Pacemaker, Indications

Tarun Dalia; Bashar S. Amr.

Author Information

Last Update: May 26, 2018.

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Introduction
Pacemakers are electronic devices that stimulate the heart with electrical impulses to maintain or
restore a normal heartbeat. In 1952, Zoll described an effective means of supporting the patients
with intrinsic cardiac pacemaker activity and/or conducting tissue by an artificial, electric,
external pacemaker. The pacing of the heart was accomplished by subcutaneous electrodes but
could be maintained only for a short period. In 1957, complete heart block was treated using
electrodes directly attached to the heart. These early observations instilled the idea that cardiac
electrical failure can be controlled. It ultimately led to the development of totally implantable
pacemaker by Chardack, Gage, and Greatbatch. Since then, there have been several
advancements in the pacemakers, and the modern-day permanent pacemaker is subcutaneously
placed device. There are 3 types of artificial pacemakers:

1. Implantable pulse generators with endocardial or myocardial electrodes

2. External, miniaturized, patient portable, battery-powered, pulse generators with
exteriorized electrodes for temporary transvenous endocardial or transthoracic
myocardial pacing
3. Console battery or AC-powered cardioverters or monitors with high-current external
transcutaneous or low-current endocardial or myocardial circuits for temporary pacing in
asynchronous or demand modes, with manual or triggered initiation of pacing

All cardiac pacemakers consist of 2 components: a pulse generator which provides the electrical
impulse for myocardial stimulation and 1 or more electrodes or leads which deliver the electrical
impulse from the generator to the myocardium. This article focuses on the indications of
pacemaker placement.

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Indications
The most common indications for permanent pacemaker implantation are sinus node dysfunction
(SND) and high-grade atrioventricular (AV) block. Guidelines for implantation of cardiac
pacemakers have been established by a task force formed jointly by the American College of
Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society
(HRS). The European Society of Cardiology has established similar guidelines. ACC/AHA/HRS
divides indications of pacemaker implantation into 3 specific classes:

 Class I: These are conditions where implantation of a pacemaker is considered necessary

and beneficial (benefits much greater than risks).
 Class II: These are conditions where placement is indicated, but there is conflicting
evidence or divergence of opinion. In Class IIa weight of evidence is in favor of efficacy
(benefits greater than risk), while in class IIb, the efficacy is less well established
(benefits greater than or equal to the risks).
 Class III: These are conditions in which permanent pacing is not recommended, and in
some cases, it may be harmful (risks greater than the benefits).

Following conditions are included in the ACC/AHA/HRS guidelines for the pacemaker insertion.
We will discuss Class I and II recommendations.

1. Sinus node dysfunction

2. Acquired Atrioventricular(AV) block
3. Chronic bifascicular block
4. After acute phase of myocardial infarction
5. Neurocardiogenic syncope and hypersensitive carotid sinus syndrome
6. Post cardiac transplantation
7. Hypertrophic cardiomyopathy
8. Pacing to detect and terminate tachycardia
9. Cardiac resynchronization therapy in patients with severe systolic heart failure
10. Patients with congenital heart disease

Sinus Node Dysfunction

Class I indications

 Documented symptomatic sinus bradycardia including frequent sinus pauses which

produce symptoms and symptomatic sinus bradycardia that results from required drug
therapy for medical condition
 Symptomatic chronotropic incompetence (failure to achieve 85% of age-predicted
maximal heart rate during formal or informal stress test or inability to mount age
appropriate heart rate during activities of daily living)

Class II indications

 Sinus bradycardia with heart rate less than 40, but no clear association between the
symptoms and bradycardia
 Unexplained syncope when clinically significant abnormalities of sinus node function are
discovered or provoked in electrophysiological (EP) studies
 Minimally symptomatic patients with chronic heart rate less than 40 while awake

Acquired Atrioventricular (AV) Block

Class I indications

 Complete third-degree AV block with or without symptoms.

 Symptomatic second degree AV block, Mobitz type I and II
 Exercise-induced second or third degree AV block in the absence of myocardial
infarction
 Mobitz II with widened QRS complex

Class II indications

 Asymptomatic Mobitz type II with the narrow QRS complex.

