The New England Journal of Medicine














Review Article
Current Concepts

Volume 346:2062-2068

June 27, 2002

Number 26

Implantable Devices for the Treatment of Atrial Fibrillation
Joshua M. Cooper, M.D., Michael S. Katcher, M.D., and Michael V. Orlov,
M.D., Ph.D.
Atrial fibrillation is a common arrhythmia that causes symptoms such as
palpitations and dyspnea but is also associated with stroke, heart failure,
and an increased risk of hospitalization and death. 1
<http://content.nejm.org/cgi/content/short/346/26/#R1> , 2
<http://content.nejm.org/cgi/content/short/346/26/#R2>  The incidence of
atrial fibrillation increases markedly with age. As the average age of the
general population increases, the overall prevalence of atrial fibrillation
is also increasing. Among the most common approaches to management are rate
control plus anticoagulation and rhythm control with antiarrhythmic
medications. Neither of these two strategies is ideal. Anticoagulation does
not eliminate the risk of stroke, and the antiarrhythmic drugs often do not
maintain sinus rhythm. 3
<http://content.nejm.org/cgi/content/short/346/26/#R3> , 4
<http://content.nejm.org/cgi/content/short/346/26/#R4>  Both approaches also
entail a risk of side effects and complications. In some cases,
antiarrhythmic drugs appear to have led to life-threatening ventricular
arrhythmias. 5 <http://content.nejm.org/cgi/content/short/346/26/#R5> , 6
<http://content.nejm.org/cgi/content/short/346/26/#R6>  One new therapeutic
option — pacemakers and defibrillators — is beginning to influence the
management of atrial fibrillation.
Ventricular Pacing during Atrial Fibrillation
During atrial fibrillation, the atrioventricular node is bombarded with
electrical impulses, which typically result in rapid ventricular rates. The
rate at which signals are transmitted to the ventricles depends on the
electrical properties of the conduction system; these properties can be
influenced by medications and autonomic input. The ventricular response may
be slow in patients with intrinsic conduction-system disease, in those who
are taking rate-controlling pharmacologic agents, or in patients with a high
vagal tone. Permanent pacemakers have long been used to treat symptomatic
bradycardia caused by any of these factors.
If rapid ventricular rates persist after pharmacologic therapies for atrial
fibrillation have proved unsuccessful or intolerable to the patient,
permanent ablation of the atrioventricular node is an effective therapy. 7
<http://content.nejm.org/cgi/content/short/346/26/#R7>  An ablation catheter
is introduced through a femoral vein and positioned at the atrioventricular
node under fluoroscopic and electrocardiographic guidance. Radio-frequency
energy is delivered to this site, destroying the underlying conduction
tissue and thus producing permanent heart block and eliminating tachycardia.
This procedure is irreversible and typically leaves the patient with only a
slow escape rhythm, necessitating the implantation of a permanent pacemaker.
In patients with atrial fibrillation that is refractory to drug therapy,
atrioventricular-node ablation decreases the incidence of palpitations,
dyspnea, and fatigue by controlling the ventricular rate and also increases
exercise tolerance. 8 <http://content.nejm.org/cgi/content/short/346/26/#R8>
, 9 <http://content.nejm.org/cgi/content/short/346/26/#R9> , 10
