Objetivo: Evaluar la seguridad y la efectividad inicial en la ablación de fibrilación auricular sin uso de fluoroscopia en un centro de alta complejidad de la Argentina. Método: Estudio observacional, prospectivo y unicéntrico en el Instituto Cardiovascular de Buenos Aires, donde se realizaron 100 procedimientos de ablación de fibrilación auricular sin uso de fluoroscopia entre marzo y noviembre de 2024. Se utilizaron mapeo electroanatómico CARTO 3, ecografía intracardiaca y catéteres específicos para guiar el procedimiento. Resultados: Se logró el aislamiento completo de las venas pulmonares en el 100% de los casos. La media de edad fue de 63.5 años, con predominio del sexo masculino (71%). Las complicaciones ocurrieron en el 3% de los procedimientos (dos derrames pericárdicos y un accidente cerebrovascular). No se registraron complicaciones esofágicas ni vasculares. Conclusiones: La ablación de fibrilación auricular sin fluoroscopia en un centro de alta complejidad fue factible, segura y eficaz, reduciendo la exposición a radiación sin comprometer los resultados clínicos.
BACKGROUND AND AIMS:Stroke and systemic embolism are recognized but poorly characterized complications of atrial fibrillation (AF) and left atrial flutter (AFL) catheter ablation. Their incidence, outcomes, and procedural associations remain insufficiently defined. METHODS:Retrospective global registry was initiated by the European Heart Rhythm Association Scientific Committee. A secure database captured data from ablation centres worldwide on general AF and left AFL ablation activity, as well as detailed information on patients with symptomatic embolic events between 2017 and 2024. RESULTS:Overall, 204 centres reported 335 743 ablation procedures and 550 embolic events (incidence 0.16%). Centre-level rate ranged from 0% to 3.1%. Most events were cerebral (94%), followed by peripheral (5%), and combined (1%). Coronary air embolism accounted for 62% of all peripheral events. Intraprocedural events occurred in 93 patients (17%), within 72 h in 357 (78%) and beyond 72 h in 100 (22%); 128 cases (23%) were diagnosed after hospital discharge. Nonparoxysmal AF (0.23% vs 0.15%; P < .001), centre experience, and ablation energy source (radiofrequency, 0.16%; cryoballoon, 0.16%; pulsed field ablation, 0.25%; laserballoon, 0.88%; P < .001) were associated with embolic risk. Median NIHSS score after stroke was 4 (interquartile range, 2-9). Three-month follow-up was available for 518 patients with embolism (95%): 181 (35%) had sequelae and 16 (3%) died. CONCLUSIONS:Symptomatic embolic events are infrequent but associated with significant morbidity and mortality. Most events occur early, though a substantial proportion arise later. Higher event rates were observed with laser and possibly with pulsed field ablation. A greater centre experience was associated with a lower embolism incidence.
Introducción: En la ablación de la fibrilación auricular paroxística por radiofrecuencia o crioablación existe poca información acerca de la superioridad de una técnica sobre la otra.Objetivo: Comparar los resultados agudos y a largo plazo de las técnicas de ablación de la fibrilación auricular paroxística por catéter irrigado y mediante crioablación con balón de segunda generación.Material y métodos: Estudio retrospectivo, observacional, unicéntrico, en el que se evaluaron 159 pacientes consecutivos con fibrilación auricular paroxística, a los cuales se les realizó aislamiento de venas pulmonares mediante radiofrecuencia o crioablación. Se examinaron las características de los pacientes y del procedimiento, así como el éxito inmediato y en elseguimiento a 12 meses.Resultados: Sobre un total de 159 pacientes, 89 procedimientos se realizaron con crioablación y 70 mediante radiofrecuencia. La tasa de éxito inmediato fue del 97,8% con crioablación versus 97,1% con radiofrecuencia (p = 0,8). La tasa libre de fibrilación auricular a los 12 meses luego de un único procedimiento fue del 77,5% mediante crioablación versus 71,4% con radiofrecuencia(p = 0,33). La crioablación con balón se asoció con menor duración del procedimiento respecto de la radiofrecuencia (60,19± 15 minutos frente a 75,8 ± 31 minutos, respectivamente; p < 0,00001), con menor tiempo en la aurícula izquierda (45 ±14 minutos frente a 58 ± 26 minutos; p < 0,00001). Los tiempos de fluoroscopia fueron significativamente mayores para el grupo crioablación (18 ± 3,76 minutos vs. 13 ± 2,23 minutos para radiofrecuencia; p < 0,0001). La tasa de complicaciones crioablación vs. radiofrecuencia fue similar (p = 0,76).Conclusión: La crioablación con balón, en comparación con radiofrecuencia mediante catéter irrigado, se asoció con menor tiempo del procedimiento, similar tasa de complicaciones y tasa libre de fibrilación auricular a los 12 meses luego de un único procedimiento.
