RESUMO
BACKGROUND AND AIMS: Risk stratification of sudden cardiac death after myocardial infarction and prevention by defibrillator rely on left ventricular ejection fraction (LVEF). Improved risk stratification across the whole LVEF range is required for decision-making on defibrillator implantation. METHODS: The analysis pooled 20 data sets with 140 204 post-myocardial infarction patients containing information on demographics, medical history, clinical characteristics, biomarkers, electrocardiography, echocardiography, and cardiac magnetic resonance imaging. Separate analyses were performed in patients (i) carrying a primary prevention cardioverter-defibrillator with LVEF ≤ 35% [implantable cardioverter-defibrillator (ICD) patients], (ii) without cardioverter-defibrillator with LVEF ≤ 35% (non-ICD patients ≤ 35%), and (iii) without cardioverter-defibrillator with LVEF > 35% (non-ICD patients >35%). Primary outcome was sudden cardiac death or, in defibrillator carriers, appropriate defibrillator therapy. Using a competing risk framework and systematic internal-external cross-validation, a model using LVEF only, a multivariable flexible parametric survival model, and a multivariable random forest survival model were developed and externally validated. Predictive performance was assessed by random effect meta-analysis. RESULTS: There were 1326 primary outcomes in 7543 ICD patients, 1193 in 25 058 non-ICD patients ≤35%, and 1567 in 107 603 non-ICD patients >35% during mean follow-up of 30.0, 46.5, and 57.6 months, respectively. In these three subgroups, LVEF poorly predicted sudden cardiac death (c-statistics between 0.50 and 0.56). Considering additional parameters did not improve calibration and discrimination, and model generalizability was poor. CONCLUSIONS: More accurate risk stratification for sudden cardiac death and identification of low-risk individuals with severely reduced LVEF or of high-risk individuals with preserved LVEF was not feasible, neither using LVEF nor using other predictors.
RESUMO
Importance: The emergence of novel programming guidelines that reduce premature and inappropriate therapies along with the availability of new implantable cardioverter-defibrillator (ICD) technologies lacking traditional endocardial antitachycardia pacing (ATP) capabilities requires the reevaluation of ATP as a first strategy in terminating fast ventricular tachycardias (VTs) in primary prevention ICD recipients. Objective: To assess the role of ATP in terminating fast VTs in primary prevention ICD recipients with contemporary programming. Design, Setting, and Participants: This global, prospective, double-blind, randomized clinical trial had an equivalence design with a relative margin of 35%. Superiority tests were performed at interim analyses and the final analysis if equivalence was not proven. Patients were enrolled between September 2016 and April 2021 at 134 sites in 8 countries, with the last date of follow-up on July 6, 2023. Patients were required to have an indication for a primary prevention ICD, including left ventricular ejection fraction less than or equal to 35%. Interventions: Patients were randomized in a 1:1 ratio to receive ATP plus shock vs shock only. Main Outcomes and Measures: The primary end point was time to first all-cause shock. Secondary end points included time to first appropriate shock, time to first inappropriate shock, all-cause mortality, and the composite of time to first all-cause shock plus all-cause mortality. Results: A total of 2595 patients were randomized (mean age, 63.9 years; 22.4% were females). At a mean follow-up of 38 months, first all-cause shock occurred in 129 participants in the ATP plus shock group and 178 participants in the shock only group. The hazard ratio (HR) for the primary end point was 0.72 (95.9% CI, 0.57-0.92), with P = .005 for superiority of the ATP plus shock group over the shock only group. During follow-up in an intention-to-treat analysis, the total shock burden per 100 patient-years was not statistically different, at 12.3 and 14.9, respectively (P = .70). Conclusions and Relevance: The use of a single burst of ATP prior to shock in primary prevention ICD recipients with modern ICD detection programming prolonged the time to first all-cause ICD shock. Trial Registration: ClinicalTrials.gov Identifier: NCT02923726.
