Background And Aim Of The Study: The study aim was to compare preoperative and intraoperative features, and long-term outcome of patients operated on for native (NVE) and primary prosthetic valve endocarditis (PVE).
Methods: Between January 1978 and December 2002, 258 patients (mean age 47.5 +/- 16 years) were referred for NVE, and 95 for PVE. Demographics, clinical preoperative conditions, indications to surgery, microbiological data, surgical pathology, early postoperative course and long-term outcome were compared via hospital chart review and outpatient clinic follow up.
Results: Female sex prevailed in the PVE group (49.5%) versus NVE (27.1%; p < 0.0001). Mitral valve involvement was more common in PVE (46.3% versus 24.8%, p = 0.0001), and multivalvular in 16.3% of NVE patients versus 4.2% of PVE (p = 0.001). Active endocarditis (80.6% versus 58.9%, p = 0.00004) and preoperative embolism (29.5% versus 11.6%, p = 0.0002) were significantly prevalent in the NVE group. Emergency operation (21.1% versus 10.5%, p = 0.009) and preoperative NYHA class IV or V (40% versus 19.8%, p < 0.0001) were significantly more frequent in PVE. Overall hospital mortality was 11.3% (n = 40), with 6.6% among NVE patients and 24.2% among PVE (p < 0.0001). Mean follow up (94% complete) was 5.8 +/- 5.3 years (6.0 +/- 5.5 years for NVE versus 5.1 +/- 4.6 years for PVE, p = 0.191), and total follow up was 1,707.85 patient-years. Actuarial survival at 1, 5, 10 and 15 years was respectively 91, 82, 67.5 and 48.8% in NVE, and 79.7, 64.2, 33.5 and 33.5% in PVE (p = 0.0016). A significantly lower survival in PVE versus NVE was found for the mitral site subgroup (p = 0.018), but not for the aortic site (p = 0.14). Actuarial freedom from reoperation for recurrent endocarditis at 1, 5, 10 and 15 years was 97.5, 91.4, 80.5 and 49.4% in NVE versus 90.8, 84.9, 59.4 and 43.9% in PVE (p = 0.015).
Conclusion: PVE patients were older, presented with more compromised clinical conditions, and had worse early and long-term outcomes than NVE patients. PVE had a higher incidence of recurrence and worse prognosis, especially if the mitral valve was involved.
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Neurology
August 2015
From Janssen Alzheimer Immunotherapy Research & Development, LLC (E.L., R.M., P.C., K.M.G., J.D., Y.L., I.C.T., S.B., E.Y., H.R.B.), South San Francisco, CA; Janssen Pharmaceutical (M.E.S.), Beerse, NV; Brigham & Women's Hospital (R.S.), Boston, MA; University of Michigan (R.K.), Ann Arbor; University of Pittsburgh (N.S.M., W.E.K., C.A.M.), PA; Butler Hospital (S.S.), Providence, RI; UCL Institute of Neurology (N.C.F.), London, UK; IXICO plc (D.L.H., A.S.L.), London, UK; Pfizer Inc. (B.T.W.), Groton, CT; Pfizer Inc. (K.B.), Collegeville, PA; Global R&D Partners, LLC (M.G.), San Diego, CA; and University of California (M.G.), San Diego.
Objective: To evaluate the effects of bapineuzumab on brain β-amyloid (Aβ) burden using (11)C-Pittsburgh compound B ((11)C-PiB)-PET.
Methods: Two phase 3 clinical trials, 1 each in apolipoprotein APOE ε4 carriers and noncarriers, were conducted in patients with mild to moderate Alzheimer disease dementia. Bapineuzumab, an anti-Aβ monoclonal antibody, or placebo, was administered by IV infusion every 13 weeks for 78 weeks.
N Engl J Med
January 2014
From Butler Hospital, Providence, RI (S.S.); Brigham and Women's Hospital, Boston (R.S.); University College London, Institute of Neurology, London (N.C.F.); University of Göteborg, Sahlgrenska University Hospital, Mölndal, Sweden (K.B.); University of Pittsburgh, Pittsburgh (W.K.); Veterans Affairs Medical Center, Seattle (M.R.); Cleo Roberts Center for Clinical Research/Sun Health Research Institute, Sun City, AZ (M.S.); Columbia University (L.S.H.) and New York University Langone Medical Center (S.F.), New York; University of Rochester School of Medicine and Dentistry, Rochester, NY (A.P.P.); Janssen Alzheimer Immunotherapy Research and Development, South San Francisco, CA (M.R., N.K., B.N., V.G., M.M., D.W., Y.L., I.C.T., E.L., E.Y., H.R.B.); Janssen Research and Development, Titusville, NJ (J.L.); Global R&D Partners and the University of California, San Diego - both in San Diego (M.G.); and Pfizer, Collegeville, PA (R.B.).
Background: Bapineuzumab, a humanized anti-amyloid-beta monoclonal antibody, is in clinical development for the treatment of Alzheimer's disease.
Methods: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials involving patients with mild-to-moderate Alzheimer's disease--one involving 1121 carriers of the apolipoprotein E (APOE) ε4 allele and the other involving 1331 noncarriers. Bapineuzumab or placebo, with doses varying by study, was administered by intravenous infusion every 13 weeks for 78 weeks.
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