electrophysiology 2011 taresh taneja, md, facc assistant professor of medicine texas a & m hsc...

Electrophysiology 2011

Taresh Taneja, MD, FACC

Assistant Professor of Medicine

Texas A & M HSC COM

Scott & White Hospital

“The more things change, the more they stay the same.”

Jean-Baptiste Alphonse Karr

EP 2011

Sudden Cardiac Death Cardiac Resynchronization Therapy Syncope Atrial Fibrillation

Case Vignette

• A 74-year-old man with a history of hypertension and myocardial infarction that occurred 5 years previously presents with breathlessness on exertion.

• His current medications include a statin and aspirin.• On examination, his pulse is 76 beats per minute and

regular, and his blood pressure is 121/74 mm Hg.• There is jugular venous distention, lateral displacement of

the apex beat, and edema in his lower limbs.• The lung examination is normal.• An echocardiogram shows left ventricular dilatation, globally

reduced contractility, and an ejection fraction of 33%.• How should his case be managed?

Pathophysiology of Systolic Heart Failure

McMurray J. N Engl J Med 2010;362:228-238

Clinical Classifications of Heart Failure Severity


Treatment Algorithm for Systolic Heart Failure


Telemetry Strip Showing Pause-Independent Polymorphic Ventricular Tachycardia.

Britton KA et al. N Engl J Med 2010;362:1721-1726.

Sudden Cardiac Death (SCD)

Death from unexpected circulatory arrest, usually due to cardiac arrhythmia

occurring within an hour of the onset of symptoms.

Sudden Cardiac Arrest (SCA)- Episode of resuscitated SCD

Sudden Cardiac Death

Estimates range 200,000 - 450, 000 SCD’s annually depending on the definition used.

13% of all natural deaths are SCD using the 1 hour definition.

50% of all CHD deaths are sudden. Overall incidence of SCD 1 to 2/1000

population.

Implantable Cardioverter Defibrillator (ICD)

Secondary Prevention- Multiple studies have shown a 50% relative-risk reduction in arrhythmic death and a 25% relative-

risk reduction in all-cause mortality.

Patients who die once are more likely to die again.

Primary Prevention of SCD

• Patients with a history of myocardial infarction and a reduced ejection fraction are at increased risk for life-threatening ventricular arrhythmias.

• Which of these patients are the most appropriate candidates for implantable cardioverter–defibrillator (ICD) therapy is unclear.

Summary of Major Randomized Trials of ICD Therapy for Primary Prevention of Sudden Death after

Myocardial Infarction

Myerburg R. N Engl J Med 2008;359:2245-2253

Amiodarone or an Implantable Cardioverter-Defibrillator for Congestive Heart Failure

Gust H. Bardy, M.D., Kerry L. Lee, Ph.D., Daniel B. Mark, M.D., Jeanne E. Poole, M.D., Douglas L. Packer, M.D., Robin Boineau, M.D., Michael Domanski, M.D.,

Charles Troutman, R.N., Jill Anderson, R.N., George Johnson, B.S.E.E., Steven E. McNulty, M.S., Nancy Clapp-Channing, R.N., M.P.H., Linda D. Davidson-Ray, M.A., Elizabeth S. Fraulo, R.N., Daniel P. Fishbein, M.D., Richard M. Luceri, M.D., John H.

Ip, M.D. and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators

N Engl J MedVolume 352;3:225-237

January 20, 2005

Study Overview This placebo-controlled study compared the effect

of amiodarone and an implantable cardioverter-defibrillator (ICD) on mortality in patients with New York Heart Association class II or III congestive heart failure (CHF)

Amiodarone had no benefit overall and slightly increased mortality among patients with class III CHF

ICD therapy reduced mortality overall, but the benefit appeared to be restricted to patients with class II CHF

These important results will broaden the use of ICD therapy

SCD-HeFT Protocol

DCM + CAD and CHF

Placebo N = 847 ICD Implant N = 829

Minimum of 2.5 years follow-up required

45 months average follow-up Optimized B, ACE-I, Diuretics

Amiodarone N = 845

EF < 35%

NYHA Class II or III

6-Minute Walk, Holter

R 2521 Patients

Bardy GH. N Engl J Med. 2005;352:225-237.

