Should Patients with Implantable Cardioverter-Defibrillators Be Allowed to Drive? Observations in 291 Patients from a Single Center over an 11-year Period

Motor-vehicle driving restrictions for patients with implantable cardioverter-defibrillators (ICDs) vary widely throughout the world because safety concerns have never been adequately resolved in this patient population. To address this issue, we examined the driving behavior of 291 ICD patients to correlate the frequency of device therapy during driving, the occurrence of syncopal symptoms, and the incidence of traffic accidents. Fifty of the 291 patients had never driven. Of the remaining 241 patients, 171 (59%) continued driving postimplant and 70 (24%) elected to stop prior to (n = 30) or at the time of ICD implantation (n = 40). Patients were followed for a mean of 38 ± 26 months (range <1–124). During this period, no patients died while driving. Of 11 accidents involving 11 driving patients (6%), only 1 was caused by the driver, and none was related to syncopal symptoms or ICD therapy. Although 2 accidents (8%) occurred within 12 months postimplant, the majority (50%) took place after more than 36 months. ICD therapy was delivered in 8 patients (5%) while driving: 13% (1 episode) of the discharges occurred within the first year postimplant, 13% (1 episode) occurred between 1–2 years, and 74% (6 episodes) occurred >2 years. None of these patients experienced syncope before or during these episodes. A multivariate analysis was unable to identify any variables that might predict increased risk of ICD therapy (with or without sudden death) while driving and consequent motor vehicle accidents. Our data suggest that such events occur only rarely     

Role of the Automatic Implantable Cardioverter Defibrillator in the Post-myocardial Infarction Patient

Patients with a myocardial infarction are at an increased risk of sudden cardiac death largely due to ventricular arrhythmias associated with myocardial scarring. Implantable cardioverter defibrillators (ICDs) have been established as the best available treatment for the secondary prevention of an arrhythmic death in patients at high risk. This includes patients who have survived sudden cardiac death, have had sustained ventricular tachycardia or fibrillation, or have had syncope assumed to be due to a ventricular arrhythmia. High-risk features of patients with infarction without a previous arrhythmic event who qualify for a primary prevention ICD are an ejection fraction (EF) <30% or symptoms of Class II or III heart failure with an EF ≤ 35%. In addition, patients with nonsustained ventricular tachycardia, a positive electrophysiology study, and EF ≤ 40% are candidates under the current primary prevention guidelines. The current guidelines have specified the timing for ICD implantation as >40 days following the acute myocardial infarction. Despite the establishment of the guidelines, current clinical practice has revealed that ICDs are underutilized in patients who qualify. This article reviews the ICD implantation guidelines to encourage the appropriate use of the device.     

A Systematic Review of the Risk of Motor Vehicle Collision in Patients With Syncope

BackgroundDrivers at risk of sudden incapacitation from syncope pose a potential threat to themselves and to society. The purpose of this systematic review is to synthesize the risk of motor vehicle collisions (MVCs) for patients with a history of syncope.MethodsWe systematically searched Medline (1946-2019) as well as Cinahl, Embase, Psychinfo, and the Transportation Research Information Documentation (1806-2017) for articles on MVCs and drivers with vasovagal syncope (VVS), arrhythmic syncope, or syncope not yet diagnosed (NYD). Quality ratings were assigned by team consensus.ResultsEleven studies of moderate quality were included (n = 42,972). Compared with the general populations of Canada, the United States, and the United Kingdom (0.49%-2.29% per driver-year), the prospective MVC risk was lower for VVS (0.0%-0.31% per driver-year; 3 studies; n = 782) and higher for arrhythmic syncope (1.9%-3.4% per driver-year; 2 studies; n = 730). The results were more variable for syncope NYD (0.0%-6.9% per driver-year prospectively; 6 studies; n = 41,460). Patients with syncope NYD had an almost 2-fold increased MVC risk in the largest study, although the smaller studies showed contradictory findings.ConclusionsVVS patients appear to be at very low risk for MVCs, supporting current guidelines which do not recommend driving suspension for these patients in most cases. Although the data for other forms of syncope are too limited for definitive conclusions and must be improved, arrhythmic syncope appears to be associated with nontrivial risk.     