<http://content.nejm.org/cgi/content/short/346/26/#R10>  This approach
eliminates the need for rate-controlling medications. The restoration of a
regular ventricular rhythm with pacing may also have an important role, 11
<http://content.nejm.org/cgi/content/short/346/26/#R11>  since
cardiovascular hemodynamics are impaired by an irregular ventricular rhythm.
12 <http://content.nejm.org/cgi/content/short/346/26/#R12> , 13
<http://content.nejm.org/cgi/content/short/346/26/#R13>
Although ventricular pacing can be used to treat either spontaneous or
treatment-induced bradycardia, it has no effect on the fibrillation in the
atria or on the associated risk of thromboembolism.
Prevention of Atrial Fibrillation with Atrial Pacing
The first evidence that permanent pacing could potentially affect atrial
pathophysiology was derived from retrospective analyses of patients who had
pacemakers implanted for the sick sinus syndrome. Patients with atrial or
dual-chamber pacemakers had fewer episodes of atrial fibrillation than those
with ventricular pacemakers alone. 14
<http://content.nejm.org/cgi/content/short/346/26/#R14> , 15
<http://content.nejm.org/cgi/content/short/346/26/#R15> , 16
<http://content.nejm.org/cgi/content/short/346/26/#R16>  Although
retrospective studies are subject to bias, the data suggested a beneficial
effect of pacing the atrium. In one retrospective analysis of patients who
were followed for up to 12 years after receiving a pacemaker, atrial
fibrillation developed in 26 percent of those with ventricular pacemakers
but in only 5 percent of those with dual-chamber devices. 14
<http://content.nejm.org/cgi/content/short/346/26/#R14>
These retrospective data led to several prospective trials 17
<http://content.nejm.org/cgi/content/short/346/26/#R17> , 18
<http://content.nejm.org/cgi/content/short/346/26/#R18> , 19
<http://content.nejm.org/cgi/content/short/346/26/#R19> , 20
<http://content.nejm.org/cgi/content/short/346/26/#R20> , 21
<http://content.nejm.org/cgi/content/short/346/26/#R21> , 22
<http://content.nejm.org/cgi/content/short/346/26/#R22> , 23
<http://content.nejm.org/cgi/content/short/346/26/#R23> , 24
<http://content.nejm.org/cgi/content/short/346/26/#R24>  that evaluated
whether atrial or dual-chamber pacemakers led to a lower incidence of atrial
fibrillation than did ventricular pacemakers ( Table 1
<http://content.nejm.org/cgi/content/short/346/26/#T1> ). The Canadian Trial
of Physiologic Pacing prospectively followed patients with symptomatic
bradycardia who had either a ventricular or a dual-chamber pacemaker
implanted. Dual-chamber pacing decreased the incidence of both atrial
fibrillation and progression to chronic atrial fibrillation, although these
effects were not seen until two years after the pacemakers had been
implanted. 19 <http://content.nejm.org/cgi/content/short/346/26/#R19> , 20
<http://content.nejm.org/cgi/content/short/346/26/#R20>  The Pacemaker
Selection in the Elderly trial also prospectively followed patients with
either ventricular or dual-chamber pacemakers. Dual-chamber pacing was
associated with a lower incidence of atrial fibrillation in patients with
sinus-node dysfunction but not in patients with atrioventricular block. 21
<http://content.nejm.org/cgi/content/short/346/26/#R21>  The contrasting
outcomes in these two groups suggest that the mechanisms of progression to
atrial fibrillation differ among patients with different types of conduction
disturbances.