espanolIntroduccion: El aislamiento de las venas pulmonares es actualmente la terapeutica de eleccion en pacientes con fibrilacion auricular paroxistica, sintomatica y refractaria al tratamiento antiarritmico. Diferentes grupos abocados al tratamiento de la fibrilacion auricular paroxistica han publicado su experiencia y se conocen varios predictores de recurrencia. Sin embargo, hasta el presente no se ha reportado en nuestro medio una experiencia similar. Objetivos: Primario: Analizar los predictores de recurrencia posaislamiento de venas pulmonares con radiofrecuencia. Secundario: Evaluar la tasa de exito y las complicaciones asociadas con el procedimiento. Material y metodos: Analisis prospectivo, observacional, unicentrico, realizado entre mayo de 2009 y agosto de 2015 de 1.000 casos consecutivos de ablacion de fibrilacion auricular paroxistica con radiofrecuencia y mapeo electroanatomico. Para el analisis del seguimiento se utilizaron 507 aislamientos de venas pulmonares con al menos un ano de seguimiento, excluyendo las reablaciones y los pacientes que no cumplieron con todas las visitas de seguimiento. Resultados: En un analisis multivariado utilizando regresion de Cox se observo que la mayor frecuencia de episodios de fibrilacion auricular previos a la ablacion [HR 1,354 (1,059-1,732); p = 0,016] y la recurrencia temprana (0-3 meses) [HR 4,006 (2,703-5,937); p EnglishBackground: Pulmonary vein isolation is currently the treatment of choice in patients with symptomatic paroxysmal atrial fibrillation refractory to antiarrhythmic therapy. Different groups specialized in treating paroxysmal atrial fibrillation have published their experience and many predictors of recurrence have been identified. However, so far, a similar experience has not been reported in our environment. Objectives: The primary endpoint was to analyze the predictors of recurrence after pulmonary vein isolation with radiofrequency catheter ablation. The secondary endpoint was to evaluate the success rate and procedure-related complications. Methods: A retrospective, observational and single-center study was conducted between May 2009 and August 2015 on 1,000 consecutive cases of radiofrequency catheter ablation procedures for paroxysmal atrial fibrillation guided by electroanatomical mapping. A total of 507 pulmonary vein isolation procedures with at least 1-year follow-up were analyzed, excluding repeat ablation procedures and patients who did not complete all follow-up visits. Results: A multivariate analysis using the Cox regression model showed that the higher rate of episodes of atrial fibrillation before ablation [HR 1.354 (1.059-1.732); p = 0.016] and early recurrence (0-3 months) [HR 4.006 (2.703-5.937); p
Objective: To evaluate the initial safety and effectiveness of fluoroscopy-free atrial fibrillation ablation in a high-complexity center in Argentina. Method: Prospective, observational, single-center study at the Cardiovascular Institute of Buenos Aires, where 100 atrial fibrillation ablation procedures were performed without fluoroscopy between March and November 2024. Electroanatomical mapping (CARTO 3), intracardiac echocardiography, and specialized catheters were used to guide the procedures. Results: Complete pulmonary vein isolation was achieved in 100% of cases. The mean patient age was 63.5 years, with a male predominance (71%). Complications occurred in 3% of cases (two pericardial effusions and one post-procedural stroke). No esophageal or vascular complications were reported. Conclusions: Atrial fibrillation ablation without fluoroscopy in a high-complexity center is feasible, safe, and effective, reducing radiation exposure without compromising clinical outcomes.
