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Innovative medical technologies in the percutaneous treatment of tricuspid regurgitation in Poland
Affiliations- Department of Cardiology and Interventional Angiology, National Institute of Cardiology, Warsaw, Poland
- Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland
- Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Ravenna, Italy
- Division of Cardiology and Structural Heart Diseases, SMK in Katowice, Poland
- Jagiellonian University, Medical College, Institute of Cardiology, Department of Coronary Disease and Heart Failure, Noninvasive Cardiovascular Laboratory, John Paul II Hospital, Krakow, Poland
- First Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
- Department of Cardiac Surgery and Transplantology, National Institute of Cardiology, Warsaw, Poland
- First Department of Cardiology, Medical University of Gdansk, Poland
- Department of Congenital Heart Diseases, National Institute of Cardiology, Warsaw, Poland
- Law Office Bondaryk, Warsaw, Poland
- Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland
- HealthQuest, Poland
- Abbott Medical sp. z o.o., Health Economics and Reimbursement, Warsaw, Poland
- SGH Warsaw School of Economics, Poland
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Abstract
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.
Abstract
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.
Keywords
tricuspid regurgitation, transcatheter tricuspid valve interventions, transcatheter tricuspid valve repair, TriClip TTVr System, MitraClip
About this articleTitle
Innovative medical technologies in the percutaneous treatment of tricuspid regurgitation in Poland
Journal
Issue
Article type
Review Article
Pages
369-380
Published online
2021-10-18
Page views
7262
Article views/downloads
2121
DOI
10.5603/CJ.a2021.0130
Pubmed
Bibliographic record
Cardiol J 2022;29(3):369-380.
Keywords
tricuspid regurgitation
transcatheter tricuspid valve interventions
transcatheter tricuspid valve repair
TriClip TTVr System
MitraClip
Authors
Adam Witkowski
Dariusz Dudek
Stanisław Bartuś
Wojciech Wojakowski
Andrzej Gackowski
Marek Grygier
Mariusz Kuśmierczyk
Miłosz J. Jaguszewski
Ewa Kowalik
Katarzyna Bondaryk
Maciej Niewada
Piotr Przygodzki
Michał Jakubczyk
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