Best practices in robotic magnetic navigation-guided catheter ablation of cardiac arrhythmias, a position paper of the Society for Cardiac Robotic Navigation.

Preamble: Robotic magnetic navigation (RMN)-guided catheter ablation (CA) technology has been used for the treatment of cardiac arrhythmias for almost 20 years. Various studies reported that RMN allows for high catheter stability, improved lesion formation and a superior safety profile. So far, no guidelines or recommendations on RMN-guided CA have been published. Purpose: The aim of this consensus paper was to summarize knowledge and provide recommendations on management of arrhythmias using RMN-guided CA as treatment of atrial fibrillation (AF) and ventricular arrhythmias (VA). Methodology: An expert writing group, performed a detailed review of available literature, and drawing on their own experience, drafted and voted on recommendations and summarized current knowledge and practice in the field. Recommendations on RMN-guided CA are presented in a guideline format with three levels of recommendations to serve as a reference for best practices in RMN procedures. Each recommendation is accompanied by supportive text and references. The various sections cover the practical spectrum from system and patient set-up, EP laboratory staffing, combination of RMN with fluoroscopy and mapping systems, use of automation features and ablation settings and targets, for different cardiac arrhythmias. Conclusion: This manuscript, presenting the combined experience of expert robotic users and knowledge from the available literature, offers a unique resource for providers interested in the use of RMN in the treatment of cardiac arrhythmias.

Outcomes of ventricular tachycardia ablation in patients with ischemic and non-ischemic cardiomyopathy: A propensity-score matched analysis.

INTRODUCTION AND OBJECTIVES: Catheter ablation (CA) is effective in the treatment of ventricular tachycardia (VT). Although some observational data suggest patients with non-ischemic cardiomyopathy (NICM) have less favorable outcomes when compared to those with an ischemic etiology (ICM), direct comparisons are rarely reported. We aimed to compare the outcomes of VT ablation in a propensity-score matched population of ICM or NICM patients. METHODS: Single-center retrospective study of consecutive patients undergoing VT ablation from 2012 to 2023. A propensity score (PS) was used to match ICM and NICM patients in a 1:1 fashion according to age, sex, left ventricular ejection fraction (LVEF), NYHA class, electrical storm (ES) at presentation, and previous endocardial ablation. The outcomes of interest were VT-free survival and all-cause mortality. RESULTS: The PS yielded two groups of 71 patients each (mean age 63±10 years, 92% male, mean LVEF 35±10%, 36% with ES at presentation, and 23% with previous ablation), well matched for baseline characteristics. During a median follow-up of 2.3 (interquartile range IQR 1.3-3.8) years, patients with NICM had a significantly lower VT-free survival (53.5% vs. 69.0%, log-rank p=0.037), although there were no differences regarding all-cause mortality (22.5% vs. 16.9%, log-rank p=0.245). Multivariate analysis identified NICM (HR 2.34 [95% CI 1.32-4.14], p=0.004), NYHA class III/IV (HR 2.11 [95% CI 1.11-4.04], p=0.024), and chronic kidney disease (HR 2.23 [95% CI 1.25-3.96], p=0.006), as independent predictors of VT recurrence. CONCLUSION: Non-ischemic cardiomyopathy patients were at increased risk of VT recurrence after ablation, although long-term mortality did not differ.

Bradyarrhythmia in a marathonist: Cardiac vagal denervation as alternative treatment.

Although not routinely used, cardioneuroablation or modulation of the cardiac autonomic nervous system has been proposed as an alternative approach to treat young individuals with enhanced vagal tone and significant atrioventricular (AV) disturbances. We report the case of a 42-year-old athlete with prolonged ventricular pauses associated with sinus bradycardia and paroxysmal episodes of AV block (maximum of 6.6 s) due to enhanced vagal tone who was admitted to our hospital for pacemaker implantation. Cardiac magnetic resonance and stress test were normal. Although he was asymptomatic, safety concerns regarding possible neurological damage and sudden cardiac death were raised, and he accordingly underwent electrophysiological study (EPS) and cardiac autonomic denervation. Mapping and ablation were anatomically guided and radiofrequency pulses were delivered at empirical sites of ganglionated plexi. Modulation of the parasympathetic system was confirmed through changes in heart rate and AV nodal conduction properties associated with a negative cardiac response to atropine administration. After a follow-up of nine months, follow-up 24-hour Holter revealed an increase in mean heart rate and no AV disturbances, with rare non-significant ventricular pauses, suggesting that this technique may become a safe and efficient procedure in this group of patients.

