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  • 1.
    Andreassen, A. K.
    et al.
    Oslo University Hospital, Norway.
    Andersson, B.
    Sahlgrens University Hospital, Sweden.
    Gustafsson, F.
    Rigshosp, Denmark.
    Eiskjaer, H.
    Aarhus University Hospital, Denmark.
    Radegran, G.
    Lund University, Sweden; Lund University, Sweden.
    Gude, E.
    Oslo University Hospital, Norway.
    Jansson, Kjell
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Clinical Physiology in Linköping.
    Solbu, D.
    Novartis Norge AS, Norway.
    Karason, K.
    Sahlgrens University Hospital, Sweden.
    Arora, S.
    Oslo University Hospital, Norway.
    Dellgren, G.
    Sahlgrens University Hospital, Sweden.
    Gullestad, L.
    Oslo University Hospital, Norway; University of Oslo, Norway; University of Oslo, Norway.
    Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study2016In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 16, no 4, p. 1238-1247Article in journal (Refereed)
    Abstract [en]

    In a randomized, open-label trial, de novo heart transplant recipients were randomized to everolimus (3-6ng/mL) with reduced-exposure calcineurin inhibitor (CNI; cyclosporine) to weeks 7-11 after transplant, followed by increased everolimus exposure (target 6-10ng/mL) with cyclosporine withdrawal or standard-exposure cyclosporine. All patients received mycophenolate mofetil and corticosteroids. A total of 110 of 115 patients completed the 12-month study, and 102 attended a follow-up visit at month 36. Mean measured GFR (mGFR) at month 36 was 77.4mL/min (standard deviation [SD] 20.2mL/min) versus 59.2mL/min (SD 17.4mL/min) in the everolimus and CNI groups, respectively, a difference of 18.3mL/min (95% CI 11.1-25.6mL/min; p < 0.001) in the intention to treat population. Multivariate analysis showed treatment to be an independent determinant of mGFR at month 36. Coronary intravascular ultrasound at 36 months revealed significantly reduced progression of allograft vasculopathy in the everolimus group compared with the CNI group. Biopsy-proven acute rejection grade 2R occurred in 10.2% and 5.9% of everolimus- and CNI-treated patients, respectively, during months 12-36. Serious adverse events occurred in 37.3% and 19.6% of everolimus- and CNI-treated patients, respectively (p=0.078). These results suggest that early CNI withdrawal after heart transplantation supported by everolimus, mycophenolic acid and steroids with lymphocyte-depleting induction is safe at intermediate follow-up. This regimen, used selectively, may offer adequate immunosuppressive potency with a sustained renal advantage. A follow-up study of the SCHEDULE trial, which randomized de novo heart transplant recipients to everolimus with cyclosporine discontinuation or to standard-exposure cyclosporine, shows that measured glomerular filtration rate remains significantly higher in the everolimus group at three years posttransplant, with significantly reduced progression of allograft vasculopathy compared to cyclosporine therapy.

  • 2.
    Andreassen, A.K.
    et al.
    University of Oslo, Norway .
    Andersson, B.
    Sahlgrens University Hospital, Sweden .
    Gustafsson, F.
    Rigshosp, Denmark .
    Eiskjaer, H.
    Aarhus University Hospital, Denmark .
    Rdegran, G.
    Skåne University Hospital, Sweden Lund University, Sweden .
    Gude, E.
    University of Oslo, Norway .
    Jansson, Kjell
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Department of Cardiology in Linköping.
    Solbu, D.
    Novartis Norge AS, Norway .
    Sigurdardottir, V.
    Sahlgrens University Hospital, Sweden .
    Arora, S.
    University of Oslo, Norway .
    Dellgren, G.
    Sahlgrens University Hospital, Sweden .
    Gullestad, L.
    University of Oslo, Norway University of Oslo, Norway University of Oslo, Norway .
    Everolimus Initiation and Early Calcineurin Inhibitor Withdrawal in Heart Transplant Recipients: A Randomized Trial2014In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 14, no 8, p. 1828-1838Article in journal (Refereed)
    Abstract [en]

    In a randomized, open-label trial, everolimus was compared to cyclosporine in 115 de novo heart transplant recipients. Patients were assigned within 5 days posttransplant to low-exposure everolimus (3-6 ng/mL) with reduced-exposure cyclosporine (n 56), or standard-exposure cyclosporine (n = 59), with both mycophenolate mofetil and corticosteroids. In the everolimus group, cyclosporine was withdrawn after 7-11 weeks and everolimus exposure increased (6-10 ng/mL). The primary efficacy end point, measured GFR at 12 months posttransplant, was significantly higher with everolimus versus cyclosporine (mean +/- SD: 79.8 +/- 17.7 mL/min/1.73m 2 vs. 61.5 +/- 19.6 mL/min/1.73m 2; pless than0.001). Coronary intravascular ultrasound showed that the mean increase in maximal intimal thickness was smaller (0.03 mm [95% CI 0.01, 0.05 mm] vs. 0.08 mm [95% CI 0.05, 0.12 mm], p = 0.03), and the incidence of cardiac allograft vasculopathy (CAV) was lower (50.0% vs. 64.6%, p = 0.003), with everolimus versus cyclosporine at month 12. Biopsy-proven acute rejection after weeks 7-11 was more frequent with everolimus (p = 0.03). Left ventricular function was not inferior with everolimus versus cyclosporine. Cytomegalovirus infection was less common with everolimus (5.4% vs. 30.5%, pless than0.001); the incidence of bacterial infection was similar. In conclusion, everolimus-based immunosuppression with early elimination of cyclosporine markedly improved renal function after heart transplantation. Since postoperative safety was not jeopardized and development of CAV was attenuated, this strategy may benefit long-term outcome.

