Experiencia latinoamericana en crioablación de fibrilación auricular paroxística y persistente con criobalón de segunda generación. Resultados en agudo y a 12 meses / Latin-American experience in cryoablation of paroxysmal and persistent atrial fibrillation using second generation cryo-balloon. Acute success and 12 months of follow-up

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.

Latin-American experience in cryoablation of paroxysmal and persistent atrial fibrillation using second generation cryo-balloon. Acute success and 12 months of follow-up / Experiencia latinoamericana en crioablación de fibrilación auricular paroxística y persistente con criobalón de segunda generación. Resultados en agudo y a 12 meses

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.

Evaluation of stroke incidence with duty-cycled multielectrode-phased radiofrequency ablation of persistent atrial fibrillation results of the VICTORY AF Study.

INTRODUCTION: The VICTORY AF Study was designed to evaluate the risk of the procedure and/or device-related strokes in patients with PersAF on warfarin undergoing ablation with a phased radiofrequency (RF) system. METHODS: The VICTORY AF trial was a prospective, multicenter, single-arm, investigational study. PersAF patients on vitamin K antagonism without major structural heart disease or history of stroke/transient ischemic attack undergoing phased RF ablation for atrial fibrillation (AF) were included. The primary outcome was the incidence of the procedure and/or device-related stroke within 30 days of the ablation by a board-certified neurologist's assessment. The secondary outcomes were an acute procedural success, 6 months effectiveness (defined as the reduction in AF/atrial flutter episodes lasting ≥10 minutes by 48-hour Holter 6 months postablation) and the number of patients with pulmonary vein (PV) stenosis. RESULTS: A total of 129 (108 PersAF, 21 long-standing PersAF) patients were treated (mean age: 60.6 ± 7.7; 79.8% male, 54.3% CHA2Ds2-VASc score ≥ 2). Two nondisabling strokes were reported (1.6%); one before discharge and the second diagnosed at the 30-day visit. Due to slow enrollment, the study was terminated before reaching the 95% one-sided upper confidence boundary for stroke incidence. Acute procedural success was 93.8%, and at 6 months, 72.8% of patients demonstrated ≥90% reduction in AF burden, 78.9% were off all antiarrhythmic drugs. There were no patients with PV stenosis of greater than 70%. CONCLUSIONS: VICTORY AF demonstrated a 1.6% incidence of stroke in PersAF undergoing ablation with a phased RF system which did not meet statistical confidence due to poor enrollment. The secondary outcomes suggest comparable efficacy to phased RF in the tailored treatment of permanent AF trial. Rigorous clinical evaluation of the stroke risk of new AF ablation technologies as well as restriction to Vitamin K antagonist anticoagulation appears to be unachievable goals in a clinical multicenter IDE trial of AF ablation in the current era.

Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry.

AIMS: The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). METHODS AND RESULTS: GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan-Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. CONCLUSION: Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.

Repeat Ablation for Atrial Fibrillation Recurrence Post Cryoballoon or Radiofrequency Ablation in the FIRE AND ICE Trial

Background: The FIRE AND ICE trial assessed efficacy and safety of pulmonary vein (PV) isolation using cryoballoon versus radiofrequency current (RFC) ablation in patients with drug refractory, symptomatic, paroxysmal atrial fibrillation (AF). The purpose of the current study was to assess index lesion durability as well as reablation strategy and outcomes in trial patients undergoing a reablation procedure. Methods: Patients with reablation procedures during FIRE AND ICEwere retrospectively consented and enrolled at 13 trial centers. The first reablation for each patient was included in the analysis. Documented arrhythmias before reablation, number and location of reconnected PVs, lesions created during reablations, procedural characteristics, and acute as well as long-term outcomes were assessed. Results: Eighty-nine (36 cryoballoon and 53 RFC) patients were included in this study. Paroxysmal atrial fibrillation was the predominant recurrent arrhythmia (69%) before reablation. Reablations occurred at a median of 173 and 182 days (P=0.54) in the cryoballoon and RFC cohorts, respectively. The number of reconnected PVs was significantly higher in the RFC than the cryoballoon group (2.1±1.4 versus 1.4±1.1; P=0.010), which was driven by significantly more reconnected left superior PVs and markedly more reconnected right superior PVs. The number of (predominantly RFC) lesions applied during reablation was significantly greater in patients originally treated with RFC (3.3±1.3 versus 2.5±1.5; P=0.015) with no difference in overall acute success (P=0.70). After reablation, no differences in procedure-related rehospitalization or antiarrhythmic drug utilization were observed between cohorts. Conclusions: At reablation, patients originally treated with the cryoballoon had significantly fewer reconnected PVs, which may reflect RFC catheter instability in certain left atrial regions, and thus required fewer lesions for reablation success. Repeat ablations were predominantly performed with RFC and resulted in similar acute success, duration of hospitalization, and antiarrhythmic drug prescription between the study cohorts.

Standing body sway in women with and without morning sickness in pregnancy.

Morning sickness typically is attributed to hormonal changes in pregnancy. We asked whether morning sickness is associated with changes in standing postural equilibrium, as occurs in research on visually induced motion sickness. Twenty-one pregnant women (mean age=30 years, mean height=163cm; mean weight=63kg) were tested during the first trimester. Laboratory-based balance measures were collected, along with perceived postural stability, the presence of morning sickness, and the severity of subjective symptoms. We varied the distance between the feet and the visual task performed during stance. Participants were classified as either experiencing (Sick, n=12) or not experiencing (Well, n=9) morning sickness. Perceived balance stability was lower for Sick than for Well women. The positional variability of sway was reduced for the Sick group, relative to the Well group. Positional variability decreased with wider stance width, and was reduced during performance of a more demanding visual task. Stance width and visual task also influenced the temporal dynamics of sway. Effects of stance width and visual task on postural sway were similar to effects in non-pregnant adults, suggesting that sensitive tuning of posture is maintained during the first trimester. The findings suggest that women with morning sickness may attempt to stabilize their bodies by reducing overall body sway. It may be useful to recommend that women adopt wider stance early in pregnancy.