Introduction:Cryoballoon ablation (CBA) is a well-established treatment for atrial fibrillation (AF). However, evidence on the impact of sex on outcome is sparse. This real-world analysis aims to describe outcome after CBA in both sexes. Methods:This registry is an ongoing, global evaluation of CBA procedures in standard-of-care practice. Females undergoing CBA were compared to males at baseline and 12-, and 24-months post-ablation. Serious procedure-related adverse event rate, rate of atrial arrhythmia (AA) recurrence, repeat ablation, hospitalization, cardioversion, and quality-of-life (QoL; EQ-5D-3l) were compared. Results:Of 3,089 patients with 12-month follow-up, 1,136 (36.8%) were female; and a subset of 1,099 patients (400 female) were followed through 24 months. Females presented with different comorbidities at baseline. The complication rate was low overall in females (3.9%) and males (2.7%, p = 0.07). At 24-month follow-up, the rate of AA recurrence was 25.0% in females and 22.1% in males and female sex was a predictor of AA recurrence (HR adj = 1.21, p = 0.047) and rehospitalizations (HR adj = 1.25, p = 0.03) in a propensity score adjusted analysis. In addition, females stayed in the hospital longer compared to males during the index ablation procedure (47.9% with 2 or more days in hospital vs. 39.3% in males, p < 0.01), as well as during the first hospital stay post-ablation (78.2% with 2 or more days in hospital vs. 60.2% in males, p < 0.01). QoL improved from baseline to 12 months in females (0.85 ± 0.15-0.90 ± 0.13) and males (0.91 ± 0.13-0.94 ± 0.11) and remained high at 24 months. Discussion:CBA performed according to standard-of-care practice was safe in both sexes. The efficacy of CBA is marginally lower in females, but 75% of females remained free from AA recurrence at 24-months and reported a meaningful improvement in QoL post ablation. Systematic Review Registration:https://clinicaltrials.gov/ct2/show/NCT02752737, The Cryo Global Registry (NCT02752737).
Introducción: Las arritmias ventriculares pueden originarse en los músculos papilares del ventrículo izquierdo. Objetivos: Describir sus características clínicas más relevantes y comparar resultados de la ablación por catéter utilizando crioenergía o radiofrecuencia. Métodos: En el estudio, se incluyó a cuarenta y siete pacientes (47 ± 16 años; 70% sexo masculino; fracción de eyección 55 ± 11%) con arritmias originadas en los músculos papilares del ventrículo izquierdo, tratados mediante ablación por catéter. Las arritmias clínicas fueron localizadas utilizando sistemas de mapeo 3D, tomografía cardíaca multicorte y ecografía intracardíaca. La ablación fue efectuada utilizando un catéter de crioenergía focal de 8 mm o un catéter de ablación con irrigación abierta de 4 mm. Resultados: Las arritmias exhibieron una morfología de bloqueo de rama derecha (100%), con una duración media del QRS de 150 ± 13 ms y patrón R > r’ en el ventrículo izquierdo en el 71,4% de los casos. La tasa de éxito agudo fue de 100% para crioenergía (n = 18) y 83% para radiofrecuencia (n = 20) (p = 0,06). La recurrencia a 12 meses fue 4% para crioenergía y 46% para radiofrecuencia (p = 0,02). Las variables asociadas con mayor riesgo de recurrencia fueron el uso de RF (HR 0,2;p = 0,04) y la falta de ecografía intracardíaca (HR 0,1; p = 0,01). Conclusiones: La morfología de bloqueo de rama derecha con patrón R > r’ y duración del QRS > 135 mseg representan las características más frecuentes. El uso de ecografía intracardíaca y crioenergía se asoció a una menor tasa de recurrencia. El uso de radiofrecuencia presentó un incremento del riesgo de recurrencia del 20%.
