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Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 344-344
Giancarlo Castaman ◽  
Jerzy Windyga ◽  
Hazza Alzahrani ◽  
Susan Robson ◽  
Fabian Sanabria ◽  

Abstract Background: Emicizumab, a bispecific monoclonal antibody, bridges activated factor (F) IX and FX, replacing the function of missing activated FVIII in persons with hemophilia A (PwHA). The Phase IIIb, multicenter, single-arm STASEY study (NCT03191799) assessed the safety and efficacy of emicizumab prophylaxis in PwHA with FVIII inhibitors. Surgical experiences in STASEY are reported here. Methods: Following informed consent and ethics committee approval, PwHA aged ≥12 years with FVIII inhibitors received 3 mg/kg/week emicizumab for 4 weeks (loading dose), then 1.5 mg/kg/week for the remaining 2-year treatment period. Minor and major surgeries were managed per the investigators' discretion. The type and number of procedures performed, additional prophylaxis, and frequency and management of postoperative bleeds were analyzed. Surgeries occurring up to 28 days after the last dose of emicizumab were included, due to emicizumab's ~28-day half-life (Emicizumab Prescribing Information, United States Food and Drug Administration, 2017). Surgeries were documented using an electronic case report form by the treating physicians and classified as minor or major based on manual medical review (Santagostino, et al. Haemophilia, 2015). Bleed and prophylactic hemophilia medication data were recorded in the electronic Bleed Medication Questionnaire by participants. Case narratives were provided by trial investigators. Results: Overall, 46 patients reported ≥1 on-study surgery. Thirty-seven patients had 56 minor surgeries (central venous access device [CVAD], n=9; dental, n=20; joint, n=4; other, n=23) (Figure), one of which (skin laceration and suture insertion on Day 9) was performed during the loading phase. Twenty-four surgeries (42.9%) were managed with additional prophylactic medications (Table). Of these, 11/24 (45.8%) resulted in postoperative bleeds, of which 6/11 were treated (54.5%). Of surgeries managed without additional prophylactic medications, 15/32 (46.9%) resulted in postoperative bleeds, of which 5/15 (33.3%) were treated. A total of 13 patients had 22 major on-study surgeries (arthroplasty, n=13; other, n=9). 'Other' included hemorrhoid operations, coronarography, sigmoidectomy, colostomy, laparotomy and polypectomy. Eighteen (81.8%) major surgeries, including all arthroplasties, were managed with additional prophylactic medications (Table). Of these, 12/18 (66.7%) resulted in postoperative bleeds (including 10/13 arthroplasties), of which six (50.0%) were treated (all arthroplasties). Four (18.2%) major surgeries were managed without additional prophylactic medication, including three hemorrhoid operations in one patient, and a coronarography in a patient with acute myocardial infarction. One hemorrhoid operation resulted in a postoperative treated bleed. Major surgeries included a 55-year-old male with Grade 4 device dislocation of left knee prosthesis on Day 7, who was diagnosed with recurrent infection and prosthesis misalignment on Day 62. Amputation of the left leg above the knee was performed, with treatment including tranexamic acid and rFVIIa. A 61-year-old male with left knee prosthesis infection underwent left knee arthrodesis on Day 457, vacuum-assisted closure therapy on Day 495, skin grafting on Day 512, and left knee arthrodesis with skin flap placement on Day 527. Throughout these surgeries, the individual experienced recurrent joint bleeding and received rFVIIa. Neither of these individuals had a change in their study treatment due to these events. No thrombotic events (TEs) or thrombotic microangiopathies (TMAs) related to surgeries were observed. Conclusions: In the STASEY study of PwHA with FVIII inhibitors receiving emicizumab prophylaxis, most minor surgical procedures were performed without additional prophylactic coagulation factor and did not result in postoperative treated bleeds. Therefore, emicizumab alone provided adequate hemostatic coverage for some PwHA undergoing certain types of minor surgery, such as tooth extraction and CVAD removal. Major surgeries were safely performed with additional coagulation prophylaxis. Management of surgeries with rFVIIa did not result in TE or TMA. In case of bleeds, a bleed management plan should be in place. Effects of emicizumab on coagulation and assays may persist for up to 6 months after the last dose, which may be relevant when planning postoperative treatment. Figure 1 Figure 1. Disclosures Castaman: Uniqure: Honoraria; Bayer: Honoraria; Sobi: Honoraria; CSL Behring: Honoraria; Novo Nordisk: Honoraria; Kedrion: Honoraria; LFB: Honoraria; Grifols: Honoraria; Werfen: Honoraria; Biomarin: Honoraria; Sanofi: Honoraria; F Hoffmann-La Roche Ltd: Honoraria. Windyga: Swixx BioPharma: Honoraria; Octapharma: Honoraria, Research Funding; Sobi: Honoraria, Research Funding; Sanofi-Aventis: Honoraria, Research Funding; Werfen: Honoraria; Bayer AG: Honoraria; Aspen: Honoraria; Alfasigma: Honoraria; Takeda: Honoraria, Research Funding; Shire: Honoraria, Research Funding; Alnylam Pharmaceuticals: Research Funding; Sanofi/Genzyme: Honoraria, Research Funding; F. Hoffmann-La Roche Ltd: Honoraria, Research Funding; Alexion: Honoraria; CSL Behring: Honoraria; Rigel Pharmaceuticals: Research Funding; Novo Nordisk: Honoraria, Research Funding; Baxalta: Honoraria, Research Funding. Alzahrani: Sobi: Consultancy, Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; Bayer: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria; King Faisal Specialist Hospital and Research Centre: Current Employment. Robson: F. Hoffmann-La Roche Ltd: Current Employment, Ended employment in the past 24 months. Sanabria: F. Hoffmann-La Roche Ltd: Current Employment, Current holder of individual stocks in a privately-held company. Howard: F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company. Jiménez-Yuste: Octapharma: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Sobi: Consultancy, Honoraria, Research Funding; BioMarin: Consultancy; CSL Behring: Consultancy, Honoraria, Research Funding; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; NovoNordisk: Consultancy, Honoraria, Research Funding; Grifols: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Research Funding.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4859-4859
Firas Bayoudh ◽  
Julie Descy ◽  
Corentin Fontaine ◽  
Frederic Baron ◽  
Evelyne Willems ◽  