Outcomes of a combined vs non-combined endo-epicardial ventricular tachycardia ablation strategy.

BACKGROUND: Direct comparisons of combined (C-ABL) and non-combined (NC-ABL) endo-epicardial ventricular tachycardia (VT) ablation outcomes are scarce. We aimed to investigate the long-term clinical efficacy and safety of these 2 strategies in ischemic heart disease (IHD) and non-ischemic cardiomyopathy (NICM) populations. METHODS: Multicentric observational registry included 316 consecutive patients who underwent catheter ablation for drug-resistant VT between January 2008 and July 2019. Primary and secondary efficacy endpoints were defined as VT-free survival and all-cause death after ablation. Safety outcomes were defined by 30-day mortality and procedure-related complications. RESULTS: Most of the patients were male (85%), with IHD (67%) and mean age of 63 ± 13 years. During a mean follow-up of 3 ± 2 years, 117 (37%) patients had VT recurrence and 73 (23%) died. Multivariate survival analysis identified electrical storm (ES) at presentation, IHD, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) functional class III / IV, and C-ABL as independent predictors of VT recurrence. In 135 patients undergoing repeated procedures, only C-ABL and ES were independent predictors of relapse. The identified independent predictors of mortality were C-ABL, ES, LVEF, age, and NYHA class III / IV. C-ABL survival benefit was only seen in patients with a previous ablation (P for interaction = 0.04). Mortality at 30 days was similar between NC-ABL and C-ABL (4% vs. 2%, respectively, P = 0.777), as was complication rate (10.3% vs. 15.1%, respectively, P = 0.336). CONCLUSION: A combined or sequential endo-epicardial VT ablation strategy was associated with lower VT recurrence and lower all-cause death in IHD and NICM patients undergoing repeated procedures. Both approaches seemed equally safe.

Relação entre Gordura Epicárdica e Fibrilação Atrial Não Pode Ser Totalmente Explicada pela Fibrose Atrial Esquerda / The Relationship between Epicardial Fat and Atrial Fibrillation Cannot Be Fully Explained by Left Atrial Fibrosis

Resumo Fundamento O tecido adiposo epicárdico (TAE) tem sido associado à fibrilação atrial (FA), mas seus mecanismos fisiopatológicos permanecem obscuros. Objetivos Medir a correlação entre TAE e fibrose do átrio esquerdo (AE), e avaliar sua capacidade de prever recidiva após o isolamento da veia pulmonar (IVP). Métodos Pacientes com FA inscritos para um primeiro procedimento de IVP foram submetidos à tomografia computadorizada (TC) cardíaca e ressonância magnética cardíaca (RMC) em menos de 48 horas. Quantificou-se o TAECE em imagens de TC realçadas com contraste no nível do tronco da coronária esquerda. Quantificou-se a fibrose do AE em RMC tridimensional com realce tardio isotrópico de 1,5 mm. Após o isolamento da veia pulmonar (IVP), os pacientes foram submetidos a seguimento para checar a recidiva da FA. A significância estatística foi definida com p<0,05. Resultados A maioria dos 68 pacientes (46 homens, idade 61±12 anos) tinha FA paroxística (71%, n=48). Os pacientes apresentavam volume TAECE mediano de 2,4 cm3/m2 (intervalo interquartil [IIQ] 1,6-3,2 cm3/m2) e um volume médio de fibrose do AE de 8,9 g (IIQ 5-15 g). A correlação entre TAECE e fibrose do AE foi estatisticamente significativa, mas fraca (coeficiente de correlação de postos de Spearman = 0,40, p=0,001). Durante um seguimento médio de 22 meses (IIQ 12-31), 31 pacientes (46%) tiveram recidiva da FA. A análise multivariada produziu dois preditores independentes de recidiva da FA: TAECE (FC 2,05, IC de 95% 1,51-2,79, p<0,001) e FA não paroxística (FC 2,36, IC de 95% 1,08-5,16, p=0,031). Conclusão A correlação fraca entre TAE e AE sugere que a fibrose do AE não é o principal mecanismo que liga o TAE e a FA. O TAE mostrou-se mais fortemente associado à recidiva da FA do que à fibrose do AE, corroborando a existência de outros mediadores mais importantes do TAE e da FA.