Background: The evaluation of novel energy sources for the treatment of paroxysmal atrial fibrillation (PAF) is of great clinicalinterest. Cryoballoon ablation appears as an attractive alternative for patients with PAF refractory to pharmacological therapy.Objectives: The purpose of this study was to describe the initial cryoballoon ablation experience performed at our institutionfrom November 2013 to May 2015 in patients with PAF, evaluating the safety, efficacy and characteristics of the procedure.Methods: This was a retrospective, observational study analyzing the first 100 consecutive cases performed with 28-mm ArticFront™ cryoballoon (Medtronic, Inc.) from November 2013 to May 2015.Immediate success was defined as isolation of all pulmonary veins.Atrial fibrillation recurrence was assessed in 72 patients with more than 6 months follow-up.Results: The procedure lasted 78.03±19.84 min with fluoroscopy duration of 20.79±11.91 min and a total radiation dose of202.93±81 mGy. The rate of acute success was 100%. The complication rate was 1% due to transient diaphragmatic paralysis.The AF-free rate was 81.95% in patients with over 6-months follow-up.Conclusions: Our initial experience with cryoballoon ablation was safe and effective with a high rate of acute success and lowrate of complications. The procedure was short and the AF-free rate was more than acceptable.
BACKGROUND:Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized.METHODS:Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up.RESULTS:A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection.CONCLUSIONS:Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world.CLINICAL TRIAL REGISTRATION:https://clinicaltrials.gov/ct2/show/NCT02752737.
Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA. AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients’ reporting of symptoms. Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47–0.88); p < 0.01) regardless of the centers’ CBA experience; when controlling for baseline characteristics, the difference was not significant (HRadj 0.87 (95% CI 0.56–1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29). In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up. https://clinicaltrials.gov/ct2/show/NCT02752737
Historically, catheter ablation, including cryoballoon ablation (CBA), has been evaluated in a smaller proportion of female study patients with atrial fibrillation (AF) compared to male participants. The resulting consequences of this differential representation are largely unexplored.
Background: Cryoablation is superior to antiarrhythmic drugs (AAD) for the prevention of arrhythmia recurrence in drug naïve (first-line) patients with paroxysmal atrial fibrillation (AF). The adoption and outcomes of first-line cryoablation in a real-world setting are unknown. Purpose: To describe global usage, safety, efficacy, and healthcare utilization outcomes in patients treated with cryoablation for first-line management of AF. Methods: Cryo Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. AF patients with an index cryoballoon ablation performed according to local standards of care at 58 centers in 26 global countries were included. Subjects undergoing first-line cryoablation were compared to patients with prior failed AAD usage and/or taking AADs at baseline. Serious procedure-related complication rates, 12-month freedom from a ≥30sec AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence after a 90-day blanking period, and healthcare utilization were compared. Results: Of 1,394 total patients, 433 (31.1%) were treated with first-line cryoablation. The proportion of first-line enrollments varied widely by world region and country. AAD-refractory patients failed a mean of 1.2 ± 0.5 AADs prior to cryoablation. Freedom from AF/AFL/AT after cryoablation in first-line and AAD-refractory was 90.0% (95% CI: 86.4-92.7%) vs 84.4% (95% CI: 81.5-86.8%) in paroxysmal AF and 72.9% (95% CI: 58.6-83.0%) vs 70.2% (95% CI: 62.9-76.4%) in persistent AF (overall p=0.02), respectively. Serious adverse event rates were not statistically different between first-line and AAD-refractory patients (2.3% vs 3.4%; p=0.32), with highest rates being groin-site complications (0.7% vs 0.5%), respectively. Freedom from repeat ablations in first-line vs AAD-refractory was 95.5% (95% CI: 92.7 - 97.2%) vs 93.1% (95% CI: 91.0 - 94.7%) in paroxysmal AF and 84.7% (95% CI: 71.8 - 92.1%) vs 88.2% (95% CI: 82.5 - 92.2%) in persistent AF (overall p=0.35), respectively. Conclusion: The current data support cryoablation as an early intervention strategy for treatment of patients with AF.
