Identification of cavotricuspid isthmus voltage patterns in typical atrial flutter ablation.

Background: Electroanatomical mapping is an essential tool in the ablation of typical AFL. Objectives: To identify the existence of voltage patterns in the CTI voltage maps and their relevance for typical AFL ablation. Methods: A voltage map of the CTI was made prior to ablation, identifying the areas of maximum voltage and their location along the CTI, allowing classification into patterns according to their distribution. A stepwise ablation approach targeting the areas of maximum voltage was conducted. The ablation characteristics were compared based on the pattern obtained. Results: Two voltage patterns were identified, with differences in ablation time to bidirectional CTI block. No complications occurred. Conclusions: Voltage mapping identifies patterns in the CTI with implications for typical AFL ablation.

Cardiac magnetic resonance outperforms echocardiography to predict subsequent implantable cardioverter defibrillator therapies in ST-segment elevation myocardial infarction patients.

Background: Implantable cardioverter defibrillators (ICD) are effective as a primary prevention measure of ventricular tachyarrhythmias in patients with ST-segment elevation myocardial infarction (STEMI) and depressed left ventricular ejection fraction (LVEF). The implications of using cardiac magnetic resonance (CMR) instead of echocardiography (Echo) to assess LVEF prior to the indication of ICD in this setting are unknown. Materials and methods: We evaluated 52 STEMI patients (56.6 ± 11 years, 88.5% male) treated with ICD in primary prevention who underwent echocardiography and CMR prior to ICD implantation. ICD implantation was indicated based on the presence of heart failure and depressed LVEF (≤ 35%) by echocardiography, CMR, or both. Prediction of ICD therapies (ICD-T) during follow-up by echocardiography and CMR before ICD implantation was assessed. Results: Compared to echocardiography, LVEF was lower by cardiac CMR (30.2 ± 9% vs. 37.4 ± 7.6%, p < 0.001). LVEF ≤ 35% was detected in 24 patients (46.2%) by Echo and in 42 (80.7%) by CMR. During a mean follow-up of 6.1 ± 4.2 years, 10 patients received appropriate ICD-T (3.16 ICD-T per 100 person-years): 5 direct shocks to treat very fast ventricular tachycardia or ventricular fibrillation, 3 effective antitachycardia pacing (ATP) for treatment of ventricular tachycardia, and 2 ineffective ATP followed by shock to treat ventricular tachycardia. Echo-LVEF ≤ 35% correctly predicted ICD-T in 4/10 (40%) patients and CMR-LVEF ≤ 35% in 10/10 (100%) patients. CMR-LVEF improved on Echo-LVEF for predicting ICD-T (area under the curve: 0.76 vs. 0.48, p = 0.04). Conclusion: In STEMI patients treated with ICD, assessment of LVEF by CMR outperforms Echo-LVEF to predict the subsequent use of appropriate ICD therapies.

Validation of multiparametric approaches for the prediction of sudden cardiac death in patients with Brugada syndrome and electrophysiological study.

INTRODUCTION AND OBJECTIVES: Multiparametric scores have been designed for better risk stratification in Brugada syndrome (BrS). We aimed to validate 3 multiparametric approaches (the Delise score, Sieira score and the Shanghai BrS Score) in a cohort with Brugada syndrome and electrophysiological study (EPS). METHODS: We included patients diagnosed with BrS and previous EPS between 1998 and 2019 in 23 hospitals. C-statistic analysis and Cox proportional hazard regression models were used. RESULTS: A total of 831 patients were included (mean age, 42.8±13.1; 623 [75%] men; 386 [46.5%] had a type 1 electrocardiogram (ECG) pattern, 677 [81.5%] were asymptomatic, and 319 [38.4%] had an implantable cardioverter-defibrillator). During a follow-up of 10.2±4.7 years, 47 (5.7%) experienced a cardiovascular event. In the global cohort, a type 1 ECG and syncope were predictive of arrhythmic events. All risk scores were significantly associated with events. The discriminatory abilities of the 3 scores were modest (particularly when these scores were evaluated in asymptomatic patients). Evaluation of the Delise and Sieira scores with different numbers of extra stimuli (1 or 2 vs 3) did not substantially improve the event prediction c-index. CONCLUSIONS: In BrS, classic risk factors such as ECG pattern and previous syncope predict arrhythmic events. The predictive capabilities of the EPS are affected by the number of extra stimuli required to induce ventricular arrhythmias. Scores combining clinical risk factors with EPS help to identify the populations at highest risk, although their predictive abilities remain modest in the general BrS population and in asymptomatic patients.

