CRT-700.34 Short-Term Outcomes Among Aortic Valve Stenosis Patients Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention

Background: Among patients undergoing percutaneous coronary intervention (PCI), severe aortic stenosis (AS) is associated with an increased risk of adverse outcomes. Although the use of mechanical circulatory support with Impella has been shown to improve 90-day outcomes in patients undergoing high-risk PCI (HRPCI), there is little information about the safety of this approach in pts with severe AS. We, therefore, sought to evaluate the efficacy and safety outcomes of Impella-supported HRPCI among patients with varying severity of AS. Methods: We studied patients enrolled in PROTECT III—a multicenter study of patients undergoing Impella-supported HRPCI. Patients were classified according to the severity of AS: none/trivial, mild, moderate, and severe. The primary outcome was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 90 days, defined as the composite of all-cause death, MI, stroke/ TIA, and revascularization. Secondary outcomes included in-hospital PCI-related complications, stroke/TIA, and vascular complications requiring surgery. Results: Of 596 patients with echocardiographic data, 490 had no/trivial AS, and 34, 27, and 45 had mild, moderate, or severe AS, respectively. Patients with AS were older, less likely to have diabetes, more likely to have left main disease, and had higher left ventricular ejection fractions (Table). Severely calcified lesions and the use of atherectomy were more frequent among patients with moderate or severe AS. There were no differences in rates of PCI-related complications, stroke/TIA, 30-day MACCE, or 90-day MACCE according to AS severity. Rates of transfusion were higher among patients with AS—regardless of severity. Conclusion: Among patients undergoing Impella-supported HRPCI, PCI-related complications and 90-day outcomes did not differ based on AS status or severity

Man and the Last Great Wilderness: Human Impact on the Deep Sea

The deep sea, the largest ecosystem on Earth and one of the least studied, harbours high biodiversity and provides a wealth of resources. Although humans have used the oceans for millennia, technological developments now allow exploitation of fisheries resources, hydrocarbons and minerals below 2000 m depth. The remoteness of the deep seafloor has promoted the disposal of residues and litter. Ocean acidification and climate change now bring a new dimension of global effects. Thus the challenges facing the deep sea are large and accelerating, providing a new imperative for the science community, industry and national and international organizations to work together to develop successful exploitation management and conservation of the deep-sea ecosystem. This paper provides scientific expert judgement and a semi-quantitative analysis of past, present and future impacts of human-related activities on global deep-sea habitats within three categories: disposal, exploitation and climate change. The analysis is the result of a Census of Marine Life – SYNDEEP workshop (September 2008). A detailed review of known impacts and their effects is provided. The analysis shows how, in recent decades, the most significant anthropogenic activities that affect the deep sea have evolved from mainly disposal (past) to exploitation (present). We predict that from now and into the future, increases in atmospheric CO2 and facets and consequences of climate change will have the most impact on deep-sea habitats and their fauna. Synergies between different anthropogenic pressures and associated effects are discussed, indicating that most synergies are related to increased atmospheric CO2 and climate change effects. We identify deep-sea ecosystems we believe are at higher risk from human impacts in the near future: benthic communities on sedimentary upper slopes, cold-water corals, canyon benthic communities and seamount pelagic and benthic communities. We finalise this review with a short discussion on protection and management methods

Proactive Peer (Mother-to-Mother) Breastfeeding Support by Telephone (Ringing up About Breastfeeding Early [RUBY]):A Multicentre, Unblinded, Randomised Controlled Trial

Background: Breastfeeding rates are suboptimal internationally, and many infants are not receiving any breast milk at all by six months of age. Few interventions increase breastfeeding duration, particularly where there is relatively high initiation. The effect of proactive peer (mother-to-mother) support has been found to increase breastfeeding in some contexts but not others, but if it is shown to be effective would be a potentially sustainable model in many settings. We aimed to determine whether proactive telephone-based peer support during the postnatal period increases the proportion of infants being breastfed at six months of age. Methods: RUBY (Ringing Up about Breastfeeding earlY) was a multicentre, two-arm un-blinded randomised controlled trial conducted in three hospitals in Victoria, Australia. First-time mothers intending to breastfeed were recruited after birth and prior to hospital discharge, and randomly assigned (1:1) to usual care or usual care plus proactive telephone-based breastfeeding support from a trained peer volunteer for up to six months postpartum. A computerised random number program generated block sizes of four or six distributed randomly, with stratification by site. Research midwives were masked to block size, but masking of allocation was not possible. The primary outcome was the proportion of infants receiving any breast milk at six months of age. Analyses were by intention to treat; data were collected and analysed masked to group. The trial is registered with ACTRN, number 12612001024831. Findings: Women were recruited between Feb 14, 2013 and Dec 15, 2015 and randomly assigned to peer support (n = 574) or usual care (n = 578). Five were not in the primary analysis [5 post-randomisation exclusions]. Infants of women allocated to telephone-based peer support were more likely than those allocated to usual care to be receiving breast milk at six months of age (intervention 75%, usual care 69%; Adj. RR 1·10; 95% CI 1·02, 1·18). There were no adverse events. Interpretation: Providing first time mothers with telephone-based support from a peer with at least six months personal breastfeeding experience is an effective intervention for increasing breastfeeding maintenance in settings with high breastfeeding initiation. Funding: The Felton Bequest, Australia, philanthropic donation and La Trobe University grant. Keywords: Breastfeeding, Clinical trial, Peer support, Telephone intervention, Peer volunteer, Community-base

May 2017 Meeting

Notes from the May Meetin

A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit

Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit. To examine whether CoQ10 could slow disease progression in early PD. A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation. The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E. Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo. The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants required treatment (94 received placebo, 87 received 1200 mg/d of CoQ10, and 86 received 2400 mg/d of CoQ10), and 65 participants (29 who received placebo, 19 who received 1200 mg/d of CoQ10, and 17 who received 2400 mg/d of CoQ10) withdrew prematurely. Treatments were well tolerated with no safety concerns. The study was terminated after a prespecified futility criterion was reached. At study termination, both active treatment groups showed slight adverse trends relative to placebo. Adjusted mean changes (worsening) in total UPDRS scores from baseline to final visit were 6.9 points (placebo), 7.5 points (1200 mg/d of CoQ10; P = .49 relative to placebo), and 8.0 points (2400 mg/d of CoQ10; P = .21 relative to placebo). Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit. clinicaltrials.gov Identifier: NCT00740714

13Th International Conference On Conservative Management Of Spinal Deformities And First Joint Meeting Of The International Research Society On Spinal Deformities And The Society On Scoliosis Orthopaedic And Rehabilitation Treatment – Sosort-Irssd 2016 Meeting

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