Oddi括约肌压力测定及内镜下十二指肠乳头括约肌切开术对Oddi括约肌功能紊乱诊治的意义

目的针对反复右上腹痛的患者进行Oddi括约肌测压,以评价Oddi括约肌测压术(SOM)在慢性胆胰疾病诊治中的应用价值,并探讨内镜下十二指肠乳头切开术(EST)对Oddi括约肌基础压升高患者的疗效。方法回顾分析该院2012年10月-2014年9月30例慢性上腹痛疑似Oddi括约肌功能紊乱(SOD)的患者在内镜逆行胰胆管造影术(ERCP)检查时接受SOM的临床资料,观察Oddi括约肌基础压、收缩幅度、频率和传播方式。对Oddi括约肌基础压40.0 mm Hg者及30.0 mm Hg并存在血淀粉酶、脂肪酶、谷丙转氨酶(ALT)、谷草转氨酶(AST)、碱性磷酸酶(AKP)升高超过正常值2倍以上和(或)胆总管、胰管管增宽者行EST治疗,并随访其疗效。结果 30例患者SOM均存在不同程度的异常,Oddi括约肌基础压力为(36.6±21.1)mm Hg,收缩幅度为(210.6±25.7)mm Hg,收缩频率为(10.1±3.1)次/min,逆向收缩率为(55.0±8.0)%。30例患者均接受EST治疗,术后随访,其中27例(90.0%)有效。结论 SOM助于评价Oddi括约肌功能,对诊断SOD具有较大价值,测压发现Oddi括约肌基础压升高患者EST治疗可获得满意疗效。     

Needlescopic intragastric surgery facilitated by newly developed 2mm instruments

Background: Intragastric surgery is a percutaneous endoluminal surgery in the stomach aimed at resection of tumors located at the esophagogastric junction (EGJ). We developed needlescopic intragastric surgery performed via 2?mm, 2?mm, and 5?mm ports (PEIGS-225).

Material and methods: In cooperation with Niti-On Co., Ltd. we developed a series of 2?mm instruments including grasping forceps, a cannula, a laparoscope, an electrocautery, scissors, and a needle holder. Operative technique: Two 2?mm trocars and a 5?mm one are inserted into the gastric lumen percutaneously. Intragastric procedures are performed by the instruments brought through those three ports. The specimen is extracted via the esophageal-oral route. The defect in the gastroesophageal wall is closed by hand-suture. After the intragastric procedure, the 5?mm stab wound on the gastric wall is closed by hand-suture, while the 2?mm wounds are left untreated. Patients: Between March and August 2015 PEIGS-225 was performed in five patients.

Results: There was no operative conversion. The mean operation time was 96?minutes. There were no perioperative complications. Pathological findings indicated that the margin was negative in all cases.

Conclusion: Needlescopic intragasric surgery performed via the smallest access (2?mm, 2?mm, 5?mm) is enabled by the 2?mm instruments developed by us.     

Correlation between sphincter of Oddi manometry and intraductal ultrasound morphology in patients with suspected sphincter of Oddi dysfunction

BACKGROUND AND STUDY AIMS: Intraductal ultrasonography (IDUS) makes it possible to study sphincter of Oddi morphology during endoscopy. Two recent IDUS studies have described the sphincter of Oddi as a circumferential hypoechoic layer in the papilla, but there have as yet been few published data from patients with suspected sphincter of Oddi pathology. PATIENTS AND METHODS: Twenty-one consecutive patients with suspected biliary sphincter of Oddi dysfunction (seven men, 14 women; age 54 +/- 17 years) were enrolled in the study. Endoscopic sphincter of Oddi manometry was carried out using a 4-Fr electronic microtransducer device. After this, a wire-guided 6-Fr ultrasound catheter was placed in the common bile duct (CBD), and IDUS was carried out while the ultrasound catheter was being withdrawn from the CBD toward the duodenum. RESULTS: Sphincter of Oddi manometry and IDUS were carried out successfully in 18 of the 21 patients. Sphincter of Oddi manometry revealed sphincter of Oddi hypertension (baseline pressure > 35 mmHg) in eight patients. The mean sphincter of Oddi baseline pressure was 32 +/- 17 mmHg, and the mean phasic sphincter of Oddi pressure was 132 +/- 31 mmHg. During IDUS, a circumferential hypoechoic layer was clearly delineated in all patients. There was a significant correlation between the manometrically determined length of the sphincter of Oddi (8 +/- 2 mm) and the thickness of the hypoechoic layer (6 +/- 2 mm) as assessed by IDUS (r = 0.66, P < 0.001). However, no correlation was found between the baseline or phasic sphincter of Oddi pressures and the thickness of the hypoechoic layer. Accordingly, IDUS did not allow identification of patients with sphincter of Oddi hypertension. Mild pancreatitis was observed in one of the 18 patients (6 %). CONCLUSIONS: The circumferential hypoechoic layer of the papilla visualized by IDUS is the ultrasonographic correlate of the sphincter of Oddi. IDUS of the papilla is technically feasible and safe in patients with suspected sphincter of Oddi dysfunction. IDUS may provide additional information at the sphincter of Oddi level, but cannot be used as a substitute for sphincter of Oddi manometry.     

Ingestive Skill Difficulties are Frequent Among Acutely-Hospitalized Frail Elderly Patients,and Predict Hospital Outcomes

ABSTRACT

Purpose?: To examine the relationship between ingestive skill performance while eating and drinking and frailty status in acutely-hospitalized elderly patients and to examine whether there is a relationship between the proportion of ingestive skill difficulties and Length of Hospital Stay (LOS) and discharge destination. Methods?: Frail (n = 64) and robust (n = 40) acutely-hospitalized elderly patients were assessed using The McGill Ingestive Skills Assessment. Results?: Forty-three ingestive skills were significantly more affected in frail patients (21.9% to 95.3%) versus robust patients (2.5% to 65.0%). When adjusting for frailty status, difficulties in self-feeding and texture management were related to prolonged LOS, and difficulties in positioning and liquid ingestion were related to discharge to institutional care. Conclusion?: Ingestive skill difficulties among acutely-hospitalized frail elderly patients were frequent and characterized by great complexity. This necessitates a broad range of management strategies related to the patients’ ability in positioning, self-feeding skills, as well as oropharyngeal sensorimotor skills.     

内镜逆行胰胆管造影术后并发胰腺炎的相关因素分析与对策探讨

目的 探讨内镜逆行胰胆管造影术（ERCP）后并发胰腺炎（PEP）的影响因素。方法 回顾性分析2018年2月－2021年2月该院343例行ERCP患者的临床资料,根据是否发生胰腺炎分为PEP组（n = 51）和非PEP组（n = 292）。采用Logistic回归法分析发生PEP的相关危险因素,并提出预防对策。结果 两组患者在性别、年龄 < 60岁、胆总管结石、胰腺炎病史、Oddi括约肌功能障碍、胰腺显影、行胰管括约肌切开术、行Oddi括约肌测压术、ERCP手术结局、插管困难和导丝多次进胰管等方面比较,差异均有统计学意义（P < 0.05）。Logistic回归分析显示,胆总管结石、胰腺炎病史、Oddi括约肌功能障碍、胰腺显影、行胰管括约肌切开术、行Oddi括约肌测压术、ERCP手术失败、插管困难及导丝多次进胰管是PEP的独立危险因素（P < 0.05）。结论 胆总管结石、胰腺炎病史、Oddi括约肌功能障碍、胰腺显影、行胰管括约肌切开术、行Oddi括约肌测压术、ERCP手术失败、插管困难及导丝多次进胰管是PEP的独立危险因素。     

A plug-and-play brain-computer interface to operate commercial assistive technology

Abstract

Purpose: To determine if a brain-computer interface (BCI) could be used as a plug-and-play input device to operate commercial assistive technology (AT), and to quantify the performance impact of such operation. Method: Using a hardware device designed in our lab, participants (11 with amyotrophic lateral sclerosis, 22 controls) were asked to operate two devices using a BCI. Results were compared to traditional BCI operation by the same users. Performance was assessed using both accuracy and BCI utility, a throughput metric. 95% confidence bounds on performance differences were developed using a linear mixed model. Results: The observed differences in accuracy and throughput were small and not statistically significant. The confidence bounds indicate that if there is a performance impact of using a BCI to control an AT device, the impact could easily be overcome by the benefits of the AT device itself. Conclusions: BCI control of AT devices is possible, and the performance difference appears to be very small. BCI designers are encouraged to incorporate standard outputs into their design to enable future users to interface with familiar AT devices.