Predictores e impacto de la adopción de programación basada en la evidencia en la incidencia de terapias del desfibrilador automático implantable / Predictors of adoption and impact of evidence-based programming on the incidence of implantable cardioverter-defibrillator therapies

Introducción y objetivos El estudio ADVANCE III mostró una reducción de terapias del desfibrilador automático implantable (DAI) con el empleo de tiempos de detección de arritmia prolongados. Se describe la adopción y el impacto de dicha estrategia en la incidencia de terapias del DAI. Métodos Estudio observacional retrospectivo de pacientes con implante de DAI Medtronic (2005-2016) en un registro multicéntrico (UMBRELLA-NCT01561144). Se describe la evolución de la adopción de programación ADVANCE en relación con: publicación del estudio, implementación de una campaña de formación y publicación de un consenso de expertos. Se identificaron con regresión logística los predictores de la adopción. Se comparó la incidencia de terapias en pacientes con y sin programación ADVANCE estimando la razón de tasas de incidencia ajustada (RTIa) mediante regresión binomial negativa. Resultados Se incluyó a 3.528 pacientes. Se utilizó la estrategia ADVANCE en el 20% del total y el 44% al final del estudio. La adopción se incrementó tras publicarse el estudio ADVANCE, y en menor grado tras la campaña de formación y consenso de expertos. Predictores de la adopción: DAI con detección nominal 30/40 (ORa=4,4; IC95%, 3,5-5,4), implantador electrofisiólogo (ORa=1,7; IC95%, 1,4-2,2) y prevención secundaria (ORa=3,2; IC95%, 2,6-3,9). El implante de DAI bicameral (ORa=0,6; IC95%, 0,5-0,8) o tricameral (ORa=0,5; IC95%, 0,4-0,7) se asoció con menor adopción. La programación ADVANCE se asoció con reducción de terapias totales (RTIa=0,77; IC95%, 0,69-0,86) y choques inapropiados (RTIa=0,66; IC95%, 0,52-0,85). Conclusiones La adopción de la programación ADVANCE es poco amplia y puede mejorarse mediante una adecuada selección de los parámetros nominales. Emplearla se asocia con una reducción de las terapias del DAI. (AU)

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. ... (AU)

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.

Safety, efficacy, and reproducibility of cavotricuspid isthmus ablation guided by the ablation index: acute results of the FLAI study.

AIMS: Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). METHODS AND RESULTS: This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI 'first-pass' block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional 'first-pass' block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. CONCLUSION: AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

Effect of mountain ultramarathon distance competition on biochemical variables, respiratory and lower-limb fatigue.

The study aimed at assessing the acute physiological effects of running a 65-km vs a 107-km mountain ultramarathon. Nineteen athletes (15 males and 4 females) from the shorter race and forty three athletes (26 males and 17 females) from the longer race were enrolled. Body weight, respiratory and lower limb strength were assessed before and after the race. Blood samples were obtained before, after and 24-h post-race. Body weight loss did not differ between races. A decrease in squat jump height (p<0.01; d = 1.4), forced vital capacity (p<0.01; d = 0.5), forced expiratory volume in 1 s (p<0.01; d = 0.6), peak inspiratory flow (p<0.01; d = 0.6) and maximal inspiratory pressure (p<0.01; d = 0.8) was observed after the longer race; while, after the shorter race only maximal inspiratory pressure declined (p<0.01; d = 0.5). Greater post-race concentrations of creatine kinase (p<0.01; d = 0.9) and C-reactive protein (p<0.01; d = 2.3) were observed following the longer race, while high-sensitivity cardiac troponin was higher after the shorter race (p<0.01; d = 0.3). Sodium decreased post-competition only after the shorter race (p = 0.02; d = 0.6), while creatinine increased only following the longer race (p<0.01; d = 1.5). In both groups, glomerular filtration rate declined at post-race (longer race: p<0.01, d = 2.1; shorter race: p = 0.01, d = 1.4) and returned to baseline values at 24 h post-race. In summary, expiratory and lower-limb fatigue, and muscle damage and inflammatory response were greater following the longer race; while a higher release of cardiac troponins was observed after the shorter race. The alteration and restoration of renal function was similar after either race.

Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial.

BACKGROUND: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. METHODS AND RESULTS: This prospective, randomized, multicenter, noninferiority study included 140 patients with paroxysmal atrial fibrillation, which was refractory to antiarrhythmic drugs. Patients were randomly assigned to a conventional strategy of 180-second cryoballoon applications per vein with a bonus freeze (control group, n=70) or to a shorter-time application protocol, with 1 application that lasted the time required for electric block time to effect plus 60- and a 120-second freeze bonus (study group, n=70). Patients were followed with a long-term monitoring system of 30 days. At 1-year follow-up, no difference was observed in terms of free atrial fibrillation-recurrence rates: 79.4% in control versus 78.3% in study group (Δ=1.15%; 90% confidence interval, -10.33% to 12.63%; P=0.869). Time to effect was detected in 72.1% of veins. The control and study groups had similar mean number of applications per patient (9.6±2 versus 9.9±2.4; P=0.76). Compared with controls, the study group had a significantly shorter cryotherapy time (28.3±7 versus 19.4±4.3 minutes; P<0.001), left atrium time (104±25 versus 92±23 minutes; P<0.01), and total procedure time (135±35 versus 119±31 minutes; P<0.01). No differences were observed in complications or acute reconnections. CONCLUSIONS: The new time-to-effect-based cryotherapy dosage protocol led to shorter cryotherapy and procedure times, with equal safety, and similar acute and 1-year follow-up results, compared with the conventional approach. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT02789358.

Evaluación comparativa de cuatro puntuaciones de riesgo para predecir la mortalidad de pacientes con desfibrilador automático implantable en prevención primaria / Comparative evaluation of four risk scores for predicting mortality in patients with implantable cardioverter-defibrillator for primary prevention

Introducción y objetivos: Se han elaborado varias puntuaciones clínicas del riesgo para identificar a los pacientes con un riesgo de mortalidad por cualquier causa elevado a pesar del implante de un desfibrilador implantable. El objetivo de este trabajo es examinar y comparar la capacidad predictiva de 4 sistemas de puntuación sencillos (MADIT-II, FADES, PACE y SHOCKED) por lo que respecta a la predicción de la mortalidad tras implante de desfibrilador para la prevención primaria de la muerte súbita cardiaca en un país mediterráneo. Métodos: Se llevó a cabo un estudio multicéntrico retrospectivo en 15 hospitales españoles. Se incluyó a los pacientes consecutivos remitidos para implante de desfibrilador entre enero de 2010 y diciembre de 2011. Resultados: Se incluyó a 916 pacientes con cardiopatía isquémica o no isquémica (media de edad, 62 ± 11 años; el 81,4% varones). Durante un periodo de 33,4 ± 12,9 meses, fallecieron 113 pacientes (12,3%), el 9,4% (86 pacientes) por causa cardiovascular. A los 12, 24, 36 y 48 meses, la tasa de mortalidad fue del 4,5, el 7,6, el 10,8 y el 12,3% respectivamente. Todas las puntuaciones de riesgo mostraron un aumento escalonado del riesgo de muerte a lo largo de todo el sistema de puntuación de cada una de ellas y las 4 identificaron a los pacientes en mayor riesgo de mortalidad. Las puntuaciones tuvieron asociación significativa con la mortalidad por cualquier causa en todo el periodo de seguimiento. La puntuación PACE fue la que mostró un valor del índice c más bajo, tanto si la población tenía una cardiopatía de origen isquémico (estadístico c = 0,61) como si era de origen no isquémico (estadístico c = 0,61), mientras que la puntuación MADIT-II (estadístico c = 0,67 y 0,65 en la miocardiopatía isquémica y no isquémica respectivamente), las puntuaciones SHOCKED (estadístico c = 0,68 y 0,66 respectivamente) y FADES (estadístico c = 0,66 y 0,60) mostraron unos valores del estadístico c similares (p ≥ 0,09). Conclusiones: En esta cohorte de pacientes mediterráneos que no formaba parte de un ensayo clínico, las 4 puntuaciones de riesgo evaluadas mostraron un significativo aumento escalonado del riesgo de muerte. De entre las puntuaciones de riesgo existentes, MADIT-II, FADES y SHOCKED aportan un rendimiento ligeramente superior al de la puntuación PACE (AU)

