Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis.

BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases. Percutaneous closure is the preferred treatment, but certain complications remain a concern. The most common devices are AMPLATZER™ (ASO) (St. Jude Medical, St. Paul, MN, USA) and Figulla Flex® septal occluders (FSO) (Occlutech GmbH, Jena, Germany). The present study aimed to assess main differences in outcomes. METHODS: A systematic search in Pubmed and Google scholarship was performed by two independent reviewers for any study comparing ASO and FSO. Searched terms were "Figulla", "Amplatzer", and "atrial septal defect". A random-effects model was used. RESULTS: A total of 11 studies including 1770 patients (897 ASO; 873 FSO) were gathered. Baseline clinical and echocardiographic characteristics were comparable although septal aneurysm was more often reported in patients treated with ASO (32% vs. 25%; p = 0.061). Success rate (94% vs. 95%; OR: 0.81; 95% CI: 0.38-1.71; p = 0.58) and peri-procedural complications were comparable. Procedures were shorter, requiring less fluoroscopy time with an FSO device (OR: 0.59; 95% CI: 0.20-0.97; p = 0.003). Although the global rate of complications in long-term was similar, the ASO device was associated with a higher rate of supraventricular arrhythmias (14.7% vs. 7.8%, p = 0.009). CONCLUSIONS: Percutaneous closure of ASD is a safe and effective, irrespective of the type of device. No differences exist regarding procedural success between the ASO and FSO devices but the last was associated to shorter procedure time, less radiation, and lower rate of supraventricular arrhythmias in follow-up. Late cardiac perforation did not occur and death in the follow-up was exceptional.

Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis.

OBJECTIVES: This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). BACKGROUND: DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. METHODS: This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25 ±â€¯0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months. CONCLUSIONS: In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. SUMMARY: We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25 ±â€¯0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.

Ecocardiografía intracardiaca como única guía para el implante de MitraClip / Intracardiac echocardiography as sole guidance for the MitraClip procedure

No disponible

Efficacy of atorvastatin in prevention of atrial fibrillation after heart valve surgery in the PROFACE trial (PROphylaxis of postoperative atrial Fibrillation After Cardiac surgEry).

BACKGROUND: To evaluate the efficacy of perioperative atorvastatin administration for prophylaxis of postoperative atrial fibrillation (POAF) after heart valve surgery. METHODS: Our study included 90 patients with heart valve disease who were scheduled to undergo elective cardiac surgery. Cases with previous AF or preoperative beta-blocker therapy were excluded. Patients were randomized into the atorvastatin group, which included 47 patients who received 40 mg/day of atorvastatin 7 days before and after the surgery and the control group, which included 43 patients. Primary endpoint was the occurrence of POAF. Secondary endpoints included modifications in the preoperative and postoperative levels of the markers of inflammation (C-reactive protein [CRP]), myocardial injury (ultrasensitive troponin T and creatinine phosphokinase MB [CPK-MB]), and cardiac dysfunction (pro-brain natriuretic peptide [proBNP]) related to POAF and changes in the echocardiographic parameters, such as atrial electromechanical interval, A wave, E/A ratio, and Doppler imaging systolic velocity wave amplitude, related to POAF. RESULTS: No relationship between atorvastatin administration and reduction in the incidence of POAF was observed (42.6% in the atorvastatin vs. 30.2% in the control group) (p=0.226). No difference in the levels of CPK-MB, ultrasensitive troponin T, CRP, or proBNP and in the analyzed echocardiographic parameter was detected between both groups. CONCLUSIONS: Atorvastatin in the described dose, was not adequate for the prophylaxis of POAF after heart valve surgery. It was ineffective in controlling the inflammatory phenomena, myocardial injury, and echocardiographic predictors of POAF.

Grosor íntima-media carotídeo en población española: valores de referencia y asociación con los factores de riesgo cardiovascular / Carotid intima-media thickness in the spanish population: reference ranges and association with cardiovascular risk factors

