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

Abstract

IntroductionLow 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.MethodsBetween 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.ResultsWe 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% ³ four 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%.DiscussionThe 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.ConclusionHELP 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.

Lipoprotein apheresis: an update

“…n Side effects Side effects from all lipoprotein apheresis meth ods are observed in approximately 5% of the sessions [33,[53][54][55]. This is in agreement with our own practice.…”

“…n Effect on cardiovascular events Several papers describe an effective reduction in the incidence of new cardiovascular events and/or nonprogression or even regression (documented by angiography) when comparing prior years with those under apheresis treatment [10,53,54,[58][59][60][61][62]. It must be admitted that the apheresis treatment does not completely prevent new events.…”

Management of patients with familial hypercholesterolaemia

“…64 Clinical evidence has suggested that long-term lipoprotein apheresis can contribute to atherosclerotic plaque regression and stabilization. 65,66 Although apheresis might increase longevity in patients with HoFH and decrease CVD morbidity in patients with HeFH who are refractory or intolerant to statins, 67 no hard efficacy data from double-blind, randomized trials exists and, owing to several reasons (primarily ethical), such studies will probably not be performed. 68 In very young patients with HoFH, venous access can be difficult to find, which can lead to treatment postponement for 1-2 years: the youngest patient with HoFH treated with statin therapy only underwent apheresis at the age of 3 years; 69 as of 2015, 12 years later, the patient remains alive and with no cardiovascular events.…”

Role of Lipoprotein Apheresis in Cardiovascular Disease Risk Reduction

“…Thompson et al [129], published the FH Regression Study, in which they assessed 20 patients with FH undergoing dextran sulfate LA, compared to 19 FH patients who were relying on medication. Although the apheresis group showed marked reduction in both LDL and Lp(a) levels, the progression of atherosclerosis (followed angio- apheresis treatments, with an average follow-up period of 7.0 ± 5.2 years, indicated that LA was successful in reducing LDL levels (average reduction of 63.49 ± 7.1%) and produced low levels of coronary intervention [131].…”