ATRIAL FIBRILLATION
Verification of pacemaker automatic mode switching for the detection of atrial fibrillation and atrial tachycardia with Holter recording
1 Department of Cardiology, St Lucas Andreas Hospital, J. Tooropstraat 164, 1061 AE Amsterdam, The Netherlands; 2 University of Utrecht, Utrecht, The Netherlands; 3 Amphia Ziekenhuis, Breda, The Netherlands; 4 Turku University Central Hospital, Turku, Finland; 5 Streekziekenhuis Midden-Twente, Hengelo, The Netherlands
Manuscript submitted 30 December 2005. Accepted after revision 11 May 2006.
* Corresponding author: Tel: +31 23 5383989; fax: +31 23 5490309. E-mail address: w.g.devoogt{at}planet.nl
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Abstract |
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 Top Abstract IntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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Aims Verification of the accuracy of onset, offset, and duration of automatic mode switching (AMS) of pacemakers compared with onset and end of atrial fibrillation (AF) or atrial tachycardia (AT). Correct pacemaker diagnosis of atrial tachyarrhythmias (AA) is indispensable for reliable automatic prevention and intervention algorithms of AA.
Methods and results Comparison was made of the AMS registration of the pacemaker-stored electrograms (EGMs) and the number and cumulative duration of these episodes with continuous 7-day Holter monitoring. Atrial sensitivity was kept at 0.5 mV and far field R-wave recognition in the atrial channel was excluded by blanking of this signal. Lead types were confined to leads with short-ring tip spacing (10–13.8 mm). During Holter monitoring, 18 of 57 included patients with standard reason for pacemaker implantation showed episodes of AF or AT. Cumulative duration of AF and AT from Holter was correctly interpreted by the pacemaker in 99.9% of the patients. All episodes of AF, as seen on the Holter recording, were recognized by the pacemaker (correlation 99.9%). During AF, multiple episodes of undersensing were detected. The number of AMS episodes was influenced by undersensing during AF. The influence of these short episodes of undersensing on the total duration of AF was trivial (cumulative duration of AF was 99.9% correct). In patients with AT without AF on Holter (n=7) and in contrast to the AF episodes, the cumulative AT duration did not correlate well (63%) with the Holter recordings. The number of AMS episodes in the setting of AT was influenced by the atrial tachycardia detection rate setting and the duration of the post-ventricular atrial blanking interval.
Conclusion The total duration of AF is correctly represented by the total duration of AMS and can be considered a reliable measure of total AF duration. AT duration was poorly correlated with AMS duration. The number of mode switches does not reflect the number of episodes of AF/AT. Increased memory capacity allowing the storing of all EGMs triggered by the initiation of AF/AT would be the ideal setting with which to optimize the diagnostic performance of pacemakers.
Key Words: Atrial fibrillation, Pacemaker, Automatic mode switch, Holter monitoring, Atrial fibrillation burden, Stored electrograms
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Introduction |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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Recently, pacemaker (PM) algorithms have become available for the prevention and interruption of atrial fibrillation (AF) and atrial tachycardia (AT). Automatic mode switching (AMS) of the PM is nowadays considered a reliable marker for the identification of the onset and offset as well as the duration of AF and AT. However, undersensing, as well as oversensing, resulting in inappropriate AMS occurrence1
–4 undermines its accuracy. Therefore, the daily use of PM-derived parameters of occurrence of AF or AT need not be questioned, provided the reliability of the diagnostics of the PM selected for implantation is known.5
To validate the PM diagnostics for AT and AF, long-term Holter monitoring continues to be the most appropriate tool for a comparative study instead of symptoms. Until now, the number of studies addressing such comparison is limited. In addition, the reported success rate of PM interventions for AF and AT prevention and termination varies widely.6–12 Differences in the chain of atrial lead configuration, signal sensing, pattern recognition, and diagnostic PM algorithms fully explain the variability of AMS occurrences as a marker of actual episodes of AT and AF.13–17
The purpose of our study was a beat-to-beat comparison of PM-diagnosed AF and AT episodes, using the internal diagnostics in the Identity dual-chamber PM (St Jude Medical, Sylmar, CA, USA), with 7 days of continuous Holter monitoring in a large cohort of PM patients. The global accuracy of AMS as the marker of onset, offset, and duration of paroxysmal atrial arrhythmias was determined; and secondly, accuracy differences between AT and AF detection were investigated.
