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INTRODUCTION: Cryoballoon ablation is a safe and efficient rhythm control strategy in atrial fibrillation (AF) patients. The impact of time from diagnosis to ablation is unclear. The aim of this study was to examine the impact of timing of first-time cryoballoon ablation on AF recurrence in a nationwide cohort of AF patients. METHODS AND RESULTS: From nationwide registers, all AF patients ≥18 years of age who underwent first-time AF cryoballoon ablation in Denmark from 2012 to 2018 were included. The AF patients were stratified by ablation timing: Early group (≤1 year after AF diagnosis), intermediate group (1-3 years after AF diagnosis), and late group (≥3 years after AF diagnosis). By adjusted Cox regression models, the effect of timing on AF recurrence was examined. This study included 1064 AF patients with a median age of 63 years. Most patients were male (66%) and had paroxysmal AF (67%). The 1-year risk of AF recurrence increased from 31% in the early group to 41% and 44% in the intermediate and late group. The hazard ratios (95% confidence intervals) were 1.28 (0.95, 1.74) in the intermediate group and 1.42 (1.09, 1.86) in the late group when compared to the early group. Continuous diagnosis-to-ablation time seemed to have the greatest impact on AF recurrence within the first 2 years. CONCLUSION: In AF patients undergoing cryoballoon ablation, late timing of ablation was associated with a significantly higher AF recurrence rate when compared to early timing of ablation. These findings support early cryoballoon ablation to improve the outcomes after ablation.
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Fibrilación Atrial , Criocirugía , Frecuencia Cardíaca , Recurrencia , Sistema de Registros , Tiempo de Tratamiento , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Masculino , Criocirugía/efectos adversos , Femenino , Dinamarca/epidemiología , Persona de Mediana Edad , Anciano , Factores de Riesgo , Factores de Tiempo , Medición de Riesgo , Resultado del Tratamiento , Potenciales de Acción , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatologíaRESUMEN
BACKGROUND AND AIM: Catheter ablation (CA) is a well-established treatment option for atrial fibrillation (AF), where sedation and analgesia are pivotal for patient comfort and lesion formation. The impact of anaesthesia type on AF recurrence rates remains uncertain. This study aimed to examine AF recurrence rates depending on conscious sedation (CS) versus general anaesthesia (GA) during CA. METHODS: Utilizing nationwide data from The Danish healthcare registries, we conducted this cohort study involving adults (≥18 years) undergoing first-time CA for AF between 2010 and 2018. Patients were categorized by anaesthesia type (CS or GA), with the primary endpoint being AF recurrence, defined by a composite endpoint of either antiarrhythmic drugs (AAD) prescriptions, AF-related hospital admissions, electrical cardioversions, or AF re-ablation. The impact of anaesthesia type was evaluated using multivariable Cox proportional hazards analysis. RESULTS: The study cohort comprised 7,957 (6,421 CS and 1,536 GA) patients. Persistent AF, hypertension, and heart failure, as well as use of AAD were more prevalent in the GA group. Cumulative incidences of recurrent AF were higher in the CS group at one year (46% vs 37%) and at five years (68 % vs 63%). Multivariate analysis revealed CS as significantly associated with increased risk of AF recurrence at five-year follow-up (HR 1.26 (95% CI: 1.15-1.38)), consistent across paroxysmal and persistent AF subtypes. CONCLUSIONS: This nationwide cohort study suggests a higher risk of AF recurrence with CS during CA compared to GA. These results advocate for considering GA as the preferred anaesthesia type for improved CA outcomes.
