Health Product Comparison System (HPCS)

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Device Overviews & Specifications ‐ Comparative Data

Pacemakers, Cardiac, External, Invasive

Electrodes, Transvenous
Published 7/1/2018

EXECUTIVE SUMMARY
Comparison Chart
Pacemakers, Cardiac, External, Invasive Electrodes, Transvenous

This Product Comparison covers battery-powered external, invasive-electrode pacemakers that deliver electrical
impulses from an external pulse generator using electrodes inserted into the heart through a major vein (e.g., the
subclavian) or attached directly to the heart wall. It excludes higher-voltage pulse generators using esophageal or
transcutaneous electrodes as well as special-purpose stimulators intended primarily for cardiac
electrophysiologic studies.
An external invasive pacemaker is used for temporary stimulation of heart contractions when the sinoatrial (SA)
node is not functioning properly or when the heart has a conductive disorder. The heart normally regulates its
own rate through a group of specialized cells located at the SA node that provide electrical pulses to the right and
left atria at regular intervals (the sinus heart rate). While the atria contract, the pulses are transmitted to the
atrioventricular (AV) node, which then stimulates the ventricles to contract. A cardiac disorder may result in
asystole, in which the heart stops pumping blood. In other cases, impulses may travel through the heart
intermittently, or sinus rhythm may be lost altogether, and another part of the heart, such as the AV node or
ventricular tissue, will control pacing. These disorders usually result in slow heart rate (bradycardia). Pacemakers
can be used to control this slow rate (including bradycardia occurring during anesthesia) as well as an overly
rapid heart rate (tachycardia).

An external invasive pacemaker is most commonly used after open-heart surgery until the heart recovers,
providing backup pacing during this postoperative period. It can also be used in an emergency until a pacemaker
can be surgically implanted to control the heart rate, and for cardiac electrophysiologic studies.

The following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature
System™ (UMDNS™) is covered:

Pacemakers, Cardiac, External, Invasive Electrode, Transvenous [12-912]

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Comparison Chart
Pacemakers, Cardiac, External, Invasive Electrodes, Transvenous

Scope of this Product Comparison

This Product Comparison covers battery-powered external, invasive-electrode pacemakers that deliver electrical
impulses from an external pulse generator using electrodes inserted into the heart through a major vein (e.g., the
subclavian) or attached directly to the heart wall. It excludes higher-voltage pulse generators using esophageal or
transcutaneous electrodes as well as special-purpose stimulators intended primarily for cardiac electrophysiologic
studies.

Purpose
An external invasive pacemaker is used for temporary stimulation of heart contractions when the sinoatrial (SA)
node is not functioning properly or when the heart has a conductive disorder. The heart normally regulates its own
rate through a group of specialized cells located at the SA node that provide electrical pulses to the right and left
atria at regular intervals (the sinus heart rate). While the atria contract, the pulses are transmitted to the
atrioventricular (AV) node, which then stimulates the ventricles to contract. A cardiac disorder may result in
asystole, in which the heart stops pumping blood. In other cases, impulses may travel through the heart
intermittently, or sinus rhythm may be lost altogether, and another part of the heart, such as the AV node or
ventricular tissue, will control pacing. These disorders usually result in slow heart rate (bradycardia). Pacemakers
can be used to control this slow rate (including bradycardia occurring during anesthesia) as well as an overly rapid
heart rate (tachycardia).

An external invasive pacemaker is most commonly used after open-heart surgery until the heart recovers, providing
backup pacing during this postoperative period. It can also be used in an emergency until a pacemaker can be
surgically implanted to control the heart rate, and for cardiac electrophysiologic studies.

Principles of Operation
External invasive pacemakers generate impulses outside the body and deliver them to the heart through an
electrode catheter (also known as a pacing lead or pacing wire) inserted through a vein or, in open-heart
procedures, attached directly to the myocardium.
Invasive pacing can be performed on the left atrium, the left ventricle, or both, depending on the location of the
electrodes. Following open-heart surgery, pacing of both chambers is common, although single-chamber pacing
may also be used. Pacing of the ventricle is common when using transvenous catheters to stimulate the heart.
High-rate atrial pacing (overdrive pacing) is used in some patients to control tachycardia.
The Heart Rhythm Society (formerly the North American Society of Pacing and Electrophysiology [NASPE])/British
Pacing and Electrophysiology Group (BPEG) Generic Pacemaker Mode Code, abbreviated as the NBG (for
NASPE/BPEG Generic) code, is used to identify pacing modes. The code consists of three to four letters, each of
which describes a different aspect of pacing. Positions I through III in the NBG code are used exclusively to describe
antibradyarrhythmia functions. The letter in the first position of the NBG code represents the chamber being paced,
the second position represents the chamber in which the sensing occurs, and the third position represents the
mode of response to the sensed signal. The chamber codes are V (ventricle), A (atrium), D (dual—atrium and

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ventricle), S (single—atrium or ventricle), T (triggered), or I (inhibited). An O is used in Positions I, II, and III to indicate
no pacing, no sensing, and no response to sensing, respectively. Positions I through III are used exclusively to
describe antibradyarrhythmia functions. The fourth position indicates programmability and the presence or absence
of rate modulation (see Table 1).

