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BACKGROUND: Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial. METHODS: This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population. RESULTS: In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65–1.52]; P =0.97). There was no significant difference in patients experiencing IAS between both groups (P =0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05–3.76]; P =0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41–5.02]; P =0.003), and smoking (HR, 2.46 [95% CI, 1.31–4.09]; P =0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34–7.31]; P =0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups (P =0.046). CONCLUSIONS: There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022. [ABSTRACT FROM AUTHOR]

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life. METHODS: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54–69) years in the S-ICD group versus 64 (interquartile range, 56–69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P =0.008) and role limitations due to emotional problems (P =0.001) than patients without a shock, but this effect did not differ between treatment arms. CONCLUSIONS: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) remains the most relevant arrhythmia with a prevalence of 2%. The treatment options are either highly invasive and cost-intensive or limited by potential side effects or insufficient efficacy. However, no direct means of prevention that could reduce the burden of AF have been tested.Objective: The purpose of this study was to determine whether remote ischemic preconditioning (RIPC) has an impact on inducibility and sustainability of AF.Methods: A total of 146 patients with paroxysmal AF undergoing electrophysiology study were randomized to receive either RIPC, performed by short episodes of forearm ischemia, or sham intervention (clinicaltrials.gov identifier: NCT02779660). Effective refractory periods, conduction times, velocities, and conduction delays measured were analyzed by pacing from the coronary sinus (CS). End points of the study were the inducibility and sustainability of AF after prespecified rapid pacing sequences.Results: RIPC significantly reduces the inducibility (odds ratio 0.35; 95% confidence interval 0.17-0.71; P = .003) and sustainability (odds ratio 0.36; 95% confidence interval 0.16-0.81; P = .01) of AF. Furthermore, it decreased dispersion of atrial refractory periods (16.0 ± 14.0 ms vs 22.7 ± 19.0 ms; P = .021) as well as atrial conduction delays (49.2 ± 19.6 ms vs 56.2 ± 22.5 ms; P = .049 for proximal CS and 42.4 ± 16.6 ms vs 49.8 ± 22.2 ms; P = .029 for distal CS). In the whole cohort, longer atrial conduction delay (57.6 ± 22.2 ms vs 50.0 ± 20.5 ms; P = .044) and slower conduction velocity (1.74 ± 0.3 mm/ms vs 1.93 ± 0.5 mm/ms; P = .006) were associated with inducibility of AF whereas a wider dispersion of effective refractory periods (25.9 ± 18.3 ms vs 15.7 ± 11.6 ms; P = .028) maintained AF episodes.Conclusion: RIPC reduces the inducibility and sustainability of AF, which is possibly mediated by changes in electrophysiological properties of the atria. It may be used as a simple noninvasive procedure to reduce AF burden. [ABSTRACT FROM AUTHOR]

Recurrent ventricular tachycardia (VT) is an important cause of increased morbidity and mortality in patients with non-ischemic dilated cardiomyopathy (DCM). Current recommendations for the treatment of VT in patients with structural heart disease mainly rely on data derived from patients with ischemic cardiomyopathy. Unlike postinfarction ischemic cardiomyopathy, DCM comprises multiple different etiologies with variable disease progression and prognosis, which often requires an individualized approach to risk stratification and treatment. Prevention of VT recurrence in DCM is challenging, especially when antiarrhythmic drugs are ineffective or contraindicated. The implantable cardioverter-defibrillator is in fact able to terminate but not prevent recurrent VT. Catheter ablation is the criterion standard for substrate-based treatment in DCM. However, the available data from recent studies on VT ablation in DCM are inconsistent and morphological and functional features of the arrhythmogenic substrates are poorly defined. Advanced substrate-based research is required to increase the understanding of arrhythmia mechanisms and improve ablation outcome in this heterogeneous patient population. [ABSTRACT FROM AUTHOR]

