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Archives of cardiovascular diseases
Volume 109, n° 10
pages 517-526 (octobre 2016)
Doi : 10.1016/j.acvd.2016.02.008
Received : 2 October 2015 ;  accepted : 5 February 2016
Long-term outcome of implantable cardioverter–defibrillator implantation in secondary prevention of sudden cardiac death
Devenir à long terme des patients implantés d’un défibrillateur automatique implantable en prévention secondaire
 

Stéphane Boulé a, b, , Marc Sémichon a, Laurence Guédon-Moreau a, Élodie Drumez c, Claude Kouakam a, Christelle Marquié a, François Brigadeau a, Salem Kacet a, b, Charlotte Potelle a, b, William Escande a, b, Zouheir Souissi b, Dominique Lacroix a, b, Alain Duhamel c, Didier Klug a, b
a Department of Cardiovascular Medicine, Lille University Hospital, 59370 Lille, France 
b Faculty of Medicine, University of Lille 2, 59000 Lille, France 
c Unité de biostatistique, université de Lille, CHU de Lille, EA 2694 – santé publique : épidémiologie et qualité des soins, 59000 Lille, France 

Corresponding author. Pôle de cardiologie, hôpital cardiologique, CHRU, 59370 Lille, France.
Summary
Background

Little is known about the long-term outcomes of patients who receive an implantable cardioverter–defibrillator (ICD) for purely secondary prevention indications.

Aims

To assess the rates and predictors of appropriate therapies over a very long-term follow-up period in this population.

Methods

Between June 2003 and August 2006, 239 consecutive patients with structural left ventricular disease and a secondary prophylaxis indication for ICD therapy (survivors of life-threatening ventricular tachyarrhythmias) were prospectively enrolled. An extended follow-up of these patients was carried out. The primary endpoint was the occurrence of appropriate device therapy. Secondary endpoints were all-cause death, electrical storm and inappropriate therapy.

Results

The study population consisted of 239 patients (90% men; mean age 64±12 years; 72% ischaemic cardiomyopathy; left ventricular ejection fraction 37±12%). During a median follow-up of 7.8 (3.5–9.3) years, appropriate device therapy occurred in 139 (58.2%) patients. Death occurred in 141 patients (59%), electrical storm in 73 (30.5%) and inappropriate therapy in 42 (17.6%). Multivariable analysis identified patients whose presenting arrhythmia was ventricular fibrillation as being less likely to require appropriate device therapy than those whose presenting arrhythmia was ventricular tachycardia (sub-hazard ratio 0.62, 95% confidence interval 0.40–0.97; P =0.04). Independent predictors of all-cause death were age at implantation (P <0.0001), wide QRS complexes (P =0.024), creatinine concentration (P =0.0002) and B-type natriuretic peptide at implantation (P =0.0001).

Conclusion

Secondary prevention ICD recipients exhibit a high risk of appropriate device therapy and death over prolonged follow-up. Patients who presented initially with ventricular fibrillation were less likely to require the delivery of appropriate device therapy.

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Résumé
Contexte

Il y a peu de données dans la littérature sur le suivi à long terme des patients implantés d’un défibrillateur automatique implantable (DAI) en prévention secondaire.

Objectifs

Déterminer les taux et facteurs prédictifs de thérapies appropriées au terme d’un suivi très prolongé dans cette population.

Méthodes

Entre juin 2003 et août 2006, nous avons inclus prospectivement 239 patients implantés d’un DAI en prévention secondaire dans le cadre d’une cardiopathie gauche. Un suivi à très long terme de ces patients a été effectué.

Résultats

La population était composée de 239 patients (hommes 90 % ; 64±12ans ; cardiopathie ischémique 72 % ; FEVG 37±12 %). Au terme d’un suivi médian de 7,8 (3,5–9,3) ans, ≥1 thérapie(s) appropriée(s) a été délivrée chez 139 (58,2 %) patients. Un décès est survenu chez 141 patients (59 %), des orages rythmiques chez 73 (30,5 %), et des thérapies inappropriées chez 42 patients (17,6 %). En analyse multivariée, l’implantation pour fibrillation ventriculaire (FV) (versus tachycardie ventriculaire) était le seul facteur associé à un moindre risque de thérapies appropriées (HR 0,62, IC 95 % 0,40–0,97 ; p =0,04). Les facteurs prédictifs indépendants de décès étaient l’âge à l’implantation (p <0,0001), des QRS larges (p =0,02), l’insuffisance rénale (p <0,001) et un taux élevé de BNP (p =0,0001).