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Table 1. Results of Prospective, Randomized Trials of Atrial, Dual-Chamber,
and Ventricular Pacemakers.

One of the largest prospective trials to date, the Mode Selection Trial,
followed more than 2000 patients with the sick sinus syndrome. 25
<http://content.nejm.org/cgi/content/short/346/26/#R25>  Patients were
randomly assigned to receive either a ventricular or a dual-chamber
pacemaker, and the primary end points were mortality and stroke. Although
the two groups did not differ significantly with respect to the primary end
points, dual-chamber pacing had a clear effect on the incidence of atrial
fibrillation. There was almost a 50 percent decrease in the likelihood of a
first episode of atrial fibrillation and a reduction in the risk of
progression to chronic atrial fibrillation with dual-chamber pacing.
Currently, it is common to implant either an atrial or a dual-chamber device
in patients with the sick sinus syndrome who require a pacemaker.
The benefits of dual-chamber pacing over ventricular pacing are both
mechanical and electrical. Atrial pacing allows coordinated contraction of
the chambers, which in turn lowers average atrial pressure and decreases any
stretch-related changes that might be induced in atrial tissue. 26
<http://content.nejm.org/cgi/content/short/346/26/#R26> , 27
<http://content.nejm.org/cgi/content/short/346/26/#R27>  Pacing the atrium
also prevents pauses and thus reduces the risk of atrial fibrillation that
is associated with increased vagal tone and bradycardia. 28
<http://content.nejm.org/cgi/content/short/346/26/#R28>  Lastly, atrial
pacing may suppress ectopic atrial beats that can precipitate bouts of
atrial fibrillation. 29
<http://content.nejm.org/cgi/content/short/346/26/#R29> , 30
<http://content.nejm.org/cgi/content/short/346/26/#R30>
Because all patients in the prospective trials just described received a
pacemaker, the results cannot be compared with those in patients without
devices. Although atrial pacing was associated with a lower incidence of
atrial fibrillation than was isolated ventricular pacing, it is unclear
whether this finding was due to the beneficial effects of pacing the atrium
or to the deleterious effects of pacing the ventricle. It is possible, for
example, that retrograde activation of the atria during ventricular pacing
increases the likelihood of atrial fibrillation. Only studies that compared
atrial pacing with no pacing could prove that pacing the atria had a truly
protective effect.
Alternative-Site and Dual-Site Atrial Pacing
In healthy atrial tissue, each sinus beat initiates the rapid, synchronous
depolarization of the atria and is present as a P wave on the surface
electrocardiogram. In diseased atrial tissue, however, electrical conduction
is slower and more variable, resulting in less coordinated atrial
depolarization and a broader P wave. This slowed, nonuniform conduction may
provide an ideal substrate for reentrant wavelets and atrial fibrillation.
31 <http://content.nejm.org/cgi/content/short/346/26/#R31>
In an effort to promote more synchronized atrial activation in patients with
atrial fibrillation, investigators have studied the effects of pacing the
atria at novel sites. Attaching a pacing lead to the interatrial septum or
to the opening of the coronary sinus allows both atria to be stimulated
simultaneously, resulting in a narrower P wave. 32
<http://content.nejm.org/cgi/content/short/346/26/#R32> , 33
<http://content.nejm.org/cgi/content/short/346/26/#R33> , 34
<http://content.nejm.org/cgi/content/short/346/26/#R34>  A similar result
can be achieved by pacing at Bachmann's bundle, which is a band of tissue
that electrically connects the right and left atria. 35
<http://content.nejm.org/cgi/content/short/346/26/#R35>  Among patients with
paroxysmal atrial fibrillation who required a pacemaker, patients in whom
the atrial lead was placed at Bachmann's bundle 36
<http://content.nejm.org/cgi/content/short/346/26/#R36>  or on the
interatrial septum 37
<http://content.nejm.org/cgi/content/short/346/26/#R37>  had a lower
incidence of paroxysmal and chronic atrial fibrillation than those in whom
the lead was positioned in the traditional right atrial appendage.
Another way to resynchronize the atria is to pace two sites simultaneously.
38 <http://content.nejm.org/cgi/content/short/346/26/#R38>  The most common
configuration is a lead attached to the right atrial appendage in order to
stimulate the right atrium and a lead placed in the coronary sinus in order
to stimulate the left atrium. When two sites are paced concurrently, there
is greater synchronization of the atrial tissue during depolarization. In
the electrophysiology laboratory, this electrical coordination immediately
reduces the ability to provoke atrial fibrillation. 39
<http://content.nejm.org/cgi/content/short/346/26/#R39>  The clinical
relevance of this pacing strategy has been evaluated in studies of patients
who have undergone cardiac surgery, a high-risk group with an incidence of
postoperative atrial fibrillation of 25 to 50 percent. 40
<http://content.nejm.org/cgi/content/short/346/26/#R40> , 41
<http://content.nejm.org/cgi/content/short/346/26/#R41> , 42
<http://content.nejm.org/cgi/content/short/346/26/#R42> , 43
<http://content.nejm.org/cgi/content/short/346/26/#R43>  In these studies,
patients were randomly assigned to receive single-site or dual-site atrial
pacing postoperatively. In three of the studies, 40
<http://content.nejm.org/cgi/content/short/346/26/#R40> , 41
<http://content.nejm.org/cgi/content/short/346/26/#R41> , 42
<http://content.nejm.org/cgi/content/short/346/26/#R42>  patients with
simultaneous pacing from right and left atrial wires had a significant
reduction in the occurrence of atrial fibrillation ( Table 2
<http://content.nejm.org/cgi/content/short/346/26/#T2> ).


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Table 2. Results of Prospective, Randomized Trials of Dual-Site and
Single-Site Atrial Pacing.