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Methods |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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Patient recruitment
Patients with an American College of Cardiology/American Heart Association class I or II PM indication18
were included. Presence of paroxysmal AF before implantation was neither an exclusion nor inclusion criteria. Written informed consent, approved by the local and National Medical Ethics Committees, was obtained in all patients.
PM and mode switch algorithm
All patients received an Identity PM (St Jude Medical) capable of storing the atrial electrograms (EGMs) starting 10 s before and continuing 10 s after AMS occurs. The EGM telemetry of the PM allows for the detection of intracardiac signals prior to their being filtered by the PM's sensing circuitry. The band-pass filter of the telemetry circuit is 
1–100 Hz, far wider than that of the sensing circuit, facilitating identification and recognition of intracardiac signals. Maximum storage was up to eight registrations of 20 s EGMs per episode, depending on the number of episodes programmed to be stored. Although there were other EGM triggers that could be enabled, for the purpose of this study, only AMS entry was selected. The EGM diagnostic can also store a single channel, both A and V channels or a shared channel (Atip–Vtip). For the purpose of this study, a single channel atrial (Atip–Aring) PM-stored EGM was selected to maximize the number and duration of EGMs that could be stored.
There was a separate AMS histogram that was also active. This diagnostic event counter registered the number of AMS episodes, the duration of each episode, and the total time the PM was in AMS. The histogram was accompanied by an AMS log. This provided a detailed report of the date, time of onset, and duration of the previous 16 AMS episodes prior to the data being retrieved from the implanted PM. The AT detection rate (ATDR) was programmed to one value for each patient during the study (Table 1). The AMS algorithm monitors the atrial rate on a beat-to-beat basis and calculates a filtered atrial rate interval (FARI) that is continuously updated (Figure 1A and B). When the FARI exceeds the ATDR and there is a cycle of atrial-sensed ventricular pacing (PV), the system mode switches to the non-tracking DDI/R mode.
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Pacing leads
The Tendril bipolar screw-in leads (St Jude Medical) were implanted in the atrium [Model types: 1388T (n=51), 1488T (n=3), and 1688T (n=3)] in all patients. Tip-ring spacing is 10 (1388T and 1688T) or 13.8 mm (1488T). Leads were placed either in the right atrial appendage (RAA) or in the low atrial septum (LAS), depending on the implanter's preference. The LAS and RAA lead locations were confirmed by fluoroscopy and by 12 lead ECG. The LAS lead positions were additionally confirmed with a negative P-wave in leads II and aVF and a terminal positive deflection in lead V1.19
Atrial sensitivity setting
Sensitivity configuration was bipolar and the sensitivity was set to 0.5 mV even in the presence of a large sinus P-wave. Deviations are shown in Table 1.
Holter recording and AMS comparison
Continuous 2-channel Holter recording was performed over a continuous 7-day period (Lifescreen, Del Mar Reynolds Medical, Hertford, UK). Timing in the Holter monitor and the PM was synchronized by application of a magnet on the PM, resulting in DOO pacing at 98.5 ppm with a foreshortened AV delay of 120 ms that was readily identified at the start of the Holter recordings.
Analysis was performed without the patient's knowledge and both automatically and visually controlled by an independent blinded core laboratory. Rhythm strip printouts of the recordings 1 min before and after the start and the termination of AF/AT were obtained. The AMS log in the PM reports a date and time stamp for the previous 16 AMS episodes. In addition, there is a date and time stamp on the stored EGMs. These episodes, which were recorded by the PM with respect to date and time, were specifically compared with the Holter recordings as well as with the PM AMS atrial EGM recording (Figure 2). The PM-derived cumulative time in AF/AT was based on a calculation from the AMS histogram.
