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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.
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The demonstration of a peritricuspid circular movement with a zone of slow conduction in the cavotricuspid isthmus, together with the high efficacy of linear ablation and widely accepted acute endpoints, has established typical flutter as a disease with a well-defined physiopathology and treatment. However, certain aspects regarding its deeper physiopathology, ablation targets, and methods for verifying the results remain to be clarified. While current research efforts have primarily been focused on the advancement of effective ablation techniques, it is crucial to continue exploring the intricate electrophysiological, ultrastructural, and pharmacological pathways that underlie the development of atrial flutter. This ongoing investigation is essential for the development of targeted preventive strategies that can act upon the specific mechanisms responsible for the initiation and maintenance of this arrhythmia. In this work, we will discuss less ascertained aspects alongside the most widely recognized general data, as well as the most recent or less commonly used contributions regarding the electrophysiological evaluation and ablation of typical atrial flutter. Regarding electrophysiological characteristics, one of the most intriguing findings is the presence of low voltage zones in some of these patients together with the presence of a functional, unidirectional line of block between the two vena cava. It is theorized that episodes of paroxysmal atrial fibrillation can trigger this line of block, which may then allow the onset of stable atrial flutter. Without this, the patient will either remain in atrial fibrillation or return to sinus rhythm. Another of the most important pending tasks is identifying patients at risk of developing post-ablation atrial fibrillation. Discriminating between individuals who will experience a complete arrhythmia cure and those who will develop atrial fibrillation after flutter ablation, remains essential given the important prognostic and therapeutic implications. From the initial X-ray guided linear cavotricuspid ablation, several alternatives have arisen in the last decade: electrophysiological criteria-directed point applications based on entrainment mapping, applications directed by maximum voltage criteria or by wavefront speed and maximum voltage criteria (omnipolar mapping). Electro-anatomical navigation systems offer substantial support in all three strategies. Finally, the electrophysiological techniques to confirm the success of the procedure are reviewed.
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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.
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Ablação por Cateter , Taquicardia Ventricular , Humanos , Estudos Prospectivos , Arritmias Cardíacas , Ventrículos do Coração , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Resultado do TratamentoRESUMO
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.
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Algoritmos , Fotopletismografia , Artefatos , Eletrocardiografia , Frequência CardíacaRESUMO
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.
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Fibrilação Atrial , Ablação por Cateter , Algoritmos , Fibrilação Atrial/diagnóstico , Ablação por Cateter/métodos , Técnicas Eletrofisiológicas Cardíacas , HumanosRESUMO
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.
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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.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Átrios do Coração , Humanos , Veias Pulmonares/cirurgia , Recidiva , Resultado do TratamentoRESUMO
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.
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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¯10.1â¯years, 77% male, QRS 139.8⯱â¯36.0â¯ms, ejection fraction 26.8⯱â¯7.0%) implanted with a CRT-D (67%) or an ICD (33%) for 21.4⯱â¯8.1â¯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, pâ¯<â¯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).
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Cardiografia de Impedância/instrumentação , Insuficiência Cardíaca/fisiopatologia , Idoso , Algoritmos , Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Impedância Elétrica , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/terapia , Humanos , Masculino , Estudos Prospectivos , Sensibilidade e Especificidade , Volume SistólicoRESUMO
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.