Whereas these four studies evaluated the effect of dual-site pacing on the
incidence of atrial fibrillation during a brief, high-risk period, other
trials have examined the effects in the general population of patients with
atrial fibrillation ( Table 2
<http://content.nejm.org/cgi/content/short/346/26/#T2> ). 44
<http://content.nejm.org/cgi/content/short/346/26/#R44> , 45
<http://content.nejm.org/cgi/content/short/346/26/#R45>  A study of patients
who had a prolonged P wave consequent to delayed atrial activation found
that simultaneous pacing from two atrial sites shortened the P wave and
significantly decreased the rate of progression to persistent atrial
fibrillation. 44 <http://content.nejm.org/cgi/content/short/346/26/#R44>  In
a recently completed crossover study of 120 patients with atrial
fibrillation, long-term dual-site atrial pacing combined with treatment with
antiarrhythmic drugs reduced the incidence of atrial fibrillation by 34
percent. 46 <http://content.nejm.org/cgi/content/short/346/26/#R46>
The role of dual-site pacing in the long-term management of atrial
fibrillation is unclear, since medical therapy alone can usually control the
symptoms of atrial fibrillation. Placing a second atrial lead can be
technically challenging, and there is a risk of coronary-sinus lead
dislodgement. In addition, the presence of two atrial leads creates unique
sensing issues: native atrial beats may be counted twice, leading to an
inappropriate pacemaker response. In patients who require a pacemaker for
concomitant bradycardia, single-site atrial pacing remains the standard of
care. If future improvements reduce the problems associated with the
implantation of dual atrial leads, however, this approach could become a
useful adjunctive therapy, particularly in patients with a delay in
interatrial conduction.
Overdrive Atrial Pacing
The fundamental function of a pacemaker is to prevent the heart rate from
falling below a certain threshold. The amount of pacing that actually occurs
depends on the relation between the programmed lower limit and the native
heart rate. The faster the setting of the pacemaker, the more it will
override the intrinsic rate (referred to as "overdrive"). In addition to
influencing the pattern of atrial depolarization, atrial pacing most likely
also suppresses premature atrial beats, which precede and trigger episodes
of atrial fibrillation. 29
<http://content.nejm.org/cgi/content/short/346/26/#R29> , 30
<http://content.nejm.org/cgi/content/short/346/26/#R30>  Both these effects
reduce the initiation of atrial fibrillation, particularly when atrial
pacing predominates over native atrial activity.
Several prospective studies have demonstrated that a faster atrial pace
results in a higher percentage of paced beats and fewer episodes of atrial
fibrillation. In one small trial in which the atrial pacing rate was 10
beats per minute faster than the mean heart rate, 47
<http://content.nejm.org/cgi/content/short/346/26/#R47>  the incidence of
atrial arrhythmias was significantly reduced over a 30-day period, and
atrial fibrillation was eliminated in 14 of the 22 patients. In another
study, patients who had a higher percentage of paced beats had a lower
incidence of atrial arrhythmia. 48
<http://content.nejm.org/cgi/content/short/346/26/#R48>  In other studies,
however, fixed atrial pacing did not significantly suppress atrial
fibrillation. 49 <http://content.nejm.org/cgi/content/short/346/26/#R49>
These negative trials did not achieve as much of an increase in the level of
atrial pacing, suggesting that atrial pacing needs to predominate over
intrinsic atrial activity to reduce the initiation of atrial fibrillation.
In an attempt to increase the effectiveness of atrial pacing as an
antiarrhythmic therapy without the use of excessive rates of pacing, complex
algorithms have been developed. 50
<http://content.nejm.org/cgi/content/short/346/26/#R50> , 51
<http://content.nejm.org/cgi/content/short/346/26/#R51>  These approaches
advocate continuous monitoring of native atrial activity and the use of a
pacing rate that is slightly faster than the sinus or ectopic atrial rate.
The goals of these algorithms include achieving a higher degree of atrial
pacing and reducing the sudden rate change that occurs after premature
beats. In several studies, the use of sophisticated pacing strategies led to
rates of atrial pacing of more than 80 percent and to a more consistent
ability of the pacemaker to suppress bouts of atrial fibrillation. 52
<http://content.nejm.org/cgi/content/short/346/26/#R52> , 53
<http://content.nejm.org/cgi/content/short/346/26/#R53>  A recent trial
achieved a rate of atrial pacing of 93 percent with the use of a
dynamic-atrial-overdrive algorithm and decreased the number of days during
which atrial fibrillation occurred by 25 percent. 54
<http://content.nejm.org/cgi/content/short/346/26/#R54>  The use of this
algorithm has been approved by the Food and Drug Administration, and devices
with this feature are now being used in clinical practice. Clinical studies
of overdrive atrial pacing in patients who do not meet the traditional
criteria for the implantation of a pacemaker are now under development.
High-Frequency Pacing and Electrical Cardioversion
Although aggressive atrial pacing may help to prevent atrial fibrillation,
it has no effect on atrial fibrillation once it occurs. Sinus rhythm should
be restored soon after the onset of atrial fibrillation in order to minimize
the risk of stroke, rapidly restore physiologic hemodynamics, and avoid the
electrical changes in the atria that tend to maintain a fibrillatory
substrate. 55 <http://content.nejm.org/cgi/content/short/346/26/#R55> , 56
<http://content.nejm.org/cgi/content/short/346/26/#R56>  The concept of
using an implanted device to terminate supraventricular arrhythmias is not
