Update on the Current Landscape of Transcatheter Options for Tricuspid Regurgitation Treatment

Jonathan Curio, Ozan M Demir, Matteo Pagnesi, Antonio Mangieri, Francesco Giannini, Giora Weisz, Azeem Latib, Jonathan Curio, Ozan M Demir, Matteo Pagnesi, Antonio Mangieri, Francesco Giannini, Giora Weisz, Azeem Latib

Abstract

Most patients with severe tricuspid regurgitation lack treatment options because of prohibitive surgical risk. New transcatheter treatments under development and investigation might be able to address this unmet clinical need. This article gives an update on the landscape of devices for transcatheter tricuspid regurgitation treatment including different approaches (i.e. repair with leaflet approximation or annuloplasty and replacement using orthotopic or heterotopic valves) at different stages of development, from experimental to clinical trial. Repair devices such as the Cardioband or the MitraClip are leading the field with promising preliminary data and further trials are ongoing. However, with implantations of the Gate bioprosthesis, replacement devices are catching up. Potential advantages of different approaches and most recent data are discussed.

Keywords: Tricuspid regurgitation; annuloplasty; devices; repair; replacement; transcatheter; treatment options; tricuspid valve.

Conflict of interest statement

Disclosure: AL is a consultant for Medtronic, Abbott Vascular, Mitralign and Millipede. All other authors have no conflicts of interest to declare.

Figures

Figure 1:. Transcatheter Tricuspid Landscape
Figure 1:. Transcatheter Tricuspid Landscape
Figure 2:. Different Stages of Tricuspid Regurgitation…
Figure 2:. Different Stages of Tricuspid Regurgitation and Suitable Transcatheter Treatments

