心臟植入性電子儀器之適應症(Indications for CIED)

高雄榮民總醫院心臟內科江承鴻 醫師

2013.10.19 (Sat)

2013 THRS Allied Professional Education Program Cardiovascular Implantable Electronic Device (CIED)

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2012 ACCF/AHA/HRS Focused Update Incorporated Into the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

Developed in Collaboration With the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons

DBT Guideline

Class I Benefit >>> Risk

Procedure/ Treatment SHOULD be performed/ administered

Class IIa Benefit >> RiskAdditional studies with focused objectives needed

IT IS REASONABLE to perform procedure/administer treatment

Class IIb Benefit ≥ RiskAdditional studies with broad objectives needed; Additional registry data would be helpful

Procedure/Treatment MAY BE CONSIDERED

Class III Risk ≥ BenefitNo additional studies needed

Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL

Recommendations & Level of Evidence

Level A: Data derived from multiple randomized clinical trials or meta-analyses

Multiple populations evaluated;

Level B: Data derived from a single randomized trial or nonrandomized studies Limited populations evaluated

Level C: Only consensus of experts opinion, case studies, or standard of care

Very limited populations evaluated

Level of Evidence:

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Indications for pacing

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Symptomatology +Documented Events

ECG documentation in the medical record is essential !

Reliable Indicationsfor Pacing

=

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• Sick Sinus Syndrome• Heart Block• Chronic Bifascicular Block• Carotid Sinus Hypersensitivity

& Neurocardiogenic Syncope• HOCM, DCM

Indications For Pacing

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• Sinus Bradycardia • Sinus Arrest• SA Exit Block• Bradycardia-Tachycardia

Syndrome• Symptomatic chronotropic

incompetence

Sinus Node Dysfunction (Sick Sinus Syndrome)

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Sinus Node Dysfunction

• Class I– SND with symptomatic bradycardia,

including frequent sinus pauses that produce symptoms (c)

– Symptomatic chronotropic incompetence (c)

– Symptomatic sinus bradycardia from required drug therapy (c)

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Sinus Node Dysfunction

• Class IIa – SND with HR < 40 BPM but the

symptoms and bradycardia has not been documented (c)

– Syncope of unexplained origin when SND is discovered in EP study (c)

• Class IIb– Minimal symptoms with chronic HR < 40

BPM while awake (c)9

Sinus Node Dysfunction

• Class III – Without symptoms (c)

– Symptoms unrelated to bradycardia (c)

– Symptomatic sinus bradycardia due to nonessential medications (c)

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Sinus Node Dysfunction - Sinus Bradycardia

• Patient case:• Elderly gentleman denied symptoms.• Family reported that he napped frequently,

would fall asleep at the kitchen table during a meal and often fell asleep when friends were visiting.

• Patient was proud of his “athletic heart”, particularly as he never exercised.

Inappropriate marked sinus bradycardia

Sinus Node Dysfunction

Single APB with marked overdrive suppressionof sinus node, mild sinus bradycardia

Holter monitor

Sinus Node Dysfunction - Brady-Tachy Syndrome

Marked sinus node suppression post-spontaneous termination of AFib, predisposes to APBs which triggers next episode of PAF

YesNo

Sinus Node Dysfunction

No

AAI AAIR

DDDRDDDVVI VVIR

Yes

No Yes No Yes

No Yes

Selection of Pacemaker for Sinus Node Dysfunction

Epstein A, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol 2008; 51:e1–62. Figure 2.

Evidence for impaired AV conduction or concern over future development of AV block

Desire for rate response

Desire for AV synchrony

Desire for rate response

Desire for rate response

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AV Block

• First degree

• Second degree- Wenckebach- Mobitz II- 2:1 (high grade)

• Third degree- Chronic stable- Asystole

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AV Block

• Class I– 3rd & advanced 2nd degree AV block at any level

- Bradycardia with symptoms or ventricular arrhythmia due to AV block (c)

- Drug therapy results in symptomatic bradycardia (c)

- Awake, symptom-free, asystole > 3.0 seconds or escape rate< 40 BPM (c)

- Awake, symptom-free, AF with pauses 5 ≧seconds (c)

- Post-AV ablation or post heart surgery (c)- Neuromuscular disease (b)

– 2nd degree AV block if symptomatic and not reversible (b)

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AV Block

• Class IIa –“Asymptomatic” 3rd degree AV block of HR > 40 BPM (c)

–“Asymptomatic” 2nd degree AV block at intra-His or infra-His levels at EP study (b)

–1st degree or 2nd degree AV block with symptoms (b)

–“Asymptomatic” Mobitz II 2nd degree AV block (b)

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AV Block

• Class IIb– Neuromuscular disease, with or without

symptoms, as the progression is unpredictable (b)

– AV block due to medications or drug toxicity, expected to recur even after drug withdrawn (b)

