Long-term hyperuricemia impact on atrial fibrillation outcomes.

BACKGROUND: No studies have been conducted to analyze the impact of serum uric acid (UA) levels on the outcome of atrial fibrillation (AF) patients. We aimed to evaluate the effect of hyperuricemia (HU) on the prognosis of AF. METHODS AND RESULTS: Consecutive patients who consulted our emergency room for an episode of AF, already known or newly diagnosed, between January 1, 2010, and December 31, 2015 (n=2017) were enrolled. After applying exclusion criteria, 1772 patients were included. Serum UA levels in the 6 months before or after the date of the episode were recorded and classified into quartiles: Q1 (n=443) serum UA levels <4.6 mg/dL; Q2 (n=430) 4.6-5.6 mg/dL; Q3 (n=435) 5.7-6.9 mg/dL; and Q4 (n=464) ≥7 mg/dL. Two groups were differentiated: patients without HU (Q1-Q3) and those with HU (Q4). The mean follow-up was 3.7 ± 1.4 years. The primary endpoint was all-cause mortality during follow-up. Mortality during follow-up in the bivariate analysis was higher (p < 0.001) in patients with HU (52.1 %) compared to those without it (35.3 %), confirming multivariate Cox analysis of HU as an independent risk factor for death [hazard ratio 1.89 (1.59-2.25)]. Kaplan-Meier survival analysis showed a shorter survival time in patients with HU (log-rank test, p<0.001). Cox analysis confirmed significant differences in the risk of heart failure (30 % vs. 22 %) in patients with HU. CONCLUSIONS: HU is independently associated with an increased risk for all-cause mortality and hospitalization for heart failure in patients with AF.

Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium.

This preliminary ethical appraisal from the STOPSTORM.eu consortium is meant to raise critical points that clinicians administering stereotactic arrhythmia radioablation should consider to meet the highest standards in medical ethics and thus promote quality of life of patients recruited for radiotherapy treatments at a stage in which they experience a significant degree of vulnerability.

Gender-Based Clinical, Therapeutic Strategies and Prognosis Differences in Atrial Fibrillation.

BACKGROUND: There are limited data on gender-based differences in atrial fibrillation (AF) treatment and prognosis. We aimed to examine gender-related differences in medical attention in an emergency department (ED) and follow-up (FU) among patients diagnosed with an AF episode and to determine whether there are gender-related differences in clinical characteristics, therapeutic strategies, and long-term adverse events in this population. METHODS: We performed a retrospective observational study of patients who presented to a tertiary hospital ER for AF from 2010 to 2015, with a minimum FU of one year. Data on medical attention received, mortality, and other adverse outcomes were collected and analyzed. RESULTS: Among the 2013 patients selected, 1232 (60%) were female. Women were less likely than men to be evaluated by a cardiologist during the ED visit (11.5% vs. 16.6%, p = 0.001) and were less likely to be admitted (5.9% vs. 9.5%, p < 0.05). Electrical cardioversion was performed more frequently in men, both during the first episode (3.4% vs. 1.2%, p = 0.001) and during FU (15.9% vs. 10.6%, p < 0.001), despite a lower AF recurrence rate in women (9.9% vs. 18.1%). During FU, women had more hospitalizations for heart failure (26.2% vs. 16.1%, p < 0.001). CONCLUSIONS: In patients with AF, although there were no gender differences in mortality, there were significant differences in clinical outcomes, medical attention received, and therapeutic strategies. Women underwent fewer attempts at cardioversion, had a lower probability of being evaluated by cardiologists, and showed a higher probability of hospitalization for heart failure. Being alert to these inequities should facilitate the adoption of measures to correct them.

STereotactic Arrhythmia Radioablation (STAR): the Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM.eu) and review of current patterns of STAR practice in Europe.

The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions' experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs.

A Novel Signal Restoration Method of Noisy Photoplethysmograms for Uninterrupted Health Monitoring.