Conclusion

Chez les patients implantés d’un DAI en prévention secondaire, le risque de thérapies appropriées est élevé et persiste bien à distance de l’implantation. Le seul facteur associé à un moindre risque de thérapies appropriées est l’implantation pour FV.

The full text of this article is available in PDF format.

Keywords : Implantable cardioverter–defibrillator, Sudden cardiac death, Ventricular tachycardia, Ventricular fibrillation, Secondary prevention

Mots clés : Défibrillateur automatique implantable, Mort subite, Tachycardie ventriculaire, Fibrillation ventriculaire, Prévention secondaire

Abbreviations : ATP, CI, CRT, HR, ICD, IQR, LVEF, SCD, SHR, VF, VT


Background

Guidelines from the European Society of Cardiology recommend an implantable cardioverter–defibrillator (ICD) for patients with documented ventricular fibrillation (VF) or haemodynamically not tolerated ventricular tachycardia (VT), in the absence of reversible causes or within 48hours after myocardial infarction, who are receiving optimal therapy and have a reasonable expectation of survival with a good functional status beyond 1year [1]. The benefit of ICD therapy in this population has been well established by evidence from three clinical trials (the Antiarrhythmic drugs Versus Implantable Defibrillator [AVID] Study [2], the Canadian Implantable Defibrillator Study [CIDS] [3] and the Cardiac Arrest Study Hamburg [CASH] [4]) conducted in the late 1990s. In these patients, ICD therapy was associated with a 28% reduction in total mortality, driven by a 50% reduction in death because of arrhythmia [1, 5]. Previous studies have demonstrated that patients undergoing secondary prevention treatment by implantation of ICD carry a high risk of recurrence of their ventricular tachyarrhythmia in the short term [6, 7, 8]. However, outcomes over a long-term follow-up period remain poorly characterized in this population, as most studies focused on outcomes in the few months after device implantation.

We now report the long-term outcomes of a large cohort of prospectively enrolled patients who had undergone ICD implantation for secondary prophylaxis more than 10 years ago. We sought to determine the rates and predictors of appropriate device therapies in this population, as well as the rates and predictors of electrical storms and all-cause death.

Methods
Study population

Between June 2003 and August 2006, 239 survivors of life-threatening ventricular tachyarrhythmias were prospectively included at our institution. All patients received an ICD for secondary prophylaxis indications. Inclusion criteria were patients who had survived an aborted cardiac arrest or a symptomatic episode of spontaneous sustained VT, and patients with left ventricular structural heart disease. Exclusion criteria were ventricular tachyarrhythmias with a transient reversible cause (acute myocardial infarction, drugs, electrolyte abnormalities); structurally normal heart or isolated right ventricular heart disease without left ventricular involvement; unexplained syncope with left ventricular dysfunction and inducible VT; and age<18 years. Written informed consent was obtained from all enrolled patients.

Data collection and follow-up

Clinical and paraclinical characteristics of the study population were collated at baseline. A diagnosis of ischaemic cardiomyopathy was made in patients with previous myocardial infarction and/or previous coronary revascularization and/or50% coronary stenosis by angiography. The presenting arrhythmia (VT/VF) was assessed in each patient, as well as whether it was tolerated (cardiac arrest or not). Sustained VT was defined as VT lasting30seconds or terminated by cardioversion before that time. Symptomatic VT was defined as VT that caused haemodynamic compromise requiring prompt termination (hypotension, presyncope or syncope, angina, heart failure symptoms, dyspnoea). The medication regimen was recorded at hospital discharge. All patients underwent ICD implantation before hospital discharge, with prepectoral cans and endocardial bipolar leads. Single-chamber, dual-chamber or biventricular ICDs were implanted, as appropriate. All devices were programmed to store far-field electrograms of detected episodes; they were programmed with three detection zones (two VT zones and one VF zone), and algorithms for the discrimination of supraventricular tachycardias were activated in the VT zones. In the VT zones, antitachycardia pacing (ATP) was the first-line therapy in all patients. The VF zone was set at240beats/min, and the fast VT zone was set in the range 200–240beats/min. The lower limit of the slow VT zone was set at 150beats/min in patients who had VF, and was set to be 10beats/min below the slowest episode of VT in those who had VT.