new. In the past, these devices were used exclusively to treat
supraventricular tachycardias that were electrically organized, such as
atrioventricular-node reentry and atrial flutter, and therefore amenable to
termination by rapid atrial pacing. 57
<http://content.nejm.org/cgi/content/short/346/26/#R57> , 58
<http://content.nejm.org/cgi/content/short/346/26/#R58>  The problem with
these early antitachycardia devices, however, was that rapid pacing did not
terminate atrial fibrillation.
The goal of detecting and promptly treating symptomatic atrial fibrillation
inspired the development of the implantable atrial defibrillator. The first
of these devices (the Metrix Atrioverter, InControl) was implanted in a
small group of patients but is no longer manufactured. It consisted of two
atrial defibrillation leads, one in the right atrium and one in the coronary
sinus, as well as a ventricular pacing lead, which was used to synchronize
shocks to the QRS complex. The device was programmed to detect atrial
fibrillation and administer a shock to restore sinus rhythm. Because atrial
fibrillation is usually not immediately life-threatening, the shock can be
discharged under manual control or after a delay. In the initial trial, this
device was used only to deliver shocks under a physician's supervision, 59
<http://content.nejm.org/cgi/content/short/346/26/#R59>  and patients were
sedated, since atrial shocks may be painful. The device was also tested in
an outpatient setting; almost half the patients were permitted to trigger
the delivery of shocks at home. The overall efficacy of the device in
terminating atrial fibrillation was 90 percent, with almost one third of
episodes requiring more than one shock. 60
<http://content.nejm.org/cgi/content/short/346/26/#R60>  Although the
patients experienced moderate discomfort from the shocks, they reported a
high degree of satisfaction with the device. There were no instances of
ventricular proarrhythmia.
A combined atrial and ventricular defibrillator (the Jewel AF device,
Medtronic) was approved by the Food and Drug Administration to treat either
drug-refractory atrial fibrillation or ventricular arrhythmias. It
demonstrated a high degree of discrimination between atrial and ventricular
tachyarrhythmias, resulting in cardioversion of 76 percent of rhythms
identified as atrial fibrillation. 61
<http://content.nejm.org/cgi/content/short/346/26/#R61>  An updated version
of the device (the GEM III AT, Medtronic) is currently in use. The shocks
for atrial fibrillation can be activated by the patient or can be programmed
to occur automatically in the early morning while the patient is asleep,
thus ensuring that a shock is delivered within 24 hours after the onset of
atrial fibrillation. Theoretically, prompt cardioversion may prevent
thrombus and stroke, although this outcome has not yet been studied. This
device can also deliver rapid atrial pacing to treat atrial arrhythmias.
High-frequency (burst) pacing terminates atrial fibrillation about 17
percent of the time, suggesting that painful shocks can occasionally be
avoided. 61 <http://content.nejm.org/cgi/content/short/346/26/#R61>  These
various therapies for atrial arrhythmias have been very safe, with no
reported instances of ventricular proarrhythmia.
Evaluation of the electrogram strips stored in implantable defibrillator
devices has provided new insights into the mechanisms of the initiation of
atrial fibrillation. In one study, all the patients had had clinical atrial
fibrillation before the device was implanted, but only 19 percent of
device-detected atrial arrhythmias were found to be atrial fibrillation. 62
<http://content.nejm.org/cgi/content/short/346/26/#R62>  The rest were other
types of atrial tachyarrhythmias, suggesting that episodes of atrial
fibrillation may often be preceded by more organized rhythms. These
organized arrhythmias are much more amenable to termination by rapid atrial
pacing, with success rates of about 50 percent. 63
<http://content.nejm.org/cgi/content/short/346/26/#R63> , 64
<http://content.nejm.org/cgi/content/short/346/26/#R64> , 65
<http://content.nejm.org/cgi/content/short/346/26/#R65>
Atrial-defibrillator therapy is currently suitable only for a small subgroup
of patients with symptomatic, drug-refractory atrial fibrillation, since
there is no evidence that treating asymptomatic episodes of atrial
fibrillation has clinical benefit. The frequency of atrial fibrillation is
another important variable. The episodes should be frequent enough to
warrant the implantation of a device, but not so frequent that the patient
would experience many shocks. The ideal patient population for this invasive
antiarrhythmic strategy has not yet been defined. Because approximately 25
percent of patients who receive an implantable defibrillator for ventricular
arrhythmias also have paroxysmal atrial fibrillation, 66
<http://content.nejm.org/cgi/content/short/346/26/#R66>  a combined
treatment device may also be appropriate.
Conclusions
Implantable pacemakers and defibrillators are undergoing rapid evolution.
Currently used devices combine pacing and cardioversion therapies both to
prevent and to treat atrial fibrillation ( Figure 1
<http://content.nejm.org/cgi/content/short/346/26/#F1> ). Recent studies
have shown that these devices can significantly decrease the incidence of
atrial fibrillation 63
<http://content.nejm.org/cgi/content/short/346/26/#R63>  and improve the
quality of life. 67 <http://content.nejm.org/cgi/content/short/346/26/#R67>
Although the current guidelines for the management of atrial fibrillation
predominantly encompass pharmacologic strategies, 68
<http://content.nejm.org/cgi/content/short/346/26/#R68>  implantable devices
are likely to have an increasing role in the near future, particularly when
they are used in combination with other treatments.