References

    1. Singh JP, Evans JC, Levy D et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study) Am J Cardiol. 1999;83:897–902. doi: 10.1016/S0002-9149(98)01064-9.
    1. Topilsky Y, Maltais S, Medina Inojosa J et al. Burden of tricuspid regurgitation in patients diagnosed in the community setting. JACC Cardiovasc Imaging. 2019;12((3)):433–42. doi: 10.1016/j.jcmg.2018.06.014.
    1. Nath J, Foster E, Heidenreich PA et al. Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol. 2004;43:405–9. doi: 10.1016/j.jacc.2003.09.036.
    1. Mangieri A, Montalto C, Pagnesi M et al. Mechanism and implications of the tricuspid regurgitation: from the pathophysiology to the current and future therapeutic options. Circ Cardiovasc Interv. 2017;10 doi: 10.1161/CIRCINTERVENTIONS.117.005043.
    1. Ong K, Yu G, Jue J et al. Prevalence and spectrum of conditions associated with severe tricuspid regurgitation. Echocardiography. 2014;31:558–62. doi: 10.1111/echo.12420.
    1. Badano LP, Muraru D, Enriquez-Sarano M et al. Assessment of functional tricuspid regurgitation. Eur Heart J. 2013;34:1875–85. doi: 10.1093/eurheartj/ehs474.
    1. Rodés-Cabau J, Taramasso M, O’Gara PT. Diagnosis and treatment of tricuspid valve disease: current and future perspectives. Lancet. 2016;42:388–2431. doi: 10.1016/S0140-6736(16)00740-6.
    1. Kilic A, Saha-Chaudhuri P, Rankin JS, Conte JV. Trends and outcomes of tricuspid valve surgery in North America: an analysis of more than 50,000 patients from the Society of Thoracic Surgeons database. Ann Thorac Surg. 2013;96:1546–52. doi: 10.1016/j.athoracsur.2013.06.031.
    1. Zack CJ, Fender EA, Chandrashekar P et al. National trends and outcomes in isolated tricuspid valve surgery. J Am Coll Cardiol. 2017;70:2953–60. doi: 10.1016/j.jacc.2017.10.039.
    1. Stuge O, Liddicoat J et al. Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg. 2006;132:1258–61. doi: 10.1016/j.jtcvs.2006.08.049.
    1. McCarthy PM, Sales VL et al. Evolving indications for tricuspid valve surgery. Curr Treat Options Cardiovasc Med. 2010;12:587–97. doi: 10.1007/s11936-010-0098-1.
    1. Guenther T, Noebauer C, Mazzitelli D et al. Tricuspid valve surgery: a thirty-year assessment of early and late outcome. Eur J Cardiothorac Surg. 2008;34:402–9. doi: 10.1016/j.ejcts.2008.05.006.
    1. Latib A, Grigioni F, Hahn RT. Tricuspid regurgitation: what is the real clinical impact and how often should it be treated? EuroIntervention. 2018;14:AB101–11. doi: 10.4244/EIJ-D-18-00533.
    1. Latib A, Mangieri A et al. Transcatheter tricuspid valve repair: new valve, new opportunities, new challenges. J Am Coll Cardiol. 2017;69:1807–10. doi: 10.1016/j.jacc.2017.02.016.
    1. Rodés-Cabau J, Hahn RT, Latib A et al. Transcatheter therapies for treating tricuspid regurgitation. J Am Coll Cardiol. 2016;67:1829–45. doi: 10.1016/j.jacc.2016.01.063.
    1. Asmarats L, Puri R, Latib A, Navia JL, Rodés-Cabau J. Transcatheter tricuspid valve interventions: landscape, challenges, and future directions. J Am Coll Cardiol. 2018;71:2935–56. doi: 10.1016/j.jacc.2018.04.031.
    1. Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38:2739–91. doi: 10.1093/eurheartj/ehx391.
    1. Feldman T, Foster E, Glower DD et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364:1395–406. doi: 10.1056/NEJMoa1009355.
    1. Maisano F, Franzen O, Baldus S et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013;62:1052–61. doi: 10.1016/j.jacc.2013.02.094.
    1. Stone GW, Lindenfeld J, Abraham WT et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018;379:2307–18. doi: 10.1056/NEJMoa1806640.
    1. Taramasso M, Alessandrini H, Latib A et al. Outcomes after current transcatheter tricuspid valve intervention: mid-term results from the International TriValve Registry. JACC Cardiovasc Interv. 2019;12:155–65. doi: 10.1016/j.jcin.2018.10.022.
    1. Latib A, Mangieri A, Agricola E et al. Percutaneous bicuspidalization of the tricuspid valve using the MitraClip system. Int J Cardiovasc Imaging. 2017;33:227–8. doi: 10.1007/s10554-016-0996-8.
    1. Braun D, Orban M, Hagl C et al. Transcatheter edge-to-edge repair for severe tricuspid regurgitation using the triple- orifice technique versus the bicuspidalization technique. JACC Cardiovasc Interv. 2018;11:1790–2. doi: 10.1016/j.jcin.2018.05.049.
