Long-term incidence of upper extremity venous obstruction in implantable cardioverter defibrillator patients.

BACKGROUND: Very little is known about the long-term prevalence of severe venous obstruction and occlusion in patients with transvenous implantable cardioverter-defibrillator leads. The objective of the current investigation was to elucidate the incidence and prevalence and to identify predisposing conditions in an ICD cohort over a long follow-up period. METHODS: Based on a prospective database, we analyzed consecutive patients who received an ICD implantation in our hospital between 06/1988 and 2009 as well as all corresponding follow-up data until 02/2018. Cavographies were used for analysis, and all patients with at least one device replacement and one follow-up cavography were included. RESULTS: Over a mean follow-up period of 94 ± 50 months, severe venous obstruction was found in 147 (33%) of 448 patients. Kaplan-Meier analysis shows a severe obstruction or occlusion in 50% of patients after a period of 14.3 years. The total number of leads (p < .001, HR 2.01, CI 2.000-2.022), an advanced age (p = .004, HR 1.023 per year, CI 1.022-1.024) and the presence of dilated cardiomyopathy (p = .035, HR 1.49, CI 1.47-1.51) were predictive of venous obstruction whereas the presence of anticoagulation was not. CONCLUSION: Severe obstruction of the access veins after ICD implantation occurs frequently and its prevalence shows a nearly linear increase over long-time follow-up. Multiple leads, an advanced age and DCM as underlying disease are associated with an increased risk of venous obstruction while the role of anticoagulation to prevent venous obstruction in ICD patients is unclear.

Clinical Course of Dual-Chamber Implantable Cardioverter-Defibrillator Recipients followed by Cardiac Remote Monitoring: Insights from the LION Registry.

Patients receiving dual-chamber implantable cardioverter-defibrillator (DR-ICD) therapy are at risk of developing atrial arrhythmia because of the increased rate of ventricular pacing and the progression of heart failure. Remote monitoring (RM) may identify the patients at highest risk of adverse events such as atrial arrhythmias. A total of 283 patients with 91,632 remote transmissions during a 15-month follow-up (FU) period enrolled in the LION registry were analysed. The parameters retrieved included the pacing mode, lower rate limit, percentage of atrial (%AP) and ventricular pacing (%VP), and percentage of atrial arrhythmia burden (%AB). In 92.7% of patients, the devices were initially programmed in DDD(R) or DDI(R), with changes of the pacing mode in 19.3% only. The lower rate limit remained stable in 80.4% of patients. At the first transmission, 8.7% of patients suffered from RM-detected atrial arrhythmia, which reached 36% during FU. The %AP was not associated with increased AB (p = 0.67), but the %VP was different in patients developing RM-detected atrial arrhythmia (26.9% vs. 13.7%, p < 0.00001). The %VP increased in 105 patients (significance level of α = 0.05), and 11 patients crossed the border of 50% VP. The LION substudy supports the concept of using RM in a real-world DR-ICD population. Remote monitoring of DR-ICDs allows for the quantification of the course of the pacing parameters and AB. Based on these observations, device parameters can be adjusted and optimized.

Prospective survey of implantable defibrillator shock anxiety in Japanese patients: Results from the DEF-Chiba study.

BACKGROUND: Patient-reported outcomes of implantable cardioverter defibrillator (ICD), such as those with shock anxiety, have emerged as important endpoints that are related to quality of life (QOL), but they have not been well studied in a sample of the Japanese population. Therefore, we prospectively examined changes in shock anxiety in a large sample of Japanese patients with an ICD. METHODS: We recruited 214 consecutive patients with an ICD who visited the outpatient clinic. At registration and 12 months later, all patients completed the Florida Shock Anxiety Scale (FSAS) questionnaire to allow us to examine changes in shock anxiety over the course of the first year after registration. RESULTS: During the 12-month follow-up period, 10.5% of the patients received ICD shock therapy. Female sex, secondary prevention, and experience of ICD shock therapy were associated with high FSAS scores at registration. The FSAS scores in both patients with appropriate and inappropriate shock were significantly higher at the 12-month follow-up interval than at registration, and there was no significant difference in the extent of changes in FSAS scores (Δ = 5.2 ± 5.1 and Δ = 6.3 ± 9.9, respectively, P = 0.62). CONCLUSIONS: Female sex, secondary prevention, and experience of ICD shock therapy are important risk factors affecting shock anxiety in Japanese patients. Attention should be paid to the after-effects of ICD shock in these patients, regardless of the shock type, with particular attention to women and patients who require secondary prevention.