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INTRODUCTION: Reconnections to pulmonary vein (PV) triggers of atrial fibrillation (AF) are the primary cause of AF recurrence after PV isolation (PVI) with radiofrequency (RF) or cryoballoon catheter ablation (CRYO), but method-specific contributions to PV reconduction pattern and conductive gap location are incompletely understood. METHODS: The objective of this radiofrequency versus cryoballoon catheter ablation for paroxysmal atrial fibrillation substudy was to determine procedure-specific patterns of PV reconduction in a randomized population with protocol-mandated repeat procedures, irrespective of AF recurrence. Each PV was assessed in turn and PV reconnection sites were identified by high-density electroanatomical mapping and locating the earliest activation site. Gap locations were verified by PV re-isolation. RESULTS: In 98 patients, 81% versus 76% previously isolated PVs remained isolated after CRYO versus RF (risk ratio [RR]: 1.06; 95% confidence interval [CI]: 0.96-1.18; p = .28). There were no significant differences for any PV: left superior PV: 90% versus 80%; left inferior PV: 80% versus 78%; right superior PV: 81% versus 80%, and right inferior PV: 76% versus 73%. For each reconnected PV, 34% of ipsilateral PVs were also reconnected after CRYO compared with 64% after RF (RR: 0.54; 95% CI: 0.32-0.90; p = .01). After RF, gaps were clustered by the carina and adjacent segments, whereas they were more heterogeneously distributed after CRYO. CONCLUSION: Although RF and CRYO produce similar proportions of durably isolated PVs, gap locations appear to develop in procedure-specific patterns. After RF, ipsilateral PV reconduction is more frequent and gap sites cluster by the carina, suggesting that this region should be selectively ablated for more durable PVI.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Humanos , Criocirugía/métodos , Venas Pulmonares/cirugía , Recurrencia , Fibrilación Atrial/cirugía , Frecuencia Cardíaca , Ablación por Catéter/métodos , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION: Atrial tachyarrhythmia recurrence during the blanking period (early ATA) after pulmonary vein isolation (PVI) is associated with an increased risk of later recurrence, but its relationship with pulmonary vein reconduction (PVR) is poorly understood. The objective of the present study was to evaluate the relationship between early ATA and PVR. Second, to provide data on the optimal blanking period by (a) evaluating how the predictive values of ATA for PVR are affected by blanking period duration, and (b) assessing the temporal development in atrial fibrillation (AF) burden. METHODS: In this RACE-AF substudy, 91 patients with paroxysmal AF undergoing PVI randomized to radiofrequency or cryoballoon ablation were included. All patients received an implantable cardiac monitor and underwent a protocol-mandated repeat procedure after 4-6 months for assessment of PVR. ATA ≥ 30 s. ≤ 90 days after PVI constituted early ATA. RESULTS: PVR was found in 37/54 (69%) patients with early ATA and in 11/37 (30%) patients without (p < .001). The positive predictive value of ATA for PVR was independent of blanking period duration (range 0-90 days). In both patients with and without PVR, AF burden was higher in the first month after PVI, but AF burden from the second month was similar to AF burden after the conventional blanking period. CONCLUSION: Early ATA indicates PVR, and the positive predictive value is independent of the blanking period duration. Altogether, the results of this study support substantially shortening the blanking period after PVI for paroxysmal AF.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/etiología , Venas Pulmonares/cirugía , Resultado del Tratamiento , Atrios Cardíacos , Taquicardia , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Criocirugía/efectos adversos , Criocirugía/métodos , RecurrenciaRESUMEN
AIMS: Overweight is associated with increased risk of atrial fibrillation (AF), but the impact of overweight and AF recurrence after ablation is less clear. Despite this, an increasing number of AF ablations are carried out in overweight patients. We investigated the impact of body mass index (BMI) on AF recurrence rates after ablation. METHODS AND RESULTS: Through Danish nationwide registers, all patients undergoing first-time AF ablation between 2010 and 2018 were identified. Exposure of interest was BMI. The primary outcome was recurrent AF, defined from either any usage of antiarrhythmic medication, AF hospitalization, cardioversion, or re-ablation. A total of 9188 patients were included. Median age and interquartile range was 64 (60-75) in the normal-weight group and 60 (53-66) in the morbidly obese. There was an increase in comorbidity burden with increasing BMI, including a higher prevalence of heart failure, chronic obstructive pulmonary disease, diabetes, and hypertension. At 1- and 5-year follow ups, recurrence rates of AF increased incrementally by BMI categories. The hazard ratios and 95% confidence intervals of recurrent AF after ablation were 1.15 (1.07-1.23), 1.18 (1.09-1.28), and 1.26 (1.13-1.41) in overweight, obese, and morbidly obese, respectively, compared with normal-weight patients. Procedure duration and X-ray dose exposure also increased with increasing BMI. CONCLUSION: Following AF ablation, recurrence rates of AF increased incrementally with increasing BMI. Therefore, aggressive weight management pre ablation in overweight patients could potentially provide substantial benefits and improve short- and long-term outcomes after ablation.
