scholarly journals Using stent retriever pRESET during embolization of intracranial aneurisms

2019 ◽  
Vol 21 (4) ◽  
pp. 24-28
Author(s):  
M. Yu. Volodyukhin
Keyword(s):  
Informed Consent ◽  
Conflict Of Interest ◽  
Stent Retriever ◽  
Technical Success ◽  
Brain Aneurysm ◽  
Study Objective ◽  
Neurological Outcomes ◽  
Written Informed Consent ◽  
Temporary Stent ◽  
Additional Option

The study objective is to present the results of applying stent retriever pRESET as assistance device in embolization of brain aneurysm.Materials and methods. Between January 2017 and May 2018, were threated 10 patients with brain aneurism using temporary stent-assistant method. The average aged was 41. Asymptomatic aneurysmal disease was observed in five patients, two patients were operated on in the acute period of subarachnoid hemorrhage, in two cases temporary stent assistance was used for pre-embolization of previously operated aneurysms. Temporary stent assistance was performed using a stent retriever pRESET (Phenox, Germany).Results. The technical success of the intervention was 100 %. Total embolization of aneurysms was achieved in seven patients, in three patients subtotal embolization was observed. All observations had positive neurological outcomes on discharge.Conclusion. Temporary stent assistance using a stent retriever pRESET is an additional option for endovascular treatment of brain aneurysms.Conflict of interest. The author declares no conflict of interest.Informed consent. All patients gave written informed consent to participate in the study

scholarly journals Videoimage endoscopy in surgical treatment of patients with upper orbital roof fractures

2019 ◽  
Vol 21 (4) ◽  
pp. 50-56
Author(s):  
O. V. Levchenko ◽  
A. A. Kalandari ◽  
N. Yu. Kutrovskaya
Keyword(s):  
Surgical Treatment ◽  
Informed Consent ◽  
Conflict Of Interest ◽  
Ocular Motility ◽  
Septic Complications ◽  
Study Objective ◽  
Orbital Roof ◽  
Anterior Cranial Base ◽  
Rehabilitation Period ◽  
Written Informed Consent

The study objective is to assess the effectiveness and safety of videoimage endoscopy during minimally invasive surgery in fractures of the upper orbital roof.Materials and methods. We examined and operated 9 patients (7 men and 2 women) aged 16 to 53 years (mean age 28.4 years) with fractures of the upper orbital roof with intraorbital (n = 7) and intracranial (n = 2) fragments displacement. Surgery was aimed at eliminating oculomotor disorders, preventing purulent-septic complications and restoring tightness of the intracranial space and orbital anatomy. All patients were operated using 4 mm rigid endoscopes with 0 and 30° viewing angles.Results. All patients underwent fraction resection and intraorbital structures decompression. No case of intraoperative liquorrhea was registered. The surgery did not change visual acuity. Ocular motility disturbances were eliminated in all patients. Videoimage endoscopy made it possible to avoid wide craniotomy used to approach orbital roof and to shorten the rehabilitation period and hospitalization time. With intraorbital fragments displacement it allowed to reconstruct the orbit with minimal eyeball traction, while preserving important neurovascular bundles, as well as simultaneously revise dura mater and anterior cranial base in order to exclude intraoperative liquorrhea. No complications of surgical treatment were reported.Conclusion. The results demonstrate the wide possibilities of endoscopy in cranioorbital lesions surgery.Conflict of interest. The authors declare no conflict of interest.Informed consent. All patients gave written informed consent to participate in the study

scholarly journals Interlaminar decompression for patients with degenerative lumbar stenosis. Literature review and results of a prospective study

2019 ◽  
Vol 21 (4) ◽  
pp. 57-66 ◽  
Author(s):  
A. A. Grin ◽  
A. S. Nikitin ◽  
A. A. Kalandari ◽  
S. A. Asratyan ◽  
S.‑E. R. Yusupov
Keyword(s):  
Informed Consent ◽  
Prospective Study ◽  
Satisfactory Result ◽  
Conflict Of Interest ◽  
Herniated Disc ◽  
Lumbar Stenosis ◽  
Study Objective ◽  
Clinical Instability ◽  
One Year ◽  
A Prospective Study