New horizon for infection prevention technology and implantable device.

There has been a significant increase in the number of patients receiving cardiovascular implantable electronic devices (CIED) over the last two decades. CIED infection represents a serious complication after CIED implantation and is associated with significant morbidity and mortality. Recently, newly advanced technologies have offered attractive and suitable therapeutic alternatives. Notably, the leadless pacemaker and anti-bacterial envelope decrease the potential risk of CIED infection and the resulting mortality, when it does occur. A completely subcutaneous implantable cardioverter defibrillator is also an alternative to the transvenous implantable cardioverter defibrillator (ICD), as it does not require implantation of any transvenous or epicardial leads. Among the patients who require ICD removal and subsequent antibiotics secondary to infection, the wearable cardioverter defibrillator represents an alternative approach to inpatient monitoring for the prevention of sudden cardiac death. In this review paper, we aimed to introduce the advanced technologies and devices for prevention of CIED infection.

Usefulness of the wearable cardioverter defibrillator in patients in the early post-myocardial infarction phase with high risk of sudden cardiac death: A single-center European experience.

BACKGROUND: The effectiveness of the wearable cardioverter defibrillator (WCD) therapy in early post-myocardial infarction (MI) patients remains uncertain. METHODS: We analyzed the characteristics and outcomes of patients who received a WCD in the early post-MI phase. RESULTS: Twenty-four patients were followed-up for 8 months (range, 4-16 months). Two patients (8.3%) received appropriate shocks. Left ventricular ejection fraction improved after the WCD therapy (P<0.01). Fourteen patients (58%) received an implantable cardioverter defibrillator at the end of the follow-up period. CONCLUSION: Early post-MI patients at high risk of sudden cardiac death may benefit from WCD therapy.

Programming implantable cardioverter/defibrillators and outcomes.

Implantable cardioverter-defibrillators are complex technical devices with a multitude of programming options for the physician. In recent years, numerous randomized trials have been performed to define the optimal programming strategies and have provided valuable insights, especially in primary prevention patients. This article provides an actual overview on the existing evidence on the most important programming features for accurate detection and therapy of ventricular arrhythmias.

Solitary right ventricular metastasis of endometrial adenocarcinoma.

A woman presented with a solitary cardiac metastasis 5 months after curative surgery for endometrial adenocarcinoma (FIGO IB). The tumor was deemed inoperable and palliative ambulatory chemotherapy was initiated. We aimed at a palliative reduction of tumor mass after chemotherapy and atypical vascularization of the metastasis was demonstrated by coronary angiography. We identified two tumor vessels originating from the ramus circumflexus suitable to palliative percutaneous coronary intervention. Within 5 weeks, the initially mild dyspnea increased to New York Heart Association class III and readmission was planned. Regrettably, our patient died from congestive right heart failure only 2 months after diagnosis of tumor recurrence. This report illustrates the need for resolute action without delay even in cases of only mild right heart failure. .

Acute myocarditis: multiparametric cardiac MR imaging.

PURPOSE: To evaluate the diagnostic value of cardiac magnetic resonance (MR) imaging at 3 T in patients suspected of having acute myocarditis by using a multiparametric cardiac MR imaging approach including T1 relaxation time as an additional tool for tissue characterization. MATERIALS AND METHODS: Ethics commission approval was obtained for this prospective study, and written informed consent was obtained from all subjects. Twenty four patients with acute myocarditis (mean age ± standard deviation, 34.7 years ± 15.1; 75% men) and 42 control subjects (mean age, 38.7 years ± 10.2; 64% men) were included. Cardiac MR imaging approaches included relative T2 short tau inversion-recovery signal intensity ratio (T2 ratio), early gadolinium enhancement ratio, late gadolinium enhancement, native T1 relaxation times, and extracellular volume fraction. Receiver operating characteristic analysis was performed to compare diagnostic performance. The reference standard was the clinical evidence for acute myocarditis. RESULTS: Native T1 relaxation times were significantly longer in patients with acute myocarditis than in control subjects (1185.3 msec ± 49.3 vs 1089.1 msec ± 44.9, respectively; P < .001). Areas under the curve of native T1 relaxation times (0.94) were higher compared with those of other cardiac MR parameters (late gadolinium enhancement, 0.90; T2 ratio, 0.79; extracellular volume fraction, 0.71; early gadolinium enhancement ratio, 0.63; P = .390, .018, .002, and < .001, respectively). Sensitivity (92%), specificity (91%), and diagnostic accuracy (91%) for native T1 relaxation times (cutoff, 1140 msec) were equivalent compared with those of the established combined Lake Louise criteria (sensitivity, 92%; specificity, 80%; diagnostic accuracy, 85%). CONCLUSION: Diagnostic performance with native T1 mapping was superior to that with T2 ratio and early gadolinium enhancement ratio, and specificity was higher with native T1 mapping than that with Lake Louise criteria. This study underlines the potential of native T1 relaxation times to complement current cardiac MR approaches in patients suspected of having acute myocarditis.

Real-world data on the lifespan of implantable cardioverter-defibrillators depending on manufacturers and the amount of ventricular pacing.

INTRODUCTION: Implantable cardioverter-defibrillator (ICD) longevity is crucial for both patients and public health systems because it determines the number of surgical ICD replacements, which can generally be considered an additional risk factor for complications, and the cost-effectiveness of ICD therapy. Our objective was to obtain insight into the "real-world" longevities of implantable cardioverter-defibrillators, which quite often differ from those stated in the manufacturers' declarations. METHODS AND RESULTS: On the basis of a prospective database, we analyzed all ICD implantations performed in our hospital from June 1988 to June 2009. We studied 980 patients (follow-up 58 ± 51 months) with 1,502 ICDs and all respective data until August 2010. We compared the percentage of still operating ICDs at different points in time in relation to manufacturers, types of device (single chamber 623, dual chamber 588, cardiac resynchronization therapy ICDs [CRT-D] 291), and amount of right ventricular pacing (VP). We found distinct differences between the mean lifespans of ICDs of different manufacturers (Biotronik 4.3 years, Sorin 4.5 years, Guidant/Boston Scientific 4.7 years, St. Jude Medical 5 years, Medtronic 5.8 years). CRT-D devices (hazard ratio [HR] 1.778, P = 0.0005) were associated with an elevated annual relative risk for device replacement while a decrease in the proportion of VP (HR 0.934 for each 10% decrease in VP, P < 0.0001) and Medtronic ICDs were associated with a reduced risk of device replacement (HR 0.544, P < 0.0001). CONCLUSION: CRT-Ds and an elevated percentage of VP are associated with a significantly elevated risk for device replacement, while Medtronic ICDs showed the longest lifespans.

Prolonged atrial fibrillation following generalized tonic-clonic seizures.

We describe two male patients with focal epilepsy in whom transitory episodes of atrial fibrillation (AF) lasting for up to 25h were detected in the context of generalized tonic-clonic seizures (GTCSs). In five of seven previously published cases of transitory AF associated with epileptic seizures, AF was also associated with GTCS, suggesting a pathophysiological link via GTCS-related increase in sympathetic tone and release of catecholamines. Importantly, AF increases the risk of thromboembolic cerebral ischemia, prompting the question of whether antithrombotic preventive treatment should be initiated in people with pharmacoresistant epilepsy and prolonged peri-ictal AF. Furthermore, AF can considerably impair cardiac output and may, via this mechanism, contribute to the risk of sudden unexpected death in epilepsy following GTCS.

