A case of electromagnetic interference between HeartMate 3 LVAD and implantable cardioverter defibrillator

Implantable cardioverter defibrillators (ICDs) have been shown to have a significant benefit in reducing sudden cardiac death (SCD) in patients with systolic heart failure. Additionally, cardiac devices as a bridge to transplant or destination therapy are often used in patients with end‐stage systolic heart failure. As a result, most patients with left ventricular assist devices (LVADs) also have an ICD. Here, we present an electromagnetic interference (EMI) between HeartMate 3 LVAD and ICD. This issue might be critical for both electrophysiologists and advanced heart failure cardiologists to understand prior to implantation of ICD/LVADs in these patients.     

Implantable cardioverter defibrillator therapy and the need for concomitant antiarrhythmic drugs

Implantable cardioverter defibrillators (ICDs) are increasingly used for the prevention of sudden cardiac death in patients with life-threatening ventricular arrhythmias (VAs); however, there is a potential for severe and debilitating anxiety caused by symptoms associated with ICD therapy and anticipation of shocks. Anxiety is a psycho-logic stressor, including physiologic components that may lead to adrenergic excitation triggering new arrhythmias and ICD therapies. This often requires concomitant antiarrhythmic medication to reduce the frequency of shocks and symptomatic arrhythmias treated by anti-tachycardia pacing. Although published studies have documented the efficacy of currently available antiarrhythmics, they have limitations in patients with heart failure, may affect the defibrillation threshold, and/or have been associated with major side-effects. In conclusion, for the patient with an ICD experiencing symptomatic ventricular tachycardia (VTs) episodes or ICD shocks, there is a need for pharmacologic therapy to reduce the incidence of such events without affecting the performance of the ICD or causing major side-effects.     

IMPLANTABLE DEFIBRILLATORS AND/OR AMIODARONE: ALTERNATIVES OR COMPLEMENTARY THERAPIES

SUMMARY Many patients with an implanted cardioverter defibrillator (ICD) also receive antiarrhythmic drug therapy. Although an expanding number of patients are receiving ICD therapy, many will not have received previous antiarrhythmic treatment. For patients with an ICD, infrequent arrhythmias and a low probability of inappropriate device discharges, no antiarrhythmic therapy is required. However, for those patients who require an antiarrhythmic drug, amiodarone is a reasonable first choice because of safety in patients with poor LV function. It may be particularly useful for patients with high density ventricular arrhythmias. However, the interactions between ICDs and antiarrhythmic therapy requires close monitoring in order that patient benefit can be optimised, and this review focuses on those interactions.     

Ventricular Arrhythmias in Dilated Cardiomyopathy

Although prognosis of dilated cardiomyopathy (DCM) has improved due to advances in diagnosis and therapy, still too many sudden cardiac deaths occur in DCM. Spontaneous ventricular ectopy is a very common finding in patients with DCM, but the prognostic significance of Holter monitoring remains controversial. Other noninvasive methods, e.g., late potentials and QT dispersion, have not yet contributed to the evaluation of prognosis for arrhythmogenic events in DCM. Programmed ventricular stimulation has been repeatedly used to stratify long-term prognosis, yet satisfactory data are still missing as many deaths occur in patients without inducible arrhythmias. Several prognostic studies are still in progess, and preliminary data for the use of ICDs already appear to be promising. In patients with poor left ventricular function and ICDs in situ, prognosis is determined by progression of heart failure. Heart transplantation may be the ultimate therapeutic instrument for end-stage heart failure patients. For patients with advanced DCM and increased risk for malignant arrhythmias who are unsuitable for orthotopic heart transplantation, the combined therapy with an ICD and dynamic cardiomyoplasty may be an alternative treatment.     