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Fibrilación Atrial , Ablación por Catéter , Obesidad Mórbida , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Estudios de Cohortes , Índice de Masa Corporal , Factores de Riesgo , Sobrepeso/etiología , Sobrepeso/cirugía , Obesidad Mórbida/complicaciones , Obesidad Mórbida/diagnóstico , Obesidad Mórbida/epidemiología , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Recurrencia , Dinamarca/epidemiología , Resultado del TratamientoRESUMEN
INTRODUCTION: Posterior wall isolation (PWI) added to pulmonary vein isolation (PVI) is increasingly used despite limited evidence of clinical benefit. We investigated the feasibility, durability, and efficacy of index-procedure PVI + PWI radio frequency ablation (RFA) in patients with persistent atrial fibrillation (PeAF). METHODS AND RESULTS: Twenty-four patients with PeAF participated in the prospective PeAF-Box study and underwent RFA with wide area circumferential ablation, roof- and inferior lines to achieve PVI + PWI at index procedure. Follow-up included monitoring by an implantable cardiac monitor, esophagoscopy and mandated invasive lesion-reassessment at 6 months. PWI was achieved at minor procedural cost in all patients following PVI. In 33% of patients a median of three ablations in the narrow zone between the center of the posterior wall (PW) and the posterior right carina was pivotal for swift achievement of PWI. At the 6-month reassessment procedure 85% (95% confidence interval [CI]: 77%-92%) of pulmonary veins (PVs) and 46% (95% CI: 26%-67%) of PWs remained durably isolated. AF recurred in 25% and was associated with PV-reconnection (p = .02) but not PW-reconnection (p = .27). AF-burden was 0% (interquartile range [IQR]: 0%-0%) overall and after recurrence 1% (IQR: 0%-7%). CONCLUSION: Index procedure PVI + PWI for PeAF was feasible when recognizing that limited ablation in a PW center-to-right-carina zone was required in a subset of patients. Despite limited chronic PWI durability this strategy was followed by low AF-burden. A PVI + PWI strategy appears promising in ablation for PeAF.
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Fibrilación Atrial , Ablación por Catéter , Atrios Cardíacos , Venas Pulmonares , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Estudios de Factibilidad , Atrios Cardíacos/cirugía , Humanos , Estudios Prospectivos , Venas Pulmonares/cirugía , Recurrencia , Resultado del TratamientoRESUMEN
AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65â min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Accidente Cerebrovascular , Adulto , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etiología , Fibrilación Atrial/cirugía , Ablación por Catéter/métodos , Femenino , Humanos , Persona de Mediana Edad , Venas Pulmonares/cirugía , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Resultado del Tratamiento , Adulto JovenRESUMEN
Aim.To validate the National Danish Ablation Database (NDAD) by investigating to what extent data in NDAD correspond to medical records.Type of study. Non-blinded, registry-based, retrospective, validation study. Material and methods. A sample of patients who underwent ablation for atrial fibrillation in Denmark between 1 January 2016 and 31 December 2016 were included. By utilizing medical records as gold standard, positive predictive (PPV) and negative predictive values (NPV) for NDAD were assessed and presented as five main categories: arrhythmia characteristics, demographics, cardiac history, complications, and medication. PPV's and NPV's exceeding 90% were considered as high agreement. Results. 597 patients (71.0% males) were included in the study. Median age was 63.1 (IQR: 54.9-68.4) years. The median PPV and NPV estimates across all variables were respectively 90.4% (95% CI: 68%-95.2%) (PPV) and 99.4% (95% CI: 98.4%-99.8%) (NPV) at baseline, and 91.7% (95% CI: 67.4%-95.4%) (PPV) and 99.3% (98.2%-99.3%) (NPV) at follow-up. Conclusion. The data registered in NDAD agrees to a great extent with the patients' medical records, suggesting NDAD is a database with high validity. As a result of low complication rate, the PPV- and NPV-estimates among complication variables were prone to somewhat greater uncertainty compared to the rest.
