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European Heart Journal Advance Access originally published online on September 23, 2005
European Heart Journal 2006 27(1):89-95; doi:10.1093/eurheartj/ehi500
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Syncope following cardioverter defibrillator implantation in patients with spontaneous syncopal monomorphic ventricular tachycardia

Mauricio Abello, José L. Merino*, Rafael Peinado, Mariana Gnoatto, Miguel A. Arias, Mar Gonzalez-Vasserot and José A. Sobrino

Clinical Cardiac Electrophysiology Laboratory, Cardiology Division, ‘La Paz’ University Hospital, Paseo de la Castellana 261, Madrid 28046, Spain

Received 29 September 2004; revised 9 July 2005; accepted 25 August 2005; online publish-ahead-of-print 23 September 2005.

* Corresponding author. Tel/fax: +34 91 7277564. E-mail address: jlmerino{at}secardiologia.es


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
 References
 
Aims We sought to determine the incidence, mechanisms, and time to syncope recurrence in patients with spontaneous syncopal monomorphic ventricular tachycardia (SyMVT) treated with an implantable cardiac defibrillator (ICD).

Methods and results Incidence and causes of syncope following ICD implantation in consecutive patients (n=26) with spontaneous SyMVT were compared with those found in consecutive patients (n=50) with spontaneous non-syncopal monomorphic ventricular tachycardia (NSyMVT). Patients with SyMVT had a higher incidence of syncope (46% patients) than those with NSyMVT (2% patients) at 31±21 and 34±23 months follow-up, respectively (hazard ratio, 0.19; 95% confidence interval, 0.04–0.42; P=0.0001). Among the former, four patients (15%) had non-arrhythmic syncope and eight patients had arrhythmic syncope (31%), which was associated with either ICD proarrhythmia (seven episodes of VT acceleration or VF degeneration by ATP or low/high-energy shocks in three patients) or spontaneous VT and VF (five episodes in five patients). Median time to the first arrhythmic syncope was 376 days. Arrhythmic syncope presented after a first non-syncopal VT recurrence in six patients (75%).

Conclusion Syncope following ICD implantation is common in patients with SyMVT in contrast to patients with NSyMVT. Late syncope presentation supports reassessment of driving restrictions in this setting.

Key Words: Syncope • Tachyarrhythmias • Defibrillation


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
 References
 
Different clinical trials have demonstrated that the implantable cardiac defibrillator (ICD) is associated with a reduction in mortality compared with antiarrhythmic drugs in patients with syncopal monomorphic ventricular tachycardia (SyMVT).1,2 This group of patients has high risk of arrhythmic recurrences and therefore require ICD implantation. Because the ICD does not prevent occurrence of life-threatening ventricular arrhythmias, ventricular tachycardia (VT) may precipitate syncope prior to termination by device therapy and could adversely affect public or private safety. In this setting, it has been suggested that the period with the highest risk for syncope recurrence is during the first 6 months after implantation, so driving restrictions are usually recommended during this time.3,4 Previous studies have investigated the incidence and causes of syncope recurrence in patients with unexplained syncope and inducible ventricular tachyarrhythmias.5,6 However, there is little data available about syncope recurrence in patients with spontaneous sustained VT.7 The purpose of this study was to assess the incidence, mechanisms, and time to syncope following ICD implantation in patients with spontaneous SyMVT.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusions
 Acknowledgements
 References
 
Patients
This was a retrospective cohort study in the whole population of patients with spontaneous documented monomorphic VT and structural heart disease, who underwent ICD implantation in our institution since May 1995. All patients who underwent ICD implantation were included in the study. Patients were divided into two groups according to the presence or absence of syncope at clinical VT presentation (exposition variable) before ICD implantation: 26 patients had a spontaneous SyMVT and the remaining 50 patients had spontaneous sustained non-syncopal monomorphic ventricular tachycardia (NSyMVT) (Table 1). No patient was excluded from the study. Ten patients (38%) complained of more than one syncope episode before ICD implantation.


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  		Table 1 Baseline characteristics among patients with and without syncopal VT
 
Programmed ventricular stimulation was performed according to a conventional protocol in all patients.8 Patients were followed and syncope recurrence following ICD implantation (response variable) was investigated.

ICD programming
All patients were recipients of third-generation ICD devices capable of storing intracardiac electrograms and R-R intervals. ICDs were programmed empirically and not accordingly to VT responses to pacing at electrophysiological evaluation in all patients. Two zones of VT detection and therapy were programmed in all patients from both groups.9 A ventricular fibrillation zone (upper heart rate) was set with a cut-off rate to detect a ventricular rhythm with a cycle length (CL) between 260 and 300 ms and lasting 1 s. Between four and seven electrical shocks were programmed in this zone for all patients. The first shock ranged between 20 and 41 J and maximum energy was programmed for the remaining shocks. A VT zone (lower heart rate) was programmed with a detection CL between 330 and 440 ms. Two antitachycardia pacing (ATP) schemes were programmed in this zone. The first ATP scheme consisted of 1–6 bursts of 5–15 beats with an initial coupling of 91% of the tachycardia CL. The second one consisted in 1–3 ramps with 8–15 pacing stimuli with 88–91% coupling to the VT CL and 8–10 ms decrement within and between subsequent ramps. This therapy was followed by one ‘low-energy’ shock (3–5 J) and then by 4–7 high-energy shocks. Initial maximal energy shocks were programmed in three and four patients with SyMVT and NSyMVT, respectively. Additionally, a third zone for VT detection was programmed in two and seven patients with SyMVT and NSyMVT, respectively. The detection cut-off ranged between 280 and 315 ms and therapies in this zone consisted of two ATP sequences. Sudden onset (9%) and stability (30–50 ms) criteria were also enabled in 11 and 17 patients with SyMVT and NSyMVT, respectively.

One zone of slow heart rate was programmed below 40 bpm in all patients, except for three patients in the SyMVT group and 7 patients in the NSyMVT group, in whom it was programmed below 50 or 60 bpm. A dual-chamber ICD was implanted in six out of 26 patients and seven out of 50 patients with SyMVT and NSyMVT, respectively (P=0.41).

Follow-up
Follow-up visits were scheduled for the first month following hospital discharge and then every 6 months. Clinical and ICD data were obtained by a cardiologist at each visit. All episodes were stored on floppy disks and reviewed by two independent observers. Consensus about the episode diagnosis was obtained in cases of discrepancy.

Definitions

  • Syncopal VT: Sustained monomorphic VT documentation less than 6 h after syncope, prior to ICD implantation.
  • Acceleration of VT: >10% heart rate increase following ATP or shock delivery.10
  • Arrhythmic syncope at follow-up: Syncope with concurrent VT detected by the device.
  • Non-arrhythmic syncope at follow-up: Syncope with no disturbances in the ventricular rhythm detected by the device.

Statistical analysis
Continuous variables were expressed as mean±SD or as median and interquartile range (IQR) according to the appropriate distribution type. Statistical significance was assumed if the null hypothesis could be rejected at the 0.05 probability level. All reported P-values are two-tailed. The baseline characteristics of the two groups were compared with the use of two-sample t-test or Mann–Whitney U test for continuous variables and {chi}2 test or Fisher's exact tests for categorical variables as appropriate. Cox proportional hazards model was used to adjust for covariates and to estimate the hazard ratio for death, syncope recurrence, arrhythmic syncope recurrence and tachycardia recurrence and corresponding 95% confidence interval in the syncope group when compared with the non-syncope group. Covariates included in this model were clinically meaningful potential confounding factors [left ventricular ejection fraction (LVEF), type of structural heart disease (ischaemic vs. non-ischaemic), age and New York Heart Association (NYHA) functional class for death and tachycardia recurrence]. Data on a patient who received a heart transplant were censored at the time of transplantation. Cox proportional hazards model was also fitted to assess the univariate prognostic value of a series of clinical variables that could affect the syncope recurrence [age, sex, presence or absence of syncope during the clinical VT, type of heart disease (ischaemic vs. non-ischaemic), LVEF, NYHA functional class, clinical VT CL, recurrent VT CL and episode duration until termination]. The adequacy of adopting a Cox model was checked graphically by comparing predicted and observed survival curves. The likelihood ratio test has been used for calculating the significance of the model. A multivariable Cox model has then be fitted by including all variables showing a P-value <0.2 at univariate analysis.


