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Background: Surrogate decision makers for incapacitated, critically ill patients often struggle with decisions related to goals of care. Such decisions cause psychological distress in surrogates and may lead to treatment that does not align with patients' preferences., Methods: We conducted a stepped-wedge, cluster-randomized trial involving patients with a high risk of death and their surrogates in five intensive care units (ICUs) to compare a multicomponent family-support intervention delivered by the interprofessional ICU team with usual care. The primary outcome was the surrogates' mean score on the Hospital Anxiety and Depression Scale (HADS) at 6 months (scores range from 0 to 42, with higher scores indicating worse symptoms). Prespecified secondary outcomes were the surrogates' mean scores on the Impact of Event Scale (IES; scores range from 0 to 88, with higher scores indicating worse symptoms), the Quality of Communication (QOC) scale (scores range from 0 to 100, with higher scores indicating better clinician-family communication), and a modified Patient Perception of Patient Centeredness (PPPC) scale (scores range from 1 to 4, with lower scores indicating more patient- and family-centered care), as well as the mean length of ICU stay., Results: A total of 1420 patients were enrolled in the trial. There was no significant difference between the intervention group and the control group in the surrogates' mean HADS score at 6 months (11.7 and 12.0, respectively; beta coefficient, -0.34; 95% confidence interval [CI], -1.67 to 0.99; P=0.61) or mean IES score (21.2 and 20.3; beta coefficient, 0.90; 95% CI, -1.66 to 3.47; P=0.49). The surrogates' mean QOC score was better in the intervention group than in the control group (69.1 vs. 62.7; beta coefficient, 6.39; 95% CI, 2.57 to 10.20; P=0.001), as was the mean modified PPPC score (1.7 vs. 1.8; beta coefficient, -0.15; 95% CI, -0.26 to -0.04; P=0.006). The mean length of stay in the ICU was shorter in the intervention group than in the control group (6.7 days vs. 7.4 days; incidence rate ratio, 0.90; 95% CI, 0.81 to 1.00; P=0.045), a finding mediated by the shortened mean length of stay in the ICU among patients who died (4.4 days vs. 6.8 days; incidence rate ratio, 0.64; 95% CI, 0.52 to 0.78; P<0.001)., Conclusions: Among critically ill patients and their surrogates, a family-support intervention delivered by the interprofessional ICU team did not significantly affect the surrogates' burden of psychological symptoms, but the surrogates' ratings of the quality of communication and the patient- and family-centeredness of care were better and the length of stay in the ICU was shorter with the intervention than with usual care. (Funded by the UPMC Health System and the Greenwall Foundation; PARTNER ClinicalTrials.gov number, NCT01844492 .).

Background: Data are needed on the safety and efficacy of device closure of large atrial septal defects., Methods and Results: Between 1998 and 2013, 336 patients (161 children <15 years) with large, isolated, secundum atrial septal defects (balloon-stretched diameter ≥34 mm in adults or echocardiographic diameter >15 mm/m(2) in children) were managed using the Amplatzer device, at the Marie Lannelongue Hospital. Transthoracic echocardiographic guidance was used starting in 2005 (n=219; 65.2%). Balloon-stretched diameter was >40 mm in 36 adults; mean values were 37.6±3.3 mm in other adults and 26.3±6.3 mm/m(2) in children. Amplatzer closure was successful in 311 (92.6%; 95% confidence interval, 89%-95%) patients. Superior and posterior rim deficiencies were more common in failed than in successful procedures (superior, 24.0% versus 4.8%; P=0.002; and posterior, 32.0% versus 4.2%; P<0.001). Device migration occurred in 4 adults (2 cases each of surgical and transcatheter retrieval); in the 21 remaining failures, the device was unreleased and withdrawn. After a median follow-up of 10.0 years (2.5-17 years), all patients were alive with no history of late complications., Conclusions: Closure of large atrial septal defects using the Amplatzer device is safe and effective in both adults and children. Superior and posterior rim deficiencies are associated with procedural failure. Closure can be performed under transthoracic echocardiographic guidance in experienced centers. Early device migration is rare and can be safely managed by device extraction. Long-term follow-up showed no deaths or major late complications in our population of 311 patients., (© 2014 American Heart Association, Inc.)

Background: The PREDIMED (Prevención con Dieta Mediterránea) randomized primary prevention trial showed that a Mediterranean diet enriched with either extravirgin olive oil or mixed nuts reduces the incidence of stroke, myocardial infarction, and cardiovascular mortality. We assessed the effect of these diets on the incidence of atrial fibrillation in the PREDIMED trial., Methods and Results: Participants were randomly assigned to 1 of 3 diets: Mediterranean diet supplemented with extravirgin olive oil, Mediterranean diet supplemented with mixed nuts, or advice to follow a low-fat diet (control group). Incident atrial fibrillation was adjudicated during follow-up by an events committee blinded to dietary group allocation. Among 6705 participants without prevalent atrial fibrillation at randomization, we observed 72 new cases of atrial fibrillation in the Mediterranean diet with extravirgin olive oil group, 82 in the Mediterranean diet with mixed nuts group, and 92 in the control group after median follow-up of 4.7 years. The Mediterranean diet with extravirgin olive oil significantly reduced the risk of atrial fibrillation (hazard ratio, 0.62; 95% confidence interval, 0.45-0.85 compared with the control group). No effect was found for the Mediterranean diet with nuts (hazard ratio, 0.89; 95% confidence interval, 0.65-1.20)., Conclusions: In the absence of proven interventions for the primary prevention of atrial fibrillation, this post hoc analysis of the PREDIMED trial suggests that extravirgin olive oil in the context of a Mediterranean dietary pattern may reduce the risk of atrial fibrillation., Clinical Trial Registration Url: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639., (© 2014 American Heart Association, Inc.)