• Implications for Rehabilitation

• Brain-computer interface (BCI) control of assistive technology (AT) devices is possible.

• The performance impact of such control is low when BCIs are commercially available, AT providers can use a BCI as an input device to existing AT devices already in use by their clients.

     

BRTO assisted endoscopic Histoacryl injection in treating gastric varices with gastrorenal shunt

Aims: We evaluated the feasibility, efficacy and safety of a novel technique of balloon-occluded retrograde transvenous obliteration (BRTO) assisted endoscopic Histoacryl (N-buthyl-2-cyanoacrylate) injection.

Material and methods: A total with 11 patients were enrolled and analyzed in this single center, open-label, prospective study. Patients with high-risk gastric varices (defined as fundal varices, large GV (>5?mm), presence of a red spot, and Child-Pugh score C) and concurrent gastrorenal shunt underwent endoscopic Histoacryl injection while the gastrorenal shunt was temporarily occluded with an occlusion balloon. Feasibility, hemostatic effect, intra- and postoperative complications, and varices recurrence were evaluated.

Results: All procedures were successfully done per protocol. Except for one patient who underwent rescue Histoacryl injection due to residual varices, single therapy was sufficient to eliminate gastric varices in ten patients. Intra-operative hemorrhage occurred in one case and was stopped after additional Histoacryl injection. One patient was confirmed to have treatment-related fungemia. No death or major complications occurred, including ectopic embolism, worsening of hepatic and renal function, etc. No recurrence of the varices was found during a median follow-up time (mean?±?SD) of 228?±?153 days.

Conclusions: BRTO assisted endoscopic Histoacryl injection is effective and safe for patients with high-risk gastric varices and concurrent gastrorenal shunt.     

Perivascular cells as mesenchymal stem cells

Importance of the field: Mesenchymal stem cells are multipotent adult stem cell populations that have broad differentiation plasticity and immunosuppressive potential that render them of great importance in cell-based therapies. They are identified by in vitro characteristics based on their differentiation potential for clinical approaches while their biological properties and in vivo identities are often less understood.

Areas covered in this review: Recent research carried out in the last decade on mesenchymal stem cell biology suggests that mesenchymal stem cells from various tissues reside in a perivascular location and these can be identified as pericytes that function as mural cells in microvessels.

What the reader will gain: This review covers recent progress on understanding the link between pericytes and mesenchymal stem cells discussing specific points such as response to injury and tissue-specific functions.

Take home message: Despite a long and controversial history, there is a growing acceptance that perivascular cells are connected with mesenchymal stem cells, all that is really lacking is genetic evidence to show differentiation of pericytes into different cells types.     

Inclusion of rehabilitation medicine concepts in school of medicine resources

Abstract

Purpose: To perform a gap analysis of rehabilitation medicine learning objectives (RMLOs) coverage within school of medicine (SOM) curriculum and educational resources as a basis for development of educational resources to fill any identified gaps. Method: Following ethics approval, interviews were carried out with SOM academics and clinicians to assess the relevance of a set of RMLOs and the extent to which RMLOs were addressed in SOM resources. Interviewee opinion was quantified via Likert scales and additional free comments were subjected to thematic analysis. Results: Most RMLOs were perceived as relevant by more than half of the 18 participants. There was evidence of relevant material relating to each RMLO in SOM resources. Thematic analysis suggested that rehabilitation medicine was addressed at the SOM in less detail than outlined in the RMLOs, and that additional rehabilitation content could be included in SOM resources across a number of courses and year levels. Conclusions: Rehabilitation medicine is considered relevant by clinicians and academics at the SOM. The most effective way of filling identified gaps in coverage of rehabilitation medicine at the SOM will be via engagement across a number of medical and surgical disciplines.