Resumen Objetivo: La ablación por catéteres es una técnica habitual para tratar la fibrilación auricular (FA). Son escasos los datos prospectivos y multicéntricos con resultados a mediano plazo de la crioablación de venas pulmonares en América Latina. El objetivo es evaluar la seguridad y la eficacia de la ablación por criobalón de segunda generación en pacientes con FA paroxística o persistente en América Latina. Método: Se evaluaron las características del procedimiento y los resultados en agudo y a 12 meses Se incluyeron pacientes con FA mayores de 18 años a quienes se realizara desconexión de venas pulmonares con criobalón de segunda generación. Se definió como fallo al tratamiento cualquier episodio de FA, aleteo auricular o taquicardia auricular de más de 30 segundos fuera del periodo de cegamiento de 90 días. Resultados: Se incluyeron 218 pacientes (57 ± 11 años, 66.5% hombres, CHA2DS2-VASc 1.2 ± 1.1). Presentaron FA paroxística el 83.9%, FA persistente el 12.8% y FA persistente de larga duración el 2.3%. Quince pacientes presentaban antecedentes de aleteo auricular. Habían fracasado a una droga antiarrítmica el 89.4%. El éxito en agudo se obtuvo en 211 pacientes (96.8%). El tiempo promedio del procedimiento fue de 73.2 ± 26.7 minutos, el tiempo de fluoroscopia fue de 21.4 ± 23.9 minutos y el tiempo total de ocupación del laboratorio fue de 114.6 ± 41.3 minutos. Durante los 12 meses de seguimiento, el tiempo libre de recurrencia de FA fue del 88.6% en FA paroxística y del 73.1% en FA persistente. Veintiún pacientes (9.6%) presentaron eventos adversos relacionados con el procedimiento. Conclusiones: Estos resultados indican que la desconexión de venas pulmonares con criobalón es un tratamiento seguro y efectivo para la FA en América Latina.
Cyoablation is a ablation technique underutilized except in parahissian pathways and atrial fibrillation ablation. Ablation inside venous coronary sinus remains a dreaded incursion, and cryoablation is rarely used. We present the case of a 43 YO female who had a recurrent wolff parkinson white syndrome due to an epicardial pathway inside the coronary sinus successfully treated with a large bore(8mm) cryocatheter. We also review literature and describe the advantages and similar reports of use of cryo in low flow recesses inside the heart.
Maze surgery was developed for the treatment of atrial fibrillation. However safety and effectiveness has been questioned. Objectives: To analyze the perioperative morbidity and mortality of Maze surgery and its effectiveness and impact on survival in the follow-up. Materials and methods: Were included consecutively between January 2004 and December 2013 all patients undergoing cardiac surgery (n = 4918) of which 383 (7.7%) had atrial fibrillation in context of valvular pathology constituting the study population. A comparative analysis of patients undergoing surgery Maze for treatment of atrial fibrillation (Maze group; n = 120, 31%) was conducted or absence Maze procedure (Group not Maze, n = 263, 69%) in the all patients (n = 383) and adjusted risk propensity score groups. Results: Maze group patients were younger (66.5 ± 10.5 vs. 69.5 ± 11.5 years, p ≤0.022) less hypertension (70% vs. 58.3%, p ≤0.026), had a higher rate of anticoagulation (34.2% vs 23.2%, p ≤0.024), had a lower Euroscore high risk (35% vs 58.2%, p ≤0.0001) and were more elective surgeries (80.8% vs 65%, p ≤0.002). The Maze procedure was performed in the left atrium (Left Maze, n = 35 patients, 29%) or both atria (Biatrial Maze, n = 85 patients, 71%). Hospital mortality (4.5% vs 6.1 Maze Surgery no surgery Maze%, p = 0.698), and perioperative complications were similar in both matched groups by risk score. Freedom of atrial fibrillation at follow-up was 72.7% at 2 years and 62.6% at 4 years. Overall survival was higher for the group of patients who underwent Maze surgery (77.9±4.6% vs 56.9±5.1%, log rank p = 0.046). After adjusting for risk score this difference in mortality follow-up did not reach statistical significance (86.5±4.5% Maze surgery vs 67.6±9.2% no Maze surgery, p = 0.351 log rank).Conclusions: Maze surgery for the treatment of atrial fibrillation is a safe procedure that does not increase perioperative morbidity and mortality, provides a high rate of return of sinus rhythm and pro�vides an advantage in the long-term survival.
