(Circulation. 2000;101:878.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
ls, MDFrom Cedars-Sinai Medical Center, Los Angeles, Calif (C.D.S.); University of Heidelberg, Heidelberg, Germany (W.S.); University of Maastricht, Maastricht, the Netherlands (B.D.); University of Bonn, Bonn, Germany (W.J.); and Medtronic Inc, Minneapolis, Minn (N.V.S., W.H.O., B.D.G.).
Correspondence to Charles D. Swerdlow, MD, 8635 W. Third Street, Ste 1190 W, Los Angeles, CA 90048. E-mail swerdlow{at}ucla.edu
| Abstract |
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Methods and ResultsWe studied 80 patients with AT/AF and ventricular arrhythmias who were treated with a new atrial/dual-chamber ICD. During a follow-up period lasting 6±2 months, we validated spontaneous, device-defined AT/AF episodes by stored electrograms in all patients. In 58 patients, we performed 80 Holter recordings with telemetered atrial electrograms, both to validate the continuous detection of AT/AF and to determine the sensitivity of the detection of AT/AF. Detection was appropriate in 98% of 132 AF episodes and 88% of 190 AT episodes (98% of 128 AT episodes with an atrial cycle length <300 ms). Intermittent sensing of far-field R waves during sinus tachycardia caused 27 inappropriate AT/AF detections; these detections lasted 2.6±2.0 minutes. AT/AF was detected continuously in 27 of 28 patients who had spontaneous episodes of AT/AF (96%). The device memory recorded 90 appropriate AT/AF episodes lasting >1 hour, for a total of 2697 hours of continuous detection of AT/AF. During Holter monitoring, the sensitivity of the detection of AT/AF (116 hours) was 100%; the specificity of the detection of non-AT/AF rhythms (1290 hours) was 99.99%. Of 166 appropriate episodes detected as AT, 45% were terminated by antitachycardia pacing.
ConclusionsA new ICD detects AT/AF accurately and continuously. Therapy may be programmed for long-duration AT/AF, with a low risk of underdetection. Discrimination of AT from AF permits successful pacing therapy for a significant fraction of AT.
Key Words: atrial fibrillation defibrillators, implantable arrhythmia atrial flutter
| Introduction |
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24
hours. To achieve this goal, an ICD must sense low and
varying-amplitude AF electrograms and detect AF continuously. It must
distinguish continuous AF, which may require shocks, from termination
and subsequent reinitiation of AF, for which shocks should be withheld.
However, atrial sensing of far-field R waves should not cause
inappropriate detection of AT/AF. Further, an atrial ICD should
discriminate between AT, which may be terminated by
antitachycardia pacing, and AF, which requires
cardioversion. A new dual-chamber ICD (Medtronic Jewel AF 7250) detects specific atrial and ventricular tachyarrhythmias; has independently programmable therapy for AT, AF, ventricular tachycardia (VT), and ventricular fibrillation (VF); and functions as a DDD pacemaker. We studied patients treated with this ICD to determine if the device could detect AT/AF accurately and continuously and discriminate AT from AF.
| Methods |
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2 episodes of
AF and/or AT in the 3 months before implantation. All patients gave
written, informed consent according to a protocol approved by the Human
Subjects Committee of the institution at which the devices were
implanted.
Implant Procedure
The ICD pulse generator and electrodes were inserted through a
single left pectoral incision. A closely spaced (9.1 or 9.5 mm)
right atrial bipole was used for atrial sensing. The P-wave amplitude
in sinus rhythm was measured. A 2-lead defibrillation system (right
atrium and right ventricle) was used in 74 patients, and a 3-lead
system (including a coronary sinus electrode) was used in 6
patients. The electrode system was selected by investigator
preference.
Detection of AT/AF
AT/AF was detected by a combination of median atrial cycle
length and an AT/AF evidence counter that uses the number of
sensed atrial electrograms in consecutive RR intervals. This counter
provides high specificity for detecting AT with N:1
atrioventricular conduction (Figure 1A
). The counter operates in 2 different
modes for preliminary and sustained detection. Preliminary detection
occurs when the count reaches 32 and the median cycle length for the
last 12 PP intervals is less than the programmed AT or AF detection
interval. Preliminary detection initiates an AT/AF episode. The episode
timer begins, and the evidence counter switches to the
sustained-detection mode in which AT/AF remains detected if the count
is
27 and the atrial rate criterion remains fulfilled (Figure 2
).