 First degree AV block when there is a hemodynamic compromise.
 Asymptomatic second degree AV block at Intra or Infra-His levels found in EP studies

Chronic Bifascicular Block

Class I indications

 Advanced second-degree AV block or intermittent third-degree AV block

 Alternating bundle-branch block
 Type II second-degree AV block.

Class II indications

 In patients having syncope not demonstrated to be due to AV block when other likely
causes have been excluded, specifically ventricular tachycardia (VT)
 Incidental finding at EP study of a markedly prolonged HV interval (greater than 100 ms)
or pacing-induced infra-His block in asymptomatic patients. HV interval is conduction
time from the His bundle which is located just below the AV node to first identifiable
onset of ventricular activation
 Can be considered in patients with neuromuscular disease such as myotonic muscular
dystrophy, Erb dystrophy and peroneal muscular dystrophy with bifascicular block or any
fascicular block, with or without symptoms

After Acute Phase of Myocardial Infarction

Class I indications

 Permanent ventricular pacing for persistent second degree AV block in the His-Purkinje
system with alternating bundle branch block or third degree AV block within or below
the His-Purkinje system after the ST-segment elevation MI (STEMI)
 Permanent ventricular pacing for a transient advanced second or third-degree infranodal
AV block and associated bundle branch block
 Permanent ventricular pacing for persistent and symptomatic second or third degree AV
block
Class II indications

 Permanent ventricular pacing may be considered for the asymptomatic persistent second
or third degree AV block at AV node level.

Neurocardiogenic Syncope and Hypersensitive Carotid Sinus Syndrome

Class I indications

 Recurrent syncope caused by spontaneously occurring carotid sinus stimulation and

carotid sinus pressure that induces ventricular asystole of more than 3 seconds

Class II indications

 Reasonable in patients having syncope without clear and provocative event, and with a
hypersensitive cardioinhibitory response of 3 seconds or longer
 Can be considered for significantly symptomatic neurocardiogenic syncope associated
with bradycardia documented spontaneously or at the time of tilt-table testing

Post Cardiac Transplantation

Class I indications

 For persistent inappropriate or symptomatic bradycardia not expected to resolve and for
other class I indications of permanent pacing.

Class II indications

 Can be considered when relative bradycardia is prolonged or recurrent, which limits

rehabilitation or discharge after postoperative recovery.
 Can be considered for syncope after cardiac transplantation even when bradycardia has
not been documented.

Hypertrophic Cardiomyopathy (HCM)

Class I indications

 Patients with HCM having Sinus node dysfunction and AV block

Class II indications

 Can be considered in medically refractory symptomatic patients with HCM and with
significant resting or provoked left ventricular outflow tract obstruction

Pacing to Prevent Tachycardia

Class I indications

 For sustained pause dependent VT, with or without QT prolongation

Class II indications

 Reasonable for high-risk patients with congenital QT syndrome.

 Can be considered for prevention of symptomatic, drug refractory, recurrent atrial
fibrillation in a patient with co-existing sinus node dysfunction

Cardiac Resynchronization Therapy (CRT) in Patients with Severe Systolic Heart Failure

Class I indications

 Patients with left ventricular ejection fraction (LVEF) of less than or equal to 35%, sinus
rhythm, LBBB (left bundle branch block), New York Heart Association (NYHA) Class
II, III or IV symptoms while on optimal medical therapy with a QRS duration of greater
than or equal to 150 ms, CRT with or without ICD is indicated

Class II indications

 LVEF less than or equal to 35%, sinus rhythm, LBBB with NYHA Class III or IV
symptoms while on optimal medical therapy and QRS duration of 120 to 149 ms, CRT
with or without ICD is recommended.
 LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS greater
than or equal to 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT
 Useful in patients with atrial fibrillation and LVEF less than or equal to 35% on GDMT if
the patient requires ventricular pacing or otherwise meets CRT criteria and AV nodal
ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT
 LVEF less than or equal to 35%, NYHA class III or IV while on optimal medical therapy
and who have frequent dependence on ventricular pacing, CRT is reasonable

