Effect of using smaller blood volume tubes and closed blood collection devices on total blood loss in patients undergoing major cardiac and vascular surgery.

BACKGROUND: Diagnostic laboratory tests are an integral part of managing hospitalized patients. In particular, patients in the intensive care units (ICUs) can experience a concerning amount of blood loss due to diagnostic testing, which can increase the risk developing iatrogenic anemia. Several interventions exist to curtail avoidable blood loss, for example computerized decision support, smaller phlebotomy tubes, and other blood conservation devices. Nevertheless, use of these interventions is not standardized. Therefore, the objective of our study was to quantify the daily phlebotomy volume taken from patients who had undergone major cardiac or vascular surgery. METHODS: We estimated the number of blood analyses and volumes of drawn blood of 400 consecutive patients (≥ 18 yr) undergoing major cardiac or vascular surgery. The amount of blood saved using small-volume tubes and in combination with blood conservation device rather than standard-volume tubes was estimated for serum chemistry (serum), ethylenediaminetetraacetic acid (EDTA) tubes, sodium citrate coagulation (SCC) tubes, and arterial blood gas (ABG) analysis. RESULTS: The mean total blood loss due to phlebotomy drawing using standard-volume tubes during hospitalization was 167.9 mL (95% confidence interval [CI], 158.0 to 177.8), 255.6 mL (95% CI, 226.5 to 284.6), and 695.3 mL (95% CI, 544.1 to 846.4) for patients undergoing cardiac surgery with a hospital length of stay (LOS) of 0-10, 11-20, and ≥ 21 days, respectively. The mean total blood loss due to phlebotomy during hospitalization was 80.5 mL (95% CI, 70.5 to 90.6), 225.0 mL (95% CI, 135.1 to 314.8 mL) and 470.3 mL (95% CI, 333.5 to 607.1) for vascular surgery patients with LOS 0-10, 11-20, and ≥ 21 days, respectively. Patients with at least a two-day stay at the ICU had a mean blood loss of 146.6 mL (95% CI, 134.6 to 158.6 mL) and those with ≥ 11 days incurred a loss of 1,428 mL (95% CI, 1,117.8 to 1,739.2). The use of closed blood collection device and small-volume tubes (serum, EDTA, SCC, and ABG) reduced blood loss by 82.8 mL for patients with an ICU stay of 2 days and up to 824.0 mL for patients with a ICU stay of ≥ 11 days. CONCLUSION: Diagnostic laboratory tests are associated with significant patient blood loss, but are a modifiable risk factor. The use of small-volume tubes and closed blood collection devices decreases the volume of patient blood drawn for analysis and prevents blood waste.