Background: Approximately 105 000 cardiac electronic devices are newly implanted in Germany each year. Germany has the highest implantation rate with respect to population of any European country. Infections in cardiac implants are serious complications, with an associated in-hospital mortality of 5--15%. It is thus very important to optimize the diagnostic and therapeutic strategies by which such infections can be detected early and treated effectively. Methods: This review is based on pertinent publications retrieved by a search in PubMed, with special attention to the current recommendations of international medical specialty societies. Results: According to the international literature, the incidence of device-associated infection is 1.7% (in six months) for im- planted defibrillators and 9.5% (in two years) for resynchronization devices. No absolute figures on infection rates are available for Germany. Infection can involve either the site where the impulse generator is implanted or the intravascular portion of the electrodes. The most important elements of the diagnostic evaluation are: assessment of the local findings; pathogen identification by culture of peripheral blood, swabs of the infected site, or material recovered at surgery; and transesophageal echocardiography to detect endocarditic deposits on the electrodes or cardiac valves. The treatment consists of appropriate antibiotic administration and the complete removal of all foreign material. These special extractions are generally performed via the transvenous route. With the aid of various sheath systems, the procedure can be carried out safely and effectively, with a success rate above 95% and a complication rate below 3%. The indications for the implantation of a new device after eradication of the infection should be critically reassessed. Conclusion: Untreated infection carries a high mortality. Evaluation and treatment according to a standardized clinical algorithm facilitate correct and timely diagnosis and the choice of an appropriate therapeutic strategy. [ABSTRACT FROM AUTHOR]

Background: Ventricular arrhythmias (VAs) are common in patients after left ventricular assist device (LVAD) implantation.Objective: The purpose of this study was to determine the predictors of VAs and their impact on mortality in LVAD patients.Methods: A total of 98 consecutive patients with an implantable cardioverter-defibrillator (ICD) (86 [88%] male, mean age 57 ± 10 years), 57 [58%] with nonischemic dilated cardiomyopathy) who had received an LVAD between May 2011 and December 2013 at our institution were included in the study.Results: Mean left ventricular ejection fraction and left ventricular end-diastolic diameter were 20% ± 8% and 73 ± 11 mm, respectively. Seventy-three patients (75%) had atrial fibrillation (AF). During the 12 months before LVAD implantation, 38 patients (39%) had experienced ≥1 episode of VAs (11.5 ± 20) requiring ICD therapies. The number of patients with VAs was comparable among all types of ICDs (P = .48). During the 12-month follow-up after LVAD implantation, 48 patients (49%) experienced ≥1 episode of VAs (30 ± 98) with appropriate ICD therapies. The prevalence of VAs was significantly higher among patients with pre-LVAD VAs compared to those without VAs during the year before LVAD implantation (66% vs 38%; P = .008). In a binary multiple logistic regression analysis, pre-LVAD VAs (hazard ratio 5.36, 95% confidence interval 2.0-14.3; P = .001) and AF (hazard ratio 3.1, 95% confidence interval 1.1-11.9; P = .024) predicted post-LVAD VAs.Conclusion: Pre-LVAD VAs and AF predict the occurrence of VAs after LVAD implantation. According to the latest data on the negative impact of post-LVAD VAs on all-cause mortality, further studies should clarify the reasonability of maintaining sinus rhythm in patients with AF and/or prophylactic catheter ablation of ventricular tachycardias before LVAD implantation. [ABSTRACT FROM AUTHOR]