Introduction and objectives: Several clinical risk scores have been developed to identify patients at high risk of all-cause mortality despite implantation of an implantable cardioverter-defibrillator. We aimed to examine and compare the predictive capacity of 4 simple scoring systems (MADIT-II, FADES, PACE and SHOCKED) for predicting mortality after defibrillator implantation for primary prevention of sudden cardiac death in a Mediterranean country. Methods: A multicenter retrospective study was performed in 15 Spanish hospitals. Consecutive patients referred for defibrillator implantation between January 2010 and December 2011 were included. Results: A total of 916 patients with ischemic and nonischemic heart disease were included (mean age, 62 ± 11 years, 81.4% male). Over 33.4 ± 12.9 months, 113 (12.3%) patients died (cardiovascular origin in 86 [9.4%] patients). At 12, 24, 36, and 48 months, mortality rates were 4.5%, 7.6%, 10.8%, and 12.3% respectively. All the risk scores showed a stepwise increase in the risk of death throughout the scoring system of each of the scores and all 4 scores identified patients at greater risk of mortality. The scores were significantly associated with all-cause mortality throughout the follow-up period. PACE displayed the lowest c-index value regardless of whether the population had heart disease of ischemic (c-statistic = 0.61) or nonischemic origin (c-statistic = 0.61), whereas MADIT-II (c-statistic = 0.67 and 0.65 in ischemic and nonischemic cardiomyopathy, respectively), SHOCKED (c-statistic = 0.68 and 0.66, respectively), and FADES (c-statistic = 0.66 and 0.60) provided similar c-statistic values (P ≥ .09). Conclusions: In this nontrial-based cohort of Mediterranean patients, the 4 evaluated risk scores showed a significant stepwise increase in the risk of death. Among the currently available risk scores, MADIT-II, FADES, and SHOCKED provide slightly better performance than PACE (AU)

Comparative Evaluation of Four Risk Scores for Predicting Mortality in Patients With Implantable Cardioverter-defibrillator for Primary Prevention.

INTRODUCTION AND OBJECTIVES: Several clinical risk scores have been developed to identify patients at high risk of all-cause mortality despite implantation of an implantable cardioverter-defibrillator. We aimed to examine and compare the predictive capacity of 4 simple scoring systems (MADIT-II, FADES, PACE and SHOCKED) for predicting mortality after defibrillator implantation for primary prevention of sudden cardiac death in a Mediterranean country. METHODS: A multicenter retrospective study was performed in 15 Spanish hospitals. Consecutive patients referred for defibrillator implantation between January 2010 and December 2011 were included. RESULTS: A total of 916 patients with ischemic and nonischemic heart disease were included (mean age, 62 ± 11 years, 81.4% male). Over 33.4 ± 12.9 months, 113 (12.3%) patients died (cardiovascular origin in 86 [9.4%] patients). At 12, 24, 36, and 48 months, mortality rates were 4.5%, 7.6%, 10.8%, and 12.3% respectively. All the risk scores showed a stepwise increase in the risk of death throughout the scoring system of each of the scores and all 4 scores identified patients at greater risk of mortality. The scores were significantly associated with all-cause mortality throughout the follow-up period. PACE displayed the lowest c-index value regardless of whether the population had heart disease of ischemic (c-statistic = 0.61) or nonischemic origin (c-statistic = 0.61), whereas MADIT-II (c-statistic = 0.67 and 0.65 in ischemic and nonischemic cardiomyopathy, respectively), SHOCKED (c-statistic = 0.68 and 0.66, respectively), and FADES (c-statistic = 0.66 and 0.60) provided similar c-statistic values (P ≥ .09). CONCLUSIONS: In this nontrial-based cohort of Mediterranean patients, the 4 evaluated risk scores showed a significant stepwise increase in the risk of death. Among the currently available risk scores, MADIT-II, FADES, and SHOCKED provide slightly better performance than PACE.

