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The percutaneous extraction of endovascular cardiostimulation and defibrillation leads is the most frequent technique nowadays. The tools used today must guarantee the success of the procedure, with the minimum of complications. Our objective was to analyze the safety and efficacy of lead extraction using the Evolution mechanical dissection tool (Cook Medical, USA).A retrospective study was carried out in a total of 826 consecutive patients from October 2009 to December 2018 who underwent the procedure with the Evolution mechanical dissection tool. Preoperative study included complete blood tests, echocardiogram, and chest X-ray. The procedures were performed in the operating room, under general anesthesia and echocardiographic control.A total of 1227 leads were extracted with a mean chronicity of 10.3 ± 5.1 years. Clinical success (CS) rate was 99.7%. A total of 16 (1.9%) complications occurred, 2 (0.24%) were major complications and 14 (1.7%) were minor complications. There was no operative mortality. There was no statistically significant relationship between implant chamber and complete efficacy. The complete extraction was achieved in all left ventricular leads, in 762 of 774 (98.45%) of right ventricular lead removal, and in 330 of 334 (98.8%) of right atrial leads (p = .31).In our experience, percutaneous extraction of intravenous leads via the use of the Evolution tool (Cook Medical, USA), is a very effective and safe technique that offers low morbidity and mortality.

BACKGROUND: Sudden cardiac death (SCD) is the main preventable cause of death in patients with adult congenital heart disease (ACHD). Since robust risk stratification methods are lacking, we developed a risk score model to predict SCD in patients with ACHD: the PRospEctiVE study on implaNTable cardIOverter defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease (PREVENTION-ACHD) risk score model. OBJECTIVE: The purpose of this study was to prospectively study predicted SCD risk using the PREVENTION-ACHD risk score model and actual SCD and sustained ventricular tachycardia/ventricular fibrillation (VT/VF) rates in patients with ACHD. METHODS: The PREVENTION-ACHD risk score model assigns 1 point each to coronary artery disease, New York Heart Association class II/III heart failure, supraventricular tachycardia, systemic ejection fraction < 40%, subpulmonary ejection fraction < 40%, QRS duration ≥ 120 ms, and QT dispersion ≥ 70 ms. SCD risk was calculated for each patient. An annual predicted risk of ≥3% constituted high risk. The primary outcome was SCD or VT/VF after 2 years. The secondary outcome was SCD. RESULTS: The study included 783 consecutive patients with ACHD (n=239 (31%) left-sided lesions; n=138 (18%) tetralogy of Fallot; n=108 (14%) closed atrial septal defect; median age 36 years; interquartile range 28-47 years; n=401 (51%) men). The PREVENTION-ACHD risk score model identified 58 high-risk patients. Eight patients (4 at high risk) experienced the primary outcome. The Kaplan-Meier estimates were 7% (95% confidence interval [CI] 0.1%-13.3%) in the high-risk group and 0.6% (95% CI 0.0%-1.1%) in the low-risk group (hazard ratio 12.5; 95% CI 3.1-50.9; P < .001). The risk score model's sensitivity was 0.5 and specificity 0.93, resulting in a C-statistic of 0.75 (95% CI 0.57-0.90). The hazard ratio for SCD was 12.4 (95% CI 1.8-88.1) (P = .01); the sensitivity and specificity were 0.5 and 0.92, and the C-statistic was 0.81 (95% CI 0.67-0.95). CONCLUSION: The PREVENTION-ACHD risk score model provides greater accuracy in SCD or VT/VF risk stratification as compared with current guideline indications and identifies patients with ACHD who may benefit from preventive implantable cardioverter-defibrillator implantation. ispartof: HEART RHYTHM vol:18 issue:5 pages:785-792 ispartof: location:United States status: published

Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic Inc. Introduction Catheter ablation of atrial fibrillation, both cryoablation and radiofrequency pulmonary vein isolation, have demonstrated to be safe and effective techniques for treating symptomatic atrial fibrillation as a first procedure. However, about one in three patients may face a redo procedure due to AF recurrence. The most suitable technique for redo is unknown. Purpose The aim of this study is to assess the efficacy of cryoballoon AF ablation as a redo technique in patients with prior cryoballoon or radiofrequency AF ablation. Methods We analyzed a nation-wide real-world cryoablation registry (RECABA) and compared patients who were referred for a first cryoballoon AF ablation procedure with those who had previously undergone cryoballoon or radiofrequency pulmonary vein isolation. The primary endpoint was AF recurrence during the first year after a 3-month blanking period. We performed survival analysis and built univariate and multivariate cox regression models. Results From 1742 patients, 1625 had a 12-month follow-up visit. 1551 (95.45%) underwent a first cryoballoon ablation, whereas 33 (2.03%) had a previous CB ablation performed and 41 (2.52%) a previous RF ablation. Mean age was 58.6 ±10.4 years and 511 (31.5%) were women. 463 (28.5%) had persistent atrial fibrillation and there were no major clinical differences between groups. Prior-CB group had a higher share of veins without electrogram visualization, with a median of 100% (IQR 75%-100%), compared to prior-RF group (median 67%, IQR 25%-75%) and first procedure group (median 25%, IQR 0%-50%). Kruskal-Wallis test Chi2=54.35, p 12-month Kaplan–Meier estimate of freedom from AF recurrence after the blanking period was 78.5% (95% CI 76.2% - 80.7%) in the first procedure group, 61.0% (95% CI 41.4% - 75.8%) in the prior-CB and 89.2% (95% CI 73.6% - 95.9%) in the prior-RF group. Log-rank test Chi2=17.49, p Multivariate cox regression analysis pointed female sex, persistent AF, and prior-CB ablation as independent predictors of AF recurrence. The adjusted HR for AF recurrence of prior-CB ablation vs first-CB ablation was 3.13 (95% CI 1.82 -5.40) and for prior-RF vs first CB-ablation was 1.01 (95% CI 0.51 – 1.97). Conclusion Repeat cryoballoon AF ablation shows higher rates of AF recurrences compared to first CB procedures or after prior RF ablation. These data suggest that patients with AF recurrence after CB-ablation have worse arrhythmic outcomes and may benefit from other ablation techniques after a recurrence.

Introduction and objectives: This report presents the findings of the 2018 Spanish Catheter Ablation Registry. Methods: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. Results: Data sent by 100 centers were analyzed, with a total number of 16,566 ablation procedures performed (the highest historically reported in this registry) for a mean of 165.5 ± 127.9 and a median of 119 procedures per center. The ablation targets most frequently treated were atrial fibrillation (n = 4234; 25.6%), atrioventricular nodal re-entrant tachycardia (n = 3525; 21.3%) and cavotricuspid isthmus (n = 3425; 20.7%). A new peak was observed in the ablation of atrial fibrillation, increasing the distance from the other substrates. The overall success rate was 91%. The rate of major complications was 2.2%, and the mortality rate was 0.04%. A total of 2.1% of the ablations were performed in pediatric patients. Conclusions: The Spanish Catheter Ablation Registry systematically and continuously enrolls the ablation procedures performed in Spain, showing a progressive increase in the number of ablations over the years, with a high success rate and low percentage of complications.

