Transcatheter aortic valve replacement (TAVR) using the next-generation, self-expanding transcatheter heart valve (THV) system is safe and effective for treating older patients with severe aortic stenosis who are at an increased operative risk, according to a study published Aug. 7 in the Journal of the American College of Cardiology.

The FORWARD trial, led by Eberhard Grube, MD, PhD, et al., included 1,038 patients with severe aortic stenosis who underwent attempted THV implantation at 53 centers in 20 countries between January 2016 and December 2016. A novel feature of the THV is a resheathing ability for repositioning or full recapturing and retrieval. This was used in 265 patients (25.8 percent) to achieve accurate positioning of the valve.

The mean aortic valve gradient was significantly reduced from 41.7 ± 16.1 mm Hg at baseline to 8.5 ± 5.6 mm Hg at discharge. The mean effective orifice area was 0.8 ± 0.3 cm2 at baseline and 1.9 ± 0.6 cm2 at discharge. Most patients (67.1 percent) had no or only trace aortic regurgitation, and 30.9 percent had mild, 1.8 percent had moderate and 0.1 percent had severe aortic regurgitation at discharge. At 30 days, the all-cause mortality rate was 1.9 percent and 1.8 percent of patients had a disabling stroke. The expected-to-observed early surgical mortality ratio was 0.35.

While the study only examined 30-day outcomes, the researchers write that they believe it reflects contemporary TAVR practice and that the use of an independent clinical event committee and echocardiographic core laboratory strengthen the validity of the data.

In an accompanying editorial comment, Christian Hengstenberg, MD, and Oliver Husser, MD, PhD, ask if the FORWARD study is taking us forward in daily clinical practice.

"Yes and no," they write. "Yes, because it offers large-scale clinical data on a promising THV with very good valve performance. No, because the opportunity to provide important VARC-2–defined endpoints has been missed. The way forward requires randomized comparisons to determine the true comparative effectiveness of each THV in our armamentarium. This will enable us to better customize THV therapy, and ultimately, to offer better care to our patients."

Keywords: Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement, Aortic Valve, Research Personnel, Aortic Valve Stenosis, Echocardiography, Stroke

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