Late Gadolinium Enhancement in Patients with Nonischemic Dilated Cardiomyopathy

One‐third of all patients with heart failure have nonischemic dilated cardiomyopathy (NIDM). Five‐year mortality from NIDM is as high as 20% with sudden cardiac death (SCD) as the cause in 30% of the deaths. Currently, the left ventricular ejection fraction (LVEF) is used as the main criteria to risk stratify patients requiring an implantable cardioverter defibrillator (ICD) to prevent SCD. However, LVEF does not necessarily reflect myocardial propensity for electrical instability leading to ventricular tachycardia (VT) or ventricular fibrillation (VF). Due to the differential risk in various subgroups of patients for arrhythmic death, it is important to identify appropriate patients for ICD implantation so that we can optimize healthcare resources and avoid the complications of ICDs in individuals who are unlikely to benefit. We performed a systematic search and review of clinical trials of NIDM and the use of ICDs and cardiac magnetic resonance imaging with late gadolinium enhancement (LGE) for risk stratification. LGE identifies patients with NIDM who are at high risk for SCD and enables optimized patient selection for ICD placement, while the absence of LGE may reduce the need for ICD implantation in patients with NIDM who are at low risk for future VF/VT or SCD.     

Circadian variations in the occurrence of ventricular tachyarrhythmias in patients with implantable cardioverter defibrillators

A circadian distribution has been demonstrated in episodes of sudden cardiac death, acute myocardial infarction, ventricular premature complexes, heart rate variability, and ventricular tachyarrhythmias. The aim of this study was to evaluate the circadian distribution of ventricular tachyarrhythmia episodes in a population of ICD patients. Data were gathered from 72 patients (55 men, 17 women; mean age 62.7 +/- 12.2 years, mean LVEF 0.0037 +/- 0.0011) with ICDs implanted for standard indications. Patients were followed every 3 months over a mean period of 21 +/- 12.8 months. At each examination, symptoms at arrhythmia onset and perception of ICD therapy were recorded, and the ICD memory was interrogated. During follow-up, 1,023 episodes' of malignant ventricular arrhythmias were detected and effectively terminated, 506 of which were fully analyzed. A morning peak in ventricular tachyarrhythmias was demonstrated between 7:00 and 11:00 AM, and an afternoon peak between 6:00 and 7:00 PM. A significantly lower occurrence of VT was observed at 1:00 AM and between 4:00 and 6:00 AM. A circadian distribution in the occurrence of ventricular tachycardias was found. The three striking features of the data are: the early morning peak (about three hours after waking up), relatively stable incidence throughout waking hours, and decline in incidence in the previous period.     

Mortality, Morbidity, and Complications in 3,344 Patients with Implantable Cardioverter Defibrillators:

ICDs are the therapy of choice in patients with life-threatening ventricular arrhythmias. Mortality, morbidity, and complication rates including appropriate and inappropriate therapies are unknown when ICDs are used in routine medical care and not in well-defined patients included in multicenter trials. Therefore, the data of 3,344 patients (   61.1 ± 12.1  years   ; 80.2% men; CAD 64.6%, dilated cardiomyopathy 18.9%; NYHA Class I–III: 19.1%, 54.3%, 20.1%, respectively;   LVEF > 0.50   : 0.234, LVEF 0.30–0.50: 0.472,   LVEF < 0.30   : 0.293, respectively) implanted in 62 German hospitals between January 1998 and October 2000 were prospectively collected and analyzed as a part of the European Registry of Implantable Defibrillators (EURID Germany). The 1-year survival rate was 93.5%. Patients in NYHA Class III and a   LVEF < 0.30   had a lower survival rate than patients in NYHA Class I and a preserved LVEF (0.852 vs 0.975,   P = 0.0001   ). Including the 1-year follow-up, 49.5% of patients had an intervention by the ICD, 39.8% had appropriate ICD therapies, 16.2% had inappropriate therapies. Overall, 1,691 hospital readmissions were recorded. The main causes for hospital readmissions were ventricular arrhythmias (61.3%) and congestive heart failure symptoms (12.9%). Thus, demographic data and mortality of patients treated with an ICD in conditions of standard medical care seems to be comparable and based on, or congruent with, the large secondary preventions trials. When ICDs are used in standard medical care, the 1-year survival rate is high, especially in patients with NYHA Class I and preserved LVEF. However, nearly half of all patients suffer from ICD intervention. (PACE 2003; 26[Pt. I]:1511–1518)     