RéSUMé: CONTEXTE: Les tests diagnostiques de laboratoire font partie intégrante de la prise en charge des personnes hospitalisées. Plus spécifiquement, la patientèle des unités de soins intensifs (USI) peut perdre une quantité inquiétante de sang en raison des tests de diagnostic, ce qui peut augmenter le risque d'anémie iatrogène. Plusieurs interventions existent pour réduire les pertes de sang évitables, par exemple une aide à la décision informatisée, des tubes de phlébotomie plus petits et d'autres dispositifs de conservation du sang. Néanmoins, le recours à ces interventions n'est pas normalisé. Par conséquent, l'objectif de notre étude était de quantifier le volume quotidien de phlébotomie prélevée chez des patient·es ayant bénéficié d'une chirurgie cardiaque ou vasculaire majeure. MéTHODE: Nous avons estimé le nombre d'analyses sanguines et les volumes de sang prélevés de 400 personnes consécutives (≥ 18 ans) bénéficiant d'une chirurgie cardiaque ou vasculaire majeure. La quantité de sang économisée à l'aide de tubes de petit volume et en combinaison avec un dispositif de conservation du sang plutôt que des tubes de volume standard a été estimée pour la chimie sérique (sérum), les tubes d'acide éthylène-diamine-tétra-acétique (EDTA), les tubes de coagulation au citrate de sodium (CCS) et l'analyse des gaz du sang artériel (GSA). RéSULTATS: La perte sanguine totale moyenne due au prélèvement de phlébotomie à l'aide de tubes de volume standard pendant l'hospitalisation était de 167,9 mL (intervalle de confiance [IC] à 95 %, 158,0 à 177,8), 255,6 mL (IC 95 %, 226,5 à 284,6) et 695,3 mL (IC 95 %, 544,1 à 846,4) chez les patient·es bénéficiant d'une chirurgie cardiaque avec une durée de séjour à l'hôpital de 0 à 10, 11 à 20, et ≥ 21 jours, respectivement. La perte sanguine totale moyenne due à la phlébotomie pendant l'hospitalisation était de 80,5 mL (IC 95 %, 70,5 à 90,6), 225,0 mL (IC 95 %, 135,1 à 314,8 mL) et 470,3 mL (IC 95 %, 333,5 à 607,1) chez les patient·es ayant bénéficié d'une chirurgie vasculaire avec des durées de séjour de 0-10, 11-20 et ≥ 21 jours, respectivement. Les patient·es ayant séjourné au moins deux jours à l'USI ont eu une perte de sang moyenne de 146,6 mL (IC 95 %, 134,6 à 158,6 mL) et celles et ceux ayant séjourné ≥ 11 jours ont subi une perte de 1428 mL (IC 95 %, 1117,8 à 1739,2). L'utilisation d'un dispositif de prélèvement sanguin fermé et de tubes de petit volume (sérum, EDTA, SCC et gsa) a réduit la perte de sang de 82,8 mL pour les patient·es ayant séjourné à l'USI 2 jours et jusqu'à 824,0 mL pour les patient·es ayant séjourné en USI ≥ 11 jours. CONCLUSION: Les tests de laboratoire diagnostiques sont associés à une perte de sang importante chez les patient·es, mais constituent un facteur de risque modifiable. L'utilisation de tubes de petit volume et de dispositifs fermés de prélèvement sanguin diminue le volume de sang prélevé pour analyse et prévient le gaspillage de sang.

Ropeginterferon phase 2 randomized study in low-risk polycythemia vera: 5-year drug survival and efficacy outcomes.

In patients with low-risk polycythemia vera, exposure to low-dose Ropeginterferon alfa-2b (Ropeg) 100 µg every 2 weeks for 2 years was more effective than the standard treatment of therapeutic phlebotomy in maintaining target hematocrit (HCT) (< 45%) with a reduction in the need for phlebotomy without disease progression. In the present paper, we analyzed drug survival, defined as a surrogate measure of the efficacy, safety, adherence, and tolerability of Ropeg in patients followed up to 5 years. During the first 2 years, Ropeg and phlebotomy-only (Phl-O) were discontinued in 33% and 70% of patients, respectively, for lack of response (12 in the Ropeg arm vs. 34 in the Phl-O arm) or adverse events (6 vs. 0) and withdrawal of consent in (3 vs. 10). Thirty-six Ropeg responders continued the drug for up to 3 years, and the probability of drug survival after a median of 3.15 years was 59%. Notably, the primary composite endpoint was maintained in 97%, 94%, and 94% of patients still on drug at 3, 4, and 5 years, respectively, and 60% of cases were phlebotomy-free. Twenty-three of 63 Phl-O patients (37%) failed the primary endpoint and were crossed over to Ropeg; among the risk factors for this failure, the need for more than three bloodletting procedures in the first 6 months emerged as the most important determinant. In conclusion, to improve the effectiveness of Ropeg, we suggest increasing the dose and using it earlier driven by high phlebotomy need in the first 6 months post-diagnosis.

A donor safety evidence literature review of the short- and long-term effects of plasmapheresis.

