Automatic analysis of pacemaker

diagnostic data in the identication of

atrial tachyarrhythmias in patients with
no prior history of them
A. Schuchert
a,
*, S. Lepage
b
, J.J. Ostrander
c
, R.J. Bos
d
,
M. Gwechenberger
e
, A. Nicholls
f
, G. Ringwald
g
a
Heart Center, University Hospital Hamburg-Eppendorf, Hamburg,
Martinistrasse 52, D-20251 Hamburg, Germany
b
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada
c
Grey Bruce Health Services Corporation, Owen Sound, ON, Canada
d
Franciscus Ziekenhuis, Roosendaal, The Netherlands
e
AKH, Wien, Austria
f
Leeds General Inrmary, Leeds, UK
g
Gemeinschafts Praxis, Bruchsal, Germany
Submitted 27 September 2004, and accepted after revision 30 January 2005
KEYWORDS
pacemaker
diagnostics;
expert system;
atrial tachyarrhythmia
Abstract Aims Modern pacemakers provide a large amount of diagnostic data.
Given the limited time available during a pacemaker follow-up visit essential
information may be overlooked. This registry was conducted to assess the utility of
an expert system that analyses the diagnostic data collected by an implanted
pacing device and noties and advises the physician about suspected technical
issues and arrhythmias that need further attention.
Methods Patients with various standard indications for pacing were included in
this registry and received single or dual chamber pacemakers. Data were collected
and analysed by the expert system during at least two subsequent follow-up visits.
The evaluation of this system focused on data obtained from patients with a dual
chamber pacing device without prior history of atrial arrhythmias.
Results A total number of 239 patients without prior history of atrial tachyar-
rhythmias were included in this analysis. Atrial tachyarrhythmias were detected in
73 (31%) of these patients. The highest incidence of newly detected arrhythmias
occurred in the group of patients with high-degree AV block and VDD pacemakers.
* Corresponding author. Tel.: C49 404 717 5304; fax: C49 404 717 7420.
E-mail address: [email protected] (A. Schuchert).
1099-5129/$30 2005 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.eupc.2005.01.005
Europace (2005) 7, 242e247

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Furthermore, newly detected arrhythmias predominantly occurred in the period
shortly after implantation. Device programming suggestions by the expert system
were adopted in 30% of the cases. Following detection of atrial tachyarrhythmias by
the expert system, pharmacological management was adjusted at 71% of the rst
follow-up visits and at 27% of later follow-up visits.
Conclusion Results of this registry show that this expert system provides
a valuable tool for the detection of atrial tachyarrhythmias during pacemaker
follow-up visits.
2005 The European Society of Cardiology. Published by Elsevier Ltd. All rights
reserved.
Introduction
Modern pacemakers are capable of storing a large
amount of diagnostic data related to various ar-
rhythmias. One of the most striking advantages of
having such diagnostic data is that it is collected on
a 24-h day and 7-day week basis. This allows
physicians to evaluate the appropriate function of
the device, the status and progression of the
patients arrhythmias and the effects of pacing
and pharmacological therapies [1e4]. However, it
also means that the data have to rst be retrieved
and carefully analysed, which adds considerably to
the length of each follow-up visit. Furthermore,
correct interpretation of the retrieved data re-
quires extensive experience with pacemaker man-
agement, especially since specialized information
in the form of textbooks or original reports is rare.
One solution to this problem is to develop
software that is capable of automatically analysing
the data obtained during pacemaker interrogation.
Such software, which is also referred to as an expert
system, combines the expert knowledge that is
embedded in the software with individual patient
diagnostic data. It is designed to provide relevant
messages if technical issues arise such as sensing
failures or if signicant arrhythmic events occur.
The progressively increasing functionality of modern
pacemaker programmers allows for the introduction
of such an expert system, known as Diagnostic
Observations (DOs), into daily clinical routine.
The DORE registry (Diagnostic Observation REg-
istry) was designed to carry out a prospective
evaluation of the performance of an expert system
for the automatic analysis of diagnostic pacemaker
data in a large patient population.
Only patients with a newly implanted pace-
maker that had the DOs feature were included in
the registry. Since newly implanted devices in
particular often require reprogramming, auto-
matic systems that evaluate device performance
and alert the physician to signicant arrhythmic
events are expected to have the most utility during
the immediate post implantation period.
