Last year, the Cardioband mitral reconstruction system (Valtech) was approved in Europe for mitral valve repair. It joins MitraClip (Abbott Vascular) as one of the few options available for patients with mitral regurgitation who are unable to undergo surgery because of a high risk of complications. Francesco Maisano (Klinik für Herz- und Gefässchirurgie, UniversitätsSpital Zürich, Zürich, Switzerland), reviews the available data for the system.
Why are non-surgical approaches for mitral valve regurgitation needed?
Although surgery is very effective for treating mitral regurgitation, a large portion of patients are not eligible for surgery because of a high risk profile. This is very often the case in patients with functional mitral regurgitation. Less invasive treatments, therefore, have the potential to improve quality of life in these patients.
How does the Cardioband system work?
The Cardioband is a surgical grade annuloplasty ring implanted with a catheter-based approach. The device is delivered by a sophisticated multi-steerable catheter, under 3D echocardiographic and fluoroscopic guidance. The device is fixated to the annulus with a series of anchors, working in the left atrium, with no impact on haemodynamics. In my experience, the procedure is very well tolerated by patients with very severe left ventricular dysfunction. As the device is implanted, it can be contracted under echo guidance to reduce the annular dimensions and improve mitral regurgitation.
In my view, the great advantage of Cardioband compared with surgery is the fact that it is performed on the beating heart, without cardioplegia, and the amount of annular reduction is titrated by live echo.
What data are available for the system?
It has been implanted in more than 80 patients in Europe. Data from 50 patients enrolled in the CE mark safety and feasibility trial are available, and these show that system is efficacious with reduction of mitral regurgitation to the same degree to that of surgical annuloplasty.
What are the potential advantages and disadvantages of the system compared with other percutaneous approaches (eg. MitraClip)?
MitraClip is today the most commonly performed percutaneous procedure; therefore a direct comparison is not appropriate. However, it makes sense to compare the repair techniques. Annuloplasty has the advantage of less aggressive changes on mitral anatomy compared with how MitraClip repairs the mitral valve. Thus, Cardioband has the potential to be used for patients with less severe mitral regurgitation—particularly in patients in the early stages of heart failure. Being totally implanted supra-annular, Cardioband’s associated risk for leaflet lesions are minimal, so that it is almost impossible to make the mitral regurgitation worse than it was prior to the procedure. Finally, unlike MitraClip, the system leaves the option for transcatheter mitral replacement open.
However, as the experience progresses, there are more opportunities for complementary use rather than for a real competition between the two devices. While I believe Cardioband will work better in patients with prevalent annular dilatation, I think MitraClip may be more effective in patients with predominant leaflet tethering. A combined use is not only possible but could be very beneficial in selected patients. Compared with other percutaneous annuloplasty devices, Cardioband is the only that realistically reproduces surgical annuloplasty and the only one is associated with the realistic expectation to reproduce surgical outcomes.
Which patients would you consider using the system in?
Today, Cardioband is mainly indicated in patients with functional mitral regurgitation; however, it is possible to foresee its application in patients with degenerative mitral regurgitation, in combination with leaflet repair
Why do think there are so few percutaneous devices available for the mitral valve compared with those available for the aortic valve?
The mitral valve is more complex and, therefore, it took more time to develop technologies and to learn the procedures. However, the speed of development has had a strong acceleration.
What is your view of the developing field of transcatheter mitral valve implantation (TMVI)?
TMVI has been already implanted in man. What is clear from this experience is that the risk profile associated with TMVI procedures is much higher than is associated with repair. I think TMVI will remain a solution reserved to patients who will not be good responders to repair.