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

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.     

Guidelines of the Spanish Society of Cardiology for car driving, airplane flying,and underwater activities in subjects with heart disease

Car driving, airplane piloting and underwater activities by subjects with heart disease may cause sudden incapacitation leading to the loss of the safety margins necessary to avoid accidents. In the case of car driving and airplane piloting the risk affects, not only the driver or pilot, but also passengers and/or bystanders within an accident zone. In the case of diving the risk resides basically in the loss of control of the vital support mechanisms necessary in a very hostile medium. This document reviews the possible causes of unexpected incapacitation, with or without loss of consciousness, in the light of the pathophysiologic consequences of fatigue, hypoxia, stress or barotrauma posed by each activity. Detailed recommendations are made for limiting driving, piloting and diving, based on official Spanish and European regulations and the addresses of specialized centers are provided for consultation. Moreover, recommendations for airplane travel for patients with heart disease are indicated.     

Evaluation and management of syncope

Syncope is a common symptom and accounts for approximately 1% of all emergency visits. There are four main causes of syncope: reflex, neurally mediated syncope, orthostatic hypotension and cardiac syncope. The prognosis of patients with reflex syncopes is good, whereas patients with cardiac syncope are at increased risk for sudden cardiac death. The first diagnosic step after transient loss of consciousness the diagnosis syncope has to be established. It has to be differentiated from other forms of loss of consciousness according to current definition. Careful evaluation of the patient with syncope is mandatory. If the underlying cause of syncope can be diagnosed during initial evaluation, the patient should be treated accordingly. If the cause of syncope remains unclear, the patient has to be stratified with respect to the risk of a cardiovascular event and sudden cardiac death and further evaluation initiated. This review gives a comprehensive summary of definition, work-up and treatment of syncope based on the current guidelines for the evaluation of syncope.     

Electrocardiographic methods for diagnosis and risk stratification in the Brugada syndrome

The Brugada syndrome (BrS) is a malignant, genetically-determined, arrhythmic syndrome manifesting as syncope or sudden cardiac death (SCD) in individuals with structurally normal hearts. The diagnosis of the BrS is mainly based on the presence of a spontaneous or Na + channel blocker induced characteristic, electrocardiographic (ECG) pattern (type 1 or coved Brugada ECG pattern) typically seen in leads V1 and V2 recorded from the 4th to 2nd intercostal (i.c.) spaces. This pattern needs to be distinguished from similar ECG changes due to other causes (Brugada ECG phenocopies). This review focuses mainly on the ECG-based methods for diagnosis and arrhythmia risk assessment in the BrS. Presently, the main unresolved clinical problem is the identification of those patients at high risk of SCD who need implantable cardioverter-defibrillator (ICD), which is the only therapy with proven efficacy. Current guidelines recommend ICD implantation only in patients with spontaneous type 1 ECG pattern, and either history of aborted cardiac arrest or documented sustained VT (class I), or syncope of arrhythmic origin (class IIa) because they are at high risk of recurrent arrhythmic events (up to 10% or more annually for those with aborted cardiac arrest). The majority of BrS patients are asymptomatic when diagnosed and considered to have low risk (around 0.5% annually) and therefore not indicated for ICD. The majority of SCD victims in the BrS, however, had no symptoms prior to the fatal event and therefore were not protected with an ICD. While some ECG markers such as QRS fragmentation, infero-lateral early repolarisation, and abnormal late potentials on signal-averaged ECG are known to be linked to increased arrhythmic risk, they are not sufficiently sensitive or specific. Potential novel ECG-based strategies for risk stratification are discussed based on computerised methods for depolarisation and repolarisation analysis, a composite approach targeting several major components of ventricular arrhythmogenesis, and the collection of large digital ECG databases in genotyped BrS patients and their relatives.Abbreviations: AP, action potential; ARI, activation-recovery intervals; BrS, Brugada syndrome; ECG, electrocardiogram; EPS, electrophysiology study; ICD, implantable cardioverter-defibrillator; IHD, ischaemic heart disease; LBBB, left bundle branch block; MAP, monophasic action potential; MI, myocardial infarction; PCA, principal component analysis; RVOT, right ventricular outflow tract; SAECG, signal-averaged electrocardiogram; SCD, sudden cardiac death; SNP, single-nucleotide polymorphism; VF, ventricular fibrillation; VT, ventricular tachycardia; WT, wavelet transform     