• Implications for Rehabilitation

• Rehabilitation-related knowledge and skills are relevant to medical education.

• Many of these issues are already partially addressed in existing educational resources.

• The design and delivery of medical school curricula should include a trans-disciplinary and inter-year approach to the inclusion of rehabilitation concepts and aptitudes.

• This could be done by introducing relevant concepts early, making resources available online, and embedding rehabilitation items across different disciplines, courses and assessments.

     

A wearable fabric-based speech-generating device: system design and case demonstration

Abstract

Purpose: Existing speech generating devices (SGD) often require caregiver intervention for setup and positioning, and thus limit opportunities for spontaneous social interaction. The advent of conductive fabrics presents an opportunity to render SGDs wearable, thus persistently available. Our goal was to design and test a wearable SGD incorporating resistive textile-based switches for a nonverbal pediatric participant with vision impairment.

Materials and methods: Quad-key fabric keypads were designed using two conductive fabrics in combination with felt and mesh insulators. The keypad with the most repeatable low force activations and the least cross-talk among keys was chosen for implementation in a wrist-worn, four-message textile SGD. The fabric-based SGD was used by a nonverbal pediatric participant for two one-week analysis periods, alternating with the user’s current device for usage reference. Data were derived from usage logs, parent questionnaires and an end-of-study participant interview.

Results: The best performing keypad consisted of two layers of woven conductive fabrics and one layer of insulating felt with 10?mm apertures. Communicative interactions were higher with the fabric-based SGD, particularly at school. Unprompted initiation of communication was observed only with the fabric-based SGD. The persistent availability of the textile solution, along with esthetic appeal likely contributed to its utilization. While the participant preferred the fabric-based SGD, the parent opted for the iPod alternative, citing enhanced message intelligibility.

Conclusions: Fabric-based SGDs are a new alternative to conventional SGD designs using rigid electronics. As such, tactile differentiability of keys, device wearability and esthetic personalization may be promising advantages for pediatric users.

• Implications for rehabilitation

• Fabric-based switches may be a promising alternative to conventional electro-mechanical switches for the control of speech-generating devices, offering functional (e.g., comfort and tactile differentiability), expressive (e.g., non-stigmatizing textile integration) and esthetic (e.g., colors and textures) appeal.

• The material combination of two layers of woven conductive material and one insulating layer of felt with 10?mm diameter apertures seems to provide a fabric-based keypad suitable for pediatric use, requiring low-force activation and minimal cross-talk among buttons.

• Fabric-based devices offer advantages of tactile differentiability and thus may be particularly suited to individuals with vision impairments.

• Wearable textile SGDs can be persistently available and may thus increase opportunities for communication.

     

Development of scar-less laparoscopic hernia repair (TAPP-252) facilitated by new 2mm instruments

Introduction: To minimize the invasiveness of laparoscopic transabdominal preperitoneal hernia repair (TAPP) for the treatment of adult inguinal hernia, we developed a new operative technique with the use of only one 5?mm port and two 2?mm punctures (TAPP-252).

Material and methods: To facilitate TAPP-252, we developed seven kinds of new 2?mm instruments, including grasping forceps, hook shaped electrode, mesh pusher, needle driver, scissors, laparoscope and port.

Results: TAPP-252 was stably performed in 35 patients with minimal abdominal wall destruction and excellent cosmetic result without any recurrence or morbidity.

Conclusions: The newly developed 2?mm devices showed sufficient performance and durability in TAPP-252. Further investigation is necessary to assess durability and long-term outcomes.     

Comparison of extracorporeal shock wave therapy with botulinum toxin type A in the treatment of plantar fasciitis

Objective: To compare the efficacy of extracorporeal shock wave therapy (ESWT) with botulinum toxin type A (BoNT-A) in the treatment of plantar fasciitis (PF).

