Author: BCI

The panel is part of the European Medicines Agency’s (EMA) Expert Council for Medical Devices

Prof. Dr. Iana Simova is the Executive Director of the Bulgarian Cardiac Institute. She is a cardiologist, leading specialist in echocardiography, head of a scientific group on post-COVID syndrome; she is involved in comprehensive investigation, diagnosis and treatment of patients with syncope (transient loss of consciousness), including telemedicine and telecardiology, cardiac stress testing, analysis of vascular function. She has held leadership positions in the European Society of Cardiology and the European Cardiovascular Imaging Association. She has received numerous awards for scientific achievements, including the prestigious High Scientific Achievement Award of the Union of Scientists in Bulgaria. A renowned lecturer and professor, editor of six journals, with over 350 scientific publications.

After an election in August this year and among more than 30 candidates, Prof. Iana Simova was elected chair of the thematic panel “Circulatory System” of the Expert Council for Medical Devices of the European Medicines Agency (EMA). Her mandate is for three years and will end in 2026. Her medical expertise will be applied/useful in the sub-group “Active implantable cardiac devices and electrophysiological devices”. The Medical Expert Panel consists of recognised leading scientific experts appointed by the European Commission, on the proposal of the Medical Device Coordination Group (MDCG), based on their scientific, clinical and technical expertise in different medical fields and specialties. The expert panels currently number more than 200 experts in 12 different panels. They are orthopedics, trauma, rehabilitation, rheumatology; circulatory system; neurology; respiratory system, anesthesiology, critical care; endocrinology and diabetes; general and plastic surgery and dentistry; Obstetrics and gynaecology, including reproductive medicine; gastroenterology and hepatology; nephrology and urology; ophthalmology; in vitro diagnostic medical devices and expert screening group to assess the need for scientific opinions.

EMA’s thematic panel on the circulatory system also includes 27 experts from different nationalities, led by Prof. It has five sub-groups:

1. Active implantable cardiac devices and electrophysiological devices
2. Cardiac Surgery
3. Cardiovascular stents (metallic and bio-resorbable) and vascular prostheses
4. Prosthetic heart valves and devices for heart valve repair
5. Structural interventions and new devices

Prof. Iana Simova is the only representative from Bulgaria not only for the thematic panel “Circulatory System”, but also for the entire EMA Expert Council for Medical Devices, as well as the only woman elected Chair in the twelve expert groups.

The event is a collaboration with the University Clinic Stolzalpe, one of the largest orthopaedic clinics in Austria

A course on ‘Problematic Primary Knee Joint Endoprosthesis’, brings together orthopaedic surgeons from across the country in Pleven this week. The organizer of the event is the orthopaedics and traumatology clinic of the high-tech “Heart and Brain”, which is a pioneer in the country in this field.

“The event is a collaboration with the University Clinic Stolzalpe, one of the largest orthopaedic clinics in Austria and a centre where a significant proportion of revision surgeries for knee pathology with problematic endoprosthesis are performed. Guest lecturer and course operator is Dr. Oliver Jahani. Within two days, a program with maximum efficiency has been organized – lecture and discussion part, we have also included two thematic elective surgeries”, informs prof. Asparuh Asparuhov, head of the orthopaedic clinic. He commented that most of the cases, the subject of the course, are in elderly patients who have neglected the problem for years for various reasons, including financial ones. The delay in treatment usually leads to severe deformities and this subsequently requires the insertion of additional implants to the prosthesis in order to compensate for the orthopaedic defect.

The course for the problematic primary knee joint arthroplasty is part of the policy of the Orthopaedics and Traumatology Clinic of the Heart and Brain Hospital to continuously train medical professionals and upgrade knowledge by introducing the best modern technologies.

My name is Rositsa Atanasova and I would like to express my gratitude to some exceptional professionals – my surgeon Assoc. Prof. Dimitar Haritonov and his right hand in this process – Dr. Alan Ibrahim Mohamad,  and their neurosurgery team at the Heart and Brain hospital.

I spent six months unsuccessfully seeking treatment, met with many doctors… I had a problem was my right arm, which was blocked, and for me, as a passionate hairdresser, it was very hard. For my lucky God met me in time with these wonderful people and extraordinary specialists, without whom I would still be wandering around the offices, which in the end would have been disastrous for my arm.

After neck surgery vertebrae with a pinched nerve, made by Assoc. Prof: Haritonov, I feel wonderful and moving my arm. Two hours after the operation I was on my feet and with happy smile on my face!

Thank goodness we have you to help those in need! May God keep you!

Genetics plays a vital role in the field of paediatrics, providing valuable insights into the origins and development of many childhood diseases. A series of analyses conducted over the years at the Cleveland Clinic Children’s Hospital (Ohio, USA) have shown that in nearly one-third of young patients, chronic and frequent hospitalizations were associated with a subsequently identified genetic condition. Although no official statistics are kept in Bulgaria, paediatricians at the Maternal and Child Health Clinic ‘Mama and I’ have similar observations. They say that their immediate collaboration with the specialists from the genetics laboratory at ‘Heart and Brain’ is an invaluable asset for their clinical practice. Working together allows them to diagnose faster, more accurately and provide personalized treatment approaches for their young patients.