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AV Block

• Class III – Asymptomatic 1st degree AV Block (b)– Asymptomatic Mobitz I 2nd degree AV block at

supra-His (AV node) level (c)– AV block due to reversible etiology (b)

- Lyme’s disease- Acute inferior wall MI- Drug effect or toxicity- Sleep apnea

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AV Block - First Degree AV Block

•Significant FIRST degree AV Block (PR 400 ms+) will predispose to late diastolic regurgitation, compromised hemodynamics and induce pseudo pacemaker syndrome

AV Block - First Degree AV Block

A

AV

V

First degree AV Block that induces symptoms c/wpacemaker syndrome (functional retrograde conduction)

AV Block - 2nd Degree - Wenckebach

• Progressive increase in PR interval until a P wave is not conducted

• Pause terminated by shortened PR interval

AV Block - Mobitz II

• No change in PR interval preceding or following blocked P wave

• Wide QRS (tri fascicular conduction system disease)

AV Block - 2nd Degree Mobitz II

Mobitz II 2nd AV Block may be associated with abrupt asystolic complete heart block without astable escape focus

AV Block - 2:1(High Grade) 2nd Degree AVB

Narrow QRS - block in AV node (or Bundle of His)

Wide QRS - cannot identify level of block

2:1 AV Block Mechanism based on preceding or following

rhythms

Lead II

Lead V1

AV BlockChronic Stable Complete Heart Block

•75-year-old man referred for “slow pulse”. Denies syncope, presyncope. BUT lacks energy which he attributed to his age!

In the presence of a normal sinus node, use the atrial rate as an indicator of the degree of physiologic stress.

AV BlockComplete in presence of A Fib

AV Block Not Always Obvious

• What is this rhythm?

• Sinus bradycardia• First degree AV Block

AV Block Not Always Obvious

Baseline

Sinus rate accelerates, unmasks complete heart block, ventricular rate does NOT change, hence top tracing was sinus brady with isorhythmic AV dissociation and CHB

Post-Atropine

Selection of Pacemaker for Atrioventricular Block

Epstein A, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol 2008; 51:e1–62. Figure 1.

AV block

Chronic atrial tachyarrhythmia, reversion to sinus

rhythm not anticipated

Desire for AV synchrony

Desire for rate response

No Yes

Desire for rate response

No

Desire for atrial pacing

Yes

VVI VVIR

No Yes

VDDDesire for rate response

DDD DDDR

No Yes

No Yes

VVI VVIR

No Yes

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Neurally Mediated Syndromes

• Hypersensitive carotid sinus syndrome

• Malignantvasovagal syncope (neurocardiogenic syncope)

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Neurally Mediated Syndromes

• Carotid Sinus Massage (CSM)

• Check for bruits• Always monitor ECG• One side at a time• Gentle

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Neurally Mediated Syndromes

• Class I– Recurrent syncope, CSM > 3 seconds of

asystole without vagomimetic medications (c)

• Class IIa – Recurrent syncope without clear and provocative

cause, CSM > 3 seconds of asystole (c)

• Class IIb – Recurrent syncope, tilt table test with marked

bradycardia (b)

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Neurocardiogenic SyncopeCardioinhibitory

• Tilt-test

Indications for Cardiac

Resynchronization (CRT) Therapy

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Right AtrialLead

Right VentricularLead

Left VentricularLead

CRT in Systolic Heart Failure

• Class I- LVEF 35%, ≦ sinus rhythm, LBBB with QRS

150 ms, and NYHA II, III, or ambulatory IV ≧[(a) for NYHA III/IV; (b) for NYHA II].

• Class IIa- LVEF 35%, sinus rhythm, LBBB with ≦ QRS

120 ~ 149 ms, and NYHA II, III, or ambulatory IV (b)

- LVEF 35%, sinus rhythm, ≦ non-LBBB with QRS 150 ms≧ , and NYHA II, III, or ambulatory IV

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CRT in Systolic Heart Failure

• Class IIa- AF and LVEF ≦ 35% if a) require ventricular

pacing or meet CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT (b)

- Patients with LVEF 35% and undergoing ≦new or replacement device placement with requirement for significant (>40%) ventricular pacing (c)

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CRT in Systolic Heart Failure

• Class IIb- LVEF 30%, ≦ ischemic heart failure, sinus rhythm,

LBBB QRS with ≧ 150 ms, & NYHA I.- LVEF 35%, sinus rhythm, ≦ non-LBBB QRS with

120 ~ 149 ms, and NYHA III/ambulatory class IV (b)- LVEF 35%, sinus rhythm, ≦ non-LBBB QRS with ≧

150 ms, and NYHA II (b)

• Class III- NYHA I/II, non-LBBB QRS with <150ms (b)- Comorbidities and/or frailty limit survival with

good functional capacity <1 year (c)