Many blood establishments are expanding plasmapheresis collection capacity to achieve increasing plasma for fractionation volume targets, driven by immunoglobulin product demand. Some adverse events occur in both apheresis and whole blood collection, such as venepuncture-related trauma and vasovagal reactions. Others are specifically related to the apheresis procedure, such as citrate reactions, haemolysis, infiltration and air embolism. Whilst plasmapheresis procedures are generally well tolerated, theoretical longer term donor health considerations, such as the effects on donor plasma protein levels, bone mineral density, iron deficiency and malignancy also require consideration. An evidence-based framework that supports a safe and sustainable increase in the collection of plasma is essential. Our review demonstrates a lack of high-quality evidence on risks and outcomes specifically in plasmapheresis. Whilst conservative procedural controls and donor harm minimization policies will mitigate risk, high-quality evidence is needed to facilitate practice change that is safe and sustainable and maximizes the potential of individual donor differences.

Remote Neuronal Activation Coupled with Automated Blood Sampling to Induce and Measure Circulating Luteinizing Hormone in Mice.

Circulating luteinizing hormone (LH) levels are an essential index of the functioning of the hypothalamic-pituitary control of reproduction. The role of numerous inputs and neuronal populations in the modulation of LH release is still unknown. Measuring changes in LH levels in mice is often a challenge since they are easily disrupted by environmental stress. Current techniques to measure LH release and pulsatility require long-term training for mice to adapt to manipulation stress, certain restraint, the presence of the investigator, and working on individual animals, reducing its usefulness for many research questions. This paper presents a technique to remotely activate specific neuronal populations using Designer Receptor Exclusively Activated by Designer Drugs (DREADDs) technology coupled with automated sequential blood sampling in conscious, freely moving, and undisturbed mice. We first describe the stereotaxic surgery protocol to deliver adeno-associated virus (AAV) vectors expressing DREADDs to specific neuronal populations. Next, we describe the protocol for carotid artery and jugular vein cannulation and postsurgical connection to the CULEX automated blood sampling system. Finally, we describe the protocol for clozapine-N-oxide intravenous injection for remote neuronal activation and automated blood collection. This technique allows for programmed automated sampling every 5 min or longer for a given period, coupled with intravenous substance injection at a desired time point or duration. Overall, we found this technique to be a powerful approach for research on neuroendocrine control.

Differences in the child, mother, and nurses' pain score measurements during pediatric venipuncture.

BACKGROUND: Self-reporting is the gold standard for measuring pain in adult pain management; however, this issue is unique and different in children. Accurate pain assessment for the appropriate management of children's pain is important. PURPOSE: This study was conducted to assess the pain level by the child, mother, and nurse during intravenous line insertion in preschool children, candidates for surgery in Tabriz Children's Hospital. DESIGN AND METHODS: This is descriptive observational study. A total of 140 eligible children were included in the study using convenience and sequential methods. The intravenous line was inserted by an experienced nurse and pain assessment was performed by the child, mother, and nurse immediately after procedure, using the Wong-Baker face scale (WBFS). The data were analyzed through descriptive statistics and repeated measures ANOVA test using SPSS version 13 software. RESULTS: The difference between child-mother and nurse-mother mean scores was not statistically significant; however, there was a statistically significant difference between the score measured by the child and the nurse (P = 0.017). CONCLUSION: The children's pain assessment score during venipuncture was higher than that of mothers and nurses. The mothers' score was more closely related to the children's score. As a result, a mother's assessment can be considered a reliable estimation of proper pain management in young children and mothers can act as a moderator and actualize the nurses' score. Consequently, establishing a three-way communication between mother, child, and nurses is necessary to precisely estimate the child's actual pain and take appropriate measures to reduce it.

Survey on the usage of therapeutic erythrocytapheresis in transfusion services in Italy for the treatment of polycythemia vera, secondary erythrocytosis and hemochromatosis.