Antiarrhythmic therapy in patients with heart failure

In patients with severe chronic heart failure, many deaths are sudden due to life-threatening ventricular arrhythmias. Supraventricular arrhythmias such as paroxysmal or chronic atrial fibrillation may also cause serious complications in those patients due to acute loss of atrial contraction, pump failure during rapid ventricular response and embolic events. Two therapeutic strategies are currently available for therapy and prevention of malignant ventricular arrhythmias and subsequent sudden arrhythmic death: antiarrhythmic drug therapy and implantable defibrillators. However, selection of the most beneficial strategy for the individual patient to reduce the risk of sudden death remains a major challenge in cardiology. Betablockers exert a favorable antiarrhythmic action without increasing proarrhythmia, thus betablockers may serve as a basic medication in patients at risk for sudden death. However, the general use of antiarrhythmic drug therapy for symptomatic ventricular arrhythmias is not recommended, as these drugs have been shown to increase mortality in patients with severe congestive heart failure due to proarrhythmic or negative inotropic effects (e.g. class Ia antiarrhythmics). Even class III antiarrhythmic drugs such as amiodarone, which has been studied sufficiently in patients with left ventricular dysfunction, is not effective enough for significant reduction of cardiac mortality in patients with symptomatic ventricular arrhythmias and depressed ventricular function (e.g. EMIAT, CAMIAT). But as a positive result of available studies, amiodarone does not increase mortality in those patients. Dofetilide has also not been shown to prolong life significantly by suppressing malignant ventricular arrhythmias (DIAMOND-Study). In patients with symptomatic ventricular arrhythmias or aborted sudden death, ICD therapy has been proven to be superior to antiarrhythmic drug therapy in cardiac mortality reduction as a secondary prevention strategy (e.g. AVID, CASH, CIDS). For primary prevention of sudden arrhythmic death in high risk patients, 2 studies (MADIT, MUSST) have already demonstrated favorable results, decreasing mortality by ICD therapy in selected patient populations with partly-reduced ventricular function and unsustained but inducible ventricular tachycardias. This topic is, however, undergoing further evaluation by ongoing trials (e.g. MADIT II, SCD-HeFT). From available data, antiarrhythmic drug therapy in high risk patients is not justified on a routine basis, whereas ICD therapy as a secondary and perhaps primary prevention strategy will significantly reduce cardiac mortality in patients with severe heart failure. Sotalol, a class III antiarrhythmic agent, has recently been shown to reduce ICD-shock delivery which indicates that concomitant drug therapy in patients with an ICD device already implanted may be beneficial in terms of reducing ICD discharges due to ventricular and supraventricular tachycardias. In patients with paroxysmal atrial fibrillation and congestive heart failure, restitution of sinus rhythm is the primary therapeutic goal which can be safely achieved by amiodarone and dofetilide (DIAMOND). In the latter, continuous monitoring of the patient is mandatory because of increased risk of torsade de pointes arrhythmias during the first days of drug administration. In patients with chronic atrial fibrillation rate control and anticoagulation with warfarin is the primary therapeutic option, which can be achieved with either drug treatment (Digoxin, betablockers, amiodarone) or by His bundle ablation with subsequent pacemaker insertion.     

Heart failure and sudden death

Sudden death in patients with heart failure (HF) is a topic of great complexity. Neurohumoral activation including adrenergic and renin-angiotensin-aldosterone system has been a suspected trigger for lethal ventricular arrhythmias and sudden deaths. Randomized clinical trials have demonstrated that angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-adrenergic blockers improve survivals in patients with HF. Although prophylactic implantable cardioverter defibrillator (ICD) therapy is effective reducing mortality in patients with left ventricular (LV) systolic dysfunction, the ICD is unlikely to be appropriate for all patients with LV systolic dysfunction. In addition, the effect of routine prophylactic use of ICDs on health care costs must be carefully considered. The care of patients with LV systolic dysfunction should be individualized for each patient.     

Risk stratification for ventricular arrhythmias and sudden cardiac death in arrhythmogenic right ventricular cardiomyopathy: an update

ABSTRACT

Introduction: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a genetically determined disease associated with a significant risk of ventricular arrhythmias and sudden cardiac death (SCD). Implantable cardioverter-defibrillators (ICDs) are the only effective preventive measure. Over the past 30 years, much effort has been invested in determining predictors of adverse arrhythmic events in these patients.