Congenital Heart Disease

Class I indications

 For advanced second or third-degree AV block associated with symptomatic bradycardia,

ventricular dysfunction, or low cardiac output; also for advanced second or third-degree
AV block which is not expected to resolve or persists for 7 days or longer after cardiac
surgery
 For sinus node dysfunction with a correlation of symptoms during age inappropriate
bradycardia
 Congenital third-degree AV block with a wide QRS escape rhythm, complex ventricular
ectopy or ventricular dysfunction
  Congenital third-degree AV block in an infant with a ventricular rate of less than or equal
to 55 bpm or with congenital heart disease with a ventricular rate of less than or equal to
70 bpm

Class II indications

 For patients with congenital heart disease and sinus bradycardia for the prevention of
recurrent episodes of intra-atrial re-entrant tachycardia; sinus node dysfunction may be
intrinsic or secondary to antiarrhythmic treatment.
 For congenital third-degree AV block beyond the first year of life with an average heart
rate less than 50 bpm, abrupt pauses in ventricular rate which are 2 or 3 times the basic
cycle length, or associated with symptoms due to chronotropic incompetence.
 May be considered for transient postoperative third-degree AV block that reverts to sinus
rhythm with the residual bifascicular block.
 Considered for asymptomatic sinus bradycardia after biventricular repair of congenital
heart disease in patients with a resting heart rate less than 40 bpm or with pauses in
ventricular rate longer than 3 seconds

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Contraindications
Like in any procedure, the insertion of pacemaker insertion should be chosen wisely for a
particular patient. There are situations in which pacemaker insertion is not beneficial or is not
enough data to support its use. These are sometimes also called class III indications in
ACC/AHA/HRS guidelines or European Society of Cardiology guidelines.

 Sinus bradycardia without significant symptoms; asymptomatic first-degree AV block

 AV block that is expected to resolve and unlikely to recur example drug toxicity, Lyme
disease, or transient increase in vagal tone
 A pacemaker is not indicated for sinus node dysfunction in patients with symptoms
suggestive of bradycardia that have been documented to occur even in the absence of
bradycardia.
 Asymptomatic second-degree Mobitz, type-I block
 Asymptomatic prolonged RR interval with atrial fibrillation or other causes of transient
ventricular pauses
 Hypersensitive cardioinhibitory response to carotid sinus stimulation in the absence of
symptoms or in the presence of vague symptoms such as dizziness, lightheadedness
 Asymptomatic bradycardia during the sleep
 CRT is not indicated in patients whose functional status and life expectancy are limited
predominantly by non-cardiac conditions
 Right bundle branch block with left axis deviation without syncope or other symptoms
compatible with intermittent AV block
 Long QT syndrome or Torsade de pointes due to reversible causes
 In the presence of an accessory pathway that has the capacity for rapid anterograde
conduction
  Patients with NYHA class I or II symptoms and non-LBBB pattern with QRS duration
less than 150 ms

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Complications
The pacing and CRT are associated with complications. The majority of complications occur in
the hospital or during first 6 months. Lead complications are the main reason for the re-
implantation of the pacemaker and CRT devices. Other complications include, but are not
limited to infections, hematoma formation, pericardial effusion or tamponade, pneumothorax,
coronary sinus dissection, or perforation.

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Clinical Significance
Pacemaker implantation has shown a mortality benefit. The CARE-HF (Cardiac
Resynchronization in Heart Failure) trial limited subjects to the QRS duration greater than 150
ms (89% of patients) or QRS duration 120 to 150 ms with echocardiographic evidence of dys-
synchrony (11% of patients). It was the first study to show a significant (36%) reduction in the
death rate for resynchronization therapy unaccompanied by backup defibrillation compared with
guideline-directed medical therapy (GDMT). There has been evidence from the multiple
randomized trials of CRT-D in patients with reduced LVEF and NYHA class II shows that CRT
can provide functional improvement and decrease the risk of HF events and composite outcomes.
In clinical trials, CRT-D has not shown improvement in NYHA class I Heart failure. The
ACC/AHA/HRS guidelines from 2012 thoroughly reviewed the conditions of hypertrophic
cardiomyopathy, arrhythmogenic right ventricular dysplasia/cardiomyopathy, genetic arrhythmia
syndrome, terminal care, and congenital heart disease, and no changes were made as compared
to 2008 guidelines in these conditions. There was a change in guidelines for indications of CRT
insertion in the 2012 ACC/AHA/HRS guidelines as compared to 2008 guidelines. These are
incorporated in the indications for pacemaker section mentioned above.