INTRODUCTION: Erythrocytapheresis, an apheresis treatment which selectively removes red blood cells, is an alternative to therapeutic phlebotomy, over which it has several advantages. Actually there is a high degree of variability in the use of this treatment. This prompted SIdEM (Italian Society of Hemapheresis and Cell Manipulation) to conduct a survey on the use of erythrocytapheresis in the Italian Transfusion Services. The purpose is to monitor this activity in the treatment of Polycythemia Vera (pv), secondary erythrocytosis and hemochromatosis. MATERIALS AND METHODS: A data collection file was sent to the SIdEM regional delegates who, in turn, involved the Transfusion Centers in the areas they cover. The data collected were processed on a Microsoft Excel spreadsheet. RESULTS: 75 centers from 14 Italian regions responded to the Survey: 36 centers (48 %) use erythrocytapheresis (35 centers perform therapeutic apheresis and 1 center only donor apheresis), 39 centers (52 %) do not (15 centers perform therapeutic apheresis, 18 centers only donor apheresis and 6 centers do not perform either therapeutic apheresis or donor apheresis). Although most centers have a substantially uniform attitude concerning the indications for which erythrocytapheresis is used, the survey shows that there are still differences more evident in the treatment of secondary erythrocytosis than in the treatment of pv or hemochromatosis. CONCLUSIONS: This survey has been useful to document the current Italian reality and to raise awareness about the need for improvement in optimizing and standardizing the use of a therapy with a great potential to exploit properly.

Haemochromatosis.

Haemochromatosis is one of the most common genetic diseases affecting patients of northern European ancestry. It is overdiagnosed in patients without iron overload and is underdiagnosed in many patients. Early diagnosis by genetic testing and therapy by periodic phlebotomy can prevent the most serious complications, which include liver cirrhosis, liver cancer, and death. This Seminar includes an update on the origins of haemochromatosis; and an overview pathophysiology, genetics, natural history, signs and symptoms, differential diagnoses, treatment with phlebotomy, outcomes, and future directions.

Methotrexate Drug Monitoring From Central Access: Can Blood Sample Collection From Central Venous Access Replace Peripheral Venipuncture in Adults?

BACKGROUND: Intravenous high-dose methotrexate (MTX ≥ 1 g/m 2 ) is frequently used in patients with cerebral lymphoma or other malignancies. In addition to its potent efficacy, it is known to have pronounced toxicity and life-threatening side effects. Regular-level monitoring at short and defined intervals is mandatory. This study aimed to evaluate the possibility of replacing peripheral blood sampling with blood samples from central venous catheters for therapeutic monitoring of MTX in adults. METHODS: A total of 6 patients and 7 cycles of chemotherapy (6 females; 5 with cerebral non-Hodgkin lymphoma and 1 with osteosarcoma, median age 51 years; range 33-62 years) were included. An immunoassay was used for quantitative analysis of MTX levels. The measurement points were obtained in the time intervals of 24, 42, 48, and 72 hours, and afterward, every 24 hours until the level was below <0.1 µmol/L. After flushing with 10 mL of saline solution and discarding 10 mL of venous blood, blood was drawn from the central venous access through which MTX had previously been administered. Simultaneously, MTX levels were obtained from peripheral venipuncture. RESULTS: Methotrexate levels from central venous access and MTX levels from peripheral venipuncture showed a significant correlation (r = 0.998; P < 0.01; n = 35). During withdrawal from the central access group, 17 values showed a lower MTX level, 10 showed a higher level, and 8 showed no difference. However, the MTX level difference was not significant ( P = 0.997, linear mixed model). No increase in the dose of calcium folinate was necessary based on the collected MTX levels. CONCLUSIONS: In adults, MTX monitoring from central venous access is not inferior to monitoring from peripheral venipuncture. Repeated venipuncture to measure MTX levels can be replaced after establishing standardized instructions for proper sampling by a central venous catheter.

Relative bioavailability and food effect study of an oral suspension of alectinib in healthy volunteers using venipuncture and capillary microsampling.