Background: The modern era of cardiology has changed the population of implantable cardioverter-defibrillator (ICD) recipients. Identifying predictors of electrical storm (ES) in contemporary ICD patients could improve risk stratification, therapeutic strategies, and mortality.Objective: The purpose of this study was to address these points in a real-world setting.Methods: In 330 consecutive patients (65 ± 11 years, 81% male, left ventricular ejection fraction 29% ± 9%) with ICD implanted because of ischemic (n, 204) or nonischemic dilated cardiomyopathy (n, 126), we analyzed the prevalence, predictors, and outcome of ES (≥3 separate VT/VF episodes within 24 hours) therapy.Results: During a median of 21 months (range 17-36 months), 23 patients (7%) had ES. Secondary prevention (61% vs 24%, P <.01), single-chamber devices (57% vs 38%, P = .02), and prior appropriate (96% vs 24%, P < .001) and inappropriate (30% vs 9%, P = .004) therapies were more prevalent in these patients. In ES patients, first appropriate therapy occurred more often in the first year after implantation than in the rest of the cohort (85% vs 45%, P = .008), and mortality was significantly higher (22% vs 2%, P < .001). Multivariate Cox regression analysis showed that secondary prevention (hazard ratio [HR] 2.83, 95% confidence interval [CI] 1.21-6.61, P = .016) and prior appropriate (HR 88.99, 95% CI 11.73-675, P < .001) and inappropriate (HR 2.83, 95% CI 1.14-7.0, P = .04) therapies were independent predictors of ES.Conclusion: ES is not uncommon in ICD recipients. A secondary prevention indication and the occurrence of both appropriate and inappropriate ICD therapies increase the risk for ES. Prompt initiation of aggressive treatment, especially catheter ablation, should be considered for these patients. [ABSTRACT FROM AUTHOR]

Background Numerous electrocardiographic (ECG) criteria have been proposed to identify localization of outflow tract ventricular arrhythmias (OT-VAs); however, in some cases, it is difficult to accurately localize the origin of OT-VA using the surface ECG. Objective The purpose of this study was to assess a simple criterion for localization of OT-VAs during electrophysiology study. Methods We measured the interval from the onset of the earliest QRS complex of premature ventricular contractions (PVCs) to the distal right ventricular apical signal (the QRS-RVA interval) in 66 patients (31 men aged 53.3 ± 14.0 years; right ventricular outflow tract [RVOT] origin in 37) referred for ablation of symptomatic outflow tract PVCs. We prospectively validated this criterion in 39 patients (22 men aged 52 ± 15 years; RVOT origin in 19). Results Compared with patients with RVOT PVCs, the QRS-RVA interval was significantly longer in patients with left ventricular outflow tract (LVOT) PVCs (70 ± 14 vs 33.4±10 ms, P < .001). Receiver operating characteristic analysis showed that a QRS-RVA interval ≥49 ms had sensitivity, specificity, and positive and negative predictive values of 100%, 94.6%, 93.5%, and 100%, respectively, for prediction of an LVOT origin. The same analysis in the validation cohort showed sensitivity, specificity, and positive and negative predictive values of 94.7%, 95%, 95%, and 94.7%, respectively. When these data were combined, a QRS-RVA interval ≥49 ms had sensitivity, specificity, and positive and negative predictive values of 98%, 94.6%, 94.1%, and 98.1%, respectively, for prediction of an LVOT origin. Conclusion A QRS-RVA interval ≥49 ms suggests an LVOT origin. The QRS-RVA interval is a simple and accurate criterion for differentiating the origin of outflow tract arrhythmia during electrophysiology study; however, the accuracy of this criterion in identifying OT-VA from the right coronary cusp is limited. [ABSTRACT FROM AUTHOR]

Background and purpose Approximately 20–25% of the patients with hypertrophic cardiomyopathy (HCM) develop atrial fibrillation (AF) during the clinical course of the disease, a percentage significantly larger than that of the general population. The purpose of the present study was to report on the procedural results of patients with AF and either primary or secondary left ventricular hypertrophy (LVH). Methods and subjects Twenty-two consecutive HCM patients (55% male, mean age 57 ± 8 years) with symptomatic AF, having undergone AF ablation procedures between September 2009 and July 2012 were compared with respect to procedural outcome and follow-up characteristics with 22 matched controls with secondary cardiac hypertrophy (64% male, 63 ± 10 years) from our prospective AF catheter ablation registry. Results and conclusion Radiofrequency catheter ablation (RFCA) was successful in restoring long-term sinus rhythm in patients with LVH due to HCM and due to secondary etiology. However, patients with HCM needed more RFCA procedures and frequently additional antiarrhythmic drug therapy in order to maintain sinus rhythm. [ABSTRACT FROM AUTHOR]