An impaired renal function: a predictor of ventricular arrhythmias and mortality in patients with nonischemic cardiomyopathy and heart failure.

BACKGROUND: This study investigated the overall mortality and the incidence of ventricular tachyarrhythmia (VT) in 99 patients with nonischemic cardiomyopathy (NICM) and with an implantable cardioverter defibrillator (ICD) suffering from heart failure. METHODS: We performed a stepwise regression model to identify independent risk factors for the occurrence of ventricular arrhythmias. Using a Cox regression model, independent risk factors for total mortality were evaluated and, subsequently, a Kaplan-Meier analysis was applied. The primary endpoint of this study was the identification of independent predictors of overall mortality and the incidence of malignant arrhythmias. RESULTS: One hundred twenty-five VT (≥310 ms), 51 fast VT (between 310 ms and 240 ms), and 48 episodes of ventricular fibrillation (≤240 ms) were documented in 32 patients. Independent predictors of arrhythmias detected and treated by the ICD included female gender (odds ratio [OR] 3.4), lack of statin therapy (OR 3.5), and increased serum creatinine (OR 3.7). The Kaplan-Meier analysis showed no difference in survival between participants with or without VT. Total mortality was predicted by increased age (OR 2.3) and an impaired renal function (OR 1.9), independently. CONCLUSIONS: In this cohort of NICM patients with heart failure, female gender, lack of statin therapy, and increased creatinine represented independent risk factors for the incidence of malignant arrhythmias. Furthermore, renal insufficiency and age favored total mortality. Considering these results, impaired renal function might represent a valuable noninvasive tool to identify NICM patients who, despite ICD implantation, have the highest risk of mortality and therefore require a particularly thorough follow-up.

Optimizing ICD programming for shock reduction.

With the increasing numbers of patients with implantable cardioverter/defibrillators for primary prevention (PP), the topic of inappropriate therapy becomes more and more important. If a shock intervention, e.g. for rapidly conducted atrial fibrillation or fast VT (FVT), represents the first reminder of the implantable cardioverter/defibrillator (ICD), the adherence to the therapy will decrease. Moreover, anxiety to receive the next inappropriate ICD Rx is able to initiate a bad quality of life or depression. Starting with the PainFREE Rx II Trial results, the programming of antitachycardia pacing was able to terminate even fast ventricular arrhythmia, i.e. ≥ 188 bpm, in three of four episodes. Thereafter, several studies evaluated whether a prolongation in ventricular tachyarrhythmia (VT) detection is able to reduce unnecessary ICD Rx owing to nonsustained VT. The PREPARE trial evaluated this concept in a cohort of PP patients. This nonrandomized study compared a historical control group to patients with a prolonged detection interval. The results underline the idea that an extension in detection time leads to a significant decrease in ICD Rx for supra- as well as VT. The RELEVANT study investigated in a randomized fashion the outcome of an increase in detection time in nonischemic patients under CRT including an ICD. The findings clearly demonstrated a reduction in ICD Rx as well as hospital admissions, significantly. Currently, the ADVANCE III trial investigates a 30/40 interval detection compared to 18/24 for FVT in prospective randomized fashion in patients for primary or secondary prevention including all ICD devices.

Achieving low defibrillation thresholds at implant: pharmacological influences, RV coil polarity and position, SVC coil usage and positioning, pulse width settings, and the azygous vein.

Approximately 30% of implantable cardioverter defibrillator (ICD) patients still die of sudden death. A major cause of these sudden deaths is the failure to defibrillate because of failure to achieve a low defibrillation threshold (DFT). Anti-arrhythmic drugs can have a profound positive or negative effect on the DFT. Unfortunately, present clinical practice continues to feature many procedures and tactics that have minimal to negative DFT benefit. In addition, many demonstrated helpful tactics are not understood or followed. This review covers the optimal RV (right ventricular) coil position and polarity, superior vena cava (SVC) coil positioning and usage, pulse width settings, and azygous vein coil implants. Specifically, the RV coil should be set to an anodal polarity and never 'reversed'. The optimal RV coil position appears to be along the mid-septum. The SVC coil should be kept out of the right atrium and placed in the innominate vein junction. The SVC coil should be always on for high impedance patients. For low impedance patients, the SVC coil should be set on or off depending on which setting gives the lowest DFT. Pulse widths should be set to correspond to optimally charging and discharging a cardiac membrane time constant of between 3.5 and 4.5 ms. For the highest DFT patients, a separate coil should be placed in the azygous vein and connected to the ICD 'SVC' port. Anachronistic approaches such as the use of polarity reversal, apical RV coil tip forcing, and subcutaneous arrays are also discussed.