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Indications for CRTcardiomyopathy on GDMT for >3 mo or on GDMT and >40 d after MI,

or with implantation of pacing or defibrillation device for special indications

LVEF <35%

Evaluate general health status

Acceptable noncardiac health

Comorbidities and/or frailty limit survival with good functional capacity to <1 y

Continue GDMT without implanted device

Evaluate NYHA clinical status

NYHA class II, III, and ambulatory class IV symptoms

NYHA class IV (stage D)Refractory symptoms ordependence on intravenous inotropes

NYHA class I symptoms

Class IIb

•LVEF <30%•QRS >150 ms•LBBB pattern•Ischemic cardiomyopathy

Class I

LBBB pattern, sinus rhythm, QRS duration ≥150 ms

Class IIa

LBBB pattern, QRS 120-149 ms

OR

Non-LBBB pattern, QRS >150 ms

OR

Anticipated to require frequent ventricular pacing (>40%)

OR

Atrial fibrillation, if ventricular pacing is required or QRS criteria above are met and rate control will result in near 100% ventricular pacing with CRT

Class IIb

Non-LBBB pattern, QRS 120-149 ms

Device not indicated except in selected patients listed for transplantation or with LV assist devices

If device already in place, consider deactivation of defibrillation

心房同步雙心室節律器 (CRT)中央健康保險局適應症

98.7.1.修訂( 一 ) 應事先審查。( 二 ) 正常竇房節心律， LVEF≦ 35%且CLBBB(QRS寬度≧ 0.12sec)，且 NYHA Functional Class III, IV及經適當藥物治療仍不能改善之病患。

( 三 ) 心房顫動之病患， LVEF≦35%且CLBBB(QRS寬度≧ 0.12sec)，且 NYHA Functional Class III, IV及經適當藥物治療仍不能改善之病患。

( 四 ) 心室節律器依賴之病患， LVEF≦35%， NYHA Functional Class III, IV及經適當藥物治療仍不能改善者。

Indications for Implantable

Cardioverter-Defibrillators (ICD) Therapy

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ICD (Secondary Prevention)

• Class I- Survivors of cardiac arrest due to VF or

hemodynamically unstable sustained VT after exclude reversible causes (a)

- Structural heart disease & spontaneous sustained VT, whether hemodynamically stable or unstable (b)

- Syncope of undetermined origin with hemodynamically significant sustained VT or VF induced at EP study (b).

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ICD (Primary Prevention)

• Class I- LVEF 35% ≦ due to prior MI, ≧ 40 days

post-MI, NYHA II/III (a)- Non-ischemic DCM, LVEF 35%, ≦ NYHA

II/III (b) - LVEF < 30% due to prior MI, ≧ 40 days

post-MI, NYHA I (a)- Non-sustained VT due to prior MI, LVEF ≦

40%, inducible VF/sustained VT at EP study (b)

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ICD

• Class IIa- Unexplained syncope, significant LV

dysfunction, non-ischemic DCM (c)- Sustained VT and normal or near-normal

ventricular function (c)- HCM & Arrhythmogenic right ventricular

dysplasia/cardiomyopathy (ARVD/C) with 1 or more major risk factors for SCD (c)

- Long-QT syndrome with syncope and/or VT while receiving beta blockers (b)

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ICD

• Class IIa- Non-hospitalized patients awaiting

transplantation (c)- Brugada syndrome with syncope (c)- Brugada syndrome with documented VT that

has not resulted in cardiac arrest (c)- Catecholaminergic polymorphic VT with

syncope and/or documented sustained VT while receiving beta blockers (c)

- Cardiac sarcoidosis, giant cell myocarditis, or Chagas disease (c)

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ICD

• Class IIb- Non-ischemic heart disease with LVEF ≦

35%, NYHA I (c) - Long-QT syndrome and risk factors for SCD

(b) - Syncope and advanced structural heart

disease, failed to define a cause (c) - Familial cardiomyopathy associated with

sudden death (c) - LV non-compaction (c)

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ICD

• Class III- Do not have a reasonable expectation of

survival with an acceptable functional status for at least 1 year (c)

- Incessant VT or VF (c) - Psychiatric illnesses that may be

aggravated by device implantation or that may preclude systematic follow-up (c)

- NYHA IV with drug-refractory CHF, not candidates for cardiac transplantation or CRT-D (c)

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ICD

• Class III- Syncope of undetermined cause, without inducible

ventricular tachyarrhythmias, without structural heart disease (c)

- VF / VT is amenable to surgical or catheter ablation (e.g., atrial arrhythmias associated with the WPW syndrome, RV or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease) (c)

- Ventricular tachyarrhythmias due to a completely reversible disorder, without structural heart disease (e.g., electrolyte imbalance, drugs, or trauma) (b)

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Thanks

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