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UMDNS information
This Product Comparison covers the following
device terms and product codes as listed in ECRIs
Universal Medical Device Nomenclature System
(UMDNS):
Pacemakers, Cardiac, External, Invasive Elec-
trodes, Transesophageal [17-494]
Pacemakers, Cardiac, External, Noninvasive
Electrodes [16-516] Transesophageal pacer
the SA node is the hearts natural pacemaker. The other electrode. As current flows between the elec-
electrical stimulus is transmitted to the atrioventricu- trodes, part of it should be conducted through the
lar (AV) node, located in the septal wall of the right heart, inducing it to contract. The electrodes are ap-
atrium, which then stimulates the ventricles to con- plied in either the anterior-posterior position one
tract (see Fig. 1). electrode over the heart and one directly behind it
or the anterior-anterior position one electrode near
Compared to transvenous pacing (in which a pacing
the apex of the heart and one on the right chest below
lead is inserted through a vein into the heart), external
the clavicle (see Fig. 2). The anterior-posterior position
noninvasive pacing is preferred in some emergency
is generally preferred because it reduces pectoral mus-
situations because it can be applied more quickly and
cle stimulation and does not interfere with defibrilla-
easily and does not require the skills of a physician. It
tor paddle placement. Multifunction electrodes that
can be used by emergency medical services for prehos-
allow pacing, defibrillation, and monitoring are some-
pital therapy and/or during transport and is indicated
times used. Electrodes are sometimes left in place for
for emergency temporary treatment of asystole, severe
24 to 72 hours; however, manufacturers may have
bradycardia, SA node dysfunction (also called sick-si-
specific instructions for their particular model.
nus syndrome, or SSS), implantable pacemaker fail-
ure, certain types of tachycardia, and acute myocardial
Electrodes for transesophageal pacing are inserted
infarction. transnasally (bipolar catheter) or are swallowed (bipo-
External noninvasive pacemakers can also provide lar catheter or pill electrode) to a predetermined depth,
backup pacing during surgical placement of pacemak- approximately at the esophageal-gastric junction be-
ers and temporary and permanent pacemaker leads. yond the atrium. The electrode must then be gradually
During other types of surgery, external noninvasive withdrawn until the maximum P-wave (representing
pacing can serve as a standby therapy for patients the depolarization of the atria) is detected. Radio-
predisposed to cardiac disorders. Noninvasive pacing graphic imaging can be used to confirm correct elec-
has also been used in place of certain resuscitative trode placement.
drug therapies (see the American Heart Association
citation in Standards and Guidelines). When the pacemaker is turned on, current is ad-
justed until pacing occurs. The clinician can confirm
Transesophageal pacing stimulates only the atrial capture (stimulation resulting in heart contraction)
chambers of the heart; it is used primarily in the when a one-to-one ratio between the pacing stimulus
diagnosis and temporary treatment of atrial arrhyth- and the QRS complex is detected; however, signs of
mias but can also be used to induce cardiac stress for improved perfusion such as pulse strength and/or
ECG diagnosis of heart disease. skin color and temperature, blood pressure, and level
of consciousness should also be used.
Principles of operation
External noninvasive and transesophageal pace-
makers generate repetitive electrical stimuli. Their
electronic circuitry controls the pulse rate and output SA Node Left Atrium
2 2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Pacemakers, Cardiac, External
Reported problems
Transesophageal pacemakers may cause diaphrag-
matic stimulation and myocardial contracture in the
presence of electrical capture. They may also cause
vomiting, with the consequent risk of aspiration, and
difficulty in swallowing.
When an external noninvasive pacemaker is used
as a backup or standby during fluoroscopic procedures,
including monitoring of pacemaker lead insertion, the
large electrodes may obstruct the clinicians view. In
addition, certain surgical procedures preclude proper
placement of the electrodes; cardiac capture may then
be impossible or may require excessive current.
Clear recognition of capture has been a problem
Figure 2. Electrode positions with all available noninvasive pacemaker units. An
easily distinguished pacemaker artifact and a blank-
ing period to reduce noncardiac electrical response
Pacing threshold, the minimum current amplitude both help recognition of capture on the ECG monitor.
necessary to achieve capture, is affected by the condi- Pacemakers should allow the clinician to distinguish
tion of the myocardium, electrode placement, and pulse among the pacemaker pulse, a pacing-generated QRS
width (the duration of the pulse stimulus) and typically response, a muscular response, and other noise with-
decreases as therapy continues and the heart becomes out QRS response. However, users should never rely
perfused. Current amplitude should not unduly exceed solely on their ability to recognize capture on the ECG
that necessary for capture because excessive current monitor to determine the effectiveness of pacing the
can cause discomfort or pain. The pacemakers output- patients clinical signs must be the deciding factor.
