Lipoprotein apheresis standard for apheresis competence centers--an updated synthesis and amendment to pre-existing standards.

With several techniques of selective apheresis treatment, some of which have been established for over 30 years, severe and pharmacologically unmanageable dyslipidemia can be treated successfully. The long-term lowering of LDL cholesterol and lipoprotein(a) by 60-80 percent, together with pleiotropic effects, allow for significant risk reduction in otherwise progressive chronic atherosclerotic disease, i.e. chronic coronary artery disease in most apheresis patients, and improvement of quality of life. For various reasons, worldwide only an estimated 2500 patients, among them 1400 to 1500 in Germany, are regularly treated by apheresis. This relatively small number of apheresis patients in Germany is being cared for in more than 200 centers, by more than 750 physicians approved for extracorporeal treatment, resulting in unraveling of expertise and diversity of treatment strategies instead of the needed concentration. Here we present a comprehensive standard for competence centers in apheresis treatment, which is an updated synthesis and amendment to previously published standards, based on the experience from more than 30,000 apheresis treatments in our own center. The presented standard provides a guideline for apheresis treatments, comprising all procedures, indications, detailing the application procedure, as well as suggestions for supportive care in extracorporeal therapy. In the absence of large studies of sufficient quality, this standard represents our "good clinical practice" and refers the "best available evidence", providing the indispensable basis for working in an apheresis center. The apheresis standard also aims to contribute to quality assurance, another intention is to increase the acceptance of this valuable treatment, with a view to admitting more patients in need to apheresis programs, on the basis of reliable cost reimbursement.

Indication and implementation of lipidapheresis, rheopheresis, or immunoadsorption (lessons learnt from Germany's largest apheresis center).

Efficient modes of extracorporeal blood purification are available today for apheresis treatment of progressive atherosclerosis, autoimmune disease, or for improving hemorheology. Advanced technology and sophisticated care render apheresis treatment selective, safe and tolerable. Our task is to constantly update indications for apheresis based on best evidence available and good clinical practice, as well as, to determine how apheresis therapy can be made available to those in need or with otherwise refractory disease. Presenting examples of lipid apheresis, rheopheresis, or immunoadsorption for treatment of hypercholesterolemia, hyperlipoproteinemia (a), acute hearing loss, refractory or exacerbating multiple sclerosis, we highlight real world obstacles for implementation of treatment, resulting in still too many patients with proven or recommended indication left untreated. Based on the experience of the largest apheresis center in Germany, with more than 3,300 treatments per year, we depict the necessary structure for identification of patients, defining indication, referral, implementation of therapy, and reimbursement. Apheresis is unfamiliar to most patients and many practitioners or consultants. Nephrologists, performing >90% of apheresis treatments in Germany, have to form a network for referral comprising all regional care-givers, general practitioners as well as the respective specialists (mainly, cardiologists, endocrinologists, diabetologists, ORL specialists, neurologists, ophthalmologists, or rheumatologists), and insurances or other cost-bearing parties for offering a scientifically approved therapeutic regimen and comprehensive care. We have realized this concept in a high volume apheresis center acting in a closely knit network characterized by an unrelenting effort at ongoing medical education. As a consequence, we include approximately 10 times more patients with appropriate diagnoses in our apheresis program as compared to the national average.