Abstract Background Epicardial adipose tissue (EAT) has been associated with atrial fibrillation (AF), but its pathophysiological mechanisms remain unclear. Objectives To measure the correlation between EAT and left atrium (LA) fibrosis, and to assess their ability to predict relapse after pulmonary vein isolation (PVI). Methods Patients with AF enrolled for a first PVI procedure underwent both cardiac computerized tomography (CT) and cardiac magnetic resonance (CMR) imaging within less than 48 hours. EATLMwas quantified on contrast-enhanced CT images at the level of the left main. LA fibrosis was quantified on isotropic 1.5 mm 3D delayed enhancement CMR. After pulmonary vein isolation (PVI), patients were followed up for AF relapse. Statistical significance was set at p<0.05. Results Most of the 68 patients (46 men, age 61±12 years) had paroxysmal AF (71%, n=48). Patients had a median EATLMvolume of 2.4 cm3/m2(interquartile range [IQR] 1.6-3.2 cm3/m2), and a median amount of LA fibrosis of 8.9 g (IQR 5-15 g). The correlation between EATLMand LA fibrosis was statistically significant but weak (Spearman's R=0.40, p=0.001). During a median follow-up of 22 months (IQR 12-31), 31 patients (46%) had AF relapse. Multivariate analysis yielded two independent predictors of AF relapse: EATLM(HR 2.05, 95% CI 1.51-2.79, p<0.001), and non-paroxysmal AF (HR 2.36, 95% CI 1.08-5.16, p=0.031). Conclusion The weak correlation between EAT and LA suggests that LA fibrosis is not the main mechanism linking EAT and AF. EAT was more strongly associated with AF relapse than LA fibrosis, supporting the existence of other more important mediators of EAT and AF.

The Relationship between Epicardial Fat and Atrial Fibrillation Cannot Be Fully Explained by Left Atrial Fibrosis. / Relação entre Gordura Epicárdica e Fibrilação Atrial Não Pode Ser Totalmente Explicada pela Fibrose Atrial Esquerda.

BACKGROUND: Epicardial adipose tissue (EAT) has been associated with atrial fibrillation (AF), but its pathophysiological mechanisms remain unclear. OBJECTIVES: To measure the correlation between EAT and left atrium (LA) fibrosis, and to assess their ability to predict relapse after pulmonary vein isolation (PVI). METHODS: Patients with AF enrolled for a first PVI procedure underwent both cardiac computerized tomography (CT) and cardiac magnetic resonance (CMR) imaging within less than 48 hours. EATLMwas quantified on contrast-enhanced CT images at the level of the left main. LA fibrosis was quantified on isotropic 1.5 mm 3D delayed enhancement CMR. After pulmonary vein isolation (PVI), patients were followed up for AF relapse. Statistical significance was set at p<0.05. RESULTS: Most of the 68 patients (46 men, age 61±12 years) had paroxysmal AF (71%, n=48). Patients had a median EATLMvolume of 2.4 cm3/m2(interquartile range [IQR] 1.6-3.2 cm3/m2), and a median amount of LA fibrosis of 8.9 g (IQR 5-15 g). The correlation between EATLMand LA fibrosis was statistically significant but weak (Spearman's R=0.40, p=0.001). During a median follow-up of 22 months (IQR 12-31), 31 patients (46%) had AF relapse. Multivariate analysis yielded two independent predictors of AF relapse: EATLM(HR 2.05, 95% CI 1.51-2.79, p<0.001), and non-paroxysmal AF (HR 2.36, 95% CI 1.08-5.16, p=0.031). CONCLUSION: The weak correlation between EAT and LA suggests that LA fibrosis is not the main mechanism linking EAT and AF. EAT was more strongly associated with AF relapse than LA fibrosis, supporting the existence of other more important mediators of EAT and AF.

