Expert:

Prof. Dr. med. Markus J. Barten

Institution:

University Heart & Vascular Center Hamburg, Department of Cardiovascular Surgery, Hamburg, Germany

Speciality:

Heart and Lung Transplantation (HTx and LuTx)

Therapeutic Areas of interest:

ECP in Heart Transplantation

Expertise:

Principal investigator and first author of the European multicenter study on the real-world use and clinical impact of extracorporeal photopheresis after heart transplantation 2023
Member of the External Expert Advisory Board: exTra - Innovative applications of ECP in SOT (Horizon Europe Programme) HTx and LTx postcare
Cardiac surgeon from education

Bio:

Prof. Barten has worked in Transplantation Centres of Excellence across Europe and North America for more than 25 years
His clinical research focus is on therapeutic monitoring of immunosuppressive drugs, management of AMR and de novo DSA, monitoring and treatment of viral infections, e.g. CMV, and developing renal sparing regimens
Membership in international transplantation societies: International Society of Heart- and Lung Transplantation (ISHLT), The Transplantation Society (TTS), European Society of Organ transplantation (ESOT), Swiss Transplantation Society (STS)
Afiliations and congress activities in the transplantation societies: ISHLT 2025 Program
Planning Committee for the ISHLT 45th Annual Meeting and Scientific Sessions Boston (April 2025); Member of the ISHLT expert group to develop guidelines for AMR after HTx 2023; TTS abstract reviewer and presenter; ESOT member of the expert group for ECP after SOT; STS jury head for the awards since 2018
Member of the editorial staf of scientific journals: Transplantation, Cytometry A Reviewer of scientific journals: Journal Heart and Lung Transplantation, American Journal of Transplantation, European Society of Cardiology Heart Failure, Transplantation, Transplantation International

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

Indications

The THERAKOS^TM CELLEX^TM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications

THERAKOS^TM Photopheresis is contraindicated in:

Patients possessing a specific history of a light sensitive disease.
Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm³.
Patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions

THERAKOS^TM Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure. Safety in children has not been established.

Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
When prescribing and administering THERAKOS^TM Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
Treatment frequency exceeding labelling recommendations may result in anaemia.
Venous access carries a small risk of infection and pain.

Please refer to the THERAKOS^TM CELLEX^TM Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

Contraindications

Methoxsalen is contraindicated in:

Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients
Patients with co-existing melanoma, basal cell or squamous cell skin carcinoma
Patients who are pregnant, and sexually active men and women of childbearing potential unless adequate contraception is used during treatment
Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens

Warnings and Precautions

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
Safety in children has not been established.

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOS^TM CELLEX^TMPhotopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.

Expert:

Prof. Dr. med. Markus J. Barten

Expertise:

Bio:

Request to book a session with Prof. Dr. med. Markus J. Barten

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS