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New treatment possibilities and modalities are now available globally for patients with haemophilia requiring surgery or invasive procedures. The first is the appropriate application of low-dose protocols of clotting factor concentrates (CFC) achieving adequate perioperative haemostasis in resources constraint environments. The increasing availability of CFC through humanitarian aid programs allows more invasive surgeries to be performed for which efficacy and safety data should be more widely collected and reported. Second, extended half-life CFC that are increasingly available in many countries represent valuable alternatives to standard half-life products in surgical patients allowing reduced number of infusions and lower consumption, in particular for extended half-life factor IX. Third, in the era of recently introduced nonfactor prophylaxis, some minor surgical procedures can now be performed without additional haemostatic treatment, others with few low-dose administrations of CFC or bypassing agents. Additional factor VIII/IX or recombinant activated factor VII has proven to be safe and effective in association with emicizumab for major surgeries and it was effectively given at low doses in association with fitusiran (including activated prothrombin complex concentrate). No thrombotic complications have been reported in the surgical setting so far. A multidisciplinary team/facility remains crucial to manage major surgery in patients on prophylaxis with these new agents.

Objective To compare the clinical efficacy between robot‐assisted minimally invasive transforaminal lumbar interbody fusion (robot‐assisted MIS‐TLIF) and traditional open TLIF surgery in the treatment of lumbar spondylolisthesis. Methods According to the inclusion and exclusion criteria, 48 cases with lumbar spondylolisthesis who received surgical treatment from June 2016 to December 2017 in the spinal surgery department of Beijing Jishuitan Hospital were analyzed in this study, including 23 patients who received robot‐assisted MIS‐TLIF and 25 patients who received traditional open TLIF surgery. The two groups were compared in terms of pedicle screw accuracy evaluated by Gertzbein‐Robbins classification on postoperative computed tomography (CT), operation time, blood loss, postoperative drainage, hospitalization, time to independent ambulation, low back pain evaluated by visual analog scale (VAS), lumbar function evaluated by Oswestry Disability Index (ODI), paraspinal muscles atrophy on magnetic resonance imaging (MRI), and complications. Results Postoperative CT showed that the rate of Grade A screws in the robot‐assisted MIS‐TLIF group was significantly more than that in the open surgery group (χ 2 = 4.698, P = 0.025). Compared with the open surgery group, the robot‐assisted MIS‐TLIF group had significantly less intraoperative blood loss, less postoperative drainage, shorter hospitalization, shorter time to independent ambulation, and lower VAS at 3 days post‐operation (P, Compared to the open surgery group, the robot‐assisted MIS‐TLIF group had achieved a better clinical result of significantly more precise pedicle screw placement, less intraoperative blood loss, less postoperative drainage, shorter hospitalization, shorter time to independent ambulation, lower VAS at 3 days post‐operation, and less paraspinal muscle atrophy.

Invasive procedures commonly cause recurring pain in preterm infants. Noninvasive pain management is an essential part of nursing intervention in the Neonatal Intensive Care Unit (NICU). The study’s aim is to identify the impact of touch therapy on pain in premature infants undergoing invasive treatments. The method was a quasi- experiment with 63 premature infants. The premature infants were classified into four groups: i) Mother’s touch Therapy (MTT), ii) Mother’s Voice Stimulus (MVS), iii) a combination of MTT and MVS, and iv) routine care. The observed infants’ pain scores were determined through a multiple regression model using the Generalized Estimating Equation (GEE) method. The GEE test showed that the combination of touch and sound therapy significantly reduced pain in premature infants undergoing invasive measures (p

Objectives To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. Study Design and Setting RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. Results One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. Conclusion Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.

Background Placebo‐controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In‐depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs. Methods A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics. Results The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co‐interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel. Conclusion DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high‐quality RCTs, which are needed to underpin delivery of healthcare interventions., There are challenges in RCTs of invasive interventions with a placebo control. The DITTO framework outlines five stages to optimize invasive placebo design and delivery: deconstruction of the treatment intervention, identification (and removal) of the critical surgical element from the proposed placebo, consideration of risk, feasibility and the role of the placebo in the RCT, and optimization of placebo delivery to ensure effective blinding of patients and trial personnel. DITTO will be useful

Worldwide, there are at least 230 million invasive procedures performed annually and most of us will undergo several in our lifetime. There is therefore a need for high-quality evidence to underpin this clinical area. Currently, however, there is no widely accepted definition of an invasive procedure and the terms ‘surgery’ and ‘interventional procedure’ are characterised inconsistently. We propose a definition for invasive procedures which addresses the limitations of those currently available. Our definition was developed from an analysis of the 3946 papers from the last decade. A preliminary definition was created based on existing definitions and applied to a variety of papers reporting all types of procedures. This definition was continuously updated and applied iteratively to all articles. The definition has three key components: (1) method of access to the body, (2) instrumentation and (3) requirement for operator skill. It therefore encapsulates all types of invasive procedure regardless of the method of access to the body (incision, natural orifice or percutaneous access), and is relevant whatever the clinical discipline (eg, obstetric, cardiac, dental, interventional cardiology or radiology). Crucially, the definition excludes medicinal products, except where their administration occurs within an invasive procedure (and thereby involves operator skill). The application of a universal definition of an invasive procedure will (1) inform the selection of relevant methods for study design, (2) streamline evidence synthesis and (3) improve research tracking, helping to identify evidence gaps and direct research funds.

