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Access to Ethics Committees in Bulgaria – Possibility or Probability

Abstract

The study of the legal framework regulating the activities of the Ethics Committees in the Member States of the European Union outlines several key factors forming the basis of the activity of the Ethics Committees. Compliance with the ethical principles of behaviour by physicians, patients, patients relatives, patient organizations and by the society as a whole requires professionals dealing with medical ethics and law to form, defend and bring to the knowledge and implementation an ethical code of behaviour of all participants in clinical trials as well as in the provision of medical services in general. The modern legal framework in Bulgaria, regulating the nature, functions and powers of the ethics committees, is complex and multi-layered, including both constitutional law and a number of acts at the law and bylaw level. Ethical committees set up in medical establishments aim to help physicians and other medical and non-medical specialists in the hospital, patients and their families coping with the ethical and legal dilemmas they face in everyday life. The results of a survey conducted among 149 medical specialists and 269 patients working and being treated in three different medical establishments in the country show that there is a low level of awareness of the types of ethical committees and their functions. 51% of the questioned medical specialists and 62.5% of the questioned patients replied that they were not aware when issues could be referred to the ethics committees in the country. The analysis of the regulation of the activities of ethics committees in the healthcare systems within the EU and in the health system in Bulgaria shows that there is a need to optimize the activity of the ethics committees operating on the territory of the country.

Open access
CRT Implantation in a Patient with Congenital Heart Malformation

Abstract

Treatment of patients with functional single-ventricle physiology is achieved using surgical corrections known as the “Fontan Procedure”. Two separate blood circulations are created from the single-ventricle function. These are non-cyanogenic patients, but at high risk of developing HF. CRT implantation is an option to improve the functional class and EF.

Open access
Family-based Association Study of Killer Cell Immunoglobulin-Like Receptor Genes with Leukemia

Abstract

NK cell function is controlled by the cell expression of killer immunoglobulin-like receptors (KIRs) and their ligation with the corresponding HLA ligands. Various malignancies have been associated with certain KIRs surface cell expression and various KIR/HLA ligand combinations. Prior research using case/control study design demonstrates the role of KIR and KIR HLA ligands as genetic factor involved in tumor susceptibility. The objective of this study was to investigate the family-based association of KIRs, HLA class I ligands and KIR/ligand combinations with leukemia diagnosis in families having a leukemia diagnosed child. Sixty-seven families that met the index leukemia case criteria (acute lymphoblastic leukemia, ALL, n = 45; acute myeloid leukemia, AML, n = 13; chronic myeloid leukemia, CML, n = 9; first degree healthy relatives n = 159) were examined. Our study consisted of two phases. In Phase1 case-control study, we primarily compared patients to their healthy siblings to asses if a marker or genotype may be associated with leukemia, excluding the impact of the environment. Phase 2 consisted of a secondary family-based association study. KIR genotyping was performed by PCR-SSP method. KIR HLA ligands were defined by direct method using PCR-SSP method and/or indirect base on high resolution typing of HLA-A, -B, -C alleles. Results of phase 1 showed an increase in the frequency of KIR genotype (with a ratio = 0.57; higher frequency for inhibitory KIRs vs. activating KIRs) among leukemia patients compared to healthy siblings. Results of the phase 2 familial study observed an association between HLA-C1+/BBw4+/ABw4+ haplotype (a mediator of inhibitory signals) and leukemia. Also, we concluded that the absence of HLA-ABw4 alleles was related to leukemia development.

Open access
Laryngeal Mask Ventilation during Tracheostomy Improves Intraoperative Hemodynamic Stability in Patients Undergoing Total Laryngectomy

Abstract

Background and objectives: Laryngectomy with extensive extirpational neck dissection is still the treatment of choice for patients with advanced laryngeal cancer. During the initial part of laryngectomy – tracheostomy, there is a significant upper airway obstruction, caused by the cancer process itself and worsened by surgical pressure and manipulation during creation of tracheostomy. This study aims to make comparative assessment of the patient’s hemodynamic parameters, operated using three of the most popular approaches during tracheostomy: local anesthesia with preserved spontaneous ventilation; general anesthesia with ventilation by endotracheal intubation and general anesthesia with ventilation by laryngeal mask airway.

Methods: A prospective cohort study was conducted in a tertiary referral center. Sixty patients with advanced laryngeal cancer appointed for total laryngectomy, were enrolled in the study. They were randomly assigned into three groups, according to the ventilation method used during the tracheostomy.

Results: Patients who underwent tracheostomy under local anesthesia displayed statistically the highest levels of SAP, DAP, MAP and heart rate intraoperatively. The group of patients who underwent tracheostomy with endotracheal intubation, also displayed significantly higher levels of hemodynamic parameters during the procedure compared with the group with laryngeal mask airway ventilation, despite the fact that both groups were under general anesthesia.

Conclusions: To our knowledge, this is the first study to demonstrate that laryngeal mask ventilation during tracheostomy improves intraoperative hemodynamic stability in patients undergoing total laryngectomy compared to endotracheal intubation.

Open access
Markers for Inflammation and Oxidative Stress in Patients with Coronary Artery Disease and Microvascular Disease – Is there a Difference?

Abstract

Introduction: The clinical significance of inflammation (and markers such as resistin, hsCRP) and oxidative stress (e.g. 8-isoprostanes) for microvascular disease (MVD) and coronary artery disease (CAD) is still elusive.

Aims: To determine the role of the markers for inflammation and oxidative stress as independent markers for MVD.