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Fibrilación Atrial , Ablación por Catéter , Bases de Datos Factuales , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Dinamarca/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Estudios RetrospectivosRESUMEN
AIMS: Catheter ablation for atrial fibrillation (CAF) improves symptoms, but whether CAF improves outcome is less clear. The purpose of this study was to investigate whether CAF is associated with improved outcome in atrial fibrillation (AF) patients with previous direct current (DC) cardioversion. METHODS AND RESULTS: We performed a nationwide cohort study including all patients who underwent their 1st direct current cardioversion for AF in the period 2003-15 (N = 25 439). End points were all-cause death, cardiovascular death, stroke/thromboembolism, and incident heart failure (HF). Catheter ablation for AF was treated as a time-varying covariate and the association with outcome was assessed using Cox regression. We also constructed a propensity-matched cohort and assessed the association between CAF and outcome. Median follow-up was 5.3 years (inter-quartile range 3.0-8.7 years). A total of 3509 patients (13.8%) underwent CAF during the study period. Following adjustment for age, gender, comorbidities, medications, educational level, household income, and CHA2DS2VASc score, CAF was associated with reduced risks of all-cause death, cardiovascular death, and incident HF [all-cause death: hazard ratio (HR) 0.69, P < 0.001; cardiovascular death: HR 0.68, P = 0.003; incident HF: HR 0.76, P = 0.011]. Catheter ablation for AF was not associated with a reduced risk of stroke/thromboembolism. These results were replicated in a propensity-matched cohort. CONCLUSION: In AF patients with a prior DC cardioversion, CAF was associated with a reduced risk of all-cause and cardiovascular death. This may be due to a reduced risk of HF.
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Fibrilación Atrial , Ablación por Catéter , Insuficiencia Cardíaca , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Estudios de Cohortes , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Humanos , IncidenciaRESUMEN
Following general life history theory, immediate reproductive investment (egg mass × fecundity/body mass) in oviparous teleosts is a consequence of both present and past environmental influences. This clarification questions the frequent use of season-independent (general) fecundity formulas in marine fish recruitment studies based on body metrics only. Here we test the underlying assumption of no lag effect on gametogenesis in the planktivorous, determinate-fecundity Atlantic herring (Clupea harengus) displaying large plasticity in egg mass and fecundity, examining Norwegian summer-autumn spawning herring (NASH), North Sea autumn-spawning herring (NSAH), and Norwegian spring-spawning herring (NSSH). No prior reproductive information existed for NASH. Compared with the 1960s, recent reproductive investment had dropped markedly, especially for NSAH, likely reflecting long-term changes in zooplankton biography and productivity. As egg mass was characteristically small for autumn spawners, although large for spring spawners (cf. different larval feeding conditions), fecundity was the most dynamic factor within reproductive investment. For the data-rich NSSH, we showed evidence that transient, major declines in zooplankton abundance resulted in low fecundity over several subsequent seasons, even if Fulton's condition factor (K) turned high. Temporal trends in Kslope (K on total length) were, however, informative. These results clarify that fecundity is defined by (i) dynamics of primary (standing stock) oocytes and (ii) down-regulation of secondary oocytes, both processes intimately linked to environmental conditions but operating at different timescales. Thus, general fecundity formulas typically understate interannual variability in actual fecundity. We therefore argue for the use of segmented fecundity formulas linked to dedicated monitoring programs.
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Fertilidad/fisiología , Oocitos/fisiología , Oogénesis/fisiología , Reproducción/fisiología , Animales , Peces , Larva/fisiología , Mar del Norte , Noruega , Alimentos Marinos , ZooplanctonRESUMEN
AIMS: Prolonged corrected QT interval (QTc) might be associated with arrhythmia recurrence after atrial fibrillation (AF) ablation. The effect of short-term amiodarone in this setting remains unknown. This study seeks to quantify short-term amiodarone's impact on QTc, and to investigate QTc and amiodarone treatment as predictors of recurrence of arrhythmia after ablation. METHODS AND RESULTS: The Short-term AMIOdarone treatment after CATheter ablation for atrial fibrillation (AMIO-CAT) trial randomized patients to 8 weeks of oral amiodarone or placebo following AF ablation. Scheduled and symptom-driven 12-lead electrocardiography and 3-day Holter-monitorings were performed. The endpoint was atrial fibrillation, atrial flutter or atrial tachycardia (AF/AT) lasting >30 s. The cut-off for prolonged QTc was 450 ms for men and 460 ms for women. A total of 212 patients were included, of which 108 were randomized to amiodarone and 104 to placebo. From baseline to 1 month QTc in the amiodarone group increased by 27 (±30) ms, while at 6 months QTc had normalized. After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023]. Among patients with baseline QTc below median, amiodarone treatment decreased the rate of AF/AT recurrences (HR 0.43, P = 0.008). CONCLUSIONS: Amiodarone increased QTc with 27 ms compared to placebo, and this effect decreased rapidly after drug discontinuation. Prolonged QTc at baseline independently predicted AF/AT recurrence, and baseline QTc identified patients who would possibly benefit from short-term amiodarone following ablation.
