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(Circulation. 1995;92:1819-1824.)
© 1995 American Heart Association, Inc.
Articles |
From the Department of Medicine, Division of Cardiology, University Hospital, University of Western Ontario, London, Ontario, Canada.
Correspondence to Dr Andrew Krahn, Division of Cardiology, University Hospital, 339 Windermere Rd, London, Ontario, Canada N6A 5A5.
| Abstract |
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Methods and Results A long-term subcutaneous monitoring device was implanted in patients with negative ambulatory monitoring, tilt table and electrophysiological testing to establish cardiac rhythm during spontaneous syncope. Sixteen patients aged 57±19 years with a mean of 8.4±4.4 previous episodes of syncope underwent device implantation. Fifteen patients (94%) had recurrent syncope 4.4±4.2 months after implantation. The remaining patient has not had recurrent syncope and continues to be followed. A diagnosis was obtained in every patient who had recurrent episode. Syncope was secondary to sinus arrest in 5, atrioventricular block in 2, ventricular tachycardia in 1, supraventricular tachycardia in 1, and nonarrhythmic in 6. Successful therapy was implemented in all 15 patients, without recurrence of syncope during 13.0±8.4 months of follow-up.
Conclusions Unexplained syncope in patients with negative investigations has a broad spectrum of etiologies, the most common of which is bradycardia. An implantable long-term monitoring device is useful for establishing a diagnosis when symptoms are recurrent but too infrequent for conventional monitoring techniques.
Key Words: syncope electrophysiology
| Introduction |
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| Methods |
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Laboratory Investigations
Patients underwent a minimum of 48
hours of ambulatory or
in-hospital monitoring as well as cardiac imaging with
transthoracic echocardiography or
radionuclide ventriculography. An exercise treadmill test or
neurological investigations were also performed in selected cases. Tilt
table testing was performed with the use of 60° head-up tilt for 15
minutes with continuous ECG and noninvasive blood pressure monitoring
(Finipres). If no response occurred, intravenous
isoproterenol was administered at 1 µg/minute and titrated to a 25%
increase in heart rate for an additional 15 minutes. A positive test
was defined when syncope or presyncope occurred, accompanied by a
significant fall (>30 mm Hg) in blood pressure with or without a drop
in heart rate. This protocol has previously been shown to have 61%
sensitivity and 93% specificity in our laboratory.19
Electrophysiological studies were performed in the postabsorptive, nonsedated state. Standard multipolar catheters were inserted into the right femoral vein and placed in the high right atrium, right ventricle, and near the His bundle. Sinus node recovery time, sinoatrial conduction time, and antegrade and retrograde AV node function were assessed using atrial and ventricular pacing and extrastimuli.20 Programmed electrical stimulation was performed at the right ventricular apex at a drive cycle length of 600 and 400 ms for 8 beats, followed by up to 3 extrastimuli. This protocol has been found to be 90% sensitive for induction of sustained monomorphic ventricular tachycardia in patients with spontaneous ventricular tachycardia in our laboratory.21 A positive test was defined as induction of ventricular tachycardia longer than 30 seconds in duration or requiring urgent intervention, sustained supraventricular tachycardia, a corrected sinus node recovery time greater than 550 ms, or an HV (His to ventricle) interval greater than 75 ms.
Device
The implantable syncope monitor is a pacemaker-sized
device
(53x60x8 mm, 2.1x2.4x0.3 in) with 2 electrodes 32 mm
(1.25 in)
apart within its shell (Fig 1
). It continuously
records a single-lead electrocardiogram (Medtronic
USA Inc.). The ECG signal is stored in a circular buffer capable of
retaining either one 15-minute or two 7.5-minute segments of
recorded rhythm. Using a magnet, the patient, family member, or
friend "freezes" the device during or after a spontaneous
syncopal episode, storing the preceding 7.5- or 15-minute segment,
which is retrievable at a later date. The syncope monitor has a battery
life of approximately 2 years.22
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A subcutaneous pocket was fashioned in the left pectoral region under local anesthesia. The device was placed within the pocket and rotated through 360° to optimize the magnitude of the recorded R-wave electrogram. It was then fastened to the underlying tissue at opposite corners of the device with nonabsorbable sutures. The incision was then closed with absorbable sutures, and a satisfactory electrogram was verified after wound closure. Devices were explanted after a diagnosis was obtained.