The study objective is to assess the effectiveness of interlaminar decompression in patients with degenerative lumbar stenosis.Materials and methods. A prospective study was conducted among 100 patients with degenerative lumbar stenosis. All patients were operated, interlaminar decompression of the symptomatic side was made. Outcomes were assessed by using a visual analogue scale and Oswestry questionnaire 1 and 2 years after surgery. Among patients with an unsatisfactory result, the cause of the unsatisfactory outcome was studied.Results. One year after surgery a satisfactory result was noted in 71 patients, and 2 years after surgery a satisfactory result was noted in 67 patients. The following causes of unsatisfactory outcome were found in 33 patients: 9 – spinal canal restenosis, 2 – herniated disc at the operation level, 4 – the facet syndrome, 4 – development of clinical instability, 3 – pain in the opposite leg (there was no pain before the operation), 2 – development of delayed radiculopathy, 9 – decompensation of concomitant diseases (4 – coxarthrosis, 3 – gonarthrosis, 2 – chronic ischemia of the lower extremities). Among the risk factors for restenosis, statistically significant relationship was found only with the presence of spondylolisthesis.Conclusion. Interlaminar decompression is an effective surgical option in patients with degenerative lumbar stenosis. The presence of spondylolisthesis is a risk factor for the inefficiency of this operation.Conflict of interest. The authors declare no conflict of interest.Informed consent. All patients gave written informed consent to participate in the study

scholarly journals Effectiveness of stereotaxic radiosurgery for supratentorial cavernous malformations

2019 ◽  
Vol 21 (4) ◽  
pp. 29-38
Author(s):  
L. Ya. Kravets ◽  
S. N. Gryaznov ◽  
S. Ya. Kalinina ◽  
P. I. Ivanov
Keyword(s):  
Informed Consent ◽  
Conflict Of Interest ◽  
Size Reduction ◽  
Type I ◽  
Type Ii ◽  
Study Objective ◽  
Cavernous Malformations ◽  
Type Iii ◽  
Epileptic Syndromes ◽  
The Mean

The study objective is an objective assessment of the treatment outcome with a gamma knife radiosurgery (GKRS) in different types of supratentorial cavernous malformations on the basis of their sizes and clinical symptoms dynamic changes after the treatment.Materials and methods. GKRS outcomes in 145 patients with hemisphere cavernous malformations (58 male, 87 female, the mean age 43,3 ± 11,9) were analyzed by comparing the initial and control data in all the patients and the telephone interview of 91 (37 male, 54 female, the mean age being 42,2 ± 11,9) patients.Results. On the basis of the “CM size reduction” criterion the efficacy of GKRS in the first magnetic resonance imaging control was 70 %. It was comparable in type I and type II CMs (76,3 and 72,5 % accordingly), but it was evidently worse in type III CMs (p = 0,0032). Repeated hemorrhages were noted in 3 observations in deep type I CM. Totally, statistically evident dependence on CM size reduction (p = 0,0413) was obtained on the clinical efficacy criterion with initially developed symptoms, which in turn means does not prove its effectiveness in type III CMs. In epileptic syndromes accompanying CMs, the efficacy of GKRS was selective, and did not correlate with CM size reduction, but mostly depended on the genesis and course of epileptic seizures.Conclusion. GKRS appears to be a justified method of treatment for clinically compensated mobile patients with type I and type II CMs. The clinical effectiveness of GKRS in such patients is in no way inferior to open surgery and does not exceed the number of its complications. CM type III should be excluded from the objects of treatment by GKRS.Conflict of interest. The authors declare no conflict of interest.Informed consent. All patients gave written informed consent to participate in the study and for the publication of their data.

scholarly journals Surgical treatment of patients with primary and metastatic spinal tumor with use of the O-Arm intraoperative portable computed tomography scanner

2019 ◽  
Vol 21 (4) ◽  
pp. 39-49
Author(s):  
A. A. Sufianov ◽  
V. I. Manashchuk ◽  
D. N. Nabiev ◽  
A. G. Shapkin ◽  
M. K. Zaytsev ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Informed Consent ◽  
Conflict Of Interest ◽  
Navigation System ◽  
Surgical Intervention ◽  
Pain Syndrome ◽  
Neurological Status ◽  
Spinal Tumors ◽  
Study Objective ◽  
Mass Lesions

