Novel transcatheter valve shows promise in real-world, high-risk patients

BARCELONA, Spain — The Direct Flow Medical transcatheter aortic valve, which is retrievable and repositionable, was shown to be safe and effective in real-world data that included patients with severe aortic stenosis at high-surgical risk.

“This study was performed in real-world, elderly, high-risk patients with severe aortic stenosis,” Stylianos A. Pyxaras, MD, study investigator with Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Germany, said during a press conference at ESC Congress. “Our results demonstrate low mortality rates at 30 days [with the Direct Flow Medical valve], and the comparison with the DISCOVER trial — which was the trial that introduced the Direct Flow Medical valve — found similar rates in early outcomes, safety and efficacy.”

The study involved 105 patients from an international, multicenter, prospective registry. Patients were aged 81 ± 4.9 years, 26.7% had chronic obstructive pulmonary disease/lung disease, 71.4% had NYHA class III or IV HF, and LV ejection fraction was 51.3 ± 13.1%.

According to Pyxaras, the aim was to assess the performance of the Direct Flow Medical transcatheter aortic valve in multicenter, real-world experience and to compare the findings with the DISCOVER trial.

The study’s primary endpoint — all-cause mortality at 30 days — was reported in 1.9% of patients compared with 1.3% in the DISCOVER trial population. Device success, as determined by VARC 2 criteria, was similar between studies (registry, 98.1% vs. DISCOVER, 93.3%; P=.103).

The composite safety endpoint — freedom from death, MI, stroke, stage 3 acute kidney injury and major vascular complications — was 89.5% in the real-world study compared with 91% in the DISCOVER trial population (P=.801).

Four patients experienced a major vascular complication defined according to the Valve Academic Research Consortium – 2 criteria.

The Direct Flow Medical valve (Direct Flow Medical) features a nonmetallic design with a pressurized support structure that allows for precise positioning, retrieval and assessment of valve performance prior to implantation. – by Brian Ellis

For more information:

Pyxaras SA. Abstract P5853. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Disclosure: Pyxaras reports receiving travel reimbursement from Direct Flow Medical.