Areas covered: This review summarizes available evidence on risk stratification for ARVC, with an emphasis on recent research findings. While efforts are ongoing to define risk predictors, several recent publications have synthetized and built on this knowledge base. A recently published meta-analysis has clarified the strongest predictors of ventricular arrhythmias in ARVC, which vary depending on the population included. Three management guidelines/expert consensus documents have integrated the previously described risk predictors into proposed ICD recommendations. Furthermore, a risk prediction model has allowed the integration of multiple risk factors to provide individualized risk prediction and to inform shared-decision making regarding ICD implantation.

Expert opinion: Over the past few years, knowledge of risk prediction in ARVC has been consolidated and refined. Further improvements may be made by the considering additional predictors such as exercise and by targeting more specific surrogate outcomes for SCD.     

Implantable Defibrillator Diagnostic Storage Capabilities: Evolution, Current Status, and Future Utilization

There has been a rapid and significant evolution in the stored diagnostic information available from implantable cardioverter defibrillatars (ICDs). The diagnostic information available in current generation ICDs has greatly enhanced the clinicians' ability to determine the rhythm triggering device therapy as well as to identify potential problems with the ICD system. Furthermore, this information may be useful in identifying triggers of ventricular arrhythmias in patients at high risk for sudden death. The history, evolution, value, and limitations of the stored diagnostic capabilities of implantable defibrillators are discussed.     

Implantable cardioverter-defibrillator in patients with chronic heart failure

Sudden cardiac death (SCD) is a major cause of death in patients with chronic heart failure. The implantable cardioverter-defibrillator (ICD) effectively treats malignant ventricular tachyarrhythmias and reduces significantly the total mortality as well as the incidence of SCD in heart failure patients. It is evident that ICD is indicated for the secondary prevention of SCD. There is growing evidence for the use of the ICD for the primary prevention of SCD in patients with LV systolic dysfunction without documented arrhythmia. However, the efficacy of ICD seems to be modest in patients with advanced heart failure. Individualized combined therapies such as ICD plus amiodarone and ICD plus cardiac resynchronization therapy are necessary for advanced heart failure patients. It is doubtful whether ICD is indicated for MADIT II and SCD -HeFT population in Japan, where the incidence of SCD is thought to be lower than the Western countries.     

The PREFIB Study: PREvention of Atrial FIBrillation by Rapid Atrial Pacing. Preliminary Results

Introduction: The devices used to prove the benefit of ICD therapy had only VVI pacing but most current ICD devices provide dual chamber pacing therapy. The DAVID trial sought to measure the impact of dual chamber pacing at 70 bpm (DDDR-70) vs. ventricular backup pacing at 40 bpm (VVI-40) in patients with standard indications for ICD implantation but without indications for bradycardia pacing. Methods: This single-blind, multicenter, parallel-group, randomized clinical trial enrolled 506 patients with indications for ICD therapy between 10/2000 and 9/2002. All patients had an LVEF ≤0.40, no indication for pacemaker therapy and no persistent atrial arrhythmias. ICDs with dual chamber, rate-responsive pacing capability were implanted and programmed to VVI-40 or DDDR-70. Results: The combined endpoint of mortality or hospitalization for congestive heart failure (CHF) at one year was 16.1% (VVI-40) vs. 26.7% (DDDR-70), (p ∼ 0.03), mortality 6.5% vs. 10.1% (p ∼ 0.15) and CHF hospitalization 13.3% vs. 22.5% (p ∼ 0.07). Conclusion: For ICD patients, DDDR-70 pacing exhibits no clinical advantage over VVI-40 pacing and may increase CHF and mortality.     

