Author: BCI

Excellent outcomes and approach to patients were confirmed in FDA report

Second place in the world for care and follow-up of patients in a clinical trial is another recognition for the Cardiology Clinic of , Heart and Brain Hospital’. The high ranking comes exactly two years after the clinic began participating in a number of clinical trials in 2021. The success was reported by prof. Iana Simova – Executive Director of the Bulgarian Cardiology Institute and Head of the Cardiology Clinic at ‘Heart and Brain’ Pleven.

The clinical trial covers patients with established vascular disease who, despite drug therapy, continue to have high cholesterol values. Lowering LDL-cholesterol has been shown to reduce the risk of death, myocardial infarction, stroke and peripheral vascular disease. Patients should therefore be carefully monitored to select the most appropriate medication. If LDL levels remain high on the background of antilipid therapy, an upgrade of therapy is necessary. CETP inhibitors aim to block cholesterol ester transfer protein, which will result in a reduction in bad cholesterol levels and an increase in good cholesterol. This would avoid future cardiovascular events. All this with just the addition of one tablet daily to the concomitant therapy. Through their active work, Prof. Dr. Yana Simova’s team, composed of cardiologists and nurses, provided round-the-clock access to medical care for the enrolled patients, ensuring the possibility of new treatments and last but not least – contributed to the development of science.

“The good results are based on the dedication of the team, continuous communications and international meetings in order to exchange experiences, as well as on the good organisation in the follow-up of the patients – all visits ensure a comprehensive examination, and further tests and consultations are carried out on site if necessary. This is also possible thanks to the fact that the Centre is part of the Heart and Brain Hospital, where multidisciplinarity and high technology are at the heart of patient care”, said Prof. Simova. Thanks to its continuous work and development, the centre has already established itself as a leader in a number of clinical trials.

The good results and excellent approach to patient have been inspected and confirmed by the FDA (US Food and Drug Administration), the world’s most prestigious institution for quality and safety control related to public health.

A 74-year-old patient from Gabrovo with severe abdominal pain and general impairment was admitted to the Vascular Surgery Department of ‘Heart and Brain’ on an emergency basis. After a contrast scan, a rupture (tear) of an abdominal aortic aneurysm was found. This is a life-threatening condition in which a large amount of blood pours into the abdominal cavity and the only treatment is surgical intervention.

The risk of a fatal outcome in classic open surgery for ruptured aneurysm is over 90%. Endovascular aortic aneurysm repair (EVAR) is routinely performed at Heart and Brain Hospital in Pleven, both in elective and emergency patients. The challenge in this case is that the aneurysm involves both renal arteries and the main artery feeding the bowel, and therefore standard endovascular surgery cannot be applied. The only option is to insert a fenestrated endograft, which is not available in the country and whose cost exceeds BGN 70 000.

After a lengthy analysis and a consilium between doctors from different fields, the specialists decided to apply a new approach for our country – a personalized and physiologically modeled prosthesis. This technique has been applied only once in Bulgaria, but not in emergency conditions.

With a series of measurements and precise calculations, vascular surgeons modify the implant for the specific needs of the patient through 3D imaging, followed by the fabrication of the fenestrations (holes) of the endoprostheses in a sterile environment, through which blood supply to the vital organs is ensured. This is followed by the extremely delicate process of inserting stents into the renal arteries and the mesenteric artery (the artery that supplies blood to the intestines). The operation is minimally invasive, lasting 10 hours. Through a small incision in the femoral arteries, under X-ray control in a hybrid operating room, the vascular surgery team was able to save the patient’s life. This highly complex, complex and multi-step procedure requires careful advance preparation, a lot of knowledge and additional skills of the doctors.

“We can count on the fingers of our hands the hospital centres around the world that have successfully implemented this type of surgery. The fabrication of a finished custom prosthesis would take a lot of time and money. Thanks to the teams of ‘Heart and Brain’ and my colleagues from the capital – Dr. Nikola Kolev and Dr. Dimitar Nikolov, we successfully modified an existing graft, which is covered by the NHIF. The patient was in good general condition, up on his feet the very next day,” said vascular surgeon Dr. Todor Samardzhiev, who supervised the surgery.

The team says that with this new step, the high-tech hospital complex already has all the valves available for transcatheter implantation. This allows for the most suitable valve to be selected for each patient according to their anatomy

Aortic stenosis is a disease in which a narrowing of the valve, which is located at the outlet of the heart, develops. Until recently, the only method of treatment for this valvular malformation was surgery. For several years, as an alternative for high-risk patients, non-operative transcatheter aortic valve implantation (TAVI) has been used, which is performed through a small opening in a peripheral blood vessel. This method is routinely applied in ‘Heart and Brain’ Burgas and Pleven.

In TAVI, two basic types of valves are implanted – self-expanding and balloon release. So far, valves of the first type have been used, but in the last three patients a new type of balloon-release valve has been implanted.

The interventions were performed by a multidisciplinary team including the invasive cardiologists Dr. Plamen Penchev and Dr. Krasimir Trifonov, as well as the cardiac surgeons Assoc. Prof. Dr. Vladimir Kornovski and Dr. Petar Petrov. One of the leading European specialists in this field, Dr. Daniel Unic from the University Hospital “Dubrava” in Zagreb, Croatia, was also involved as a consultant.

The full article is available here in Bulgarian.

Rapid intervention and teamwork of cardiac surgeons, invasive cardiologists, resuscitation and imaging specialists saved a human life through a hybrid method of aortic vessel debranching, extra anatomical bypass and TEVAR (endovascular implantation of vascular prosthesis).

A 64-year-old patient with acute dissection (wall rupture) of the distal aortic arch and the descending aorta was admitted as an emergency to Heart and Brain Burgas.

The Heart Тeam was quickly built – Assoc. Prof. Dr. Vladimir Kornovski, Head of the Cardiac Surgery Clinic, Dr. Plamen Penchev, Head of Invasive Cardiology, and Dr. Tsvetan Gradinarov, Head of Cardiac Resuscitation, decided that the patient was indicated for an emergeny hybrid procedure – aortic arch debranching and TEVAR.

Read the full story here in Bulgarian.

When it comes to cancer, most of us think of patients at a very advanced age, usually retirement age, who have been exposed to harmful factors for many years – in their personal and professional lives. Recent epidemiological data from countries in the European Union and the United States over the last 2-3 decades show a worrying steady trend of increasing numbers of cancer patients at a much younger age – so-called adolescent and young adult (AYA) cancers. The concern is not only medical and scientific, but also social and economic.

These are people aged between 15 and 39 (by definition, adolescence covers the teenage years, and young adults are those in the third and fourth decade of life), who according to population data comprise approximately 40% of the world’s population.

After a gradual increase in the number of newly diagnosed cancer cases in AYA in recent decades, these patients currently (2023) represent about 4% of all new cancer cases in countries with high socioeconomic standards. This implies the occurrence of 50 000-70 000 new cases of AYA cancer in Europe per year (according to EUROCARE-5). The good news is that cancer mortality in this age group does not follow the trend of incidence. Five-year survival in Europe for the most common tumours is around 87% (calculated for 30 187 cancer patients treated between 1994 and 2002, according to data from 83 cancer registries in 23 European countries). Unfortunately, Bulgaria is among the EU countries with the most negative indicators in this category, with one of the highest AYA mortality rates in Europe (ca. 11 per 100,000).

The full analysis is available here in Bulgarian.