RESUMO
BACKGROUND: In electrocardiographic imaging (ECGI), selecting an optimal regularization parameter (λ) is crucial for obtaining accurate inverse electrograms. The effects of signal and geometry uncertainties on the inverse problem regularization have not been thoroughly quantified, and there is no established methodology to identify when λ is sub-optimal due to these uncertainties. This study introduces a novel approach to λ selection using Tikhonov regularization and L-curve optimization, specifically addressing the impact of electrical noise in body surface potential map (BSPM) signals and geometrical inaccuracies in the cardiac mesh. METHODS: Nineteen atrial simulations (5 of regular rhythms and 14 of atrial fibrillation) ensuring variability in substrate complexity and activation patterns were used for computing the ECGI with added white Gaussian noise from 40 dB to -3dB. Cardiac mesh displacements (1-3 cm) were applied to simulate the uncertainty of atrial positioning and study its impact on the L-curve shape. The regularization parameter, the maximum curvature, and the most horizontal angle of the L-curve (ß) were quantified. In addition, BSPM signals from real patients were used to validate our findings. RESULTS: The maximum curvature of the L-curve was found to be inversely related to signal-to-noise ratio and atrial positioning errors. In contrast, the ß angle is directly related to electrical noise and remains unaffected by geometrical errors. Our proposed adjustment of λ, based on the ß angle, provides a more reliable ECGI solution than traditional corner-based methods. Our findings have been validated with simulations and real patient data, demonstrating practical applicability. CONCLUSION: Adjusting λ based on the amount of noise in the data (or on the ß angle) allows finding optimal ECGI solutions than a λ purely found at the corner of the L-curve. It was observed that the relevant information in ECGI activation maps is preserved even under the presence of uncertainties when the regularization parameter is correctly selected. The proposed criteria for regularization parameter selection have the potential to enhance the accuracy and reliability of ECGI solutions.
RESUMO
AIMS: In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training. METHODS AND RESULTS: In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance. CONCLUSION: Proficiency-based progression training produces superior objectively assessed novice operators' surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training's effect on surgery-related device complications.
Assuntos
Competência Clínica , Treinamento por Simulação , Humanos , Estudos Prospectivos , Feminino , Masculino , Suínos , Currículo , Animais , Análise e Desempenho de Tarefas , Implantação de Prótese/educação , Gravação em Vídeo , Educação de Pós-Graduação em Medicina/métodos , Curva de Aprendizado , Erros Médicos/prevenção & controle , Adulto , Desfibriladores Implantáveis , Cardiologistas/educação , Modelos AnimaisRESUMO
A 53-year-old patient with a history of heart transplant is referred for atrial tachycardia ablation. Two dissociated concomitant rhythms are observed: a focal atrial tachycardia in the donor atrium and atrial fibrillation in the remaining recipient atrium.
RESUMO
BACKGROUND: The prevalence and impact of obesity on outcomes of atrial fibrillation (AF) ablation randomized controlled trials (RCTs) have not been well studied. OBJECTIVE: To examine the proportion of participants with obesity enrolled in RCTs of AF ablation and outcomes of ablation when subgroup analysis of participants with obesity were available. METHODS: We systematically searched PubMed and EMBASE for AF ablation RCTs published between January 1, 2015 to May 31, 2022. When body mass index (BMI) data were available, normal distribution was assumed and a z score was used to estimate the proportion of obesity. Results categorized by BMI or body weight status were reviewed. Authors were contacted for additional information. RESULTS: Of 148 eligible RCTs with 30174 participants, 144 (97.30%) RCTs did not report the proportion of participants with obesity, while published information regarding BMI was available in 63.51%. Three trials excluded patients based on BMI. Using reported BMI, we estimated the proportion of participants with obesity varied greatly across these trials, ranging from 5.82%-71.9% (median 38.02%, interquartile 29.64%, 49.10%). Patients with obesity were represented in a greater proportion among trials conducted in North America (50.23%) and Asia (44.72%), compared to others (32.16%), p < .001. Subgroup analysis or analysis adjusting for BMI was reported in only 13 (8.78%) RCTs; four (30.77%) of these suggested that BMI or body weight might negatively affect primary outcomes. CONCLUSION: Obesity is a common comorbidity among AF patients. However, most AF ablation RCTs underreported the proportion of participants with obesity and its impact on the primary outcomes.