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Far field R-wave
The far field R-wave (FFRW) in the atrial channel could be detected from the programmer printout of the atrial and ventricular bipolar EGM and event marker registrations. The presence or absence of FFRWs was specifically sought, and sensing was excluded by programming the post-ventricular atrial blanking (PVAB) period to 100 ms or longer on an individual basis, as mandated by the evaluation of the FFRW signals.
Definitions
AF is defined as an irregular ventricular rhythm on Holter recording >8 s without a stable organized atrial depolarization (paced or native) identified on the rhythm strips (Figure 1A and B).
AT is defined as a regular atrial (non-sinus) rhythm over 120 bpm on Holter, with a sudden onset.
No AF/AT means no runs of AT or AF on the Holter recording.
Statistical analysis
Continuous variables are expressed as mean±SD. Paired data were compared using non-parametric techniques when the data proved not to follow a normal distribution using the Wilcoxon-signed-rank test. A P-value <0.05 was considered statistically significant. As the data did not follow a normal distribution, it was opted to use the Spearman correlation coefficient instead of Pearson's correlation coefficient. To measure the degree of association between the Holter and PM measurements, the correlation coefficient was calculated.
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Results |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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From 30 January 2003 to 19 October 2004, 57 patients were enrolled in this study. Primary indication for pacing was sinus node disease in 40 patients being manifest as brady-tachy syndrome in 33 patients, sinus arrest in six patients, sinus bradycardia in five patients, and chronotropic incompetence in three patients (some patients had more than one manifestation of sinus node disease). For atrioventricular conduction disorders the diagnoses included eight patients with 2nd degree AV block Wenckebach and 2:1 block (2 intermittent), 11 patients with 3rd degree AV block (2 intermittent), seven patients had RBBB, two had LBBB, one had LAHB and one had bradycardia during episodes of AF. Prior to implantation, 36 patients had a history of AF. Patient demographics and PM settings are depicted in Table 1.
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Holter verification of AF/AT duration |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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Patients with AF/AT
Of the 543557 min of Holter registration, 403492 min or 74.2% did not show AF/AT and 140065 min or 25.8% contained paroxysmal AF/AT. Of the 18 patients with AF/AT episodes, 15 had data that could be analysed for total duration of episodes. One Holter was lost for evaluation due to early detachment; a second was lost during transport. In a third Holter a very low voltage of the atrial signal and only minimal irregularity of the ventricular rhythm made interpretation unreliable.
The total time in AMS calculated by the PM in the remaining 15 patients with AF/AT episodes was 31196 min using the AMS diagnostics from the PM. Holter-verified AF/AT duration in these patients was 32198 min (correlation 99.9%). There appeared to be no statistically significant difference in total time in AMS between the Holter and PM recordings (P=0.45).
Patients without AF/AT
In patients without AF/AT on Holter (n=40), two were not available for evaluation: one because of inadequately stored data and the other because of the poor quality of the registration. Both Holter recordings were obtained from patients without AMS episodes reported on the PM diagnostics. Total duration of good quality monitoring in patients without AF/AT was 403492 min. In one patient, 98 min of AMS was reported. On the basis of the analysis of the Holter monitoring during this period, the AMS was triggered by a loss of capture of the atrial lead, resulting in short atrial stimulus-sensed P-wave intervals incrementing the FARI. The absence of AF/AT was correctly seen by the PM in 99.9% of patients (P<0.0001).