Kaplan-Meier Estimates of Death from Any Cause

Bardy, G. et al. N Engl J Med 2005;352:225-237

Kaplan-Meier Estimates of Death from Any Cause for the Prespecified Subgroups of Ischemic CHF (Panel A)

and Nonischemic CHF (Panel B)


Kaplan-Meier Estimates of Death from Any Cause for the Prespecified Subgroups of NYHA Class II (Panel A)

and Class III (Panel B)


Hazard Ratios for the Comparison of Amiodarone and ICD Therapy with Placebo in Various Subgroups of Interest


Conclusions In patients with NYHA class II or III CHF

and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent

Incremental Cost-EffectivenessCardiovascular Interventions

HypertensionTherapy(diastolic95 - 104mmHg)

Expensive

BorderlineCost-Effective

Cost-Effective

HighlyCost-Effective

Incr

emen

tal

Co

st p

er L

ife-

Yea

r S

aved

EconomicallyUnattractive

Lovastatin(chol. =

290 mg/dL,50 yrs old,

male, no riskfactors)

PTCA(chronic CAD,severe angina

1 VD)

CABG(chronic

CADmild angina,

3 VD)

End Stage Renal

Disease Treatment

Exercise SPECT (atypical

angina who can walk

on treadmill)

RoutineCoronary

Angiography(35 - 84 yrs

old, low risk MI,has CHF)

$8,461$17,701

$40,750

$67,000

$135,000

$150,000

Carotid Disease

Screening(65 yrs old,

male, no

symptoms)

$200,000

$120,000

Incremental Cost-Effectiveness ICD, CRT, and CRT-D Therapies

COMPANIONCRT-D1

Incr

emen

tal

Co

st p

er L

ife-

Yea

r S

aved

COMPANIONCRT1

MADIT-IIICD3

AVIDICD4

$28,000 $38,200

$50,000$67,000

Expensive

BorderlineCost-Effective

Cost-Effective

HighlyCost-Effective

EconomicallyUnattractive

SCD-HeFTICD2

$33,000

1 Feldman AM. www.theheart.org. ACC News. March 16, 2005.2 Mark DB. www.theheart.org. AHA News. November 11, 2004.3 Ak-Khatib S. Ann Intern Med. 2005;142:593-600.4 Larsen G. Circulation. 2002;105:2049-2057.

Original Article Defibrillator Implantation Early after Myocardial

Infarction

Gerhard Steinbeck, M.D., Dietrich Andresen, M.D., Karlheinz Seidl, M.D., Johannes Brachmann, M.D., Ellen Hoffmann, M.D., Dariusz Wojciechowski, M.D., Zdzisława

Kornacewicz-Jach, M.D., Beata Sredniawa, M.D., Géza Lupkovics, M.D., Franz Hofgärtner, M.D., Andrzej Lubinski, M.D., Mårten Rosenqvist, M.D., Alphonsus

Habets, Ph.D., Karl Wegscheider, Ph.D., Jochen Senges, M.D., for the IRIS Investigators

N Engl J MedVolume 361(15):1427-1436

October 8, 2009

Study Overview

• Implantation of a defibrillator early after myocardial infarction (MI) in high-risk patients reduced the risk of sudden cardiac death, but there was a reciprocal increase in the risk of nonsudden cardiac death

• Overall mortality was not affected by early defibrillator implantation, and therefore this intervention cannot be recommended after MI in high-risk patients

Baseline Demographic and Clinical Characteristics of the Patients, According to Study Group

Steinbeck G et al. N Engl J Med 2009;361:1427-1436

Cumulative Risk of Death from Any Cause According to Study Group


Cumulative Risk of Cardiac Death, According to Study Group


Conclusion

Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features

that placed them at increased risk

ICD implantation Post Acute MI

Acute MI-Sudden Cardiac Death paradox firmly established

SCD post-MI may not be due to arrhythmia alone

Potential deleterious effect of ICD implantation and testing

?

Sudden cardiac death after myocardial infarction in patients with type 2 diabetes

M. Juhani Junttila, MD, Petra Barthel, MD, Robert J. Myerburg, MD, Timo H. Mäkikallio, MD, Axel Bauer, MD, Kurt Ulm, PhD, Antti Kiviniemi, PhD, Mikko Tulppo, PhD, Juha S.

Perkiömäki, MD, Georg Schmidt, MD and Heikki V. Huikuri, MD

Heart RhythmVolume 7, Issue 10, Pages 1396-1403 (October 2010)

DOI: 10.1016/j.hrthm.2010.07.031

Sudden cardiac death after myocardial infarction in patients with type 2 diabetes

Study population included enrollees in two prospective post-MI studies: Multiple Risk Factor Analysis Trial and Improved Stratification of Autonomic Regulation for Risk Prediction postinfarction survey program.

