New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice. results from the international prospective observational SMART Registry

Aims: Insertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx™, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications. Methods and results: The SMART Registry is an international prospective observational study. The main endpoints were ICM safety (incidence of serious adverse device and procedure-related events (SADEs) at 1 month), ICM clinical value (incidence of device-detected true arrhythmias and of clinical diagnoses and interventions), and patient-reported experience measurements (PREMs). A total of 1400 subjects were enrolled. ICM indications included syncope (49.1%), AF (18.8%), unexplained palpitations (13.6%), risk of ventricular arrhythmia (6.6%), and cryptogenic stroke (6.0%). Freedom from SADEs at 1 month was 99.4% (95% Confidence Interval: 98.8-99.7%). In the 6-month monitoring period, the ICM detected true cardiac arrhythmias in 45.7% of patients and led to clinical interventions in a relevant proportion of patients; in particular, a pacemaker implant was performed after bradycardia detection in 8.9% of subjects who received an ICM for syncope and oral anticoagulation therapy was indicated after AF detection in 15.7% of subjects with cryptogenic stroke. PREMs showed that 78.2% of subjects were satisfied with the remote monitoring patient app. Conclusion: The evaluated ICM is associated with an excellent safety profile and high diagnostic yield. Patients reported positive experiences associated with the use of their smartphone for the device remote monitoring

A Primary Prevention Clinical Risk Score Model for Patients With Brugada Syndrome (BRUGADA-RISK).

OBJECTIVES: The goal of this study was to develop a risk score model for patients with Brugada syndrome (BrS). BACKGROUND: Risk stratification in BrS is a significant challenge due to the low event rates and conflicting evidence. METHODS: A multicenter international cohort of patients with BrS and no previous cardiac arrest was used to evaluate the role of 16 proposed clinical or electrocardiogram (ECG) markers in predicting ventricular arrhythmias (VAs)/sudden cardiac death (SCD) during follow-up. Predictive markers were incorporated into a risk score model, and this model was validated by using out-of-sample cross-validation. RESULTS: A total of 1,110 patients with BrS from 16 centers in 8 countries were included (mean age 51.8 ± 13.6 years; 71.8% male). Median follow-up was 5.33 years; 114 patients had VA/SCD (10.3%) with an annual event rate of 1.5%. Of the 16 proposed risk factors, probable arrhythmia-related syncope (hazard ratio [HR]: 3.71; p < 0.001), spontaneous type 1 ECG (HR: 3.80; p < 0.001), early repolarization (HR: 3.42; p < 0.001), and a type 1 Brugada ECG pattern in peripheral leads (HR: 2.33; p < 0.001) were associated with a higher risk of VA/SCD. A risk score model incorporating these factors revealed a sensitivity of 71.2% (95% confidence interval: 61.5% to 84.6%) and a specificity of 80.2% (95% confidence interval: 75.7% to 82.3%) in predicting VA/SCD at 5 years. Calibration plots showed a mean prediction error of 1.2%. The model was effectively validated by using out-of-sample cross-validation according to country. CONCLUSIONS: This multicenter study identified 4 risk factors for VA/SCD in a primary prevention BrS population. A risk score model was generated to quantify risk of VA/SCD in BrS and inform implantable cardioverter-defibrillator prescription

Incidence, determinants, and prognostic implications of true pleomorphism of ventricular tachycardia in patients with implantable cardioverter-defribillators a substudy of the datas trial

Background— The occurrence of monomorphic ventricular tachycardia (M-VT) with >1 QRS morphology during the same episode (pleomorphism [PL]) or in different episodes (multiple morphologies [MM]) has been described through ECG. Implantable cardioverter-defribillator (ICD) electrograms (EGs) provide the opportunity to analyze virtually all spontaneous M-VT episodes. We sought to study the incidence, determinants, and prognostic significance of PL and MM as assessed by ICD-EG in a prospective series of patients with ICDs. Methods and Results— Spontaneous episodes of M-VT were analyzed before ICD intervention. PL was defined as >1 ICD-EG morphology, each having ≥6 consecutive identical beats during the same VT episode, and MM as >1 ICD-EG morphology in different M-VT episodes in the same patient. We analyzed 1881 M-VT episodes from 315 patients followed for 17 months. PL and MM occurred in 6% and 19%, respectively, of the total population (16% and 62% of patients with M-VT). Recurrent M-VT as diagnosis for ICD indication predicted PL and MM. Patients with PL more frequently developed MM (85% versus 15%; P<0.001) compared to patients without PL. Total mortality (5%) was significantly higher in patients with PL (20%), in patients with MM (11.5%), and in women (12%). In multivariate analysis, only PL (odds ratio, 5.33; P=0.009) and female sex (odds ratio, 3.1; P=0.038) predicted mortality. Conclusions— In a prospective series of patients with ICDs, mostly indicated for secondary prevention, both PL and MM of VT, as judged by ICD-EG, were not uncommon and were strongly associated. Female sex and the development of PL VT were the only independent predictors of mortality.Postprint (published version