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.

Prevención primaria de muerte súbita en pacientes con miocardiopatía valvular / Primary prevention of sudden death in patients with valvular cardiomyopathy

Introducción y objetivos: Existe escasa evidencia sobre la evolución de los pacientes con miocardiopatía valvular remitidos para implante de desfibrilador por prevención primaria. Se pretende describir la evolución de este subgrupo particular. Métodos: Estudio multicéntrico retrospectivo en 15 centros españoles que incluyó pacientes consecutivos remitidos para implante de desfibrilador en los años 2010 y 2011, y en tres centros desde el 1 enero de 2008. Resultados: De un total de 1.174 pacientes, 73 (6,2%) presentaron miocardiopatía valvular. Comparados con los pacientes con miocardiopatía isquémica (n = 659; 56,1%) o dilatada (n = 442; 37,6%), presentaron peor clase funcional, mayor anchura del QRS y antecedente de fibrilación auricular. Durante un seguimiento de 38,1 ± 21,3 meses, 197 (16,7%) pacientes fallecieron por cualquier causa, sin diferencias significativas entre grupos (19,2% en miocardiopatía valvular, 15,8% en isquémica y 17,9% en miocardiopatía dilatada; p = 0,2). De estos, 136 murieron por causa cardiovascular (11,6%), sin diferencias significativas (12,3%; 10,5% y 13,1%, respectivamente; p = 0,1). Tampoco hubo diferencias en la proporción de intervenciones apropiadas del desfibrilador (13,7%; 17,9% y 18,8%; p = 0,4), pero sí en el de inapropiadas (8,2%; 7,1% y 12,0%, respectivamente; p = 0,03). Conclusiones: Las tasas de mortalidad por cualquier causa y por causa cardiovascular en pacientes con miocardiopatía valvular fueron similares a las del resto de los pacientes remitidos para implante de desfibrilador. También presentaron similares tasas de intervenciones apropiadas. Estos datos parecen indicar que el implante de un desfibrilador en este grupo confiere un beneficio similar al que obtienen los pacientes con miocardiopatía isquémica y miocardiopatía dilatada (AU)

Introduction and objectives: Few data exist on the outcomes of valvular cardiomyopathy patients referred for defibrillator implantation for primary prevention. The aim of the present study was to describe the outcomes of this cardiomyopathy subgroup. Methods: This multicenter retrospective study included consecutive patients referred for defibrillator implantation to 15 Spanish centers in 2010 and 2011, and to 3 centers after 1 January 2008. Results: Of 1174 patients, 73 (6.2%) had valvular cardiomyopathy. These patients had worse functional class, wider QRS, and a history of atrial fibrillation vs patients with ischemic (n = 659; 56.1%) or dilated (n = 442; 37.6%) cardiomyopathy. During a follow-up of 38.1 ± 21.3 months, 197 patients (16.7%) died, without significant differences among the groups (19.2% in the valvular cardiomyopathy group, 15.8% in the ischemic cardiomyopathy group, and 17.9% in the dilated cardiomyopathy group; P = .2); 136 died of cardiovascular causes (11.6%), without significant differences among the groups (12.3%, 10.5%, and 13.1%, respectively; P = .1). Although there were no differences in the proportion of appropriate defibrillator interventions (13.7%, 17.9%, and 18.8%; P = .4), there was a difference in inappropriate interventions (8.2%, 7.1%, and 12.0%, respectively; P = .03). Conclusions: All-cause and cardiovascular mortality in patients with valvular cardiomyopathy were similar to those in other patients referred for defibrillator implantation. They also had similar rates of appropriate interventions. These data suggest that defibrillator implantation in this patient group confers a similar benefit to that obtained by patients with ischemic or dilated cardiomyopathy (AU)

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.