3276 acute MI patients Diabetic vs Non Diabetic patients: Mean Age

64 vs 59 years, 32 vs 22% females, LVEF 49% vs 52, 3 vs CAD 42 vs 30%

Figure 1

Figure 2

Aggregate National Experience With the Wearable Cardioverter-Defibrillator: Event Rates, Compliance,

and SurvivalChung et al. JACC. 2010;56;194

3,569 patients

Indications: ICD explants (23.4%), VT/VF (16.1%), LVEF ≤ 35% with Recent MI (12.5%), Post-CABG (8.9%),

Nonischemic CM (20.0%), and LVEF> 35% with recent MI (3.8%)

Copyright ©2010 American College of Cardiology Foundation. Restrictions may apply.

Chung, M. K. et al. J Am Coll Cardiol 2010;56:194-203

Actual WCD Use

Copyright ©2010 American College of Cardiology Foundation. Restrictions may apply.

Chung, M. K. et al. J Am Coll Cardiol 2010;56:194-203

Events While Wearing the WCDAggregate National Experience With the Wearable

Cardioverter-Defibrillator

Original Article An Entirely Subcutaneous Implantable

Cardioverter-Defibrillator

Gust H. Bardy, M.D., Warren M. Smith, M.B., Margaret A. Hood, M.B., Ian G. Crozier, M.B., Iain C. Melton, M.B., Luc Jordaens, M.D., Ph.D., Dominic Theuns,

Ph.D., Robert E. Park, M.B., David J. Wright, M.D., Derek T. Connelly, M.D., Simon P. Fynn, M.D., Francis D. Murgatroyd, M.D., Johannes Sperzel, M.D., Jörg Neuzner, M.D., Stefan G. Spitzer, M.D., Andrey V. Ardashev, M.D., Ph.D., Amo Oduro, M.B.,

B.S., Lucas Boersma, M.D., Ph.D., Alexander H. Maass, M.D., Isabelle C. Van Gelder, M.D., Ph.D., Arthur A. Wilde, M.D., Ph.D., Pascal F. van Dessel, M.D., Reinoud E. Knops, M.D., Craig S. Barr, M.B., Pierpaolo Lupo, M.D., Riccardo

Cappato, M.D., and Andrew A. Grace, M.B., Ph.D.


July 1, 2010

Locations of the Components of a Subcutaneous Implantable Cardioverter-Defibrillator In Situ

Bardy GH et al. N Engl J Med 2010;363:36-44

Chest Radiographs and an Electrocardiogram in a Patient Who Underwent Placement and Testing of a Subcutaneous

Implantable Cardioverter-Defibrillator (ICD)

Bardy GH et al. N Engl J Med 2010;363:36-44

Cardiac Resynchronization Therapy

Case Vignette A 55-year-old man who had had an anterior-wall

myocardial infarction six months previously is admitted with an exacerbation of congestive heart failure.

An electrocardiogram shows sinus rhythm with a left bundle-branch block; an echocardiogram demonstrates a left ventricular ejection fraction of 25 percent.

He is treated with furosemide, lisinopril, and carvedilol. However, during an office visit three months later, he

reports persistent shortness of breath with mild exertion. He is referred to a cardiologist, who recommends

implantation of a biventricular pacemaker.

The Cardiac Conduction System and Biventricular Pacing

Jarcho J. N Engl J Med 2006;355:288-294

The Cardiac Conduction System and Biventricular Pacing

In patients with a LBBB, conduction of the wave of depolarization in the left ventricle is

markedly altered, proceeding from the anterior septum through the left ventricular

myocardium to the inferior and lateral left ventricular walls- left ventricular contraction is dyssynchronous, mechanically inefficient with decreases in left ventricular ejection farction

and cardiac output.