When should we seek a consultation with a medical geneticist?

Consultation with a physician geneticist is advisable even before planning a pregnancy, as the primary goal of genetics is to prevent or predict potential genetic diseases and conditions through the information we obtain from a family tree or genetic analyses performed.

Every person carries genetic variations associated with some disease. Usually people do not know they are carriers of an inherited genetic disease because they have no symptoms and are healthy. They only find out after they produce offspring in which one or more children develop signs of some disease. Rarely, this happens when the second parent also carries the same (or similar) genetic variations. Genetic analyses can be performed before, during and after pregnancy, with earlier diagnosis providing more opportunities for targeted action.

With a mission to provide high quality genetic analyses and to support expectant parents with innovative solutions, the genetics laboratory of ‘Mаma and I’ is a leader in the field of molecular genetics and medicine in Bulgaria. The highly qualified team of specialists, advanced technology and ethical approach can benefit all expectant parents and families.

Interview with Dr. Velimir Simov, leading specialist in paediatrics at the clinic for maternal and child health ‘Mama and I’

Barely 100 days after opening, ‘Mama and I’ specialists have helped hundreds of children, babies and young mothers across the country – how have you managed to fill the capacity of your newly built clinic so quickly?

The round-the-clock work of all the specialists at ‘Mama and I’ in caring for young patients and their mothers left us no time to make special analyses, but the high expertise, excellent conditions, modern equipment, the uncompromising reception of all severe cases and all patients in need, regardless of the financial, ethnic or educational indicators of the family, did not go unnoticed. Our clinical successes are already receiving recognition from Europe, and we were delighted to welcome our first triplets!

What’s next?

We discussed many different plans with the management and the main investor. For us, children’s healthcare is an absolute national priority and we have a clear vision for the future. Staff development and upskilling in a number of rare paediatric specialties is without alternative and takes precedence over further expansion of the clinic. That is why the national pride ‘Mama and I’ in Pleven is open to cooperation with all children’s wards and maternity hospitals across the country, so that together we can reduce the record infant mortality rate and confront the severe demographic crisis. As part of the high-tech ‘Heart and Brain’ hospital complex, we are very strongly supported with clinical expertise and comprehensive capacity in a number of specialties such as orthopaedics, cardiology, neurology, surgery, genetics and others.

In a number of places, paediatric and even maternity wards are facing closure or are on the brink of survival. The examples are many and, unfortunately, even in regional centres such as Vratsa, Veliko Tarnovo and Lovech – all in state hospitals.

For all the teams at ‘Mama and I’, children and mothers are patients who always come first, regardless of where they are referred from. We do not differentiate whether they are state, municipal or private health facilities. We are equally open to collaboration with university hospitals or those with first level of competence. Patients and mothers come to us from almost all over the country, including the aforementioned regional centres. We are striving to catch up with the huge national backlog in the development of child and maternal healthcare that has deepened over the past five decades. We do not have the time and energy to engage in fruitless intrigues and confrontations with self-serving objectives. Even the historical balance sheet is irrelevant – lives are being saved now, in this moment, and raising and educating a person takes a long time. Forward-thinking decisions, large and small, unite our vast collective – for the dreams and prospects of elevating our medical qualifications and, above all, for the long-term development of our country and our society.

Concentration of high expertise cannot substitute for well-organized specialties at the regional level such as pediatric medicine and maternity care, can it?

Yes, of course it is. That is why we are great supporters and support the rapid construction of the new national children’s hospital in Sofia and the specialised children’s hospitals in Burgas and Varna, which we learned about from the media. With the national leader in hospital care ‘Heart and Brain’ we have a clear common understanding and the plans for the new hospitals also include small maternity and paediatric units, which will be methodically managed and staffed by the ‘Mama and I’ Pleven clinic together with a number of luminaries from the United States and Europe. Concentration of expertise is the only successful model for development in global hospital care, which is heavily influenced by advances in high medical technology. True success at the national level comes only when this concentrated high expertise is available to the entire population, providing satisfactory (or above minimum standard) access to diagnosis and medical care in small and remote locations. So here is a private example with the clear understanding that neither the state alone nor a single entrepreneur alone can solve the health care problems of any country in the world. Since 2007, the Bulgarian Cardiac Institute, of which ‘Mama and I’ and ‘Heart and Brain’ are a part, has built and managed seven modern hospitals outside Sofia and because of their narrow specialisation, fellow cardiologists, invasive cardiologists and cardiac surgeons have reduced mortality from cardiovascular disease and specifically myocardial infarction in the face of high overall mortality nationally.

You mentioned dreams?

We share many collective and individual dreams. There is a lot of collective and individual energy behind them. I will share just one very special one: that over the next 10 years, European statistics will objectively report a drastic reduction in infant mortality and that Bulgaria will rise to at least the European average in child and maternal healthcare.