Cardioband Transcatheter Mitral Annulus Repair Appears Safe, Effective in Functional MR

CHICAGO, IL—One-year results for the first 50 patients with functional mitral regurgitation treated using a Cardioband for transcatheter mitral annulus repair suggest that the procedure and the device are safe and lead to meaningful and durable improvements in mitral regurgitation (MR) grade, with corresponding improvements in heart function.

Karl-Heinz Kuck, MD (Asklepios Klinic St. Georg, Hamburg, Germany), presented results from the early feasibility trial this week at the American College of Cardiology 2016 Scientific Sessions. While his data covered the first 50 patients—an incremental update to what was previously presented at TCT 2015—the number of treated patients is now 86.

Cardioband (Valtech) is a partial annuloplasty ring, delivered transfemorally with transseptal puncture under echo guidance. CT is used prior to the procedure to size the ring, and fluoroscopy is used to guide the delivery catheter. The implant is positioned and deployed supra-annularly, much like surgical rings, using a series of repositionable screws to anchor the ring in place. After deployment, a second sizing tool is introduced over the wire to reshape and cinch the device under echo guidance until the desired degree of annular resizing is achieved.

The device was granted CE Mark based on early results in these 50 patients treated at six centers in three European countries.

An Option for Patients Passed Over for Surgery?

Medically managed MR patients have poor outcomes, with 1-year mortality in the range of 20%, and 5-year mortality reaching 50%. Heart failure hospitalization rates are also high, reaching 90% at 5 years, Kuck said. “We know that many of these patients are not undergoing surgical correction, despite the fact that it has been shown that MR in this population is associated with poor outcome.”

To be included in the study, patients had to have symptomatic heart failure (NYHA class II-IV), including CRT if needed; an LVEF ≥ 25%, a left ventricular end diastolic diameter ≤ 70, and moderate to severe functional MR. Finally, patients had to be high-risk candidates for surgery, based on the opinion of both a cardiac surgeon and an interventional cardiologist. At baseline, nearly three-quarter of the patients in the series had MR grade 3 or higher by core lab evaluation, and nearly 90% had NYHA class III or IV. Mean STS score was 7.2% (EuroSCORE II 7.7%), and mean age was 71.

The 30-day event rate was low, Kuck said. Two patients died, although neither death was deemed directly related to the device or procedure (one patient was converted to mitral valve surgery after unsuccessful device positioning and died within days of the surgery). Two patients suffered renal failure, one patient had a TIA, one patient had major bleeding complications, and one patient suffered cardiac tamponade. Septal-lateral diameters were significantly reduced, from a mean of 39 mm to 34 mm post-procedure.

“I do believe that for the initial experience, first-in-man, it was really remarkable that the complication rate was so low,” Kuck observed.

By 12 months, among the 20 patients alive and available for follow-up, both 6-minute walk test and heart failure quality of life score (by Minnesota Living with Heart Failure Questionnaire) had significantly improved. NYHA class had improved such that 71% of patients were in class I or II heart failure. A full 90% had MR grade ≤ 2+.

“Transcatheter surgical annuloplasty is feasible, with a safety profile similar to equivalent transcatheter procedures,” Kuck concluded. “The procedure results in significant and consistent reduction in septal-lateral annular dimensions, with significant and consistent reduction in MR.”

Importantly, he added, the procedure leaves open all options for future mitral valve interventions, surgical or otherwise.

Speaking with TCTMD after his talk, Kuck stressed that he’d tried out a range of transcatheter annuloplasty rings attempting to break into this market and in his opinion, “there is no other device that can reproduce what the Cardioband has done.”

He acknowledged that surgical annuloplasty is a procedure that has been largely abandoned by surgeons as a stand-alone procedure, but said he believes the Cardioband differs in that the 6-mm long anchors used to position and cinch the device “go deep into the left ventricular myocardium,” unlike surgical devices which tend to be sutured towards the supra-annular part of the left atrium.

“So we think, if we cinch with this device and we adapt based on the amount of effect that we see, we do not only cinch the annulus, but we also cinch the basic parts of the left ventricle” Kuck explained. “So that leads to a significantly different effect than if you just superficially cinch the annulus itself, without any effect on the base of the left ventricle.”

Some experts believe that full or partial annuloplasty devices might be able to improve on results with the MitraClip (Abbott Vascular), which itself mimics a surgical edge-to-edge valve leaflet repair. MitraClip is currently approved for use in patients with degenerative repair and while it is being increasingly used, particularly in Europe, for functional mitral regurgitation, results from the COAPT, MITRA-FR, and MATTERHORN trials investigating MitraClip in this setting are still at least a year off.

“If you look into the data from Dr. Alfieri who introduced the clip-like procedure in surgery, [known as] the edge-to-edge procedure, the results were even better if this procedure was combined with a ring,” Kuck said. He and his coauthors have not yet done a planned combination clip-and-band procedure, but they have used MitraClip in a patient who had a partial detachment of a Cardioband and “they went perfectly well together.”

“I would expect to see even better results if the procedures were done in combination,” Kuck said, predicting that this may happen down the road. The primary barriers are procedure time—the Cardioband procedure takes approximately 85 minutes, he noted—as well as price. The costs of both devices currently are very high, he noted. To combine both at this point in time at least within the German healthcare system, where both are currently approved, “would be extremely challenging,” Kuck commented.

Session moderator Sunil Rao, MD (Duke University, Durham, NC), commenting on the early results for TCTMD, pointed to the tremendous number of devices currently vying for success in the mitral space. “I think there is a lot of enthusiasm for these devices, but to some extent I think the enthusiasm is outpacing the available data.”

CE Mark on the basis of preliminary outcomes in 50 patients is somewhat disquieting, he suggested. “Overall it’s a very positive thing to have more technology in the mitral space, because we do need more options. We just need to be a little bit careful about how enthusiastic we are about those devices without having the kind of data that you would expect for something like this,” that would need to follow the full Class III pathway for regulatory approval in the United States. For this, Rao said, “US clinicians would expect something more robust than 1-year results in 50 patients.”

Related Stories:  

• Will the MitraClip and Other Gadgets Make Headway in Functional MR?
• Early Results for Transcatheter Mitral Valve Replacement Reveal Complications and Challenges for the Long Road Ahead
• Cardioband Shows Benefits for Secondary Mitral Regurgitation