Assuntos
Fibrilação Atrial , Índice de Massa Corporal , Ablação por Cateter , Obesidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Fibrilação Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/fisiopatologia , Obesidade/epidemiologia , Obesidade/diagnóstico , Ablação por Cateter/efeitos adversos , Resultado do Tratamento , Masculino , Feminino , Prevalência , Pessoa de Meia-Idade , Fatores de Risco , Idoso , Medição de Risco , Frequência CardíacaRESUMO
BACKGROUND AND AIMS: In patients with atrial fibrillation (AF), recurrent AF and sinus rhythm during follow-up are determined by interactions between cardiovascular disease processes and rhythm-control therapy. Predictors of attaining sinus rhythm at follow-up are not well known. METHODS: To quantify the interaction between cardiovascular disease processes and rhythm outcomes, 14 biomarkers reflecting AF-related cardiovascular disease processes in 1586 patients in the EAST-AFNET 4 biomolecule study (71 years old, 46% women) were quantified at baseline. Mixed logistic regression models including clinical features were constructed for each biomarker. Biomarkers were interrogated for interaction with early rhythm control. Outcome was sinus rhythm at 12 months. Results were validated at 24 months and in external datasets. RESULTS: Higher baseline concentrations of three biomarkers were independently associated with a lower chance of sinus rhythm at 12 months: angiopoietin 2 (ANGPT2) (odds ratio [OR] 0.76 [95% confidence interval 0.65-0.89], p=0.001), bone morphogenetic protein 10 (BMP10) (OR 0.83 [0.71-0.97], p=0.017) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (OR 0.73 [0.60-0.88], p=0.001). Analysis of rhythm at 24 months confirmed the results. Early rhythm control interacted with the predictive potential of NT-proBNP (pinteraction=0.033). The predictive effect of NT-proBNP was reduced in patients randomized to early rhythm control (usual care: OR 0.64 [0.51-0.80], p<0.001; early rhythm control: OR 0.90 [0.69-1.18], p=0.453). External validation confirmed that low concentrations of ANGPT2, BMP10 and NT-proBNP predict sinus rhythm during follow-up. CONCLUSIONS: Low concentrations of ANGPT2, BMP10 and NT-proBNP identify patients with AF who are likely to attain sinus rhythm during follow-up. The predictive ability of NT-proBNP is attenuated in patients receiving rhythm control.
RESUMO
BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.
Assuntos
Anticoagulantes , Fibrilação Atrial , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Ataque Isquêmico Transitório/prevenção & controle , Ataque Isquêmico Transitório/etiologia , Feminino , Idoso , Masculino , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/etiologia , Método Duplo-Cego , Administração Oral , Idoso de 80 Anos ou mais , Resultado do Tratamento , Hemorragia/induzido quimicamente , Fatores de Tempo , Marca-Passo ArtificialRESUMO
AIM: Reduced left atrial PITX2 is associated with atrial cardiomyopathy and atrial fibrillation. PITX2 is restricted to left atrial cardiomyocytes in the adult heart. The links between PITX2 deficiency, atrial cardiomyopathy and atrial fibrillation are not fully understood. METHODS AND RESULTS: To identify mechanisms linking PITX2 deficiency to atrial fibrillation, we generated and characterized PITX2-deficient human atrial cardiomyocytes derived from human induced pluripotent stem cells (hiPSC) and their controls. PITX2-deficient hiPSC-derived atrial cardiomyocytes showed shorter and disorganised sarcomeres and increased mononucleation. Electron microscopy found an increased number of smaller mitochondria compared to the control. Mitochondrial protein expression was altered in PITX2-deficient hiPSC-derived atrial cardiomyocytes. Single-nuclear RNA-sequencing found differences in cellular respiration pathways and differentially expressed mitochondrial and ion channel genes in PITX2-deficient hiPSC-derived atrial cardiomyocytes. PITX2 repression in hiPSC-derived atrial cardiomyocytes replicated dysregulation of cellular respiration. Mitochondrial respiration was shifted to increased glycolysis in PITX2-deficient hiPSC-derived atrial cardiomyocytes. PITX2-deficient human hiPSC-derived