Design: Open label, prospective, randomized study.

Results: A total of 72 patients were included. In all participants the median (and interquartile range) of the visual analog scale (VAS) of pain result, when taking the first steps, was 8 (6–9) points before treatment and 6 (4–8) points after treatment (p?p?=?0.009). In the group of patients that received ESWT, the median (and interquartile range) of improvement in the Roles and Maudsley scale of pain result was 1 (0–1) points, and in the group of patients that received BoNT-A the same result was 0 (0–1) points (p?=?0.006). In a multivariate analysis use of ESWT and lower weight were associated with improvement of pain with treatment in at least one of the three VAS of pain scales used in the study.

Conclusion: ESWT was superior to BoNT-A in the control of pain in patients with PF.

• Implications for Rehabilitation

• Plantar fasciitis is characterized by pain at the calcaneal origin of the plantar fascia, exacerbated by weight bearing after prolonged periods of rest.

• Although studies comparing extracorporeal shock wave therapy or botulinum toxin type A to placebo suggest a superiority of the first one, no reliable data exist about it.

• Extracorporeal shock wave therapy was superior to botulinum toxin type A in the control of pain in patients with PF.

     

Emergency management of chlorine gas exposure – a systematic review

Introduction: Chlorine exposure can lead to pulmonary obstruction, reactive airway dysfunction syndrome, acute respiratory distress syndrome and, rarely, death.

Objective: We performed a systematic review of published animal and human data regarding the management of chlorine exposure.

Methods: Three databases were searched from 2007 to 2017 using the following keywords “(“chlorine gas” OR “chlorine-induced” OR” chlorine-exposed”) AND (“therapy” OR “treatment” OR “post-exposure”)”. Forty-five relevant papers were found: 22 animal studies, 6 reviews, 19 case reports and 1 human randomized controlled study.

General management: Once the casualty has been removed from the source of exposure and adequately decontaminated, chlorine-exposed patients should receive supportive care.

Humidified oxygen: If dyspnea and hypoxemia are present, humidified oxygen should be administered.

Inhaled bronchodilators: The use of nebulized or inhaled bronchodilators to counteract bronchoconstriction is standard therapy, and the combination of ipratropium bromide with beta₂-agonists effectively reversed bronchoconstriction, airway irritation and increased airway resistance in experimental studies.

Inhaled sodium bicarbonate: In a randomized controlled trial, humidified oxygen, intravenous prednisolone and inhaled salbutamol were compared with nebulized sodium bicarbonate. The only additional benefit of sodium bicarbonate was to increase the forced expiratory volume in one second, 2 and 4?h after administration.

Corticosteroids: Dexamethasone 100?mg/kg intraperitoneally (IP) reduced lung edema when given within 1?h of chlorine inhalation and when administered within 6?h significantly decreased (p?Antioxidants: An ascorbic acid/deferoxamine combination (equivalent to 100?mg/kg and 15?mg/kg, respectively) was administered intramuscularly 1?h after chlorine exposure, then every 12?h up to 60?h, then as an aerosol, and produced a significant reduction (p?p?Sodium nitrite: Sodium nitrite 10?mg/kg intramuscularly (IM), 30?min post-chlorine exposure in mice and rabbits significantly reduced (p?Dimethylthiourea: Dimethylthiourea 100?mg/kg IP significantly decreased (p?AEOL 10150: Administration of AEOL10150 5?mg/kg IP at 1?h and 9?h post-chlorine exposure reduced significantly the neutrophil (p?p?Transient receptor potential vanilloid 4 (TRPV4): IM or IP TRPV4 reduced significantly (p?Reparixin and triptolide: In experimental studies, triptolide 100–1000 µg/kg IP 1?h post-exposure caused a significant decrease (p?Rolipram: Nanoemulsion formulated rolipram administered intramuscularly returned airway resistance to baseline. Rolipram (40%)/poly(lactic-co-glycolic acid) (60%) 0.36?mg/mouse given intramuscularly 1?h post-exposure significantly reduced (p?t?+?6?h.

Prophylactic antibiotics: Studies in patients have failed to demonstrate benefit.

