2025 • In EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 21 (22), p. 1377-1385
[en] BACKGROUND: Given the poor prognosis of tricuspid regurgitation (TR) patients, there is growing interest in addressing TR, particularly since the emergence of novel transcatheter tricuspid valve interventions for patients at high risk for surgery. AIMS: The TRICURE first-inhuman (FIH) study evaluates the initial feasibility and clinical safety of the Topaz transcatheter tricuspid valve replacement (TTVR) system in treating TR. Featuring a novel dual-stent design, the system is specifically engineered for the unique anatomy of the tricuspid valve. It has a flexible outer stent with low radial force designed to accommodate annular dynamics and conform to the non-circular, variable shapes of the tricuspid valve, coupled to a rigid inner stent aiming to maintain valve function integrity. METHODS: TRICURE FIH is a prospective, multicentre, first-inhuman study with follow-up extending to 5 years. The primary safety endpoint is a composite measure including all-cause mortality, heart failure rehospitalisation, and reintervention for failed tricuspid therapy at 30 days. The primary performance endpoint is device success, defined as a TR reduction ≥1 grade with no more than moderate TR post-procedure. RESULTS: A total of 20 patients were enrolled. The procedure time (from delivery system insertion to removal) was 35±16 minutes. At 30 days, the primary safety endpoint, a composite of major adverse events, was observed in 35%, and the primary performance endpoint was successfully achieved in all patients (100%), with all patients having a TR reduction of at least 3 grades, and none of the patients having more than mild TR post-procedure. No device-related pacemaker implant was reported. An exemplary case report demonstrates complete elimination of TR and a reverse remodelling of the right ventricle of 19% at 6 months. CONCLUSIONS: The TRICURE FIH study provides evidence of the feasibility and safety of a novel TTVR system. Outcomes need to be confirmed in a larger series. (ClinicalTrials.gov: NCT05126030)
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Teiger, Emmanuel; Av du Mal de Lattre de Tassigny, Créteil, France
Nejjari, Mohammed; Av du Mal de Lattre de Tassigny, Créteil, France
Rosseel, Liesbeth; Av du Mal de Lattre de Tassigny, Créteil, France
Kefer, Joëlle ; Université de Liège - ULiège > Département des sciences cliniques > Médecine interne générale ; Av du Mal de Lattre de Tassigny, Créteil, France
Verheye, Stefan; Av du Mal de Lattre de Tassigny, Créteil, France
Lancellotti, Patrizio ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie - Pathologie spéciale et réhabilitation ; Av du Mal de Lattre de Tassigny, Créteil, France
Oliver, Léopold; Av du Mal de Lattre de Tassigny, Créteil, France
Obadia, Jean-François; Av du Mal de Lattre de Tassigny, Créteil, France
Asch, Federico; Av du Mal de Lattre de Tassigny, Créteil, France
Blanke, Philipp; Av du Mal de Lattre de Tassigny, Créteil, France
Dreyfus, Julien; Av du Mal de Lattre de Tassigny, Créteil, France
Chu, Henri; Av du Mal de Lattre de Tassigny, Créteil, France
Mondor; Av du Mal de Lattre de Tassigny, Créteil, France
Agarwal V, Hahn R. Tricuspid Regurgitation and Right Heart Failure: The Role of Imaging in Defining Pathophysiology, Presentation, and Novel Management Strategies. Interv Cardiol Clin. 2024;13:81-99.
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Haugaa KH, Jeppsson A, Jüni P, Pierard L, Prendergast BD, Sádaba JR, Tribouilloy C, Wojakowski W. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. EuroIntervention. 2022;17:e1126-96.
Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O’Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/ American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;77:e25-197.
Ben Ali W, Ruf T, Perrin N, Bouhout I, Fam N, Kresoja KP, Lurz P, von Bardeleben RS, Modine T, Ibrahim R. Indications, Limitations, and Development of Tricuspid Valve Interventions in Adults. Can J Cardiol. 2022;38:S66-78.
Cammalleri V, Carpenito M, Bono MC, Mega S, Ussia GP, Grigioni F. Transcatheter Tricuspid Valve Therapy: From Anatomy to Intervention. Front Cardiovasc Med. 2021;8:778445.
Alperi A, Almendárez M, Álvarez R, Moris C, Leon V, Silva I, Hernández-Vaquero D, Pascual I, Avanzas P. Transcatheter tricuspid valve interven-tions: Current status and future perspectives. Front Cardiovasc Med. 2022;9:994502.
