Association of 3-Year Multidomain Intervention and Omega-3 Supplementation with Frailty Incidence.

OBJECTIVES: To assess the associations of long-term lifestyle multidomain intervention (MI) and omega-3 supplementation with frailty level evolution and frailty incidence in community-dwelling older persons. DESIGN: Secondary analysis of the randomized controlled Multidomain Alzheimer Preventive Trial. SETTING: Thirteen memory centers in France and Monaco between 2008 and 2011. PARTICIPANTS: A total of 1588 community-dwelling persons aged 70 years or older with memory complaints (without dementia), slow gait speed, or limitation in one instrumental activity of daily living. INTERVENTION: A 3-year MI (43 group sessions including cognitive training, physical activity, and nutrition advice and three preventive consultations) plus daily omega-3 fatty acids, MI plus placebo, omega-3 alone, or placebo alone. MEASUREMENTS: The frailty phenotype (unintentional weight loss, exhaustion, low physical activity, slow gait, low handgrip strength: 0 to 5 score, higher is worse; a score of 3 or higher defines frailty) was assessed at baseline, 6, 12, 24, and 36 months. We used mixed-effect models for frailty level (0-5 score as an ordinal variable) and Cox models for frailty incidence. RESULTS: No differences were found between the intervention groups and placebo on the 3-year evolution of frailty level. Among 1394 non-frail participants at baseline, frailty incidence occurred in 134 (9.6%) persons: 26 (7.6%) in the MI plus omega-3 group, 34 (10%) in the omega-3 alone group, 31 (8.5%) in the MI plus placebo group, and 43 (12.3%) in the placebo-alone group). No differences regarding frailty incidence were found between intervention groups and placebo. After exclusion of 53 participants with incident frailty during the first year of follow-up, MI plus omega-3 was associated with a lower frailty incidence compared with placebo (hazard ratio = .43; 95% confidence interval = .22-.81). CONCLUSION: In community-dwelling older persons, the combination of a long-term lifestyle MI and omega-3 supplementation did not reduce frailty level or incidence. The reduction of frailty incidence associated with the combined intervention in a sensitivity analysis needs to be further confirmed. J Am Geriatr Soc 67:1700-1706, 2019.

Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy.

OBJECTIVES: The aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Several issues remain unresolved post-TAVR, including CVEs. METHODS: The FRANCE-2 (French Aortic Nation CoreValve and Edwards-2) registry prospectively included all patients who underwent TAVR in France and Monaco from January 2010 to October 2011. A total of 3,191 patients were analyzed. Six-month follow-up data were obtained. Events were adjudicated according to Valve Academic Research Consortium (VARC)-1 definition. RESULTS: Of the cohort, 3.98% experienced a CVE: 55% were major strokes, 14.5% minor strokes, and 30.5% transient ischemic attacks. The mean delay for CVE occurrence was 2 days (interquartile range: 0 to 7 days) with 48.5% of CVEs occurring within 2 days. There was no statistically significant difference in CVE rate with regard to the type of valve (p = 0.899) and the access route (p = 0.128). Patients with a CVE more frequently had new-onset paroxysmal atrial fibrillation (13.6% vs. 7.6%; p = 0.015). During follow-up, the unadjusted mortality rate was higher in patients with a CVE (26% vs. 16.5%; p = 0.002). By multivariate analysis, only advanced age (odds ratio: 1.05; 95% confidence interval: 1.02 to 1.08; p = 0.02) and having 2 valves implanted (odds ratio: 3.13; 95 confidence interval: 1.40 to 7.05; p = 0.006) were associated with a significant risk of CVEs. CONCLUSIONS: CVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE.