The American Heart Association (AHA) has issued a comprehensive scientific statement advocating for broader implementation of lipoprotein apheresis, highlighting its critical role in treating patients with familial hypercholesterolemia (FH) and elevated lipoprotein levels who don't respond adequately to standard therapies.
Powerful Treatment Option for High-Risk Patients
Lipoprotein apheresis demonstrates remarkable efficacy, capable of reducing low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) [Lp(a)] levels by 65% to 85% in a single treatment session. The FDA has approved this therapeutic intervention for specific patient populations, including those with homozygous FH showing LDL-C levels above 500 mg/dL and heterozygous FH patients with LDL-C levels ≥300 mg/dL.
"In this scientific statement on lipoprotein apheresis, we review the historical development, available devices, indications, efficacy, vascular effects, outcomes data, use in special populations, availability, access, cost, and patient perspectives," explains Dr. Laurence S. Sperling, the Katz Professor in Preventive Cardiology at Emory University School of Medicine and chair of the writing committee.
Clinical Benefits and Cardiovascular Outcomes
Observational studies have demonstrated that lipoprotein apheresis can reduce major adverse cardiovascular events (MACE) by approximately 50% to 85%. The treatment shows particular promise for patients with elevated Lp(a) and LDL-C levels. Beyond lipid reduction, the procedure enhances endothelial function and reduces inflammatory markers, though the long-term impact of these effects requires further study.
Access Challenges and Treatment Gaps
Despite its proven benefits, lipoprotein apheresis remains significantly underutilized in the United States. While an estimated 11,000 to 15,000 Americans could qualify for the treatment, fewer than 400 currently receive it. Geographic access presents a major barrier, with only 33 states housing lipid apheresis facilities, forcing some patients to travel hundreds of miles for treatment.
Cost Considerations and Economic Impact
The annual cost of lipoprotein apheresis in the United States ranges from $50,000 to $150,000, varying by setting and payer. While this represents a significant investment, it proves more economical than alternative treatments such as lomitapide or evinacumab, which can cost up to $450,000 annually.
Future Directions and Implementation Needs
The AHA committee emphasizes the necessity for expanding access to this vital treatment through increased referrals to existing centers and the establishment of new facilities. Additionally, they stress the importance of patient education about treatment benefits and the need for comprehensive research on social determinants of health affecting long-term adherence.
"Although cost-effectiveness and quality of life effects are important factors to consider in shared decision-making regarding treatment, lipid apheresis may provide substantial clinical benefit for many high-risk patients, in whom it is frequently underused," the committee concludes.