Methods
Patients and devices
Patients with a wide variety of pacemaker indica-
tions, who received both single and dual chamber
pacemakers, were included in the registry. No
specic inclusion criteria applied to this registry.
For the study we used the Clarity DDDR, Clarity
SSIR and the Collection 3 series of pacemakers
(Saphir VVD/R, Diamond DDDR, Ruby DDD and Topaz
SSIR, Vitatron BV, Arnhem, The Netherlands). These
are state-of-the-art pacemakers equipped with the
DO function.
These pacemakers continuously collect data on
cardiac events and carry out measurements by, for
example, periodically measuring the amplitude of
atrial signals. This information is then stored in the
pacemaker memory for later retrieval and auto-
matic analysis by the DOs function. The diagnostic
information used by the DOs function is identical to
the information provided to the physician; the DOs
function interprets these data and presents con-
densed information and recommendations to the
physician. Information related to possible atrial
tachycardia is based on diagnostics, emanating
from the mode switching algorithm, such as the
amount of atrial sensed rhythm that is classied as
pathological and the percentage of atrioventricular
(AV) dissociation. Mode switching itself is an algo-
rithm that has been used for many years in these
devices and is based on a beat-to-beat analysis of
the atrial rhythm [5].
Messages such as Low paced atrial rates
(indicative of chronotropic incompetence), or
Suspected atrial undersensing can be solved
by reprogramming sensing parameters or activat-
ing rate adaptive pacing. Messages indicat-
ing signicant arrhythmic events may require
additional intervention or adjustment of pacing
parameters and/or pharmacological therapy.
This is very important if the events are new or
have not previously been seen. Particularly rele-
vant is any suggestion of the presence of atrial
Automatic analysis of pacemaker diagnostic data 243
tachyarrhythmias (AT) that the expert system
detects on the basis of a relatively low percentage
of AV synchrony (Less than 96% AV synchrony) in
combination with mode switching (percentage of
pathological atrial rates).
Design
One year of postoperative pacemaker follow-up
data were used for the DORE registry. This could
include up to four follow-up visits: one week after
implantation, and after 3, 6 (as an option), and 12
months. Unscheduled follow-up visits were sepa-
rately reported.
At the start of each follow-up visit, patient
symptoms were recorded and pacemaker data
were retrieved. Upon retrieval, the expert system
analysed the diagnostic information and recog-
nized and responded to several events. The phys-
ician was alerted to any notable events by an
appropriate message (a Diagnostic Observation),
which was displayed on the programmer screen.
All DOs were documented at each follow-up. The
physician was asked to conrm the presented
message by reviewing the underlying diagnostic
data, such as 24 h heart rate trend and various
histograms and event counters. Subsequently, any
changes in pacing and drug therapy and their
relationship to the DOs were documented.
Analysis
The DORE registry included patients with a wide
variety of pacemaker indications and included
single and dual chamber pacemakers. The data
analysis presented in this manuscript focuses on
the detection of AT, the most frequent observation
indual chamber devices. Our particular interest was
in patients with no known history of AT and the
proportion of these patients in whom the expert
system detected the presence of this tachyarrhyth-
mia. In addition we stratied the patients by in-
dication for pacing.
Results
Patients
Multiple centres from eight European countries
and from Canada contributed to the registry. A
total of 358 pacemaker patients were entered,
comprising 192 (53%) males and 166 (47%) females.
In the rst year after implantation, all patients
underwent at least two follow-up examinations,
with 46% of them having at least three. Hospital
discharge data were available for 351 patients. The
1e3 months follow-up was reported for 276 pa-
tients, the 5e7 months follow-up for 175 patients
and the 10e14 months follow-up for 146 patients.
Of all included patients, 280 patients with a dual
chamber device had at least two scheduled follow-
up visits from which diagnostic pacemaker data
were available. Of these 280 patients, 145 were
males (age 62.5 G12 years), and 135 were females
(age 82.0 G8.4 years).