Hagemeyer D, Ong G, Peterson MD, Fam NP. Transcatheter tricuspid valve intervention: to repair or to replace? Curr Opin Cardiol. 2022;37:495-501.
Chang CC, Veen KM, Hahn RT, Bogers AJJC, Latib A, Oei FBS, Abdelghani M, Modolo R, Ho SY, Abdel-Wahab M, Fattouch K, Bosmans J, Caliskan K, Taramasso M, Serruys PW, Bax JJ, van Mieghem NMDA, Takkenberg JJM, Lurz P, Modine T, Soliman O. Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: a state-of-the-art expert review. Eur Heart J. 2020;41:1932-40.
Hahn RT, Lawlor MK, Davidson CJ, Badhwar V, Sannino A, Spitzer E, Lurz P, Lindman BR, Topilsky Y, Baron SJ, Chadderdon S, Khalique OK, Tang GHL, Taramasso M, Grayburn PA, Badano L, Leipsic J, Lindenfeld J, Windecker S, Vemulapalli S, Redfors B, Alu MC, Cohen DJ, Rodés-Cabau J, Ailawadi G, Mack M, Ben-Yehuda O, Leon MB, Hausleiter J. Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints. Eur Heart J. 2023;44:4508-32.
Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015;66:308-21.
Hahn RT, Makkar R, Makar M, Davidson C, Puthamana J, Zahr F, Chadderdon S, Fam N, Ong G, Yadav PK, Thourani VH, Vannan MA, Tchétché D, Dumonteil N, Bonfils L, Lepage L, Smith R, Grayburn PA, Webb JG, Moss R, Windecker S, Brugger N, Nabauer M, Hausleiter J, Kodali S. EVOQUE Tricuspid Valve Replacement System: State-of-the-Art Screening and Intraprocedural Guidance. JACC Cardiovasc Interv. 2024;17:2093-112.
Sondergaard L, Møller JE, De Backer O, Møller-Sørensen PH, Cheng Y, Rossing K, Smerup M, Quadri A. First-in-Human Implantation of a New Transcatheter Tricuspid Valve Replacement System. JACC Case Rep. 2023;14:101841.
Wong LN, Kam KK, Lai LK, Chow SC, Lam YY, Wan S, Lee AP, So KC. Step-by-Step Transcatheter Tricuspid Valve Replacement Using the LuX-Valve Plus System. JACC Case Rep. 2024;29:102699.
Kodali S, Hahn RT, Makkar R, Makar M, Davidson CJ, Puthumana JJ, Zahr F, Chadderdon S, Fam N, Ong G, Yadav P, Thourani V, Vannan MA, O’Neill WW, Wang DD, Tchétché D, Dumonteil N, Bonfils L, Lepage L, Smith R, Grayburn PA, Sharma RP, Haeffele C, Babaliaros V, Gleason PT, Elmariah S, Inglessis-Azuaje I, Passeri J, Herrmann HC, Silvestry FE, Lim S, Fowler D, Webb JG, Moss R, Modine T, Lafitte S, Latib A, Ho E, Goldberg Y, Shah P, Nyman C, Rodés-Cabau J, Bédard E, Brugger N, Sannino A, Mack MJ, Leon MB, Windecker S; the TRISCEND study investigators. Transfemoral tricuspid valve replacement and one-year out-comes: the TRISCEND study. Eur Heart J. 2023;44:4862-73.
Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O’Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, Kodali SK; TRISCEND II Trial Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025;392:115-26.
Faqih SA, Noto-Kadou-Kaza B, Abouamrane LM, Mtiou N, El Khayat S, Zamd M, Medkouri G, Benghanem MG, Ramdani B. Pulmonary hyperten-sion: prevalence and risk factors. Int J Cardiol Heart Vasc. 2016;11:87-9.
Kovacs G, Zeder K, Rosenstock P, Avian A, Bachmaier G, Douschan P, Foris V, Sassmann T, Olschewsk H. Clinical Impact of the New Definition of Precapillary Pulmonary Hypertension. Chest. 2021;159:1995-7.
Opitz I, Ulrich S. Chronic thromboembolic pulmonary hypertension. Swiss Med Wkly. 2018;148:w14702.
Galiè N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hyper-tension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015;46:903-75.
Gall H, Hoeper MM, Richter MJ, Cacheris W, Hinzmann B, Mayer E. An epidemiological analysis of the burden of chronic thromboembolic pulmonary hypertension in the USA, Europe and Japan. Eur Respir Rev. 2017;26:160121.
