Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy
Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular events or interventions, angina, and serious unanticipated adverse effects. Laboratory assessments will be made to document low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood components. Quality of life assessments will also be made.
The study will also assess the modifications to the H.E.L.P. System, including:
The safety and efficacy of the device specific to these modifications will be evaluated by comparing the safety and efficacy data from the patient registry to the data from the initial clinical study on the device as originally designed.
H.E.L.P. therapy is indicated for use in treating patients with familial hypercholesterolemia (FH) who have undergone six months of optimal diet and drug therapy and whose LDL-C level remains > 300 mg/dl in the absence of CHD or > 200 mg/dl with documented CHD. These patients are divided into three subgroups of interest:
Optimal diet therapy is defined as having received instruction by a trained dietitian in the use of a diet meeting the National Cholesterol Education Program (NCEP) Step 2 criteria (< 30% of calories as fat, < 7% of calories as saturated fat, and < 200 mg of dietary cholesterol per day). Optimal drug therapy is defined as having been tried on at least two separate classes of effective serum LDL-C lowering agents (>15% reduction) as currently available for at least six months. These drugs include hydroxy methyl glutaryl (HMG) CoA reductase inhibitors, fibric acid derivatives, niacin, and anion exchange resins. These agents should be used in combination at maximal doses as tolerated by the patient under the supervision of their treating physician to monitor side effects.
Documented coronary heart disease (CHD) includes documentation of coronary heart disease by coronary angiography or a history of myocardial infarction (MI), coronary artery bypass surgery (CABG), percutaneous transluminal coronary angioplasty (PTCA) or alternative revascularization procedure (e.g., atherectomy or stent), or progressive angina documented by exercise or non-exercise stress test.
The primary criteria for evaluating the safety and effectiveness of the device will be:
Occurrence of Death
Occurrence of Cardiovascular Events
Occurrence of Surgical or Non-Surgical Intervention Procedure of the Treatment of Atherosclerotic Cardiovascular Disease (ASCVD) including:
Frequency and severity of CHD Symptoms:
Use of CHD Medications for treatment of:
Use of Lipid-Lowering Medications and Other Cardiovascular Medications Concomitantly
Laboratory Assessments (lipid, lipoprotein, chemistry, and clotting factors)
Quality of life assessments (SF-36)
Occurrence of Serious and/or Unanticipated Adverse Events Reported During Treatment (e.g., hypotension, nausea, vomiting, syncope)
Occurrence of other serious illnesses
Acute Reduction of LDL-C
Inclusion Criteria:
Adequate venous access
Laboratory values:
Premenopausal women must be surgically sterilized or be on oral contraceptive therapy and have a negative pregnancy test at the onset of treatment with H.E.L.P.
Patients have familial hypercholesterolemia and have undergone at least 6 months optimal diet and drug therapy and fit group A, B, or C
Exclusion Criteria:
Presence of any of the following conditions: