Innovative medical technologies in the percutaneous treatment of tricuspid regurgitation in Poland.

Tricuspid regurgitation (TR) usually develops secondarily to left-sided heart diseases, whereas primary lesions to the valve apparatus is less common. Untreated severe TR has a poor prognosis and surgical treatment, i.e., valve repair or replacement, is the only treatment option with class I recommendation. However, cardiac surgical procedures may be associated with a high risk of complications. Recent advances in percutaneous approaches to managing structural heart diseases, especially mitral valve diseases, have enabled the implementation of this therapeutic strategy in the population of patients with TR. This paper presents data on the clinical efficacy, cost-effectiveness and expected population size for one of these procedures, namely the TriClip TTVr System procedure. Its efficacy was assessed in the TRILUMINATE study involving 85 patients with co-morbidities and at high surgical risk. After 1 year of follow-up, the reduction in the TR grade was reported in 71% of patients. Clinical improvement in New York Heart Association functional class, a 6-minute walk test, and the quality of life were also observed. A published analysis comparing percutaneous treatment modalities with a drug therapy based on data from medical registers was utilized, and propensity score matching was also employed. Percutaneous treatment reduced 1-year mortality and rehospitalization risk. The economic analysis showed the use of TriClip TTVr System is cost-effective: the cost of an additional quality-adjusted life year ranged from approximately PLN 85,000 to PLN 100,000, which is below the official threshold in Poland. The potential annual number of candidates for this treatment modality in Poland is estimated at 265.

Heart failure in Poland: Left ventricular assist device destination therapy and other challenges of interventional cardiology and cardiac surgery.

Patients with severe heart failure (HF), who are not eligible for cardiac transplantation and receive optimal medical management, based mainly on the use of pharmacological treatment and devices such as resynchronization therapy (implantable cardioverter-defibrillator), achieve poor clinical outcomes and constitute a group with extremely poor prognosis. Currently, the technology used in the latest generation left ventricular assist devices (LVADs), such as the HeartMate 3, makes it possible to achieve patient survival at the level obtained by patients after heart transplantation, and they can be used not only in patients eligible for heart transplantation as a bridge to transplant, but also in those with significantly worse prognosis, who are ineligible for heart transplantation as destination therapy. The objective of this publication is to present recommendations from experts in cardiology and cardiac surgery, supported by clinical trial results, on the use of LVADs as a destination therapy in HF patients who are not eligible for cardiac transplantation. The paper also presents the issue of cardiac transplantation and extracorporeal membrane oxygenation therapy in Poland, as well as current challenges faced by interventional cardiology and cardiac surgery in Poland.

Recommendations on the use of innovative medical technologies in cardiology and cardiac surgery and solutions leading to increased availability for Polish patients.

There is a great need for innovative technologies that will improve the health and quality of life (QoL) of Polish patients with cardiac problems. It is important that the safety and effectiveness of the technology are confirmed by scientific evidence on which guidelines and clinical recommendations are based. Scientific evidence for medical devices is also increasingly important for decision-making in finance approval from public funds. New technologies in cardiology and cardiac surgery contribute to improved patient QoL, increased treatment effectiveness and facilitated diagnosis. Hence, it is necessary to increase accessibility to such technologies, primarily through the development of clinical recommendations, and education of medical personnel in conjunction with public funding. The aim of this publication is to present the recommendations of leading experts in the field of cardiology and cardiosurgery, supported by clinical research results, regarding the use of the cited innovative medical technologies and solutions leading to their increased availability for Polish patients.