Follow-up started at the time of ICD implantation (June 2003 to August 2006), and ended in December 2014. Initially, ambulatory follow-up was scheduled, with routine consultations twice a year. Beginning in 2007, a substantial proportion of the study population was also followed up with remote monitoring. All stored electrograms were reviewed to determine whether ICD therapies were delivered appropriately or inappropriately. The occurrence of electrical storms, defined as at least three episodes of ventricular tachyarrhythmia over a 24-hour period terminated by ATP and/or shock, was also noted. Finally, the survival status of each patient was collected at the end of the follow-up period.

Endpoints

The primary endpoint was the occurrence of the first appropriate ICD therapy. Secondary endpoints were the occurrence of electrical storms and all-cause mortality.

Statistical analysis

Qualitative variables are expressed as numbers and percentages. Continuous variables are reported as means±standard deviations or as medians and interquartile ranges (IQRs) in case of non-Gaussian distribution. The normality of continuous variables was checked graphically and by using the Shapiro-Wilk test. We estimated cumulative incidences of appropriate device therapies and electrical storms using a competing risk method, treating death as the competing risk. Cumulative incidences of appropriate device therapies and electrical storms were estimated using the approach of Kalbfleisch and Prentice [9]. Univariate predictors of appropriate device therapies and electrical storms were identified using Fine-Gray regression models. Variables with values of P <0.20 in bivariate analyses were entered into a multivariable Fine-Gray regression analysis. To assess the effect of electrical storm occurrence on all-cause mortality, we used a time-varying Cox regression analysis. We estimated overall survival using the Kaplan–Meier method. Univariate analyses were performed using Cox proportional hazard regression models. Variables with values of P <0.20 in bivariate analyses were entered into a multivariable Cox proportional hazard regression analysis. For both the Fine-Gray and Cox models, the proportional hazards assumption for each potential predictor was assessed by plotting the Schoenfeld residuals. We derived from Fine-Gray and Cox models, sub-hazard ratios (SHRs) and hazard ratios (HRs) with their 95% confidence intervals (CIs).

All statistical tests were performed at the two-tailed α level of 0.05. Data were analysed using SAS software, version 9.4 (SAS Institute Inc., Cary, NC, USA).

Results
Study population

The study population consisted of 239 patients, prospectively included from June 2003 to August 2006. Baseline characteristics of the study population are presented in Table 1. The main characteristics were as follows: mean age 64±12 years (range, 24–82years); 215 men (90%); and mean LVEF 37±12%, with 128 (54%) patients having an LVEF35%. A history of atrial fibrillation was noted in 74 patients (31%). The main underlying cardiac condition was ischaemic heart disease (n =172, 72%), the other underlying cardiomyopathies being idiopathic dilated cardiomyopathy (n =53, 22%), valvular heart disease (n =7, 3%), arrhythmogenic right ventricular cardiomyopathy (n =3, 1%), hypertrophic cardiomyopathy (n =2, 1%), congenital heart disease (n =2, 1%) and cardiac sarcoidosis (n =1, 0.5%). Presenting ventricular tachyarrhythmias were VT in 187 patients (78%) and VF in the 52 remaining patients (22%). Among patients with VT, 183 (98%) had monomorphic VT and 4 (2%) had polymorphic VT. Sixty-six patients (28%) presented with aborted sudden cardiac death (SCD) requiring cardiopulmonary resuscitation. At hospital discharge, the majority of patients were receiving β-blockers (n =229, 96%) and angiotensin converting enzyme inhibitors or angiotensin receptor blockers (n =221, 93%). Cardiac resynchronization therapy (CRT) was associated with the ICD in 33 patients (14%).

The median overall follow-up period was 7.8 years (range, 3.5–9.3 years; mean 6.6±3.4 years), the longest being 11.4 years after ICD implantation. During follow-up, appropriate device therapy (ATP and/or shocks) occurred in 139 (58.2%) patients, electrical storm in 73 (30.5%), and death in 141 (59%). Inappropriate device therapies occurred in 42 (17.6%) patients. Five (2%) patients underwent heart transplantation.