Improved survival in patients with nonischemic advanced heart failure and syncope treated with an implantable cardioverter-defibrillator

The purpose of this study was to assess whether in patients with syncope and heart failure due to nonischemic cardiomyopathy, treatment with an implantable cardioverter-defibrillator (ICD) compared with conventional medical therapy is associated with a reduction in sudden death and total mortality. Patients with advanced heart failure who have syncope have been shown to be at high risk for sudden death. Further risk stratification has been difficult in patients with nonischemic cardiomyopathy in whom inducibility on electrophysiologic study is not predictive of future risk. Of 639 consecutive patients with nonischemic cardiomyopathy referred for heart transplantation, 147 patients with history of syncope and no prior history of sustained ventricular tachycardia or cardiac arrest were identified. Outcomes were compared for the 25 patients managed with an ICD and 122 patients managed with conventional medical therapy. There were no differences in the baseline variables in the 2 groups of patients, including age, ejection fraction, and medical treatments for heart failure, but patients receiving an ICD were more likely to have had nonsustained ventricular tachycardia (56% vs. 15%, p = 0.001). During a mean follow-up of 22 months, there were 31 deaths, 18 sudden, in patients treated with conventional therapy, whereas there were 2 deaths, none sudden, in patients treated with an ICD. An appropriate shock occurred in 40% of the ICD patients. Actuarial survival at 2 years was 84.9% with ICD therapy and 66.9% with conventional therapy (p = 0.04). Thus, in patients with nonischemic cardiomyopathy and syncope, therapy with an ICD is associated with a reduction in sudden death and an improvement in overall survival.     

Congenital long QT syndrome: Diagnosis and management in pediatric patients

Opinion statement The long QT syndrome (LQTS) is characterized by electrocardiographic abnormalities and a high incidence of syncope and sudden cardiac death (SCD). The diagnosis is suggested when ventricular repolarization abnormalities result in prolongation of the corrected QT interval. When LQTS is suspected, genetic screening may identify a specific long QT subtype and provide guidance for appropriate therapy. Treatment depends on the relative risk of SCD, which is increased with longer QT durations, prior cardiac events, and a family history of SCD. β Blockers are considered the initial treatment of choice, with implantable cardioverter-defibrillator (ICD) therapy warranted in high-risk patients. In patients with frequent ICD shocks or in those at high risk for SCD where ICD placement cannot be performed, cardiac pacing and/or left cardiac sympathetic denervation may be indicated.     

Arrhythmic syncope: From diagnosis to management

Syncope is a concerning symptom that affects a large proportion of patients. It can be related to a heterogeneous group of pathologies ranging from trivial causes to diseases with a high risk of sudden death. However, benign causes are the most frequent, and identifying high-risk patients with potentially severe etiologies is crucial to establish an accurate diagnosis, initiate effective therapy, and alter the prognosis. The term cardiac syncope refers to those episodes where the cause of the ce...     

Syncope and trauma. Are syncope-related traumatic injuries the key to find the specific cause of the symptom?