The study objective is to demonstrate our experience of employment of O-Arm intraoperative portable сomputed tomography scanner combined with navigation system Stealth Station Treon Plus (Medtronic Navigation) during decompressive-stabilizing surgeries for patients with primary and metastatic spinal tumors.Materials and methods. We have reviewed results of surgical treatment of 44 patients (24 males and 20 females, average age is 54.3 ± 1.8), who were hospitalized and operated in the department of spinal neurosurgery in Federal Centre of Neurosurgery (Tyumen). All surgeries were performed by one surgical team in the period of April 2011 to June 2017. All patients underwent full clinical examination according to diagnostic algorithm, including assessment of general condition, degree of bone and visceral dissemination, neurological status, quality of life, pain syndrome intensity. The most common cause of vertebral lesions was plasma cell myeloma (15 patients, 34.1 %), metastatic spinal lesions (12 patients, 27.3 %). Patients were subjected to posterior decompression and stabilization with total and subtotal excision of mass lesions. Assessment of degree of decompression and transpedicular fixation were carried out visually using O-Arm combined with navigation station.Results. In 6 to 12 months after surgery 79.5 % of patients demonstrated significant improvement of neurological status, specifically a decrease of conduction and sensory disorders. Degree of pain syndrome was reduced by 3.6 times. Using O-Arm combined with navigation station we placed screws adequately in 99.6 % of the cases. The main technical problem that occurred during the surgery was the failure of navigation system caused by: defect of reflective spheres, distant installation and shift of referential frame, aging of Jamshidi needle, malfunction of navigation camera, failure of data transfer from navigation station.Conclusion. The use of O-Arm combined with navigation station for decompressive and stabilizing surgeries in patients with spine and spinal cord tumors let us perform surgeries with 3D control and navigation, conduct surgeries in areas where it is hard to determine surgical landmarks, ensure precision of transpedicular screw implantation, accomplish total resection of mass lesions with minimal blood loss and less aggressive surgical intervention and properly decompress the spinal canal which, eventually, result in positive anatomical and functional characteristics, and contribute to good general outcome of surgical intervention.Conflict of interest. The authors declare no conflict of interest.Informed consent. All patients gave written informed consent to participate in the study and to the publication of their data.

Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

2020 ◽  
Vol 15 (3) ◽  
pp. 181-189
Author(s):  
Omotayo Fatokun
Keyword(s):  
Informed Consent ◽  
Drug Use ◽  
Perceived Risk ◽  
Adverse Drug Events ◽  
Community Pharmacists ◽  
Risk Minimization ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Off Label ◽  
Written Informed Consent

Background: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia. Objectives: This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures. Methods: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia. Results: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002). Conclusion: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

274 Tumoral and peripheral immunophenotype of refractory vs relapse to PD-(L)1 blockade in patients with advanced non-small cell lung cancer

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A299-A299
Author(s):  
Maria Ascierto ◽  
Matthew Hellmann ◽  
Nathan Standifer ◽  
Song Wu ◽  
Han Si ◽  
...  
Keyword(s):  
Gene Expression ◽  
Informed Consent ◽  
Checkpoint Inhibitors ◽  
Patient Response ◽  
Calcium Dependent ◽  
Immune Exhaustion ◽  
Previously Treated ◽  
Expression Pathways ◽  
Relapsed Disease ◽  
Written Informed Consent

BackgroundDespite the encouraging successes of immune checkpoint inhibitors, many patients do not benefit and are either refractory or relapse. The mechanisms of refractory or relapsed disease following PD-(L)1 blockade are largely unknown. To identify characteristics associated with refractory or relapsed disease we explored the immune and genomic landscape of samples derived from NSCLC patients who previously received PD-(L)1 blockade and had blood and fresh tumor biopsies collected at the time of progression.MethodsPatient response categories were defined prospectively; ‘refractory’ defined as progression within 16 weeks of initiating PD-(L)1 and ‘relapse’ defined as initial clinical benefit (CR, PR, SD) followed by progression. RNAseq (n=52) and PD-L1 IHC (n=22) were performed on tumor tissue. Immune profiling of whole blood was assessed using flow cytometry or Biomark HD (Fluidigm) gene expression panel (n=54 and n=62, respectively). Differential gene expression was defined as unadjusted p<0.05 and fold-difference >1.5. Pathways analysis was conducted by David tool. Patient samples were collected during screening for clinical trial of second line immunotherapy. Written informed consent was obtained from the patients for publication of this abstract.ResultsIn patients with NSCLC previously treated with PD-(L)1 blockade, tumors of relapsed patients were characterized by increased expression of genes associated with interferon signaling (e.g. CXCL9, SPIC, IFNg), immune suppression (e.g. ARG1, TGFB), immune exhaustion (e.g. ADORA2A), and increased PD-L1 expression (by gene expression and IHC). Refractory disease was associated with increased cadherin signaling and calcium-dependent-cell-adhesion gene expression pathways. In the periphery, reduced quantities of B cells and activated (HLA-DR+ or CD38+) or proliferating (Ki67+) CD8+ T cells were observed in refractory patients.ConclusionsThe tumor and peripheral compartments of patients with NSCLC previously treated with PD-(L)1 blockade differ based on prior response. Relapsed patients tend to have signals of sturdy immune activation and chronic inflammation thus ultimately leading to immune exhaustion. These results may help inform rational therapeutic strategies to overcome resistance to PD-(L)1 blockade in NSCLC.Trial RegistrationNCT02000947Ethics ApprovalResearch on human samples here analyzed have been performed in accordance with the Declaration of Helsinki.ConsentWritten informed consent was obtained from the patient for publication of this abstract.