Appropriate device therapies

The cumulative incidences of appropriate therapies were 33%, 46%, 54% and 57% at 1, 2, 5 and 8 years, respectively. As shown in Figure 1, the risk of appropriate device therapy was the highest in the early period of time after ICD implantation, and persisted over long-term follow-up. The median period between ICD implantation and the first appropriate ICD discharge was 5.3 months (IQR 4–23months; range, 1 day to 9.7years). The first appropriate therapy was delivered during the first year after ICD implantation in 78 out of the 139 patients (56%) who received appropriate ICD discharges. Among these 139 patients, the first treated arrhythmia was VT in 127 patients (91%) and VF in the remaining 12 patients (9%). In patients who received an ICD for VT, the first arrhythmia recurrence terminated by the ICD was VT in almost all cases (96%), whereas in those with VF as the index arrhythmia, the first arrhythmia recurrence was VT in 71% of cases and VF in the remaining cases (29%). Shock therapy was triggered in nearly one of three cases (n =43, 30.9%), specifically the 12 patients with VF plus 31 patients with VT (12 patients with very fast VTs detected in the VF zone and 19 patients with slower VTs but failure of ATP). Among the 127 patients in whom the first appropriate therapy was delivered to terminate an episode of VT, the median VT rate was 180 beats/min (IQR 166–203 beats/min). Table 2 shows the type of ICD therapies according to the main characteristics of the patients.



Figure 1


Figure 1. 

Cumulative incidence rates for appropriate device therapies. Note that the risk of appropriate therapies is high during the first 2 years after implantable cardioverter–defibrillator implantation (line “A”); this risk is lower but persistent over long-term follow-up (line “B”).

Zoom

As shown in Figure 2 and Table 3, univariate analysis identified VT as presenting arrhythmia as the single factor associated with an increased risk of appropriate device therapies during follow-up (SHR 1.60, 95% CI 1.04–2.45; P =0.03). Among the 187 patients who received an ICD for VT, 115 (61%) experienced appropriate therapies versus 24 of the 52 patients (46%) who were implanted after an aborted SCD related to VF. This increased risk appeared early after ICD implantation and persisted over time (Figure 2). None of the other factors could predict the occurrence of appropriate device therapies (Table 3). On multivariable analysis, including body mass index, B-type natriuretic peptide and VT as presenting arrhythmia, only VT remained predictive of appropriate device therapies (SHR 1.56, 95% CI 1.01–2.40; P =0.04). When considering the VT and VF groups individually, no variables could predict the occurrence of appropriate ICD therapies (Table 3).



Figure 2


Figure 2. 

Risk of appropriate device therapy over long-term follow-up according to the presenting arrhythmia. SHR: sub-hazard ratio; VF: ventricular fibrillation; VT: ventricular tachycardia.

Zoom

Electrical storms

During follow-up, electrical storms occurred in 73 patients (30.5%), 27 (37%) of whom experienced multiple episodes of electrical storms (17 patients had two episodes, eight had three episodes and two had four episodes). Electrical storms occurred after a median time of 19 months (IQR 6–35 months) years after ICD implantation (minimum 14 days, maximum 6.8 years), and during the first year in 40% of the patients. The majority of patients experienced recurrent episodes of monomorphic VTs (n =69, 95%), whereas electrical storms related to VF episodes were noted in 12 patients (four patients with pure VF episodes and eight patients who experienced both VT and VF episodes). In patients with VTs, the median number of VT episodes was 34 (IQR 12–60 VT episodes) and the maximum was 422. Eight patients (11%) were already receiving amiodarone therapy at the time of admission. These electrical storms triggered ATP delivery in virtually all cases (n =70, 96%), and ICD shock(s) in 54 cases (74%), the median number of delivered shocks per admission being 2 (IQR 1–5 shocks) and the maximum being 39. Hospital admission was required in 56 cases (77%, with a median length of stay of 7 days [IQR 4–9 days]). Measures taken after electrical storms were as follows: loading dose of amiodarone (n =31, 42%), increase in the dosage of β-blocker therapy (n =35, 48%), catheter ablation of VT (n =20, 27%), changes in ICD programming (n =10, 14%) and deep sedation (n =3, 4%).

The mortality rate was significantly increased in these patients compared with in those who did not experienced electrical storms (70 vs 56%; HR 2.31, 95% CI 1.63–3.26; P <0.001).