Alectinib, approved as 150 mg capsules for the treatment of adults with advanced ALK-positive non-small cell lung cancer, is being assessed in children with ALK-positive solid and central nervous system tumors. An ad hoc pediatric-friendly suspension of alectinib, prepared from capsule contents, is under investigation as an alternative formulation for children who cannot swallow capsules. This randomized, crossover, relative bioavailability, and food effect study evaluated alectinib administered as an oral suspension versus capsule formulation following conventional venipuncture and capillary microsampling. A total of 28 healthy adult subjects received a 600 mg single dose of alectinib in two groups: fasted (n = 14) and mixed fed (n = 14; seven receiving high-fat meal and seven receiving low-fat meal). Combined alectinib + M4 (active metabolite) exposure was higher for suspension versus capsule, with geometric mean ratio (GMR) of 2.6 for area under the concentration-time curve extrapolated to infinity (AUC0-∞ ) and 3.0 for maximum observed concentration (Cmax ) under fasted conditions, and 1.7 for both parameters for mixed fed. The suspension showed increased alectinib + M4 AUC0-∞ following a high-fat meal versus fasted conditions (GMR 1.7 [90% confidence interval 1.4-2.2]). Alectinib AUC0-∞ and Cmax measured in venous and capillary samples were generally similar for the suspension and capsule. Single oral doses of 600 mg alectinib suspension and capsule were well tolerated, with no safety concerns. Based on these findings, the oral suspension of alectinib appears suitable for use in pediatric studies after appropriate dose adjustment relative to the capsule.

Lidocaine Tape Application for 3 Hours Prevents Vasovagal Syncope During Venipuncture: A Case Series.

Vasovagal syncope (VVS) or reflex is usually caused by physical and mental stress-related factors, like pain, anxiety, and fear, and it is one of the most frequent complications during dental treatment. Two patients, both with histories of dental phobia and of VVS during vaccination, venipuncture, and dental treatment with local anesthetics, were scheduled for dental treatment under intravenous (IV) sedation. However, both experienced episodes of VVS that occurred during venipuncture using a 24-gauge indwelling needle. We determined that pain was the main trigger of VVS for these patients and attempted to reduce venipuncture-associated pain using 60% lidocaine tape applied 3 hours before venipuncture at their next dental visits, respectively. Use of the lidocaine tape was successful and permitted comfortable placement of the IV catheter without any onset of VVS.

Proposed dietary recommendations for iron overload: a guide for physician practice.

PURPOSE OF REVIEW: Iron overload disorders such as hemochromatosis involve unregulated absorption of dietary iron, leading to excessive iron accumulation in multiple organs. Phlebotomy is the standard of care for removal of excess iron, but dietary modification is not standardized in practice. The purpose of this article is to help standardize hemochromatosis diet counseling based on commonly asked patient questions. RECENT FINDINGS: The clinical benefit regarding dietary modification in iron overload patients is limited due to lack of large clinical trials, but preliminary results are promising. Recent studies suggest diet modification could reduce iron burden in hemochromatosis patients resulting in less annual phlebotomy as supported through small patient studies, concepts of physiology, and animal studies. SUMMARY: This article is a guide for physicians to counsel hemochromatosis patients based on commonly asked questions such as foods to avoid, foods to consume, use of alcohol, and use of supplements. The goal of this guide is to help standardize hemochromatosis diet counseling to reduce phlebotomy amount in patients. Standardization of diet counseling could help facilitate future patient studies to analyze the clinical significance.

Magnetic Resonance Liver Iron Concentration Can Guide Venesection Decision-Making in Hyperferritinemia.

BACKGROUND: The clinical benefit of venesection in suspected iron overload can be unclear and serum ferritin may overestimate the degree of iron overload. AIMS: To help inform practice, we examined magnetic resonance liver iron concentration (MRLIC) in a cohort investigated for haemochromatosis. METHODS: One hundred and six subjects with suspected haemochromatosis underwent HFE genotyping and MRLIC with time-matched serum ferritin and transferrin saturation values. For those treated with venesection, volume of blood removed was calculated as a measure of iron overload. RESULTS: Forty-seven C282Y homozygotes had median ferritin 937 µg/l and MRLIC 4.83 mg/g; MRLIC was significantly higher vs non-homozygotes for any given ferritin concentration. No significant difference in MRLIC was observed between homozygotes with and without additional risk factors for hyperferritinemia. Thirty-three compound heterozygotes (C282Y/H63D) had median ferritin 767 µg/l and MRLIC 2.58 mg/g; ferritin < 750 µg/l showed 100% specificity for lack of significant iron overload (< 3.2 mg/g). 79% of C282Y/H63D had additional risk factors-mean MRLIC was significantly lower in this sub-group (2.4 mg/g vs 3.23 mg/g). 26 C282Y heterozygous or wild-type had median ferritin 1226 µg/l and MRLIC 2.13 mg/g; 69% with additional risk factors had significantly higher ferritin concentrations (with comparable MRLIC) and ferritin < 1000 µg/l showed 100% specificity for lack of significant iron overload. In 31 patients (26 homozygotes, 5 C282Y/H63D) venesected to ferritin < 100 µg/l, MRLIC and total venesection volume correlated strongly (r = 0.749), unlike MRLIC and serum ferritin. CONCLUSION: MRLIC is an accurate marker of iron overload in haemochromatosis. We propose serum ferritin thresholds in non-homozygotes which, if validated, could tailor cost-effective use of MRLIC in venesection decision-making.