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Holter verification of PM-stored EGMs |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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In two patients, the PM telemetry-stored EGM printout was not correctly performed and timed because of errors in the time in the programmer clock, but the total duration in AMS could still be examined. In two patients, the difference in the duration of the Holter recording (early detachment) and the duration of the properly completed registration time from the PM ruled out the correct evaluation of AMS duration in comparison with the Holter recording. However, all AMS episodes occurred in those patients during the time of Holter recording. As such, verification of correctness could be performed. Of the 55 patients with Holter recordings that could be analysed, 37 patients did not have any periods of AF/AT, whereas 18 patients had periods of AF and/or AT. Twenty patients had AMS episodes recorded by the PM diagnostics. A total of 2202 AMS episodes were reported in these 20 patients. In 13 patients, all AMS episodes were verified. In eight patients, more than eight AMS episodes were reported by the PM memory, but the memory capacity only allowed for eight high-quality retrievable registrations from the stored EGM diagnostic event counter. These eight patients accounted of a total of 2172 AMS episodes.
Eighty-nine initiations of AMS stored by the PM were verified on Holter: 53 demonstrated that AF triggered the AMS episode, whereas 26 episodes were initiated by AT. One patient had AT but no AMS. Finally, 11 mode switches occurring in two patients were initiated by various causes as described in Figure 3.
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AMSs caused by AF
Of all 53 AMS initiated by AF, only 20 could positively be identified by the start of AF; 33 of these AMS episodes were preceded by a period of undersensing of AF, although atrial sensitivity was set at a mean of 0.49±0.16 mV in these patients (Figures 3 and 4).
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’ in the middle strip. This behaviour of the PM explains the incorrect counting and high numbers of AMS during a continuous period of AF. P in black box, sensed atrial activity in the refractory period; R, ventricular sensed.AMSs in patients who had only AT
Of all 26 AMS episodes initiated by AT, 18 could positively be identified by the start of an AT. Eight of the mode switch episodes were preceded by a period of undersensing of AT, with the P-waves coinciding with the PVAB (Figure 5) and not being identified by the PM. Because the stored EGM channel detects the signals before they are processed by the sensing circuit, these P-waves could be recognized on the stored EGM even though they were not ‘seen’ by the PM. In seven patients with only AT, as diagnosed by Holter tracings, 1764 min of AMS were reported, whereas 2761 min of AT were detected using the Holter (correlation is 63%) monitor.
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One patient with ADTR programmed at 225 bpm had 540 min (5.6% of total registration duration) of AT (180 bpm) on the Holter recording, but no episodes of AMS on the PM diagnostics.
The PM diagnostics reporting five AMS episodes in another patient showed that the initiation of AT was by the autocapture procedure of the PM (Figure 6) associated with a functional long AV delay when there was loss of ventricular capture resulting in the delivery of a high-output back-up pulse 100 ms after the primary pulse.20
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AMSs not caused by AF/AT
In one of the two patients with AMS episodes identified by the PM but without AF on Holter recordings, these events were caused by intermittent loss of atrial capture. The atrial lead had been inserted in the LAS in this patient. Atrial depolarization, retrograde atrial depolarization from the ventricle, and the ineffective atrial stimulus resulted in repetitive short atrial cycles that triggered repeated AMS episodes of short duration. Each individual AMS episode was <18 s in duration.
The second patient had AMS due to pre-ventricular FFRW sensing in the atrium. This was detection of the normally conducted ventricular depolarization in the atrium before it was detected by the ventricular channel of the PM (Figure 7). The atrial lead position was LAS. Each of these episodes of AMS was short of duration (<6 s) based on the AMS log.
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Difference between RAA and LAS lead location |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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The atrial lead location was not prescribed in the protocol and left to the discretion of the implanting physician. Twenty-nine leads were positioned in the LAS and 28 leads in the RAA. There were no significant differences between the programmed ATDR (LAS 213±18 bpm; RAA 207±24 bpm), atrial sensitivity setting (LAS 0.50±0.22 mV; RAA 0.49±0.06 mV), or PVAB (LAS 116±14 ms; RAA 124±14 mV).
The number of AMS episodes per patient during the 7-day monitoring period was equal in the two groups (LAS 1.48±2.77; RAA 1.64±2.8). The cumulative PM-defined AMS duration per patient during the 7-day monitoring period in LAS was 706±2456 min and in RAA was 642±2070 min (ns). The Holter AF/AT duration for the LAS was 722±2453 min and for the RAA was 1841±6754 min.