Background: The efficacy of mindfulness-based interventions to reduce anxiety or improve quality of life (QoL) in patients with cardiac pathologies is well established. However, there is scarce information on the efficacy, applicability, and safety of these interventions in adult patients with an implantable cardioverter-defibrillator (ICD). In this study, we examined their efficacy on QoL, psychological and biomedical variables, as well as the applicability and safety of a mindfulness-based intervention in patients with an ICD. Methods : Ninety-six patients with an ICD were randomized into two intervention groups and a control group. The interventions involved training in mindfulness-based emotional regulation, either face-to-face or using the “REM Volver a casa” mobile phone application (app). Results: The sample presented medium-high QoL baseline scores (mean: 68), low anxiety (6.84) and depression (3.89), average mindfulness disposition (128), and cardiological parameters similar to other ICD populations. After the intervention, no significant differences were found in the variables studied between the intervention and control groups. Retention was average (59%), and there were no adverse effects due to the intervention. Conclusions : After training in mindfulness-based emotional regulation (face-to-face or via app), no significant differences were found in the QoL or psychological or biomedical variables in patients with an ICD. The intervention proved to be safe, with 59% retention.

Background Many adult congenital heart disease (ACHD) patients are at risk of sudden cardiac death (SCD). An implantable cardioverter-defibrillator (ICD) may prevent SCD, but the evidence for primary prevention indications is still unsatisfactory. Study Design PREVENTION-ACHD is a prospective study with which we aim to prospectively validate a new risk score model for primary prevention of SCD in ACHD patients, as well as the currently existing guideline recommendations. Patients are screened using a novel risk score to predict SCD as well as current ICD indications according to an international Consensus Statement. Patients are followed up for two years. The primary endpoint is the occurrence of SCD and sustained ventricular arrhythmias. The Study was registered at ClinicalTrials.gov (NCT03957824). Conclusion PREVENTION-ACHD is the first prospective study on SCD in ACHD patients. In the light of a growing and aging population of patients with more severe congenital heart defects, more robust clinical evidence on primary prevention of SCD is urgently needed. Electronic supplementary material The online version of this article (10.1007/s12471-019-1297-3) contains supplementary material, which is available to authorized users.

Resumen Introduccion y objetivos Se detallan los resultados del Registro Espanol de Ablacion con Cateter ano 2014. Metodos La recogida de datos se llevo a cabo mediante dos sistemas: retrospectivo, mediante cumplimentacion de un formulario, y prospectivo, a traves de una base de datos comun. La eleccion de uno u otro fue voluntaria de cada uno de los centros. Resultados Se recogieron datos de 85 centros. El numero total de procedimientos de ablacion fue 12.871, con una media de 149,5 ± 103 procedimientos. Los tres sustratos abordados con mas frecuencia fueron la taquicardia intranodular (n = 3.026; 23,5%), la ablacion del istmo cavotricuspideo (n = 2.833; 22,0%) y la fibrilacion auricular (n = 2.498; 19,4%). La ablacion de arritmias ventriculares ha permanecido estable, con un ligero incremento de todos los sustratos ventriculares, en especial las taquicardias ventriculares idiopaticas y las asociadas a cicatriz tras infarto. La tasa total de exito fue del 95%; la de complicaciones mayores, del 1,3% y la de mortalidad, del 0,02%. Conclusiones En el registro del ano 2014 se mantiene una linea de continuidad ascendente en el numero de ablaciones realizadas y muestra, en lineas generales, una elevada tasa de exito y bajo numero de complicaciones. Continua el aumento del abordaje de sustratos mas complejos.

Aims This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted with dual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced. Methods and results Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (> 24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting > 48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 +/- 0.13, 69% were in functional class > or = II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14-0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated. Conclusion In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.