A venipuncture robot with decoupled position and attitude guided by near-infrared vision and force feedback.

BACKGROUND: This study aims to develop a venipuncture robot to replace manual venipuncture to ease the heavy workload, lower the risk of 2019-nCoV infection, and boost venipuncture success rates. METHOD: The robot is designed with decoupled position and attitude. It consists of a 3-degree-of-freedom positioning manipulator to locate the needle and a 3-degree-of-freedom end-effector that is always vertical to adjust the yaw and pitch angles of the needle. The near-infrared vision and laser sensors obtain the three-dimensional information of puncture positions, while the change in force detects the state feedback of punctures. RESULTS: The experimental results demonstrate that the venipuncture robot has a compact design, flexible motion, high positioning accuracy and repeatability (0.11 and 0.04 mm), and a high success rate when puncturing the phantom. CONCLUSION: This paper presents a decoupled position and attitude venipuncture robot guided by near-infrared vision and force feedback to replace manual venipuncture. The robot is compact, dexterous, and accurate, which helps to improve the success rate of venipuncture, and it is expected to achieve fully automatic venipuncture in the future.

Hepcidin mimetics in polycythemia vera: resolving the irony of iron deficiency and erythrocytosis.

PURPOSE OF REVIEW: Development of hepcidin therapeutics has been a ground-breaking discovery in restoring iron homeostasis in several haematological disorders. The hepcidin mimetic, rusfertide, is in late-stage clinical development for treating polycythemia vera patients with a global phase 3 trial [NCT05210790] currently underway. Rusfertide serves as the first possible noncytoreductive therapeutic option to maintain haematocrit control and avoid phlebotomy in polycythemia vera patients. In this comprehensive review, we discuss the pathobiology of dysregulated iron metabolism in polycythemia vera, provide the rationale for targeting the hepcidin-ferroportin axis and elaborate on the preclinical and clinical trial evidence supporting the role of hepcidin mimetics in polycythemia vera. RECENT FINDINGS: Recently, updated results from two phase 2 clinical trials [NCT04057040 & NCT04767802] of rusfertide (PTG300) demonstrate that the drug is highly effective in eliminating the need for therapeutic phlebotomies, normalizing haematological parameters, repleting iron stores and relieving constitutional symptoms in patients with polycythemia vera. In light of these findings, additional hepcidin mimetic agents are also being evaluated in polycythemia vera patients. SUMMARY: Hepcidin agonists essentially serve as a 'chemical phlebotomy' and are poised to vastly improve the quality of life for phlebotomy requiring polycythemia vera patients.

Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial.

INTRODUCTION: Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. METHODS: This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION: The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.

Real-world treatments and thrombotic events in polycythemia vera patients in the USA.

