Registry Outcomes Match Positive Trial Findings for Repositionable TAVR Device

BARCELONA, Spain—The Direct Flow Medical transcatheter aortic valve system appears to work as well in a real-world setting as it did in the trial supporting its approval in Europe, with similar 30-day outcomes seen in a multicenter registry, according to a study presented on August 31, 2014, at the European Society of Cardiology Congress.

On average, the registry patients were slightly younger than those in the trial (81 vs 83 years, P = .013), but had a poorer risk profile, including higher rates of COPD/lung disease (26.7% vs 12%; P = .024) and NYHA class III or IV symptoms (71.4% vs 54.7%; P = .027) and a lower left ventricular ejection fraction (51.3% vs 56.1%; P = .005). 

But despite the difference in risk, all-cause mortality (primary endpoint) and other outcomes occurred at similar rates in the registry and trial through the first 30 days (table 1).

Table 1. 30-Day Outcomes

^aFreedom from death, MI, stroke, stage 3 acute kidney injury, and major vascular complications.

Confirming the high rate of device success seen in the DISCOVER trial, there was a problem with implantation for only one of the registry patients, who had to be treated with a different device. 

“The results suggest that the [Direct Flow Medical] valve appears to be a valuable addition to conventional [TAVR] methods in patients with severe aortic stenosis,” Dr. Pyxaras said in a press release. “However, our results are only hypothesis-generating and should be confirmed in larger, randomized trials.”

Note: Study co-author Antonio Colombo, MD, is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD. 
 

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