The French Working Group on Perioperative Haemostasis (GIHP)and the French Study Group on Haemostasis and Thrombosis (GFHT)in collaboration with the French Society of Anaesthesia and Intensive Care Medicine (SFAR)drafted up-to-date proposals on the management of antiplatelet therapy for non-elective invasive procedures or bleeding complications. The proposals were discussed and validated by a vote; all proposals could be assigned with a high strength. Emergency management of oral antiplatelet agents (APA)requires knowledge on their pharmacokinetic/pharmacodynamics parameters, evaluation of the degree of the alteration of haemostatic competence and the associated bleeding risk. Platelet function testing may be considered. When APA-induced bleeding risk may worsen the prognosis, measures should be taken to neutralise antiplatelet therapy by considering not only the efficacy of available means (which can be limited for prasugrel and even more for ticagrelor)but also the risks that these means expose the patient to. The measures include platelet transfusion at the appropriate dose and haemostatic agents (tranexamic acid; rFVIIa for ticagrelor). When possible, postponing non-elective invasive procedures at least for a few hours until the elimination of the active compound (which could compromise the effect of transfused platelets)or if possible a few days (reduction of the effect of APA)should be considered., SCOPUS: ar.j, info:eu-repo/semantics/published

La gestione dei pazienti con nota o sospetta cardiopatia, che sono ricoverati o che devono essere sottoposti ad intervento chirurgico non cardiaco o ad una procedura invasiva, è molto complessa, sia per le comorbilità spesso presenti, sia per le molteplici terapie assunte, sia perché spesso sono portatori di dispositivi cardiaci impiantabili. Scopo di questo documento è di fornire indicazioni e standardizzare i comportamenti dei vari medici nella gestione dei pazienti cardiopatici o sospetti tali, al fine di (a) gestire le acuzie cardiologiche con timing e accuratezza adeguati, e (b) definire il rischio cardiologico nel singolo paziente con tempi ed indicazioni appropriate, permettendogli di affrontare la procedura chirurgica o invasiva con il rischio più basso correlato alla presenza della cardiopatia.

IntroductionPatients with Von Willebrand disease (VWD) are regularly treated with VWF-containing concentrates in case of acute bleeding, trauma and dental or surgical procedures.AimIn this multicentre retrospective study, current perioperative management with a von Willebrand factor (VWF)/Factor VIII (FVIII) concentrate (Haemate((R)) P) in patients with VWD was evaluated.Patients/MethodsPatients with VWD undergoing minor or major surgery between 2000 and 2015, requiring treatment with a VWF/FVIII concentrate (Haemate((R)) P), were included. Achieved VWF activity (VWF:Act) and FVIII during FVIII-based treatment regimens were compared to predefined target levels in national guidelines.ResultsIn total, 103 patients with VWD (148 surgeries) were included: 54 type 1 (73 surgeries), 43 type 2 (67 surgeries) and 6 type 3 (8 surgeries). Overall, treatment resulted in high VWF:Act and FVIII levels, defined as 0.20IU/mL above predefined levels. In patients with type 1 VWD, respectively, 65% and 91% of trough VWF:Act and FVIII levels were higher than target levels. In patients with type 2 and type 3 VWD, respectively, 53% and 57% of trough VWF:Act and 72% and 73% of trough FVIII levels were higher than target level. Furthermore, FVIII accumulation over time was observed, while VWF:Act showed a declining trend, leading to significantly higher levels of FVIII than VWF:Act.ConclusionHigh VWF:Act and accumulation of FVIII were observed after perioperative FVIII-based replacement therapy in patients with VWD, both underlining the necessity of personalization of dosing regimens to optimize perioperative treatment.

Preoperative hemostasis testing may have limited use in patients with liver disease, and an abnormal platelet count, prothrombin time, activated partial thromboplastin time, and fibrinogen level should not trigger prophylactic transfusion of blood product components.