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Amiodarona/administración & dosificación , Antiarrítmicos/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Ablación por Catéter/métodos , Síndrome de QT Prolongado/complicaciones , Síndrome de QT Prolongado/tratamiento farmacológico , Administración Oral , Terapia Combinada , Dinamarca , Método Doble Ciego , Electrocardiografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , RecurrenciaRESUMEN
Aims: During the last decade, ablation has increasingly been used in rhythm control management of patients with atrial fibrillation (AF). Over time, experience and techniques have improved and indications for ablation have expanded. The purpose of this study was to investigate whether the recurrence rate of AF following ablation has improved during last decade. Methods and results: Through Danish nationwide registers, all patients with first-time AF ablation, between 2005 and 2014 in Denmark were identified. Recurrent AF after ablation was identified with 1 year follow-up. A total of 5425 patients undergoing first-time ablation were included. While patient median age increased over time the median AF duration prior to ablation decreased. The rates of recurrent AF decreased from 45% in 2005-2006 to 31% 2013-2014 with the relative risk of recurrent AF almost halved with an odds ratio of 0.57 [95% confidence intervals (95% CI) 0.47-0.68] in 2013-2014 compared with patients undergoing ablation in 2005-2006. Female gender, hypertension, AF duration >2 years, and cardioversion within 1 year prior to ablation were all associated with an increased risk of recurrent AF. Conclusion: One year risk of recurrent AF following first-time ablation has almost halved from 2006 to 2014. Hypertension, female sex, cardioversion 1 year prior to ablation, and AF duration for more than 2 years all increased the associated risk of recurrent AF.
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Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Ablación por Catéter/estadística & datos numéricos , Anciano , Estudios de Cohortes , Dinamarca/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , RecurrenciaRESUMEN
Aims: Early identification of patients who could benefit from early re-intervention after catheter ablation is highly warranted. Our aim was to investigate the association between post-procedural burden of supraventricular ectopic complexes (SVEC) and the risk of long-term atrial fibrillation (AF) recurrence. Methods and results: A total of 125 patients undergoing catheter ablation for AF were included. Patients underwent 7-day Holter recordings immediately post-procedural. The number of SVEC in post-procedural Holter recordings was categorized into quartiles: 0-72, 73-212, 213-782 and ≥ 783 SVEC/day. Long-term AF recurrence was defined as a combined endpoint of AF ≥ 1 min during follow-up Holter recordings, cardioversion or hospitalization for AF after a 3-month blanking period and within 24 months of follow-up. High post-procedural supraventricular ectopy burden was associated with an increased risk of long-term AF recurrence in a dose-dependent manner (≥ 783 SVEC: HR 4.6 [1.9-11.5], P < 0.001) irrespective of AF recurrence during the blanking period or other risk factors. In patients with early AF recurrence < 90 days after catheter ablation ectopy burden was also highly predictive of long-term AF recurrence (SVEC ≥ 213: HR 3.0 [1.3-6.7], P = 0.007). Correspondingly, patients with early AF recurrence but low ectopy burden remained at low risk of long-term AF recurrence after the blanking period. Conclusion: Our results indicate that post-procedural ectopy burden is highly associated with long-term AF recurrence and could be a potent risk marker for selection of patients for early re-ablation. Development of future ablation risk stratification and strategies should include focus on post-procedural ectopy burden.
