Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial
Janusz Lipiecki, Tomasz Siminiak, Horst Sievert, Jochen Müller-Ehmsen, Hubertus Degen, Justina C Wu, Christian Schandrin, Piotr Kalmucki, Ilona Hofmann, David Reuter, Steven L Goldberg, Michael Haude, Janusz Lipiecki, Tomasz Siminiak, Horst Sievert, Jochen Müller-Ehmsen, Hubertus Degen, Justina C Wu, Christian Schandrin, Piotr Kalmucki, Ilona Hofmann, David Reuter, Steven L Goldberg, Michael Haude
Abstract
Objective: Functional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR.
Methods: 36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant.
Results: There was 1 major adverse event within 30 days-a death (not device related)-occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study.
Conclusions: The modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.
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References
- Trichon BH, O'Connor CM. Secondary mitral and tricuspid regurgitation accompanying left ventricular systolic dysfunction: is it important, and how is it treated? Am Heart J 2002;144:373–6. 10.1067/mhj.2002.123576
- Trichon BH, Felker GM, Shaw LK et al. . Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure. Am J Cardiol 2003;91:538–43. 10.1016/S0002-9149(02)03301-5
- Patel JB, Borgeson DD, Barnes ME et al. . Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail 2004;10:285–91. 10.1016/j.cardfail.2003.12.006
- Strauss RH, Stevenson LW, Dadourian BA et al. . Predictability of mitral regurgitation detected by Doppler echocardiography in patients referred for cardiac transplantation. Am J Cardiol 1987;59:892–4. 10.1016/0002-9149(87)91114-3
- Blondheim DS, Jacobs LE, Kotler MN et al. . Dilated cardiomyopathy with mitral regurgitation: decreased survival despite a low frequency of left ventricular thrombus. Am Heart J 1991;122:763–71. 10.1016/0002-8703(91)90523-K
- Cabell CH, Trichon BH, Velazquez EJ et al. . Importance of echocardiography in patients with severe nonischemic heart failure: the second Prospective Randomized Amlodipine Survival Evaluation (PRAISE-2) echocardiographic study. Am Heart J 2004;147:151–7. 10.1016/j.ahj.2003.07.010
- Bursi F, Barbieri A, Grigioni F et al. . Prognostic implications of functional mitral regurgitation according to the severity of the underlying chronic heart failure: a long-term outcome study. Eur J Heart Fail 2010;12:382–8. 10.1093/eurjhf/hfq014
- Agricola E, Ielasi A, Oppizzi M et al. . Long-term prognosis of medically treated patients with functional mitral regurgitation and left ventricular dysfunction. Eur J Heart Fail 2009;11:581–7. 10.1093/eurjhf/hfp051
- Cioffi G, Tarantini L, De Feo S et al. . Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail 2005;7:1112–17. 10.1016/j.ejheart.2005.01.016
- De Servi S, Vaccari L, Assandri J et al. . Clinical significance of mitral regurgitation in patients with recent myocardial infarction. Eur Heart J 1988;9(Suppl F):5–9. 10.1093/eurheartj/9.suppl_F.5
- Grayburn PA, Appleton CP, DeMaria AN et al. . Echocardiographic predictors of morbidity and mortality in patients with advanced heart failure: the Beta-blocker Evaluation of Survival Trial (BEST). J Am Coll Cardiol 2005;45:1064–71. 10.1016/j.jacc.2004.12.069
- Junker A, Thayssen P, Nielsen B et al. . The hemodynamic and prognostic significance of echo-Doppler-proven mitral regurgitation in patients with dilated cardiomyopathy. Cardiology 1993;83:14–20. 10.1159/000175942
- Koelling TM, Aaronson KD, Cody RJ et al. . Prognostic significance of mitral regurgitation and tricuspid regurgitation in patients with left ventricular systolic dysfunction. Am Heart J 2002;144: 524–9. 10.1067/mhj.2002.123575
- Tada H, Tamai J, Takaki H et al. . Mild mitral regurgitation reduces exercise capacity in patients with idiopathic dilated cardiomyopathy. Int J Cardiol 1997;58:41–5. 10.1016/S0167-5273(96)02839-2
- Schofer J, Siminiak T, Haude M et al. . Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation 2009;120:326–33. 10.1161/CIRCULATIONAHA.109.849885
- Siminiak T, Wu JC, Haude M et al. . Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail 2012;14:931–8. 10.1093/eurjhf/hfs076
- Siminiak T, Firek L, Jerzykowska O et al. . Percutaneous valve repair for mitral regurgitation using the Carillon Mitral Contour System. Description of the method and case report. Kardiol Pol 2007;65:272–8; discussion 279.
- Topilsky Y, Vaturi O, Watanabe N et al. . Real-time 3-dimensional dynamics of functional mitral regurgitation: a prospective quantitative and mechanistic study. J Am Heart Assoc 2013;2:e000039 10.1161/JAHA.113.000039
- Braun J, Klautz RJ. Mitral valve surgery in low ejection fraction, severe ischemic mitral regurgitation patients: should we repair them all? Curr Opin Cardiol 2012;27:111–17. 10.1097/HCO.0b013e32834fec29
- 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. 10.1093/eurjhf/hfr029
- Young JB, Abraham WT, Smith AL et al. . Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA 2003;289:2685–94. 10.1001/jama.289.20.2685
Source: PubMed