Real-World Results Support Direct Flow Medical's TAVR System

August 31, 2014—The European Society of Cardiology (ESC) announced that a study presented by Stylianos Pyxaras, MD, at the ESC Congress 2014 demonstrated that the Direct Flow Medical, Inc. retrievable and repositionable transcatheter aortic valve replacement (TAVR) system is effective and safe in a real-world setting. 

“TAVR is well established as a percutaneous treatment option in patients with severe aortic stenosis, in whom surgery carries a high risk and is often prohibited,” commented Dr. Pyxaras in the ESC announcement. He added, “The Direct Flow Medical prosthesis can be retrieved and repositioned before permanent implantation and allows enhanced control during the implantation procedure. The CE Mark DISCOVER study previously showed high efficacy and safety rates of the Direct Flow Medical valve in patients with severe aortic stenosis, but until now, this experience had not been confirmed in a real-world setting.”

According to the ESC, the current study assessed early safety and device success in an international, multicenter, prospective registry. The study prospectively enrolled 105 patients who had severe aortic stenosis and were defined as high risk using the EuroSCORE. All patients underwent TAVR with the Direct Flow Medical valve. The findings were compared with the DISCOVER trial population results. 

The study’s primary endpoint of all-cause mortality at 30 days was observed in only two patients (1.9%). Success of the device, as defined by the VARC-2 (Valvular Academic Research Consortium) criteria, was similar in the real-world experience when compared to the DISCOVER trial population (98.1% vs 93.3%, respectively; P = .103). Major vascular complications that required intervention by a vascular surgeon were observed in three cases.

The combined patient safety event endpoint was similar between the two cohorts (89.5% in the current trial vs 91 % in DISCOVER; P = .333). Ten patients (9.5%) underwent permanent pacemaker implantation due to postprocedural persistent advanced atrioventricular block compared to 17% in the DISCOVER trial (P = .148). The observed rate of residual moderate aortic regurgitation was very low in the current patient population at 1.9%, reported the ESC.

Dr. Pyxaras concluded, “We observed—for the first time in a real-world setting—high device success and early safety rates with the Direct Flow Medical prosthesis. The observed trend towards a higher device success rate compared to DISCOVER could be because cardiologists had more experience with the technique, since some of the centers in our study also participated in the CE Mark trial.” He noted, “The device has two unique features—it can be retrieved and repositioned. These characteristics guarantee enhanced control during positioning and may be responsible for the low rates of postimplantation aortic regurgitation."