Sevoflurane: Sevoflurane has been used in one intubated patient in addition to beta₂-agonists. Although the peak inspiratory pressure was decreased after 60?min, the role of sevofluorine is not known.

Conclusions: Various therapies seem promising based on animal studies or case reports. However, these recommendations are based on low-level quality data. A systematic list of outcomes to monitor and improve may help to design optimal therapeutic protocols to manage chlorine-exposed patients.     

Mesenchymal stem cells: biological properties and clinical applications

Importance of the field: In the last decade, knowledge of mesenchymal stem cells (MSCs) has evolved rapidly; their immunomodulatory properties and paracrine interactions with specific cell types in damaged tissues and promising results in some clinical applications have made these cells an attractive option for the treatment of certain diseases.

Areas covered in this review: We present some relevant methodological issues and biological properties of MSCs, as well as clinical applications of MSC therapies with particular emphasis in the treatment of graft versus host disease (GVHD), complex perianal fistula and refractory metastatic neuroblastoma. Other topical aspects relevant to the application of cellular therapies such as biosafety studies and cellular production of MSCs are also discussed in this review.

What the reader will gain: The growing optimism regarding MSCs research is based on the promising results obtained in in vitro and in vivo studies. The rapid translational research with MSCs necessitated standardization of methodology and terminology and greater focus on other aspects such as biosafety and cellular production, especially for clinical use of MSCs.

Take home message: Much has been learned about the biology and applications of MSCs and much remains to be learned.     

Influence of patient related factors on number of mesenchymal stromal cells reached after in vitro culture expansion for clinical treatment

Background: Number of stromal cells injected in patients with ischaemic heart disease (IHD) may be of importance for the treatment efficacy, which in turn may be influenced by various patient-related factors. In this study, we investigate whether patient-related factors influence the number of autologous stromal cells reached after in vitro culture expansion for clinical therapy.

Methods: Culture expansion data from 111 patients with IHD treated with autologous stromal cells in three clinical trials were used. We correlated the final cell count after two passages of cultivation with different patient factors.

Results: There was a significant relation between body mass index (BMI) and the number of adipose derived stromal cells (ASCs) reached after culture expansion and for all patients included into the three studies (r?=?0.375, p?=?.019 and r?=?0.200, p?=?.036, respectively). Moreover, there was a significantly higher number of ASCs reached in patients with hypertension compared to those without hypertension and for all patients overall (68.8?±?39.6?×?10⁶ vs. 39.1?±?23.6?×?10⁶, p?=?.020 and 62.0?±?55.0?×?10⁶ vs. 29.0?±?19.3?×?10⁶, p?<?.001, respectively). The same tendency was seen with bone marrow derived mesenchymal stromal cells (MSCs) in patients with hypertension compared to those without hypertension (58.4?±?61.8?×?10⁶ vs. 22.6?±?13.3?×?10⁶, p?<?.001) and in males compared to females (56.4?±?61.5?×?10⁶ vs. 30.9?±?27.9?×?10⁶, p?=?.041). Moreover, a significant negative correlation between left ventricular ejection fraction and number of MSCs was found (r?=??0.287, p?=?.017).

Conclusions: Patient related factors such as BMI, hypertension and gender may influence the number of MSCs reached after in vitro culture expansion.     

The Wheelchair Use Confidence Scale: Italian translation,adaptation, and validation of the short form

Objective: We developed an Italian version of the Wheelchair Use Confidence Scale for Manual Users-Short Form (WheelCon-M-I-short form) and examined its reliability and validity.

Methods: The original scale was translated from English to Italian using the “Translation and Cultural Adaptation of Patient Reported Outcomes Measures–Principles of Good Practice” guidelines. The WheelCon-M-I-short form was administered to experienced manual wheelchair users who had a variety of diagnoses. Its internal consistency and test–retest reliability were examined. Its concurrent validity was evaluated using Pearson correlation coefficients with the Italian version of the Wheelchair Outcome Measure (WhOM-I) and the Italian version of the Barthel index (BI).