    1. Nickenig G, Kowalski M, Hausleiter J et al. Transcatheter treatment of severe tricuspid regurgitation with the edge-to-edge MitraClip technique. Circulation. 2017;135:1802–14. doi: 10.1161/CIRCULATIONAHA.116.024848.
    1. Lurz P, Besler C, Noack T et al. Transcatheter treatment of tricuspid regurgitation using edge-to-edge repair: procedural results, clinical implications and predictors of success. EuroIntervention. 2018;14:e290–7. doi: 10.4244/EIJ-D-17-01091.
    1. Nickenig G, Hausleiter J, Hahn R Percutaneous edge-to-edge repair for tricuspid regurgitation: study design and initial results from the TRILUMINATE clinical trial. Presented at PCR London Valves, London, 31 August. 2018. (accessed 9 April 2019)
    1. Praz F, Spargias K, Chrissoheris M et al. Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. Lancet. 2017;390:773–80. doi: 10.1016/S0140-6736(17)31600-8.
    1. Fam NP, Ho EC, Zahrani M, Samargandy S, Connelly KA et al. Transcatheter tricuspid valve repair with the PASCAL system. JACC Cardiovasc Interv. 2018;11:407–8. doi: 10.1016/j.jcin.2017.12.004.
    1. Fam N, Ruf T, Connelly K Compassionate use of the PASCAL system for transcatheter tricuspid repair: a prospective, multicentre, first-in-man study Poster presentation. Presented at PCR London Valves, London, 31 August 2018. Available at: (accessed 9 April 2019)
    1. Fam NP. Pascal tricuspid: early experience technology and clinical updates Presented at Transcatheter Cardiovascular Therapeutics San Diego 23 September 2018
    1. Latib A. 4Tech TriCinch – enhanced design technology and clinical update Presented at The Structural Heart Disease Summit Chicago 21 June 2018
    1. Rosser BA, Taramasso M, Maisano F. Transcatheter interventions for tricuspid regurgitation: TriCinch (4Tech) EuroIntervention. 2016;12:Y110–2. doi: 10.4244/EIJV12SYA30.
    1. Latib A, Agricola E, Pozzoli A et al. First-in-man implantation of a tricuspid annular remodeling device for functional tricuspid regurgitation. JACC Cardiovasc Interv. 2015;8:e211–4. doi: 10.1016/j.jcin.2015.06.028.
    1. Gheorghe L, Swaans M, Denti P et al. Transcatheter tricuspid valve repair with a novel cinching system. JACC Cardiovasc Interv. 2018;11:e199–e201.. doi: 10.1016/j.jcin.2018.09.019.
    1. Nietlispach F. Tricinch for TR: technique and outcomes Presented at Transcatheter Valve Therapies Chicago 16 June 2017
    1. Bapat V. New percutaneous tricuspid valve repair system Presented at Transcatheter Cardiovascular Therapeutics Denver 30 October 2017
    1. Puri R, Rodés-Cabau J. Transcatheter interventions for tricuspid regurgitation: the FORMA Repair System. EuroIntervention. 2016;12:Y113–5. doi: 10.4244/EIJV12SYA31.
    1. Campelo-Parada F, Perlman G, Philippon F et al. First-in-man experience of a novel transcatheter repair system for treating severe tricuspid regurgitation. J Am Coll Cardiol. 2015;66:2475–83. doi: 10.1016/j.jacc.2015.09.068.
    1. Perlman G, Praz F, Puri R et al. Transcatheter tricuspid valve repair with a new transcatheter coaptation system for the treatment of severe tricuspid regurgitation: 1-year clinical and echocardiographic results. JACC Cardiovasc Interv. 2017;10:1994–2003. doi: 10.1016/j.jcin.2017.06.036.
    1. Perlman G. The FORMA Spacer – technology and clinical updates Presented at: Transcatheter Cardiovascular Therapeutics San Diego 23 September 2018
    1. Asmarats L. Long-term outcomes following transcatheter tricuspid valve repair with the FORMA system Presented at Transcatheter Cardiovascular Therapeutics San Diego 21 September 2018
    1. Hahn RT, Zamorano JL et al. The need for a new tricuspid regurgitation grading scheme. Eur Heart J Cardiovasc Imaging. 2017;18:1342–3. doi: 10.1093/ehjci/jex139.
    1. Asmarats L, Philippon F, Bédard E, Rodés-Cabau J. FORMA tricuspid repair system: device enhancements and initial experience. EuroIntervention. 2018. epub ahead of press.
    1. Chon MK. Novel concept of catheter-based treatment for tricuspid regurgitation (Cerclage-TR block) Presented at Transcatheter Cardiovascular Therapeutics San Diego 21 September 2018
    1. Park YH, Chon MK, Lederman RJ et al. Mitral loop cerclage annuloplasty for secondary mitral regurgitation: first human results. JACC Cardiovasc Interv. 2017;10:597–610. doi: 10.1016/j.jcin.2016.12.282.