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Termination of Device-Defined AT/AF Episodes
A device-defined atrial arrhythmia episode ends with the
detection of 5 consecutive beats of sinus- or atrial-paced rhythm or 3
minutes of unclassified atrial rhythm. Sinus rhythm is defined by a
previously described dual-chamber algorithm (PR Logic).1 2
This algorithm is also used to discriminate between rapidly conducted
AT/AF and VT/VF for the purpose of withholding ventricular
therapy. Accuracy of this discrimination was not analyzed in
the present study. The AT/AF detection algorithm studied in this
report was used only for delivering or withholding AT/AF therapy, not
to discriminate AT/AF from VT/VF.
Far-Field R-Wave Discrimination
To ensure the accurate sensing of atrial rate and rhythm, the
ICD has minimal postventricular atrial blanking. Minimal
blanking and autoadjusting atrial sensitivity may result in
inappropriate atrial sensing of far-field R waves. The detection
algorithm discriminates far-field R waves from AT/AF using the
following 3 criteria: exactly 2 atrial events in each RR interval, a
stable and short interval between the R wave on the
ventricular channel and the far-field R wave on the atrial
channel, and stable alternation in atrial intervals. If all 3 criteria
are met, the atrial electrogram after the R wave is classified as a
far-field R wave and excluded from the AT/AF evidence count (Figure 3
).2 3
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AT/AF Autodiscrimination
AF and AT detection zones may overlap to permit
antitachycardia pacing for fast, regular atrial
arrhythmias (Figure 1B
). If the atrial cycle length is
in this overlap zone, the atrial rhythm is classified as AT if it is
regular and AF if it is not.
ICD Programming
Automatic therapies for AT/AF were programmed using a
randomized, crossover design: on or off for the first 3 months and the
opposite setting for the next 3 months. Thus, not all episodes of
spontaneous AT/AF were treated.
Holter Recordings
Digital Holter recordings were performed in 59 patients.
Recordings included 1 ECG lead, a telemetered atrial
electrogram, and atrioventricular pace/sense markers.
In 14 patients, Holter recordings were used to mark the time
for the initial detection of AF in a postoperative electrophysiologic
study. In 58 patients, a total of 80 Holter recordings were
performed during follow-up both to validate the continuous detection of
spontaneous AF and to determine the sensitivity of the detection
algorithm for AT/AF. Patients who had frequent AT/AF, AF in progress,
or inappropriate detection of AT/AF were selected for multiple
recordings.
Follow-Up
Patients were followed for a total of 491 patient-months from
the date of implant until the date of study closure or patient death.
Five patients died during follow-up, 4 from heart failure and 1 from
cancer. The mean duration of follow-up was 6±2 months (median, 6
months; range, 1 to 11 months). ICDs were interrogated at 1 month and 3
months, every 3 months thereafter, and whenever patients reported
shocks or palpitations.
Data Analysis
Appropriate versus inappropriate detection of spontaneous AT/AF
was determined from electrograms and intervals stored before therapy.
Because the ICD does not store electrograms or intervals for untreated
AT/AF episodes, only treated episodes were analyzed for the
group as a whole.
Continuous versus intermittent detection of ongoing, sustained AT/AF
was determined from intervals stored before the termination of
device-defined episodes. Termination was judged appropriate when the
P:R pattern showed sinus rhythm or DDI pacing. Inappropriate episode
termination caused by atrial undersensing was suspected if
50% of
intervals before episode termination were shorter than the detection
interval corresponding to that episode (AT or AF). A pattern of
repetitive detections and terminations was used to identify
inappropriate episode termination. Device-defined sustained AT/AF was
classified as continuous if episode termination was appropriate and as
intermittent if episode termination was inappropriate.
Data are presented as means±1SD. P<0.05 was used to reject the null hypothesis. Basic comparisons were made using the paired t-test, unpaired t-test, Mann-Whitney U test, or chi-squared test.
| Results |
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Initial Detection of AF
The initial detection of AF was analyzed during an
electrophysiologic study in 14 patients for 129 induced and 36
spontaneous episodes of AF (Figure 2
). The time for initial
detection was 18±4 s. The median PP interval was 192±27 ms.
Spontaneous AT/AF
During follow-up, 31 patients had episodes of spontaneous AT/AF
that were detected and treated: AF only occurred in 13 patients, AT
only in 8 patients, and both in 10 patients. Twenty-eight patients had
only appropriate detections, 3 had only inappropriate detections, and 2
patients had both.
