Mitraclip Plus Medical Therapy Versus Medical Therapy Alone for Functional Mitral Regurgitation: A Meta-Analysis

Cardiology and Therapy - Tập 9 - Trang 5-17 - 2019
Sunny Goel1, Ravi Teja Pasam2, Karan Wats2, Srilekha Chava2, Joseph Gotesman2, Abhishek Sharma3,4, Bilal Ahmad Malik2, Sergey Ayzenberg2, Robert Frankel2, Jacob Shani2, Umesh Gidwani1
1Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, USA
2Department of Cardiology, Maimonides Medical Center, Brooklyn, New York, USA
3Division of Cardiology, Gundersen Health System, La Crosse, USA
4Institute of Cardiovascular Science and Technology, New York, USA

Tóm tắt

The purpose of this meta-analysis is to compare the efficacy of MitraClip plus medical therapy versus medical therapy alone in patients with functional mitral regurgitation (FMR). FMR caused by left ventricular dysfunction is associated with poor prognosis. Whether MitraClip improves clinical outcomes in this patient population remains controversial. We conducted an electronic database search of PubMed, CINAHL, Cochrane Central, Scopus, Google Scholar, and Web of Science databases for randomized control trials (RCTs) and observational studies with propensity score matching (PSM) that compared MitraClip plus medical therapy with medical therapy alone for patients with FMR and reported on subsequent mortality, heart failure re-hospitalization, and other outcomes of interest. Event rates were compared using a random-effects model with odds ratio as the effect size. Five studies (n = 1513; MitraClip = 796, medical therapy = 717) were included in the final analysis. MitraClip plus medical therapy compared to medical therapy alone was associated with a significant reduction in overall mortality (OR = 0.66, 95% CI = 0.44–0.99, P = 0.04) and heart failure (HF) re-hospitalization rates (OR = 0.57, 95% CI = 0.36–0.91, P = 0.02). There was reduced need for heart transplantation or mechanical support requirement (OR = 0.48, 95% CI = 0.25–0.91, P = 0.02) and unplanned mitral valve surgery (OR = 0.21, 95% CI = 0.07–0.61, P = 0.004) in the MitraClip group. No effect was observed on cardiac mortality (P = 0.42) between the two groups. MitraClip plus medical therapy improves overall mortality and reduces HF re-hospitalization rates compared to medical therapy alone in patients with FMR.

Tài liệu tham khảo

De Marchena E, Badiye A, Robalino G, et al. Respective prevalence of the different Carpentier classes of mitral regurgitation: a stepping stone for future therapeutic research and development. J Card Surg. 2011;26:385e92. Sannino A, Smith RL II, Schiattarella GG, Trimarco B, Esposito G, Grayburn PA. Survival and cardiovascular outcomes of patients with secondary mitral regurgitation: a systematic review and meta-analysis. JAMA Cardiol. 2017;2:1130–9. Goel S, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure. J Am Coll Cardiol. 2014;63(2):185–6. DiSalvo TG, Acker MA, Dec GW, Byrne JG. Mitral valve surgery in advanced heart failure. J Am Coll Cardiol. 2010;55:272e82. Mirabel M, Lung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28:1358–65. Mack MJ. New techniques for percutaneous repair of the mitral valve. Heart Fail Rev. 2006;11:259e68. Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364:1395e406. Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med. 2018. https://doi.org/10.1056/NEJMoa1805374. Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018. https://doi.org/10.1056/NEJMoa1806640. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009;151(4):W65–9. https://sites.google.com/site/riskofbiastool/welcome/home/current-version-of-robins-i/robins-i-tool-2016. Last Accessed 4 Aug 2019. Armeni P, Boscolo PR, Tarricone R, et al. Real-world cost effectiveness of MitraClip combined with medical therapy versus medical therapy alone in patients with moderate or severe mitral regurgitation. Int J Cardiol. 2016;209:153–60. Asgar AW, Khairy P, Guertin MC, et al. Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients. J Med Econ. 2017;20:82–90. Giannini C, Fiorelli F, De Carlo M, et al. Comparison of percutaneous mitral valve repair versus conservative treatment in severe functional mitral regurgitation. Am J Cardiol. 2016;117:271–7. Giannini C, D’ascenzo F, Fiorelli F, et al. A meta-analysis of MitraClip combined with medical therapy vs. medical therapy alone for treatment of mitral regurgitation in heart failure patients. ESC Heart Fail. 2018;5(6):1150–8. Marmagkiolis K, Hakeem A, Ebersole DG, Iliescu C, Ates I, Cilingiroglu M. Clinical outcomes of percutaneous mitral valve repair with MitraClip for the management of functional mitral regurgitation. Catheter Cardiovasc Interv. 2019. https://doi.org/10.1002/ccd.28203. Enriquez-Sarano M, Akins CW, Vahanian A. Mitral regurgitation. Lancet. 2009;373(1382):1394. Franzen O, van der Heyden J, Baldus S, et al. MitraClip® therapy in patients with end-stage systolic heart failure. Eur J Heart Fail. 2011;13:569–76. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivar Behav Res. 2011;46(3):399–424. 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. Nishimura RA, Otto CM, Bonow RO, et al. 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. Circulation. 2017;135(25):e1159–95. Grayburn PA, Sannino A, Packer M. Proportionate and disproportionate functional mitral regurgitation: a new conceptual framework that reconciles the results of the MITRA-FR and COAPT trials. JACC Cardiovasc Imaging. 2019;12(2):353–62. Swaans MJ, Bakker AL, Alipour A, et al. Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high surgical risk patients. JACC Cardiovasc Interv. 2014;7:875–88.