Contains fulltext : 171161.pdf (Publisher’s version ) (Closed access) Essentials Targeting of factor VIII values is a challenge during perioperative replacement therapy in hemophilia. This study aims to identify the extent and predictors of factor VIII underdosing and overdosing. Blood group O predicts underdosing and is associated with perioperative bleeding. To increase quality of care and cost-effectiveness of treatment, refining of dosing is obligatory. SUMMARY: Background Perioperative administration of factor VIII (FVIII) concentrate in hemophilia A may result in both underdosing and overdosing, leading to respectively a risk of bleeding complications and unnecessary costs. Objectives This retrospective observational study aims to identify the extent and predictors of underdosing and overdosing in perioperative hemophilia A patients (FVIII levels < 0.05 IU mL(-1) ). Patients and Methods One hundred nineteen patients undergoing 198 elective, minor, or major surgical procedures were included (median age 40 years, median body weight 75 kg). Perioperative management was evaluated by quantification of perioperative infusion of FVIII concentrate and achieved FVIII levels. Predictors of underdosing and (excessive) overdosing were analyzed by logistic regression analysis. Excessive overdosing was defined as upper target level plus >/= 0.20 IU mL(-1) . Results Depending on postoperative day, 7-45% of achieved FVIII levels were under and 33-75% were above predefined target ranges as stated by national guidelines. A potential reduction of FVIII consumption of 44% would have been attained if FVIII levels had been maintained within target ranges. Blood group O and major surgery were predictive of underdosing (odds ratio [OR] 6.3, 95% confidence interval [CI] 2.7-14.9; OR 3.3, 95% CI 1.4-7.9). Blood group O patients had more bleeding complications in comparison to patients with blood group non-O (OR 2.02, 95% CI 1.00-4.09). Patients with blood group non-O were at higher risk of overdosing (OR 1.5, 95% CI 1.1-1.9). Additionally, patients treated with bolus infusions were at higher risk of excessive overdosing (OR 1.8, 95% CI 1.3-2.4). Conclusion Quality of care and cost-effectiveness can be improved by refining of dosing strategies based on individual patient characteristics such as blood group and mode of infusion.

Resumen: En las últimas décadas, el modelo de medicina paternalista se ha sustituido por un modelo centrado en el sujeto y sus familiares. En el ámbito de las urgencias pediátricas, este hecho ha conllevado un mayor protagonismo de los padres, especialmente durante la realización de procedimientos invasivos. Numerosos autores han estudiado las ventajas y los inconvenientes de esta nueva práctica, tanto para los sujetos y sus familiares como para el personal sanitario. Dada la escasa bibliografía española, se revisó la literatura médica publicada hasta el momento y se analizaron los posibles beneficios y perjuicios para el sujeto y sus familiares, así como la posición de los profesionales sanitarios. Abstract: Over the last decades, health care has been moving away from the paternalistic model, to one of family-centered care. In the pediatric emergency department, this new trend has led to parents playing a larger role in the health care of children, particularly during invasive procedures and/or resuscitation. Despite the increased attention to family presence, it remains a controversial topic, especially among emergency medical staff. Several studies have been performed that look at the advantages and disadvantages of this new way of conceiving child health care. To our knowledge, there is only one Spanish article on this topic, which is the reason why we performed a literature review on family presence in the emergency department.

Simple Summary The Fawn Hooded (FH) rat population is commonly used in biomedical research. It is widely acknowledged that the FH rat has a bleeding disorder, which may lead to abundant bleeding. However, the clinical consequences of this bleeding disorder have not been described in current literature. During our study, surgical procedures on FH rats led to an unanticipated loss of animals due to abundant bleeding. Adjustments made to minimize the impact of this disorder in animals undergoing invasive procedures are described. It is strongly recommended to take the bleeding diathesis into account when performing invasive procedures in FH rats and to apply the described refinements. Abstract The Fawn hooded (FH) rat is commonly used in biomedical research. It is widely acknowledged that the FH rat has a bleeding disorder; leading to abundant bleedings. Although this bleeding disorder is investigated to model the storage pool defect; its impact on commonly performed invasive laboratory procedures has not yet been described. Our research group experienced clinically significant consequences of this bleeding disorder following invasive procedures (including intraperitoneal injections and neurocranial surgery) in the Rjlbm: FH stock. The clinical consequences of the surgical and anesthetic protocols applied; are described including the subsequent procedural refinements applied to minimize the impact of this disorder. It is strongly recommended to take the bleeding diathesis into account when performing invasive procedures in FH rats and to apply the suggested refinement of procedures.

The biggest technical development within the field of surgery is focused on minimal invasive procedures. With new robot assisted solutions can the surgeons work more precise with a great level of flexibility. The work is nevertheless connected to a long set-up time and big costs. This project, based on pure user studies and in-depth surgery observations, discovers a possibility to, in a cost efficient way, offer robot benefits to an open surgery scenario. With a minimal effort can the surgeon merge the suggested product concept into their regular workflow and enhance the stability in their movements, get improved vision and aid in holding tissue in static positions.