Detection was appropriate in 88% of 190 AT episodes, and 98% of 132
AF episodes. See Table 2
for details. The
longest inappropriate episode lasted 9.5 minutes. The 27 inappropriate
AT/AF detections resulted in 29 antitachycardia pacing
therapies; 28 were asymptomatic, and 1 induced AF, which
was terminated by atrial defibrillation.
|
Figure 4
shows a histogram of the median
atrial cycle length for treated AT and AF episodes. The median cycle
length was
240 ms in 84% of appropriate AF episodes, but it was
250 ms for all 3 inappropriate AF episodes (P<0.01). Of
the 128 AT episodes with a median cycle length <300 ms, 98% were
appropriate. However, 22 of 24 inappropriate AT episodes (92%) had a
median cycle length
300 ms. Overall, the median cycle length was
longer for inappropriately detected episodes than for appropriately
detected episodes (AT, 336±52 versus 246±57 ms, P<0.001;
AF, 267±17 versus 203±37 ms, P<0.01).
|
Inappropriate Detection of AT/AF
Misclassification of far-field R waves caused all inappropriate
detections. These occurred most commonly because of conducted premature
atrial complexes that changed the pattern of the stable alternation of
PP intervals (n=19, 2 patients; Figure 5A
). A second cause was DDI pacing, which
resulted in unstable PR intervals (n=6, 1 patient; Figure 5B
).
Other causes included variations in the intervals between the right
ventricular electrogram and the far-field R-wave
electrogram (n=1) and first-degree atrioventricular
block in sinus tachycardia, resulting in equal PR and R to
far-field R intervals (n=1).3 In all
cases, the short duration of inappropriate detection was due to rapid
redetection of the sinus-rhythm pattern or correct classification of
far-field R waves.
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Inappropriate detection of far-field R waves was corrected in 3 patients by decreasing atrial sensitivity. No parameters were reprogrammed in 2 patients who had no subsequent inappropriate detections.
Detection of Ongoing AT/AF
Of the 295 appropriate episodes of spontaneous AT/AF, 294 (99.7%)
were detected continuously (Figure 6
).
One episode was detected continuously for 10 days. There were 90 AT/AF
episodes >1 hour in 19 patients, with a total duration of 2697 hours.
One episode of asymptomatic AF was undersensed and
intermittently underdetected because the atrial sensitivity had been
set to 0.9 mV to prevent oversensing of far-field R waves. Undersensing
was corrected by reprogramming atrial sensitivity. No patient had
symptomatic, undetected AT/AF.
|
Holter Recordings
Of the 80 Holter recordings made during follow-up, 1406
hours had a suitable quality of both telemetered atrial electrograms
and surface ECG for analysis (18±7 hours of
recording). Tables 3 through 5![]()
![]()
summarize all Holter-recorded episodes of AT/AF that satisfied the
minimum duration corresponding to the initial detection criterion (32
RR intervals). All 120 AT and 26 AF episodes that satisfied the
programmed atrial rate criterion were detected continuously, for a
total of 116 hours. Three episodes of AT lasting a total of 3 minutes
were not detected because the AT cycle length exceeded the programmed
detection interval. Holter-recorded AF electrograms had a wide
variation in slew rate and amplitude, as shown in Figures 2
, 5
, and 6
.
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A total of 1290 hours of Holter recordings were made during which the atrial rhythm was sinus- or atrial-paced. In this period, 6 inappropriate detections of AT/AF occurred, lasting a total of 7 minutes. Expressed in terms of duration of ICD-classified rhythms, sensitivity for the detection of AT/AF that satisfied detection criteria according to Holter analysis was 100%, whereas specificity for the detection of rhythms other than AT/AF was 99.99%.
AT/AF Discrimination
Of the 166 spontaneous, appropriate, and treated AT episodes, 116
(70%) had a cycle length in the AT/AF overlap zone (214±22 ms), and
50 (30%) had a cycle length more than the AF detection interval
(321±39 ms) (Figure 7
). No significant
difference existed between the success rate of
antitachycardia pacing in the overlap zone (49 of 116
episodes, 42%) and the success rate in the slower AT zone (26 of 50
episodes, 52%; P=0.34).
|
| Discussion |
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Goals of AT/AF Detection
Antiarrhythmic devices detect AT/AF to perform 3 functions: mode
switching to prevent inappropriate tracking of AT/AF,4 5
withholding inappropriate ventricular
therapy,1 6 and delivery of atrial
therapy.7 8 The dual-chamber ICD evaluated in the
present study performs all 3 functions. It is the first ICD that
permits therapy for long-duration AT/AF while withholding therapy from
self-terminating AT/AF. It is, thus, the first ICD that must detect low
and varying fibrillation electrograms continuously for extended
periods. It also discriminates between AT and AF to deliver
antitachycardia pacing for AT; thus, it must determine the
atrial rate and rhythm accurately.