Methods: Ninety consecutive patients were recruited: twenty-five of them had CAD; thirty – MVD and thirty-five were controls. The latter included patients with atypical chest pain, risk factors, lack of coronary artery disease and negative adenosine test. Coronary angiography was performed in all participants. The adenosine test was performed in those without CAD, hs CRP, resistin in plasma and urine 8-isoprostanes were measured. The correlation of all these indicators with CAD and MVD was analyzed.

Results: The 8-isoprostanes showed significant differences between patients with MVD and CAD (0,055/0,52 pg/mmol Cre; p = 0,028). The same trend was found between CAD patients and the control group (0,055/0,003 pg/mmol Cre; p = 0,041); as well as between those with MVD and the control group (0,52/0,003 pg/mmol Cre; p = 0,001). The highest values of 8-isoprostanes were detected in patients with MVD – 0,52 pg/mmol Cre. Markers for inflammation were similar in patients with MVD and CAD (hsCRP- p = 0,091; resistin − p = 0,32).

Conclusions: hs CRP, resistin and 8-isoprostanes are involved in the pathogenesis of both CAD and MVD. However, oxidative stress is probably more important for MVD, therefore 8-isoprostanes can be a part of panel of markers for its detection and analysis.

Open access
Minimally Invasive Radiofrequency Ablation for Large Thyroid Toxic Adenoma

Abstract

Background: Most thyroid nodules are benign and do not need intervention. Toxic adenoma and toxic multinodular goiter (MNG) are common causes of hyperthyroidism, second in prevalence only to Graves’ disease. Toxic adenoma and MNG are the result of focal or diffuse hyperplasia of thyroid follicular cells whose functional capacity is independent from regulation by the thyroid stimulating hormone (TSH). When conservative treatment modalities fail to ensure an euthyroid state, surgical intervention is required, typically surgical left or right thyroid lobectomy. Radiofrequency ablation (RFA) is a new percutaneous treatment option that results in thermal tissue necrosis and fibrosis. As a result of this process, the thyroid nodules shrink.

Case presentation: We describe a case of a young woman with a large toxic thyroid adenoma who refused surgery. She was admitted to a one-day surgery unit and underwent radiofrequency ablation under total intravenous anesthesia. Using “moving shot technique” the procedure went uneventfully and the toxic adenoma displayed a significant volume reduction with resolution of the hyperthyroid symptoms. The patient also reported a significant improvement of her neck symptoms (from 7/10 to 1/10 on a Visual Analogue Scale).

Conclusions: Radiofrequency ablation is a new, well tolerated, safe and effective treatment option in selected patients with benign thyroid nodules, toxic adenomas of the thyroid gland and multinodular goiter. To the best of our knowledge, this is the first time such treatment modality is used in Bulgaria.

Open access
Multiple Congenital Heart Abnormalities

Abstract

Congenital heart abnormalities are rare and most often occur separately. These structural and functional disorders can cause a range of diseases that vary in severity, from mild or even asymptomatic to severe and life-threatening. Occasionally these conditions could cause no symptoms in which case they are found accidentally when the patient is examined for other reasons or during autopsy. In this article we present the case of a 47-year-old male patient with triple congenital heart anomaly detected in two consecutive tests performed in pre-hospital medical care.

Open access
The Role of Control in the Effective Hospital Management

Abstract

The objective of the present study was to investigate the opinion of the managers working in the health system concerning their attitude towards the operations of control within the system and the impact of these operations on the activity of the health-care institutions.

Materials and Methods: From October 2016 till January 2017 using an anonymous questionnaire we studied the opinion of 407 medical doctors, medical and healthcare specialists working in various types of healthcare institutions for hospital care in Sofia and the countryside. Results: Only 1/5 of the respondents shared the opinion that the adequate control resulted in quality improvement of the provided medical caregiving, one in four (25,8%) believed that the control could raise the responsibilities of the officials with managerial titles; one in three (34,2%) shared the opinion it improved the responsibilities of the executives.

Conclusion: The new operational terms and conditions implemented in the health insurance system do not result in improving the work quality in the hospital, which allows the conclusion that by changing only the healthcare funding the desired positive changes could not be attained. The organization, management and provision of medical care should be generally revised.

Open access
Sebaceous Carcinoma – Unexpected Tumor of the Nasal Ala Dorsum

Abstract

Today, the extraocular variant of sebaceous carcinoma is still being poorly recognized. This type of carcinoma is rarely diagnosed correctly, which, together with its aggressive behavior, contributes to its poor prognosis. We present a case of an 84-year-old man with a history of left nasal ala tumor formation, diagnosed morphologically and immunohistochemically as sebaceous carcinoma.

Open access
Serialization and Verification of Medicinal Products – A Pilot Study Among Pharmacists in Bulgaria

Abstract

Background. In an attempt to stop the distribution of falsified medicinal products, the EU has adopted Directive 2011/62/EU. Since 9th February 2019, each package of medicinal product must be given a unique number in combination with a mandatory indicator of integrity. The Directive requires the creation of a system of serialization and verification of the medicinal products.

Aim of the study: To determine the level of awareness about the serialization and verification system among masters of pharmacy and the preparedness of Bulgarian pharmacies to meet the new challenges.

Materials and methods: A pilot survey was conducted in 25 pharmacies in Sofia. 41 specialists in pharmacy holding a master degree were interviewed using the “direct individual survey” method.

Results and discussion: The knowledge about the availability of new regulatory requirements is in serious dissonance with the established high level of non-awareness of the forthcoming initiatives. Over 2/3 (78%) of the respondents do not know what the practical challenges to their pharmacy practices will be.

Open access