Polycythemia vera (PV) is a myeloproliferative neoplasm associated with increased risk of thrombotic events (TE) and death. Therapeutic interventions, phlebotomy and cytoreductive medications, are targeted to maintain hematocrit levels < 45% to prevent adverse outcomes. This retrospective observational study examined medical and pharmacy claims of 28,306 PV patients initiating treatment for PV in a data period inclusive of 2011 to 2019. Study inclusion required ≥ 2 PV diagnosis codes in the full data period, at least 1 year of PV treatment history, and ≥ 1 prescription claim and medical claim in both 2018 and 2019. Patients having ≥ 2 hematocrit (HCT) test results in linked outpatient laboratory data (2018-2019) were designated as the HCT subgroup (N = 4246). Patients were characterized as high- or low-risk at treatment initiation based on age and prior thrombotic history. The majority of patients in both risk groups (60% of high-risk and 83% of low-risk) initiated treatment with phlebotomy monotherapy, and during a median follow-up period of 808 days, the vast majority (81% low-risk, 74% high-risk) maintained their original therapy during the follow-up period. Hematocrit control was suboptimal in both risk groups; 54% of high-risk patients initiating with phlebotomy monotherapy sometimes/always had HCT levels > 50%; among low-risk patients, 64% sometimes/always had HCT levels above 50%. Overall, 16% of individuals experienced at least 1 TE subsequent to treatment initiation, 20% (n = 3920) among high-risk and 8% (n = 629) among low-risk patients. This real-world study suggests that currently available PV treatments may not be used to full advantage.

Comparison of a Novel Thin-Walled 25-gauge Needle Push Button Blood Collection Set to a Standard 23-gauge Needle in a Cancer Patient Population.

BACKGROUND: Phlebotomy can be an uncomfortable and even painful experience that increases in likelihood in patients who require frequent blood draws, such as those with cancer. The 25-gauge BD Vacutainer® UltraTouch™ Push Button Blood Collection Set has a smaller outer bore needle size and unique bevel configuration, which in theory should reduce pain associated with phlebotomy. Smaller needles typically cause less pain, however, they have a higher incidence of compromising the specimen integrity. Innovative engineering allows this particular needle to maintain a larger inner bore size similar to a standard 23-gauge needle. This study compares pain and specimen integrity between this novel device and a standard 23-gauge needle. METHODS: Two cohorts of 190 patients each had phlebotomy performed with either needle. Pain experienced was assessed by patient surveys, rating pain from 0 (low) to 10 (high). Sample integrity was assessed by determining the hemolysis index (Abbott Architect c8000). RESULTS: No statistically significant difference in median pain scores was observed between the 2 cohorts, P-value: 0.068. The 23-gauge cohort more frequently reported 3+ pain than the 25-gauge cohort, 14/190 vs 5/190. Pain scoring 1 and 2 was more frequent in the 25-gauge cohort, 84/190 vs 54/190. Pain scores of 0 were more frequent in the 23-gauge cohort, 122/190 vs 101/190. This stratification is statistically significant, P-value: 0.003. The 25-gauge needle showed no increase in hemolysis rates, P-value: 0.5. CONCLUSIONS: Sample integrity was identical between both needles. The 25-gauge needle resulted in less 3+ pain, while pain scoring 1 and 2 was more frequent in the 25-gauge cohort.

Planning of Medical Flexible Needle Motion in Effective Area of Clinical Puncture.

Lung cancer is the leading cause of cancer deaths worldwide. Although several lung cancer diagnostic methods are available for lung nodule biopsy, there are limitations in terms of accuracy, safety, and invasiveness. Transbronchial needle aspiration (TBNA) is a common method for diagnosing and treating lung cancer that involves a robot-assisted medical flexible needle moving along a curved three-dimensional trajectory, avoiding anatomical barriers to achieve clinically meaningful goals in humans. Inspired by the puncture angle between the needle tip and the vessel in venipuncture, we suggest that different orientations of the medical flexible needle puncture path affect the cost of the puncture trajectory and propose an effective puncture region based on the optimal puncture direction, which is a strategy based on imposing geometric constraints on the search space of the puncture direction, and based on this, we focused on the improved implementation of RCS*. Planning within the TBNA-based lung environment was performed using the rapidly exploring random tree (RRT), resolution-complete search (RCS), and RCS* (a resolution-optimal version of RCS) within an effective puncture region. The experimental results show that the optimal puncture direction corresponding to the lowest cost puncture trajectory is consistent among the three algorithms and RCS* is more efficient for planning. The experiments verified the feasibility and practicality of our proposed minimum puncture angle and puncture effective region and facilitated the study of the puncture direction of flexible needle puncture.