Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

Initial experience and treatment of atrial fibrillation using a novel irrigated multielectrode catheter: Results from a prospective two-center study.

BACKGROUND: PV electrical isolation has become the cornerstone of catheter ablation for the treatment of atrial fibrillation (AF). Several strategies have been proposed to achieve this goal. The aim of this study was to assess the efficacy and safety of AF ablation using a new circular irrigated multielectrode ablation catheter designed to achieve single-delivery pulmonary vein (PV) isolation. METHODS: Thirty-five patients with drug refractory paroxysmal AF and normal ejection fraction from two centers were prospectively enrolled in this study. All patients underwent PV isolation with an nMARQ circular irrigated multielectrode ablation catheter guided by an electroanatomic mapping system. Magnetic resonance imaging was performed to exclude PV stenosis. RESULTS: PV isolation was achieved in 138 of 140 (98.57%) targeted veins. The mean procedure time was 79.5 min (SD 39.3 min). During a mean follow up of 16.8±2.8 months, 27 of 35 (77.2%) patients were free of AF. No PV narrowing was observed. One case of pericardial effusion due to perforation of the left atrial free wall during catheter manipulation did occur. CONCLUSIONS: PV isolation with a circular irrigated multielectrode ablation catheter is a feasible technique with a high acute success rate. The majority of patients remained asymptomatic during the midterm follow-up period. PV stenosis was not detected. While only a single serious adverse event occurred, this technique׳s safety profile should be tested in larger studies.

Prevención primaria con cardiodesfibrilador implantable y terapia de resincronización cardíaca en pacientes ancianos: resultados de un estudio multicéntrico español

Propósito: a la fecha sigue sin haber pruebas en cuanto a los resultados del uso de dispositivos para arritmias ventriculares en pacientes añosos, y menos aun para indicaciones de prevención primaria. La finalidad del estudio fue describir la evolución en términos de la eficacia y seguridad de la terapia con cardiodesfibriladores implantables (CDI) en una gran cohorte de pacientes añosos. Métodos y resultados: estudio multicéntrico retrospectivo realizado en 15 hospitales españoles. Se incluyeron pacientes consecutivos referidos para implante de CDI antes de 2011. Se consideró que 162 de los 1.174 pacientes (13,8%) con 75 años o más eran “añosos”. Comparado con aquellos pacientes <75 años, este subgrupo presentaba más comorbilidades como hipertensión, enfermedad pulmonar obstructiva crónica y falla renal, y más internaciones previas debido a insuficiencia cardíaca (IC). A lo largo de una media de seguimiento de 104,4 ± 3,3 meses, fallecieron 162 pacientes (14%), 120 de los más jóvenes (12,4%) y 42 (24,4%) de los añosos. El análisis de Kaplan-Meier mostró un aumento de la probabilidad de morir con el aumento de la edad (17, 24, 28, y 69% a los 12, 24, 48, y 60 meses de seguimiento en el grupo de pacientes añosos). No hubo diferencias entre la tasa de intervenciones con CDI apropiadas o inapropiadas. Conclusión: en el mundo real, los pacientes añosos constituyen ~15% de los implantes de CDI para prevención primaria de la muerte súbita cardíaca (MSC). Si bien la tasa de terapias apropiadas es similar en los diferentes grupos, el beneficio de CDI se ve atenuado por un mayor aumento del riesgo de mortalidad entre los pacientes que son mayores de 75 años al momento del implante.

Stroke and Systemic Embolism After Successful Ablation of Typical Atrial Flutter.

