Sex-Specific Ventricular Arrhythmias and Mortality in Cardiac Resynchronization Therapy Recipients.

OBJECTIVES: The study goal was to examine whether there are sex-related differences in the incidence of ventricular arrhythmias and mortality in CRT-defibrillator (CRT-D) recipients. BACKGROUND: Few studies have evaluated sex-related benefits of cardiac resynchronization therapy (CRT). Moreover, data on sex-related differences in the occurrence of ventricular tachyarrhythmias in this population are limited. METHODS: A multicenter retrospective study was conducted in 460 patients (355 male subjects and 105 female subjects) from the UMBRELLA (Incidence of Arrhythmia in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant) national registry. Patients were followed up through remote monitoring after the first implantation of a CRT-D during a median follow-up of 2.2 ± 1.0 years. Sex differences were analyzed in terms of ventricular arrhythmia-treated incidence and death during the follow-up period, with a particular focus on primary prevention patients. RESULTS: Baseline New York Heart Association functional class was worse in women compared with that in men (67.0% of women in New York Heart Association functional class III vs. 49.7% of men; p = 0.003), whereas women had less ischemic cardiac disease (20.8% vs. 41.7%; p < 0.001). Female sex was an independent predictor of ventricular arrhythmias (hazard ratio: 0.40; 95% confidence interval: 0.19 to 0.86; p = 0.020), as well as left ventricular ejection fraction and nonischemic cardiomyopathy. Mortality in women was one-half that of men, although events were scarce and without significant differences (2.9% vs. 5.6%; p = 0.25). CONCLUSIONS: Women with left bundle branch block and implanted CRT have a lower rate of ventricular tachyarrhythmias than men. All-cause mortality in patients is, at least, similar between female and male subjects.

Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator: UMBRELLA Study Final Results.

Background Large-scale studies describing modern populations using an implantable cardioverter-defibrillator (ICD) are lacking. We aimed to analyze the incidence of arrhythmia, device interventions, and mortality in a broad spectrum of real-world ICD patients with different heart disorders. Methods and Results The UMBRELLA study is a prospective, multicenter, nationwide study of contemporary patients using an ICD followed up by remote monitoring, with a blinded review of arrhythmic episodes. From November 2005 to November 2017, 4296 patients were followed up. After 46.6±27.3 months, 16 067 episodes of sustained ventricular arrhythmia occurred in 1344 patients (31.3%). Appropriate ICD therapy occurred in 27.3% of study population. Patients with ischemic cardiomyopathy (hazard ratio [HR], 1.51; 95% CI, 1.29-1.78), dilated cardiomyopathy (HR, 1.28; 95% CI, 1.07-1.53), and valvular heart disease (HR, 1.94; 95% CI, 1.43-2.62) exhibited a higher risk of appropriate ICD therapies, whereas patients with hypertrophic cardiomyopathy (HR, 0.72; 95% CI, 0.54-0.96) and Brugada syndrome (HR, 0.25; 95% CI, 0.14-0.45) showed a lower risk. All-cause death was 13.4% at follow-up. Ischemic cardiomyopathy (HR, 3.09; 95% CI, 2.58-5.90), dilated cardiomyopathy (HR, 3.33; 95% CI, 2.18-5.10), and valvular heart disease (HR, 3.97; 95% CI, 2.25-6.99) had the worst prognoses. Delayed high-rate detection was enabled in 39.7% of patients, and single-zone programming occurred in 52.6% of primary prevention patients. Both parameters correlated with lower risk of first appropriate ICD therapy, with no excess risk of mortality. The rate of inappropriate shocks at follow-up was low (6%) and did not differ among type of ICD but was lower in SmartShock-capable devices. Conclusions Irrespective of the cause, contemporary ICD patients with heart failure-related disorders had a similar risk of ICD life-saving interventions and death. Current ICD programming recommendations still need to be implemented. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NTC01561144.

Predictors of adoption and impact of evidence-based programming on the incidence of implantable cardioverter-defibrillator therapies.