CRT- The Evidence

Trial Patie-nts

Age (yrs)

LVEF CAD QRS (ms)

LBB MR▼

Meta-Analysis

1,634 63-66 21-23% 37-69% 158-176 54-87% 23%

COMPANION 1,520 65 22% 56% 158 71% 24%

1520 patients, NYHA III/ IV, QRS 120 ms, EF 35% RANDOMIZED

Optimal medical therapy vs. OMT + cardiac resynchronization pacemaker vs. OMT + cardiac resynchronization defibrillator

CRT Indications

Class I- EF ≤ 35%, QRS ≥ 0.12 sec, SR, NYHA III/ Ambulatory Class IV + OMT- CRT±ICD

Class IIA- EF ≤ 35%, QRS ≥ 0.12 sec, AF, NYHA III/ Ambulatory Class IV + OMT- CRT±ICD

Original Article Cardiac-Resynchronization Therapy for the

Prevention of Heart-Failure Events

Arthur J. Moss, M.D., W. Jackson Hall, Ph.D., David S. Cannom, M.D., Helmut Klein, M.D., Mary W. Brown, M.S., James P. Daubert, M.D., N.A. Mark Estes, III, M.D.,

Elyse Foster, M.D., Henry Greenberg, M.D., Steven L. Higgins, M.D., Marc A. Pfeffer, M.D., Ph.D., Scott D. Solomon, M.D., David Wilber, M.D., Wojciech Zareba,

M.D., Ph.D., for the MADIT-CRT Trial Investigators


October 1, 2009

Kaplan-Meier Estimates of the Probability of Survival Free of Heart Failure

Moss AJ et al. N Engl J Med 2009;361:1329-1338

Conclusion

CRT combined with ICD decreased the risk of heart-failure events in relatively

asymptomatic patients with a low ejection fraction and wide

QRS complex

MADIT-CRTEditorial- Mariell Jessup, MD

CRT benefit solely driven by a 41% reduction in risk of first heart failure event, since mortality not influenced.

In CRT trials with symptomatic patients, 29 patients need to be treated for 6 months, 13 patients for 2 years and 9 patients for 3 years to prevent 1 death.

MADIT CRT enrolled patients with stage C and NOT stage B (truly asymptomatic).

MADIT CRT- treat 12 patients to prevent 1 heart failure hospitalization

Cardiac Resynchronization- Effect of Bundle Branch Block

Analyzed the results of MADIT-CRT 1820 patients, NYHA I/II, LVEF≤ 30%, QRS

≥130 ms, on optimal medical therapy 1281 LBBB, 228 RBBB, 308 IVCD Hazard ratios for the primary end-point of

death or heart failure event were significantly lower in the LBBB patients than in the non-LBBB patient.

Zareba et al. JACC 2011

Cardiac Resynchronization In Hypertrophic Obstructive Cardiomyopathy

Biventricular pacing was attempted in 12 severely symptomatic HOCM patients and was successful in 9 patients.

Functional capacity and QOL improved NYHA class decreased from 3.2±0.4 at

baseline to 1.4±0.5 at 1 year with a reduction in the LV gradient from 74±23 mmHg at baseline to 28±17 mmHg at 1 year.

Berruezo et al. Heart Rhythm 2011

US Registry of Sudden Death in Athletes

Healthy young competitive athletes assembled over 27 years, 1,866 died suddenly (or survived cardiac arrest).

Sudden death were due to cardiovascular disease in 56% and 82% occurred with physical exertion.

HCM – 36% and congenital coronary anomalies- 17%

Pre-participation screening with history, PE and EKG did not impact the rate of sudden death.

Maron et al. Circ. 2009;119:1085

US Registry of Sudden Death in Athletes

Pathophysiology of Commotio Cordis

Maron B, Estes N. N Engl J Med 2010;362:917-927

Syncope

Transient loss of consciousness due to transient global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous

complete recovery.

www.escardio.org/guidelines

Original Article Lenient versus Strict Rate Control in Patients with

Atrial Fibrillation

Isabelle C. Van Gelder, M.D., Hessel F. Groenveld, M.D., Harry J.G.M. Crijns, M.D., Ype S. Tuininga, M.D., Jan G.P. Tijssen, Ph.D., A. Marco Alings, M.D., Hans L.