AT/AF Detection in Other Devices
Dual-chamber pacemakers and some ICDs do not require
accurate determination of atrial rate and rhythm. They have
postventricular atrial blanking and refractory periods that
prevent atrial oversensing of far-field R waves9 but
result in undersensing of AT/AF, particularly during high
ventricular rates and AT with 2:1
atrioventricular conduction.5
An atrial ICD10 detects AF intermittently. Thus, continuous AF cannot be distinguished from sequential, self-terminating episodes. Atrial electrograms are analyzed only during the electrocardiographic ST segment, so the precise rate and regularity of the atrial rhythm cannot be determined. AT is not detected, AF is not detected during ventricular-paced rhythm, and a coronary sinus electrode is required for sensing. Wellens et al8 reported that the sensitivity for the detection of AF was 92%.
AT/AF Detection and Discrimination in the Jewel AF
Several features combined to permit continuous detection of
AF for extended periods. A closely spaced, atrial sensing
bipole,11 autoadjusting sensitivity with a short time
constant, and minimal atrial blanking all minimize atrial undersensing.
The detection algorithm continues to detect AF, despite some
undersensing and brief periods of unclassified atrial rhythm.
Determining the atrial rate and rhythm accurately requires that postventricular, atrial blanking be minimized to a value insufficient to blank far-field R waves. Thus, the detection algorithm must prevent the sensing of far-field R waves from causing inappropriate detection of AT/AF.
Accuracy of AT/AF Detection
The present study describes the initial, multicenter
experience with this ICD, during which the importance of minimizing
far-field R waves was not recognized uniformly. Nevertheless, the
true-positive detection rate was 98% for AF and 98% for AT, with a
detection interval
300 ms. All inappropriate detections with a median
atrial cycle length
320 ms lasted
5 minutes. However, an AT
detection interval >300 ms facilitates inappropriate detection by
increasing the probability that inappropriately classified far-field
R-wave intervals will reduce the measured atrial cycle length below the
AT detection interval.
All sustained episodes of AF were detected continuously when atrial
sensitivity was
0.6 mV. Holter monitoring with telemetered atrial
electrograms confirmed the 100% sensitivity for continuous detection
of AT/AF and the high specificity for the rejection of non-AT/AF atrial
rhythms.
Discrimination of AT and AF
The Jewel AF classifies the atrial rhythm as AT if the atrial rate
is in the AT zone or if the atrial rhythm is regular and the atrial
rate is in the AT/AF overlap zone. The success rates for
antitachycardia pacing were similar in the 2 zones, which
permitted painless termination of some regular atrial
arrhythmias in the AF rate zone.
Limitations
The study had some limitations. (1) The sensitivity for the
detection of AT/AF could not be evaluated for the entire population.
(2) Continuous detection of AT/AF was inferred for most episodes and
validated only for those recorded by Holter monitoring. (3) AT/AF
was classified on the basis of rate and regularity of bipolar atrial
electrograms. Some episodes classified as AT may have been
electrophysiological AF.12 (4)
The study protocol did not require repositioning the atrial electrodes
during implantation to avoid sensing far-field R waves or
recording the amplitude of far-field R waves.
Clinical Implications
This study clarifies several principles for the optimal
application of atrial ICDs that have minimal atrial blanking periods.
(1) The atrial electrode should be positioned to minimize far-field R
waves. (2) The AT/AF detection interval should be set slightly greater
than the anticipated AT/AF interval. In contrast, optimal programming
for DDD pacemakers or dual-chamber ICDs requires setting the
mode-switch or AT/AF rate threshold slightly above the maximum sinus
rate to compensate for atrial blanking and refractory periods. (3) The
AT detection interval should be
300 ms to minimize inappropriate
detection due to far-field R waves. It may be
300 ms only if no
atrial sensing of far-field R waves occurs. (4) Inappropriate detection
of AT/AF caused by atrial oversensing of far-field R waves is
transient, and it need not result in inappropriate therapy. Restricting
therapy to episodes >10 minutes prevents inappropriate AT/AF therapy
and does not delay VT/VF therapy. Attention to the first 3 principles
should minimize inappropriate detection, whereas attention to the
fourth should minimize inappropriate AT/AF therapy in the event of
inappropriate detection.
Conclusions
AT/AF can be detected rapidly and continuously by a
dual-chamber, atrial ICD. Thus, shocks may be programmed for
long-duration AT/AF without the risk of inappropriate episode
termination due to atrial undersensing. Discrimination of AT versus AF
on the basis of the regularity of the atrial rhythm permits successful,
painless antitachycardia pacing for some rhythms that would
otherwise require painful cardioversion.
| Acknowledgments |
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| Footnotes |
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| Appendix 1 |
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Received June 7, 1999; revision received September 8, 1999; accepted September 23, 1999.
| References |
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