This article presents the 2007 findings of the Spanish Implantable Cardioverter-Defibrillator (ICD) Registry, established by the Working Group on Implantable Cardioverter-Defibrillators, Electrophysiology and Arrhythmia Section, Spanish Society of Cardiology.The Spanish Society of Cardiology received prospective data recorded on a single-page questionnaire on 96.6% of device implantations.Overall, 3,291 implantations were reported (90.1% of the estimated total). The reported implantation rate was 72.8 per million inhabitants, and 77.1% were first implantations. The majority of ICDs were implanted in males (mean age, 61 [12] years) in functional class II with severe or moderate-to-severe left ventricular dysfunction. The most frequent form of heart disease was ischemic heart disease, followed by dilated cardiomyopathy. Indications for primary prevention remained unchanged relative to the previous year and now account for half of all first implantations, with an increasing number of patients with dilated cardiomyopathy. The number of ICDs incorporating cardiac resynchronization therapy has increased slightly and now comprises 30.1% of the total. Around 70% of ICD implantations were performed in an electrophysiology laboratory by a cardiac electrophysiologist. The incidence of complications was very low.The 2007 Spanish Implantable Cardioverter-Defibrillator Registry contains data on more than 90% of all ICD implantations performed in Spain, thereby confirming that it has become increasingly representative in recent years. The number of implantations has continued to grow, though the proportion carried out for primary prevention has stabilized at around 50%.

Los pacientes con desfibrilador automatico implantable (DAI) constituyen una poblacion en riesgo de presentar alteraciones psicologicas y una peor calidad de vida. Sin embargo, datos derivados de la mayoria de los grandes ensayos clinicos aleatorios con DAI ponen de manifiesto que el efecto del dispositivo sobre la calidad de vida es beneficioso o neutro. El principal predictor de empeoramiento de la calidad de vida y ajuste psicologico al DAI, tras el implante, es el numero de descargas del dispositivo. Otros predictores son la juventud, los antecedentes de trastornos de ansiedad o depresion, y el escaso apoyo social o familiar. En la mayor parte de los estudios se han realizado evaluaciones de la calidad de vida a corto plazo y se desconoce si esta puede cambiar a mas largo plazo. Ademas, hay menos informacion sobre la calidad de vida en pacientes con indicacion de DAI como prevencion primaria. Disponemos de diversos recursos para ayudar al paciente en el proceso de adaptacion a la vida con DAI. Una adecuada programacion de los criterios de deteccion y las terapias de estimulacion antitaquicardia reducira significativamente el numero de descargas y hara menos probable el deterioro de la calidad de vida. En pacientes que han experimentado una reduccion en esta tras el implante de DAI, diversas terapias psicologicas, tanto farmacologicas como de intervencion psicoterapeutica, han demostrado ser eficaces en la mejoria de la calidad de vida.

Sudden death (SD) is in most cases due to cardiac causes, mainly secondary to ischemic heart disease. However, the angiographic characteristics in SD survivors in the context of an acute coronary syndrome (ACS) remain controversial. The aim of this study was to evaluate the clinical and angiographic characteristics of patients who suffered cardiac arrest during an ACS.We evaluated 46 patients with SD related to ACS, who were divided into two groups according to their presentation: an ST-elevation myocardial infarction (SD-STEMI) group and a non ST-elevation myocardial infarction (SD-NSTEMI) group. Consecutive STEMI patients without SD served as a double size-matched control group. We compared the clinical and angiographic characteristics and the in-hospital mortality between groups.Patients in the SD-NSTEMI group (n=13) were older and had a higher incidence of hypertension. The left anterior descending coronary artery was the most frequent culprit vessel in all groups. SD-STEMI patients (n=33) had a higher prevalence of proximal coronary culprit segment involvement than did the nonSD STEMI group (75% vs. 36.3%, p0.001). The SD-NSTEMI group was characterized by multivessel and multi-segment disease. Outcomes were similar for both SD groups.SD in patients with NSTEMI occurred in patients who were older, with more cardiovascular risk factors, diffuse and multivessel coronary disease, complex coronary lesions, and a lower rate of angioplasty success as compared with the STEMI group. SD STEMI patients had a significant higher association with proximal coronary acute occlusion than STEMI patients without SD.