At the time of pacemaker implantation, 36% of
patients had bradycardiaetachycardia syndrome,
33% were in sinus rhythm, 30% had sinus node
dysfunction and 1% had other atrial rhythms. With
respect to the ventricular rhythm, 59% of patients
had normal ventricular activation, 25% presented
with idioventricular rhythms, 6% had frequent
premature ventricular complexes and 10% had
other ventricular rhythms.
The indication for pacemaker implantation was
high-degree AV block in 52% of patients, sinus node
dysfunction in 47%, and other diagnoses in 1%.
As mentioned earlier, we analysed only patients
without a history of AT. Of the 280 dual chamber
patients with diagnostic data from at least two
follow-up visits, 239 patients had no prior history of
atrial tachyarrhythmias. These patients were strat-
ied according to the indication for pacing. We
considered two main subgroups: those with a high-
degree AV block (n Z168) and those without AV
block, i.e. with intact AV conduction (n Z71). The
rst group was subdivided into patients receiving
a dual lead (DDD, n Z128) and a single lead (VDD;
n Z40) dual chamber pacemaker.
Frequency of diagnostic observations
A total of 1433 follow-up visits were reported and
in 323 (23%) one or more DOs were presented.
During the follow-up period, 43% of all patients
presented with at least one DOs.
Fig. 1 shows that 43% of all DOs messages were
related to a low percentage of AV synchrony (Less
than 96% AV synchrony) and that 12% were
related to High sensed atrial rates. Both mes-
sages are indicative of the presence of AT. The
device responds to high sensed atrial rates by
means of mode switching; mode switching itself
reduces the percentage of AV synchrony.
Fig. 2 illustrates the distribution of DOs over the
various follow-up visits. Although the absolute
number of DOs decreases over time, the percent-
age of patients with DOs does not substantially
decline. This may be explained by the fact that
during early follow-ups many DOs are related to
244 A. Schuchert et al.
technical issues such as over- or undersensing.
Once these issues are resolved, other issues that
are possibly related to the occurrence of AT remain
and will trigger the expert system. Non-scheduled
follow-ups were usually due to signicant symp-
toms. However, DOs obtained during these non-
scheduled follow-ups did not frequently result in
the detection of AT that was not previously known.
Atrial tachyarrhythmia detection
Patients with high-degree AV block
and a DDD(R) pacemaker
Table 1 shows the proportion of patients with
a DDD(R) pacemaker and high-degree AV block
and no prior history of AT in whom the expert
system issued a message indicating that such an
arrhythmia had indeed been detected. At the rst
scheduled follow-up after approximately 3
months, AT was detected in 24 patients (19%) and
within 1 year of follow-up AT was rst detected in
36 of these patients (almost 30%).
Patients with high-degree AV block
and a VDD pacemaker
Table 2 shows the number of patients with high-
degree AV block, a single lead VDD pacemaker and
no prior history of AT in whom the expert system
issued a message indicating that such a tachyar-
rhythmia had been detected. At the rst scheduled
follow-up visit after approximately 3 months, AT
was detected in 14 patients (35%). In 50% of these
patients, the presence of AT was detected for the
rst time within 1 year.
Patients without high-degree AV block
Table 3 shows the number of patients with intrinsic
AV conduction and no prior history of AT in whom
the expert system issued a message indicating that
such a tachyarrhythmia had been detected. At the
rst scheduled follow-up visit after approximately
3 months, AT was detected in 10 patients (14%). In
22.5% of these patients, the presence of AT was
detected for the rst time within 1 year.
The cumulative incidence of newly detected AT
stratied according to the indication for pacing is
shown in Fig. 3. Combining all the data shows that
in 73/239 patients (31%) with no prior history of AT,
such an arrhythmia was detected over a 1-year
follow-up period. AT is predominantly detected in
the period shortly after implantation and dimin-
ishes after the 3-month follow-up visit. These
ndings are in line with earlier reports [6].
Response to diagnostic observations
Responses to DOs were either pacemaker reprog-
ramming, adaptation of the drug regimen or di-
agnostic strategy.
In response to DOs, the suggested programming
recommendations were followed in 30% of cases.
In 71% of the rst follow-ups and in 27% of the
later follow-ups, the pharmacological manage-
ment was adjusted after atrial tachyarrhythmias
had been detected.
< 96% AV
synchrony
Low paced
atrial rates
High sensed
atrial rates
Low paced
ventricular rates
Suspected
atrial
undersensing
Others
Figure 1 Incidence of diagnostic observations.
Number of DO % of patients with DO
D
i
s
c
h
a
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e
1
-
3

m
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n
t
h
s
5
-
7

m
o
n
t
h
s
1
0
-
1
4

m
o
n
t
h
s
U
n
s
c
h
e
d
u
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f
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l
l
o
w
-
u
p
0
20
40
60
80
100
120
140
0%
5%
10%
15%
20%
25%
30%
35%
Figure 2 Distribution of DOs over the various follow-up
visits.
Table 1 Frequency of newly detected atrial
tachyarrhythmias in patients with AV block and
a DDD(R) pacemaker and no known previous history
of atrial tachyarrhythmias (n Z128)
Follow-up Patients with
newly detected AT
1e3 months 24 (19%)
5e7 months 6 (5%)
10e14 months 6 (5%)
Unscheduled follow-up 1 (0.8%)
Automatic analysis of pacemaker diagnostic data 245
Discussion
In 43% of all follow-up visits, the DOs function
reported signicant diagnostic events.
A major result of this study was the detection of
AT in 31% of patients with no known history of
them. AT may be asymptomatic and unrecognized
in many patients as has been reported in previous
studies. For instance, in the AIDA trial, 65% of the
patients in whom atrial tachyarrhythmias were
detected had no documented history of them.
Detection of AT in asymptomatic patients is im-
portant, given the risk of AT related stroke [7,8].
Most rst detections of AT occur shortly after
implantation and diminish after the 3-month fol-
low-up visit. These ndings are in line with earlier
reports [9].
Since this registry was not designed to investi-
gate the effects of atrial and ventricular pacing on
the incidence of AT we did not statistically analyse
our data with respect to this issue. However,
the trends observed in this study with regard to
the percentage of patients with AT in relation
to the amount of atrial and ventricular pacing are
consistent with earlier reports. Patients treated
with dual chamber pacing have been reported to
show a lower incidence of AT, compared with
patients receiving ventricular pacing [10]. Consis-
tently, the percentage of patients with AT de-
tected by the pacemaker in combination with the
expert system was considerably higher in the
subgroup with a single lead VDD pacemaker,
compared with patients with a dual lead dual
chamber device. It is possible that the ventricular
pacing which occurs at a lower rate in VDD mode
contributed to this AT detection. In addition, in
patients with a high-degree AV block, who are
expected to receive a high amount of ventricular
pacing, the percentage of newly discovered AT
over a 1-year follow-up period was higher than in
the group with intact AV conduction (30% versus
22.5%). This observation is in line with previous
reports that conclude that frequent ventricular
pacing correlates with a higher incidence of AT
[11,12].
Atrial undersensing is a common issue with
a VDD lead and may have been related to in-
appropriate detection of atrial tachyarrhythmias.
This would suggest that the amount of AT detected
by the expert system in patients with a VDD device
is an underestimation. The expert system noties
the user with regard to suspected undersensing,
based on the available diagnostic information.
The expert system evaluated in this registry
proved to be valuable in detecting new onset or
asymptomatic episodes of AT. It needs to be
emphasized that pacemaker DOs were particularly
frequent during non-scheduled follow-up examina-
tions of patients with signicant symptoms. How-
ever, apart from one follow-up (see Table 1), the
expert system did not detect AT in patients without
a history of atrial tachyarrhythmias during these
non-scheduled follow-up visits. This registry was
conducted in order to assess the ability of the
expert system to alert the user of issues potentially
requiring adjustment in the therapy. The relation-
ship between these adjustments in response to DOs
and the effects on symptoms has not been in-
vestigated during this study. Future studies should
address to what extent the expert system may be
helpful in effectively reducing symptoms.