Living with an implantable cardioverter-defibrillator: a review of the current literature related to psychosocial factors

Sudden cardiac death (SCD) is responsible for 300,000 deaths annually. Lethal ventricular dysrhythmias account for the majority of SCDs. Implantable cardioverter-defibrillators (ICDs) are the emerging treatment for lethal dysrhythmias. Although reductions in SCD mortality with ICDs are clear, the psychologic and social consequences of these devices reveal a mixed success. Patients with ICDs have high levels of anxiety and depressive symptoms. Conversely, most studies of quality of life in patients with ICDs report that the device is well accepted despite fears of being shocked. The ICD shocks are a unique aspect of treatment and have the potential to cause psychologic distress. Nursing needs to provide care from a holistic perspective. Support groups provide reassurance and allow patients to discuss expectations and fears related to the ICD. Research needs to be conducted to explore the impact of these devices on the lives of patients and their families.     

Implantable defibrillator use for de novo ventricular tachyarrhythmias encountered after cardiac surgery

De novo postoperative life-threatening ventricular arrhythmias are poorly understood. Long-term benefits of, and need for, treatment is uncertain. To assess the therapeutic advantage of ICD to manage new-onset, life-threatening ventricular tachyarrhythmias after cardiac surgery. Patients included were those with an ICD implanted for de novo life-threatening ventricular tachyarrhythmias encountered 48 hours or more after cardiac surgery. Primary endpoints were total survival, time to first ICD therapy, and appropriateness of ICD therapy. Mean projected survival and projected time to first ICD therapy were calculated by the Kaplan-Meier method. Twenty-seven postoperative patients (left ventricular ejection fraction 0.22 +/- 0.07) were followed for 26 +/- 17.6 months. The index arrhythmia was sustained monomorphic ventricular tachycardia in 17 (63%) and ventricular fibrillation in 10 (37%). Electrophysiological study was positive in 22 (81%) of 27. Total survival and mean projected survival after ICD implant were 22 (81%) of 27 and 25.6 months, respectively, to end of follow-up. The majority received ICD therapy (21/27 [78%]), 20 (74%) of 27 receiving appropriate therapy. The mean time to first ICD therapy and mean projected time to first ICD therapy was 5.6 +/- 7.8 months and 10.5 months, respectively. De novo postoperative ventricular arrhythmias are associated with a high probability of late recurrence. The ICD is useful for these patients.     

The clinical challenge of preventing sudden cardiac death immediately after acute ST-elevation myocardial infarction

Unfortunately, of all patients experiencing acute myocardial infarction (MI), usually in the form of ST-elevation MI, 25–35% will die of sudden cardiac death (SCD) before receiving medical attention, most often from ventricular fibrillation. For patients who reach the hospital, prognosis is considerably better and has improved over the years. Reperfusion therapy, best attained with primary percutaneous coronary intervention compared to thrombolysis, has made a big difference in reducing the risk of SCD early and late after ST-elevation MI. In-hospital SCD due to ventricular tachyarrhythmias is manageable, with either preventive measures or drugs or electrical cardioversion. There is general agreement for secondary prevention of SCD post-MI with implantation of a cardioverter defibrillator (ICD) when malignant ventricular arrhythmias occur late (>48 h) after an MI, and are not due to reversible or correctable causes. The major challenge remains that of primary prevention, that is, how to prevent SCD during the first 1–3 months after ST-elevation MI for patients who have low left ventricular ejection fraction and are not candidates for an ICD according to current guidelines, due to the results of two studies, which did not show any benefits of early (<40 days after an MI) ICD implantation. Two recent documents may provide direction as to how to bridge the gap for this early post-MI period. Both recommend an electrophysiology study to guide implantation of an ICD, at least for those developing syncope or non-sustained ventricular tachycardia, who have an inducible sustained ventricular tachycardia at the electrophysiology study. An ICD is also recommended for patients with indication for a permanent pacemaker due to bradyarrhythmias, who also meet primary prevention criteria for SCD.     

Overcoming Electromagnetic Interference by LVADs on ICD Function by Shielding the ICD Programmer Wand and Extension Cable

Patients with end-stage cardiomyopathy and congestive heart failure are increasingly undergoing implantation with left ventricular assist devices (LVADs). In addition, implantable cardioverter-defibrillator (ICD) therapy has been proven to be an important part of the treatment for cardiomyopathy/congestive heart failure. Previous reports have noted a potential and dramatic electromagnetic interference from LVADs on ICDs that cause impaired telemetry communication between the ICD and ICD programmer. Such interference has necessitated explantation and generator replacement in order to resume communication between the ICD and programmer. We report two patients with advanced congestive heart failure and ICD programming impairment caused by a HeartMate II LVAD (Thoratec Corporation, Pleasanton, CA, USA) that was overcome by placing aluminum shielding around the ICD programmer wand and steel shielding around the extension cable during ICD interrogation.     