T-wave variability detects abnormalities in ventricular repolarization: a prospective study comparing healthy persons and Olympic athletes.

BACKGROUND: Sudden cardiac death in athletes is more common than in the general population. Routine screening procedures are performed to identify competitors at risk. A new Holter-based parameter analyzes variation of the ventricular repolarization (TVar). The aim of this study was to evaluate differences in electrocardiogram (ECG), Echo, and Holter (H) in competitive athletes compared to a healthy control group consisting of medical students (MS). METHODS: A total of 40 athletes (19 females, Olympic team, Luxembourg) and 40 MS (22 females) were examined by means of a resting ECG, treadmill exercise (TE), echocardiogram (Echo), as well as H recordings during a routine screening visit. To analyze TVar, a 20-minute H recording at rest (sampling rate 1000 per second) was performed. Moreover, heart rate variability (HRV) as well as HR turbulence (HRT) was computed. RESULTS: No differences in demographic variables were detected. Quantification of HRV detected a significant increase in the vagal component of autonomic cardiac modulation. In contrast, no differences for HRT were found. Echo parameter demonstrated a thicker septal wall without differences of the posterior wall. TVar values were normal in range, but did differ significantly between the two groups. No correlation between TVar and echo as well as Holter parameters was detected. CONCLUSIONS: TVar was able to demonstrate significant differences in terms of alterations of ventricular activation. This might indicate an early change of myocardial repolarization representing a substrate for life-threatening arrhythmia. Larger studies on the predictive value of TVar including follow-up are necessary to confirm this preliminary finding.

Avoid delivering therapies for nonsustained fast ventricular tachyarrhythmia in patients with implantable cardioverter/defibrillator: the ADVANCE III Trial.

INTRODUCTION: The purpose of this investigation is to evaluate whether a prolonged detection interval for life threatening ventricular tachyarrhythmia (VT) is able to reduce therapies (Rx) delivered by an implantable cardioverter/defibrillator (ICD). Until now, only the PREPARE trial demonstrated a reduction of ICD Rx in a cohort of primary prevention patients. METHODS AND RESULTS: The ADVANCE III study is a prospective, randomized, parallel trial with 2 arms evaluating different intervals to detect (NID), i.e., 18/24 (as currently used) versus 30/40. The primary endpoint is to demonstrate a 20% reduction of ICD Rx (antitachycardia pacing or shocks) delivered to terminate spontaneous VT with a cycle length < or =320 ms in patients with Class I-IIA indication for ICD therapy, regardless of cardiac resynchronization capabilities. The worldwide investigation started in spring 2008 and is expected to be finished in 2011. CONCLUSIONS: The ADVANCE III trial is the first randomized investigation evaluating the reduction of ICD Rx for fast VT due to a prolongation of NID in a general ICD patient cohort.

Optimizing implantable cardioverter-defibrillator treatment of rapid ventricular tachycardia: antitachycardia pacing therapy during charging.

