Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system

ObjectiveEndovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif).MethodsThis prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee.ResultsAmong 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases.ConclusionsEarly results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up

Who pays for home care? A study of nationally representative data on disabled older Americans

Background: We examine who pays for services that support disabled older Americans at home. We consider both personal sources (e.g., out-of-pocket payment, family members) and publicly funded programs (e.g., Medicaid) as sources of payment for services. We examine how the funding mix for home care services is related to older people’s economic resources, needs for care, and other socio-demographic characteristics. Methods: Our sample consists of 11,725 person-years from the 1989, 1994, 1999, and 2004 waves of the National Long-Term Care Survey. Two-part regression analyses were performed to model hours of care received from each payer. “Random effects” and “fixed effects” estimation yielded similar results. Results: About six in ten caregivers (63 %) providing home care services are paid by personal sources alone. By contrast, 28 % receive payment from publicly funded programs alone, and 9 % from a combination of personal and public program sources. Older people with family incomes over 75,000 dollars per year receive 8.5 more hours of home care overall than those in the lowest income category (less than 15,000 dollars). While the funding mix for home care services is strongly related to older people’s economic resources, in all income groups at least 65 % of services are provided by caregivers paid in whole or in part from personal sources. In fact, almost all (97 %) home care received by those with family incomes over 75,000 dollars per year are financed by personal sources alone. Conclusions: We outline the implications that heavy reliance on personally financed services and economic disparities in overall services use has for disabled older Americans and their families

Between elderly parents and adult children: a new look at the intergenerational care provided by the ‘sandwich generation’

The ‘sandwich generation’ has been conceptualised as those mid-life adults who simultaneously raise dependent children and care for frail elderly parents. Such a combination of dependants is in fact very unusual, and the more common situation is when adults in late mid-life or early old age have one or more surviving parents and adult but still partly dependent children. It can be hypothesised that for parents in this pivotal position, the demands from adult children and from elderly parents compete, with the result that those who provide help to one are less likely to provide help to the other. An alternative hypothesis, however, is that family solidarity has an important influence but is not universal, so that some pivotal-generation parents engage in intergenerational exchange in both directions, and there is a positive association between helping parents and helping children. To investigate this question, the paper presents an analysis of data from two broadly comparable national surveys, in Great Britain and the United States, on the care provided by women aged 55–69 years to their descendent and ascendent relatives. The results show that around one-third of the women reported providing help to members of both generations, and that around one-fifth provided support to neither. They broadly support the solidarity hypothesis, but provide some evidence that having three or more children is associated with a reduced likelihood of providing help to a parent.</jats:p

Early motherhood and mental health in midlife: a study of British and American cohorts.

OBJECTIVES: Examine the relationship between early age at first birth and mental health among women in their fifties. METHODS: Analysis of data on women from a British 1946 birth cohort study and the U.S. Health and Retirement Study birth cohort of 1931-1941. RESULTS: In both samples a first birth before 21 years, compared to a later first birth, is associated with poorer mental health. The association between early first birth and poorer mental health persists in the British study even after controlling for early socioeconomic status, midlife socioeconomic status and midlife health. In the U.S. sample, the association becomes non-significant after controlling for educational attainment. CONCLUSIONS: Early age at first birth is associated with poorer mental health among women in their fifties in both studies, though the pattern of associations differs

The influence of socio-economic and health differences on parents' provision of help to adult children: a British–United States comparison

Transfers of assistance from older to younger family members are an important, though often ignored, component of intergenerational exchanges. The ability to help younger family members, either financially or practically, may be influenced by the health and socio-economic status of older parents, but very little is known about these patterns. This article examines the effects of socio-economic and health status on the help that late mid-life parents in Britain and the United States give their children with money, domestic tasks, and grandchild care. Results for the different types of family support yield three main findings. First, there are relatively few differences between Britain and the USA in the factors affecting the provision of support. Secondly, socioeconomic factors appear to be more important among married respondents while health is more important among the unmarried. Thirdly, children's co-residence has greater effects on the provision of domestic task help in Britain than in the United States

Early-life circumstances and later-life loneliness in ireland.

Purpose of the study: This article examines the impact of early- and later-life circumstances on loneliness among people aged 65+ in Ireland. Design and methods: Data are from the first wave of the Irish Longitudinal Study on Ageing, a nationally representative sample of community-dwelling adults aged 50+. The participants (N = 2,645) aged 65+ were included in the analysis. Because of the large number of never married persons in the older Irish population, we first used a multinomial logistic model to examine which childhood circumstances are associated with current marital status. We then estimated multiple regression models for loneliness, in stages conforming to the life course, to examine the extent to which early events are mediated by later events. Results: Poor childhood socioeconomic status (for men and women) and parental substance abuse (for men) have direct effects on loneliness at older ages. Implications: The results indicate the significance of the childhood environment for understanding loneliness in later life. Future research should examine possible pathways not currently measured that may be responsible for the association of early environment and later-life loneliness and explore the links between childhood and other measures of well-being in old age. The relationship of childhood socioeconomic deprivation and parental substance abuse with adult well-being should be an important consideration in social policy planning