Primary Prevention of Sudden Death in Patients With Valvular Cardiomyopathy.

INTRODUCTION AND OBJECTIVES: Few data exist on the outcomes of valvular cardiomyopathy patients referred for defibrillator implantation for primary prevention. The aim of the present study was to describe the outcomes of this cardiomyopathy subgroup. METHODS: This multicenter retrospective study included consecutive patients referred for defibrillator implantation to 15 Spanish centers in 2010 and 2011, and to 3 centers after 1 January 2008. RESULTS: Of 1174 patients, 73 (6.2%) had valvular cardiomyopathy. These patients had worse functional class, wider QRS, and a history of atrial fibrillation vs patients with ischemic (n=659; 56.1%) or dilated (n=442; 37.6%) cardiomyopathy. During a follow-up of 38.1 ± 21.3 months, 197 patients (16.7%) died, without significant differences among the groups (19.2% in the valvular cardiomyopathy group, 15.8% in the ischemic cardiomyopathy group, and 17.9% in the dilated cardiomyopathy group; P=.2); 136 died of cardiovascular causes (11.6%), without significant differences among the groups (12.3%, 10.5%, and 13.1%, respectively; P=.1). Although there were no differences in the proportion of appropriate defibrillator interventions (13.7%, 17.9%, and 18.8%; P=.4), there was a difference in inappropriate interventions (8.2%, 7.1%, and 12.0%, respectively; P=.03). CONCLUSIONS: All-cause and cardiovascular mortality in patients with valvular cardiomyopathy were similar to those in other patients referred for defibrillator implantation. They also had similar rates of appropriate interventions. These data suggest that defibrillator implantation in this patient group confers a similar benefit to that obtained by patients with ischemic or dilated cardiomyopathy.

[Electrical storm in patients with prophylactic defibrillator implantation]. / Evolución de los pacientes portadores de desfibrilador como prevención primaria tras un episodio de tormenta arrítmica.

INTRODUCTION: Little is known about the prevalence of electrical storm, baseline characteristics and mortality implications of patients with implantable cardioverter defibrillator in primary prevention versus those patients without electrical storm. We sought to assess the prevalence, baseline risk profile and survival significance of electrical storm in patients with implantable defibrillator for primary prevention. METHODS: Retrospective multicenter study performed in 15 Spanish hospitals. Consecutives patients referred for desfibrillator implantation, with or without left ventricular lead (at least those performed in 2010 and 2011), were included. RESULTS: Over all 1,174 patients, 34 (2,9%) presented an electrical storm, mainly due to ventricular tachycardia (82.4%). There were no significant baseline differences between groups, with similar punctuation in the mortality risk scores (SHOCKED, MADIT and FADES). A clear trigger was identified in 47% of the events. During the study period (38±21 months), long-term total mortality (58.8% versus 14.4%, p<0.001) and cardiac mortality (52.9% versus 8.6%, p<0.001) were both increased among electrical storm patients. Rate of inappropriate desfibrillator intervention was also higher (14.7 versus 8.6%, p<0.001). CONCLUSIONS: In the present study of patients with desfibrillator implantation for primary prevention, prevalence of electrical storm was 2.9%. There were no baseline differences in the cardiovascular risk profile versus those without electrical storm. However, all cause mortality and cardiovascular mortality was increased in these patients versus control desfibrillator patients without electrical storm, as was the rate of inappropriate desfibrillator intervention.

Endo-epicardial versus only-endocardial ablation as a first line strategy for the treatment of ventricular tachycardia in patients with ischemic heart disease.