Introducción y objetivos. El grosor íntima-media carotídeo medido por ultrasonografía es un predictor de acontecimientos cardiovasculares barato y no invasivo. Se analizaron los valores de referencia del grosor íntima-media carotídeo en población española de 35-84 años y su asociación con los factores de riesgo cardiovascular (edad, tabaquismo, diabetes mellitus, presión de pulso, perfil lipídico e índice de masa corporal). Métodos. Estudio transversal de base poblacional llevado a cabo en Girona (España). Se describieron los grosores íntima-media medio y máximo de la arteria carótida y sus tres segmentos (carótida común, interna y bulbo carotídeo). Se recogió información sobre factores de riesgo cardiovascular y se analizó su asociación con el grosor íntima-media carotídeo mediante modelos de regresión lineal. Resultados. Se incluyó a 3.161 sujetos (el 54% mujeres), con una media de edad de 58 años. La media del grosor íntima-media carotídeo común fue mayor en los varones que en las mujeres (0,71 frente a 0,67 mm). Los principales predictores de esta medida fueron la edad (coeficiente para incremento de 10 años, 0,65 y 0,58 en varones y mujeres respectivamente), el tabaquismo en los varones (coeficiente, 0,26), el colesterol unido a lipoproteínas de alta densidad en las mujeres (coeficiente para incremento de 10mg/dl, incremento de -0,08) y la presión de pulso en ambos sexos (coeficientes para incremento de 10mmHg, 0,23 los varones y 0,08 las mujeres). Los resultados fueron similares en las medias de grosor íntima-media carotídeo de los tres segmentos. Conclusiones. Este estudio de base poblacional muestra la amplitud de valores de referencia para el grosor íntima-media carotídeo en población española. Sus principales determinantes son la edad y la presión de pulso en ambos sexos (AU)

Introduction and objectives. Carotid intima-media thickness as measured with ultrasonography is an inexpensive and noninvasive predictor of cardiovascular events. The objectives of this study were to determine the population reference ranges of carotid intima-media thickness for individuals aged 35-84 years in Spain and to analyze the association of carotid intima-media thickness with cardiovascular risk factors (age, smoking, diabetes, pulse pressure, lipid profile, and body mass index). Methods. Population-based cross-sectional study conducted in Gerona (Spain). We described the mean and maximal values of carotid intima-media thickness of the carotid artery and of its 3 segments (common carotid, carotid bulb and internal carotid). We assessed cardiovascular risk factors and analyzed their association with carotid intima-media thickness using adjusted linear regression models. Results. A total of 3161 individuals (54% women) were included, with mean age 58 years. Men showed significantly higher mean common carotid intima-media thickness than did women (0.71 vs 0.67mm). The strongest predictors of this measure were age (coefficients for 10-year increase: 0.65 and 0.58 for women and men, respectively), smoking in men (coefficient: 0.26), high-density lipoprotein cholesterol in women (coefficient for 10mg/dL, increase: −0.08) and pulse pressure in both sexes (coefficients for 10mmHg increase: 0.08 and 0.23 for women and men, respectively). The results were similar for the mean carotid intima-media thickness of all the segments. Conclusions. This population-based study presents the reference ranges for carotid intima-media thickness in the Spanish population. The main determinants of carotid intima-media thickness were age and pulse pressure in both sexes (AU)

Carotid intima-media thickness in the Spanish population: reference ranges and association with cardiovascular risk factors.

INTRODUCTION AND OBJECTIVES: Carotid intima-media thickness as measured with ultrasonography is an inexpensive and noninvasive predictor of cardiovascular events. The objectives of this study were to determine the population reference ranges of carotid intima-media thickness for individuals aged 35-84 years in Spain and to analyze the association of carotid intima-media thickness with cardiovascular risk factors (age, smoking, diabetes, pulse pressure, lipid profile, and body mass index). METHODS: Population-based cross-sectional study conducted in Gerona (Spain). We described the mean and maximal values of carotid intima-media thickness of the carotid artery and of its 3 segments (common carotid, carotid bulb and internal carotid). We assessed cardiovascular risk factors and analyzed their association with carotid intima-media thickness using adjusted linear regression models. RESULTS: A total of 3161 individuals (54% women) were included, with mean age 58 years. Men showed significantly higher mean common carotid intima-media thickness than did women (0.71 vs 0.67 mm). The strongest predictors of this measure were age (coefficients for 10-year increase: 0.65 and 0.58 for women and men, respectively), smoking in men (coefficient: 0.26), high-density lipoprotein cholesterol in women (coefficient for 10 mg/dL, increase: -0.08) and pulse pressure in both sexes (coefficients for 10 mmHg increase: 0.08 and 0.23 for women and men, respectively). The results were similar for the mean carotid intima-media thickness of all the segments. CONCLUSIONS: This population-based study presents the reference ranges for carotid intima-media thickness in the Spanish population. The main determinants of carotid intima-media thickness were age and pulse pressure in both sexes.