Transcatheter annuloplasty device reduces mitral regurgitation, improves quality of life

SAN FRANCISCO — An implantable mitral reconstruction device with an adjustable annuloplasty ring was found to be a feasible treatment approach for patients requiring mitral valve repair, according to data presented at the annual TCT Scientific Symposium.

In a multicenter European trial, the Cardioband Mitral Reconstruction System (Valtech Cardio) — a transfemoral, transseptal delivery system that recently earned CE mark approval — demonstrated safety comparable to other transcatheter mitral procedures.

“The Valtech Cardioband is a safe and easy-to-use device that helps to reduce functional mitral regurgitation in patients with [HF] and impaired left ventricular function,” Alec Vahanian, MD, head of the department of cardiology at Bichat Hospital in Paris, said in a news release. “Patients can receive early intervention with the Cardioband, meaning a better chance of [LV] remodeling and, thus, a higher probability of a successful clinical outcome.”

Alec Vahanian

Vahanian and colleagues evaluated 45 high-risk patients (mean age, 71 years; 34 men and 11 women; mean EuroSCORE II, 7%) with significant secondary mitral regurgitation enrolled at six sites. Overall, 87% of patients had moderate or severe HF based on NYHA functional classification with a mean LV ejection fraction of 32%.

Patients underwent a heart team evaluation, followed by echocardiography and cardiac CT screening. Echocardiographic data were analyzed by an independent core lab.

For primary endpoints, the investigators sought serious adverse events (death, MI, cardiac tamponade, device-related cardiac surgery and stroke), as well as technical success of implantation, feasibility of adjustment and ability to reduce mitral valve regurgitation.

Device implantation was feasible in all patients, and 96% of the patients achieved acute procedural success, defined as successful device implantation with an acute reduction of mitral regurgitation up to 2+, at 30 days.

During the same follow-up period, two deaths (4.4%) unrelated to the device occurred; one patient experienced hemorrhagic stroke and the other had elective mitral operation. No patients experienced MI or cardiac tamponade.

After device-cinching, the researchers observed an average 20% reduction of the septo-lateral diameter, from 39.16 mm to 34.17 mm (P < .01), and mitral regurgitation was 2+ or less in 95.6% of patients

At follow-up periods of 6 and 12 months, 80% (n = 25) and 71% (n = 20) of patients, respectively, experienced mild to no symptoms based on the NYHA functional classification, improved quality of life and continued mitral regurgitation up to 2+ (87% and 95%, respectively; P < .05 for both).

“In my experience, I have found the system is easy to learn due to a well-structured training,” Vahanian said in the release.

Amir Gross, Valtech Cardio founder and CEO, called the CE mark approval a significant milestone for the technology and patients with HF.

“The designation by the European regulatory body signifies that Cardioband is a safe treatment option for patients with mitral regurgitation, and recent clinical trial data demonstrate its efficacy,” Gross said in the release.

The research took first prize among the oral abstracts presented to the editors of Catheterization and Cardiovascular Interventions and EuroIntervention. – by Allegra Tiver

Reference:

Vahanian AS, et al. Up-to-1-year follow-up results of the transcatheter annuloplasty ring multicenter trial. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.

Disclosure: Vahanian reports no relevant financial disclosures.