atrial cardiomyocytes showed higher spontaneous beating rates. Action potential duration was more variable with an overall prolongation of early repolarization, consistent with metabolic defects. Gene expression analyses confirmed changes in mitochondrial genes in left atria from 42 patients with atrial fibrillation compared to 43 patients in sinus rhythm. Dysregulation of left atrial mitochondrial (COX7C) and metabolic (FOXO1) genes was associated with PITX2 expression in human left atria. CONCLUSIONS: In summary, PITX2 deficiency causes mitochondrial dysfunction and a metabolic shift to glycolysis in human atrial cardiomyocytes. PITX2-dependent metabolic changes can contribute to the structural and functional defects found in PITX2-deficient atria.
RESUMO
AIMS: The concept of "atrial cardiomyopathy" (AtCM) had been percolating through the literature since its first mention in 1972. Since then, publications using the term were sporadic until the decision was made to convene an expert working group with representation from four multinational arrhythmia organizations to prepare a consensus document on atrial cardiomyopathy in 2016 (EHRA/HRS/APHRS/SOLAECE expert consensus on atrial cardiomyopathies: definition, characterization, and clinical implication). Subsequently, publications on AtCM have increased progressively. METHODS AND RESULTS: The present consensus document elaborates the 2016 AtCM document further to implement a simple AtCM staging system (AtCM stages 1-3) by integrating biomarkers, atrial geometry, and electrophysiological changes. However, the proposed AtCM staging needs clinical validation. Importantly, it is clearly stated that the presence of AtCM might serve as a substrate for the development of atrial fibrillation (AF) and AF may accelerates AtCM substantially, but AtCM per se needs to be viewed as a separate entity. CONCLUSION: Thus, the present document serves as a clinical consensus statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asian Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS) to contribute to the evolution of the AtCM concept.
Assuntos
Fibrilação Atrial , Cardiomiopatias , Consenso , Humanos , Potenciais de Ação , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Cardiomiopatias/diagnóstico , Cardiomiopatias/fisiopatologia , Cardiomiopatias/epidemiologia , Átrios do Coração/fisiopatologia , Frequência Cardíaca , Prognóstico , Terminologia como AssuntoRESUMO
BACKGROUND: Left bundle branch pacing (LBBP) is considered an alternative to cardiac resynchronization therapy (CRT). However, LBBP is not suitable for all patients with heart failure. OBJECTIVE: The aim of our study was to identify predictors of unsuccessful LBBP implantation in CRT candidates. METHODS: A cohort of consecutive patients with indications for CRT were included. Clinical, echocardiographic, and electrocardiographic variables were prospectively recorded. RESULTS: A total of 187 patients were included in the analysis. LBBP implantation was successful in 152 of 187 patients (81.2%) and failed in 35 of 187 patients (18.7%). The causes of unsuccessful implantation were unsatisfactory paced QRS morphology (28 of 35 [80%]), inability to screw the helix (4 of 35 [11.4%]), lead instability (2 of 35 [5.7%]), and high pacing thresholds (1 of 35 [2.8%]). The left ventricular end-diastolic diameter (LVEDD), non-LBBB (left bundle branch block) QRS morphology, and QRS width were predictors of failed implantation according to the univariate analysis. According to the multivariate regression analysis, LVEDD (odds ratio 1.31 per 5-mm increase; 95% confidence interval 1.05-1.63 per 5-mm increase; P = .02) and non-LBBB (odds ratio 3.07; 95% confidence interval 1.08-8.72; P = .03) were found to be independent predictors of unsuccessful LBBP implantation. An LVEDD of 60 mm has 60% sensitivity and 71% specificity for predicting LBBP implant failure. CONCLUSION: When LBBP was used as CRT, LVEDD and non-LBBB QRS morphology predicted unsuccessful implantation. Non-LBBB triples the likelihood of failed implantation independent of LVEDD. Caution should be taken when considering these parameters to plan the best pacing strategy for patients.
