Forma tricuspid repair system
Tricuspid regurgitation is a significant clinical problem, with complex palliative solutions that carry a high surgical risk. Industry continues to dedicate substantial resources to the development of devices to allow percutaneous treatment.
The Forma system (Edwards, USA) has been under research for several years. It has been modified following the results from a clinical trial involving an initial compassionate use experience in patients with tricuspid regurgitation who are unsuitable for surgery.1
The Forma system is inserted via axillary access with a 24 French sheath. Through this sheath, a balloon catheter is advanced to the right ventricular apex, where the guiding rail is anchored to the ventricular wall. Using this rail, a 15 mm or 18 mm cylindrical spacer is positioned perpendicular to the tricuspid valve in the gap between the leaflets. The leaflets coapt onto this cylindrical spacer, substantially reducing the regurgitant volume from the right ventricle. One the position is confirmed by visualization on 3D echocardiography, the rail is pulled taught and fixed in the subcutaneous space next to the insertion zone in the subclavian vein.
Four-year results are now available from the first clinical trial,2 which show an improvement in quality of life, functional status based on NYHA (New York Heart Association) classification, and 6-minute walk test.
Two other clinical trials are currently underway, one of which involves 75 patients in Canada and Europe (EU/Canada SPACER trial NCT02787408).
REFERENCES
1. Rodés-Cabau J. Transcatheter Tricuspid Valve Therapies 3: FORMA. Description, Results and a Case. En: Transcatheter Cardiovascular Therapeutics 2016; 2016 November 1, 2016; Washington, USA. Available at: https://www.tctmd.com/slide/transcatheter-tricuspid-valve-therapies-3-forma-description-results-and-case. Accessed 03 Abr 2020.
2. Muntane-Carol M, Del Val D, Bedard E et al. Transcatheter innovations in tricuspid regurgitation: FORMA device. Prog Cardiovasc Dis. 2019;62:496-499.
Palabras clave: Insuficiencia tricuspídea, intervencionismo percutáneo estructural. Keywords: tricuspid regurgitation, percutaneous structural interventions.