Health-tracking from photoplethysmography (PPG) signals is significantly hindered by motion artifacts (MAs). Although many algorithms exist to detect MAs, the corrupted signal often remains unexploited. This work introduces a novel method able to reconstruct noisy PPGs and facilitate uninterrupted health monitoring. The algorithm starts with spectral-based MA detection, followed by signal reconstruction by using the morphological and heart-rate variability information from the clean segments adjacent to noise. The algorithm was tested on (a) 30 noisy PPGs of a maximum 20 s noise duration and (b) 28 originally clean PPGs, after noise addition (2-120 s) (1) with and (2) without cancellation of the corresponding clean segment. Sampling frequency was 250 Hz after resampling. Noise detection was evaluated by means of accuracy, sensitivity, and specificity. For the evaluation of signal reconstruction, the heart-rate (HR) was compared via Pearson correlation (PC) and absolute error (a) between ECGs and reconstructed PPGs and (b) between original and reconstructed PPGs. Bland-Altman (BA) analysis for the differences in HR estimation on original and reconstructed segments of (b) was also performed. Noise detection accuracy was 90.91% for (a) and 99.38-100% for (b). For the PPG reconstruction, HR showed 99.31% correlation in (a) and >90% for all noise lengths in (b). Mean absolute error was 1.59 bpm for (a) and 1.26-1.82 bpm for (b). BA analysis indicated that, in most cases, 90% or more of the recordings fall within the confidence interval, regardless of the noise length. Optimal performance is achieved even for signals of noise up to 2 min, allowing for the utilization and further analysis of recordings that would otherwise be discarded. Thereby, the algorithm can be implemented in monitoring devices, assisting in uninterrupted health-tracking.

Practical Considerations for the Application of Nonlinear Indices Characterizing the Atrial Substrate in Atrial Fibrillation.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, and in response to increasing clinical demand, a variety of signals and indices have been utilized for its analysis, which include complex fractionated atrial electrograms (CFAEs). New methodologies have been developed to characterize the atrial substrate, along with straightforward classification models to discriminate between paroxysmal and persistent AF (ParAF vs. PerAF). Yet, most previous works have missed the mark for the assessment of CFAE signal quality, as well as for studying their stability over time and between different recording locations. As a consequence, an atrial substrate assessment may be unreliable or inaccurate. The objectives of this work are, on the one hand, to make use of a reduced set of nonlinear indices that have been applied to CFAEs recorded from ParAF and PerAF patients to assess intra-recording and intra-patient stability and, on the other hand, to generate a simple classification model to discriminate between them. The dominant frequency (DF), AF cycle length, sample entropy (SE), and determinism (DET) of the Recurrence Quantification Analysis are the analyzed indices, along with the coefficient of variation (CV) which is utilized to indicate the corresponding alterations. The analysis of the intra-recording stability revealed that discarding noisy or artifacted CFAE segments provoked a significant variation in the CV(%) in any segment length for the DET and SE, with deeper decreases for longer segments. The intra-patient stability provided large variations in the CV(%) for the DET and even larger for the SE at any segment length. To discern ParAF versus PerAF, correlation matrix filters and Random Forests were employed, respectively, to remove redundant information and to rank the variables by relevance, while coarse tree models were built, optimally combining high-ranked indices, and tested with leave-one-out cross-validation. The best classification performance combined the SE and DF, with an accuracy (Acc) of 88.3%, to discriminate ParAF versus PerAF, while the highest single Acc was provided by the DET, reaching 82.2%. This work has demonstrated that due to the high variability of CFAEs data averaging from one recording place or among different recording places, as is traditionally made, it may lead to an unfair oversimplification of the CFAE-based atrial substrate characterization. Furthermore, a careful selection of reduced sets of features input to simple classification models is helpful to accurately discern the CFAEs of ParAF versus PerAF.

An Efficient Hybrid Methodology for Local Activation Waves Detection under Complex Fractionated Atrial Electrograms of Atrial Fibrillation.