RESUMO
AIMS: The aim is to describe the rationale, design, delivery, and baseline characteristics of the Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European society of cardiology in a cluster-Randomized trial in patients with Atrial Fibrillation (STEEER-AF) trial. METHODS AND RESULTS: STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomized in six countries (France, Germany, Italy, Poland, Spain, and UK; 2022-23). The STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with a mean age of 68.9 years (SD 11.7), CHA2DS2-VASc score of 3.2 (SD 1.8), and 647 (37%) women. Eight hundred and forty-three patients (49%) were in AF at enrolment and 760 (44%) in sinus rhythm. Oral anticoagulant therapy was prescribed in 1543 patients (89%), with the majority receiving direct oral anticoagulants (1378; 89%). Previous cardioversion, antiarrhythmic drug therapy, or ablation was recorded in 836 patients (48.3%). Five hundred fifty-one patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomized to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers. CONCLUSION: The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice and evaluate if a structured educational programme for healthcare professionals can improve patient-level care. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT04396418.
Assuntos
Fibrilação Atrial , Fidelidade a Diretrizes , Guias de Prática Clínica como Assunto , Humanos , Fibrilação Atrial/terapia , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/diagnóstico , Feminino , Masculino , Idoso , Europa (Continente) , Pessoa de Meia-Idade , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento , Projetos de Pesquisa , Cardiologia/normas , Cardiologia/educação , Anticoagulantes/uso terapêutico , Padrões de Prática Médica/normas , Antiarrítmicos/uso terapêuticoRESUMO
Youth and adult participation in sports continues to increase, and athletes may be diagnosed with potentially arrhythmogenic cardiac conditions. This international multidisciplinary document is intended to guide electrophysiologists, sports cardiologists, and associated health care team members in the diagnosis, treatment, and management of arrhythmic conditions in the athlete with the goal of facilitating return to sport and avoiding the harm caused by restriction. Expert, disease-specific risk assessment in the context of athlete symptoms and diagnoses is emphasized throughout the document. After appropriate risk assessment, management of arrhythmias geared toward return to play when possible is addressed. Other topics include shared decision-making and emergency action planning. The goal of this document is to provide evidence-based recommendations impacting all areas in the care of athletes with arrhythmic conditions. Areas in need of further study are also discussed.
Assuntos
Arritmias Cardíacas , Atletas , Consenso , Volta ao Esporte , Humanos , Arritmias Cardíacas/complicações , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapia , Morte Súbita Cardíaca/prevenção & controle , Morte Súbita Cardíaca/etiologia , Medição de Risco/métodos , Medicina Esportiva/métodosRESUMO
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).
Assuntos
Arritmias Cardíacas , Bradicardia , Morte Súbita Cardíaca , Desfibriladores Implantáveis , Marca-Passo Artificial , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Bradicardia/terapia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/métodos , Morte Súbita Cardíaca/prevenção & controle , Morte Súbita Cardíaca/etiologia , Desfibriladores Implantáveis/efeitos adversos , Desenho de Equipamento , Seguimentos , Marca-Passo Artificial/efeitos adversos , Tecnologia sem Fio , Arritmias Cardíacas/complicações , Arritmias Cardíacas/terapiaRESUMO
AIMS: Longitudinal dyssynchrony correction and 'strain' improvement by comparable cardiac resynchronization therapy (CRT) techniques is unreported. Our purpose was to compare echocardiographic dyssynchrony correction and 'strain' improvement by conduction system pacing (CSP) vs. biventricular pacing (BiVP) as a marker of contractility improvement during 1-year follow-up. METHODS AND RESULTS: A treatment-received analysis was performed in patients included in the LEVEL-AT trial (NCT04054895), randomized to CSP or BiVP, and evaluated at baseline (ON and OFF programming) and at 6 and 12â months (n = 69, 32% women). Analysis included intraventricular (septal flash), interventricular (difference between left and right ventricular outflow times), and atrioventricular (diastolic filling time) dyssynchrony and 'strain' parameters [septal rebound, global longitudinal 'strain' (GLS), LBBB pattern, and mechanical dispersion). Baseline left ventricular ejection fraction (LVEF) was 27.5 ± 7%, and LV end-systolic volume (LVESV) was 138 ± 77â mL, without differences between groups. Longitudinal analysis showed LVEF and LVESV improvement (P < 0.001), without between-group differences. At 12-month follow-up, adjusted mean LVEF was 46% with CSP (95% CI 42.2 and 49.3%) vs. 43% with BiVP (95% CI 39.6 and 45.8%), (P = 0.31), and LVESV was 80â mL (95% CI 55.3 and 104.5â mL) vs. 100â mL (95% CI 78.7 and 121.6â mL), respectively (P = 0.66). Longitudinal analysis showed a significant improvement of all dyssynchrony parameters and GLS over time (P < 0.001), without differences between groups. Baseline GLS significantly correlated with LVEF and LVESV at 12-month follow-up. CONCLUSION: CSP and BiVP provided similar dyssynchrony and 'strain' correction over time. Baseline global longitudinal 'strain' predicted ventricular remodelling at 12-month follow-up.
Assuntos
Terapia de Ressincronização Cardíaca , Humanos , Feminino , Masculino , Terapia de Ressincronização Cardíaca/métodos , Idoso , Pessoa de Meia-Idade , Resultado do Tratamento , Ecocardiografia , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/diagnóstico por imagem , Volume Sistólico/fisiologia , Disfunção Ventricular Esquerda/diagnóstico por imagem , Disfunção Ventricular Esquerda/terapia , Disfunção Ventricular Esquerda/fisiopatologia , Estudos Longitudinais , SeguimentosRESUMO
BACKGROUND: A partial delineation of targets for ablation of ventricular tachycardia (VT) during a stable rhythm is likely responsible for a suboptimal success rate. The abnormal low-voltage near-field functional components may be hidden within the high-amplitude far-field signal. OBJECTIVES: The aim of this study was to evaluate the benefit and feasibility of functional substrate mapping using a full-ventricle S3 protocol and to assess its colocalization with arrhythmogenic conducting channels (CCs) on late gadolinium enhancement cardiac magnetic resonance. METHODS: An S3 mapping protocol with a drive train of S1 followed by S2 (effective refractory period + 30 ms) and S3 (effective refractory period + 50 ms) from the right ventricular apex was performed in 40 consecutive patients undergoing scar-related VT ablation. Deceleration zones (DZs) and areas of late potentials (LPs) were identified for all maps. A preprocedural noninvasive substrate assessment was done using late gadolinium enhancement cardiac magnetic resonance and postprocessing with automated CC identification. RESULTS: The S3 protocol was completed in 34 of the 40 procedures (85.0%). The S3 protocol enhanced the identification of VT isthmus on the basis of DZ (89% vs 62%; P < 0.01) and LP (93% vs 78%; P = 0.04) assessment. The percentage of CCs unmasked by DZs and LPs using S3 maps was significantly higher than the ones using S2 and S1 maps (78%, 65%, and 48% [P < 0.001] and 88%, 81%, and 68% [P < 0.01], respectively). The functional substrate identified during S3 activation mapping was significantly more extensive than the one identified using S2 and S1, including a greater number of DZs (2.94, 2.47, and 1.82, respectively; P < 0.001) and a wider area of LPs (44.1, 38.2, and 29.4 cm2, respectively; P < 0.001). After VT ablation, 77.9% of patients have been VT free during a median follow-up period of 13.6 months. CONCLUSIONS: The S3 protocol was feasible in 85% of patients, allows a better identification of targets for ablation, and might improve VT ablation results.