New guidelines recommend CRT in a patient with QRS duration greater than or equal to 150 ms
instead of 120 ms based on multiple analysis/studies (class I indication). An additional difference
in CRT recommendations includes patients with QRS duration greater than or equal to 150 ms
with LBBB as class I indication. Newer guidelines based on multiple studies suggest that in
patients who have QRS greater than or equal to 120 ms but does not have complete LBBB, the
evidence of benefit from CRT is less compelling. The European Society of Cardiology
guidelines are similar to the ACC/AHA/HRS guidelines, but there are few differences. One
major difference noted is ESC guidelines have CRT indication for QRS less than or equal to 120
ms in patients with atrial fibrillation (in whom we have inadequate rate control requiring AV
node ablation) and heart failure with EF less than or equal to 35%. The ACC/AHA/HRS
guidelines have no such indication.
There are some areas where the indications for a pacemaker are clear, but there are few areas
where clinical judgment and expertise plays a greater role. Although the guidelines attempt to
define practices that meet the needs of most patients, the ultimate decision for the patient should
be based on particular patient presenting scenario, clinician judgment, and discussion with the
patient about risks and benefits of the procedure. There are specific pacemaker generators
that are used for patients with AV block and sinus node dysfunction depending upon
presentation. The different types of generators include a single chamber, dual chamber, and
biventricular. This discussion of different types of the pacemaker to be chosen is beyond the
scope of this article.

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Questions
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References
1.
ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric
stimulation. N. Engl. J. Med. 1952 Nov 13;247(20):768-71. [PubMed]
2.
WEIRICH WL, GOTT VL, LILLEHEI CW. The treatment of complete heart block by
the combined use of a myocardial electrode and an artificial pacemaker. Surg Forum.
1957;8:360-3. [PubMed]
3.
CHARDACK WM, GAGE AA, GREATBATCH W. A transistorized, self-contained,
implantable pacemaker for the long-term correction of complete heart block. Surgery.
1960 Oct;48:643-54. [PubMed]
4.
Escher DJ. Types of pacemakers and their complications. Circulation. 1973
May;47(5):1119-31. [PubMed]
5.
Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, Freedman RA, Gettes LS, Gillinov
AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL,
Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Tracy CM, Epstein AE, Darbar
D, DiMarco JP, Dunbar SB, Estes NA, Ferguson TB, Hammill SC, Karasik PE, Link MS,
Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG,
Varosy PD., American College of Cardiology Foundation. American Heart Association
Task Force on Practice Guidelines. Heart Rhythm Society. 2012 ACCF/AHA/HRS
focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based
therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology
 Foundation/American Heart Association Task Force on Practice Guidelines and the Heart
Rhythm Society. J. Am. Coll. Cardiol. 2013 Jan 22;61(3):e6-75. [PubMed]
6.
Tracy CM, Epstein AE, Darbar D, Dimarco JP, Dunbar SB, Estes NA, Ferguson TB,
Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ,
Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of
the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of
the American College of Cardiology Foundation/American Heart Association Task Force
on Practice Guidelines. J. Am. Coll. Cardiol. 2012 Oct 02;60(14):1297-313. [PubMed]
7.
TheTask Force on cardiac pacing and resynchronization therapy of the European Society
of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm
Association (EHRA). Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P,
Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B,
Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE. 2013 ESC
Guidelines on cardiac pacing and cardiac resynchronization therapy. Rev Esp Cardiol
(Engl Ed). 2014 Jan;67(1):58. [PubMed]
8.
Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L.,
Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of
cardiac resynchronization on morbidity and mortality in heart failure. N. Engl. J. Med.
2005 Apr 14;352(15):1539-49. [PubMed]
9.
Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA, Foster E,
Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W., MADIT-
CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-
failure events. N. Engl. J. Med. 2009 Oct 01;361(14):1329-38. [PubMed]
10.
Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH,
Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL., Resynchronization-
Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-
resynchronization therapy for mild-to-moderate heart failure. N. Engl. J. Med. 2010 Dec
16;363(25):2385-95. [PubMed]