Local activation waves (LAWs) detection in complex fractionated atrial electrograms (CFAEs) during catheter ablation (CA) of atrial fibrillation (AF), the commonest cardiac arrhythmia, is a complicated task due to their extreme variability and heterogeneity in amplitude and morphology. There are few published works on reliable LAWs detectors, which are efficient for regular or low fractionated bipolar electrograms (EGMs) but lack satisfactory results when CFAEs are analyzed. The aim of the present work is the development of a novel optimized method for LAWs detection in CFAEs in order to assist cardiac mapping and catheter ablation (CA) guidance. The database consists of 119 bipolar EGMs classified by AF types according to Wells' classification. The proposed method introduces an alternative Botteron's preprocessing technique targeting the slow and small-ampitude activations. The lower band-pass filter cut-off frequency is modified to 20 Hz, and a hyperbolic tangent function is applied over CFAEs. Detection is firstly performed through an amplitude-based threshold and an escalating cycle-length (CL) analysis. Activation time is calculated at each LAW's barycenter. Analysis is applied in five-second overlapping segments. LAWs were manually annotated by two experts and compared with algorithm-annotated LAWs. AF types I and II showed 100% accuracy and sensitivity. AF type III showed 92.77% accuracy and 95.30% sensitivity. The results of this study highlight the efficiency of the developed method in precisely detecting LAWs in CFAEs. Hence, it could be implemented on real-time mapping devices and used during CA, providing robust detection results regardless of the fractionation degree of the analyzed recordings.

Atrial low voltage areas: A comparison between atrial fibrillation and sinus rhythm.

BACKGROUND: Atrial fibrosis can promote atrial fibrillation (AF). Electroanatomic mapping (EAM) can provide information regarding local voltage abnormalities that may be used as a surrogate marker for fibrosis. Specific voltage cut-off values have been reproduced accurately to identify fibrosis in the ventricles, but these values are not well defined in atrial tissue. METHODS: This study is a prospective single-center study. Patients with persistent AF referred for ablation were included. EAM was performed before ablation. We recorded bipolar signals, first in AF and later in sinus rhythm (SR). Two thresholds delimited low-voltage areas (LVA), 0.5 and 0.3 mV. We compared LVA extension between maps in SR and AF in each patient. RESULTS: A total of 23 patients were included in the study. The percentage of points with voltage lower than 0.5 mV and 0.3 mV was significantly higher in maps in AF compared with maps in SR: 38.2% of points < 0.5 mV in AF vs. 22.9% in SR (p < 0.001); 22.3% of points < 0.3 mV in AF vs. 14% in SR (p < 0.001). Areas with reduced voltage were significantly larger in maps in AF (0.5 mV threshold, mean area in AF 41.3 ± 42.5 cm2 vs. 11.7 ± 17.9 cm2 in SR, p < 0.001; 0.3 mV threshold, mean area in AF 15.6 ± 22.1 cm2 vs. 6.2 ± 11.5 cm2 in SR, p < 0.001). CONCLUSIONS: Using the same voltage thresholds, LVA extension in AF is greater than in SR in patients with persistent AF. These findings provide arguments for defining a different atrial fibrosis threshold based on EAM rhythm.

Prognostic value of troponin I in atrial fibrillation.

OBJECTIVE: To evaluate whether circulating cardiac troponin I (cTnI) levels are associated with worst outcomes in patients with atrial fibrillation (AF). METHODS: Consecutive patients visiting the emergency room (ER) with a new episode of a previously diagnosed AF or a new diagnosis of AF during ER admission between January 1st, 2010 and December 31st, 2015, were enrolled in the study (n = 2617). After applying exclusion criteria and eliminating repeated episodes, 2013 patients were finally included. Of these, 1080 patients with at least one cTnI measurement in the ER were selected and classified into 4 groups according to cTnI quartiles: Q1 (n = 147) cTnI <10 ng/L (Group 1); Q2 (n = 254): 10-19 ng/L (Group 2); Q3 (n = 409): 20-40 ng/L (Group 3); and Q4 (n = 270): cTnI >40 ng/L (Group 4). The median follow-up period was 47.8 ± 32.8 months. The primary endpoint was all-cause death during the follow-up. RESULTS: A higher mortality was found in group 4 compared with the other groups (58.9% vs. 28.5%, respectively, p < 0.001), along with, hospitalizations (40.4% vs. 30.7%, p = 0.004), and readmissions due to decompensated heart failure (26.7% vs. 2.5%, p = 0.002). The probability of survival without AF recurrences was lower in the Q4 (p = 0.045). Moreover, cTnI levels >40 ng/L (Q4) were an independent risk factor of death (HR, 2.03; 95% CI, 1.64-2.51; p < 0.001). CONCLUSION: The assessment of cTnI at ER admission could be a useful strategy for risk stratification of patients diagnosed with AF by identifying a subgroup with medium-term to long-term increased risk of adverse events and mortality.