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Discussion |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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Key results
Total AF/AT duration
The total duration in AF by continuous Holter recordings was highly concordant (99.9%) with the total duration of AMS derived from PM diagnostics. However, in seven patients with only AT on Holter monitoring, the correlation was poor (63%). The occurrence of atrial activity during the PVAB, excluding the detection of AT, undermines the utility of these AMS diagnostics.
Number of AMSs
The number of AMS was not the appropriate marker for determining the number of AF episodes. In our study, 31 of 54 (57%) AMS episodes, which could be correlated with Holter-documented AF episodes, were initiated by signal dropout during the AF episode. This undersensing caused incorrect termination of AMS. When the amplitude of the AF signal passed the sensing threshold and the AF signal was again recognized, AMS was switched on and another episode on the diagnostic counter was logged. As a result of short periods of undersensing, the PM counter will falsely register many periods of AF, although continuous AF persists. In the eight patients with signal dropout, the sensitivity settings during undersensing were 0.5 (n=7) or 0.3 mV (n=1). Whether more sensitive settings in these patients would have avoided undersensing was not explored.
AF burden
The definition of AF burden has been formulated differently in studies on the efficacy of devices, drug treatment, and combinations. AF burden calculated from ECG recordings with respect to the total time in AF represents a different approach and can be labelled electrocardiographic AF burden (EAFB). This parameter can be further subdivided into total time of AF, number of (re)occurrences of AF over a specific time interval, duration of AF-free period, or a combination of these. EAFB appears a better yardstick for the quantification and correlation of symptoms and the efficacy of AF interventions. Our study showed that the number of AMS episodes is not a reliable marker to determine EAFB. Furthermore, the AF-free time to AF recurrence can only be reliably measured if the AMS onset is verified with a printout of the EGM. In contrast, the cumulative time in AF based on a calculation from the AMS histogram is a more reliable marker of EAFB. The total AF time measured with the PM had a 99.9% correlation with that of the Holter recordings. When AT is the dominant arrhythmia, the cumulative time in AMS corresponds poorly with the Holter-derived AT duration (63%).
Programming in patients with atrial arrhythmias
As AT often coexists with AF in the same patient, proper setting of the ATDR becomes imperative. The programming of the ATDR determines whether an AT of relative low rate will be detected. Although an ADTR of 225/m is adequate for the detection of AF, only ATs over 225 bpm would be detected in this setting. In the presence of normal sinus node function where the sinus rate can exceed the programmed ATDR, sinus tachycardia may trigger AMS episodes. If the AV nodal conduction functions properly, the patient will not notice the pacing change during sinus tachycardia and an AMS episode will be logged. For the elderly patient, an ATDR setting of 180/m or less is advisable, as sinus rate rarely exceeds this rate, and this will facilitate the detection of organized ATs.
During AT, the occurrence of atrial activity during the PVAB delayed recognition of the tachycardia either delaying entry into AMS or causing the premature exit of the system from the non-tracking mode even though the AT was continuing. Programming the PVAB sufficiently long to prevent FFRW sensing contributed to the inappropriately high number of AMS episodes during continuous AT (Figure 5).
PM sensing circuit
Diagnostic PM algorithms are currently dedicated to counting atrial and ventricular events and are sensed by the atrial or ventricular sense amplifier. Most of these sensing circuits have a narrower filter than the real-time or stored EGM capability in the same device. The sensing circuit filters and other components of the sensing circuit for signal processing may significantly differ from the telemetry circuit. Therefore, the absolute amplitude of the signal, as measured from the EGM, is only a rough approximation of the sensing threshold. This may result in a discrepancy between the stored or telemetered EGM and the PM-sensed signal (Figure 8). This is another reason that identification of AF depends on the design of the sensing circuit itself. No device currently employs a morphology analysis algorithm on the atrial channel. The detection of atrial tachyarrhythmia relies on interval analysis. The accuracy of the interval analysis is strongly determined by the amplitude of the atrial signal in relation to the programmed sensitivity. The PVAB and other absolute refractory periods on the atrial channel may limit the identification of some atrial tachyarrhythmias (Figure 9). Implementation of an atrial signal morphology recognition algorithm may allow reduction or elimination of the PVAB in future devices, and this technical improvement permits an extended period of sensing of atrial signals.21 As long as rate and regularity and not form recognition are the sole determinants for the recognition of AT, individual programming of atrial sensitivity, ATDR, and refractory periods is unavoidable.
