Transcatheter aortic valve implantation (TAVI) in the treatment of aortic stenosis – from high-risk to low-risk patients with a presentation of results in Serbia from 2014 to 2025

Abstract

Introduction Transcatheter aortic valve implantation (TAVI) is a treatment modality intended for patients with aortic stenosis older than 70 years who also have comorbidities that would make open-heart surgery high risk. The first TAVI procedure was performed on April 16, 2002, in Rouen, France, by Alain Cribier. Since 2008, randomized controlled trials (PARTNER 1B) have been conducted in extremely high-risk patients with a Society of Thoracic Surgeons (STS) score > 15, demonstrating the noninferiority of this method compared with surgical bioprosthetic valve replacement. Subsequent studies (PARTNER 1B and CoreValve HR) in high-risk patients with an STS score > 8 also demonstrated the noninferiority of this method compared with surgical bioprosthetic valve replacement. In intermediate-risk patients with an STS score of 4–8 (PARTNER 2 and SURTAVI), the studies likewise demonstrated the efficacy of this method compared with surgical bioprosthetic valve replacement. The TAVI procedure was also applied in low-risk patients with an STS score < 4 (PARTNER 3, Evolut Low Risk), where the results again confirmed that the TAVI valve was not inferior to surgical bioprosthetic valve replacement. In our country, the first TAVI intervention was performed at the University Clinical Centre of Serbia on April 22, 2014 (Prof. Dr. Milan A. Nedeljković, Prof. Dr. Branko Beleslin).

Methods In our three centers, self-expanding and balloon-expandable TAVI valves were used and implanted via the transfemoral approach (through the femoral artery). Before the TAVI procedure, we performed a comprehensive assessment of the severity of aortic stenosis, left ventricular function, and the size and type of valve to be implanted. The non-invasive diagnostic evaluation included: 1. Transthoracic echocardiography (TTE); 2. Transesophageal echocardiography (TEE) (when indicated); 3. Computed tomography of the heart and aorta is one of the most important examinations performed before the TAVI procedure. It is used to assess and measure the aortic valve and annulus, as well as the aorta and the blood vessels through which the catheter will be advanced (most commonly the femoral arteries). This examination is essential for selecting the appropriate prosthetic valve and determining the optimal vascular access route; 4. Coronary angiography; 5. Electrocardiogram (ECG); 6. Laboratory tests; 7. Chest X-ray; 8. Assessment of the patient’s overall clinical condition. All of these data were required by the Heart Team to assess the procedural risk for each patient.

Results From 2014 to 2021, a total of 73 TAVI valves were implanted in three centers in Serbia. In 2022, annual procurement of valves by the Health Insurance Fund of Serbia began, and 221 TAVI valves were implanted that year. In 2023, 318 TAVI valves were implanted, and in 2024, 231 TAVI valves. In 2025, 562 TAVI valves were implanted. In Serbia, a total of 1405 TAVI valves were implanted from 2014 up to and including 2025. These results demonstrate the continuous development of the TAVI program, particularly following the introduction of systematic funding. However, they also indicate that there is still room to improve access to the procedure and to further expand the network of TAVI centers in Serbia.

Conclusion This method has been widely accepted worldwide, and in certain countries it is used to treat more than 50% of patients with aortic stenosis.

Keywords: TAVI; aortic stenosis; STS score