Assuntos
Ablação por Cateter , Imageamento por Ressonância Magnética , Taquicardia Ventricular , Humanos , Taquicardia Ventricular/cirurgia , Taquicardia Ventricular/fisiopatologia , Masculino , Feminino , Pessoa de Meia-Idade , Ablação por Cateter/métodos , Idoso , Ventrículos do Coração/fisiopatologia , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/cirurgia , Adulto , Estudos de Viabilidade , Técnicas Eletrofisiológicas Cardíacas/métodosRESUMO
BACKGROUND: Atrial arrhythmogenic substrate is a key determinant of atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI), and reduced conduction velocities have been linked to adverse outcome. However, a noninvasive method to assess such electrophysiologic substrate is not available to date. OBJECTIVE: This study aimed to noninvasively assess regional conduction velocities and their association with arrhythmia-free survival after PVI. METHODS: A consecutive 52 patients scheduled for AF ablation (PVI only) and 19 healthy controls were prospectively included and received electrocardiographic imaging (ECGi) to noninvasively determine regional atrial conduction velocities in sinus rhythm. A novel ECGi technology obviating the need of additional computed tomography or cardiac magnetic resonance imaging was applied and validated by invasive mapping. RESULTS: Mean ECGi-determined atrial conduction velocities were significantly lower in AF patients than in healthy controls (1.45 ± 0.15 m/s vs 1.64 ± 0.15 m/s; P < .0001). Differences were particularly pronounced in a regional analysis considering only the segment with the lowest average conduction velocity in each patient (0.8 ± 0.22 m/s vs 1.08 ± 0.26 m/s; P < .0001). This average conduction velocity of the "slowest" segment was independently associated with arrhythmia recurrence and better discriminated between PVI responders and nonresponders than previously proposed predictors, including left atrial size and late gadolinium enhancement (magnetic resonance imaging). Patients without slow-conduction areas (mean conduction velocity <0.78 m/s) showed significantly higher 12-month arrhythmia-free survival than those with 1 or more slow-conduction areas (88.9% vs 48.0%; P = .002). CONCLUSION: This is the first study to investigate regional atrial conduction velocities noninvasively. The absence of ECGi-determined slow-conduction areas well discriminates PVI responders from nonresponders. Such noninvasive assessment of electrical arrhythmogenic substrate may guide treatment strategies and be a step toward personalized AF therapy.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Sistema de Condução Cardíaco , Veias Pulmonares , Humanos , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/cirurgia , Masculino , Feminino , Ablação por Cateter/métodos , Pessoa de Meia-Idade , Sistema de Condução Cardíaco/fisiopatologia , Veias Pulmonares/cirurgia , Veias Pulmonares/fisiopatologia , Veias Pulmonares/diagnóstico por imagem , Estudos Prospectivos , Eletrocardiografia , Átrios do Coração/fisiopatologia , Átrios do Coração/diagnóstico por imagem , Seguimentos , Imagem Cinética por Ressonância Magnética/métodos , Recidiva , Idoso , Mapeamento Potencial de Superfície Corporal/métodos , Técnicas Eletrofisiológicas Cardíacas/métodosRESUMO
BACKGROUND: Voltage mapping could identify the conducting channels potentially responsible for ventricular tachycardia (VT). Standard thresholds (0.5-1.5 mV) were established using bipolar catheters. No thresholds have been analyzed with high-density mapping catheters. In addition, channels identified by cardiac magnetic resonance (CMR) has been proven to be related with VT. OBJECTIVE: The purpose of this study was to analyze the diagnostic yield of a personalized voltage map using CMR to guide the adjustment of voltage thresholds. METHODS: All consecutive patients with scar-related VT undergoing ablation after CMR (from October 2018 to December 2020) were included. First, personalized CMR-guided voltage thresholds were defined systematically