Bacterial contamination and septic transfusion reaction rates associated with platelet components before and after introduction of primary culture: experience at a US Academic Medical Center 1991 through 2017.

BACKGROUND: The high incidence of septic transfusion reactions (STRs) led to testing being mandated by AABB from 2004. This was implemented by primary culture of single-donor apheresis platelets (APs) from 2004 and prestorage pooled platelets (PSPPs) from 2007. STUDY DESIGN/METHODS: Platelet (PLT) aliquots were cultured at issue and transfusion reactions evaluated at our hospital. Bacterial contamination and STR rates (shown as rates per million transfusions in Results) were evaluated before and after introduction of primary culture by blood centers that used a microbial detection system (BacT/ALERT, bioMerieux) or enhanced bacterial detection system (eBDS, Haemonetics). RESULTS: A total of 28,457 PLTs were cultured during pre-primary culture periods (44.7% APs; 55.3% at-issue pooled PLTs [AIPPs]) and 97,595 during post-primary culture periods (79.3% APs; 20.7% PSPPs). Forty-three contaminated units were identified in preculture and 34 in postculture periods (rates, 1511 vs. 348; p < 0.0001). Contamination rates of APs were significantly lower than AIPPs in the preculture (393 vs. 2415; p < 0.0001) but not postculture period compared to PSPPs (387 vs. 198; p = 0.9). STR rates (79 vs. 90; p = 0.98) were unchanged with APs but decreased considerably with pooled PLTs (826 vs. 50; p = 0.0006). Contamination (299 vs. 324; p = 0.84) and STR rates (25 vs. 116; p = 0.22) were similar for PLTs tested by BacT/ALERT and eBDS primary culture methods. A change in donor skin preparation method in 2012 was associated with decreased contamination and STR rates. CONCLUSION: Primary culture significantly reduced bacterial contamination and STR associated with pooled but not AP PLTs. Measures such as secondary testing near time of use or pathogen reduction are needed to further reduce STRs.

The 2019 guidelines from the American Society for Apheresis: what's new?

PURPOSE OF REVIEW: For over 30 years, the American Society for Apheresis (ASFA) has published practice guidelines on the use of therapeutic apheresis in the Journal of Clinical Apheresis (JCA) Special Issue. These guidelines are periodically reviewed with the addition of new indications, retirement of some former indications and the provision of updated recommendations for current indications based on new published literature. During the last 12 years, updated guidelines have been published every 3 years to provide a reflection of current evidence-based apheresis practice. Recently, the eighth special issue was published. Significant updates and changes to the last edition are discussed in this review. RECENT FINDINGS: This review provides a description of the development of the eighth special issue with the evolution of the ASFA guidelines since introduced in 1986. There are no new indications for therapeutic apheresis listed in the 2019 edition, however, several recommended category changes to existing indications have been made. There are also several organizational changes with the renaming of some fact sheets. SUMMARY: ASFA has recently published its latest guidelines for therapeutic apheresis in the Journal of Clinical Apheresis 'Eighth Special Edition'. This review describes the evolution of the ASFA guidelines and highlights significant changes to the prior edition.

The Italian Register of therapeutic apheresis: How it has grown, how it has changed.

In Italy therapeutic apheresis procedures were carried out for the first time in the '70s. in the '80s the Italian Society of Hemapheresis was founded, formerly named SIDE, now SIdEM (Italian Society of Hemapheresis and Cellular Manipulation). From the beginning, the collection and the analysis of activity data have been seen as a way to improve the knowledge on mechanisms of action, to identify the correct rationale in order to intervene in the most appropriate clinical indications. Over the years the data collection has been refreshed and today we can rely on information representing the evolution of TA in Italy, from an organizational/technological viewpoint and according to clinical indications. Over the years the aspects that have mainly changed are the technologies, the organizational and managerial aspects and, above all, the clinical indications. The primary indication for therapeutic apheresis is still today the thrombotic thrombocytopenic purpura, but corrently, whenever a disease recognizes an autoimmune pathogenesis, the use of apheresis may be a valid therapeutic tool in the event of failure or partial efficacy of conventional drug therapy. The continuous monitoring of apheresis activity through Registries is a useful tool to follow the evolution of the apheresis practice.

New Options of Apheresis in Renal Diseases: How and When?

