|
|
 |
All About LDL-Apheresis |
 |
Most patients with high levels of low-density lipoprotein cholesterol (LDL-C) initially
are treated with lifestyle changes (diet and exercise). If diet and exercise do
not reduce a patient’s LDL-C to goal, lipid-lowering drug therapy is added
to the patient’s regimen. However, lifestyle changes and drug therapy are
not always the solutions to elevated cholesterol problems. Case in point: Familial
hypercholesterolemia (FH) is a condition in which individuals have a genetic predisposition
to very high cholesterol levels. Traditional lipid-lowering treatments help patients
with FH but may not help these patients achieve their LDL-C goal. This is where
treatment with LDL-apheresis becomes a feasible, and effective, option.
To appreciate how important LDL-apheresis therapy can be, consider this: Left untreated,
or treated inadequately, patients with FH are at extremely high risk for premature
heart disease, heart attack, and even death. Listed below are the three categories
that qualify patients for LDL-apheresis therapy:
|
• |
Heterozygous patients: LDL-C levels of >200 mg/dL who have a documented
history of coronary heart disease (CHD) |
|
• |
Heterozygous patients: LDL-C levels of >300 mg/dL without CHD |
|
• |
Homozygous patients: LDL-C levels of >500 mg/dL |
The Procedure
LDL-apheresis is generally administered every 2 weeks and lasts approximately 2
to 4 hours per treatment session. During the procedure, two intravenous (IV) lines
are inserted into the patient’s arms (one IV per arm). Blood is drawn from
the body through one IV and filtered through a specialized machine that traps and
removes the LDL-C particles. The patient’s blood is then returned to the body
through the other IV.
The Results
Clinical trials have demonstrated that a single LDL-apheresis treatment removes
approximately 60% to 70% of harmful LDL-C from the blood. LDL-apheresis therapy
has also been shown to improve endothelial function, inhibit the coagulation system,
reduce adhesion molecules, inhibit cytokine production, reduce LDL-C oxidation,
and improve blood rheology. These effects can acutely improve the microcirculation.
Long-term effects include suppression of atherosclerotic plaque progression, and
regression in atherosclerotic lesions. After more than 20 years of use, LDL-apheresis
therapy has proven to be a safe and effective technique for treating excess LDL-C.
Where Is This Treatment Available?
LDL-apheresis is performed in more than
35 centers throughout the United States. However, in other parts
of the world, including Germany and Japan, the treatment is better known and utilized
more frequently. A perceived lack of awareness among both physicians and the general
public about the benefits and availability—and likely even the existence—of
LDL-apheresis may explain its limited use in the United States.
Approved Applications and Reimbursement
At present, the only application approved by the Food and Drug Administration (FDA)
for LDL-apheresis therapy is for treatment of chronic FH. This application is reimbursable
through Medicare as well as through most major medical insurance companies. To qualify
for Medicare reimbursement, the procedure—considered an outpatient hospital
service—must be initiated in patients who have severe, refractory FH (see
FH patient categories above) and who have failed at least 6 months of maximum
tolerated drug and diet therapy.
The table below lists the appropriate Current Procedural Terminology (CPT) code
that should be used when filing a Medicare claim for LDL-apheresis reimbursement.
|
CPT Code |
Description of Service
|
|
36516
|
Therapeutic apheresis with extracorporeal affinity column adsorption and plasma
reinfusion |
Note: The appropriate ICD-9 Code for FH is 272.0
The Future
LDL-apheresis treatment is being evaluated for several other diseases and conditions,
including cerebrovascular diseases (including stroke), unstable angina, heart transplant,
retinal infarct, sepsis, and sudden hearing loss.
And Finally…
The two LDL-apheresis systems currently FDA-approved for use in the United States
are the Heparin-Induced Extracorporeal LDL Cholesterol Precipitation (H.E.L.P.)
system by B. Braun Medical Inc., and the LipoSorber®
system by Kaneka Pharma America Corporation.
|
 |
 |
|