Univariate analysis identified two factors associated with electrical storm occurrence: VT as presenting arrhythmia (versus VF) (SHR 1.91, 95% CI 0.98–3.73; P =0.06) and presence of a CRT-D device (SHR 1.94, 95% CI 1.06–3.56; P =0.03). None of the other variables was predictive of this complication (Appendix A).

Mortality

During follow-up, 141 patients (59%) died. Survival rates were 92%, 86%, 69% and 49% at 1, 2, 5 and 8 years, respectively. The median period of time between ICD implantation and death was 4.6 (2.1–6.9) years, the shortest being 46 days. Figure 3 shows the survival curve of the population.



Figure 3


Figure 3. 

Kaplan-Meier survival curve of the study population.

Zoom

The univariate and multivariable analyses of association between characteristics at implantation and death are reported in Table 4. Besides age at ICD implantation (68±11 vs 59±11 years; HR per 10 years increased 1.41, 95% CI 1.19–1.67; P <0.0001), multivariable analysis identified three independent predictors of death: high creatinine concentrations (HR 1.04, 95% CI 1.02–1.05; P =0.0002), high B-type natriuretic peptide concentration (HR 1.08, 95% CI 1.04–1.13; P =0.0001) and wide QRS complexes (HR 1.81, 95% CI 1.08–3.02; P =0.024). These predictors were also found in the VT group, whereas only renal impairment remained significant in the VF group (Table 4).

The definite cause of death was known in 114 patients (81%). Cardiovascular deaths occurred in 53% of cases (n =60), with 11% (n =7) being of arrhythmic origin. Predictors of death of cardiovascular origin were roughly similar to those of all-cause death, and are shown in Appendix A. Figure 3 shows the incidence of cardiovascular deaths over time.

Discussion

This large prospective series describes the very long-term outcomes of patients who had undergone ICD implantation for secondary prevention of SCD. The main findings were that most patients experience ventricular tachyarrhythmia recurrence over extended follow-up; that the risk of appropriate ICD therapies remains high even many years after ICD implantation; and that VT as presenting arrhythmia (versus VF) is the single factor independently associated with a higher risk of appropriate ICD therapies over prolonged follow-up in this population.

Incidence of appropriate device therapies

The first finding of the present study is that more than half of the patients (58%) who had received an ICD for the secondary prevention of SCD experience appropriate therapies triggered by ventricular tachyarrhythmias recurrences over prolonged follow-up. Although the population of prophylactic ICD recipients has been widely studied, there is relatively little data in the wider literature regarding outcomes in patients with pure secondary prophylaxis indications. An overview of this literature is provided in Table 5. Previous studies have found high rates of VT/VF recurrences over short-term follow-up [6, 7, 8]. For example, in the LOHCAT study [7], the rate of appropriate therapies was 47% during a mean follow-up of 4.5±2.9 years. Our findings (58% of patients with appropriate ICD therapies after a mean follow-up of 6.6±3.4 years) are in line with those of Schaer et al. [10], who recently reported a risk of appropriate therapies of 59% after a mean follow-up of 6.8±4.4 years in a cohort of 357 patients implanted in secondary prevention.

It is important to note that the risk of appropriate therapies depends on ICD programming. In the present study, although ICD programming was standardized at the time of device implantation, subsequent ICD programming was left at the discretion of the physician in charge of the patient, so that changes in ICD programming may indeed have affected the risk of appropriate device therapies. Nevertheless, among the 127 patients in whom the first appropriate therapy was delivered to terminate an episode of VT, only six of these patients (4.7%) had a VT rate<150 beats/min. On the other hand, detections times were left at their nominal values; at the time of enrolment, these default device settings used short-duration detection criteria, as trials supporting the beneficial effect of long detection intervals were not yet published [11]. Despite the scarcity of data in secondary prevention patients, it is likely that “modern” tachycardia detection programming [12] (higher threshold for VT detection rate, longer detection duration, etc.) would result in a lower incidence of appropriate device therapies.