   Results
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 Abstract
 Introduction
 Methods
 Results
Discussion
 Conclusions
 Acknowledgements
 References
 
All patients were followed for at least 6 months (31 months, IQR: 11–50 and 34 months, IQR: 13–56 follow-up in the SyMVT and NSyMVT groups, respectively). At follow-up, one patient underwent heart transplantation and five died (one sudden, three cardiac non-arrhythmic, and one non-cardiac deaths) in the SyMVT group. Six patients died (one sudden, four cardiac non-arrhythmic, and one non-cardiac deaths) in the NSyMVT group (hazard ratio, 0.77; 95% confidence interval, 0.42–1.44; P=0.38; Figure 1D).



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  		Figure 1 Kaplan–Meier analysis comparing arrhythmic syncope-free survival (A), syncope-free survival (B), arrhythmic free-survival (C), and survival (D) curves in the syncope (solid lines) and non-syncope (dotted lines) groups. Sy-VT: syncope group; NSy-VT: non-syncope group.

 
Eighteen and thirty-six patients presented appropriate therapies during follow-up in the SyMVT and NSyMVT groups, respectively (hazard ratio, 0.84; 95% confidence interval, 0.44–1.13; P=0.22; Figure 1C). Syncope was reported in 12 (46%) and 1 patients (2%) in the SyMVT and NSyMVT groups, respectively (hazard ratio, 0.19; 95% confidence interval, 0.04–0.42; P=0.0001; Figure 1B). Two patients had more than one syncope recurrence in the SyMVT group. Recurrent syncope had an arrhythmic mechanism in eight and one patients in the SyMVT and NSyMVT groups, respectively (hazard ratio, 0.24; 95% confidence interval, 0.05–0.56; P=0.0002; Figure 1A) which was correlated with appropriate ICD therapies in 11 events and inappropriate ICD therapies in one event. Appropriately treated events included nine VT episodes in five patients and two ventricular fibrillation episodes in two other patients. All syncopal VT events had a longer CL than the clinical pre-implant VT except for one and three events with a similar or shorter CL, respectively. VT accelerated or degenerated into ventricular fibrillation by ATP or shocks in six syncopal events (Figures 2 and 3). All of them had an initial CL longer than the clinical pre-implant VT CL. The single inappropriate therapy was triggered by atrial fibrillation (Table 3). The single syncopal event in patients with NSyMVT was associated with VT recurrence with a shorter CL than that of the clinical pre-implant VT. All patients with syncope at follow-up but one had a single chamber ICD implanted.



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  		Figure 2 Electrograms recorded by an implantable cardioverter defibrillator during sustained monomorphic VT. The trace shows VT with a CL of 305 ms followed by a 5 J defibrillator shock. This results in degeneration into ventricular fibrillation and in sinus rhythm restoration by a subsequent 35 J shock (not shown).

 


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  		Figure 3 Electrograms recorded by an implantable cardioverter defibrillator during sustained monomorphic VT. The trace shows VT with a CL of 250 ms followed by a 34 J defibrillator shock, which results in tachycardia degeneration into ventricular fibrillation.