BACKGROUND: Following successful cavotricuspid isthmus (CTI) ablation during typical atrial flutter (AFL), anticoagulation therapy is usually withdrawn. However, potential subsequent atrial fibrillation (AF) in these patients may increase embolic risk in the long term. Embolic rates in this setting have not been clearly established. Our aim was to determine the incidence of stroke/systemic embolism following radiofrequency ablation of AFL, particularly in those without a prior history of AF. HYPOTHESIS: After succesful AFL ablation, patients may suffer embolic complications in the long-term follow-up, mainly due to asymptomatic AF episodes. METHODS: We conducted a retrospective analysis of all patients who underwent CTI ablation due to AFL in our center between 2006 and 2009. RESULTS: During the study period, 188 patients (mean age, 62.9 ± 8.6 years) underwent CTI ablation; 120 without prior AF were included in the study. At the end of the follow-up period (mean, 5.0 ± 2.4 years), 56.7% of patients (68/120) remained in sinus rhythm, 7/120 experienced a recurrence of AFL, and 45/120 (38%) developed AF. Ischemic stroke occurred in 11 patients and systemic embolism in 1. Of these patients, 5 had documented AF following AFL ablation. In the remaining 7 cases, previously undiagnosed AF was subsequently diagnosed at the time of stroke/embolism. CONCLUSIONS: Patients with AFL who undergo successful ablation are by no means free from embolic complications during long-term follow-up, mainly due to a high rate of AF development. Given the difficulties in detecting AF and the uncertainty about the temporal relation of AF and stroke, oral anticoagulation may need to be continued in those patients with underlying stroke risk factors.

Primary prevention implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator in elderly patients: results of a Spanish multicentre study.

AIMS: Currently, there continues to be a lack of evidence regarding outcomes associated with device-based therapy for ventricular arrhythmias in elderly patients, even more in primary-prevention indications. We aimed to describe the follow-up in terms of efficacy and safety of implantable cardioverter-defibrillator (ICD) therapy in a large cohort of elderly patients. METHODS AND RESULTS: Retrospective multicentre study performed in 15 Spanish hospitals. Consecutive patients referred for ICD implantation before 2011 were included. One hundred and sixty-two of 1174 patients (13.8%) ≥75 years were considered as 'elderly'. When compared with those patients <75, this subgroup presented more co-morbid conditions, including hypertension, chronic obstructive pulmonary disease , and renal failure, and more previous hospitalizations due to heart failure (HF). During a mean follow-up of 104.4 ± 3.3 months, 162 patients (14%) died, 120 in the younger age (12.4%), and 42 (24.4%) in the elderly. Kaplan-Meier analysis showed an increased probability of death with increasing age (17, 24, 28, and 69% at 12, 24, 48, and 60 months of follow-up in the elderly group). There was neither difference regarding the rate of appropriate nor inappropriate ICD intervention. CONCLUSION: In a real-world scenario, elderly patients comprise ∼15% of ICD implantations for primary prevention of sudden cardiac death (SCD). Although the rate of appropriate therapy is similar between groups, the benefit of ICD is attenuated for a major increase in mortality risk among those patients ≥75 years at the moment of device implantation.

Cryoablation versus radiofrequency ablation for the treatment of atrioventricular nodal reentrant tachycardia: results of a prospective randomized study.

PURPOSE: Radiofrequency ablation (RF) of atrioventricular reentrant tachycardia (AVNRT) is an effective method for treating this arrhythmia. However, inadverted AV block requiring implantation of permanent pacemaker is a worrisome side effect. Although permanent AV block seems to be rare nowadays, patients are by no means spared from this severe complication. Catheter cryoablation is emerging as an alternative technology with an excellent safety profile, but limited data exist regarding its efficacy. METHODS: We conducted a randomized study among patients with AVNRT remitted to our center for EP study and ablation between January 2008 and June 2010. After giving a written consent, patients were randomized to conventional RF or cryoablation, unless specific preference of patient was stated. Primary outcomes were acute success, SVT recurrence, and complications, including AV block. RESULTS: One hundred nineteen patients were included (60 cryoablation and 59 conventional RF). There were no differences in demographic and clinical baseline data between groups. Acute procedural success was achieved in 59 patients (98 %) in cryoablation group and 59 (100 %) in RF. One patient in RF group underwent complete AV block and pacemaker implantation. Over a mean follow-up period of 256.6 days, there was a significant difference in AVNRT recurrence between cryoablation and RF patients (15 versus 3.4 %, p = 0.03). CONCLUSION: Catheter cryoablation of AVNRT is a clinically effective alternative to RF ablation, with excellent acute success rate. Despite a slightly higher rate of recurrence during long-term follow-up, these results suggest that cryoablation may be considered as first-line approach, especially in younger people, where the risk of permanent pacing because of inadvertent AV block may be relevant.

Dronedarone for recurrent ventricular tachycardia: a real alternative?

Sustained ventricular tachycardia (VT) is an important cause of morbidity and sudden death in patients with dilated cardiomyopathy. Although ICD effectively terminate VT episodes and improve survival, shocks reduce quality of life, and episodes of VT predict increased risk of heart failure and death despite effective therapy. Patients suffering recurrent VT episodes remain a challenge. Antiarrhytmic therapy reduces VT episodes, but it is associated with serious adverse events, and disappointing efficacy. Catheter ablation has emerged as an important option to control recurrent VT, but major procedure-related complications, and even death, are still issues to concern. And even with these armamentaria, some patients still have recurrent VT episodes and ICD shocks. We report on a patient with non-ischemic dilated cardiomyopathy and recurrent ventricular tachycardia resistant to multiple antiarrhytmic agents, in whom dronedarone was effective in completely suppressing ventricular tachycardia episodes.

Implantación de desfibrilador tricameral en un paciente con intervención de Mustard: «Todo un reto» / No disponible

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[Management of syncope in the emergency department without hospital admission: usefulness of an arrhythmia unit coordinated protocol]. / Manejo del síncope en el servicio de urgencias sin ingreso hospitalario: utilidad de un protocolo coordinado con la unidad de arritmias.

INTRODUCTION AND OBJECTIVES: The main aim of this study was to demonstrate that a protocol for managing syncope in the emergency department that is based on the early detection of heart disease enables patients to be diagnosed quickly and with few admissions, without there being a negative impact on prognosis. METHODS: The study was performed prospectively in 199 consecutive patients (54% male; mean age, 67 [17] years) who presented with syncope at the emergency department of our hospital during a 17-month period. A two-step diagnostic algorithm was developed in which patients initially underwent clinical and electro-cardiographic assessment, and thereafter were submitted to a diagnostic protocol that involved carrying out a sequence of diagnostic tests in the emergency room to avoid hospital admission. RESULTS: A presumptive diagnosis was established in 120 (60%) patients during the initial assessment. After completion of the diagnostic protocol, 78% of patients were given a clear diagnosis within a mean stay of 19 [15] h in the emergency department. Some 10% of patients were admitted. Three patients died during a mean follow-up period of 237 days. CONCLUSIONS: Implementation of a protocol for managing syncope in the emergency department that was based on screening patients according to the presence of heart disease enabled a large percentage to receive a diagnosis. Moreover, the majority of patients could be discharged rapidly from the emergency department without there being any negative impact on medium-term prognosis.

Manejo del síncope en el servicio de urgencias sin ingreso hospitalario: utilidad de un protocolo coordinado con la unidad de arritmias / Management of syncope in the emergency department without hospital admission: usefulness of an arrhythmia unit coordinated protocol

Introducción y objetivos. El principal objetivo de este estudio es demostrar que un protocolo para el manejo del síncope en el servicio de urgencias basado en la detección precoz de cardiopatía permite diagnosticar a los pacientes de forma rápida y con una baja proporción de ingresos, sin que ello repercuta de forma negativa en su pronóstico. Métodos. El estudio se realizó de forma prospectiva en 199 pacientes consecutivos (54% varones; media de edad, 67 ± 17 años) que acudieron por síncope al servicio de urgencias de nuestro hospital en un período de 17 meses. Se desarrolló un algoritmo diagnóstico en dos pasos en el que los pacientes eran sometidos a una primera evaluación clínica y electrocardiográfica y posteriormente a un protocolo diagnóstico basado en la realización secuencial de pruebas diagnósticas en el servicio de urgencias, con lo que se evitó su ingreso hospitalario. Resultados. Tras la valoración inicial, se diagnosticó a 120 (60%) pacientes. Después de completado el protocolo, se obtuvo clasificación diagnóstica del 78% de los pacientes, con una estancia media en el servicio de urgencias de 19 ± 15 h; se ingresó al 10% de los pacientes. Con un seguimiento medio de 237 días, fallecieron 3 pacientes. Conclusiones. El manejo protocolizado del síncope en el servicio de urgencias basado en una estratificación de los pacientes según tengan o no cardiopatías permite el diagnóstico de una elevado porcentaje de pacientes y dar de alta a la mayoría de forma rápida desde el mismo servicio de urgencias, sin que ello repercuta de forma negativa en su pronóstico a medio plazo (AU)