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Figure 1. Devices Used to Treat Atrial Fibrillation.
Dual-site atrial pacing (Panel A) can resynchronize the atria when atrial
conduction is slow. One lead paces the right atrium, and the second lead is
placed in the coronary sinus to pace the left atrium. The result is a
narrower P wave on the electrocardiogram. Ventricular pacing (Panel B) can
prevent symptomatic bradycardia, which may be due to intrinsic
conduction-system disease, medications that block the atrioventricular node,
or ablation of the atrioventricular node. Atrial pacing (Panel C) is
associated with less frequent atrial fibrillation than ventricular pacing.
Overdrive atrial pacing (Panel D) can suppress premature beats and other
triggers of atrial fibrillation. Atrial defibrillators (Panel E) can detect
atrial fibrillation and deliver a shock to restore sinus rhythm. The right
atrium is depolarized by the proximal electrode (shown as a coil), and the
energy subsequently depolarizes the rest of the myocardium and reenters the
distal electrode (shown as a coil in the right ventricle).




Source Information
From the Cardiovascular Division, Brigham and Women's Hospital, Boston
(J.M.C.); and Division of Cardiology, Veterans Affairs Boston Healthcare
System, Veterans Affairs Medical Center, West Roxbury, Mass. (M.S.K.,
M.V.O.).
Address reprint requests to Dr. Katcher at Cardiology 111A, VA Boston
Healthcare System, 1400 VFW Pkwy., West Roxbury, MA 02132.
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Edward E. Rylander, M.D.
Diplomat American Board of Family Practice.
Diplomat American Board of Palliative Medicine.



Edward E. Rylander, M.D.
Diplomat American Board of Family Practice.
Diplomat American Board of Palliative Medicine.