FUNDAMENTO: O tecido adiposo epicárdico (TAE) tem sido associado à fibrilação atrial (FA), mas seus mecanismos fisiopatológicos permanecem obscuros. OBJETIVOS: Medir a correlação entre TAE e fibrose do átrio esquerdo (AE), e avaliar sua capacidade de prever recidiva após o isolamento da veia pulmonar (IVP). MÉTODOS: Pacientes com FA inscritos para um primeiro procedimento de IVP foram submetidos à tomografia computadorizada (TC) cardíaca e ressonância magnética cardíaca (RMC) em menos de 48 horas. Quantificou-se o TAECE em imagens de TC realçadas com contraste no nível do tronco da coronária esquerda. Quantificou-se a fibrose do AE em RMC tridimensional com realce tardio isotrópico de 1,5 mm. Após o isolamento da veia pulmonar (IVP), os pacientes foram submetidos a seguimento para checar a recidiva da FA. A significância estatística foi definida com p<0,05. RESULTADOS: A maioria dos 68 pacientes (46 homens, idade 61±12 anos) tinha FA paroxística (71%, n=48). Os pacientes apresentavam volume TAECE mediano de 2,4 cm3/m2 (intervalo interquartil [IIQ] 1,6­3,2 cm3/m2) e um volume médio de fibrose do AE de 8,9 g (IIQ 5­15 g). A correlação entre TAECE e fibrose do AE foi estatisticamente significativa, mas fraca (coeficiente de correlação de postos de Spearman = 0,40, p=0,001). Durante um seguimento médio de 22 meses (IIQ 12­31), 31 pacientes (46%) tiveram recidiva da FA. A análise multivariada produziu dois preditores independentes de recidiva da FA: TAECE (FC 2,05, IC de 95% 1,51­2,79, p<0,001) e FA não paroxística (FC 2,36, IC de 95% 1,08­5,16, p=0,031). CONCLUSÃO: A correlação fraca entre TAE e AE sugere que a fibrose do AE não é o principal mecanismo que liga o TAE e a FA. O TAE mostrou-se mais fortemente associado à recidiva da FA do que à fibrose do AE, corroborando a existência de outros mediadores mais importantes do TAE e da FA.

Anatomic guided ablation of the atrial right ganglionated plexi is enough for cardiac autonomic modulation in patients with significant bradyarrhythmias.

INTRODUCTION: Cardiac autonomic system modulation by endocardial ablation targeting atrial ganglionated plexi (GP) is an alternative strategy in selected patients with severe functional bradyarrhythmias, although no consensus exists on the best ablation strategy. The aim of this study was to evaluate if a simplified approach by a purely anatomical guided ablation of just the atrial right GP is enough for the treatment of these patients. METHODS: We prospectively enrolled patients with significant functional bradyarrhythmias and performed endocardial ablation purely guided by 3D electroanatomic mapping directed at the atrial right GP and accessed parameters of parasympathetic modulation and recurrence of bradyarrhythmias. RESULTS: Thirteen patients enrolled (76.9% male, median age 51, 42-63 years). After ablation, a median RR interval shortening of 28.3 (25.6-40.3)% occurred (1111, 937.5-1395.4 ms to 722.9, 652.2-882.4 ms, p = 0.0002). The AH interval also shortened (19, 10.5-35.7%) significantly after the procedure (115, 105-122 ms to 85, 71-105 ms, p = 0.0023) as well as Wenckebach cycle length (11.1, 5.9-17.8% shortening) from 450, 440-510 ms to 430, 400-460 ms, p = 0.0127. On 24-h Holter monitoring there was significant increase in heart rates (HR) of patients after ablation (minimal HR increased from 34 (26-43)bpm to 49 (43-56)bpm, p = 0,0102 and mean HR from 65 (47-72)bpm to 78 (67-87)bpm, p = 0.0004). No patients had recurrence of symptoms or significant bradyarrhythmias during a median follow-up of 8.4 months. CONCLUSIONS: A purely anatomic guided procedure directed only at the atrial right ganglionated plexi seems to be enough as a therapeutic approach for cardioneuroablation in selected patients with significant functional bradyarrhythmias.

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.

Electrocardiographic imaging (ECGI): What is the minimal number of leads needed to obtain a good spatial resolution?