The risk of hospitalization and symptoms that reduce quality of life are exacerbated in patients with heart failure (HF) concomitant to atrial fibrillation (AF). Guidelines indicate that catheter ablation for the treatment of AF is reasonable in select patients with AF and HF.
Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Methods Patients aged 18 to 75 with symptomatic paroxysmal AF naive to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. Results Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P < 0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P < 0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months ( P < 0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P < 0.001). Conclusions In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. Trial registration ClinicalTrials.gov number: NCT01803438.
Abstract Background Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF). Objectives Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry. Methods The Cryo AF Global Registry is a prospective, multi‐center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device‐ or procedure‐related adverse events over 12 month follow‐up. Results During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow‐up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device‐ and procedure‐related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%‐88.3%) in patients with PAF and 70.9% (95% CI: 64.6%‐76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first‐line PAF and PsAF was 90.0% (95% CI: 86.4%‐92.7%) and 72.9% (95% CI: 58.6%‐83.0%) at 12 months, respectively. Conclusions The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum.
Implantable cardiac defibrillators (ICDs) are particularly beneficial for selected groups of patients with a history of severe ventricular arrhythmias or at a high risk of sudden cardiac death. Despite their potential lifesaving properties, ICDs are associated with a number of complications. The most frequent include pneumothorax, myocardial perforation, lead malposition or displacement. We report the case of a 78-year-old man patient who was admitted to our institution with an asymptomatic subacute right ventricular ICD lead perforation detected by remote monitoring.
Objective: Catheter ablation has become a usual technique to treat atrial fibrillation (AF). Medium-term results of prospective and multicenter data concerning pulmonary veins cryoablation in Latin America are limited. The objective is to assess the safety and efficacy of ablation by second generation cryoballoon in patients with paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF) in Latin America. Method: We evaluate the characteristics of the procedure and the acute and 12-month results. Inclusion criteria include patients over 18 years old with AF who have a planned procedure of pulmonary veins isolation with second generation cryoballoon. Treatment failure was defined as any episode of AF, atrial flutter or atrial tachycardia greater than 30 seconds outside the 90-day blinded period. Results: A total of 218 patients (57 +/- 11 years, 66.5% men, CHA2DS2-VASc 1.2 +/- 1.1) were included in the study. Of these, 83.9% evidenced PAF, 12.8% PerAF, and 2.3% long-standing PerAF. Fifteen with history of atrial flutter. Most patients had failed at least one antiarrhythmic drug (89.4%). The acute success of the procedure was obtained in 211 patients (96.8%). The average procedure time was 73.2 +/- 26.7 min, the fluoroscopy time was 21.4 +/- 23.9 min, and the total lab occupancy time was 114.6 +/- 41.3 min. During the 12-month follow-up, freedom from AF recurrence was 88.6% in PAF, and 73.1% in PerAF. Twenty-one patients experienced device or procedure-related complications (9.6%). Conclusions: These results support pulmonary veins electrical isolation with cryoballoon as an effective treatment for AF in Latin America.