Introduction and objectives This report presents the results of the 2013 Spanish Catheter Ablation Registry. Methods Data were collected using 2 systems: retrospectively by completing a dedicated form and prospectively by reporting to a central database. Each participating center chose 1 of the 2 data collection methods. Results Eighty centers voluntarily contributed data to the registry. A total of 11 987 ablation procedures were performed, with a mean (standard deviation) of 149 (105) procedures per center. The 3 main arrhythmic substrates treated were atrioventricular nodal reentrant tachycardia (n = 2959; 24.6%), cavotricuspid isthmus ablation (n = 2700; 22.5%), and atrial fibrillation (n = 2201; 18.4%). The number of ventricular ablation procedures was similar to the 2012 activity, but there was a slight increase in procedures for scar-related postmyocardial infarction ventricular tachycardia. The success rate was 94.4%, major complications occurred in 1.8%, and the mortality rate was 0.03%. Conclusions In line with previous reports, the data from the 2013 registry show a continuing increase in the number of ablations performed. Overall, there was a high success rate and few complications. Ablation of complex substrates has continued to increase.

Clinical trials have shown that functional assessment of coronary stenosis by fractional flow reserve (FFR) improves clinical outcomes. Intravascular ultrasound (IVUS) complements conventional angiography, and is a powerful tool to assess atherosclerotic plaques and to guide percutaneous coronary intervention (PCI). Computational fluid dynamics (CFD) simulation represents a novel method for the functional assessment of coronary flow. A CFD simulation can be calculated from the data normally acquired by IVUS images. A case of coronary heart disease studied with FFR and IVUS, before and after PCI, is presented. A three-dimensional model was constructed based on IVUS images, to which CFD was applied. A discussion of the literature concerning the clinical utility of CFD simulation is provided. Resumo: Estudos clínicos demonstraram que a avaliação funcional da doença coronária com fio de pressão e determinação da reserva fracionada de fluxo (fractional flow reserve - FFR) melhora a evolução clínica. O estudo por ultra-som intravascular (IVUS) complementa a angiografia convencional, e é uma ferramenta poderosa para a avaliação das placas ateroscleróticas orientando a intervenção coronária percutânea (ICP). A simulação computorizada da dinâmica de fluidos (CFD), representa um novo método que permite avaliar funcionalmente o fluxo coronário. A CFD pode ser calculada a partir dos dados normalmente obtidos por IVUS. É apresentado um caso de doença coronária estudada com FFR e IVUS, antes e após a ICP. Foi construído um modelo tridimensional com base nas imagens obtidas por IVUS e avaliado com a técnica de CFD. É apresentada uma discussão bibliográfica sobre a utilidade clínica da simulação com CFD. Keywords: Coronary artery disease, Myocardial fractional flow reserve, Intravascular ultrasound, Fluid dynamics, Computer simulation, Palavras-chave: Doença cardíaca coronária, Reserva fracionada de fluxo miocárdico, Ultra-sonografia intravascular, Dinâmica de fluidos, Simulação computorizada

A B S T R A C T Introduction and objectives: This article presents the findings of the 2012 Spanish Catheter Ablation Registry. Methods: Data were collected in 2 ways: retrospectively using a standardized questionnaire, and prospectively using a central database. Each participating center selected its own preferred method of data collection. Results: Seventy-four Spanish centers voluntarily contributed data to the survey. A total of 11 042 ablation procedures were analyzed, averaging 149 (103) per center. The 3 main conditions treated were atrioventricular nodal reentrant tachycardia (n=2842; 25.7%), cavotricuspid isthmus (n=2485; 23%), and accessory pathways (n=1999; 18%). Atrial fibrillation was the fourth most common substrate treated (n=1852; 17%), representing a slight increase. The number of ventricular arrhythmia ablation procedures was similar to that of 2011, but there was a decrease in procedures for ventricular tachycardia associated with postinfarction scarring. The overall success rate was 94.9%, major complications occurred in 1.9%, and the overall mortality rate was 0.04%. Conclusions: Data from the 2012 registry show that the number of ablations performed continued to increase. Overall, they also show a high success rate and a low number of complications. Ablation of complex substrates continued to increase, particularly in the case of atrial fibrillation.

