 1.17

Enrolling Country U.S. 1512 0.82 0.65, 1.04Non-U.S. 164 0.37 0.17, 0.82

Beta Blocker Yes 1157 0.68 0.51, 0.91No 519 0.92 0.65, 1.30

Diabetes Yes 524 0.95 0.68, 1.33No 1152 0.67 0.50, 0.90

0.125 1 2 40.25 0.5

SCD-HeFT: ConclusionsSCD-HeFT: Conclusions

In class II or III CHF patients with EF In class II or III CHF patients with EF << 35% 35% on good background drug therapy, the on good background drug therapy, the mortality rate for placebo-controlled mortality rate for placebo-controlled patients is 7.2% per year over 5 yearspatients is 7.2% per year over 5 years

Simple, shock-only ICDs decrease mortality Simple, shock-only ICDs decrease mortality by 23%by 23%

Amiodarone, when used as a primary Amiodarone, when used as a primary preventive agent, does not improve preventive agent, does not improve survivalsurvival

SCD-HeFT – Cost-benefit analysisSCD-HeFT – Cost-benefit analysis

Cost per life-year saved (US$)Cost per life-year saved (US$) LVEF < 30%LVEF < 30% $33,509$33,509 LVEF > 30%LVEF > 30% $29,275$29,275 Age > 65Age > 65 $39,469$39,469 Age < 65Age < 65 $29,164$29,164 QRS > 120 msQRS > 120 ms $31,244$31,244 QRS < 120 msQRS < 120 ms $34,821$34,821 IschaemicIschaemic $33,603$33,603 Non-ischaemicNon-ischaemic $32,170$32,170

DB Mark, AHA November 2004DB Mark, AHA November 2004

CARE-HF: BackgroundCARE-HF: Background Cardiac dyssynchrony is common in patients Cardiac dyssynchrony is common in patients

with HF due to LVSDwith HF due to LVSD

CRT has been shown to be haemodynamically CRT has been shown to be haemodynamically effective in such patients and to improveeffective in such patients and to improve• SymptomsSymptoms• Quality of lifeQuality of life• Exercise capacityExercise capacity

Effects of CRT on hospitalisation and Effects of CRT on hospitalisation and mortality remain uncertainmortality remain uncertain

AimsAims

To assess the effect on morbidity and To assess the effect on morbidity and mortality of adding CRT to optimised mortality of adding CRT to optimised pharmacological therapy in patients with pharmacological therapy in patients with moderate and severe HF due to LVSD moderate and severe HF due to LVSD complicated by cardiac dyssynchronycomplicated by cardiac dyssynchrony

To investigate the mechanisms To investigate the mechanisms underlying the observed effect to identify underlying the observed effect to identify markers predicting success or failure of markers predicting success or failure of CRTCRT

Main Inclusion & Exclusion CriteriaMain Inclusion & Exclusion Criteria Heart failure for at least 6 weeks requiring loop Heart failure for at least 6 weeks requiring loop

diureticsdiuretics Currently in NYHA class III/IVCurrently in NYHA class III/IV A high standard of pharmacological therapyA high standard of pharmacological therapy

LV systolic dysfunction and dilationLV systolic dysfunction and dilation• EF EF 35%; EDD 35%; EDD 30mm/height in metres30mm/height in metres

QRS QRS 120 ms120 ms• Dyssynchrony confirmed by echo if QRS 120-149 Dyssynchrony confirmed by echo if QRS 120-149

msms Aortic pre-ejection delay >140msAortic pre-ejection delay >140ms Interventricular mechanical delay >40 msInterventricular mechanical delay >40 ms Delayed activation of postero-lateral LV wallDelayed activation of postero-lateral LV wall

Patients with AF or requiring pacing excludedPatients with AF or requiring pacing excluded

CARE-HF: All-Cause MortalityCARE-HF: All-Cause Mortality

557171192192321321365365404404Medical TherapyMedical Therapy

888989213213351351376376409409CRTCRT

Number at riskNumber at risk 0 500 1000 15000.00

0.25

0.50

0.75

1.00

Eve

nt-

free

Su

rviv

al

Days

Medical Therapy

HR 0.64 (95% CI 0.48 to 0.85)

P = .0019CRT

Symptoms & Quality of Life at Symptoms & Quality of Life at 90 days90 days

Outcome Outcome

Medical Medical Therapy Therapy

Mean Mean (SD)(SD)

CRT CRT Group Group Mean Mean (SD)(SD)

Difference in Difference in means (95% means (95% CI; P value)CI; P value)

NYHA classNYHA class 2.7 (0.9)2.7 (0.9) 2.1 (1.0)2.1 (1.0)0.6 0.6

(0.4 to 0.7; (0.4 to 0.7; P < 0.0001)P < 0.0001)

MLWHF MLWHF scorescore 40 (22)40 (22) 31 (22)31 (22)

-10 -10 (-8 to -12; (-8 to -12;

P < 0.0001)P < 0.0001)

Mechanistic OutcomesMechanistic Outcomes

At 18 months, compared to the control group, patients randomized to CRT had

• Shorter Interventricular Mechanical delay P < 0.0001

• Higher LVEF (by about 7%) P < 0.0001

• Less mitral regurgitation P = 0.003

• Lower ventricular volumes P < 0.0001

• Higher systolic blood pressure P < 0.0001

• Lower NT-pro-BNP P < 0.0016

ConclusionsConclusions CRT CRT should be considered as part of should be considered as part of routineroutine

therapy for patients with moderate to severe HF therapy for patients with moderate to severe HF due to LVSD with evidence (ECG supported by due to LVSD with evidence (ECG supported by Echo) of cardiac dyssynchrony to*:Echo) of cardiac dyssynchrony to*:

• Improve cardiac function and efficiencyImprove cardiac function and efficiency

• Improve symptoms and QoLImprove symptoms and QoL

• Reduce morbidityReduce morbidity

• Prolong survivalProlong survival

These benefits are in addition to those of These benefits are in addition to those of pharmacological therapypharmacological therapy

*http://content.nejm.org/

How do we improve quality of life in How do we improve quality of life in patients with ICDs?patients with ICDs?

Patient preparation for life with ICDPatient preparation for life with ICD Meticulous implant techniqueMeticulous implant technique Judicious programming Judicious programming

• Tachycardia detection- discrimination between VT and Tachycardia detection- discrimination between VT and SVT / AFSVT / AF

• Antitachycardia pacingAntitachycardia pacing Optimal pharmacological therapyOptimal pharmacological therapy Biventricular pacing if neededBiventricular pacing if needed

• For resynchronisation and ATPFor resynchronisation and ATP• Which patients need CRT with defibrillator, which Which patients need CRT with defibrillator, which

need CRT alone?need CRT alone? RehabilitationRehabilitation

• Physical and psychologicalPhysical and psychological