INTRODUCTION AND OBJECTIVES: The ADVANCE III trial showed that a delayed-detection strategy reduces implantable cardioverter-defibrillator (ICD) therapies. Here, we describe the adherence to and predictors of ADVANCE adoption and compare ICD therapy rates between patients with and without ADVANCE programming. METHODS: This observational retrospective study analyzed patients implanted with Medtronic ICDs included from 2005 to 2016 in a Spanish national multicenter registry (UMBRELLA database; ClinicalTrials.gov, NCT01561144). Changes in ADVANCE programming adoption were described in relation to a) publication of the ADVANCE trial, b) implementation of an "ADVANCE awareness" campaign, and c) publication of an expert consensus statement. Multivariate logistic regression identified predictors of adoption. Therapy incidence rates were compared between groups by estimating the adjusted incidence rate ratio (aIRR) using negative binomial regression. RESULTS: A total of 3528 patients were included. An ADVANCE strategy was used in 20% overall and in 44% at the end of the study. ADVANCE III adoption increased after trial publication, with less growth after an "ADVANCE awareness" campaign and after expert consensus statement publication. Predictors of ADVANCE adoption were as follows: ICD device with a nominal number of intervals to detect 30/40 (aOR, 4.4; 95%CI, 3.5-5.4), implantation by an electrophysiologist (aOR, 1.7; 95%CI, 1.4-2.2), and secondary prevention (aOR, 3.2; 95%CI, 2.6-3.9). Dual-chamber ICDs (aOR, 0.6; 95%CI, 0.5-0.8) and cardiac resynchronization-defibrillators (aOR, 0.5; 95%CI, 0.4-0.7) were associated with lower adoption. ADVANCE programming was associated with reduced total therapy burden (aIRR, 0.77; 95%CI, 0.69-0.86) and fewer inappropriate shocks (aIRR, 0.66; 95%CI, 0.52-0.85). CONCLUSIONS: ADVANCE adoption remains modest and can be improved through evidence-driven selection of nominal ICD settings. ADVANCE programming is associated with reduced therapy rates in real-world ICD recipients.

Association of cardiac resynchronization therapy with the incidence of appropriate implantable cardiac defibrillator therapies in ischaemic and non-ischaemic cardiomyopathy.

AIMS: Cardiac resynchronization therapy (CRT) reduces the incidence of sudden cardiac death and the use of appropriate implantable cardioverter-defibrillator (ICD) therapies (AICDTs); however, this antiarrhythmic effect is only observed in certain groups of patients. To gain insight into the effects of CRT on ventricular arrhythmia (VA) burden, we compared the incidence of AICDT use in four groups of patients: patients with ischaemic cardiomyopathy vs. non-ischaemic dilated cardiomyopathy (NIDC) and patients implanted with an ICD vs. CRT-ICD. METHODS AND RESULTS: We analysed 689 consecutive patients (mean follow-up 37 ± 16 months) included in the Umbrella registry, a multicentre prospective registry including patients implanted with ICD or CRT-ICD devices with remote monitoring capabilities in 48 Spanish Hospitals. The primary outcome was the time to first AICDT. Despite a worse clinical risk profile, NIDC patients receiving a CRT-ICD had a lower cumulative probability of first AICDT use at 2 years compared with patients implanted with an ICD [24.7 vs. 41.6%, hazard ratio (HR): 0.49, P = 0.003]; on the other hand, there were no significant differences in the incidence of first AICDT use at 2 years in ischaemic patients (22.6 vs. 21.9%, P = NS). Multivariate analysis confirmed the association of CRT with lower AICDT rates amongst NIDC patients (Adjusted HR: 0.55, CI 95% 0.35-0.87). CONCLUSIONS: These data suggest that CRT is associated with significantly lower rates of first AICDT use in NIDC patients, but not in ischaemic patients. This study suggests that ICD patients with NIDC and left bundle branch block experiencing VAs may benefit from an upgrade to CRT-ICD despite being in a good functional class.

Perfil clínico e incidencia de arritmias ventriculares de los pacientes sometidos a recambio de generador de desfibrilador en España / Clinical profile and incidence of ventricular arrhythmia in patients undergoing defibrillator generator replacement in Spain

Introducción y objetivos. Se ha demostrado que los desfibriladores automáticos implantables reducen la mortalidad de ciertos pacientes con cardiopatía. El recambio de su batería es una situación frecuente en la práctica clínica, hasta un 30% de los implantes. El beneficio/riesgo del desfibrilador no es constante en el tiempo, y debe revaluarse en el momento del recambio. El objetivo del estudio es conocer las características clínicas y la incidencia de terapias del desfibrilador en los pacientes sometidos a un recambio de generador. Métodos. Se realizó un estudio retrospectivo multicéntrico basado en los pacientes del registro nacional UMBRELLA, sometidos a recambio por agotamiento de la batería del desfibrilador. Se analizó la incidencia de arritmias ventriculares mediante monitorización a distancia. Se analizaron los factores de riesgo de arritmia ventricular sostenida tras el recambio. Resultados. Se incluyó a 354 pacientes (media de edad, 61,8 ± 14,5 años; varones, 80%; prevención secundaria, 42%; arritmias ventriculares en el generador explantado, 62%). Tras un seguimiento de 25 meses, 70 pacientes (20%) presentaron terapias apropiadas y 8 (2,3%) tuvieron descargas inapropiadas. El sexo masculino, la presencia de cardiopatía estructural, la insuficiencia cardiaca y la ausencia de resincronización fueron predictores independientes de la aparición de arritmias ventriculares. Conclusiones. Una quinta parte de los pacientes tiene terapias apropiadas de desfibrilador en los primeros 2 años desde el recambio de generador. El conocimiento de los factores asociados a la aparición de arritmias tras el recambio puede ser útil para optimizar el rendimiento de la terapia (AU)