Abstract Venous access device-related bloodstream infections (VAD-BSIs) with coagulase-negative staphylococci (CoNS) are common complications after allogeneic hematopoietic cell transplantation (alloHCT). So far, the standard systemic antimicrobial therapy for uncomplicated VAD-BSIs with methicillin-resistant CoNS consisted of intravenous (IV) vancomycin (vanco). This approach requires hospitalization, necessitates new competent venous access, exposes patients to potential (mainly renal) toxicity and increases the risk of commensal flora dysbiosis with selection of vanco-resistant enterococci. Patients after alloHCT are particularly at risk of iatrogenic and nosocomial complications. In addition, repeated hospitalizations can impact autonomy and quality of life and are associated with significant costs. Minocycline (mino) is an oral antimicrobial agent that has strong in vitro effects on most Gram positive bacteria and potential anti-biofilm activity, and can be used in the clinic for some CoNS infections. Our infectious disease specialists proposed that systemic therapy with oral mino could be used for the management of uncomplicated VAD-BSIs, primarily when the reference treatment with IV vanco was not possible (renal failure or allergy) or when hospitalization was refused by patients. We retrospectively analyzed the results of this mino-based approach. From January 2012 to December 2020, we treated 24 uncomplicated VAD-BSIs with CoNS in 23 alloHCT patients aged 17-72y with oral mino. Uncomplicated VAD-BSIs were defined as 2 or more blood cultures positive for the same CoNS drawn consecutively peripherally and through the VAD, in patients without signs of sepsis, cellulitis or suppurative thrombophlebitis and without endovascular implant or orthopedic material. VAD were implantable ports (n=17), tunneled catheter (n=1) or PICC-lines (n=6). Pathogens were S. epidermidis (n= 21) or S. haemolyticus (n=3). CoNS were in vitro susceptible to mino according to EUCAST guidelines (with MIC <= 0.5mg/L, predominantly). Mino was administered at a dose of 100 mg BID for 7-14 days. For 8 VAD-BSIs, patients were initially treated with IV vanco for the first 1-3 days followed by oral mino, while 16 VAD-SIBs were managed with oral mino alone. VAD management consisted of catheter removal (for tunneled and PICC-lines, n=7) or antibiotic locks with vanco (n=15) or gentamicin (n=2) administered at least every other day for 14 days (for ports). Overall, clearance of bacteremia (as assessed by negativity of surveillance peripheral blood cultures with the same CoNS drawn between d+3 and +30 after initiation of systemic therapy) was achieved in all but 1 patient (with port, treated with mino alone) who had persistent bacteremia at day +9. No complication such as suppurative thrombophlebitis, endocarditis or metastatic foci of infection was observed in any patient during the 3-month period after initiation of treatment. Among the 17 patients for whom VAD salvage was attempted, VAD decontamination was successful in 10 cases while 4 patients experienced persistently positive VAD-derived blood cultures during the early (d+3 to +14) surveillance period and 3 patients experienced delayed relapse of VAD-BSIs with the same CoNS 1-3 months later (with 1 patient with cellulitis). All these events led to VAD removal. Treatment with mino was well tolerated with the exception of mild skin rash in one patient. Our results in this retrospective cohort suggest that oral mino can be a promising alternative to standard IV vanco for systemic therapy in VAD-BSIs with CoNS and that a strategy combining oral mino and antibiotic locks may salvage VAD in approximately half of the cases. This remains to be confirmed in prospective studies. Disclosures No relevant conflicts of interest to declare.

