When to Intervene—Should Surgical Guidelines Apply to Transcatheter Techniques in Treating Mitral Regurgitation?
Ron Waksman
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA
Search for more papers by this authorToby Rogers
Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA
Search for more papers by this authorSummary
In clinical practice, guidelines attempt to summarize the status quo of the best available evidence for managing patients with a given disease. Given the rapid expansion of transcatheter mitral valve interventions in inoperable or high-surgical-risk individuals, considerable interest lies in how one should contextualize the emerging transcatheter technologies within the framework of clinical guidelines. Surgery remains the gold-standard approach for treating severe primary mitral regurgitation (MR). However, the dramatic and ongoing evolution of transcatheter mitral valve therapies, coupled with significant long-standing (largely European) experience with the edge-to-edge MitraClip system for both primary and secondary severe MR, has allowed a percutaneous approach to find its place in the treatment armamentarium of high-risk MR patients. Further trials are needed to evaluate the efficacy of transcatheter treatment approaches for severe MR, as well as the use of small footprint devices on lower-surgical-risk patients with secondary MR of moderate severity.
References
- Holmes, D.R. Jr., Mohr, F., Hamm, C.W., and Mack, M.J. (2013). Venn diagrams in cardiovascular disease: the heart team concept. Eur. J. Cardiothorac. Surg. 43: 255–257.
- Baumgartner, H., Falk, V., Bax, J.J. et al. (2017). 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur. Heart J. 38: 2739–2791.
- Nishimura, R.A., Otto, C.M., Bonow, R.O. et al. (2014). 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. J. Am. Coll. Cardiol. 63: e57–e185.
- Nishimura, R.A., Otto, C.M., Bonow, R.O. et al. (2017). 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the Management of Patients with Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. J. Am. Coll. Cardiol. 70: 252–289.
- Regueiro, A., Granada, J.F., Dagenais, F., and Rodes-Cabau, J. (2017). Transcatheter mitral valve replacement: insights from early clinical experience and future challenges. J. Am. Coll. Cardiol. 69: 2175–2192.
- Saccocci, M., Taramasso, M., and Maisano, F. (2018). Mitral valve interventions in structural heart disease. Curr. Cardiol. Rep. 20: 49.
- Tribouilloy, C., Rusinaru, D., Grigioni, F. et al. (2014). Long-term mortality associated with left ventricular dysfunction in mitral regurgitation due to flail leaflets: a multicenter analysis. Circ. Cardiovasc. Imaging 7: 363–370.
- Suri, R.M., Vanoverschelde, J.L., Grigioni, F. et al. (2013). Association between early surgical intervention vs watchful waiting and outcomes for mitral regurgitation due to flail mitral valve leaflets. JAMA 310: 609–616.
- Praz, F., Spargias, K., Chrissoheris, M. et al. (2017). 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 390: 773–780.
- Maisano, F., Torracca, L., Oppizzi, M. et al. (1998). The edge-to-edge technique: a simplified method to correct mitral insufficiency. Eur. J. Cardiothorac. Surg. 13: 240–245; discussion 245-6.
- Alfieri, O., Maisano, F., De Bonis, M. et al. (2001). The double-orifice technique in mitral valve repair: a simple solution for complex problems. J. Thorac. Cardiovasc. Surg. 122: 674–681.
- Feldman, T., Kar, S., Elmariah, S. et al. (2015). Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J. Am. Coll. Cardiol. 66: 2844–2854.
- Maisano, F., Franzen, O., Baldus, S. et al. (2013). 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. 62: 1052–1061.
- Geis, N.A., Puls, M., Lubos, E. et al. (2018). Safety and efficacy of MitraClip therapy in patients with severely impaired left ventricular ejection fraction: results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur. J. Heart Fail. 20: 598–608.
- Puls, M., Lubos, E., Boekstegers, P. et al. (2016). One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur. Heart J. 37: 703–712.
- Schafer, U., Maisano, F., Butter, C. et al. (2016). Impact of Preprocedural left ventricular ejection fraction on 1-year outcomes after MitraClip implantation (from the ACCESS-EU phase I, a prospective, multicenter, nonrandomized Postapproval study of the MitraClip therapy in Europe). Am. J. Cardiol. 118: 873–880.
- Javadikasgari, H., Suri, R.M., Tappuni, B. et al. (2017). Robotic mitral valve repair for degenerative posterior leaflet prolapse. Ann. Cardiothorac. Surg. 6: 27–32.
- Gillinov, A.M., Mihaljevic, T., Javadikasgari, H. et al. (2018). Early results of robotically assisted mitral valve surgery: analysis of the first 1000 cases. J. Thorac. Cardiovasc. Surg. 155: 82–91.e2.
- Bakaeen, F.G., Shroyer, A.L., Zenati, M.A. et al. (2018). Mitral valve surgery in the US veterans administration health system: 10-year outcomes and trends. J. Thorac. Cardiovasc. Surg. 155: 105–117.e5.
- Levine, R.A. and Schwammenthal, E. (2005). Ischemic mitral regurgitation on the threshold of a solution: from paradoxes to unifying concepts. Circulation 112: 745–758.
- Bertrand, P.B., Schwammenthal, E., Levine, R.A., and Vandervoort, P.M. (2017). Exercise dynamics in secondary mitral regurgitation: pathophysiology and therapeutic implications. Circulation 135: 297–314.
- Acker, M.A., Parides, M.K., Perrault, L.P. et al. (2014). Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N. Engl. J. Med. 370: 23–32.
- Kron, I.L., Hung, J., Overbey, J.R. et al. (2015). Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J. Thorac. Cardiovasc. Surg. 149: 752–61.e1.
- Smith, P.K., Puskas, J.D., Ascheim, D.D. et al. (2014). Surgical treatment of moderate ischemic mitral regurgitation. N. Engl. J. Med. 371: 2178–2188.
- Mirabel, M., Iung, B., Baron, G. et al. (2007). What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur. Heart J. 28: 1358–1365.
- Taramasso, M., Inderbitzin, D.T., Guidotti, A. et al. (2016). Transcatheter direct mitral valve annuloplasty with the Cardioband system for the treatment of functional mitral regurgitation. Multimed. Man. Cardiothorac. Surg. https://doi.org/10.1093/mmcts/mmw004, https://mmcts.org/tutorial/102.
- De Bonis, M., Lapenna, E., Maisano, F. et al. (2014). Long-term results (</=18 years) of the edge-to-edge mitral valve repair without annuloplasty in degenerative mitral regurgitation: implications for the percutaneous approach. Circulation 130: S19–S24.
- De Bonis, M., Lapenna, E., La Canna, G. et al. (2005). Mitral valve repair for functional mitral regurgitation in end-stage dilated cardiomyopathy: role of the “edge-to-edge” technique. Circulation 112: I402–I408.
- Witte KK, Lipiecki J, Siminiak T, et al. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019; 7(11): 945–955. doi:10.1016/j.jchf.2019.06.011