    1. Kim JH, Sung SC, Chon MK et al. Mitral loop cerclage as a variant form of mitral cerclage annuloplasty that adds a device (CSTV) for preventing potential complications: a preclinical proof of concept and feasibility study. EuroIntervention. 2016;11:e1669–79. doi: 10.4244/EIJV11I14A319.
    1. Maisano F, Alfieri O, Banai S et al. The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs replacement? Eur Heart J. 2015;36:1651–9. doi: 10.1093/eurheartj/ehv123.
    1. Testa L, Latib A, Montone RA, Bedogni F et al. Transcatheter mitral valve regurgitation treatment: State of the art and a glimpse to the future. J Thorac Cardiovasc Surg. 2016;152:319–27. doi: 10.1016/j.jtcvs.2016.04.055.
    1. Planer D, Beeri R, Danenberg H. MATTERS study: First-in-man transcatheter tricuspid valve repair by the Mistral device Presented at Transcatheter Cardiovascular Therapeutics San Diego 21 September 2018
    1. Quinn M. CroíValve tricuspid valve repair: pre-clinical results Presented at PCR London Valves Innovators Day London 9 September 2018
    1. Maisano F, Taramasso M, Nickenig G et al. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016;37:817–25. doi: 10.1093/eurheartj/ehv603.
    1. Kuwata S, Taramasso M, Nietlispach F, Maisano F et al. Transcatheter tricuspid valve repair toward a surgical standard: first-in-man report of direct annuloplasty with a cardioband device to treat severe functional tricuspid regurgitation. Eur Heart J. 2017;38:1261. doi: 10.1093/eurheartj/ehw660.
    1. Nickenig G. Transcatheter tricuspid valve repair: results from the multicentre CE mark trial – six-month outcomes Presented at PCR London Valves London 9 September 2018
    1. Mangieri A, Colombo A, Demir OM et al. Percutaneous direct annuloplasty with edge-to-edge technique for mitral regurgitation: replicating a complete surgical mitral repair in a one-step procedure. Can J Cardiol. 2018;34:1088.e1–1088.e2. doi: 10.1016/j.cjca.2018.04.003.
    1. von Bardeleben RS, Ruf T, Schulz E, Muenzel T, Kreidel F. First percutaneous COMBO therapy of tricuspid regurgitation using direct annuloplasty and staged edge-to-edge repair in a surgical-like Clover technique. Eur Heart J. 2018;39:3621–2. doi: 10.1093/eurheartj/ehy536.
    1. Sugiura A, Weber M, Sinning JM, Werner N, Nickenig G et al. Staged transcatheter valve repair via MitraClip XTR after Cardioband for tricuspid regurgitation. Eur Heart J Cardiovasc Imaging. 2019;20:118. doi: 10.1093/ehjci/jey153.
    1. Rogers J. Transcatheter Tricuspid Valve Therapies 5: Millipede Presented at Transcatheter Cardiovascular Therapeutics Washington DC 1 November 2016
    1. Rogers J. Millipede Ring for the Tricuspid Valve Presented at Transcatheter Cardiovascular Therapeutics Denver 1 November 2017
    1. Rogers T, Ratnayaka K, Sonmez M et al. Transatrial intrapericardial tricuspid annuloplasty. JACC Cardiovasc Interv. 2015;8:483–91. doi: 10.1016/j.jcin.2014.10.013.
    1. Rogers T. TRAIPTA – an update for 2017 Presented at Transcatheter Cardiovascular Therapeutics Denver 1 November 2017
    1. Kuck KH. Cardiac implants’ complete ring delivery system for mitral and tricuspid valve annuloplasty Presented at Transcatheter Cardiovascular Therapeutics San Francisco 12 October 2015
    1. Kerner A. DaVingi™ Tricuspid repair system: technology and clinical updates Presented at Transcatheter Cardiovascular Therapeutics San Diego 23 September 2018
    1. Schofer J, Bijuklic K, Tiburtius C et al. First-in-human transcatheter tricuspid valve repair in a patient with severely regurgitant tricuspid valve. J Am Coll Cardiol. 2015;65:1190–5. doi: 10.1016/j.jacc.2015.01.025.
    1. Besler C, Meduri CU, Lurz P et al. Transcatheter treatment of functional tricuspid regurgitation using the trialign device. Interv Cardiol. 2018;13:8–13. doi: 10.15420/icr.2017:21:1.
    1. Hahn RT, Meduri CU, Davidson CJ et al. Early feasibility study of a transcatheter tricuspid valve annuloplasty: SCOUT Trial 30-day results. J Am Coll Cardiol. 2017;69:1795–806. doi: 10.1016/j.jacc.2017.01.054.
    1. Hahn RT. SCOUT I 12-month data Presented at Transcatheter Cardiovascular Therapeutics Denver 1 November 2017
    1. Lurz P, Besler C, Kiefer P, Ender J, Seeburger J et al. Early experience of the trialign system for catheter-based treatment of severe tricuspid regurgitation. Eur Heart J. 2016;37:3543. doi: 10.1093/eurheartj/ehw253.