BACKGROUND: Previous studies in implantable cardioverter-defibrillator (ICD) patients demonstrated the efficacy and safety of antitachycardia pacing (ATP) for rapid ventricular tachycardias (VT). To prevent shock delay in case of ATP failure, a new feature (ATP during charging) was developed to deliver ATP for rapid VT while charging for shock. OBJECTIVE: The purpose of this study was to determine the efficacy and safety of this new feature. METHODS: In a prospective, nonrandomized trial, patients with standard ICD indication received an EnTrust ICD. VT and ventricular fibrillation (VF) episodes were reviewed for appropriate detection, ATP success, rhythm acceleration, and related symptoms. RESULTS: In 421 implanted patients, 116 VF episodes occurred in 37 patients. Eighty-four (72%) episodes received ATP during or before charging. ATP prevented a shock in 58 (69%) of 84 episodes in 15 patients. ATP stopped significantly more monomorphic (77%) than polymorphic VTs (44%, P = .05). Five (6%) episodes accelerated after ATP but were terminated by the backup shock(s). No symptoms were related to ATP during charging. In four patients, 38 charges were saved by delivering ATP before charging. Of 98 induced VF episodes, 28% were successfully terminated by ATP versus 69% for spontaneous episodes (P <.01). CONCLUSION: Most VTs detected in the VF zone can be painlessly terminated by ATP delivered during charging, with a low risk of acceleration or symptoms. ATP before charging allows delivery of two ATP attempts before shock in the same time that would otherwise be required to deliver only one ATP plus a shock. It also offers potential battery energy savings.

Pro-arrhythmic effects of amiodarone and concomitant rate-control medication.

AIMS: Amiodarone is one of the most efficient and safe antiarrhythmic drugs in the treatment of atrial fibrillation (AF). Although pro-arrhythmic effects of amiodarone therapy are rare, the aim of the present study was to identify clinical constellations which may lead to amiodarone-associated pro-arrhythmia. METHODS AND RESULTS: Sixty-three consecutive patients (pts) (49 males; 64+/-10.3 years; 35 with coronary heart disease, 17 with lone AF) were retrospectively included in this study. All received an oral (92.1%) or i.v. (7.9%) loading dose of amiodarone for the treatment of AF. Cardiac diseases, concomitant medical treatment, and incidence of pro-arrhythmic effects were analysed. Three pts (4.8% of the total population) developed a clinical relevant, polymorphic ventricular tachyarrhythmia, 3-48 h after initiation of amiodarone loading. Coronary heart disease was present in all of these pts, and in two of them left ventricular ejection fraction was severely reduced. The mean QTc in these pts was only slightly prolonged; mean heart rate was significantly decreased compared with the total study population (61.0+/-7.5 vs. 74.5+/-24.1 bpm; P < or = 0.05). In all pts with pro-arrhythmia, amiodarone (two pts i.v., one patient oral) was initiated during concomitant beta-blocker/digitalis therapy. Twenty-five per cent of the patients receiving this 'triple' therapy developed ventricular arrhythmia. CONCLUSION: The present study implies that initiation of amiodarone therapy in pts with structural heart disease and AF that are concomitantly treated with beta-blockers and digitalis may have an increased risk of amiodarone-associated pro-arrhythmia.

Right ventricular versus biventricular antitachycardia pacing in the termination of ventricular tachyarrhythmia in patients receiving cardiac resynchronization therapy: the ADVANCE CRT-D trial.

BACKGROUND: The purpose of this investigation is to compare the efficacy of antitachycardia pacing (ATP) delivered via the right ventricular (RV) lead versus ATP delivered simultaneously via the right and left ventricular leads (biventricular [BiV]) in the termination of ventricular tachyarrhythmia (VT) in patients receiving cardiac resynchronization therapy (CRT) with ICD capabilities. METHODS AND RESULTS: The ADVANCE CRT is a prospective, multicenter, randomized, parallel trial evaluating RV versus BiV ATP in the termination of VT in CRT patients. The study will test the hypothesis that BiV ATP is superior to RV ATP in the termination of VT and fast VT. All patients with class I and IIa indications for an ICD implantation and CRT are included. The sample size has been estimated to 400 participants followed for 12 months to show a 10% benefit of BiV versus RV ATP. The efficacy of BiV ATP to terminate all VT presents the primary endpoint. The investigation is expected to be completed in 2007. CONCLUSIONS: The ADVANCE CRT trial is the first large randomized clinical investigation evaluating the efficacy of BiV ATP in patients under CRT and ICD therapy.