Hillege, M.D., Johanna A. Bergsma-Kadijk, M.Sc., Jan H. Cornel, M.D., Otto Kamp, M.D., Raymond Tukkie, M.D., Hans A. Bosker, M.D., Dirk J. Van Veldhuisen, M.D.,

Maarten P. Van den Berg, M.D., for the RACE II Investigators


April 15, 2010

Study Overview

• This clinical trial of outcomes in patients with atrial fibrillation showed that lenient rate control (resting heart rate, <110 beats per minute) was not inferior to strict rate control (resting heart rate, <80 beats per minute)

• On the basis of the results, strict rate control may be abandoned as a therapeutic strategy in many patients with permanent atrial fibrillation

Cumulative Incidence of the Composite Primary Outcome and Its Components during the 3-Year Follow-up Period, According to Treatment Group

Van Gelder IC et al. N Engl J Med 2010;362:1363-1373

Kaplan-Meier Estimates of the Cumulative Incidence of the Primary Outcome, According to Treatment Group

Van Gelder IC et al. N Engl J Med 2010;362:1363-1373

Conclusion

• In patients with permanent atrial fibrillation, lenient rate control is as effective as strict rate control and is easier to achieve

Thromboemblic Risk in Atrial Fibrillation

AF guidelines update 2011-Dabigatran

Class I Dabigatran is useful as an alternative to warfarin

for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to persistent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance < 15 ml/min) or advanced liver disease (impaired baseline clotting function). Level of evidence B

Catheter ABlation versus ANtiarrhythmic Drug Therapy in Atrial Fibrillation (CABANA) Trial

Mayo Clinic Rochester Duke Clinical Research Institute

National Heart Lung and Blood Institute

Future of AF--ATRIA StudyProjected Number of Adults with AF in the U.S.

Go et al: JAMA 285:2370, 2001Go et al: JAMA 285:2370, 2001

MillionsMillions

YearYear

Upper scenarios based onsensitivity analysesLower scenarios based onsensitivity analyses

Upper scenarios based onsensitivity analysesLower scenarios based onsensitivity analyses

Impact of Atrial Fibrillation on Mortality in Framingham Study

Benjamin et al: Circ 98:946, 1998Benjamin et al: Circ 98:946, 1998

75-94 Years Old75-94 Years Old

Follow-up (yr)Follow-up (yr)

0

20

40

60

80

0 1 2 3 4 5 6 7 8 9 10

Follow-up (yr)Follow-up (yr)

Dea

d (%

)D

ead

(%)

55-74 Years Old55-74 Years Old

Men AFMen AF

Women AFWomen AF

Men no AFMen no AF

Women no AFWomen no AF

CABANA Trial Inclusion CriteriaCABANA Trial Inclusion CriteriaSubjects must meet all of the following criteria

• Have documented AF episodes 1 hour in duration; with 2 episodes over 4 months with ECG documentation of 1 episode or at least 1 episode of AF lasting >1 week

• Warrant active therapy beyond simple ongoing observation

• Be eligible for catheter ablation and 2 sequential rhythm control and/or 3 rate control drugs

• Be 65 yr of age, or <65 yr with 1 of the following risk factors for strokeHypertensionDiabetesCongestive heart failure (including systolic or diastolic heart failure)Prior stroke or TIALA size >5.0 cm (or volume index 40 cc/m2)EF 35

CABANA Trial CABANA Trial Primary Objective and HypothesisPrimary Objective and Hypothesis

The treatment strategy of The treatment strategy of percutaneous left atrial catheter percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art medical (AF) is superior to current state-of-the-art medical therapy with either rate control or rhythm control drugs therapy with either rate control or rhythm control drugs for reducing total mortality (primary endpoint)for reducing total mortality (primary endpoint) and and decreasing the composite endpoint of total mortality, decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest (key disabling stroke, serious bleeding, or cardiac arrest (key secondary endpoint) in patients with untreated or secondary endpoint) in patients with untreated or incompletely treated AF warranting therapyincompletely treated AF warranting therapy

Design of the CABANA StudyDesign of the CABANA StudyAtrial fibrillation

Eligible for ablation and/or drug therapy

65 yr of age

<65 yr w/ 1 CVA risk factor

R

Drug Rx & AC

• Rate control

• Rhythm Rx

1° ablation & AC

• PV isolation

• Adjunctive

Descriptive analysis

• NSR vs AF impact

• w/ w/o heart disease

• AF type – (paroxysmal; persistent; long-standing persistent)

• CT/MR image analysis

• ECG/EGM analysisFollow-up

60 months

CABANA Sites International ApproachCABANA Sites International Approach

CanadaCanada1010

U.SU.S..9090

SouthSouthAmAm55

AsiaAsia55

AustraliaAustraliaNZNZ55

EuropeEurope3030

UKUK1010

electrophysiology 2011 taresh taneja, md, facc assistant professor of medicine texas a & m hsc...

Documents

percent slide

cc slide

resuscitated scd slide

sudden cardiac death

icd implant n

chf placebo n

sudden cardiac death

diuretics amiodarone