Follow-up
All patients were followed in the pacemaker clinic
at 1, 2, and
4 weeks after device implantation and subsequently at monthly
intervals. Each visit included a patient interview and device
interrogation. Patients were seen immediately if they had
activated the device.
| Results |
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Spontaneous syncope occurred in 15 of 16 patients (94%), a mean of 4.4±4.2 months after device implantation (range, 6 days to 14 months). The remaining patient has not had syncope and continues to be followed.
Table 2
summarizes the etiology and treatment of syncope
in the 15 patients with recurrence during follow-up.
Syncope was secondary to bradyarrhythmia in 7
patients (47%); sinus arrest in 4, complete heart block in 2,
and sick sinus syndrome in 1. In this group, the mean baseline
corrected sinus node recovery time was 280±105 seconds, and the HV
interval was 57±8.1 ms. Syncope was secondary to
tachyarrhythmia in 2 patients (17%). Patient 5 had AV node
reentrant tachycardia and underwent AV node modification.
Repeat electrophysiological study showed
only single AV node echo cycles after addition of isoproterenol and
atropine. Spontaneous syncope was associated with a narrow complex
tachycardia at a rate of 180 beats per minute. The patient
underwent repeat AV node modification and has had no further syncopal
episodes during 15.5 months of follow-up. Patient 6 had
nonsustained ventricular tachycardia at a rate of
240 beats per minute during spontaneous presyncope. No
ventricular arrhythmias (including nonsustained
ventricular tachycardia) were induced at baseline
electrophysiological study.
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Syncope was nonarrhythmic in 6 patients (40%), in whom a presumptive clinical diagnosis was made. In patients 10 and 14, vasodepressor syncope was diagnosed because of a reasonable prodrome and gradual slowing of heart rate to a minimum of 50 and 45 beats per minute during spontaneous syncope. Patient 16 had repeat tilt table testing which confirmed the clinical diagnosis of vasodepressor syncope. In patient 4, spontaneous syncope associated with normal heart rate and blood pressure occurred during a clinic visit. Syncope has subsequently resolved with psychotherapy. In patient 3, syncope was presumed to be on the basis of hemodynamic obstruction from hypertrophic cardiomyopathy after sinus rhythm was documented during an episode of spontaneous syncope. This patient has not had recurrence after treatment with ß-blockade. Patient 7 had witnessed syncope with seizure-like activity and normal heart rate, and is undergoing neurological evaluation.
Fig 2
illustrates the results of device interrogation
after an episode of spontaneous syncope in patient 2. The upper tracing
shows sudden onset of complete atrioventricular block
lasting 17 seconds, confirmed on the lower magnified tracing showing
atrioventricular dissociation. Fig 3
illustrates recurrent nonsustained ventricular
tachycardia in patient 6, associated with near syncope. Fig 4
illustrates sinus arrest lasting 22 seconds associated
with syncope in patient 13.
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The 12 patients in whom a diagnosis was obtained were divided into
three groups based on the etiology of syncope (Table 2
). A
univariate comparison of clinical risk factors failed to
reveal any significant baseline characteristics that predicted the
etiology of syncope.
A diagnosis was obtained in every patient who had recurrent syncope. Seven of 9 first-generation devices provided by the manufacturer were subject to inappropriate "freezing" of data. In 5 patients, a diagnosis was not obtained after the initial recurrence of symptoms, although a diagnosis was obtained after programming changes. Modification to the device software resulted in resolution of this problem. No patient had difficulty "freezing" the device.