BACKGROUND: Epicardial ablation has shown improvement in clinical outcomes of patients with ischemic heart disease (IHD) after ventricular tachycardia (VT) ablation. However, usually epicardial access is only performed when endocardial ablation has failed. Our aim was to compare the efficacy of endocardial+epicardial ablation versus only endocardial ablation in the first procedure in patients with IHD. METHODS AND RESULTS: Fifty-three patients with IHD, referred for a first VT ablation to our institution, from 2012 to 2014, were included. They were divided in 2 groups according to enrollment time: from May 2013, we started to systematically perform endo-epicardial access (Epi-Group) as first-line approach in consecutive patients with IHD (n=15). Patients who underwent only an endocardial VT ablation in their first procedure (Endo-Group) included patients with previous cardiac surgery and the historical (before May 2013; n=35). All late-potentials in the scar zone were eliminated, and if VT was tolerated, critical isthmuses were also approached. The end point was the noninducibility of any VT. During a median follow-up of 15±10 months, the combined end point (hospital or emergency admission because of a ventricular tachycardia or reablation) occurred in 14 patients of the Endo-group and in one patient in the Epi-group (event-free survival curves by Grey-test, P=0.03). Ventricular arrhythmia recurrences occurred in 16 and in 3 patients in the Endo and Epi-Group, respectively (Grey-test, P=0.2). CONCLUSIONS: A combined endocardial-epicardial ablation approach for initial VT ablation was associated with fewer readmissions for VT and repeat ablations. Further studies are warranted.

Analyses of inappropriate shocks in a Spanish ICD primary prevention population: Predictors and prognoses.

BACKGROUND: ICDs have been demonstrated to be highly effective in the primary prevention of sudden death, but inappropriate shocks (IS) occur frequently and represent one of the most important adverse effects of ICDs. The aim of this study was to analyze IS and identify the clinical predictors and prognostic implications of ISs in a real-world primary prevention ICD population. METHODS: This multicenter retrospective study was performed in 13 centers with experience in the field of ICD implantation (at least 30 per year) and ICD follow-up in Spain. All consecutive patients who underwent ICD implantation for primary prevention between January 2008 and May 2014 were included. RESULTS: One-thousand-sixteen patients were included, and 4 (0.39%) were lost to follow-up. Two-hundred-seventeen (21.4%) patients suffered from shock; 69 (6.8%) of these patients experienced IS, and 154 (15.4%) experienced appropriate shocks (AS). Age (<65 years, hazard ratio (HR) 2.588 [95% CI 1.282-5.225]; p=0.008), history of atrial fibrillation (HR 2.252 [95% CI 1.230-4.115]; p=0.009), non-ischemic myocardiopathy (HR 2.258 [95% CI 1.090-4.479]; p=0.028), and cardiac resynchronization therapy (HR 0.385 [95% CI 0.200-0.740]; p=0.004) were identified as IS predictors in a multivariate analysis. IS was not associated with rehospitalization due to heart failure, myocardial infarction, cardiovascular mortality or all-cause mortality. CONCLUSIONS: This analysis of our national registry identified the independent IS predictors of age, atrial fibrillation history and cardiac resynchronization therapy and suggests that ISs are not linked to poorer clinical endpoints.

Influence of metabolic syndrome on development of cardiac allograft vasculopathy in the transplanted heart.

BACKGROUND: Cardiac allograft vasculopathy (CAV) is the main cause of graft failure and death 1 year after heart transplantation (HTx). Metabolic syndrome (MS) increases the risk of cardiovascular events by endothelial dysfunction. The purpose of this study was to determine if patients with MS developed a higher risk of CAV 1 year after HTx. METHODS: Since January 2004 until April 2009, 155 HTx patients were recruited. Cardiopulmonary transplants were excluded (12 patients), as well as retransplants (5 patients), pediatric transplants (11 patients), patients who refused to participate (3 patients), and those who died during the first year (35 patients). The final analysis included 89 patients. MS was diagnosed when Adult Treatment Panel III modified and revised criteria were met, before HTx or after the first 3 months. CAV was diagnosed through intravascular ultrasound performed 1 month and 1 year after HTx. CAV was defined as an intimal thickening ≥ 0.5 mm in the follow-up with regard to the one of the basal study. RESULTS: Development of CAV was significantly higher in patients with MS (59% vs. 19%, P<0.0001). Patients with more criteria of MS had a higher development of CAV: no criteria (4%); one criterion (4%); two criteria (47%); three criteria (62%); four criteria (75%); and five criteria (100%). Variables related to CAV in a multivariate analysis were MS (odds ratio [OR] 7.97; 95% confidence interval [CI]: 2.77-22.96; P<0.001), donor's age (OR 1.07; 95% CI: 1.01-1.13; P=0.019), low high-density lipoprotein cholesterol (OR 0.26; 95% CI: 0.09-0.71; P=0.009), and hypertriglyceridemia (OR 4.08; 95% CI: 1.45-11.50; P=0.008). CONCLUSIONS: Presence of MS distinguishes a subgroup of patients with high risk of developing CAV. Narrow and personalized monitoring of these patients would be recommendable.