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Other sources of AMS
One patient with AT showed false AMS preceded by automatic capture detection (AutoCapture). During automatic threshold measurement, early atrial pacing after a blanked atrial depolarization with short AV interval takes place.22
In this case, no atrial capture occurred because the atrium was physiologically refractory (Figure 6). Other causes for false AMS are atrial premature beats, retrograde AV conduction, and accelerated sinus rates where the P-wave coincides with the post-ventricular atrial refractory period.
Holter recordings: the gold standard for detecting atrial arrhythmias in PM patients?
The diagnosis of AF on Holter recording is often difficult because the identification of fibrillatory waves is uncertain and the discrimination of AF and AT remains doubtful in many recordings. Continuous irregularity of the ventricular response is the appropriate clue to the diagnosis of AF. However, in paced patients with advanced AV block, the irregularity of the paced ventricular rhythm is of brief duration before AMS is engaged and afterwards a regular response can be expected to occur. Secondly, if AF undersensing arises, the atrial-pacing stimulus will be generated, followed by a paced QRS complex (DDD pacing). The stimulus is often easier to see than AF signals on a Holter, and in this condition, the loss of capture can only indirectly support the diagnosis of AF.
In patients showing AT, the Holter recording cannot show whether the PM is in AMS due to AT or sensing a high rate in case of preserved AV conduction. The verification of a mode switch on the Holter recording without a PM-EMG or simultaneously telemetered event markers is impossible in this condition. This illustrates that the Holter recording cannot always fulfil the requirements of the desired gold standard and serve as the best tool for correlative studies.
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Study limitations |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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The restriction imposed by the limited PM memory allowed only for the storage of eight consecutive episodes of 20 s of stored EGM This is the reason why not all AMS episodes of the 7-day continuous Holter recording could be manually verified. Brief non-sustained salvos of AF/AT shorter than 8 s do not trigger an AMS episode due to the design of the detection algorithm, but it is likely that these, unless very frequent, would affect the outcome of this study. Finally, verification of AF diagnostics was performed in only one specific PM; whether the results can be extrapolated to PM of other companies has to be investigated.
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Conclusions |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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The cumulative duration of AF and not the frequency of AF episodes can be reliably calculated from the diagnostic AMS histograms of the studied PM (Identity, St Jude Medical). This marker can serve as a valid measure of electrical AF burden. However, the number of AMS episodes based on the internal AMS event counter diagnostics is a poor surrogate by which to monitor therapy effectiveness unless each is able to be verified by the stored EGMs. Consequently, studies evaluating the therapeutic effectiveness of PM programmes to prevent or interrupt AF and AT can determine cumulative AMS duration and not the number of AMS episodes. Whether this is valid for all PMs with AMS options needs further investigation. Finally, the effects of atrial pacing in the prevention or termination of AT and AF can vary widely in the presence of AF or AT because the diagnostic accuracy is clearly lower in paroxysmal AT than in AF.
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Acknowledgements |
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TopAbstractIntroductionMethodsResultsHolter verification of AF/AT...Holter verification of PM-stored...Difference between RAA and...DiscussionStudy limitationsConclusionsAcknowledgementsReferences |
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The assistance of Johan Poker in EGM analyses, the statistical advice of Kristof Daems, and the review and editorial advice of P.A. Levine are greatly appreciated.
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References |
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