Background Radiofrequency catheter ablation is currently considered as the therapeutic option of choice in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) and recurrent ventricular tachycardia (VT). Methods This study intended to assess the long-term outcome of catheter ablation in patients with ARVC and electrical storm. The specific objective was to assess the relationship between precordial QRS amplitude ratio and outcome of catheter ablation in these patients. Results Twenty-eight patients (19 men, age 52.3 ± 14.2 years) underwent 48 catheter ablation procedures (range 1–6, six epicardial). During a mean follow-up of 18.7 ± 15.1 months, 13 patients (46.5%) experienced VT recurrence. Age > 50 years and ∑ QRS mv V1–V3/∑ QRS mv V1–V6 ≤ 0.48 but not right ventricular size and acute ablation outcome were associated with VT recurrence during the follow up. Conclusion Age > 50 years and ∑ QRS mv V1–V3/∑ QRS mv V1–V6 ≤ 0.48 predict recurrence of VT after successful radiofrequency catheter ablation of VT in patients with ARVC and electrical storm. [ABSTRACT FROM AUTHOR]

Background Thromboembolic complications remain one of the most severe adverse events associated with catheter ablation of atrial fibrillation (AF), but data on such events are limited. Objective The purpose of this study was to evaluate the incidence, characteristics, and risk factors of thromboembolic complications after AF ablation. Methods Cerebral thromboembolic complications occurring within 1 month of 3360 consecutive AF radiofrequency catheter ablations were assessed. Stroke was defined as a neurologic deficit lasting more than 24 hours or with imaging study showing new infarction. Transient ischemic attack (TIA) was defined as a deficit lasting less than 24 hours and without documented infarction. Results There were 17 peri-interventional cerebral thromboembolic events (0.5%). Nine cases (53%) were diagnosed as strokes and 8 (47%) as TIAs. Sixty percent of the events occurred within 48 hours after the ablation; the rest occurred within 1 week. In univariate analysis, peri-interventional thromboembolism was associated with peripheral vascular disease ( P = .010), impaired left ventricular ejection fraction ( P = .040), periprocedural bridging with heparin ( P = .007), and previous stroke ( P = .026). Multivariable analysis demonstrated that peripheral vascular disease (odds ratio [OR] 8.81, confidence interval [CI] 1.61–48.31, P = .012) and previous stroke (OR 6.13, CI 1.18–31.91, P = .031) were independent predictors. In a different model, the CHA 2 DS 2 -VASc score was associated with thromboembolism (OR 1.35, CI 1.00–1.80, P = .049). Conclusion Cerebral thromboembolic complications after AF radiofrequency catheter ablation are rare. They mostly occur within 48 hours after the procedure and remain without lasting neurologic deficits in the majority of cases. Such complications are associated with peripheral vascular disease, previous stroke, and the CHA 2 DS 2 -VASc score. [ABSTRACT FROM AUTHOR]

Background: It is suggested that the adenosine resistance of retrograde fast pathway in slow-fast atrioventricular nodal reentrant tachycardia (AVNRT) confirms the participation of a concealed retrograde atrio-Hisian pathway rather than the conventional fast pathway in the arrhythmia circuit of slow-fast AVNRT. Objective: To prospectively assess the retrograde fast pathway response to the intravenous administration of adenosine in patients with typical AVNRT and the control group. Methods: Electrophysiological parameters and adenosine sensitivity of retrograde fast pathway were studied in 21 consecutive patients (18 women; mean age 57 ± 10 years) with slow-fast AVNRT and 24 patients (11 women; mean age 46 ± 16 years) as the control group. Results: Fifteen (71%) patients with AVNRT and 18 (75%) patients in the control group developed transient ventriculoatrial (VA) block after the intravenous administration of adenosine (P = .79). In patients with slow-fast AVNRT, female sex (P = .003), longer VA interval during right ventricular pacing (P < .001), and longer tachycardia cycle length (P < .001) predicted transient VA block after the intravenous administration of adenosine. In patients in the control group, a shorter VA interval during fixed rate right ventricular apical pacing (P = .009) and the presence of dual atrioventricular nodal physiology (P = .002) were associated with the adenosine resistance of the retrograde fast pathway. Conclusions: The prevalence of the adenosine resistance of retrograde fast pathway’s conduction is comparable between patients with and those without slow-fast AVNRT. This finding can be explained better by the existence of an insulated intranodal tract with Purkinje-like properties or a superior atrionodal connection to the nodo-Hisian region of the atrioventricular node rather than the presence of an atrio-Hisian pathway. [Copyright &y& Elsevier]