Incidence, determinants, and prognostic implications of true pleomorphism of ventricular tachycardia in patients with implantable cardioverter-defribillators: a substudy of the DATAS trial

Background— The occurrence of monomorphic ventricular tachycardia (M-VT) with >1 QRS morphology during the same episode (pleomorphism [PL]) or in different episodes (multiple morphologies [MM]) has been described through ECG. Implantable cardioverter-defribillator (ICD) electrograms (EGs) provide the opportunity to analyze virtually all spontaneous M-VT episodes. We sought to study the incidence, determinants, and prognostic significance of PL and MM as assessed by ICD-EG in a prospective series of patients with ICDs. Methods and Results— Spontaneous episodes of M-VT were analyzed before ICD intervention. PL was defined as >1 ICD-EG morphology, each having ≥6 consecutive identical beats during the same VT episode, and MM as >1 ICD-EG morphology in different M-VT episodes in the same patient. We analyzed 1881 M-VT episodes from 315 patients followed for 17 months. PL and MM occurred in 6% and 19%, respectively, of the total population (16% and 62% of patients with M-VT). Recurrent M-VT as diagnosis for ICD indication predicted PL and MM. Patients with PL more frequently developed MM (85% versus 15%; P<0.001) compared to patients without PL. Total mortality (5%) was significantly higher in patients with PL (20%), in patients with MM (11.5%), and in women (12%). In multivariate analysis, only PL (odds ratio, 5.33; P=0.009) and female sex (odds ratio, 3.1; P=0.038) predicted mortality. Conclusions— In a prospective series of patients with ICDs, mostly indicated for secondary prevention, both PL and MM of VT, as judged by ICD-EG, were not uncommon and were strongly associated. Female sex and the development of PL VT were the only independent predictors of mortality

Adenosine-guided pulmonary vein isolation versus conventional pulmonary vein isolation in patients undergoing atrial fibrillation ablation: An updated meta-analysis

Background: Recurrent atrial fibrillation episodes following pulmonary vein isolation (PVI) are frequently due to reconnection of PVs. Adenosine can unmask dormant conduction, leading to additional ablation to improve AF free survival. We performed a meta-analysis of the literature to assess the role of adenosine testing in patients undergoing atrial fibrillation (AF) ablation. Methods: PubMed, EMBASE, and Cochrane databases were searched through until December 2015 for studies reporting on the role of adenosine guided-PVI versus conventional PVI in AF ablation. Results: Eleven studies including 4099 patients undergoing AF ablation were identified to assess the impact of adenosine testing. Mean age of the population was 61-3 years: 25% female, 70% with paroxysmal AF. Follow up period of 12.5 +/- 5.1 months. A significant benefit was observed in the studies published before 2013 (OR = 175; 95 C1 132-233, p &lt; 0.001, I-2 = 11%), retrospective (OR = 2.05; 95%Cl 147-2.86, p &lt; 0.001, I-2 = 0%) and single-centre studies (OR = 1.58; 95%Cl 1.19-2.10, p = 0.002, I-2 = 30%). However, analysis of studies published since 2013 (OR = 1.41; 95% Cl 0.87-229, p = 0.17, I-2 = 75%) does not support any benefit from an adenosine-guided strategy. Similar findings were observed by pooling prospective case-control (OR = 1.39; 95%Cl 0.93-2.07, p = 0.11, I-2 = 75%), and prospective randomized controlled studies (OR = 1.62; 95%Cl 0.81-3.24, p = 0.17, I-2 = 86%). Part of the observed high heterogeneity can be explained by parameters such as dormant PVs percentage, use of new technology, improvement of center/operator experience, patients’ characteristics including gender, age, and AF type. Conclusions: Pooling of contemporary data from high quality prospective case-control &amp; prospective randomized controlled studies fails to show the benefit of adenosine-guided strategy to improve Al ablation outcomes. (C) 2016 Published by Elsevier Ireland Ltd