 

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  		Table 3 Syncopal proarrhythmic events induced by the device in patients with spontaneous syncopal VT prior to ICD implantation
 
Non-arrhythmic syncope was diagnosed in the remaining four and no patients in the SyMVT and NSyMVT groups, respectively (hazard ratio, 0.0007; 95% confidence interval, 0–0.52; P=0.002). Hypoglycemia, sublingual nitrate administration, and no apparent cause in two patients were the final diagnosis in these four patients.

Clinical differences between the SyMVT and NSyMVT groups are shown in Table 1.

The occurrence of syncope during follow-up was not associated to the NYHA functional class, clinical VT CL, recurrent VT CL, episode duration until termination, age nor sex at univariate analysis. Only the occurrence of syncope during the clinical VT and the LVEF were clinical predictors of the occurrence of syncope during follow-up at multivariable analysis (Table 2).


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  		Table 2 Association between baseline clinical characteristics and syncope recurrence following ICD implantation for spontaneous syncopal VT treatment
 
The median time to the first appropriate therapy was 47 (IQR: 15–164) and 143 days (IQR: 51–403) in the SyMVT and NSyMVT groups, respectively. Median time to the first arrhythmic syncope at follow-up was 376 days (IQR: 197–561) in the SyMVT group. Time to the arrhythmic syncope in the patient of the NSyMVT group was 88 days. Arrhythmic syncope presented after the first recurrence of VT in six patients (75%).


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusions
 Acknowledgements
 References
 
Incidence of syncope
This study demonstrated a high likelihood of syncope following ICD implantation in patients with spontaneous SyMVT. Syncope presented at follow-up in almost half of the patients in this setting, which is in contrast to patients with spontaneous NSyMVT who rarely presented syncope following ICD implantation. This incidence was also higher than that reported for the general population of patients with ICD (range 7–19%)11,12 and for patients with unexplained syncope and inducible VT (range 8–30%).5,6,13 Unexplained syncope at presentation may or may not be the consequence of VT and this probably accounts for the high incidence of syncope recurrence in our study, which included only patients with syncope related to spontaneous VT.

The first potential factor for the higher incidence of syncope at follow-up in patients with SyMVT when compared with patients with NSyMVT and other ICD recipients is the higher proportion of patients with non-ischaemic heart disease in this particular population. In fact, a similar incidence of syncope recurrence at follow-up has been found in patients with chagasic cardiomyopathy and syncopal VT not treated with ICD.7

LVEF has also been found to be associated with tachycardia acceleration in other studies.14 Low LVEF was found to be associated with syncope and proarrhythmia at follow-up in the SyMVT group in the present study. However, no significant differences were seen in LVEF or clinical VT CL between the whole SyMVT and NSyMVT groups, which may have explained differences in syncope at presentation and follow-up between these two groups.

Other potential factor for the higher incidence of syncope at follow-up in the SyMVT group than in the NSyMVT group was a proarrhythmic effect of antiarrhythmic drugs, because more patients in the former were on class III drug therapy, and six out of the seven proarrhythmic episodes occurred in two patients in the SyMVT group under class III drug treatment. Whether this finding is enough evidence to support ICD testing for potential proarrhythmia identification in patients with spontaneous syncopal VT who are put on antiarrhythmic drug treatment is unclear and warrants further investigation.

Another possible explanation for the high incidence of syncopal events at follow-up in this study could be the potential proarrhythmic effect of ATP and ‘low-energy’ shocks, which were programmed in all patients (Table 3). It could be speculated that programming of high-energy shocks as the first therapy in the VT zone may reduce the incidence of VT acceleration. However, VT degeneration into ventricular fibrillation by high-energy shocks presented also in three out of seven SyMVT episodes. In addition, prior studies had shown low incidence of syncope and VT acceleration when ATP is programmed, even in episodes of fast VT.9,15 Finally, despite similar ATP and low-energy shocks programmed in patients with NSyMVT, only a single syncopal episode occurred at follow-up in this group of 50 patients.

