Download ACC/AHA/ESC 2006 Guidelines for Management of

Understanding the Guidelines
A series of three case studies evaluating the use of ICD Therapy
Provided courtesy of Dr Andrea Russo
Case 1 – A.G. – Primary Prevention
60 year old female, coronary disease, anterior wall MI 10 years ago
MUGA LVEF 32% (1 year ago)
Now dyspnea after 1/2 block, progressive worsening of symptoms over
past 2 months
Medications: enalapril 20 BID, carvedilol 25 BID, digoxin 0.25 qd,
spironolactone 25 mg qd, ASA 81 qd, furosemide 80 mg BID
Exam: JVP 9 cm, Lungs clear, Heart with laterally displaced PMI, +S3,
III/VI holosystolic murmur radiating apex to axilla, no edema
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12-lead ECG reveals the following:
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Prior testing:
ECHO 2 months ago: anterior akinesis with apical dyskinesis, overall EF
~ 30%, moderate mitral regurgitation
Cardiac catheterization 8 months ago (for angina): Totally occluded LAD
with collaterals, no other significant CAD
No further angina on increased beta blocker
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Now admitted with CHF.
Inpatient telemetry reveals the following:
7 beats NSVT
The patient denies symptoms of palpitations,
chest pain, syncope or presyncope.
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Question 1
Appropriate therapy for this patient includes:
A. ACE inhibitor
B. Beta blocker
C. Device implantation
D. A and C
E. All of the above
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Question 1 Answer
Appropriate therapy for this patient includes:
A. ACE inhibitor
B. Beta blocker
C. Device implantation
D. A and C
E. All of the above
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Question 2
You would specifically recommend:
A. Implantation of a single chamber ICD
B. Implantation of dual chamber ICD
C. Implantation of CRT pacemaker
D. Implantation of CRT-ICD
E. Implantation of an insertable loop monitor
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Question 2 Answer
You would specifically recommend:
A. Implantation of a single chamber ICD
B. Implantation of dual chamber ICD
C. Implantation of CRT pacemaker
D. Implantation of CRT-ICD
E. Implantation of an insertable loop monitor
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Supporting Data
Primary Prevention ICD Trials:
• MADIT I
Ischemic CM (CAD)
• MUSTT
• MADIT II
Non-ischemic CM
• DEFINITE
Ischemic & Non-ischemic CM
• SCD-HeFT
CRT (Ischemic & Non-ischemic)
• COMPANION
References
MADIT I: Moss NEJM 1996;335:1933
MUSTT: Buxton NEJM 1999;341:1882-90
MADIT II: Moss NEJM 2002;346:877
DEFINITE: Kadish NEJM 2004;350:2151-8
SCD-HeFT: Bardy NEJM 2005;352:225-37
COMPANION: Bristow MR NEJM 2004;350:2140
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What are the Guidelines?
ACC/AHA/ESC 2006 Guidelines for Management of Patients with
Ventricular Arrhythmias & SCD - ICD Indications: Primary
Prevention, CAD & LV dysfunction
Class I: ICD recommended to reduce mortality by reduction in SCD in
pts with LV dysfunction due to prior MI who are at least 40 days post-MI,
LVEF ≤ 30-40%, NYHA class II or III, & receiving chronic optimal medical
therapy, and have reasonable expectation of survival with good
functional status for > 1 yr (level evidence A)
Class IIa: ICD reasonable in pts with LV dysfunction due to prior MI who
are at least 40 days post-MI, LVEF ≤ 30-35%, NYHA class I on chronic
optimal medical therapy, and have reasonable expectation of survival
with good functional status for > 1 yr (level evidence B)
Zipes et al., ACC/AHA/ESC 2006 Guidelines for Management of Patients with Ventricular Arrhythmias & SCD,
Circulation 2006;114:e385-484
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What are the Guidelines?