Therapy for the underlying cause was instituted in all patients (Table
3
). No further episodes of syncope have occurred during
a mean of 13.0±8.4 months of follow-up. No complications were
encountered during or after device implantation or explantation. No
patient requested premature explantation. Fourteen of 15 patients had
their device explanted after a diagnosis was obtained. Patient 6
requested the device be left in until sotalol therapy for
ventricular tachycardia was considered effective.
No complications were encountered during or after device implantation
or explantation. No patient requested premature explantation or
declined explantation after a diagnosis was obtained.
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| Discussion |
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Conventional ambulatory monitoring is frequently undertaken in patients with syncope, but symptoms correlating with a significant rhythm occur in only 2% to 4%.28 29 30 Asymptomatic arrhythmias occur in 13%, and symptoms occur without arrhythmia in 17%.30 Linzer et al31 reported the use of long-term (up to 1 month) ambulatory monitoring with the use of a patient-activated loop recorder. Despite recurrence of symptoms in 32 of 57 patients, a diagnosis was obtained in only 14. Device malfunction, patient noncompliance, or inability to activate the recorder was responsible for the lack of diagnosis in the remaining 18. Similar results have been reported by Brown et al.32 Loop recorders were not used in this study because of the infrequent and unpredictable nature of syncope in this population. Undoubtedly, the etiology of syncope would have been discovered in some patients with use of these devices. The syncope monitor we implanted functioned as a long-term implantable loop recorder.
Electrophysiological testing is negative in 14% to 70% of patients investigated for syncope.9 10 11 12 13 14 15 16 17 18 This wide variation is strongly influenced by the prevalence of structural heart disease in the population under study. Electrophysiological studies may have low sensitivity and specificity for syncope related to intermittent bradycardia.33 In one series, the underlying cause of unexplained syncope was not determined in 26% of patients after both tilt table and electrophysiological testing.2
We utilized a long-term subcutaneous ECG monitoring device to determine the cause of syncope in 16 consecutive patients with negative investigations. Fifteen of the 16 patients (94%) developed syncope during follow-up, a higher rate than in the above-mentioned series. The ability to "freeze" the current and preceding rhythm after a spontaneous event allowed us to determine the etiology of syncope in all patients in whom syncope recurred. Implantation of the syncope monitor largely eliminated the issue of patient compliance and operator error, although patients or others were still required to "freeze" the loop. Thirteen of the 15 patients had a cardiovascular etiology for syncope, with bradycardia or tachyarrhythmia the cause in 9. There were no prospectively identifiable clinical risk factors that predicted etiology. The small number of patients with each etiology of syncope precludes definitive identification of risk factors in a pilot study such as this. Bradyarrhythmias tended to predominate in the elderly. All had normal sinus node recovery times and HV intervals at baseline electrophysiological testing. Three other patients, aged 71, 74, and 80 years, were diagnosed with vasodepressor syncope and subsequently did well on ß-blockers. Thus, a presumptive diagnosis of bradyarrhythmia would have been incorrect in 3 of the 7 patients over age 70. In addition, structural heart disease did not predict the etiology of syncope, in particular ventricular arrhythmias.
The determination of the etiology of syncope has obvious therapeutic significance. All diagnoses were amenable to intervention, with resolution of syncope in all patients after etiology was determined. This series reflects a subgroup of the overall syncope population, since we investigated only those patients referred to the arrhythmia service with recurrent but infrequent syncope with negative noninvasive and invasive investigations. The primary utilization of a long-term monitoring device may be appropriate in others, such as patients without structural heart disease in whom the yield of electrophysiological testing is low.2 3 9
This study has important limitations. Any strategy that requires recurrence of a spontaneous episode undertakes the risk of morbidity or sudden death accompanying that recurrence. This was not encountered in this series. This small risk may be balanced by the ability to arrive at a more precise diagnosis and avoid potentially nonbeneficial speculative therapy. In addition, the etiology of nonarrhythmic syncope is presumptive, although the spectrum of diagnoses is considerably narrowed, and unnecessary treatments are avoided. Ultimately, recording devices capable of monitoring other physiologic parameters such as blood pressure may lessen this problem.
Received February 28, 1995; accepted April 1, 1995.
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