Stereotactic placement of intracerebral multilead electrodes for chronic EEG recording of seizures or stereoelectroencephalography (SEEG) was introduced 50 years ago at Saint Anne Hospital in Paris, France for the presurgical evaluation of patients with drug-resistant focal epilepsy. SEEG explorations are indicated whenever the noninvasive tests fail to adequately localize the epileptogenic zone (EZ).Currently, approximately 35% of our operated-on children require a SEEG evaluation. Arrangement of electrodes is individualized according to the peculiar needs of each child, to verify a predetermined hypothesis of localization of the EZ based on pre-SEEG anatomo-electro-clinical findings. Multilead intracerebral electrodes are designed to sample cortical structures on the lateral, intermediate, and mesial aspect of the hemisphere, as well as deep-seated lesions. Stereotactic stereoscopic teleangiograms and coregistered 3-D MRI are employed to plan avascular trajectories and to accurately target the desired structures. Pre-SEEG stereotactic neuroradiology and electrode implantation are usually performed in separate procedures. Electrodes are removed once video-SEEG monitoring is completed.Intracerebral electrical stimulations are used to better define the EZ and to obtain a detailed functional mapping of critical cortical and subcortical regions.Surgical morbidity of SEEG is definitely low in children. SEEG-GUIDED RESECTIVE SURGERY: In 90% of evaluated children, SEEG provides a guide for extratemporal or multilobar resections. SEEG-guided resective surgery may yield excellent results on seizures with 60% of patients in Engel's Class I.

Do ponto de vista histórico, a inserção do psicólogo na área hospitalar se deu primordialmente por intervenções focais ou sistemáticas junto a pacientes submetidos a procedimentos cirúrgicos ou invasivos em serviços de saúde. Todavia, apesar da continuidade e relevância dessas atividades, é possível constatar a escassez de pesquisas sobre a eficácia dos métodos de preparação psicológica.Assim sendo, este trabalho propõe,inicialmente, uma revisão crítica da literatura, para em seguida, apresentar um levantamento realizado em unidades hospitalares, envolvendo observações do atendimento e entrevistas com profissionais da saúde. As necessidades e expectativas relativas à atuação do psicólogo são analisadas e discutidas, concluindo-se pela importância da formação e treinamento desse profissional. Os autores sugerem ainda a realização de maiores investigações, especialmente de meta-análise de estudos em contexto brasileiro. Para tanto, recomendam levantamentos das intervenções mais adotadas, a exemplo da presente iniciativa. In historical terms, the psychologist insertion intohospital setting has primordially been through focal and methodical interventions with patients who were submitted to surgical or invasive procedures at health services. However, despite the continuity and importance of these activities, it is possible to confirm the scarcity of researches about efficacy of psychological preparation methods. In that case, this study initially proposes a critical review of literature, and afterwards it presents a survey realized in hospital units which includes observations of medical attention and interviews with health professionals. The needs and expectations related to psychologist intervention are analyzed and discussed. The results show the importance of the formation and training of such professional. The authors also suggest the realization of more investigations specially into meta-analysis study in the Brazilian context. Therefore, they recommend of surveys of the more utilized interventions, like this study.

SummaryDirect oral anticoagulants (DOAs) – inhibitors of thrombin or factor-Xa – are expected to replace vitamin K antagonists in most of their indications. Patients receiving long-term treatment with DOAs are likely to be exposed to elective or emergency surgery or invasive procedures. Owing to the present lack of experience in such conditions, we cannot make recommendations, but only propose perioperative management for optimal safety regarding the risk of bleeding and thrombosis. DOAs may increase surgical bleeding, they have no validated antagonists, they cannot be monitored by simple standardized laboratory assays and their pharmacokinetics vary significantly between patients. Although DOAs differ in many respects, the proposals in the perioperative setting need not be specific to each. For procedures with low haemorrhagic risk, a therapeutic window of 48hours (last administration 24hours before surgery, restart 24hours after) is proposed. For procedures with medium or high haemorrhagic risk, we suggest stopping DOAs 5 days before surgery to ensure complete elimination in all patients. Treatment should be resumed only when the risk of bleeding has been controlled. In patients at high thrombotic risk (e.g. those in atrial fibrillation with a history of stroke), bridging with heparin (low molecular-weight heparin, or unfractionated heparin, if the former is contraindicated) is proposed. In an emergency, the procedure should be postponed for as long as possible (minimum 1–2 half-lives) and non-specific antihaemorrhagic agents, such as recombinant human activated factor VIIa or prothrombin complex concentrates should not be given for prophylactic reversal due to their uncertain benefit-risk.