CHICAGO (FRONTLINE MEDICAL NEWS) – One-year results of a pivotal European trial of the percutaneous Cardioband mitral valve reconstruction system show a stable, consistent, and clinically meaningful reduction in mitral regurgitation coupled with significant quality of life improvements and a safety profile equivalent to that of other transcatheter valve procedures.

“The results are quite impressive. Ladies and gentlemen, I can tell you that I’ve used almost all the devices for direct and indirect annuloplasty, and this is the only device that works in a reproducible fashion,” Dr. Karl-Heinz Kuck said at the annual meeting of the American College of Cardiology.

He presented the results for the first 50 patients to reach 12 months of follow-up after undergoing the Cardioband procedure in a multicenter prospective study in which participants served as their own before-and-after controls. On the strength of these results, the Cardioband device has been approved by European Union regulatory authorities for the nonsurgical treatment of symptomatic moderate to severe secondary, or functional, mitral regurgitation. In Germany, the Cardioband procedure is now routinely reimbursed at a level similar to that of the MitraClip, according to Dr. Kuck, president of the German Cardiac Society and head of cardiology at St. Georg Hospital in Hamburg, Germany.

The Cardioband procedure essentially entails percutaneous implantation of an adjustable surgical ring designed to remodel a severely dysfunctional mitral valve by repairing the valve annulus. The implantation procedure features transfemoral venous access, which the TAVR experience has shown to be safer than transapical access. As in surgery, the percutaneous procedure utilizes supra-annular fixation. And it accomplishes a significant reduction in annular dimensions, comparable to what is achieved with a size 28 surgical ring.

“And the most important thing: Because we are not interfering with the leaflets or any other part of the mitral valve, the procedure leaves all options open for the future by preserving the native anatomy,” Dr. Kuck noted.

The procedure entails a transseptal puncture, insertion of the system, deployment of the implant, and adjustment of its size by cinching it down under echocardiographic guidance in order to reduce the septolateral valve dimension. The whole thing takes about 75 minutes.

The connection of the implant to the annulus is achieved in sutureless fashion using a series of screw-in anchors.

All 50 participants in the consecutive series were deemed by a heart team to be at unacceptably high surgical risk. They averaged 71 years of age, with an left ventricular ejection fraction of 33% and a left ventricular end diastolic diameter of 61 mm. Among them, 31 had ischemic heart disease, 11 had chronic obstructive pulmonary disease, 38 were in moderate or severe renal failure, 39 had atrial fibrillation, 12 had severe pulmonary hypertension, and 16 had previously undergone CABG surgery.

The 30-day safety adverse events consisted of one hemorrhagic stroke, a single major bleeding complication, two cases of acute renal failure, and one of cardiac tamponade. There were no MIs, and neither of the two deaths were related to the procedure.

In terms of efficacy, at baseline three-quarters of patients had grade 3-4 mitral regurgitation (MR). At discharge that was true for only 12%. At 1 year of follow-up, 90% of subjects had MR grade 2 or less, and roughly two-thirds of patients had MR grade 0-1.

The procedure did what it was designed to do: The mean valve septolateral dimension decreased by 30%, from 37 mm at baseline to 26 mm at discharge.

Dr. Kuck provided 6-month data on functional improvement. The mean 6-minute walk distance improved from 262 to 339 meters. At baseline, 87% of subjects were NYHA class III or IV; at 6 months, 77% were NYHA class I or II. Scores on the Minnesota Living with Heart Failure Questionnaire improved from a mean of 39 to 16 at follow-up.

A much larger European postmarketing commercial use study of the Cardioband system is now underway.

The Cardioband procedure addresses a major unmet need, Dr. Kuck observed. More than 4 million patients in the United States alone have mitral valve disease. When medically managed, patients with severe secondary mitral regurgitation have a poor prognosis, with 1- and 5-year mortality rates of 20% and 50%, and an extremely high rate of rehospitalization for heart failure. And yet multiple surveys have shown only a minority of these patients undergo surgery.

Discussant Dr. Spencer B. King III called the transcatheter mitral valve reconstruction system “quite fascinating.” He wondered what happens if the operator accidentally grabs the nearby circumflex artery with one of the device anchors. The answer, Dr. Kuck replied, is that the anchors can be unscrewed and repositioned at any point during the procedure.

Dr. King, president of the Heart and Vascular Institute at Saint Joseph’s Health System in Atlanta, has developed several devices widely used in interventional cardiology. He shook his head in amazement at the speed at which the European regulatory agency operated in this case, noting that EU marketing approval for the Valtech Cardioband device was granted and a payment structure was almost immediately established on the basis of a 50-patient, first-in-man study.

“The data are very consistent. I think that‘s what made the difference,” Dr. Kuck said.

The study was funded by Valtech. Dr. Kuck reported serving as a consultant to Biosense Webster, Edwards, and St. Jude, and on a speakers’ bureau for Medtronic.