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Fibrilación Atrial/cirugía , Complejos Atriales Prematuros/etiología , Ablación por Catéter/efectos adversos , Potenciales de Acción , Adulto , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Complejos Atriales Prematuros/diagnóstico , Complejos Atriales Prematuros/fisiopatología , Electrocardiografía Ambulatoria , Femenino , Frecuencia Cardíaca , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Recurrencia , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIM: To investigate the long-term risk of thromboembolism and serious bleeding associated with oral anticoagulation (OAC) therapy beyond 3 months after radiofrequency ablation (RFA) of atrial fibrillation (AF). METHODS AND RESULTS: Linking Danish administrative registries, 4050 patients undergoing first-time RFA (2000-11) were identified. Risk of thromboembolism and serious bleeding according to OAC therapy were analysed by incidence rates (presented per 100 person-years) and Cox proportional-hazard models. The median age was 59.5 years (interquartile range, IQR: 52.8-65.2); 26.5% were females. During a median follow-up of 3.4 years (IQR: 2.0-5.6), 71 (1.8%) thromboembolism cases were identified, where incidence rates with and without OAC were 0.56 (0.40-0.78)95%CI and 0.64 (0.46-0.89)95%CI, respectively. Oral anticoagulation discontinuation remained insignificant [hazard ratio 1.42(0.86-2.35)95%CI] in multivariable analysis. Beyond 3 months after RFA 87 (2.1%) serious bleedings occurred; incidence rates with and without OAC were 0.99 (0.77-1.27)95%CI and 0.44 (0.29-0.65)95%CI, respectively. Oral anticoagulation therapy was significantly associated with serious bleeding risk [hazard ratio 2.05(1.25-3.35)95%CI]. In an age- and gender-matched cohort (1 : 4) of 15 848 non-ablated AF patients receiving rhythm-control therapy, thromboembolic rates with and without OAC were 1.34 (1.21-1.49)95%CI and 2.14 (1.98-2.30)95%CI, respectively. Adjusted incidence rate ratio was 0.53 (0.43-0.65)95%CI favouring RFA cohort. CONCLUSION: Thromboembolic risk beyond 3 months after RFA was relatively low compared with a matched non-ablated AF cohort. With cautious interpretation due to low number of events, serious bleeding risk associated with OAC seems to outweigh the benefits of thromboembolic risk reduction. Randomized studies are warranted to test our results.
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Anticoagulantes/uso terapéutico , Fibrilación Atrial/cirugía , Ablación por Catéter , Hemorragia/inducido químicamente , Tromboembolia/prevención & control , Administración Oral , Anciano , Fibrilación Atrial/epidemiología , Terapia Combinada , Dinamarca/epidemiología , Femenino , Hemorragia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Tromboembolia/epidemiologíaRESUMEN
BACKGROUND: There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation. METHODS: We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis. RESULTS: There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P=0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P=0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P=0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P=0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation. CONCLUSIONS: In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years. (Funded by the Danish Heart Foundation and others; MANTRA-PAF ClinicalTrials.gov number, NCT00133211.).
Asunto(s)
Antiarrítmicos/uso terapéutico , Fibrilación Atrial/cirugía , Ablación por Catéter , Anciano , Antiarrítmicos/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Aleteo Atrial/diagnóstico , Ablación por Catéter/efectos adversos , Costo de Enfermedad , Electrocardiografía Ambulatoria , Femenino , Flecainida/efectos adversos , Flecainida/uso terapéutico , Estudios de Seguimiento , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Propafenona/efectos adversos , Propafenona/uso terapéutico , Calidad de Vida , Estadísticas no Paramétricas , Resultado del TratamientoRESUMEN
AIM: The aim of this prospective substudy was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation (AF) with radiofrequency catheter ablation (RFA) compared with antiarrhythmic drugs (AADs) as first-line treatment. METHODS AND RESULTS: A decision-analytic Markov model, based on MANTRA-PAF (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) study data, was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment. Positive clinical effects were found in the overall population, a gain of an average 0.06 quality-adjusted life years (QALYs) to an incremental cost of 3033, resulting in an incremental cost-effectiveness ratio of 50 570/QALY. However, the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients. This implied an incremental cost-effectiveness ratio of 3434/QALY in ≤50-year-old patients respectively 108 937/QALY in >50-year-old patients. CONCLUSION: Radiofrequency catheter ablation as first-line treatment is a cost-effective strategy for younger patients with paroxysmal AF. However, the cost-effectiveness of using RFA as first-line therapy in older patients is uncertain, and in most of these AADs should be attempted before RFA (MANTRA-PAF ClinicalTrials.gov number; NCT00133211).
