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.

Figures

Figure 1
Figure 1
The top device is the XE2, used in TITAN. The bottom device is the modified XE2 (mXE2), used in TITAN II. Among other changes, the XE2 has a ‘ski-slope’ in the wireforms next to the end, not seen in the mXE2 (thin arrows). There is a little distance between the crimping tube of the proximal anchor and the locking loop of the mXE2 (thick arrow), not seen in the XE2. These helped to reduce the strain in the wireforms of the proximal anchor next to the end of the device, where the majority of the fractures occurred in TITAN.
Figure 2
Figure 2
Patient disposition in TITAN II. LTFU, lost to follow up.
Figure 3
Figure 3
Venogram and image of the Carillon device during attempted recapture and as left in situ, prior to release, and at 3-month follow-up. (A and B) Coronary sinus/great cardiac vein venogram showing a dynamic component of the vein at site where the proximal anchor was eventually deployed (straight arrows). Curved arrows show the small calibre vein site where the distal anchor was placed. (C) Distal anchor in the small calibre portion of the vein (curved arrow), during attempted recapture. The straight arrow shows buckling of the catheter. The distal anchor appears lower than the small calibre portion of the vein as it is being pulled down due to the tension in the system. (D) The tethered Carillon device in position for release, after the proximal anchor had previously been placed, locked and recaptured, and now redeployed without tension in the system, with the location at the site of the dynamic compression seen in A and B. Arrow points to proximal anchor. (E) Follow-up cine 3 months later shows fracture of the proximal anchor (arrow), at a different location than where fractures had been noted with the prior version of the device.
Figure 4
Figure 4
The 6MWT results showing improvement from baseline at 1, 6 and 12 months in patients receiving an implant (mean±SE of mean). Adjusted for correlation within repeated measures on the same participant and also adjusted for baseline value of the measure (ANCOVA). 6MWT, 6 min walk test; ANCOVA, analysis of covariance.
Figure 5
Figure 5
MR severity shown as proportion of patients in each MR grade at baseline, 1, 6 and 12 months. Core laboratory assessed. MR, mitral regurgitation.
Figure 6
Figure 6
Quantitative parameters of mitral regurgitation demonstrating improvements from baseline (mean±SE of mean). Adjusted for correlation within repeated measures (ANOVA). Core laboratory assessed. ANOVA, analysis of variance; EROA, effective regurgitant orifice area; MRJA/LAA, mitral regurgitation jet area divided by the left atrial area.
Figure 7
Figure 7
Plot of mitral annular (anterior–posterior) diameter at baseline, 1, 6 and 12 months, showing mean±SE of mean. Adjusted for correlation within repeated measures (ANOVA). Core laboratory assessed. ANOVA, analysis of variance.

References

    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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
    1. 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.
    1. 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
    1. 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
    1. 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
    1. 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

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