External invasive pacemakers can be operated in a variety of pacing

modes, including the asynchronous (or fixed rate) ventricular (VOO) mode
and the ventricular inhibited (VVI) mode. The asynchronous mode, the only
mode available in early external invasive pacemakers, is rarely used
anymore. A pacemaker in this mode emits a pacing pulse at regular
intervals, regardless of cardiac activity (i.e., no sensing functions are
active). Asynchronous pacing creates the possibility of complications due
to competition with intrinsic cardiac activity. Pacing that is not
synchronized with intrinsic cardiac activity may not offer optimal cardiac
output. Also, pacing stimulus that falls into the vulnerable period of the
intrinsic rhythm (i.e., T wave) can induce arrhythmias. The asynchronous
mode is sometimes applied for continuous pacing when electromagnetic
interference may be a problem (e.g., during use of an electrosurgical unit).

Single-chamber ventricular inhibited pacing (i.e., VVI) is commonly applied

by external invasive pacemakers. In inhibited modes, the electrical signals
generated by intrinsic cardiac activity are sensed through the pacing
lead(s). Pacemaker output is suspended, or inhibited, as long as the
intrinsic rate is greater than the rate set on the pacemaker. Unlike
asynchronous pacing, this mode does not compete with the heart's
intrinsic rate. Pacemakers sometimes allow the intrinsic rate to fall slightly
below the pacing rate before stimulating the heart. The difference between
the pacing rate and the intrinsic rate at which pacing is activated is called
rate hysteresis; it provides the heart with a better opportunity to beat in its
own intrinsic pattern. A refractory period, during which the pacemaker neither senses signals nor delivers stimuli,
follows each delivered and sensed pulse. (There is also a ventricular-triggered mode that works similarly to the VVI
mode, except when the intrinsic rate exceeds the set rate, the pacemaker continues to produce pulses to
correspond with the higher intrinsic rate. This mode may be used when an implantable pacemaker is also present.)

Dual-chamber external invasive pacemakers have been developed, incorporating many features that were
previously only available with implantable pacemakers. Currently available devices can be programmed to various
pacing modes depending on the needs of the patient. In AV sequential ventricular inhibited pacing (DVI), if the
ventricular rate falls below the set rate of the pacemaker, the pacemaker stimulates first the atrium and then, after
a short delay, the ventricle. This more closely mimics the normal action of the heart than VVI pacing and may pump
blood more effectively than ventricular pacing alone. AV sequential pacing can also play a role in some diagnostic
studies of cardiac function.

The most commonly used dual-chamber pacing mode, DDD, can offer certain advantages over DVI pacing. DDD
pacing allows for both atrial and ventricular pacing and sensing. This mode allows the pacemaker to increase the
ventricular pacing rate as the intrinsic atrial rate increases, thus optimizing the ventricular response to changes in
the sinus rate, a rate mediated by metabolic demand. In addition, this mode reduces the risk of pacemaker-induced
arrhythmias and decreases susceptibility to atrial and junctional arrhythmias.

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Reported Problems
While generally reliable, an external invasive pacemaker may fail to pace the heart or to sense cardiac activity.
These problems are usually related to poor electrode positioning or user error rather than to
pacemaker failures. The newer dual-chamber pacemakers capable of DDD pacing create the need for more
extensive operator training due to their complexity.

Signal interference from other electronic devices (e.g., radio-frequency transmitters) has been a concern but, in
practice, has rarely caused a significant problem. The use of equipment for microwave or diathermy treatment may
affect pacemaker operation. In addition, electrosurgery may interfere with the operation of external invasive
pacemakers; appropriate cardiac monitoring and precautions may be required.

Because external invasive pacing requires a conductive pathway to the heart, measures must be taken to protect
patients from microshock hazards. If an electrostatic discharge or leakage currents from a line-powered device are
inadvertently delivered to a temporary pacing catheter, the potential exists for stimulation of arrhythmias (e.g.,
ventricular fibrillation).
A pacemaker's ability to stimulate the heart can be affected by antiarrhythmic drugs; these drugs can increase the
pacing threshold, making the ventricles more difficult to capture.

On a few occasions, the DC-powered external pacemakers have caused burns to patients, so it is important to
check for DC faults during routine inspection.