Sex-Specific Ventricular Arrhythmias and Mortality in Cardiac Resynchronization Therapy Recipients.

OBJECTIVES: The study goal was to examine whether there are sex-related differences in the incidence of ventricular arrhythmias and mortality in CRT-defibrillator (CRT-D) recipients. BACKGROUND: Few studies have evaluated sex-related benefits of cardiac resynchronization therapy (CRT). Moreover, data on sex-related differences in the occurrence of ventricular tachyarrhythmias in this population are limited. METHODS: A multicenter retrospective study was conducted in 460 patients (355 male subjects and 105 female subjects) from the UMBRELLA (Incidence of Arrhythmia in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant) national registry. Patients were followed up through remote monitoring after the first implantation of a CRT-D during a median follow-up of 2.2 ± 1.0 years. Sex differences were analyzed in terms of ventricular arrhythmia-treated incidence and death during the follow-up period, with a particular focus on primary prevention patients. RESULTS: Baseline New York Heart Association functional class was worse in women compared with that in men (67.0% of women in New York Heart Association functional class III vs. 49.7% of men; p = 0.003), whereas women had less ischemic cardiac disease (20.8% vs. 41.7%; p < 0.001). Female sex was an independent predictor of ventricular arrhythmias (hazard ratio: 0.40; 95% confidence interval: 0.19 to 0.86; p = 0.020), as well as left ventricular ejection fraction and nonischemic cardiomyopathy. Mortality in women was one-half that of men, although events were scarce and without significant differences (2.9% vs. 5.6%; p = 0.25). CONCLUSIONS: Women with left bundle branch block and implanted CRT have a lower rate of ventricular tachyarrhythmias than men. All-cause mortality in patients is, at least, similar between female and male subjects.

Splitting the P-Wave: Improved Evaluation of Left Atrial Substrate Modification after Pulmonary Vein Isolation of Paroxysmal Atrial Fibrillation.

Atrial substrate modification after pulmonary vein isolation (PVI) of paroxysmal atrial fibrillation (pAF) can be assessed non-invasively by analyzing P-wave duration in the electrocardiogram (ECG). However, whether right (RA) and left atrium (LA) contribute equally to this phenomenon remains unknown. The present study splits fundamental P-wave features to investigate the different RA and LA contributions to P-wave duration. Recordings of 29 pAF patients undergoing first-ever PVI were acquired before and after PVI. P-wave features were calculated: P-wave duration (PWD), duration of the first (PWDon-peak) and second (PWDpeak-off) P-wave halves, estimating RA and LA conduction, respectively. P-wave onset (PWon-R) or offset (PWoff-R) to R-peak interval, measuring combined atrial/atrioventricular and single atrioventricular conduction, respectively. Heart-rate fluctuation was corrected by scaling. Pre- and post-PVI results were compared with Mann-Whitney U-test. PWD was correlated with the remaining features. Only PWD (non-scaling: Δ=-9.84%, p=0.0085, scaling: Δ=-17.96%, p=0.0442) and PWDpeak-off (non-scaling: Δ=-22.03%, p=0.0250, scaling: Δ=-27.77%, p=0.0268) were decreased. Correlation of all features with PWD was significant before/after PVI (p<0.0001), showing the highest value between PWD and PWon-R (ρmax=0.855). PWD correlated more with PWDon-peak (ρ= 0.540-0.805) than PWDpeak-off (ρ= 0.419-0.710). PWD shortening after PVI of pAF stems mainly from the second half of the P-wave. Therefore, noninvasive estimation of LA conduction time is critical for the study of atrial substrate modification after PVI and should be addressed by splitting the P-wave in order to achieve improved estimations.