Of interest, we found that the risk of appropriate ICD therapies was not evenly distributed over time. The highest risk was noted at the beginning of follow-up, with more than half of the appropriate therapies (56%) occurring during the first year after ICD implantation. This finding has already been noted in both primary and secondary prevention populations [7, 10, 13], and several hypotheses have been put forward to explain it. The extended follow-up performed in the present study offers the opportunity to assess what occurs beyond this early high-risk period. Although the rate of first appropriate therapy becomes lower, it is important to note that it persists over time. For example, one patient received a first appropriate therapy nearly 10 years after ICD implantation. This observation strongly supports the fact that generator replacement is still indicated in these patients, even if they have not experienced any recurrence of ventricular tachyarrhythmias.

Finally, electrical storms occurred in nearly one of three patients over the prolonged follow-up period, which further underlines the very high-risk profile of this secondary prophylaxis population.

Predictors of appropriate device therapies

In the present work, the single predictor of appropriate ICD therapies was VT as the presenting arrhythmia (SHR 1.6 compared with VF). Conflicting results have been reported regarding predictors of ICD therapies in secondary prevention patients; for instance, Borleffs et al. found that atrial fibrillation/flutter, VT as presenting arrhythmia and QRS duration were such predictors [7], whereas Schaer found only VT as presenting arrhythmia and age [10]. The finding that patients implanted for VT carry a higher risk of subsequent appropriate ICD therapies is in line with previous reports [7, 10, 14, 15], and has not been fully explained. The occurrence of an episode of monomorphic VT usually implies the presence of a ventricular scar, which provides a stable substrate for VT recurrences that will persist throughout the life course. Conversely, although the mechanisms underlying the initiation and perpetuation of VF are not fully understood, its occurrence seems more dependent on external and potentially reversible triggers (ischaemia, electrolyte imbalance, etc.) than what is seen for monomorphic VTs. Even if patients with ventricular tachyarrhythmias due to reversible causes were excluded, we could not completely rule out the influence of some of these factors. From a clinical point of view, it is interesting to notice that none of the other studied factors (LVEF in particular) could predict ICD therapies. This is a main difference with primary prevention patients, in whom low LVEF is the main criterion for ICD implantation [1]. Moreover, although a lower risk was noted in patients with VF as index arrhythmia, no recurrence-free group could be identified. Thus, the key message is that prediction of ventricular tachyarrhythmia recurrence in these patients appears rather limited.

Study limitations

This was a single-centre study and therefore subject to the usual limitations of this study design. Nevertheless, patients were prospectively included and the follow-up period is one of the longest reported so far. The second limitation is that when appropriate ICD therapies occur in a given patient, it is very difficult, if not impossible, to assess whether the patient really benefited from the ICD in terms of prevention of SCD. For this reason, results were presented in terms of appropriate ICD therapies, rather than in terms of prevention of arrhythmic death. Finally, changes in ICD programming over time may have affected the occurrence of appropriate therapies. This point has already been elucidated in the main text.

Conclusion

Patients with ICD implanted for secondary prevention of SCD exhibit a very high risk of appropriate device therapy and death over prolonged follow-up. This risk is highest in the first year following ICD implantation, but persists significantly over time. Although patients implanted for VF (compared with VT) are at lower risk of appropriate device therapy, no recurrence-free group could be identified. Prediction of appropriate device therapies in this population appears very limited.

Funding

None.

Disclosure of interest

L. G. M. and D. K. Consulting fees from the companies Biotronik, Boston Scientific, Medtronic Inc., St. Jude Medical and Sorin Group.

C. M. Consulting fees from the companies Boston Scientific, St. Jude Medical and Sorin Group.

F. B. Consulting fees from the companies Biotronik, Boston Scientific, Biosense Webster, St. Jude Medical and Sorin Group.

S. B. Travel support from the companies Biotronik and St. Jude Medical.

Z.S. Travel support from the companies Biotronik, Medtronic Inc., Sorin Group and St. Jude Medical.

C. K. Consulting fees from the companies Biotronik, Boston Scientific, Medtronic Inc. and Sorin Group.

D. L. Consulting fees from the company Medtronic Inc.

None of the companies mentioned above were involved in this study, financially or otherwise.

The other authors declare that they have no competing interest.


Acknowledgement

We are grateful to Allan Grant for his valuable help.


Appendix A. Supplementary data

(217 Ko)
 Table S1 
Table S1. 

Predictors of electrical storms.

(236 Ko)
 Table S2 
Table S2. 

Predictors of death from cardiovascular origin.

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