Background: Atrial fibrillation (AF) ablation is increasingly used in patients with reduced left ventricular ejection fraction (LVEF), but long-term outcomes are still unknown. Objective: To assess the long-term effects of AF ablation in patients with systolic heart failure according to rhythm outcome. Methods: We included 69 patients with LVEF ≤40%, referred for circumferential pulmonary vein isolation with or without additional substrate modification to our institution in 2006–2010. Follow-up included 7-day Holter electrocardiography and echocardiography at baseline and at 6, 12, and 24 months after ablation. A matched control group (n = 69) after AF ablation without heart failure was used for comparison. Results: After 28 ± 11 months and 1.6 ± 0.7 ablation procedures, 45 (65%) patients were still in the stable sinus rhythm (SSR) group. LVEF increased from 33 ± 6% to 53 ± 11% (P < .001) in the SSR group and from 33 ± 5% to 38 ± 12% (P = .03) in patients with recurrences (atrial tachycardia/fibrillation group). While LVEF increase was similar in the 2 groups at 6 months (15 ± 12% vs 8 ± 11%; P = .2), further LVEF improvements were observed in the SSR group only. Adjustments for baseline characteristics revealed that the increase in LVEF at 6 months was associated with higher baseline heart rate and not with rhythm outcome. Heart rate did not change in either group after 6 months of follow-up. Complications and procedural data of the study group were similar to the control group. Conclusion: In patients with heart failure undergoing AF ablation, there is an initial short-term LVEF improvement related to baseline heart rate. However, long-term LVEF improvement is associated with rhythm outcome. [Copyright &y& Elsevier]

Background: The MediGuide technology (MGT) represents a novel sensor-based electromagnetic 4-dimensional (4D) navigation system allowing real-time catheter tracking in the environment of prerecorded X-ray loops. Objective: To report on our clinical experience in atrial fibrillation (AF) ablation with recently available MGT-enabled ablation catheters. Methods: The MGT was used in addition to a conventional 3D mapping system in 80 patients with AF (age 61 ± 10 years; 47 men; 40 with persistent AF), who underwent circumferential pulmonary vein isolation and voltage mapping with and without substrate modification. Short native right anterior oblique/left anterior oblique loops were used as background movies for the nonfluoroscopic placement of sensor-equipped diagnostic catheters into the coronary sinus and the right ventricle. After single transseptal puncture, selective angiograms of the pulmonary veins were used as background movies for near nonfluoroscopic left atrial reconstruction. Computed tomography registration as well as mapping/ablation was performed by using the new open-irrigated MGT-enabled ablation catheter. Results: MGT application was not associated with a change in established workflow. Large parts of the procedure (mean entire duration 167 ± 47 minutes) could be done without additional fluoroscopy, whereas median residual fluoroscopy duration of 4.6 (interquartile range: 2.9, 7.1) minutes was mainly used for the acquisition of background loops, transseptal puncture, occasional verification of transseptal sheath position, and manipulation of the circular mapping catheter. Three (4%) minor complications occurred. Conclusions: The MGT integrates easily into the workflow of standard AF ablation and allows for high-quality nonfluoroscopic 4D catheter tracking. This results in low radiation exposure for patients and staff without complicating the workflow of the procedure. [Copyright &y& Elsevier]