A Deep Learning Approach for Featureless Robust Quality Assessment of Intermittent Atrial Fibrillation Recordings from Portable and Wearable Devices.

Atrial fibrillation (AF) is the most common heart rhythm disturbance in clinical practice. It often starts with asymptomatic and very short episodes, which are extremely difficult to detect without long-term monitoring of the patient's electrocardiogram (ECG). Although recent portable and wearable devices may become very useful in this context, they often record ECG signals strongly corrupted with noise and artifacts. This impairs automatized ulterior analyses that could only be conducted reliably through a previous stage of automatic identification of high-quality ECG intervals. So far, a variety of techniques for ECG quality assessment have been proposed, but poor performances have been reported on recordings from patients with AF. This work introduces a novel deep learning-based algorithm to robustly identify high-quality ECG segments within the challenging environment of single-lead recordings alternating sinus rhythm, AF episodes and other rhythms. The method is based on the high learning capability of a convolutional neural network, which has been trained with 2-D images obtained when turning ECG signals into wavelet scalograms. For its validation, almost 100,000 ECG segments from three different databases have been analyzed during 500 learning-testing iterations, thus involving more than 320,000 ECGs analyzed in total. The obtained results have revealed a discriminant ability to detect high-quality and discard low-quality ECG excerpts of about 93%, only misclassifying around 5% of clean AF segments as noisy ones. In addition, the method has also been able to deal with raw ECG recordings, without requiring signal preprocessing or feature extraction as previous stages. Consequently, it is particularly suitable for portable and wearable devices embedding, facilitating early detection of AF as well as other automatized diagnostic facilities by reliably providing high-quality ECG excerpts to further processing stages.

Spanish Catheter Ablation Registry. 19th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2019).

INTRODUCTION AND OBJECTIVES: This report presents the findings of the 2019 Spanish Catheter Ablation Registry. METHODS: Data collection was retrospective. A standardized questionnaire was filled by each of the participant centers. RESULTS: Data sent by 102 centers were analyzed, with a total number of ablation procedures performed of 18549 (the highest historically reported in this registry) for a mean of 181.9±137.0 and a median of 144.5 procedures per center. The ablation targets most frequently treated were atrial fibrillation (n=5164; 27.8%), cavotricuspid isthmus (n=3925; 21.1%) and atrioventricular nodal reentrant tachycardia (n=3768; 20.3%). A new peak is observed in the ablation of atrial fibrillation, increasing the distance from the other substrates. The overall success rate was again 91%. The rate of major complications was 1.9%, and the mortality rate was 0.03%. An electroanatomic mapping system was used in 44.5% of all procedures, with contact force-sensing irrigated catheters become the preferred for complex substrates, as atrial fibrillation (84.8%) or ventricular tachycardia (around 90%). 1.5% of the ablations were performed in pediatric patients. CONCLUSIONS: The Spanish Catheter Ablation Registry enrolls systematically and uninterruptedly the ablation procedures performed in Spain, showing a progressive increasing in the number of ablations over the years with a high success rate and low percentages of complications.

[Spanish Catheter Ablation Registry. 19th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2019)]. / Registro Español de Ablación con Catéter. XIX Informe Oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2019).

