ABSTRACT
Importance: The Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE AF) trial found that approximately 1 in 8 patients with recent ischemic stroke attributed to large- or small-vessel disease had poststroke atrial fibrillation (AF) detected by an insertable cardiac monitor (ICM) at 12 months. Identifying predictors of AF could be useful when considering an ICM in routine poststroke clinical care. Objective: To determine the association between commonly assessed risk factors and poststroke detection of new AF in the STROKE AF cohort monitored by ICM. Design, Setting, and Participants: This was a prespecified analysis of a randomized (1:1) clinical trial that enrolled patients between April 1, 2016, and July 12, 2019, with primary follow-up through 2020 and mean (SD) duration of 11.0 (3.0) months. Eligible patients were selected from 33 clinical research sites in the US. Patients had an index stroke attributed to large- or small-vessel disease and were 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor. A total of 496 patients were enrolled, and 492 were randomly assigned to study groups (3 did not meet inclusion criteria, and 1 withdrew consent). Patients in the ICM group had the index stroke within 10 days before insertion. Data were analyzed from October 8, 2021, to January 28, 2022. Interventions: ICM monitoring vs site-specific usual care (short-duration external cardiac monitoring). Main Outcomes and Measures: The ICM device automatically detects AF episodes 2 or more minutes in length; episodes were adjudicated by an expert committee. Cox regression multivariable modeling included all parameters identified in the univariate analysis having P values <.10. AF detection rates were calculated using Kaplan-Meier survival estimates. Results: The analysis included the 242 participants randomly assigned to the ICM group in the STROKE AF study. Among 242 patients monitored with ICM, 27 developed AF (mean [SD] age, 66.6 [9.3] years; 144 men [60.0%]; 96 [40.0%] women). Two patients had missing baseline data and exited the study early. Univariate predictors of AF detection included age (per 1-year increments: hazard ratio [HR], 1.05; 95% CI, 1.01-1.09; P = .02), CHA2DS2-VASc score (per point: HR, 1.54; 95% CI, 1.15-2.06; P = .004), chronic obstructive pulmonary disease (HR, 2.49; 95% CI, 0.86-7.20; P = .09), congestive heart failure (CHF; with preserved or reduced ejection fraction: HR, 6.64; 95% CI, 2.29-19.24; P < .001), left atrial enlargement (LAE; HR, 3.63; 95% CI, 1.55-8.47; P = .003), QRS duration (HR, 1.02; 95% CI, 1.00-1.04; P = .04), and kidney dysfunction (HR, 3.58; 95% CI, 1.35-9.46; P = .01). In multivariable modeling (n = 197), only CHF (HR, 5.06; 95% CI, 1.45-17.64; P = .05) and LAE (HR, 3.32; 1.34-8.19; P = .009) remained significant predictors of AF. At 12 months, patients with CHF and/or LAE (40 of 142 patients) had an AF detection rate of 23.4% vs 5.0% for patients with neither (HR, 5.1; 95% CI, 2.0-12.8; P < .001). Conclusions and Relevance: Among patients with ischemic stroke attributed to large- or small-vessel disease, CHF and LAE were associated with a significantly increased risk of poststroke AF detection. These patients may benefit most from the use of ICMs as part of a secondary stroke prevention strategy. However, the study was not powered for clinical predictors of AF, and therefore, other clinical characteristics may not have reached statistical significance. Trial Registration: ClinicalTrials.gov Identifier: NCT02700945.
Subject(s)
Atrial Fibrillation , Cardiomyopathies , Heart Failure , Ischemic Stroke , Stroke , Male , Humans , Female , Aged , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Stroke/complications , Risk Factors , Ischemic Stroke/complicationsABSTRACT
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.
Abstract 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.
ABSTRACT
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.
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.