Chronic experiences with a single lead dual chamber implantable cardioverter defibrillator system

Monitoring of atrial rhythm in patients implanted with ICDs may improve accuracy in identifying supraventricular arrhythmias and, therefore, prevent inappropriate therapies. Since difficulties were found in dual chamber ICDs with separate leads, a new designed single lead dual chamber ICD system was tested. Twenty-five patients implanted with a Deikos A+ (single coil defibrillation lead with two atrial sensing rings combined with a dual chamber ICD with a high amplifying atrial channel) were tested. Atrial and ventricular signals were analyzed during sinus rhythm (SR) and sinus tachycardias (STs), atrial flutter and AF, and VT or VF. Follow-ups were performed after 1, 3, 6, 9, and 12 months after implantation. Analysis of EGM amplitudes of stored episodes revealed that atrial signals during atrial flutter (2.1 +/- 0.51 mV) were comparable to those of ST (2.2 +/- 0.5 mV). Atrial amplitudes during AF were significantly lower (0.81 +/- 0.5 mV, P<0.01). During VF atrial "sinus" signals (2 +/- 0.8 mV) were stable. Ventricular parameters did not differ from a standard ICD lead; defibrillation threshold was 11.4 +/- 4.5 J (16 patients). During intraoperative and prehospital discharge measurements, 97.1% of SR-P waves and 99.2% of atrial flutter waves were detected correctly. In AF 91.11% of atrial signals were detected. Analysis of 505 stored episodes showed that 96.8% of ST and 100% of atrial flutter and 100% of AF episodes have been classified correctly and no underdetection of VT/VF was found. The first experiences with the new VDD-ICD system show an increase of the specificity to detect ventricular tachycardias to a level comparable to dual chamber ICDs with two leads. The reliability of this system has to be proven in a prospective randomized study.     

Interactions between a Left Ventricular Assist Device and Implantable Cardioverter-Defibrillator

Left ventricular assist devices (LVADs) are approved for both a bridge to cardiac transplantation as well as for destination therapy. Most patients with LVADs have implantable cardioverter-defibrillators (ICDs) and several interactions between LVADs and ICDs have been reported. In the present case, we describe an interaction of an approved LVAD with remote telemetry of a previously implanted Sorin ICD (Sorin Group, Milan, Italy) that could not be resolved with standard shielding techniques. (PACE 2012; 35:e272-e273).     

Results of Delivered Therapy for VT or VF in Patients with Third-Generation Implantable Cardioverter Defibrillators

Third-generation implantable cardioverter defibrillators (ICDs) offer tiered therapy and can provide significant advantage in the management of patients with life-threatening arrhythmias. Three different types of ICDs were implanted in 21 patients with ventricular tachycardia (VT) or ventricular fibrillation (VF). Arrhythmia presentation was VT(76%), VF(10%), or both (14%). The mean left ventricular ejection fraction for the group was 32.4 ± 7%. No surgical mortality occurred. Prior to discharge individual EPS determined the final programmed settings of the ICDs. During a mean follow-up of 13 ± 1.4 months (range 2–20) the overall patient survival was 85.7%. No sudden arrhythmic or cardiac death occurred. Twenty of 21 patients (95%) received therapy by their device. In 14 patients (67%) antitachycardia pacing (A TP) was programmed "on," 13 of which was self-adaptative autodecremental mode. There were 247 VT episodes, 231 of which were subjected to ATP with 97% success and 3% acceleration or failure. Low energy shocks reverted all other VT episodes. VF episodes were successfully reverted by a single shock (93%), two shocks (6%), or three shocks (1 %). We conclude that ATP therapy of VT is successful in the large majority of episodes with rare failures, and that VF episodes are generally terminated by a single ICD shock.