Syncope is a prevalent disorder, accounting for 3–5% ofemergency department (ED) visits and 1–3% of hospitaladmissions.¹ A cardiac cause of syncope is an independent predictorof sudden death, and mortality rates are higher in patientswith cardiac syncope compared with those of non-cardiac or unknownorigin.² In addition, significant morbidity may result fromfalls or accidents resulting from syncope. Bartoletti et al.³have provided valuable information about the prevalence andthe characteristics of secondary trauma among patients referredto the ED for a transient, self-limited loss of consciousness(TLOC). A total of 1114 patients with a true syncope and 139individuals with a non-syncopal condition (including seizures,cerebrovascular accidents, dizziness, intoxication, hypoglycaemia,and psychogenic     

Risk Stratification and Prevention of Sudden Death in Patients with Heart Failure

For almost the past decade, recommendations for the use of implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death have been based upon the left ventricular ejection fraction (LVEF). Current guidelines recommend an ICD for heart failure patients with LVEF ≤35% and NYHA functional class of II or III; however, because the majority of heart failure patients who qualify for ICD implantation based on these criteria will never have an event requiring ICD therapy over several years of follow-up, additional methods of risk stratification for sudden death are clearly needed. Additionally, most of the nearly 300,000 cardiac arrests that occur each year occur in patients without heart failure or significant left ventricular dysfunction. To improve the identification of patients at risk for sudden death, several criteria other than ejection fraction have been proposed and studied. Markers of autonomic tone, including heart rate turbulence and QT dynamicity, have shown some ability to predict total mortality but not arrhythmic events. Microvolt T-wave alternans testing was initially thought to be highly predictive of life-threatening arrhythmias, but prospective large sub-studies of the MADIT II and SCD-HeFT trials have failed to show a predictive value for T-wave alternans testing. Newer markers for risk are based upon the detection of myocardial fibrosis, which forms the substrate for re-entrant and malignant ventricular tachyarrhythmias. Markers of collagen turnover or quantification of myocardial scar by MRI may hold the best promise for identifying patients at highest risk for sudden cardiac death and may also identify patients at high risk but with an ejection fraction above 35%, who are not currently recommended for ICD implantation.     

Automobile driving and implantable defibrillators

The consequences of implanting an automatic cardioverter defibrillator (ICD) on vehicle driving in France are poorly known. This retrospective study examined the behaviour at the wheel of ICD recipients who were recommended to abstain from driving for 3 to 6 months after device implantation. The study population included 98 patients (mean age = 59.5 +/- 14.8 years) followed for a mean of 24. +/- 23.9 months, who underwent ICD implant for ventricular tachycardia (65% of patients ventricular fibrillation (15%), syncope (8%), as part of a research protocol of myocardial cell transplantation 6%, or for primary prevention (5%). The underlying heart disease was ischemic in 59% of patients dilated cardiomyopathy in 11%,hypertrophic cardiomyopathy in 8%, valvular in 6%. Brugada syndrome in 4%, right ventricular arrhythmogenic cardiomyopathy in 2%, and miscellaneous disorders in 9% of patients. Five patients died without post mortem interrogation of the ICD. Only 28% of drivers remembered, and 13% observed, the recommended driving limitations. However, 45% (the oldest) claimed to drive prudently. During follow-up, 47% of patients received an ICD shock. Their mean it ventricular ejection fraction was 34 +/- 14%, versus 43 +/- 18% in patients who received no ICD therapy (p = 0.015). Syncope occurred in 16% who received ICD shocks. Shocks were delivered during driving in 6 patients, without consequent accident. Despite their non-observance of recommended driving limitations. ICD recipients suffered few traffic accidents. Legislation in France should reproduce the guidelines issued by European professional societies and enacted by the British laws.     

Shock occurrence and survival in 49 patients with idiopathic dilated cardiomyopathy and an implantable cardioverter-defibrillator