Asunto(s)
Antiarrítmicos/economía , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/economía , Ablación por Catéter/economía , Costos de la Atención en Salud/estadística & datos numéricos , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/mortalidad , Ablación por Catéter/mortalidad , Análisis Costo-Beneficio/economía , Análisis Costo-Beneficio/estadística & datos numéricos , Europa (Continente)/epidemiología , Femenino , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Prevalencia , Años de Vida Ajustados por Calidad de Vida , Factores de Riesgo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Catheter ablation for atrial fibrillation (AF) is an important but expensive procedure that is the subject of some debate. Physicians' attitudes toward catheter ablation may influence promotion and patient acceptance. This is the first study to examine the attitudes of Danish cardiologists toward catheter ablation for AF, using a nationwide survey. METHODS AND RESULTS: We developed a purpose-designed questionnaire to evaluate attitudes toward catheter ablation for AF that was sent to all Danish cardiologists (n = 401; response n = 272 (67.8%)). There was no association between attitudes toward ablation and the experience or age of the cardiologist with respect to patients with recurrent AF episodes with a duration of <48 hours or >7 days and/or need for cardioversion. The majority (69%) expected a recurrence of AF after catheter ablation in more than 30% of the cases. For patients with persistent longstanding AF with a duration of >1 year, the attitude toward ablation for longstanding AF was more likely to be positive with increasing age (P < 0.01) and years of experience of the cardiologist (P = 0.002). CONCLUSIONS: Danish cardiologists generally have a positive attitude toward catheter ablation for AF, maintain up-to-date knowledge of the procedure, and are aware what information on ablation treatment should be given to patients with AF. The cardiologists had a positive attitude toward ablation for AF in patients with AF episodes <48 hours and patients with episodes >7 days, or those who needed medical/electrical conversion, but a more negative attitude toward treating longstanding AF patients.
Asunto(s)
Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Actitud del Personal de Salud , Cardiología/estadística & datos numéricos , Competencia Clínica/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Distribución por Edad , Ablación por Catéter , Dinamarca , Femenino , Encuestas de Atención de la Salud , Humanos , Masculino , Persona de Mediana Edad , Selección de Paciente , Médicos/estadística & datos numéricos , Calidad de VidaRESUMEN
AIMS: Patients undergoing catheter ablation for atrial fibrillation (AF) often experience recurrent arrhythmias within the first few months post-ablation. We aimed to investigate whether short-term use of amiodarone to prevent early arrhythmias following radiofrequency ablation for AF could reduce later recurrence. METHODS AND RESULTS: In a two-centre, randomized, double-blind, placebo-controlled study, we randomized a total of 212 patients undergoing AF ablation. Patients were stratified according to type of AF (paroxysmal/persistent) and history of previous AF ablation and randomly assigned to 8 weeks of oral amiodarone therapy or matched placebo following catheter ablation. Patients were followed for 6 months. Analyses were performed according to the intention-to-treat principle. Of 212 enrolled patients [median age 61 (inter-quartile range 54-66), 83% male, 50% paroxysmal, 29% with history of previous ablation], 206 patients were available for analysis of the primary end-point which was any documented atrial tachyarrhythmia lasting >30 s following a blanking period of 3 months. This was observed in 42/107 (39%) in the amiodarone group vs. 48/99 (48%) in the placebo group (P = 0.18). Among the secondary end-points, the amiodarone group showed significantly lower rate of atrial tachyarrhythmia-related hospitalizations [rate ratio = 0.43; 95% confidence interval (CI) = 0.23-0.77, P = 0.006] and cardioversions (rate ratio = 0.36; 95% CI = 0.20-0.62, P = 0.0004) within the blanking period. CONCLUSION: Short-term oral amiodarone treatment following ablation for paroxysmal or persistent AF did not significantly reduce recurrence of atrial tachyarrhythmias at the 6-month follow-up, but it more than halved atrial arrhythmia related hospitalization and cardioversion rates during the blanking period.