  • 3.
    Arora, Satish
    et al.
    Oslo University Hospital Rikshospitalet, Norway.
    Erikstad, I.
    Oslo University Hospital Rikshospitalet, Norway.
    Ueland, T.
    Oslo University Hospital Rikshospitalet, Norway.
    Sigurdardottir, V.
    Sahlgrenska University Hospital, Gothenburg, Sweden.
    Ekmehag, B.
    Skåne University Hospital and Lund University, Lund, Sweden.
    Jansson, Kjell
    Linköping University, Department of Medical and Health Sciences, Cardiology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Cardiology UHL.
    Eiskjaer, H.
    Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Cardiology UHL.
    Bøtker, H. E.
    Skejby University Hospital, Denmark .
    Mortensen, S.-A.
    Rigshospitalet, Copenhagen, Denmark.
    Saunamaki, K.
    Rigshospitalet, Copenhagen, Denmark.
    Gude, E.
    Oslo University Hospital Rikshospitalet, Norway.
    Ragnarsson, A.
    Oslo University Hospital Rikshospitalet, Norway.
    Solbu, D.
    Medical Department, Novartis, Norway .
    Gullestad, L
    Oslo University Hospital Rikshospitalet, Norway.
    Virtual Histology Assessment of Cardiac Allograft Vasculopathy Following Introduction of Everolimus—Results of a Multicenter Trial2012In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 12, no 10, p. 2700-2709Article in journal (Refereed)
    Abstract [en]

    In this 12-month multicenter Scandinavian study, 78 maintenance heart transplant (HTx) recipients randomized to everolimus with reduced calcineurin inhibitor (CNI) exposure or continued standard CNI-therapy underwent matched virtual histology (VH) examination to evaluate morphological progression of cardiac allograft vasculopathy (CAV). Parallel measurement of a range of inflammatory markers was also performed. A similar rate of quantitative CAV progression was observed in the everolimus (n = 30) and standard CNI group (n = 48) (plaque index 1.9 +/- 3.8% and 1.6 +/- 3.9%, respectively; p = 0.65). However, VH analysis revealed a significant increase in calcified (2.4 +/- 4.0 vs. 0.3 +/- 3.1%; p = 0.02) and necrotic component (6.5 +/- 8.5 vs. 1.1 +/- 8.6%; p = 0.01) among everolimus patients compared to controls. The increase in necrotic and calcified components was most prominent in everolimus patients with time since HTx andgt;5.1 years and was accompanied by a significant increase in levels of von Willebrand (vWF) factor (p = 0.04) and vascular cell adhesion molecule (VCAM) (p = 0.03). Conversion to everolimus and reduced CNI is associated with a significant increase in calcified and necrotic intimal components and is more prominent in patients with a longer time since HTx. A significant increase in vWF and VCAM accompanied these qualitative changes and the prognostic implication of these findings requires further investigation.

  • 4.
    Holdaas, H.
    et al.
    Rikshospitalet, Oslo, Norway.
    Fellstrom, B.
    Fellström, B., University Hospital, Uppsala, Sweden.
    Cole, E.
    University Health Network, Toronto, Canada.
    Nyberg, G.
    Sahlgrenska Academy, Göteborg, Sweden.
    Olsson, Anders G.
    Linköping University, Department of Medical and Health Sciences, Internal Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Endocrinology and Gastroenterology UHL.
    Pedersen, T.R.
    Ulleval University Hospital, Oslo, Norway.
    Madsen, S.
    Skejby Hospital, Aarhus, Denmark.
    Gronhagen-Riska, C.
    Grönhagen-Riska, C., Helsinki University Central Hospital, Helsinki, Finland.
    Neumayer, H.-H.
    Charité, Universitätsmedizin, Berlin, Germany.
    Maes, B.
    University Hospital, Leuven, Belgium.
    Ambuhl, P.
    Ambühl, P., University Hospital, Zürich, Switzerland.
    Hartmann, A.
    Rikshospitalet, Oslo, Norway.
    Staffler, B.
    Novartis Pharma AG, Basel, Switzerland.
    Jardine, A.G.
    University of Glasgow, Glasgow, United Kingdom.
    Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin: The ALERT extension study2005In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 5, no 12, p. 2929-2936Article in journal (Refereed)
    Abstract [en]