Introduction and objectives. Implantable cardioverter-defibrillators reduce mortality in some patients with heart disease. Battery replacement is a frequent occurrence in clinical practice and is required in up to 30% of implants. The benefit/risk ratio of defibrillators varies over time and should be reevaluated at the time of replacement. The aim of this study was to determine the clinical characteristics and incidence of defibrillator therapies in patients who underwent generator replacement. Results. A total of 354 patients were included (mean age [standard deviation], 61.8 [14.5] years; men, 80%; secondary prevention, 42%; ventricular arrhythmias in the explanted generator, 62%). After a 25-month follow-up, 70 patients (20%) received appropriate therapies and 8 (2.3%) received inappropriate discharges. Male sex, structural heart disease, heart failure, and the absence of resynchronization were independent predictors of ventricular arrhythmia occurrence. Conclusions. One-fifth of patients had appropriate defibrillator therapies in the first 2 years after generator replacement. Determination of the factors associated with arrhythmia occurrence after replacement may be useful to optimize implantable cardioverter-defibrillator treatment (AU)

Clinical profile and incidence of ventricular arrhythmia in patients undergoing defibrillator generator replacement in Spain.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators reduce mortality in some patients with heart disease. Battery replacement is a frequent occurrence in clinical practice and is required in up to 30% of implants. The benefit/risk ratio of defibrillators varies over time and should be reevaluated at the time of replacement. The aim of this study was to determine the clinical characteristics and incidence of defibrillator therapies in patients who underwent generator replacement. METHODS: This multicenter retrospective study involved patients from the UMBRELLA national registry who underwent replacement due to defibrillator battery depletion. The incidence of ventricular arrhythmias was determined via remote monitoring. Risk factors for sustained ventricular arrhythmia after replacement were analyzed. RESULTS: A total of 354 patients were included (mean age [standard deviation], 61.8 [14.5] years; men, 80%; secondary prevention, 42%; ventricular arrhythmias in the explanted generator, 62%). After a 25-month follow-up, 70 patients (20%) received appropriate therapies and 8 (2.3%) received inappropriate discharges. Male sex, structural heart disease, heart failure, and the absence of resynchronization were independent predictors of ventricular arrhythmia occurrence. CONCLUSIONS: One-fifth of patients had appropriate defibrillator therapies in the first 2 years after generator replacement. Determination of the factors associated with arrhythmia occurrence after replacement may be useful to optimize implantable cardioverter-defibrillator treatment.

[Giant left main coronary aneurysm without associated coronary lesions]. / Aneurisma gigante del tronco común de la arteria coronaria izquierda sin lesiones coronarias asociadas.

Left main coronary artery aneurysms are very infrequent (0.1%) and the majority are related to atherosclerotic obstructive lesions. Only a few isolated cases without associated coronary lesions have been reported until now. The management of these patients is not well established, thus both conservative and surgical treatments have been postulated. We present a case of giant left main coronary artery aneurysm with a diameter of 27.7 x 18.6 mm (the biggest reported until now) without coronary tree associated stenosis. It was treated conservatively with oral anticoagulation only and the 5 years evolution has been favourable.

Aneurisma gigante del tronco común de la arteria coronaria izquierda sin lesiones coronarias asociadas / Giant left main coronary aneurysm without associated coronary lesions

Los aneurismas del tronco común de la coronaria izquierda (TCCI) son muy infrecuentes (0,1 por ciento) y la mayoría de ellos está relacionada con lesiones obstructivas ateroscleróticas. Sin lesiones coronarias asociadas se han publicado hasta el momento sólo unos pocos casos aislados. El manejo de estos pacientes no está bien establecido y se ha postulado tanto el manejo quirúrgico como el conservador. Presentamos un caso de un aneurisma gigante del TCCI de diámetro 27,7 x 18,6 mm (el mayor publicado hasta la fecha) sin estenosis coronarias asociadas, el cual fue tratado de forma conservadora solamente con anticoagulación oral, presentando en el seguimiento a 5 años una evolución muy favorable (AU)