scholarly journals Written Informed Consent—Translating into Plain Language. A Pilot Study

Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 232
Author(s):  
Agnieszka Zimmermann ◽  
Anna Pilarska ◽  
Aleksandra Gaworska-Krzemińska ◽  
Jerzy Jankau ◽  
Marsha N. Cohen
Keyword(s):  
Informed Consent ◽  
Plain Language ◽  
Consent Forms ◽  
Software Analysis ◽  
Informed Consent Form ◽  
Education Levels ◽  
Polish Language ◽  
University Degree ◽  
Study Participants ◽  
Written Informed Consent

Background: Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability. Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

scholarly journals The combined use of proximal and distal protection devices uring carotid stenting: A case report

2019 ◽  
Vol 23 (2) ◽  
pp. 73
Author(s):  
D. U. Malaev ◽  
D. A. Redkin ◽  
V. I. Baystrukov ◽  
A. A. Prokhorikhin ◽  
A. A. Boykov ◽  
...  
Keyword(s):  
Blood Flow ◽  
Informed Consent ◽  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Conflict Of Interest ◽  
Internal Carotid ◽  
Carotid Stenting ◽  
Protection System ◽  
Combined Use ◽  
Proximal Protection

<p>Despite the development of modern medical technologies, cerebrovascular disease remains a major health and social issue. Among all the cases of ischemic stroke, approximately 20% are attributable to stenotic lesions in the carotid artery. The main drawback of carotid stenting is the risk of embolic complications during the procedure. To resolve this problem, various devices that protect against embolism have been developed. In this clinical case, we describe the ability to minimize the risk of operative stroke through a combined application of the distal and proximal protection systems in carotid stenting.</p><p>In our patient, a 65-year-old woman, angiography of the carotid arteries revealed an ulcerated atherosclerotic plaque of the right internal carotid artery, with stenosis of the lumen of up to 95%. Considering the high risk of distal embolism, the Mo MaUltra (Italy) proximal protection system was used. When evaluating the installation of the Mo MaUltra system, the preserved blood flow through the superior thyroid artery and, therefore, the antegrade blood flow in the internal carotid artery was revealed. Considering the identified risk and the anatomy of the plaque surface, we decided on the additional use of the distal SpiderFX (USA) protection device.</p><p>The combined use of proximal protection system and distal protective device for carotid stenting is technically possible and may reduce the risk of embolic complications.</p><p>Received 23 January 2019. Revised 18 March 2019. Published 23 April 2019.</p><p><strong>Informed consent:</strong> The patient’s informed consent to use the records for medical purposes is obtained.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> Authors declare no conflict of interest.</p>

scholarly journals Medical terminology circulation and interactional organisation in interpreter-mediated medical encounters

2021 ◽  
Vol 11 ◽  
Author(s):  
Sara Pittarello
Keyword(s):  
Informed Consent ◽  
Active Participation ◽  
Point Of View ◽  
Personal Interest ◽  
Medical Terminology ◽  
Institutional Talk ◽  
Italian Hospital ◽  
Ethical Approval ◽  
Medical Interpreters ◽  
Written Informed Consent

Two medical encounters taking place in a Northern Italian hospital are analysed in this paper from a qualitative point of view, based on the author’s previous research. The aim is to reveal the strategies adopted by medical interpreters, in these two specific cases, to translate medical terminology and promote/exclude interlocutors’ active participation. This latter aspect is influenced by the way the interaction is socially and linguistically organised and, in particular, by how interlocutors’ utterances are translated. The prevalence of dyadic or triadic sequences and especially the shifts between such communication exchanges are pivotal in fostering or hindering interlocutors’ participation. Furthermore, medical interactions, as a form of institutional talk, enshrine specific expectations, which are mainly of a cognitive nature but may also be affective, as in the two encounters observed. By conveying such expectations and expressions of personal interest, interpreters have proved to contribute to the fair distribution of active participation among primary interlocutors. Hospital ethical approval and subjects’ written informed consent have been obtained.

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