Cardiac magnetic resonance imaging at 1.5 T in patients with cardiac rhythm devices.

AIMS: Recent studies suggest that non-cardiac magnetic resonance imaging (MRI) scanning can be performed safely in selected cardiac rhythm device patients. However, little is known about the safety of performing specific cardiac MRI in this setting. We sought to determine the feasibility of cardiac MRI in patients with pacemakers (PMs) or implantable cardioverter-defibrillators (ICDs). METHODS AND RESULTS: Thirty-eight patients underwent a total of 39 (8 ICDs and 31 PM) cardiac MRI examinations at 1.5 T using usual protocols without specific absorption rate (SAR) restrictions. Nine PM-dependent patients were included. All devices were interrogated before and immediately after MRI. During the scan, pacing mode was programmed to asynchronous for PM-dependent patients whereas ICDs were programmed to a monitor-only mode. All devices were functioning appropriately after cardiac MRI. Comparison of device parameters obtained before and immediately after MRI revealed no significant changes in pacing threshold, lead impedance, battery status, or sensing signal amplitude. Neither clinical events nor patient complaints were reported. Significant imaging artefacts were present on 11 of 39 scans (28.2%). These artefacts were significantly more frequent in ICDs (8 of 8, 100%) vs. PMs (3 of 31, 9.7%) (P < 0.001). Diagnostic questions were answered in 92.3% of the cases, with just three pronounced artefacts preventing an adequate diagnosis in three ICD patients. CONCLUSIONS: Our results suggest that cardiac MRI may be performed safely in appropriately selected patients with close monitoring during the scan without limitation of peak SAR level using several precautionary measures. Image artefacts were more frequent in ICD patients.

Predictors of renal dysfunction at 1 year in heart transplant patients.

BACKGROUND: Renal dysfunction (RD) is one of the most significant long-term complications of heart transplantation (HT). Although RD is generally attributed to a direct effect of calcineurin inhibitors, it is more probable that multiple factors contribute to its development. The aim of this study was to search for predictor variables of RD at 1 year after HT. METHODS: Three hundred sixteen consecutive HT patients were evaluated. The relationship between RD at 1 year (glomerular filtration rate <60 mL/min/1.73 m2), and pretransplant and 1-year follow-up variables was analyzed. RESULTS: At 1 year following HT, 181 patients (57%) had a glomerular filtration rate of <60 mL/min/1.73 m2. On multivariate analysis, pretransplant serum creatinine values (odds ratio [OR] 5.106, 95% confidence interval [CI]: 2.35-11.09, P=0.0001) and cytomegalovirus (CMV) infection (OR 2.04, 95% CI: 1.08-3.83, P=0.027) were significant predictors of RD, and diabetes mellitus was almost significant (OR 1.65, 95% CI: 0.98-2.76, P=0.055). Variables protective against RD were induction therapy with interleukin-2 receptor antagonists versus muromonab-CD3 (OR 0.389, 95% CI: 0.24-0.61, P=0.0001), maintenance treatment with mycophenolate mofetil versus azathioprine (OR 0.42, 95% CI: 0.26-0.68, P=0.0001), and CMV antiviral prophylaxis (OR 0.38, 95% CI: 0.17-0.68, P=0.021). CONCLUSIONS: Fifty-seven percent of HT patients had RD at 1 year posttransplant. RD was associated with pretransplant serum creatinine values, CMV infection, and diabetes mellitus. Induction with interleukin-2 receptor antagonists, treatment with mycophenolate mofetil, and antiviral prophylaxis for CMV infection all helped maintain renal function in this cohort of HT patients.