ACC/AHA/ESC 2006 Guidelines for Management of Patients with
Ventricular Arrhythmias & SCD - ICD Indications: Primary
Prevention, Dilated CM (non-ischemic)
Class I: ICD recommended to reduce mortality by reduction in SCD in
pts with non-ischemic DCM, LVEF ≤ 30-35%, NYHA class II or III, who
are receiving chronic optimal medical therapy, and who have reasonable
expectation of survival with good functional status for > 1 yr (level
evidence B)
Class IIa: ICD can be beneficial for pts with unexplained syncope,
significant LV dysfunction, and non-ischemic DCM who are receiving
chronic optimal medical therapy, and who have reasonable expectation
of survival with good functional status for > 1 yr (level evidence C)
Class IIb: ICD might be considered in pts who have non-ischemic DCM,
LVEF ≤ 30-35%, NYHA class I receiving chronic optimal medical therapy,
and who have reasonable expectation of survival with good functional
status for > 1 yr (level evidence C)
Zipes et al., ACC/AHA/ESC 2006 Guidelines for Management of Patients with Ventricular Arrhythmias & SCD,
Circulation 2006;114:e385-484
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What are the Guidelines?
ACC/AHA/ESC 2006 Guidelines for Management of Patients with
Ventricular Arrhythmias & SCD - ICD Indications: Heart Failure –
CRT recommendations
Class IIa: ICD combined with BiV pacing can be effective for primary
prevention to reduce mortality by reduction in SCD in pts with NYHA
class III or IV receiving optimal medical therapy, in SR with QRS complex
≥ 120 ms who have reasonable expectation of survival with good
functional status for > 1 yr (level evidence B)
Zipes et al., ACC/AHA/ESC 2006 Guidelines for Management of Patients with Ventricular Arrhythmias & SCD,
Circulation 2006;114:e385-484
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Outcome:
The patient underwent implantation of a CRT-ICD
Heart failure symptoms improved, and she was able to walk 1 mile on flat
ground without problems
1 year later, she experienced a defibrillator shock, associated with presyncope
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ICD interrogation revealed a total of 6 events. An example of the
intracardiac electrograms revealed the following:
A
V
(rate)
V
(shock)
Amiodarone initiated, without further ICD shocks for 6 months
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Topics for discussion:
When do you consider adding anti-arrhythmic drug therapy with device
therapy?
This may be added to reduce frequent ICD therapy for recurrent episodes of
VT or atrial arrhythmias.
Any potential problems with amiodarone (“hybrid”) therapy?
Amiodarone may result in an increase in the defibrillation threshold or an
increase in VT cycle length, which may impact on VT detection and effective
therapy. Therefore, the ICD should be tested in the EP lab on this
antiarrhythmic agent.
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Topics for discussion
What would you have done differently if the patient had a non-ischemic
dilated cardiomyopathy without CAD? Was an ICD still indicated?
Based on current guidelines, an ICD is indicated for patients with
ischemic or nonischemic heart disease and an LVEF ≤ 35%.
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Case 2 – W.S. – Secondary Prevention
59 year old female
Syncope while shopping in mall
EMT arrival: BP 60, HR 205 bpm, semi-conscious, wide complex
tachycardia
Successful cardioversion to sinus rhythm
In ER, ECG reveals sinus rhythm with left bunch branch block
Recent history: dyspnea on exertion, progressive over past 3 months
PMH: No other known medical problems
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Additional history and testing:
Medications: None
Exam: JVP 12 cm, Lungs bibasilar rales, Heart S4 & S3 gallops, II/VI
holosystolic murmur apex, Extremities trace pedal edema
ECHO: 4 chamber dilatation, severe LV dysfunction, mild RV dysfunction
Cardiac catheterization: normal coronary arteries, LVEF 20%, nonischemic dilated cardiomyopathy, PCWP 25, CI 2.3
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Question 1
What would you recommend next?
A. Initiation of ACE inhibitor, diuretic, and digoxin
B. Beta blocker therapy after volume status improves
C. ICD implantation for syncopal VT
D. All of the above
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Question 1 Answer
What would you recommend next?