Asunto(s)
Amiodarona/administración & dosificación , Antiarrítmicos/administración & dosificación , Fibrilación Atrial/terapia , Ablación por Catéter/métodos , Taquicardia/etiología , Anciano , Terapia Combinada , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , RecurrenciaRESUMEN
BACKGROUND: Pulsed field ablation (PFA) is a novel method of cardiac ablation where there is insufficient knowledge on the durability and reconnection patterns after pulmonary vein isolation (PVI). The aim of this study was to characterize the electrophysiological findings at time of repeat procedure in real-world atrial fibrillation (AF) patients. METHODS: Patients who underwent a repeat procedure (n=26) for symptomatic recurrent arrhythmias after index first-time treatment with single-shot PFA PVI (n=266) from July 2021 to June 2023 were investigated with 3D high-density mapping and ad-hoc re-ablation by radiofrequency or focal PFA. RESULTS: Index indication for PVI was persistent AF in 17 (65%) patients. The mean time to repeat procedure was 292 ± 119 days. Of the 26 patients (104 veins), complete durable PVI was observed in 11/26 (42%) with a durable vein isolation rate of 72/104 (69%). Two patients (8%) had all four veins reconnected. The posterior wall was durably isolated in 4/5 (80%) of the cases. The predominant arrhythmia mechanism was AF in 17/26 (65%) patients and regular atrial tachycardia (AT) in 9/26 (35%). Reconnection was observed 9/26 (35%) in right superior, 11/26 (42%) in right inferior, 7/26 (27%) in left superior, 5/26 (19%) in left inferior, p=0.31 between veins. The gaps were significantly clustered in the right-sided anterior carina compared to other regions (P=0.009). CONCLUSIONS: Durable PVI was observed in less than half of the patients at time of repeat procedure. No significant difference in PV reconnection pattern was observed, but the gap location was preferentially located at the anterior aspects of the right-sided PVs. Predominant recurrence was AF. More data is needed to establish lesion formation and durability and AT circuits after PFA.
Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Taquicardia Supraventricular , Humanos , Venas Pulmonares/cirugía , Resultado del Tratamiento , Fibrilación Atrial/cirugía , Taquicardia Supraventricular/cirugía , Ablación por Catéter/métodos , RecurrenciaRESUMEN
BACKGROUND: Focal pulsed field ablation (FPFA) is a novel and promising method of cardiac ablation. The aim of this study was to report the feasibility, short-term safety, and procedural findings for a broad spectrum of ablated atrial arrhythmias. METHODS: Patients (n = 51) scheduled for ablation of atrial arrhythmias were prospectively included and underwent FPFA using the Galvanize CENTAURI generator with energy delivery through commercially available ablation catheters with ultrahigh-density (UHDx) 3D electroanatomic voltage/local activation time map evaluations. Workflow, procedural data, and peri-procedural technical errors and complications are described. RESULTS: Planned ablation strategy was achieved with FPFA-only in 48/51 (94%) of the cases. Ablation strategy was first-time pulmonary vein isolation (PVI) in 17/51 (36%), repeat ablation in 18/51 (38%), PVI + in 13/51 (28%), and cavotricuspid isthmus block (CTI)-only in 3/51 (6%). The mean procedure time was 104 ± 31 min (first-time PVI), 114 ± 26 min (repeat procedure), 152 ± 36 min (PVI +), and 62 ± 17 min (CTI). Mean UHDx mapping time to assess lesion formation and block after ablation was 7 ± 4 min with 5485 ± 4809 points. First pass acute (linear) isolation with bidirectional block for anatomical lesion sets was 120/124 (97%) for all PVs, 17/17 (100%) for (any) isthmus, and 14/17 (82%) for left atrium posterior wall (LAPW). We observed several time-consuming integration errors with the used ablation system (mean 3.4 ± 3.7 errors/procedure), one transient inferior ST elevation when ablating CTI resolved by intravenous nitroglycerine and one transient AV block requiring temporary pacing for > 24 h. CONCLUSIONS: FPFA was a highly versatile method to treat atrial arrhythmias with high first-pass efficiency. UHDx revealed acute homogenous low-voltage lesions in ablated areas. More data is needed to establish lesion durability and limitations of FPFA.