Table 2 Frequency of newly detected atrial
tachyarrhythmias in patients with AV block and
a VDD pacemaker and no known history of atrial
tachyarrhythmias (n Z40)
Follow-up Patients with
newly detected AT
1e3 months 14 (35%)
5e7 months 4 (10%)
10e14 months 2 (5%)
Unscheduled follow-up 0 (0%)
Table 3 Frequency of newly detected atrial
tachyarrhythmias in patients without AV block and
no known history of atrial tachyarrhythmias (n Z71)
Follow-up Patients with
newly detected AT
3 months 10 (14%)
6 months 5 (7%)
12 months 1 (1.5%)
Unscheduled follow-up 0 (0%)
I
n
c
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d
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n
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y

d
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t
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t
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A
T

[
%
]
AVB / VDD
AVB / DDD
Non-AVB
0
10
20
30
40
50
1 - 3 mo 10 - 14 mo
Follow up
5 - 7 mo
Figure 3 Cumulative incidence of newly detected AT
in patients with no prior history of AT.
246 A. Schuchert et al.
Conclusion
The expert system evaluated in this registry
proved to be valuable in detecting new onset or
asymptomatic episodes of AT in patients without
prior history of AT.
Acknowledgements
The authors would like to acknowledge the collab-
oration and commitment of all local investigating
physicians and their staff.
Austria: F. Rauscha, AKH Wien, Wien; A. Teubl,
A.o. Krankenhaus Wr. Neustadt, Wr. Neustadt; K.H.
Tscheliessnig, LKH Graz e Univ.-Klinikum, Graz; E.
Vesely, A.o. Krankenhaus Waidhofen a.d. Thaya,
Waidhofen a.d. Thaya; G. Zach, A.o. Krankenhaus
Bruck a.d. Mur, Bruck a.d. Mur.
Canada: R.I.G. Brown, Royal Columbian Hospi-
tal, New Westminster, QC; R. Dong, Surrey Memo-
rial Hospital, Surrey, BC; G. Evans, Hamilton
H.S.C., Hamilton, ON; W.G. Hughes, The Kawartha
Cardiology Clinic, Peterborough, ON; P. Polasek,
Kelowna General Hospital, Kelowna, BC.
France: C. Besson, Clinique Saint-Joseph, Alen-
c on; H. Bonnet, Clinique dArgonnay, Pringy; J.
Covillard, Clinique de Chenove, Dijon; Ch. Delaire,
Centre Hospitalier, Cholet; E. Favre, Centre Hos-
pitalier, Saint Vallier; J. Pellet, Clinique Belle-
done, Grenoble; F. Senellart, Clinique des Ce`dres,
Grenoble.
Germany: U. Abdel-Rahman, Klin. d. J.-W.-
Goethe Universitat, Frankfurt; A. Brattstrom, Kli-
nikum Quedlinburg, Quedlinburg; H.-P. Rebeski,
Kard. Gemeinschaftspraxis, Kiel; G. Ringwald,
Gemeinschaftspraxis, Bruchsal; T. Unger, St. Sal-
vator-Krankenhaus, Halberstadt.
Sweden: E. Baselier, Malarsjukhuset, Eskilstuna.
Switzerland: P. Dubach, Kantonsspital Chur,
Chur.
The Netherlands: L.H.M. Bouwens, Deventer
Ziekenhuis, Deventer; D.J. van Doorn, Spaarne
Ziekenhuis, Heemstede; H. Drost, Slingeland Zie-
kenhuis, Doetinchem; G.M. Jochemsen, Ziekenhuis
Tjongerschans, Heereveen; H.C. Klomps, Zorgnet-
werk De Nieuweborgh, Weert; M.R. van der Linde,
Ziekenhuis Nij Smellinghe, Drachten; F.J. de
Nooyer, Ziekenhuis Bethesda, Hoogeveen; M.H.H.
de Vaan, IJsselmeer Ziekenhuizen, lokatie Zuider-
zee, Lelystad; C.J.P.J. Werter, St. Laurentius
Ziekenhuis, Roermond.
United Kingdom: J. Campbell-Cowan, J. Mc-
Lenachan, J. Perrins, G. Reynolds, Leeds General
Inrmary, Leeds; A. Cunnington, M. Payne, Manor
Hospital, Walsall; J. Flint, P. Forsey, Wordsley
Hospital, West Midlands; A.N. Sulke, Eastbourne
District General Hospital, Eastbourne; W. McCrea,
Great Western Hospital, Swindon; P. Rees, Great
Ormond Street Hospital, London; N. Spyrou, Battle
Hospital, Reading.
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