    1. Williams M. Minimally Invasive Tricuspid Valve Annuloplasty Repair Technology (MIATM MicroInterventional Devices): Early Clinical Experience Presented at Transcatheter Cardiovascular Therapeutics San Diego 21 September 2018
    1. Micro Interventional Devices, Inc.™ announces continued successful enrollment in STTAR trial Press release. (accessed 9 April 2019)
    1. Khan J, Rogers T, Greenbaum A Transcatheter Pledget-Assisted Suture Tricuspid Annuloplasty (PASTA) Presented at Transcatheter Cardiovascular Therapeutics Denver 30 October 2017
    1. Khan JM, Rogers T, Schenke WH et al. Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve. Catheter Cardiovasc Interv. 2018;92:E175–84. doi: 10.1002/ccd.27531.
    1. Greenbaum AB. Transcatheter tricuspid valve repair: available techniques and patient candidates criteria Presented at Cardiovascular Research Technologies Washington DC 4 March 2018
    1. Fam N. NaviGate – early clinical experience of NaviGate transcatheter tricuspid valve replacement in patients with severe tricuspid valve regurgitation Presented at PCR London Valves Innovators Day London 9 September 2018
    1. Hahn RT, George I, Kodali SK et al. Early single-site experience with transcatheter tricuspid valve replacement. JACC Cardiovasc Imaging. 2019;12:416–29. doi: 10.1016/j.jcmg.2018.08.034.
    1. Navia JL, Kapadia S, Elgharably H et al. First-in-human implantations of the NaviGate Bioprosthesis in a severely dilated tricuspid annulus and in a failed tricuspid annuloplasty ring. Circ Cardiovasc Interv. 2017;10 doi: 10.1161/CIRCINTERVENTIONS.117.005840.
    1. Hahn RT. NAVIGATE transcatheter tricuspid valve replacement early findings – technology and clinical updates Presented at Transcatheter Cardiovascular Therapeutics San Diego 23 September 2018
    1. Weisz G. TRISOL Tricuspid valve replacement: a comprehensive solution for tricuspid regurgitation and RV dysfunction Presented at The Structural Heart Disease Summit Chicago 22 June 2018
    1. Chin KM, Kim NH, Rubin LJ et al. The right ventricle in pulmonary hypertension. Coron Artery Dis. 2005;16:13–8. doi: 10.1097/00019501-200502000-00003.
    1. Weisz G. Comprehensive solution for tricuspid regurgitation and RV dysfunction: Trisol Medical Presented at Transcatheter Cardiovascular Therapeutics San Diego 22 September 2018
    1. Lu F, Xu Z, Song Z TCT 88: catheter-based tricuspid valve replacement via right atrium: an animal experimental study Presented at Transcatheter Cardiovascular Therapeutics Denver 31 October 2017
    1. Laule M, Stangl V, Sanad W, Lembcke A, Baumann G, Stangl K et al. Percutaneous transfemoral management of severe secondary tricuspid regurgitation with Edwards Sapien XT bioprosthesis: first-in-man experience. J Am Coll Cardiol. 2013;61:1929–31. doi: 10.1016/j.jacc.2013.01.070.
    1. Dreger H. Treatment of Severe TRIcuspid Regurgitation in Patients with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a controlled propective randomized trial Presented at Transcatheter Cardiovascular Therapeutics San Diego 21 September 2018
    1. Figulla HR, Kiss K, Lauten A. Transcatheter interventions for tricuspid regurgitation – heterotopic technology: TricValve. EuroIntervention. 2016;12:Y116–8. doi: 10.4244/EIJV12SYA32.
    1. Lauten A, Ferrari M, Hekmat K et al. Heterotopic transcatheter tricuspid valve implantation: first-in-man application of a novel approach to tricuspid regurgitation. Eur Heart J. 2011;32:1207–13. doi: 10.1093/eurheartj/ehr028.
    1. Lauten A, Doenst T, Hamadanchi A et al. Percutaneous bicaval valve implantation for transcatheter treatment of tricuspid regurgitation: clinical observations and 12-month follow-up. Circ Cardiovasc Interv. 2014;7:268–72. doi: 10.1161/CIRCINTERVENTIONS.113.001033.
    1. Kuetting M. New valve technology – TriCento: Novel device for the treatment of tricuspid insufficiency Presented at PCR London Valves Innovators Day London 9 September 2018
    1. Toggweiler S, De Boeck B, Brinkert M et al. First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. EuroIntervention. 2018;14:758–61. doi: 10.4244/EIJ-D-18-00440.
    1. Hahn RT. Performance of tricuspid valve interventions guided by peri-procedural echocardiography Presented at PCR London Valves London 9 September 2018

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe