New Device Lets TAVR Treat Aortic Regurgitation__Early Data Favor Newer-generation Device

Transcatheter aortic valve replacement (TAVR) with an updated version of the JenaValve appeared feasible in patients with severe aortic regurgitation who were at high surgical risk, according to early data.

Zero deaths were reported in the 30 days following transfemoral delivery of the self-expanding device among 12 such patients, Stephan Baldus, MD, of University Hospital Cologne, Germany, told the audience here at the annual EuroPCR conference.

By that time, eight out of ten patients had trace paravalvular leakage or none at all, and leaks were mild for the other two. Functional improvements were observed as well: patients went from two-thirds being classified as New York Heart Association (NYHA) Class III or IV at baseline to two-thirds in Class II and the rest in Class I.

“These data are remarkable. While [they] still need to be confirmed in a larger cohort, they do suggest that the TAVI [or TAVR] revolution may soon expand to a sizable population of patients with limited options. The JenaValve might be leading the way in that regard,” commented Mohamad Alkhouli, MD, of West Virginia University in Morgantown, who was not involved in the study.

Baldus and collaborators are working on a dual European-U.S. registry that will track outcomes in up to 100 high-risk patients with severe aortic insufficiency. What Baldus offered at EuroPCR was an early peek at the European arm.

“I hope that once the trials are over, we’ll have a transfemoral system to treat AR [aortic regurgitation],” he said.

The original transapical JenaValve received the CE mark, but has since been redesigned for transfemoral delivery. Among the changes are the switch from porcine root tissue to porcine pericardial tissue.

“The Jena valve is one of the first valves that [was] designed to tackle an undertreated population (i.e., patients with severe aortic insufficiency who are at high risk for surgery),” Alkhouli said in an email. “It has a unique ability to ‘clip’ the leaflet to anchor the valve in place,” instead of depending “on aortic calcifications for anchoring.

In the study, the 12 patients averaged age 75 years and 67% were women.

Operators went without post-dilatation in all cases. They spent 22 minutes on average from device sheath in to sheath out and 71 minutes from access open to access close. Due to one patient’s conversion to surgery (following major vascular complication during TAVR), the rate of technical success was 92%.

In terms of safety, there were no strokes and one new permanent pacemaker required. A quarter of patients had at least one VARC-2 event.

At 30 days, the cohort was left with gradients averaging 4.3 mm Hg and an effective orifice area of 2.4 cm². Left ventricular ejection fraction dropped slightly from 53% before TAVR to 49.3% at 30 days.

“The excellent clinical outcomes (albeit in a small number of patients) and short procedure times indicate this valve may become a very important addition to the management of patients with valvular heart disease,” commented Charanjit Rihal, MD, of the Mayo Clinic in Rochester, Minnesota, in an email.

“Although this is a small early study, the data are very encouraging, and give hope to thousands of patients with symptomatic aortic regurgitation,” he told MedPage Today.- MedPage Today