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P-18.36 Outcomes of everolimus after heart transplantation

Maria Simonenko, Russian Federation

Cardiologist, Transplant Physician, Clinical Research Fellow
Heart Transplantation
Almazov National Medical Research Centre

Abstract

Outcomes of everolimus after heart transplantation

Maria Simonenko1,6, Petr Fedotov2, Yulia Sazonova3,4, Maria Bortsova4, Lubov Mitrofanova5, Aelita Berezina6, Maria Sitnikova7, German Nikolaev3, Mikhail Gordeev8, Mikhail Karpenko9.

1Heart Transplantation Department, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 2Heart Failure SRL, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 3Thoracic Surgery SRL, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 4Cardio Department №8, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 5Pathomorphology SRL, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 6Cardiopulmonary Exercise Test SRL, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 7Heart Failure Research Department, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 8Cardio Thoracic Surgery Research Department, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation; 9Scientific Clinical Council, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation

Purpose: to estimate the outcomes of patients managed with everolimus (EVL) after heart transplantation (HTx).
Materials and methods: From January 2010 to November 2019 it was performed 134 HTx (46±14 yrs-old, n=99 – male). Patients were managed with triple-drug therapy (tacrolimus (TAC), mycophenolate mofetil (MMF), steroids) plus induction (basiliximab – 81%; thymoglobulin – 15%; no induction – 4%). We retrospectively estimated outcomes of EVL treated patients.
Results: From 1 month to 6 years after HTx immunosuppressive regimen was changed to concentration-controlled EVL (initial dose 1.5 mg/day, C0 target 3-8 ng/ml) and reduced-exposure TAC in 28% (n=37) of patients (51±13 yrs-old; n=26 - male). Basiliximab was used as an induction therapy in 33 of them. There was no de novo use of EVL following HTx. Indications for EVL treatment were as follows: chronic kidney disease (CKD; n=24), cardiac allograft vasculopathy (CAV; n=10), progression of atherosclerosis (n=2), oncology (n=1 – breast cancer prior to HTx; n=6 after HTx: 1 – lung cancer, 1 – basal cell carcinoma, 4 – colorectal polyps), severe leucopenia (n=3) and clinically significant tremor (n=2). Seven patients had a few indications or they were developed after recipients were switched to EVL therapy. EVL was discontinued in 7 patients from 3 to 6 months after conversion due to infectious complications (n=5: 4 - pneumonia, 1 - acute cholecystitis with subhepatic abscess), interstitial pneumonitis (IP; n=3: 2 – one month after initiated treatment), steroid-resistant and recurrent rejection (n=2). IP was successfully managed with 1-3 months steroid treatment. Due to the frequency of infectious complications our C0 target for everolimus - 3.0-6.5 ng/ml. There was no difference in a frequency of rejection between patients on TAC+MMF or rTAC+EVL. In 14% (n=5) of recipients dyslipidemia progressed and in 2 of them it was normalized only after the combination of atorvastatin (20mg/per day) plus fenofibrate (145 mg/per day). Leucopenia has been noted in 5 patients but only 2 of them had indications for CSFs management. Creatinine normalized only in 4 from 24 recipients. Despite EVL treatment we registered the progression of CAV, atherosclerosis or the onset of oncology in 17% of cases. Four EVL treated recipients died due to VFib (n=2; also associated with AKI and infectious complications), chronic rejection, CAV (n=1) and lung cancer (n=1).
Conclusion: One-fourth of patients were managed with EVL. Frequent indications for EVL were CKD and CAV. Concentration-controlled EVL (C0 target 3.0-6.5 ng/ml) in combination with reduced TAC achieved good efficacy and safety, higher C0 target was associated with frequent infectious complications. Patients need to be screened for EVL adverse effects, especially during first 6 months.

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