Mitral Annuloplasty with a Cardioband Device: Effective in Functional Mitral Regurgitation

Both surgical and medical treatment options for functional mitral regurgitation are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a new transvenous, transseptal direct mitral annuloplasty device. This work studied the safety and efficacy of this new device 6 months after implantation.

Thirty-one patients with moderate to severe mitral regurgitation associated with severe impairment of the left systolic ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled. All patients presented symptomatic heart failure.

The device was successfully implanted to all patients, and there were no peri-procedural deaths. The mortality rate at 1 month and at 7 months was 5% and 9.7%, respectively.

Cinching of the Cardioband device reduced the annular septolateral dimension by 30%, from 3.7 ± 0.5 cm at baseline to 2.5 ± 0.4 cm after 1 month and to 2.4 ± 0.4 cm after 6 months (p <0.001).

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The rate of patients with severe functional mitral regurgitation was reduced from 77.4% to 10.7% 1 month after the procedure (p <0.001) and 13.6% (p <0.001) at 7 months.

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The rate of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% at 7 months; exercise capacity as assessed by a 6-minute walking test increased, and quality of life (Minnesota Living With Heart Failure Questionnaire) was also improved.

Conclusion

In this feasibility trial in patients with functional mitral regurgitation, annuloplasty transcatheter device Cardioband was effective in reducing valve regurgitation, which was associated with improvement in heart failure symptoms and quality of life.

Original title: Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation 6-Month Results with the Cardioband Percutaneous Mitral Repair System.

Reference: Georg Nickenig et al. J Am Coll Cardiol Intv. 2016;9(19):2039-2047.

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