A. Initiation of ACE inhibitor, diuretic, and digoxin
B. Beta blocker therapy after volume status improves
C. ICD implantation for syncopal VT
D. All of the above
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Initial treatment:
ACE inhibitor, diuretic, digoxin, and beta blocker initiated
Symptoms improve
Undergoes ICD implantation using single chamber device before hospital
discharge
6 months later, reports increasing dyspnea, orthopnea, and PND
Medications:
• Captopril 50 mg TID
• Furosemide 120 mg BID
• Metolazone 5 mg qd
• Carvedilol 12.5mg BID
• Warfarin 5 mg qd
• Digoxin 0.25 mg qd
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Outpatient follow-up:
Exam remarkable for BP 80/50 mmHg and biventricular CHF, with
shortness of breath at rest
Also “mentions” episode of loss of consciousness 1 week ago while
watching TV (but unsure if “fell asleep”)
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ICD interrogation revealed the following:
Shock
One shock was delivered, as above, with 9 other aborted
shocks for long non-sustained VT (asymptomatic).
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Question 2
You would now recommend:
A. Hospital admission for intravenous inotropic therapy
B. Antiarrhythmic drug therapy with amiodarone
C. Repeat right heart catheterization
D. All of the above
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Question 2 Answer
You would now recommend:
A. Hospital admission for intravenous inotropic therapy
B. Antiarrhythmic drug therapy with amiodarone
C. Repeat right heart catheterization
D. All of the above
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Treatment decisions
Amiodarone is being used to suppress frequent episodes of VT, in order
to reduce the frequency of shocks and aborted shocks
Right heart catheterization is performed to re-assess volume status and
cardiac output on medical therapy for congestive heart failure, in the
setting of a low resting blood pressure
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Following hospitalization:
Repeat right heart catheterization on milrinone reveals mean RA 12, PA
50/28, wedge 30 mmHg, CI 1.7 L/min/m2
Milrinone increased
BP systolic remains in the 80s
Normal renal function
Very supportive family, present at hospitalization and outpatient follow-up
visits
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Question 3
You would now recommend:
A. Consideration of upgrade to a device which allows biventricular
pacing for resynchronization therapy
B. Initiation of heart transplantation evaluation
C. Both A and B
D. No further evaluation or treatment indicated at this time
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Question 3 Answer
You would now recommend:
A. Consideration of upgrade to a device which allows biventricular
pacing for resynchronization therapy
B. Initiation of heart transplantation evaluation
C. Both A and B
D. No further evaluation or treatment indicated at this time
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Topics for discussion:
Should a biventricular device have been placed with the
initial implantation? (Was she a candidate with new onset
CHF?)
No, she was not a strict candidate for CRT device implantation
upon presentation with new onset CHF, in the absence of prior
medical therapy.
When do you decide to refer for heart transplantation
evaluation? Should you wait to see if her status improves
following biventricular pacing?
It’s acceptable to make an early referral, but many patients may
improve after CRT device implantation and no longer be
candidates for transplantation.
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What are the Guidelines?
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac
Rhythm Abnormalities: Secondary Prevention
Class I: ICD therapy is indicated in pts who are survivors of cardiac arrest due
to VF or hemodynamically unstable sustained VT after evaluation to define the
cause of the event and to exclude any completely reversible causes (Level of
evidence A)
Class I: ICD therapy is indicated in pts with structural heart disease and
spontaneous sustained VT, whether hemodynamically stable or unstable (Level
of evidence B)
Class IIa: ICD implantation is reasonable for pts with sustained VT and normal
or near-normal ventricular function (Level of evidence C)
Epstein et al., ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities, Circulation
2008;117:e350-408
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www.HRSonline.org
What are the Guidelines?