according to the distribution of the scar and channels. Second, to validate these new thresholds, a comparison with standard thresholds (0.5-1.5 mV) was performed. Tissue characteristics of areas identified as deceleration zones (DZs) were recorded for each pair of thresholds. In addition, the relation of VT circuits with voltage channels was analyzed for both maps. RESULTS: Thirty-two patients were included [mean age 66.6 ± 11.2 years; 25 (78.1%) ischemic cardiomyopathy]. Overall, 52 DZs were observed: 44.2% were identified as border zone tissue with standard cutoffs vs 75.0% using personalized voltage thresholds (P = .003). Of the 31 VT isthmuses detected, only 35.5% correlated with a voltage channel with standard thresholds vs 74.2% using adjusted thresholds (P = .005). Adjusted cutoff bipolar voltages that better matched CMR images were 0.51 ± 0.32 and 1.79 ± 0.71 mV with high interindividual variability (from 0.14-1.68 to 0.7-3.21 mV). CONCLUSION: Personalized voltage CMR-guided personalized voltage maps enable a better identification of the substrate with a higher correlation with both DZs and VT isthmuses than do conventional voltage maps using fixed thresholds.
Assuntos
Imagem Cinética por Ressonância Magnética , Taquicardia Ventricular , Humanos , Masculino , Feminino , Taquicardia Ventricular/fisiopatologia , Taquicardia Ventricular/diagnóstico , Idoso , Imagem Cinética por Ressonância Magnética/métodos , Ablação por Cateter/métodos , Sistema de Condução Cardíaco/fisiopatologia , Pessoa de Meia-Idade , Mapeamento Potencial de Superfície Corporal/métodos , Técnicas Eletrofisiológicas Cardíacas/métodosRESUMO
AIMS: Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). METHODS AND RESULTS: Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF. CONCLUSIONS: Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Risco , Hemorragia , Anticoagulantes/uso terapêuticoRESUMO
AIMS: Same-day discharge (SDD) after atrial fibrillation (AF) ablation is an effective means to spare healthcare resources. However, safety remains a concern, and besides structural adaptations, SDD requires more efficient logistics and coordination. Therefore, in this study, we implement a streamlined, nurse-coordinated SDD programme following a standardized protocol. METHODS AND RESULTS: As a dedicated SDD coordinator, a nurse specialized in ambulatory cardiac interventions was in charge of the full SDD protocol, including eligibility, patient flow, in-hospital logistics, patient education, and discharge as well as early post-discharge follow-up by smartphone-based virtual visits. Patients planned for AF ablation were considered eligible if they had a left ventricular ejection fraction (LVEF) ≥35%, with basic support at home and accessibility of the hospital within 60â min also forming a part of the eligibility criteria. A total of 420 consecutive patients were screened by the SDD coordinator, of whom 331 were eligible for SDD. The reasons for exclusion were living remotely (29, 6.9%), lack of support at home (19, 4.5%), or LVEF <35% (17, 4.0%). Of the eligible patients, 300 (91%) were successfully discharged the same day. There were no major post-SDD complications. Rates of unplanned medical attention (19, 6.3%) and 30-day readmission (5, 1.6%) were extremely low and driven by femoral access-site complications. These were significantly reduced upon the introduction of compulsory ultrasound-guided punctures after the initial 150 SDD patients (P = 0.0145). Standardized SDD coordination resulted in efficient workflows and reduced the total workload of the medical staff. CONCLUSION: Same-day discharge after AF ablation following a nurse-coordinated standardized protocol is safe and efficient. The concept of ambulatory cardiac intervention nurses functioning as dedicated coordinators may be key in the future transition of hospitals to SDD. Ultrasound-guided femoral puncture virtually eliminated relevant femoral access-site complications in our cohort and should therefore be a prerequisite for SDD.