Reduced incidence of cardiovascular events in hyper-Lp(a) patients on lipoprotein apheresis. The G.I.L.A. (Gruppo Interdisciplinare Aferesi Lipoproteica) pilot study.

BACKGROUND: Lipoprotein apheresis (LA) is the elective therapy for homozygous and other forms of Familial Hypercholesterolemia, Familial Combined Hypercholesterolemia, resistant/intolerant to lipid lowering drugs, and hyper-lipoproteinemia(a). Lipoprotein(a) [Lp(a)] has been classified as the most prevalent genetic risk factor for coronary artery disease and aortic valve stenosis. AIM: Our multicenter retrospective study has the aim to analyze the incidence of adverse cardiovascular events (ACVE) before and during the LA treatment, in subjects with elevated level of Lp(a) (>60 mg/dL) [hyper-Lp(a)] and chronic ischemic heart disease. METHODS: We collected data of 23 patients (mean age 63 ± 9 years, male 77%; from hospital of Pisa 11/23, Pistoia 7/23, Verona 2/23, Padova 2/23 and Ferrara 1/23), with hyper-Lp(a), pre-apheresis LDL-cholesterol <100 mg/dL, cardiovascular disease, on maximally tolerated lipid lowering therapy and LA treatment (median 7 years, interquartile range 3-9 years). The LA treatment was performed by heparin-induced LDL precipitation apheresis (16/23), dextran-sulphate (4/23), cascade filtration (2/23) and immunoadsorption (1/23). The time lapse between first cardiovascular event and beginning of apheresis was 6 years (interquartile range 1-12 years). RESULTS: The recorded ACVE, before and after the LA treatment inception, were 40 and 10 respectively (p < 0.05), notably, the AVCE rates/year were 0.43 and 0.11 respectively (p < 0.05) with a 74% reduction of event occurrence. CONCLUSIONS: Our data confirm long-term efficacy and positive impact of LA on morbidity in patients with hyper-Lp(a) and chronic ischemic heart disease on maximally tolerated lipid lowering therapy.

The introduction of intra-operative cell salvage in obstetric clinical practice: a review of the available evidence.

Intra-operative blood salvage is common practice in many surgical specialties but its safety is questioned with concerns about the risks of contamination of recovered blood with amniotic fluid and of maternal-foetal alloimmunization. However, the role of cell salvage as a blood-saving measure in this clinical setting is progressively acquiring relevance thanks to the growing body of evidence regarding its quality and safety. Modern cell savers remove most particulate contaminants and leukodepletion filtering of salvaged blood prior to transfusion adds further safety to this technique. Amniotic fluid embolism is no longer regarded as an embolic disease and the contamination of the salvaged blood by foetal Rh-mismatched red blood cells can be dealt with using anti-D immunoglobulin; ABO incompatibility tends to be a minor problem since ABO antigens are not fully developed at birth. Maternal alloimmunization can be caused also by other foetal red cell antigens, but it should also be noted that the risk of alloimmunization of the mother from allogeneic transfusion may be even greater. Therefore the use of cell savers in obstetric clinical practice should be considered in patients at high risk for haemorrhage or in cases where allogeneic blood transfusion is difficult or impossible.

The practical management of intracerebral hemorrhage associated with oral anticoagulant therapy.

Oral anticoagulant-associated intracerebral hemorrhage is increasing in incidence and is the most feared complication of therapy with vitamin K1 antagonists. Anticoagulant-associated intracerebral hemorrhage has a high risk of ongoing bleeding, death, or disability. The most important aspect of clinical management of anticoagulant-associated intracerebral hemorrhage is represented by urgent reversal of coagulopathy, decreasing as quickly as possible the international normalized ratio to values ≤1·4, preferably ≤1·2, together with life support and surgical therapy, when indicated. Protocols for anticoagulant-associated intracerebral hemorrhage emphasize the immediate discontinuation of anticoagulant medication and the immediate intravenous administration of vitamin K1 (mean dose: 10-20 mg), and the use of prothrombin complex concentrates (variable doses calculated estimate circulating functional prothrombin complex) or fresh-frozen plasma (15-30 ml/kg) or recombinant activated factor VII (15-120 µg/kg). Because of cost and availability, there is limited randomized evidence comparing different reversal strategies that support a specific treatment regimen. In this paper, we emphasize the growing importance of anticoagulant-associated intracerebral hemorrhage and describe options for acute coagulopathy reversal in this setting. Additionally, emphasis is placed on understanding current consensus-based guidelines for coagulopathy reversal and the challenges of determining best evidence for these treatments. On the basis of the available knowledge, inappropriate adherence to current consensus-based guidelines for coagulopathy reversal may expose the physician to medico-legal implications.