current configuration should have sufficiently small
Noninvasive capture current typically exceeds
amplitude increments or be continuously available to
thresholds for both cutaneous nerve stimulation and
allow the user to set a current that provides reliable
skeletal muscle contraction, resulting in significant
capture with minimal pain or discomfort.
patient discomfort. Although efforts have been made
to reduce these complications, conscious patients re-
The pacemaker typically delivers a fixed pulse quire sedation to prevent intolerable pain and anxiety.
width in the range of 20 to 40 msec for external nonin-
vasive pacemakers. Transesophageal pacemakers of-
Purchase considerations
fer an adjustable pulse width of 0 to 10 msec.
External noninvasive pacemakers are available in
different configurations: stand-alone pacemakers,
The two pacing modes are fixed rate (asynchronous)
pacemaker/monitors, and defibrillator/monitor/
and demand (synchronous). In fixed-rate mode, the
pacemakers. Depending on expected use, each unit has
pacemaker delivers the electrical stimulus at preset
significant advantages and disadvantages that should
intervals regardless of the patients underlying cardiac
be reviewed by a staff member who could also be
rhythm. This can have undesirable consequences: if
responsible for ensuring adequate staff training. Buy-
the heart reverts to its own rhythm, competition may
ers should check with the supplier for training pro-
occur between the pacemaker stimuli and the natural
gram availability. In addition, the types of patients
cardiac signals, which could cause ventricular fibrilla-
being treated and the users clinical protocol can influ-
tion or reduce cardiac output. To minimize this possi-
ence whether fixed-rate- or demand-mode pacemakers
bility, most models offer demand mode, in which the
are needed. Also, the clinical engineering staff should
pacing stimulus is delivered only when the monitored
be included in the purchasing decision to help evaluate
heart rate is lower than the pacemakers set pacing
servicing issues.
rate; if the pacemaker senses a heartbeat above the
pacing rate, artificial pacing stops and does not resume ECRI recommends that pacing capabilities be avail-
unless the heart rate again drops below the pacing able in the emergency room, critical care unit, inten-
rate. External noninvasive and transesophageal pace- sive care unit, and operating room if medically
makers typically offer adjustable pacing rates and appropriate, as well as in special procedure rooms such
continuously variable amplitudes. as cardiac catheterization laboratories. However, the
2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
Healthcare Product Comparison System
routine use of this equipment throughout the hospital Falk RH, Ngai ST. External cardiac pacing: influence
can be costly and inappropriate. of electrode placement on pacing threshold. Crit
Care Med 1986 Nov;14(11):931-2.
Stage of development
Falk RH, Zoll PM, Zoll RH. Safety and efficacy of
External noninvasive and transesophageal pacing noninvasive cardiac pacing. N Engl J Med 1983 Nov
technology has been used for cardiac resuscitation and 10;309(19):1166-8.
temporary pacing since 1952. However, the pain and
discomfort caused by early noninvasive pacemakers Guzy PM. Emergency cardiac pacing. Emerg Med Clin
could not be effectively managed using sedation. With North Am 1986 Nov;4(4):745-59.
the advent of transvenous pacing, external noninva-
sive pacing soon fell into relative disuse. McEneaney DJ, Cochrane DJ, Anderson JA, et al.
Ventricular pacing with a novel gastroesophageal
During the 1980s, changes in electrode design, electrode: a comparison with external pacing. Am
stimulus pulse width, and electrode placement made Heart J 1997 Jun;133(6):674-80.
noninvasive pacing less painful and revived the devel-
opment of this technology. Large-surface (several Zoll PM, Zoll RH, Belgard AH. External noninvasive
inches in diameter) electrodes reduce current density electric stimulation of the heart. Crit Care Med 1981
across the skin-electrode interface; pulse widths of May;9(5):393-4.
about 11 msec or greater minimize the impulse ampli-
tude required for cardiac capture; and electrode place- Zoll PM, Zoll RH, Falk RH, et al. External noninvasive
ment over areas of lower muscle mass lessens skeletal temporary cardiac pacing: clinical trials. Circula-
muscle contractions. In addition, continuously select- tion 1985 May;71(5):937-44.
able output currents allow careful adjustments for
optimum pacing thresholds. Standards and guidelines
Both external noninvasive and transesophageal Note: Although every effort is made to ensure that the
pacing have been applied in pediatric cases for ex- following list is comprehensive, please note that other
ample, during the introduction of anesthesia for pedi- applicable standards may exist.
atric heart surgery and for the control of
tachyarrhythmia. Transesophageal pacing has been American Heart Association/Australian Resuscitation
used for emergency pacing of infants and children. Council/European Resuscitation Council/Heart and
Both methods are more desirable than transvenous Stroke Foundation of Canada. Guidelines 2000 for
catheter insertion for pediatric emergencies. cardiopulmonary resuscitation and emergency car-
diovascular care. International Consensus on Sci-
Bibliography ence. Circulation 2000 Aug 22;102(8):I1-380.
Bern AI, Pane GA, Hamilton GC. Electrical interven- American National Standards Institute/Association for
tions in cardiopulmonary resuscitation: pacing. the Advancement of Medical Instrumentation. Pace-
Emerg Med Clin North Am 1983 Dec;1(3):541-52. maker emergency intervention system [standard].
ANSI/AAMI PAC49-1993. 1993.
Broka SM, Collard EL, Ducart AR, et al. Transeso-
Safe current limits for electromedical apparatus
phageal atrial pacing combined with dual-chamber
[standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re-
pacing. Anesthesiology 1996 Feb;84(2):472.
vised 1993).
Clinton JE, Zoll PM, Zoll R, et al. Emergency noninva- British Standards Institution. Medical electrical
sive external cardiac pacing. J Emerg Med equipment. Particular requirements for safety.
1985;2(3):155-62. Specification for external cardiac pacemakers with
Dick M 2nd, Scott WA, Serwer GS, et al. Acute termina- internal power source [standard]. BS EN 60601:
tion of supraventricular tachyarrhythmias in children part 2.31:1995. 1995.
by transesophageal atrial pacing. Am J Cardiol 1988 International Electrotechnical Commission. Medical
Apr 15;61(11):925-7. electrical equipment part 1: general requirements
for safety [standard]. IEC 60601-1 (1988-12). 1988.
External transcutaneous cardiac pacemaker downclas-
sification petition proposes user training, voluntary Medical electrical equipment part 1: general re-
standards as special controls. Med Devices Diagn In- quirements for safety. Amendment 1 [standard].
strum Rep Gray Sheet 1997 Mar 3;23(9):11-2. IEC 60601-1-am1 (1991-11). 1991.
4 2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Pacemakers, Cardiac, External
2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 5
Healthcare Product Comparison System
FDA U.S. Food and Drug Administration For those models whose prices were supplied to us
in currencies other than U.S. dollars, we have also
LCD Liquid crystal display listed the conversion to U.S. dollars to facilitate com-
LED Light-emitting diode parison among models. However, keep in mind that
exchange rates change often.
mA Milliampere
Need to know more?
MDD Medical Devices Directive For further information about the contents of this
Product Comparison, contact the HPCS Hotline at +1
msec Milliseconds
(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
ppm Pulses per minute hpcs@ecri.org (e-mail).
6 2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Pacemakers, Cardiac, External
PACING MODE(S) Fixed rate, Fixed rate, Demand/fixed rate Demand/fixed rate
adjustable adjustable
Continuous or
discrete settings Continuous Continuous Discrete Discrete
Monitor Yes No No No
Recorder No No No No
Pacing rate Indicator light Indicator light Digital on LCD Green LED
Output current No No Digital on LCD Orange LED
Battery status Indicator light Indicator light Message on LCD Red LED (low battery
voltage)
2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 7
Healthcare Product Comparison System
BATTERY
Type Alkaline Alkaline Two 9 V alkaline 9 V alkaline,
500 mA-hr
PURCHASE INFORMATION
List price $1,620 $2,605 $1,850 Not specified
Delivery time, ARO Not specified Not specified 10 days 2-4 weeks
Number sold to date Not specified Not specified Not specified Not specified
Fiscal year January to December January to December April to March Not specified
OTHER SPECIFICATIONS None specified. Preamplifier adapts Rapid atrial pacing None specified.
bipolar catheter to rate from 120 to
any ECG; external 600 ppm; 3 indepen-
input jack for dent programmable
programmed extra extrastimuli for
stimuli; burst electrophysiology;
pacing up to 2 tachycardia
600 ppm. termination methods
using extrastimu-
lation; audio
indicators and
alarms. Meets
requirements of TUV.
8 2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Pacemakers, Cardiac, External
Continuous or
discrete settings Continuous Continuous
Number of settings NA NA
Continuous or
discrete settings Continuous Continuous
Number of settings NA NA
Monitor No No
Recorder No No
Blanking protection No No
DISPLAY
ECG waveform No No
2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 9
Healthcare Product Comparison System
Recharge time, hr NA NA
PURCHASE INFORMATION
List price $3,450 $3,450
10 2002 ECRI. Duplication of this page by any means for any purpose is prohibited.