    Renal transplant recipients (RTR) have an increased risk of premature cardiovascular disease. The ALERT study is the first trial to evaluate the effect of statin therapy on cardiac outcomes following renal transplantation. Patients initially randomized to fluvastatin or placebo in the 5-6 year ALERT study were offered open-label fluvastatin XL 80 mg/day in a 2-year extension to the original study. The primary endpoint was time to first major adverse cardiac event (MACE). Of 1787 patients who completed ALERT, 1652 (92%) were followed in the extension. Mean total follow-up was 6.7 years. Mean LDL-cholesterol was 98 mg/dL (2.5 mmol/L) at last follow-up compared to a pre-study level of 159 mg/dL (4.1 mmol/L). Patients randomized to fluvastatin had a reduced risk of MACE (hazards ratio [HR] 0.79, 95% CI 0.63-0.99, p = 0.036), and a 29% reduction in cardiac death or definite non-fatal MI (HR 0.71, 95% CI 0.55-0.93, p = 0.014). Total mortality and graft loss did not differ significantly between groups. Fluvastatin produces a safe and effective reduction in LDL-cholesterol associated with reduced risk of MACE in RTR. The lipid-lowering and cardiovascular benefits of fluvastatin are comparable to those of statins in other patient groups, and support use of fluvastatin in RTR. Copyright © Blackwell Munksgaard 2005.

  • 5.
    Olsson, Anders
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Internal Medicine. Östergötlands Läns Landsting, Centre for Medicine, Department of Endocrinology and Gastroenterology UHL.
    Jardine, A
    Holdaas, H
    Fellström, B
    Cole, E
    Nyberg, G
    Grönhagen-Riska, C
    Madsen, S
    Neumayer, H-H
    Maes, B
    Fluvastatin prevents cardiac death and myocardial infarction in renal transplant recipients: Post-hoc subgroup analyses of the ALERT study2004In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 4, no 6, p. 988-995Article in journal (Refereed)
    Abstract [en]

    Renal transplant recipients have a greatly increased risk of premature cardiovascular disease. The ALERT study was a multicenter, randomized, double-blind, placebo-controlled trial of fluvastatin (40-80 mg/day) in 2102 renal transplant recipients followed for 5-6 years. The main study used a composite cardiac end-point including myocardial infarction, cardiac death and cardiac interventions. Although reduced by fluvastatin, this primary end-point failed to achieve statistical significance thus precluding analysis of predefined subgroups. Therefore, in the present survival analysis, we used an alternative primary end-point of cardiac death or definite nonfatal myocardial infarction (as used in other cardiac outcome trials) which was significantly reduced by Fluvastatin therapy and permits subgroup analysis. Fluvastatin reduced LDL-cholesterol by 1 mmol/L compared with placebo, and the incidence of cardiac death or definite myocardial infarction was reduced from 104 to 70 events (RR 0.65, 95% CI 0.48, 0.88, p = 0.005). Fluvastatin use was associated with reduction in cardiac death or nonfatal myocardial infarction, which achieved statistical significance in many subgroups. The subgroups included patients at lower cardiovascular risk, who were younger, nondiabetic, nonsmokers and without pre-existing CVD. These data support the early introduction of statins following renal transplantation.

  • 6.
    Poole, Jennifer
    et al.
    Ryerson University, Toronto.
    Shildrick, Margrit
    Queens University, Belfast.
    De Luca, Enza
    University Health Network, University of Toronto.
    Abbey, Susan E
    University Health Network, University of Toronto.
    Mauthner, Oliver E.
    University Health Network, University of Toronto.
    McKeever, Patricia
    Bloorview Research Institute, University of Toronto.
    Ross, Heather J.
    University Health Network, University of Toronto.
    On Heart Transplants and Distress: A Qualitative Response to Selves and Burroughs2010In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 11, no 9, p. 1996-1997Article, review/survey (Other academic)
  • 7.
    Poole, Jennifer
    et al.
    Ryerson University, Toronto.
    Shildrick, Margrit
    Queens University, Belfast.
    De Luca, Enza
    University Health Network, University of Toronto.
    Abbey, Susan E.
    University Health Network, University of Toronto.
    Mauthner, Oliver E.
    University Health Network, University of Toronto.
    McKeever, Patricia
    Bloorview Research Institute, University of Toronto.
    Ross, Heather J.
    University Health Network, University of Toronto.
    The obligation to say 'thank you': Heart transplant recipients experience of writing to the donor family2010In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 11, no 3, p. 619-622Article in journal (Refereed)
    Abstract [en]

    Transplant recipients are encouraged to write anonymous thank-you letters to the donor family. We prospectively explored heart transplant recipients' embodied responses to the 'obligation' to write a thank-you letter using audio/video-taped open-ended interviews (N = 27). Fifteen of the 19 participants, who wrote letters to the donor family, expressed or visually revealed significant distress about issues such as the obligation to write anonymously and the inadequacy of the 'thank-you'. Writing the thank-you letter is not a neutral experience for heart transplant recipients. Rethinking the obligatory practice regarding the thank-you letter and developing the necessary support for the recipient through this process is necessary.

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