To determine shock occurrence and survival, 49 patients withidiopathic dilated cardiomyopathy presenting with cardiac arrest(82%), syncope (12%) or ventricular tachycardia without syncope(6%) were followed for 28 ±28 months after cardioverter-defibrillator(ICD) implant according to the intention to treat principle.Using the Kaplan-Meier method, the actuarial incidence for anyspontaneous shocks was 20%, 58%, and 77%, and the incidenceof appropriate shocks was 16%, 49%, and 72% at 1, 3, and 5 yearsof follow-up, respectively. Only two of 49 study patients (4%)with an active ICD died suddenly during follow-up. Another twopatients, however, with an inactive device died suddenly, resultingin a sudden death rate of 2% per year with an active ICD, and5% per year, according to the intention to treat principle.The incidence of cardiac death from any cause was 8%, 25%, and35%, and the incidence of total mortality was 14%, 39%, and49% during 1, 3, and 5 years of follow-up, respectively. Therewas no difference in the Kaplan-Meier survival curves for shockedvs non-shocked patients. Thus, in this selected patient populationwith idiopathic dilated cardiomyopathy the majority of patientsreceived ‘appropriate’ shocks during follow-up,and the sudden death rate with active ICD is low.     

Hypertrophic Cardiomyopathy: Role of the Implantable Cardioverter-Defibrillator

Objectives. We report the occurrence of cardiac events during long-term follow-up in patients with hypertrophic cardiomyopathy (HCM) after cardioverter-defibrillator implantation.Background. The identification of patients at high risk for sudden death and the prevention of recurrence of sudden death in HCM represents a difficult problem.Methods. We retrospectively analyzed the occurrence of cardiac events during follow-up of 13 patients with HCM who received an implantable cardioverter-defibrillator (ICD) because of aborted sudden death (n = 10) or sustained ventricular tachycardia (n = 3) (group I). Findings were compared with those in 215 patients with an ICD and other structural heart disease or idiopathic ventricular fibrillation (group II).Results. After a mean (±SD) follow-up period of 26 ± 18 months, 2 of 13 patients in group I received appropriate shocks. The calculated cumulative incidence of shocks was 21% in group I and 66% in group II after 40 months (p < 0.05). We observed a low incidence of recurrence of ventricular tachycardia/fibrillation during follow-up in patients with HCM. No deaths occurred.Conclusions. Our data suggest that ventricular tachyarrhythmias may not always be the primary mechanism of syncope and sudden death in patients with HCM. The ICD seems to have a less important impact on prognosis in patients with HCM than in patients with other etiologies of aborted sudden death.     

Driving Restrictions and Early Arrhythmias in Patients Receiving a Primary-Prevention Implantable Cardioverter-Defibrillator (DREAM-ICD) Study

BackgroundCurrent guidelines recommend 4 weeks of private driving restriction after implantation of a primary-prevention implantable cardioverter-defibrillator (ICD). These driving restrictions result in significant inconvenience and social implications. Advances in medical treatment and ICD programming have lowered the overall rate of device therapies. The objective of this study was to assess the incidence of ICD therapies at 30, 60, and 180 days after implantation.MethodsDriving Restrictions and Early Arrhythmias in Patients Receiving a Primary-Prevention Implantable Cardioverter-Defibrillator (DREAM-ICD) was a retrospective cohort study conducted at 2 Canadian university centres enrolling patients with new implantation of a primary-prevention ICD. Device programming was standardised according to current guidelines. A total of 803 patients were enrolled.ResultsThe cumulative rates of appropriate ICD therapies at 30, 60, and 180 days were 0.12%, 0.50%, and 0.75%, respectively. There was no syncope during the first 6 months. The median duration to the first appropriate ICD therapy was 208 (range 23-1109) days after implantation. The rate of inappropriate ICD therapies at 30 days was only 0.2%. Overall, < 13.6% of all appropriate ICD therapies occurred within the first 6 months after implantation.ConclusionsThe rate of appropriate ICD therapies within the first 30 days after device insertion is extremely low in contemporary primary prevention cohorts with guideline-concordant device programming. There was no increased risk for ventricular arrhythmia early after ICD insertion. The results of DREAM-ICD suggest the need for a revision of the existing driving restrictions for primary-prevention ICD recipients.     