One study (Gupta et al. 2010) mentions the dangers of pacing wires unintentionally being placed into the left
ventricular cavity. Forceful manipulation of the pacing lead in the right ventricular cavity may cause damage to the
interventricular septum and cause the lead to migrate into the left ventricular cavity. This is dangerous because of
known complications of systemic or cerebral thromboembolic events.

Purchase Considerations
ECRI Institute Recommendations
Included in the accompanying comparison chart are ECRI Institute's recommendations for minimum performance
requirements for external, transvenous invasive-electrode cardiac pacemakers. The recommended specifications
have been separated into two categories: single- and dual-chamber pacemakers. The single-chamber category
covers pacemakers that can pace only a single chamber of the heart (atrium or ventricle). The dual-chamber
category covers pacemakers that can pace both chambers.

Single-chamber external, invasive-electrode pacemakers satisfy the requirements of most procedures requiring
external, invasive-electrode pacing. Single-chamber units should have AOO, AAI, VOO, and VVI pacing modes.

Dual-chamber pacemakers are typically used in patients undergoing open-heart surgery, in which prophylactic
placement of both atrial and ventricular epicardial leads is common. Dual-chamber pacemakers may also be used
for single-chamber pacing, but this practice is uncommon because they are more complex than single-chamber
pacemakers, requiring more user training and experience to achieve and maintain proficiency. Dual-chamber units
should have AOO, AAI, VOO, VVI, DOO, DVI, DDI, and DDD pacing modes.

Single-chamber external, invasive-electrode pacemakers are most often used in VVI mode, while dual-chamber
external, invasive-electrode pacemakers are most often used in DDD mode.

All units should have adjustable rate, output amplitude, and sensitivity settings. The postventricular atrial refractory
period and the AV interval should also be adjustable on dual-chamber pacemakers. All cables should meet the U.S.
Food and Drug Administration (FDA) lead performance standard, and all units should have a sense and pace
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indicator.

Monitoring battery life by properly testing and replacing batteries can prevent a potentially life-threatening device
failure. The most common cause of such failures is depleted or defective batteries, often associated with improper
battery maintenance. ECRI Institute recommends 336-hour minimum battery life and a low-battery indicator.

Other Considerations
Hospitals should consider whether they need single- or dual-chamber external pacemakers. Single-chamber
models, which range in price from $1,700 to $4,000, are used more frequently. Dual-chamber pacemakers can
cost from $5,000 to $7,500 and are typically used after open-heart surgery.

Stage of Development
Clinical application of cardiac pacing first occurred in the early 1950s. Today, however, cardiac pacing has become
an established and well-accepted procedure. Additional pacing modalities, such as DDD pacing, are available with
dual-chamber units. Most units have high-rate atrial pacing. External invasive pacemaker function is being
enhanced to include features that are typically included only in implantable pacemakers.
While cardiac pacing technology has matured and remains stable, manufacturers are working to make displays
easier to read, programming more straightforward, and battery indicators more obvious.

BIBLIOGRAPHY
Bernstein AD, Daubert JC, Fletcher RD, et al. The revised NASPE/BPEG generic code for antibradycardia,
adaptive-rate, and multisite pacing. North American Society of Pacing and Electrophysiology/British Pacing and
Electrophysiology Group. Pacing Clin Electrophysiol 2002 Feb;25(2):260-4.
Dwyer D, Bauer K. Take the lead on safety with temporary cardiac pacing. Nursing 2010 Mar;40(3):63-4.

Ellenbogen KA, Kaszala K. Cardiac pacing and ICDs. 6th ed. Hoboken (NJ): Wiley Blackwell; 2014.

Gupta S, Annamalaisamy R, Coupe M. Misplacement of temporary pacing wire into the left ventricle via a
anomalous vein. Hellenic J Cardiol 2010;51:175-7.
Moses HW, Mullin JC. A practical guide to cardiac pacing. 6th ed. Philadelphia: Lippincott Williams & Wilkins;
2007.
Wang EE, Baran E, Kharasch M, et al. The emergent transvenous pacemaker. Acad Emerg Med 2008
May;15(5):487.

RESOURCE LIST
​Comparison Chart
Pacemakers, Cardiac, External, Invasive Electrodes, Transvenous

Request for Proposal Template

Pacemakers, Cardiac, External, Invasive Electrodes, Transvenous

RELATED RESOURCES
Defibrillator/Pacemakers, Implantable; Resynchronization

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Defibrillators, External, Automated; Semiautomated

Defibrillators, External, Manual; Defibrillator/Pacemakers, External
Pacemakers, Cardiac, Implantable; Resynchronization

TOPICS AND METADATA

Topics
Implants
;
Technology Selection

Caresetting
Hospital Inpatient

Roles
Allied Health Personnel
;
Materials Manager/Procurement Manager

Information Type
Comparative Data

UMDNS
Pacemakers, Cardiac, External, Invasive Electrode, Transvenous [12-912]

© 2019 ECRI Institute