Intraoperative cell salvage in obstetrics: is it a real therapeutic option?

Obstetric hemorrhage is a leading cause of maternal and perinatal mortality worldwide. Intraoperative blood salvage is common practice in many surgical specialties but its safety in obstetrics is questioned for concerns on the risks of contamination of recovered blood with amniotic fluid (AF) and of maternal-fetal alloimmunization. However, the role of cell salvage as a blood-saving measure in obstetrics is progressively acquiring relevance thanks to the growing body of evidence regarding its quality and safety coming from over 800 documented procedures and more than 400 patients transfused with saved blood. Although the information about the outcomes of the patients treated and the allogeneic blood saving effect are still limited, modern cell savers remove most particulate contaminants and leukoreduction filtering of salvaged blood (SB) before transfusion adds further safety to this technique. Moreover, AF embolism is no longer regarded as an embolic disease and it is suggested that it is a rare anaphylactoid reaction to the fetal antigen. The contamination of the SB by fetal Rh-mismatched red blood cells (RBCs) can be dealt with using RhIG; ABO incompatibility tends to be a minor problem since ABO antigens are not fully developed at birth. Antibodies can be formed against other fetal RBC antigens, but it should also be noted that the risk of alloimmunization of the mother from allogeneic transfusion is probably even greater. Therefore, intraoperative cell salvage in obstetrics should be considered in patients at high risk for hemorrhage or in cases where allogeneic blood transfusion is difficult or impossible.

Quality control of recovered plasma for fractionation: an extensive Italian study.

BACKGROUND: This study was aimed at obtaining significant information on the quality of whole-blood plasma (WBP) delivered to a private pharmaceutical company by the blood transfusion centers (BTCs) of 10 Italian regions. STUDY DESIGN AND METHODS: A statistical sampling plan of plasma units took into account the contribution each selected blood transfusion center, belonging to the 10 regions, made to the plasma pool annually delivered to the pharmaceutical company. A total of 1787 plasma units were selected for coagulation Factor VIII (FVIII:C) and Factor VIII antigen (FVIII:Ag) analysis. RESULTS: The FVIII:C mean value was 0.99 IU per mL; it was significantly lower in O units (0.86 IU/mL) than in non-O units (1.08 IU/mL). The mean value of FVIII:Ag was 0.90 IU per mL; it was significantly lower in O units (0.78 IU/mL) than in non-O units (0.99 IU/mL). In units with a FVIII:C level of less than 0.70 IU per mL, the FVIII:Ag mean value (0.62 IU/mL) was higher in comparison to the FVIII:C mean value (0.57 IU/mL). Instead, in the units with a FVIII:C level of at least 0.70 IU per mL, the mean level of FVIII:C (1.08 IU/mL) was higher than that of FVIII:Ag (0.96 IU/mL). CONCLUSIONS: The mean value of FVIII:C (0.99 IU/mL) in whole-blood plasma produced by the 10 Italian regions is higher than that reported in other studies. A total of 83.1 percent of units have a FVIII:C level of at least 0.70 IU per mL. The mean level of FVIII:Ag is lower than that of FVIII:C. FVIII:Ag is higher in those units with a FVIII:C level of less than 0.70 IU per mL, while it gradually decreases as FVIII:C exceeds 0.70 IU per mL, thus showing a greater resistance to handling of plasma in the production steps mostly affecting FVIII:C stability.