AIMS: Assess the minimal number of ECGI leads needed to obtain a good spatial resolution. METHODS: We enrolled 20 patients that underwent ablation of premature ventricular or atrial contractions using Carto and ECGI with AMYCARD. We evaluated the agreement regarding the site of origin of the arrhythmia between the ECGI and Carto, the area and diameter of the earliest activation site obtained with the ECGI (EASa and EASd). Based on previous studies with pacemapping, we considered a good spatial resolution of the ECGI when the EASd measured on the isopotential map was less than 18 mm. In presence of agreement the ECGI was reprocessed: a) with half the number of electrode bands (8 leads per electrode band) and b) with 6 electrode bands. RESULTS: The initial map was obtained with 23 (22-23) electrode bands per patient, corresponding to 143 (130-170) leads. Agreement rate was 85%, the median EASa and EASd were: 0.7 (0.5-1.3) cm2 and 9 (8-13) mm. With half the number of electrode bands including 73 (60-79) leads, agreement rate was 80%, the EASa and EASd were: 2.1 (1.5-6.2) cm2 and 16 (14 -28) mm. With only six electrode bands using 38 (30-42) leads, agreement rate was 55%, EASa and EASd were: 4.0 (3.3-5.0) cm2 and 23 (21-25) mm. The number of leads was a predictor of agreement with a good spatial resolution, OR (95% CI) of 1.138 (1.050-1.234), p = .002. According to the ROC curve, the minimal number of leads was 74 (AUC 0.981; 95% CI: 0.949-1.00, p < .0001). CONCLUSION: Reducing the number of leads was associated with a lower agreement rate and a significant reduction of spatial resolution. However, the number of leads needed to achieve a good spatial resolution was less than the maximal available.

Idiopathic Premature Ventricular Contractions From the Outflow Tract Display an Underlying Substrate That Can Be Unmasked by a Type 2 Brugada Electrocardiographic Pattern at High Right Precordial Leads.

Background: Patients with premature ventricular contractions (PVCs) from the right ventricular outflow tract (RVOT) and apparently normal hearts, can have ST elevation similar to type 2 or type 3 Brugada pattern in the electrocardiographic (ECG) performed at a higher position. Cardiac magnetic resonance (CMR), has shown conflicting data regarding existence of structural abnormalities in patients with idiopathic PVCs from the RVOT. Objective: Our aim was to evaluate the prevalence of low voltage areas (LVAs) in the RVOT of patients with PVCS from the outflow tract, and in a control group. Secondly, assess for the presence of a non-invasive ECG marker. Methods: A 56 consecutive patients, 45 with frequent PVCs (>10000/24 h) LBBB, vertical axis, negative in aVL and 11 subjects without PVCs. Arrhythmogenic right ventricular cardiomyopathy was ruled out in all patients. An ECG was performed with V1-V2 at the level of the second intercostal space and the presence of ST-segment elevation with a Type 2 or 3 Brugada pattern (Type 2 BrP) was assessed. Bipolar voltage map of the RVOT was performed in sinus rhythm (0.5-1.5 mV color display). Areas with electrograms <1.5 mV represented the LVA. The area adjacent to the pulmonary valve usually displays voltage between 0.5 and 1.5 mV and is classified as transitional-voltage zone. Presence of LVAs outside this transitional-voltage zone were estimated. We compared two groups with and without ST-segment elevation and tested for the association between ECG pattern and LVAs. Results: None of the patients in the control group had ST-segment elevation or LVAs. In the PVC group, no patient had type 1 Brugada pattern, 29 patients (64%) had type 2 or 3 ST-segment elevation (Type 2 BrP), and 28 (62%) had LVAs outside the transitional-voltage zone. LVAs were more frequent in patients with Type 2 BrP; 93% versus 4%, p < 0.0001. The ECG pattern was associated with the presence of LVAs, OR (95% CI): 202.50 (16.92-2423), p < 0.0001. Conclusion: Low voltage areas were frequently present in the RVOT of patients with idiopathic PVCs. They were absent in controls and can be unmasked by the presence of Type 2 BrP in high right precordial leads.

A new electrophysiologic triad for identification and localization of the critical isthmus in atrial flutter.

INTRODUCTION: Atypical atrial flutter (AFL) is a supraventricular arrhythmia that can be treated with catheter ablation. However, this strategy yields suboptimal results and the best approach is yet to be defined. Carto® electroanatomical mapping (EAM) version 7 displays a histogram of the local activation times (LAT) of the tachycardia cycle length (TCL), in addition to activation and voltage maps. Using these EAM tools, the study aimed to assess the ability of an electrophysiologic triad to identify and localize the critical isthmus in AFL. METHODS: Retrospective analysis using Carto® EAM of a single center registry of individuals who underwent left AFL ablation over one year. Subjects with non-left AFL, no high-density EAM, under 2000 points or no left atrium wall or structure mapping were excluded. Sites where arrhythmia is terminated via ablation were compared to an electrophysiologic triad comprising areas of low-voltage (0.05 to 0.3 mV), deep histogram valleys (LAT-valleys) with less than 20% density points relative to the highest density zone and a prolonged LAT-valley duration, which included 10% or more of the TCL. The longest LAT-valley was designated as the primary valley, while additional valleys were named as secondary. RESULTS: A total of nine subjects (six men, median age 75, interquartile range 71-76 years) were included. All patients presented with left AFL and 66% had a history of ablation for atrial fibrillation and/or flutter. The median TCL and collected points were 254 ms (220-290) and 3300 (IQR 2410-3926) points, respectively. All individuals with AFL presented with at least one LAT-valley on the analyzed histograms, which corresponded to heterogeneous low voltage areas (0.05 to 0.3 mV) and affected more than 10% of TCL. Six of the nine patients presented with a secondary LAT-valley. All arrhythmias were terminated successfully following radiofrequency ablation at the primary LAT-valley location. After a minimum three-month follow-up all patients remained in sinus rhythm. CONCLUSION: An electrophysiologic triad identified the critical isthmus in AFL for all patients. Further studies are needed to assess the usefulness of this algorithm in improving catheter ablation outcomes.

Implantable Cardioverter-Defibrillators in Trials of Drug Therapy for Heart Failure: A Systematic Review and Meta-Analysis.

BACKGROUND Medical therapy for heart failure with reduced ejection fraction evolved since trials validated the use of implantable cardioverter-defibrillators (ICDs). We sought to evaluate the performance of ICDs in reducing mortality in the era of modern medical therapy by means of a systematic review and meta-analysis of contemporary randomized clinical trials of drug therapy for heart failure with reduced ejection fraction. METHODS AND RESULTS We systematically identified randomized clinical trials that evaluated drug therapy in patients with heart failure with reduced ejection fraction that reported mortality. Studies that enrolled <1000 patients, patients with left ventricular ejection fraction >40%, or patients in the acute phase of heart failure and study treatment with devices were excluded. We identified 8 randomized clinical trials, including 31 701 patients of whom 3631 (11.5%) had an ICD. ICDs were associated with a lower risk of all-cause mortality (relative risk [RR], 0.85; 95% CI, 0.78-0.94) and sudden cardiac death (RR, 0.49; 95% CI, 0.40-0.61). Results were consistent among studies published before and after 2010. In meta-regression analysis, the proportion of nonischemic etiology did not affect the associated benefit of ICD. CONCLUSIONS In our meta-analysis of contemporary randomized trials of drug therapy for heart failure with reduced ejection fraction, the rate of ICD use was low and associated with a decreased risk in both all-cause mortality and sudden cardiac death. This benefit was still present in trials with new medical therapy.

Impact of Body Mass Index on the Outcomes of Catheter Ablation of Atrial Fibrillation: A European Observational Multicenter Study.

Background Outcomes of catheter ablation of atrial fibrillation (AF) are variable and the predictors of success require further elucidation since the identification of correctable risk factors could help to optimize therapy. We aimed to assess the impact of body mass index (BMI) in the overall safety and efficacy of catheter ablation of AF, with emphasis on the use of cryoballoon ablation and novel oral anticoagulants. Methods and Results There were 2497 consecutive patients undergoing catheter ablation of AF in 7 European high volume centers were stratified according to BMI (normal weight <25 kg/m2, pre-obese 25-30 kg/m2, obesity 30-35 kg/m2, and morbid obesity ≥35 kg/m2) and comparisons of procedural outcomes evaluated. Pre-obese and obese patients presented more comorbidities (hypertension, diabetes mellitus, and sleep apnea), and had higher rates of non-paroxysmal AF ablation procedures. The rate of atrial 12-month arrhythmia relapse increased alongside with BMI (35.2%, 35.7%, 43.6%, and 48.0% P<0.001). During a median follow-up of 18.8 months (interquartile range 11-28), after adjusting for all baseline differences, BMI was an independent predictor of relapse (hazard ratio=1.01 per kg/m2; 95% CI 1.01-1.02; P=0.002), adding incremental predictive value to obstructive sleep apnea. BMI was not a predictor for any of the reported complications. Using novel oral anticoagulants and cryoballoon ablation was safe and efficacy was comparable with vitamin-K antagonists and radiofrequency ablation. Conclusions Obese patients present with a more adverse comorbidity profile, more advanced forms of AF, and have lower chances of being free from AF relapse after ablation. Use of novel oral anticoagulants and cryoballoon ablation may be an option in this patient group.