Introduction and objectives. The main aim of this study was to demonstrate that a protocol for managing syncope in the emergency department that is based on the early detection of heart disease enables patients to be diagnosed quickly and with few admissions, without there being a negative impact on prognosis. Methods. The study was performed prospectively in 199 consecutive patients (54% male; mean age, 67 [17] years) who presented with syncope at the emergency department of our hospital during a 17-month period. A two-step diagnostic algorithm was developed in which patients initially underwent clinical and electro-cardiographic assessment, and thereafter were submitted to a diagnostic protocol that involved carrying out a sequence of diagnostic tests in the emergency room to avoid hospital admission. Results. A presumptive diagnosis was established in 120 (60%) patients during the initial assessment. After completion of the diagnostic protocol, 78% of patients were given a clear diagnosis within a mean stay of 19 [15] h in the emergency department. Some 10% of patients were admitted. Three patients died during a mean follow-up period of 237 days. Conclusions. Implementation of a protocol for managing syncope in the emergency department that was based on screening patients according to the presence of heart disease enabled a large percentage to receive a diagnosis. Moreover, the majority of patients could be discharged rapidly from the emergency department without there being any negative impact on medium-term prognosis (AU)

Seguimiento a largo plazo de pacientes con miocardiopatía hipertrófica portadores de desfibrilador automático implantable / Seguimiento a largo plazo de pacientes con miocardiopatía hipertrófica portadores de desfibrilador automático implantable

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Evaluación con ultrasonografía intravascular de stents implantados sin predilatación (stents directos). Comparación de resultados según el tipo de lesión / Intravascular ultrasonographic evaluation of direct stents, implanted without predilatation. Comparison of results according to lesion types

Introducción y objetivos. El stent directo ha demostrado ser factible y seguro en lesiones seleccionadas, obteniéndose resultados angiográficos excelentes. No obstante, hasta el momento no han sido evaluados los resultados del stent directo mediante ultrasonografía intravascular. En este estudio pretendemos evaluar con ultrasonografía la expansión de los stents directos y conocer si existen diferencias en el resultado en función del tipo de lesión. Métodos. Se incluyeron pacientes con lesiones susceptibles de tratamiento con stent directo: lesiones no oclusivas, no calcificadas, sin excesiva tortuosidad o angulación, longitud 15 mm y diámetro de referencia 2,5 mm. Se realizó ultrasonografía intravascular tras la implantación. Los criterios de expansión óptima fueron la aposición completa y un área luminal mínima intrastent > 80 por ciento del área luminal de referencia y 90 por ciento del área de referencia distal. Resultados. Fueron incluidos un total de 40 pacientes (50 lesiones). El resultado angiográfico final fue óptimo en todos los casos, aunque en uno fue precisa la colocación de nuevo stent por disección proximal al stent. El examen ultrasonográfico no puso de manifiesto diferencias significativas en cuanto a resultados entre las lesiones tipo A y B de la ACC/AHA. Se logró expansión óptima en 14/21 (66 por ciento) de las de tipo A, frente a 17/29 (58 por ciento) de las de tipo B (p = 0,5). El único factor que pareció influir en el resultado ecográfico fue la relación balón/arteria, que cuando fue 1,1-1,2 (25 casos) se asoció a un 76 por ciento de buenos resultados ecográficos, mientras que una relación < 1,1 (25 casos) sólo permitió expansión óptima en un 48 por ciento (p < 0,05).Conclusiones. El estudio con ultrasonografía intravascular de los stents directos demuestra que, en lesiones seleccionadas, los resultados son similares a los comunicados en los stents implantados con predilatación, y podrían mejorarse con una relación balón/arteria 1,1-1,2. Tomando en consideración los criterios de selección, no existen diferencias significativas en los resultados según el tipo de lesión sea A o B (AU)