HELP apheresis in hypercholesterolemia and cardiovascular disease: efficacy and adverse events after 8,500 procedures.

Abstract

Introduction: Low density lipoprotein (LDL-C) apheresis is a last treatment option for hypercholesterolemic patientsresistant to conservative lipid-lowering therapy. In a retrospective analysis of 8,533 heparin-induced extra-corporeal LDL precipitation apheresis treatments (HELP), we evaluated the efficacy of LDL reduction, the rate of adverse events, and the progression of atherosclerosis.

Methods: Between July 1992 and April 2009, we performed 8,533 HELP apheresis therapies in patients with familial hypercholesterolemia (FH). Inclusion criteria were FH with insufficient lipidological status under optimal drug therapy and diet, and at least 50 HELP therapies. Left ventricular function and valvular status was checked prior to the first apheresis therapy and at the end of the individual HELP program. Blood samples were taken directly before and after each therapy. Blood count, electrolytes, total cholesterol, LDL-C, high density lipoprotein (HDL-C), triglycerides, lipoprotein (a) (Lp(a)), and fibrinogen were measured. Adverse events were documented weekly.

Results: We evaluated 27 patients (19 men) with FH (age 49.2 ± 12.5 years (range 10-67 years)). The number of HELP treatments once weekly was between 50 and 790 applications. Mean follow-up time was 7.0 ± 5.2 years (range 1.3-16.6 years). Prior to the individual apheresis program, 44.4% of the patients had a three vessel disease (VD; 25.9% two VD, 25.9% one VD) and 7.4% had a peripheral arterial occlusive disease. During the time of HELP treatment, none of the patients had a myocardial infarction; 3.7% had one percutaneous coronary intervention (PCI), 11.1% two PCI, 14.8% three PCI, 11.1% ≥ PCI. The patients received 1.2 ± 1.6 (range 0-5) PCI during follow-up time. Adverse events directly associated with HELP therapy were very rare (< 3%). Mean elimination of LDL-C was 63.49 ± 7.1%.

Discussion: The HELP apheresis therapy was well accepted by the patients in our programs. Adverse events during HELP apheresis were rare. This data is in line with the experiences published by other authors who reported an adverse event rate of 3.6% in adults. The LDL-HDL ratio, one of the strongest predictors of premature CHD events, improved significantly during the apheresis program.

Conclusion: HELP is a safe, comfortable, and highly effective treatment in which adverse events are rare. It can reduce the burden of atherosclerosis, with no myocardial infarction and a low coronary intervention rate in our patients.