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Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis/estatística & dados numéricos , Insuficiência Cardíaca , Hospitalização/estatística & dados numéricos , Monitorização Fisiológica/métodos , Tecnologia de Sensoriamento Remoto , Idoso , Algoritmos , Terapia de Ressincronização Cardíaca/métodos , Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Dispositivos de Terapia de Ressincronização Cardíaca , Europa (Continente) , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Tecnologia de Sensoriamento Remoto/instrumentação , Tecnologia de Sensoriamento Remoto/métodos , Tecnologia de Sensoriamento Remoto/estatística & dados numéricos , Reprodutibilidade dos Testes , Medição de Risco/métodosRESUMO
BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) showed that early intervention with cardiac-resynchronization therapy with a defibrillator (CRT-D) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years, as compared with defibrillator therapy alone. METHODS: We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population. Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients (phase 1) and subsequently among 854 patients who were enrolled in post-trial registries (phase 2). All reported analyses were performed on an intention-to-treat basis. RESULTS: At 7 years of follow-up after initial enrollment, the cumulative rate of death from any cause among patients with left bundle-branch block was 18% among patients randomly assigned to CRT-D, as compared with 29% among those randomly assigned to defibrillator therapy alone (adjusted hazard ratio in the CRT-D group, 0.59; 95% confidence interval [CI], 0.43 to 0.80; P<0.001). The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex, cause of cardiomyopathy, or QRS duration. In contrast, CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block (adjusted hazard ratio for death from any cause, 1.57; 95% CI, 1.03 to 2.39; P=0.04; P<0.001 for interaction of treatment with QRS morphologic findings). CONCLUSIONS: Our findings indicate that in patients with mild heart-failure symptoms, left ventricular dysfunction, and left bundle-branch block, early intervention with CRT-D was associated with a significant long-term survival benefit. (Funded by Boston Scientific; ClinicalTrials.gov numbers, NCT00180271, NCT01294449, and NCT02060110.).
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Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca/terapia , Idoso , Bloqueio de Ramo/complicações , Terapia Combinada , Desfibriladores Implantáveis , Feminino , Seguimentos , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/prevenção & controle , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Índice de Gravidade de Doença , Volume Sistólico , Disfunção Ventricular Esquerda/complicaçõesRESUMO
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.
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Flutter Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos , Ablação por Cateter , Cardiopatias/complicações , Cardiopatias/cirurgia , Adulto , Idoso , Intervalo Livre de Doença , Eletrocardiografia , Feminino , Seguimentos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Complicações Pós-Operatórias/epidemiologia , Recidiva , Estudos Retrospectivos , Espanha , Resultado do Tratamento , Valva Tricúspide/fisiopatologia , Adulto JovemRESUMO
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.
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Fibrilação Atrial , Hiperuricemia , Ácido Úrico , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/complicações , Biomarcadores/sangue , Causas de Morte/tendências , Seguimentos , Hiperuricemia/epidemiologia , Hiperuricemia/complicações , Hiperuricemia/sangue , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Ácido Úrico/sangueRESUMO
BACKGROUND: Mildly symptomatic heart failure (HF) patients derive substantial clinical benefit from cardiac resynchronization therapy with defibrillator (CRT-D) as shown in MADIT-CRT. The presence of QRS axis deviation may influence response to CRT-D. The objective of this study was to determine whether QRS axis deviation will be associated with differential benefit from CRT-D. METHODS: Baseline electrocardiograms of 1,820 patients from MADIT-CRT were evaluated for left axis deviation (LAD: quantitative QRS axis -30 to -90) or right axis deviation (RAD: QRS axis 90-180) in left bundle branch block (LBBB), right bundle branch block (RBBB), and nonspecific interventricular conduction delay QRS morphologies. The primary endpoints were the first occurrence of a HF event or death and the separate occurrence of all-cause mortality as in MADIT-CRT. RESULTS: Among LBBB patients, those with LAD had a higher risk of primary events at 2 years than non-LAD patients (20% vs 16%; P = 0.024). The same was observed among RBBB patients (20% vs 10%; P = 0.05) but not in IVCD patients (22% vs 23%; P = NS). RAD did not convey any increased risk of the primary combined endpoint in any QRS morphology subgroup. When analyzing the benefit of CRT-D in the non-LBBB subgroups, there was no significant difference in hazard ratios for CRT-D versus ICD for either LAD or RAD. However, LBBB patients without LAD showed a trend toward greater benefit from CRT therapy than LBBB patients with LAD (HR for no LAD: 0.37, 95% CI: 0.26-0.53 and with LAD: 0.54, 95% CI: 0.36-0.79; P value for interaction = 0.18). CONCLUSIONS: LAD in non-LBBB patients (RBBB or IVCD) is not associated with an increased benefit from CRT. In LBBB patients, those without LAD seem to benefit more from CRT-D than those with LAD.
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Bloqueio de Ramo/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Sistema de Condução Cardíaco/fisiopatologia , Insuficiência Cardíaca/terapia , Potenciais de Ação , Idoso , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/etiologia , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/fisiopatologia , Canadá , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/mortalidade , Distribuição de Qui-Quadrado , Eletrocardiografia , Europa (Continente) , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Seleção de Pacientes , Modelos de Riscos Proporcionais , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Função Ventricular Esquerda , Remodelação VentricularRESUMO
OBJECTIVES: The aim of the study was to combine clinical results from the European Cohort of the REVERSE study and costs associated with the addition of cardiac resynchronization therapy (CRT) to optimal medical therapy (OMT) in patients with mild symptomatic (NYHA I-II) or asymptomatic left ventricular dysfunction and markers of cardiac dyssynchrony in Spain. METHODS: A Markov model was developed with CRT + OMT (CRT-ON) versus OMT only (CRT-OFF) based on a retrospective cost-effectiveness analysis. Raw data was derived from literature and expert opinion, reflecting clinical and economic consequences of patient's management in Spain. Time horizon was 10 years. Both costs (euro 2010) and effects were discounted at 3 percent per annum. RESULTS: CRT-ON showed higher total costs than CRT-OFF; however, CRT reduced the length of hospitalization in ICU by 94 percent (0.006 versus 0.091 days) and general ward in by 34 percent (0.705 versus 1.076 days). Surviving CRT-ON patients (88.2 percent versus 77.5 percent) remained in better functional class longer, and they achieved an improvement of 0.9 life years (LYGs) and 0.77 years quality-adjusted life years (QALYs). CRT-ON proved to be cost-effective after 6 years, except for the 7th year due to battery depletion. At 10 years, the results were 18,431 per LYG and 21,500 per QALY gained. Probabilistic sensitivity analysis showed CRT-ON was cost-effective in 75.4 percent of the cases at 10 years. CONCLUSIONS: The use of CRT added to OMT represents an efficient use of resources in patients suffering from heart failure in NYHA functional classes I and II.
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Terapia de Ressincronização Cardíaca/economia , Insuficiência Cardíaca/terapia , Análise Custo-Benefício , Europa (Continente) , Insuficiência Cardíaca/classificação , Humanos , Cadeias de Markov , Estudos Retrospectivos , Espanha , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
BACKGROUND: Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. OBJECTIVE: The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. METHODS: In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. RESULTS: The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). CONCLUSIONS: RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).
Assuntos
Monitorização Fisiológica/métodos , Telemedicina/métodos , Eletrônica , HumanosRESUMO
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.
RESUMO
BACKGROUND: An important determinant of successful cardiac resynchronization therapy for heart failure is the position of the left ventricular (LV) pacing lead. The aim of this study was to analyze the impact of the LV lead position on outcome in patients randomized to cardiac resynchronization-defibrillation in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT) study. METHODS AND RESULTS: The location of the LV lead was assessed by means of coronary venograms and chest x-rays recorded at the time of device implantation. The LV lead location was classified along the short axis into an anterior, lateral, or posterior position and along the long axis into a basal, midventricular, or apical region. The primary end point of MADIT-CRT was heart failure (HF) hospitalization or death, whichever came first. The LV lead position was assessed in 799 patients, (55% patients ≥65 years of age, 26% female, 10% LV ejection fraction ≤25%, 55% ischemic cardiomyopathy, and 71% left bundle-branch block) with a follow-up of 29±11 months. The extent of cardiac resynchronization therapy benefit was similar for leads in the anterior, lateral, or posterior position (P=0.652). The apical lead location compared with leads located in the nonapical position (basal or midventricular region) was associated with a significantly increased risk for heart failure/death (hazard ratio=1.72; 95% confidence interval, 1.09 to 2.71; P=0.019) after adjustment for the clinical covariates. The apical lead position was also associated with an increased risk for death (hazard ratio=2.91; 95% confidence interval, 1.42 to 5.97; P=0.004). CONCLUSION: LV leads positioned in the apical region were associated with an unfavorable outcome, suggesting that this lead location should be avoided in cardiac resynchronization therapy. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00180271.
Assuntos
Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Eletrodos Implantados , Insuficiência Cardíaca/terapia , Adulto , Idoso , Feminino , Ventrículos do Coração , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Função Ventricular EsquerdaRESUMO
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.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Técnicas Eletrofisiológicas Cardíacas , Fibrose , Átrios do Coração , Humanos , Estudos ProspectivosRESUMO
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.