INTRODUCTION AND OBJECTIVES: This report presents the findings of the 2019 Spanish Catheter Ablation Registry. METHODS: Data collection was retrospective. A standardized questionnaire was filled by each of the participant centers. RESULTS: Data sent by 102 centers were analyzed, with a total number of ablation procedures performed of 18 549 (the highest historically reported in this registry) for a mean of 181.9 ± 137.0 and a median of 144.5 procedures per center. The ablation targets most frequently treated were atrial fibrillation (n = 5164; 27.8%), cavotricuspid isthmus (n = 3925; 21.1%) and atrioventricular nodal reentrant tachycardia (n = 3768; 20.3%). A new peak is observed in the ablation of atrial fibrillation, increasing the distance from the other substrates. The overall success rate was again 91%. The rate of major complications was 1.9%, and the mortality rate was 0.03%. An electroanatomic mapping system was used in 44.5% of all procedures, with contact force-sensing irrigated catheters become the preferred for complex substrates, as atrial fibrillation (84.8%) or ventricular tachycardia (around 90%). 1.5% of the ablations were performed in pediatric patients. CONCLUSIONS: The Spanish Catheter Ablation Registry enrolls systematically and uninterruptedly the ablation procedures performed in Spain, showing a progressive increasing in the number of ablations over the years with a high success rate and low percentages of complications.

Spanish Catheter Ablation Registry. 18th Official Report of the Spanish Society of Cardiology Working Group on Electrophysiology and Arrhythmias (2018).

INTRODUCTION AND OBJECTIVES: This report presents the findings of the 2018 Spanish Catheter Ablation Registry. METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: Data sent by 100 centers were analyzed, with a total number of 16566 ablation procedures performed (the highest historically reported in this registry) for a mean of 165.5±127.9 and a median of 119 procedures per center. The ablation targets most frequently treated were atrial fibrillation (n=4234; 25.6%), atrioventricular nodal re-entrant tachycardia (n=3525; 21.3%) and cavotricuspid isthmus (n=3425; 20.7%). A new peak was observed in the ablation of atrial fibrillation, increasing the distance from the other substrates. The overall success rate was 91%. The rate of major complications was 2.2%, and the mortality rate was 0.04%. A total of 2.1% of the ablations were performed in pediatric patients. CONCLUSIONS: The Spanish Catheter Ablation Registry enrolls systematically and continuously enrolls the ablation procedures performed in Spain, showing a progressive increasing in the number of ablations over the years, with a high success rate and low percentage of complications.

Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study.

AIMS: Remote monitoring by implantable devices substantially improves management of heart failure (HF) patients by providing diagnostic day-to-day data. The use of thoracic impedance (TI) as a surrogate measure of fluid accumulation is still strongly debated. The multicenter HomeCARE-II study evaluated clinically apparent HF events in the context of remote device diagnostics, focusing on the controversial role of TI. METHODS AND RESULTS: We followed 497 patients (66.6 ±â€¯10.1 years, 77% male, QRS 139.8 ±â€¯36.0 ms, ejection fraction 26.8 ±â€¯7.0%) implanted with a CRT-D (67%) or an ICD (33%) for 21.4 ±â€¯8.1 months. An independent event committee confirmed 171 HF events of which 82 were used to develop a TI-based algorithm for the prediction of imminent cardiac decompensation. Highly inter-individual variations in patterns of TI trends were observed. The algorithm resulted in a sensitivity of 41.5% (50.0%) with 0.95 (1.34) false alerts per patient year, and a positive predictive value of 7.9% overall and 27.9% in the HF event group of patients. Averaged ratio statistics showed a significant pre-hospital decrease and a highly significant in-hospital increase in TI after intensified diuresis. Recurrent decompensations turned out to be preceded by a significantly stronger decrease of TI compared to first events with a higher chance for detection (63.6% sensitivity, p < 0.05). CONCLUSIONS: Overall performance in predicting imminent decompensation by monitoring TI alone is limited due to its high inter-patient variability. TI stand-alone applications should be redirected towards a target population with more advanced symptoms where post-hospital observation aimed to maintain the patient's discharge status might be the most valuable approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00711360 (HomeCARE-II) and NCT01221649 (J-HomeCARE-II).

Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator.

Aims: Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results: Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P < 0.001), of HF hospitalization of 6.3 (95% CI: 3.9-10.2, P < 0.001) and of non-HF related CVH of 3.5 (95% CI: 2.0-6.9, P < 0.001). The negative predictive value of low or medium HFRS for these admissions was ≥98%. A high HFRS was associated with an increased risk of HF symptoms. Of all the automatic remote monitoring alerts generated during the study, only 10% had a high HFRS. Conclusion: The HFRS is able to risk-stratify CRT-D patients, which is potentially useful for managing automatic remote monitoring alerts, by focusing attention on the minority of high-risk patients. Clinical Trial Registration: The trial was registered at www.clinicaltrials.gov under number NCT00885677.

Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.

AIMS: The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics. METHODS AND RESULTS: The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits. CONCLUSIONS: In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety. TRIAL REGISTRATION: NCT00885677.

Impact of previous cardiac surgery on long-term outcome of cavotricuspid isthmus-dependent atrial flutter ablation.

AIMS: The aim of this study was to determine the acute and long-term outcome of radiofrequency catheter ablation (RFCA) for cavotricuspid isthmus-dependent atrial flutter (CTI-AFL) in adults with and without previous cardiac surgery (PCS), and predictors of these outcomes. Structural alterations of the anatomical substrate of the CTI-AFL are observed in post-operative patients, and these may have an impact on the acute success of the ablation and in the long-term. METHODS AND RESULTS: Clinical records of consecutive adults undergoing RFCA of CTI-AFL were analysed. Two main groups were considered: No PCS and PCS patients, who were further subdivided into acquired heart disease (AHD: ischaemic heart disease and valvular/mixed heart disease) and congenital heart disease [CHD: ostium secundum atrial septal defect (OS-ASD) and complex CHD]. Multivariate analysis identified clinical and procedural factors that predicted acute and long-term outcomes. A total of 666 patients (73% men, age 65 ± 12 years) were included: 307 of them with PCS. Ablation was successful in 647 patients (97%), 96% in the PCS group and 98% in the No PCS group (P = 0.13). Regression analysis showed that surgically corrected complex CHD was related to failure of the procedure [odds ratio 5.6; 95% confidence interval (CI) 1.6-18, P = 0.008]. After a follow-up of 45 ± 15 months, recurrences were observed in 90 patients (14%), more frequently in the PCS group: absolute risk of recurrence 18 vs. 10.5%, relative risk 1.71, 95% CI: 1.2-2.5, P = 0.006. Multivariate analysis indicated that the types of PCS [OS-ASD vs. No PCS: hazard ratio (HR) 2.57; 95% CI: 1.1-6.2, P = 0.03 and complex CHD vs. No PCS: HR 2.75; 95% CI: 1.41-5.48, P = 0.004], female gender (HR 1.55; 95% CI: 1.04-2.4, P = 0.048), and severe LV dysfunction (HR 1.36; 95% CI: 1.06-1.67, P = 0.04) were independent predictors of long-term recurrence. CONCLUSION: Radiofrequency catheter ablation of CTI-AFL after surgical correction of AHD and CHD is associated with high acute success rates. The severity of the structural alterations of the underlying heart disease and consequently the type of surgical correction correlates with higher risk for recurrence.

Spanish Implantable Cardioverter-defibrillator Registry. Eleventh Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2014).

INTRODUCTION AND OBJECTIVES: We present the results of the Spanish Implantable Cardioverter-defibrillator Registry for 2014, as compiled by the Electrophysiology and Arrhythmia Section of the Spanish Society of Cardiology. METHODS: Data collection sheets were voluntarily completed by each implantation team and prospectively sent to the Spanish Society of Cardiology. RESULTS: The number of reported implantations was 4911 (82% of the estimated total number of implantations). The implantation rate was 106 per million population while the estimated rate was 128. First implantations comprised 72.2%. Data were obtained from 162 hospitals (8 more than in 2013). Most implantations (82%) were performed in men. The mean patient age was 61.8±13.7 years. Most patients showed severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most frequent cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Implantations for primary prevention indications comprised 58.5%. Electrophysiologists performed 85.6% of the implantations. CONCLUSIONS: The 2014 Spanish Implantable Cardioverter-defibrillator Registry received information on 82% of the implantations performed in Spain. The number of implantations has increased from previous years and the percentage of implantations for primary prevention indications has increased from the previous year.