The 100-year anniversary of the first experimental apheresis performed by John Abel on uremic dogs in 1914 provides the opportunity for discussion on the current state of classic apheresis as well as technological progress and clinical experiences with its new options presented in the world literature in the last 15 years, such as the following: double filtration, plasma adsorption and immunoadsorption, leuko- and cytapheresis and low-density lipoprotein apheresis. In our review, we highlight the potential limitations for further development of those highly promising techniques, such as the following: the lack of multicenter, controlled clinical studies; insufficient knowledge of the mechanisms of those techniques and last but not least, the restricted access to apheresis, caused both by high expenditure and organizational negligence, even in highly developed countries. Special attention was paid to the most recent recommendations by the American Society of Apheresis in primary and secondary renal diseases, which are the subject of our professional interest.

The lower the better: target values after LDL-Apheresis and semi-selective LDL-elimination therapies.

Prior to 1980 the drug therapy of hereditary hypercholesterolaemia was, as compared to nowadays standards, rather limited. There was virtually no effective therapy for homozygous patients, though plasma exchange introduced in France and Britain, demonstrated the use-fullness of the introduction of apheresis techniques. Parallel to the improvement of cholesterol lowering drug therapy for heterozygous patients, apheresis was developed as therapeutic affinity chromatography since 1980 at the university of Cologne for both homozygous and therapy refractory heterozygous patients. This development was named LDL-Apheresis based on the specificity for the removal of Apoprotein B bound cholesterol, the capacity due to the development of a repetitive cycling technique and the economy determined from the reuse of affinity chromatography columns for each single patient. The capacity of the system allowed for the introduction of new standards of post-treatment values such as 100mg/dl total cholesterol or alternatively 50mg/dl LDL-cholesterol and if cholesterol lowering drugs can also applied for a limited extent the rebound can be also slowed down. After 33 years of experience with seven homozygotes and 32 heterozygotes without treatment alternative, we found that in addition to the improvement of the quality of live the extension of live expectancy are the real proof of a therapeutic success as compared to other diagnostic procedures. The average live expectancy of our seven homozygous patients is 45.6 years; our oldest heterozygous patient is 81 years. There are no comparable long term data at present available neither from studies using drugs nor from subsequently developed apheresis techniques which also removed LDL-cholesterol together with plasma constituents not participating in the development of atherosclerosis. Also two homozygous patients giving birth to four children without complication support our concept of aggressive cholesterol lowering therapy being without major side effects (3-4% minor undesired reactions).

From bloodletting to apheresis in Japan.

The ancient therapy of bloodletting that was universal in the West traveled to Japan 500 years ago on the trading vessels that carried physicians and barber-surgeons to care for the body and Christian missionaries to care for the soul. Then bloodletting was replaced by blood transfusion in the 19th century, only to return less than 50 years ago as apheresis. An understanding of those transitions can be gained from the story of the introduction of Western medicine to Japan and the events that have led to the practice of apheresis there today.

History of lipidology and lipoprotein apheresis.

This review tells the story of atherosclerosis research in the beginning of the 20th century. It presents the significance of cardiovascular diseases and addresses major questions currently being discussed among lipidologists and the current thinking with respect to low LDL-cholesterol levels and HDL. It provides an overview of the period during which lipid-modifying drugs were introduced and their relevance with respect to cardiovascular outcome data and lists possible reasons why some patients develop new cardiovascular events while being treated with statins. Especially impressive is the history of the appearance of the PCSK9 inhibitors on the market - only 12 years after PCSK9 was detected; a study completed in 2017 provides evidence about the cardiovascular effects of these new drugs. Other new drugs are also mentioned: mipomersen, lomitapide, and Alipogen Tiparvovec. Some promising drugs are still in the pipeline which inhibit the synthesis of apolipoprotein CIII, apolipoprotein(a), and the PCSK9 protein. During the 1970s, specific lipoprotein apheresis began to be used in high-risk patients with homozygous familial hypercholesterolemia, severe hypercholesterolemia and elevated Lipoprotein(a) levels and this review provides evidence of the effectiveness of the extracorporeal therapy with respect to the reduction of cardiovascular events. Particularly in patients with high Lipoprotein(a) levels, apheresis has been proven capable of reducing cardiovascular events by more than 80%. The current situation with regard to lipoprotein apheresis centers and patients in Germany is described herein, and, in conclusion, an estimation of the future of the therapeutic options in lipidology is given.