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Lipoprotein apheresis in Germany - Still more commonly indicated than implemented. How can patients in need access
Franz Heigl1, Tobias Pflederer1, Reinhard Klingel2
1Medical Care Center Kempten-Allgäu, Kempten, Germany.
Insights
Lipoprotein apheresis (LA) significantly reduces cardiovascular events by over 80% in patients with high LDL cholesterol (LDL-C) or lipoprotein(a) (Lp(a)) when drug therapies fail. Establishing apheresis competence centers improves patient access and outcomes.
Area of Science:
- Cardiology
- Lipidology
- Vascular Medicine
Background:
- Despite statins and PCSK9 inhibitors, most high-risk cardiovascular patients do not achieve target LDL cholesterol (LDL-C) levels.
- Lipoprotein apheresis (LA) effectively lowers LDL-C and lipoprotein(a) (Lp(a)), reducing cardiovascular disease (CVD) events by 70-80% in drug-intolerant patients.
- Knowledge and utilization of LA therapy remain suboptimal among medical professionals treating CVD.
Purpose of the Study:
- To establish and evaluate the model of an apheresis competence center for comprehensive LA patient care.
- To improve identification, referral, and standardized treatment of patients requiring LA.
- To increase access to LA therapy and reduce cardiovascular events in a defined region.
Main Methods:
- Leveraging two decades of experience and nearly 80,000 LA treatments at a large apheresis center.
- Developing a network structure involving nephrologists, general practitioners, specialists, and insurers for patient referral and education.
- Implementing a certification process for lipidological competence centers by the German Lipid Association (Lipid-Liga).
Main Results:
- The competence center treats 160 patients in a chronic LA program, demonstrating LA's continued importance alongside PCSK9 inhibitors.
- Analysis of 37,000 LA treatments showed an over 80% reduction in cardiovascular events compared to pre-LA therapy.
- The competence center model fosters ongoing medical education, interdisciplinary networking, and efficient patient referral.
Conclusions:
- The patient-centered approach of the competence center significantly increased LA access above the German average.
- This improved access led to a substantial reduction in cardiovascular events within the managed population.
- Apheresis competence centers are crucial for optimizing LA delivery and improving cardiovascular outcomes.
Background:
Although lipid-lowering drugs, especially statins, and recently also PCSK9 inhibitors can reduce LDL cholesterol (LDL-C) and decrease the risk for cardiovascular disease (CVD) including coronary artery disease (CAD) events most efficiently, only 5-10% of high-risk cardiovascular patients reach the target values recommended by international guidelines. In patients who cannot be treated adequately by drugs it is possible to reduce increased LDL-C and/or lipoprotein(a) (Lp(a)) values by the use of lipoprotein apheresis (LA) with the potential to decrease severe CVD events in the range of 70%->80%. Even in Germany, a country with well-established reimbursement guidelines for LA, knowledge about this life-saving therapy is unsatisfactory in medical disciplines treating patients with CVD. Starting in 1996 our aim was to offer LA treatment following current guidelines for all patients in the entire region of our clinic as standard of care.
Methods:
Based on the experience of our large apheresis competence center overlooking now nearly 80,000 LA treatments in the last two decades, we depict the necessary structure for identification of patients, defining indication, referral, implementation and standardisation of therapy as well as for reimbursement. LA is unfamiliar for most patients and even for many practitioners and consultants. Therefore nephrologists performing more than 90% of LA in Germany have to form a network for referral and ongoing medical education, comprising all regional care-givers, general practitioners as well as the respective specialists and insurances or other cost bearing parties for offering a scientifically approved therapeutic regimen and comprehensive care. The German Lipid Association (Lipid-Liga) has implemented the certification of a lipidological competence center as an appropriate way to realize such a network structure.
Results:
Working as a lipidological and apheresis competence center in a region of 400,000 to 500,000 inhabitants, today we treat 160 patients in the chronic LA program. In spite of the availability of PCSK9 inhibitors since 2015, LA has remained as an indispensable therapeutic option for targeted lipid lowering treatment. An analysis of nearly 37,000 LA treatments in our own center documented a >80% reduction of cardiovascular events in patients treated by regular LA when comparing with the situation before the start of the LA therapy. We have implemented the concept of an apheresis competence center characterised by ongoing medical education with a focus on lipidological and cardiovascular aspects, interdisciplinary networking and referral.
Conclusions:
Incidence and prevalence of LA patients in our region demonstrate that based on our ongoing patient-centered approach the access of patients in need to LA is substantially above the German average, thus contributing to an extraordinary reduction of cardiovascular events in the population we in particular feel responsible for.