2021 ◽  
Vol 2085 (1) ◽  
pp. 012007
Yang Wang ◽  
Siran Li ◽  
Xiaofei Wang ◽  
Yue Wang

Abstract In order to improve the design efficiency and quality of traditional airborne electronic equipment, the structural forms of traditional equipment are summarized. Based on the creation of basic structure modules, the parametric design of series structure modules and access devices is carried out. According to the functional requirements of the equipment, different series of structural modules are selected, combined and installed in the access device to quickly realize the modular design of airborne electronic equipment. A series of structural modules are repeatedly applied on a variety of equipment to improve the design reliability.

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e056197
John Alexander Clark ◽  
Iain Robert Louis Kean ◽  
Martin D Curran ◽  
Fahad Khokhar ◽  
Deborah White ◽  

IntroductionLower respiratory tract infection (LRTI) is the most commonly treated infection in critically ill children. Pathogens are infrequently identified on routine respiratory culture, and this is a time-consuming process. A syndromic approach to rapid molecular testing that includes a wide range of bacterial and fungal targets has the potential to aid clinical decision making and reduce unnecessary broad spectrum antimicrobial prescribing. Here, we describe a single-centre prospective cohort study investigating the use of a 52-pathogen TaqMan array card (TAC) for LRTI in the paediatric intensive care unit (PICU).Methods and analysisCritically ill children with suspected LRTI will be enrolled to this 100 patient single-centre prospective observational study in a PICU in the East of England. Samples will be obtained via routine non-bronchoscopic bronchoalveolar lavage which will be sent for standard microbiology culture in addition to TAC. A blood draw will be obtained via any existing vascular access device. The primary outcomes of the study will be (1) concordance of TAC result with routine culture and 16S rRNA gene sequencing and (2) time of diagnostic result from TAC versus routine culture. Secondary outcomes will include impact of the test on total antimicrobial prescriptions, a description of the inflammatory profile of the lung and blood in response to pneumonia and a description of the clinical experience of medical and nursing staff using TAC.Ethics and disseminationThis study has been approved by the Yorkshire and the Humber-Bradford Leeds Research Ethics Committee (REC reference 20/YH/0089). Informed consent will be obtained from all participants. Results will be published in peer-reviewed publications and international conferences.Trial registration numberNCT04233268.

2021 ◽  
Vol 11 (5) ◽  
pp. 64-72
P. J. Kumarasinghe ◽  
M. A. K. Sriyalatha

As education moves e-learning all over the world due to COIVD-19 pandemic, students spend more time on e-learning than ever before. This is also equally applied to the Sri Lankan education system. Thus this study examines the undergraduate students’ perspectives on e-learning during the COVID-19 outbreak in universities in Sri Lanka. Primary data was obtained from undergraduate students in Sri Lankan university using a structured questionnaire via Google form. The perspectives on e-learning education during the COVID-19 pandemic was investigated using descriptive statistics and frequency analysis. The majority of the undergraduate students felt that the e-learning version of education saved travel time and cost of accommodation. Furthermore, the study revealed that the majority of students were happy with the e-learning form of education during the pandemic since it allowed them to finish their degrees faster and access the labor market without a delay. The biggest challenges with e-learning, according to the student responses, were internet access, device availability, visionary issues, technical issues, and stress. As a result of this COVID -19 pandemic, if higher education officials in Sri Lankan universities want to keep e-learning education on going, they must focus on offering cost-effective, high-speed data connections while minimizing technological hurdles. At the same time, it is important to update and revise the curriculum content according to this new mode of education since this is a completely new situation for all. There is relatively little research on students’ perspectives on e-learning education during the COVID-19 pandemic in the Sri Lankan context and it will provide some important highlights to the researchers, parent and academics as well.

Claudia L. Craven ◽  
Paul Gissen ◽  
Rebecca Bower ◽  
Laura Lee ◽  
Kristian Aquilina ◽  

OBJECTIVE Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) is a rare autosomal recessive disease caused by tripeptidyl peptidase 1 enzyme deficiency. At the authors’ center, the medication cerliponase alfa is administered every 2 weeks via the intracerebroventricular (ICV) route. This requires the placement of a ventricular access device (VAD) or reservoir and frequent percutaneous punctures of this device over the child’s lifetime. In this study, the authors audited the longevity and survival of these VADs and examined the causes of device failure. METHODS A single-center survival analysis of VAD insertions and revisions (January 2014 through June 2020) was conducted. All children received cerliponase alfa infusions through a VAD. Patient characteristics and complications were determined from a prospectively maintained surgical database and patient records. For the VAD survival analysis, the defined endpoint was when the device was removed or changed. Reservoir survival was assessed using Kaplan-Meier curves and the log-rank (Cox-Mantel) test. RESULTS A total of 17 patients had VADs inserted for drug delivery; median (range) age at first surgery was 4 years 4 months (1 year 8 months to 15 years). Twenty-six VAD operations (17 primary insertions and 9 revisions) were required among these 17 patients. Twelve VAD operations had an associated complication, including CSF infection (n = 6) with Propionibacterium and Staphylococcus species being the most prevalent organisms, significant surgical site swelling preventing infusion (n = 3), leakage/wound breakdown (n = 2), and catheter obstruction (n = 1). There were no complications or deaths associated with VAD insertion. The median (interquartile range) number of punctures was 59.5 (7.5–82.0) for unrevised VADs (n = 17) versus 2 (6–87.5) for revised VADs (n = 9) (p = 0.70). The median survival was 301 days for revisional reservoirs (n = 9) versus 2317 days for primary inserted reservoirs (n = 17) (p = 0.019). CONCLUSIONS In the context of the current interest in intrathecal drug delivery for rare metabolic disorders, the need for VADs is likely to increase. Auditing the medium- to long-term outcomes associated with these devices will hopefully result in their wider application and may have potential implications on the development of new VAD technologies. These results could also be used to counsel parents prior to commencement of therapy and VAD implantation.

2021 ◽  
pp. 112972982110468
John S Dayco ◽  
Niketh DeSouza ◽  
Shaun Cardozo

Implanted ports have provided clinicians with long term venous accessibility, while maintaining comfort and convenience for their patients. One of the most commonly used implanted ports for oncological access is a Mediport (Norfork Medical, Skokie, IL). Guidelines (INS2021) strongly recommend placing central catheter tips at the cavo-atrial junction. In fact, too deep atrium position may be associated with micro-traumatism, possibly leading to a catheter associated right atrial thrombosis (CRAT). No significant literature discusses the possibility of such port masses being seeded by a bacteria, as in the case for endocarditis, which was seen in our patient. In the following case report, we will explore the case of a 41-year-old female with metastatic urothelial carcinoma who developed multiple right atrial masses possibly associated with a deeply seated totally implanted vascular access device (TIVAD) tip within the right atrial wall. These right atrial masses were of unknown origin, and in the setting of MRSA bacteremia, multiple possible etiologies would be discussed. We will also explore ways in which similar complications can be easily prevented in the future.

2021 ◽  
pp. 112972982110455
Xinpeng Wang ◽  
Yong Yang ◽  
Jing Dong ◽  
Xiaozheng Wang ◽  
Yuanyuan Zheng ◽  

Persistent left superior vena cava (PLSVC) is a rare congenital anomaly. PLSVC can be associated with clinically significant atrial septal defect (ASD) or ventricular septal defect (VSD). It is usually asymptomatic and accidentally detected during invasive procedures or imaging examinations. However, whether central venous access device (CVAD) can be placed and used in patients with PLSVC is controversial. A total of six patients were diagnosed with PLSVC and confirmed by chest CT among 3391 cancer patients who underwent CVAD placement via intracavitary electrocardiogram (IC-EKG) at the Venous Access Center (VAC) from May 2019 to December 2020. The CVADs (peripherally inserted central catheter in four patients and Ports in two patients) of these six patients were left in PLSVC. We analyzed changes in the P-wave in the IC-EKG during CVAD placement and the characteristics of the body surface electrocardiogram in these patients and discussed the catheter tip position in PLSVC. All six patients showed negative P-waves in lead II via IC-EKG from the beginning of catheterization: four patients showed negative P-waves and two showed biphasic P-waves in the body surface electrocardiogram (lead III) before catheterization. CVAD function was normal and no obvious complications were observed during the treatment of these patients. The total retention time of CVADs was 1537 days. For patients with a negative P-wave in lead II via IC-EKG during catheterization, especially in those with a negative or biphasic P-wave in lead III of the body surface electrocardiogram, PLSVC should be considered. CVAD insertion in patients with type I PLSVC is safe under certain conditions, with the proper tip position in the middle to lower part of PLSVC.

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