Mechanisms of syncope at follow-up
Spontaneous VT recurrences are considered to be the most frequent mechanism for syncope following ICD implantation.11,16 In fact, this was the case in our study population, in which syncope was associated with spontaneous arrhythmic events in most patients. However, in the present study most arrhythmic syncope episodes were associated to ICD-related proarrhythmia. This was also the case in some previous studies, which found up to 62% of proarrhythmia as the mechanism of syncope in a non-selected population of ICD recipients.12,17 Syncopal proarrhythmic events presented with all modalities of antitachycardia therapy, with no apparent association with any particular form of therapy (Table 3).

The incidence of non-arrhythmic syncope found in the syncope group in this study (15%) does not differ from previous studies (7–15%).6,18,19 Interestingly, there was higher incidence of non-arrhythmic syncope in the SyMVT group than in the NSyMVT group. Higher baroreflex sensitivity in the former group could explain syncope at VT presentation and at follow-up.20 However, this study was not designed to study the potential role of the autonomic system in non-arrhythmic syncope.

Time to syncope presentation at follow-up
Current guidelines from the American Heart Association, the North American Society of Pacing, and the European Society of Cardiology propose driving restrictions for 6 months following ICD implantation.3,4 However, in the present study median time to the first arrhythmic syncope after ICD implantation was slightly more than 1 year. Furthermore, arrhythmic syncope presented later than non-syncopal recurrence of VT in six patients (75%). These findings warrant reassessment of the driving restriction policy following ICD implantation in patients with spontaneous SyMVT. This has also been suggested in other studies, which found no relation between driving limitation duration and motor vehicle accidents.21,22

Study limitations
This retrospective cohort study included only patients with ICD for spontaneous VT. So, conclusions should not be extended to patients with unexplained syncope and inducible sustained monomorphic VT or to the whole ICD population.

The small number of patients in the study group is another limitation. However, significant differences in the incidence of syncope recurrence between the SyMVT and NSyMVT groups support the study conclusions.

Although at every visit patients were asked whether syncope had occurred, underreporting of syncopal episodes, because of oblivion or fear of driving restrictions, could have been presented in the two groups.

Slow VT cannot be ruled out as the cause of syncope in the four episodes classified as non-arrhythmic syncope. However, all patients underwent electrophysiological testing prior to ICD implantation and such a VT was not induced in any of them. In addition, the ICD detection rate was programmed at 150 bpm in all of them and, therefore, the possibility of spontaneous VT with a rate below this limit to be syncopal and self-terminating is unlikely. Finally, other causes for syncope, such as hypoglycemia and sublingual nitrate administration, were found in two of these episodes. All these factors led us to consider slow VT as the cause of syncope unlikely enough to obviate a new ventricular-programmed stimulation procedure.

Finally, we cannot completely exclude the possibility that some of the syncopal events classified as non-arrhythmic could be related to non-sustained VT, which were not recorded by the device. This is a limitation inherent to most studies with present technology ICDs.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
Acknowledgements
 References
 
Syncope following ICD implantation is common in patients with SyMVT, which is in contrast to patients with NSyMVT. The median time to the first arrhythmic syncope recurrence was slightly more than 1 year and arrhythmic syncope presented after a first non-syncopal recurrence of VT in most patients, which supports the reassessment of driving restrictions in this setting.


   Acknowledgements
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
References
 
The authors thank Dr Ignacio Fernandez-Lozano and Dr Jesús Martinez-Alday for their critical review of the manuscript, Elena Morala, RN, for her technical assistance, and Martin Hadley-Adams for his assistance with the English language.

Conflicts of interest: Dr Mauricio Abello has received grant/research support for Medtronic Ibérica, Spain. Dr José Luis Merino and Dr Rafael Peinado are Scientific consultants and researchers for Medtronic Co. & Guidant Co. The other authors have not any conflict of interest.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
 References
 

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