Results: The WheelCon-M-I-short form was administered to 31 subjects. The mean?±?SD of the WheelCon-M-I-short form score was 7.5?±?1.9. All WheelCon-M-I-short form items were either identical or similar in meaning to the WheelCon-M-short form items. Cronbach’s α for the WheelCon-M-I-short form was 0.95 (p?p?p?p?Conclusions: The WheelCon-M-I-short form was found to be reliable and a valid outcome measure for assessing manual wheelchair confidence in the Italian population.

• Implication for Rehabilitation

• The WheelCon-M-I-short form is a valid outcome measure available for assessing wheelchair confidence, according to Bandura’s social cognitive theory, self-efficacy is a better predictor of future behavior than skill itself.

• Translation of the WheelCon-M-short form into the WheelCon-M-I-short form provides a new tool for Italian professionals.

• Clinicians now have a method to measure this invisible barrier to wheelchair use, and they will be able to make informed decisions when prescribing the use of manual wheelchairs and when training clients in their use.

• The WheelCon-M-I-short form also provides researchers with a tool in an important and relevant area of study for future research.

     

Comparison of the efficacy of two human fibrinogen concentrates to treat dilutional coagulopathy in vitro

Both congenital and acquired fibrinogen deficiency can be safely treated with administration of fibrinogen concentrate.

The aim of this study was to test the efficacy of a new fibrinogen product (Fibryga) compared to a licensed product (Haemocomplettan) in an in vitro model of dilutional coagulopathy.

Ten blood specimens from healthy volunteers were diluted 1:1 with balanced crystalloid solution and subsequently supplemented with each fibrinogen concentrate at a dose replicating in vivo supplementation (50?mg kg^?1). Changes in clot firmness (FIBTEM and EXTEM assay), as well as changes in the fibrinogen antigen level, fibrinogen activity, factor XIII level and fibronectin levels were assessed at baseline, after dilution and after adding fibrinogen concentrate.

There was no significant difference between the drugs in their in vitro ability to improve clot firmness in the FIBTEM assay (Fibryga: mean MCF 14.4?mm (SD 3.4?mm) vs. Haemocomplettan: MCF 14.1?mm (2.4); p?=?.584). Fibryga led to significantly higher clot firmness in EXTEM MCF: 56.7?mm (3.8) vs. 53.7?mm (3.7); p?p??1 (SD 0.002?g L^?1) vs. 0.002?g L^?1 (SD 0.002?g L^?1; p?This is the first study to demonstrate that Fibryga and Haemocomplettan have similar efficacy in improving clot firmness in a dilutional hypofibrinogenemia model in vitro.     

Safety and efficacy of coronary intravascular lithotripsy for calcified coronary arteries– a systematic review and meta-analysis

ABSTRACT

Objectives: Intravascular lithotripsy (IVL) clinical efficacy and safety in the treatment of calcified coronary artery disease (CAC) is not well known. We sought to assess IVL safety and efficacy in CAC.

Methods: A comprehensive online databases search were performed to identify intravascular lithotripsy studies in patients with coronary artery disease. The primary outcome was IVL related change in the mean pre and post-procedural diameter of the coronary artery.

Results: A total of 4 studies with 282 patients were included. The mean pre-IVL coronary diameter for all patients was 1.01 mm, while the mean post-IVL coronary diameter was 2.70 mm. The mean pre-post IVL diameter difference of coronary arteries on the pooled analysis was significantly lower by 4.08 mm (95% CI ?4.94 to ?3.30, p ≤ 0.00001). The Overall increase in the post-IVL lumen diameter was significantly higher than the pre-IVL diameter with a mean difference of ?4.16 (95% CI ?5.08 to ?3.24, p = 0.000001). However, compared to pre-IVL, there was a significant reduction in the overall mean difference of luminal calcium angle after IVL of the stented coronary arteries (0.09, 95% CI 0.002–0.16, p = 0.01).

Conclusion: Intravascular lithotripsy can offer a significant improvement in the vessel lumen to facilitate coronary stent delivery and deployments in severely calcified coronary arteries.