The Atrial Fibrillation Ablation Pilot Study is a prospective, multinational registry conducted by the European Heart Rhythm Association of the European Society of Cardiology that has been designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation procedure, and the diagnostic/therapeutic processes applied in these patients across Europe. We present the results of the short-term (in-hospital) analysis.A total of 72 centres in 10 European countries were asked to enrol 20 consecutive patients scheduled for a first AFib ablation procedure. Between October 2010 and May 2011, 1410 patients were included, of which 1391 underwent an AFib ablation (98.7%). The median age was 60 years [inter-quartile range (IQR) 52-66], and 28% were females. Two-thirds presented paroxysmal AFib and 38% lone AFib. Symptoms were present in 86%. The indications for ablation were mostly symptomatic AFib, but in over a third of patients there was also a desire for a drug-free lifestyle and the maintenance of sinus rhythm. Pulmonary vein isolation was attempted in 98.4% of patients, the roof line in 21.3% and the mitral isthmus line in 12.8%. Complex-fractionated atrial electrograms were targeted in 17.9% and the ganglionated plexi in 3.3%. Complications occurred in 7.7%, of which 1.7% was major (i.e. cardiac perforation, myocardial infraction, endocarditis, cardiac arrest, stroke, hemothorax, pneumothorax, and sepsis). The median duration of hospitalization was 3 days (IQR 2-4). At discharge, 91.4% of patients were in sinus rhythm, 88.3% of patients were given vitamin K antagonists, and 67% antiarrhythmic medication. There was one death after the ablation procedure.The AFib Ablation Pilot Study provides crucial information on AF ablation in clinical practice across Europe. These data are relevant for further improvement of the management strategies of patients suffering from atrial fibrillation.

It has been estimated that up to 12% of patients with acute myocardial infarction do not present coronary atherosclerotic disease demonstrable with angiographic studies. We assessed the clinical characteristics and prognosis of acute coronary syndrome without ST-segment elevation with angiographically normal coronary arteries.Comparative retrospective analysis of 58 consecutive patients with this diagnosis and a sample (n = 59) with lesions in angiographic studies, analyzing demographic characteristics, analytical parameters, electrocardiogram, ventricular function and prognosis.The group represented 19% of the totality of acute coronary syndromes, showing a lower prevalence rates of hypercholesterolemia, diabetes mellitus and no record of ischemic heart disease (p = 0.043 to p = 0.005). The presence of regional wall motion abnormalities was significantly higher in the group with angiographic lesions (76.3% vs 41.4%; p0.01). In-hospital mortality rate showed a non significant trend toward to be lower in the group with normal angiogram (1.7% vs 8.4%).The absence of significant coronary artery disease in acute coronary syndrome without ST-segment elevation is not infrequent and was related to a lower cardiovascular risk profile and the absence of regional wall motion abnormalities showing a trend toward better in-hospital prognosis.

AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse how centres assess in routine clinical practice the success of the procedure and to evaluate the success rate and long-term safety/complications.METHODS AND RESULTS: Seventy-two centres in 10 European countries were asked to enrol 20 consecutive patients undergoing a first AFib ablation procedure. A web-based case report form captured information on pre-procedural, procedural, and 1-year follow-up data. Between October 2010 and May 2011, 1410 patients were included and 1391 underwent an AFib ablation (98.7%). A total of 1300 patients (93.5%) completed a follow-up control 367 ± 42 days after the procedure. Arrhythmia documentation was done by an electrocardiogram in 76%, Holter-monitoring in 52%, transtelephonic monitoring in 8%, and/or implanted systems in 4.5%. Over 50% became asymptomatic. Twenty-one per cent were re-admitted due to post-ablation arrhythmias. Success without antiarrhythmic drugs was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause).CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib in a real-world setting. The methods used to assess the success of the procedure appeared at least suboptimal. Even in this context, the 12-month success rate appears to be somewhat lower to the one reported clinical trials.