ACC/AHA/ESC 2006 Guidelines for Management of Patients with
Ventricular Arrhythmias & SCD - ICD Indications: Heart Failure –
CRT recommendations
Class IIa: ICD combined with BiV pacing can be effective for primary
prevention to reduce mortality by reduction in SCD in pts with NYHA
class III or IV receiving optimal medical therapy, in SR with QRS complex
≥ 120 ms who have reasonable expectation of survival with good
functional status for > 1 yr (level evidence B)
Zipes et al., ACC/AHA/ESC 2006 Guidelines for Management of Patients with Ventricular Arrhythmias & SCD,
Circulation 2006;114:e385-484
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Case 3 – M.P. - Syncope and Dilated CM
76 y.o. female
Episode of loss of consciousness while walking to mailbox
Exam: JVP 6 cm, cardiomegaly, S4 gallop, no S3 or murmurs
Labs: Normal
ECG: Sinus rhythm and LBBB
Echo: 4 chamber dilatation, global LV hypokinesis, trace MR, and LVEF
35-40%
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Question 1
Diagnostic evaluation should include:
A. Cardiac catheterization, to evaluate for significant CAD
B. Signal averaged ECG, to determine if EP testing is indicated
C. Invasive electrophysiological testing, to evaluate for AV conduction
disease or inducible ventricular arrhythmias
D. Endomyocardial biopsy
E. A & C
F. None of the above
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Question 1 Answer
Diagnostic evaluation should include:
A. Cardiac catheterization, to evaluate for significant CAD
B. Signal averaged ECG, to determine if EP testing is indicated
C. Invasive electrophysiological testing, to evaluate for AV conduction
disease or inducible ventricular arrhythmias
D. Endomyocardial biopsy
E. A & C
F. None of the above
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Evaluation Decisions:
Cardiac catheterization should be performed to exclude significant
coronary artery disease, which may first require revascularization.
Invasive electrophysiological testing may be performed to evaluate for
significant conduction system disease or inducible sustained ventricular
arrhythmias.
However, EP testing may have low yield in patients with non-ischemic
heart disease. Therefore, some electrophysiologists may opt to proceed
directly to ICD implantation in patients with non-ischemic cardiomyopathy.
Signal averaging would not be useful in this case, and results would not
change further evaluation and treatment decisions.
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Results of Testing:
Cardiac catheterization: Normal coronary arteries, global LV
hypokinesis, LVEF 37%
EPS: Normal sinus node function, resting HV interval = 62 msec, 1:1 AV
conduction to atrial pacing cycle length of 420 msec, no inducible
sustained or nonsustained ventricular arrhythmias
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Question 2
The best treatment option is:
A. Empiric treatment with procainamide
B. Pacemaker implantation, since the patient has an underlying LBBB
C. Implantation of a cardioverter defibrillator
D. Implantation of an insertable loop monitor
E. No treatment aimed at arrhythmias, since the EP study was negative
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Question 2 Answer
The best treatment option is:
A. Empiric treatment with procainamide
B. Pacemaker implantation, since the patient has an underlying LBBB
C. Implantation of a cardioverter defibrillator
D. Implantation of an insertable loop monitor
E. No treatment aimed at arrhythmias, since the EP study was negative
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Why is ICD the best option?
EP testing has a low yield for inducing sustained ventricular arrhythmias
in the setting of non-ischemic heart disease (as arrhythmias may not be
related to reentry)
Syncope portends a poor prognosis in patients with a non-ischemic
cardiomyopathy, and these patients frequently have symptomatic
ventricular arrhythmias detected on ICD interrogation during follow-up
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Intervention and Clinical Outcome:
Dual chamber ICD implanted
Syncopal episode 4 months after implantation – and the patient was
concerned because her ICD “did not work”
Interrogation of the device revealed the following event, coinciding with
the time of the syncopal episode:
A
V
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Outcome:
Appropriate ICD therapy occurred within 10 seconds after the onset of
the arrhythmia
Loss of consciousness resulted due to the rapid rate of the tachycardia
Continued observation was elected, without the addition of antiarrhythmic
agents
No additional events so far
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What are the Guidelines?
ACC/AHA/HRS Guidelines for ICD Implantation
“Patients with cardiac conditions associated with a high risk of sudden
death who have unexplained syncope that is likely to be due to
ventricular arrhythmias are considered to have a secondary indication”
for ICD implantation
Class IIa: ICD implantation is reasonable for patients with unexplained
syncope, significant LV dysfunction, and nonischemic dilated
cardiomyopathy (Level of evidence C)
Epstein et al., ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities, Circulation
2008;117:e350-408
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