Risk stratification and prevention of sudden death in hypertrophic cardiomyopathy

Opinion statement Sudden cardiac death is the most devastating manifestation of hypertrophic cardiomyopathy (HCM) and often occurs in young and previously asymptomatic patients. Therefore, risk stratification for sudden death has a major role in the management of HCM and has acquired even greater relevance since the implantable cardioverter-defibrillator (ICD) has proved to be highly effective in preventing sudden death in this disease. The ICD is definitely indicated for secondary prevention of sudden death in patients with HCM who have survived a cardiac arrest with documented ventricular fibrillation, or experienced one or more episodes of sustained ventricular tachycardia. However, uncertainties persist regarding the precise selection of patients for primary prophylactic ICD implantation. A number of risk markers are used to assess the magnitude of risk, including family history of premature sudden death; extreme left ventricular (LV) hypertrophy (> 30 mm) in young patients; nonsustained ventricular tachycardia on Holter electrocardiographic recording; unexplained (not neurally mediated) syncope, particularly in young patients; and blood pressure decrease or inadequate increase during upright exercise. Multiple risk factors convey a definite increase in risk. However, a single risk factor such as family history of multiple sudden deaths, massive LV hypertrophy in a young patient, or frequent and/or prolonged runs of nonsustained ventricular tachycardia on Holter, may also justify consideration of a prophylactic ICD.     

Sudden cardiac death in athletes

Sudden cardiac death in athletes is an uncommon but extremely visible event because of the high profile of amateur and professional athletes and the expected excellent health of these athletes. However, paradoxically, athletic performance may immediately increase the risk of ventricular arrhythmias and sudden cardiac death while run reducing atherosclerosis, which thus improves cardiovascular health and longevity. In athletes younger than 30 years, the most common underlying causes are due to inherited heart disease. In the older athletes, sudden death is generally due to arrhythmias in the context of coronary artery disease. Many athletes with aborted sudden death, arrhythmia-related syncope, or high-risk genetic disorders benefit from therapy with implanted cardioverter/defibrillators (ICDs) . Although ICD therapy can effectively abort sudden death, implantation of an ICD generally prohibits an individual from all competitive athletics except low-intensity sports. The screening of athletes has been notoriously inadequate; however, the optimal screening strategies have yet to be determined. Recommendations for participation in competitive athletics generally follow the recently published 36th Bethesda Conference Eligibility Recommendations for Competitive Athletes with Cardiovascular Abnormalities.     

Indications and outcome of implantable cardioverter-defibrillators for primary and secondary prophylaxis in patients with noncompaction cardiomyopathy

Prophylactic ICDs for Noncompaction Cardiomyopathy . Background: Noncompaction cardiomyopathy (NCCM) is a rare, primary cardiomyopathy, with initial presentation of heart failure, emboli, or arrhythmias, including sudden cardiac death. Implantable cardioverter‐defibrillators (ICDs) are frequently used for primary and secondary prevention in different cardiomyopathy patients, but data about ICD in NCCM are scarce. The aim of this study was, therefore, to investigate ICD indications and outcomes in NCCM patients. Methods and Results: We collected prospective data from our NCCM cohort (n = 77 pts, mean age: 40 ± 14 years). ICD was implanted in 44 (57%) patients with NCCM according to the current ICD guidelines for nonischemic cardiomyopathies: in 12 for secondary prevention (7 × ventricular fibrillation, 5 × sustained ventricular tachycardia [VT]) and in 32 patients for primary prevention (heart failure/severe LV dysfunction). During a mean follow‐up of 33 ± 24 months, 8 patients presented with appropriate ICD shocks due to sustained VT after median 6.1 [1–16] months. This included 4 of 32 (13%) patients in the primary prevention group and 4 of 12 (33%) in the secondary prevention group (P = 0.04). 9 patients presented with inappropriate ICD therapy: 6 (19%) in the primary and 3 (25%) in the secondary prevention group, at a median follow‐up of 4 (2–23) months. Conclusions: In our cohort of NCCM patients, an ICD was frequently implanted for primary or secondary prevention of sudden cardiac death. At follow‐up, frequent appropriate ICD therapy was observed in both groups, supporting the application of current ICD guidelines for primary and secondary prevention of sudden cardiac death in NCCM. (J Cardiovasc Electrophysiol, Vol. 22, pp. 898‐904, August 2011)