Could Balloon-Expansion Offer Benefits over Standard Valves?

This week has seen the American Association for Thoracic Surgery’s (AATS) 94th Annual Meeting in Toronto, Canada. Seemingly ubiquitous cardiovascular device company, Edwards Lifesciences has used the event to trumpet three-year clinical outcomes of its EDWARDS INTUITY valve platform, which demonstrated improved cardiac and valvular performance, as well as patient functional status.

Background

The Intuity Elite valve system combines a unique balloon-expandable frame with Edwards’ proven pericardial Perimount platform, which it says has demonstrated durability up to 25 years in published studies.

The new data come from the TRITON Trial, which involved six European centers and treated a total of 287 patients with the EDWARDS INTUITY platform between Jan. 2010 and Oct. 2012. Data were presented AATS event by Thorsten Wahlers, M.D., Ph.D., Hospital and Health Center for Heart and Thoracic Surgery, University Clinic, Cologne, Germany.

The interim analysis of 287 patients who underwent aortic valve replacement with the EDWARDS INTUITY platform included 138 that received the next-generation EDWARDS INTUITY Elite rapid-deployment valve. The EDWARDS INTUITY valve platform combines the proven Carpentier-Edwards PERIMOUNT design with a balloon-expandable, cloth-covered frame, which enables the use of fewer sutures during valve replacement surgery.

At three years, the study reported that rapid deployment aortic valve replacement using the EDWARDS INTUITY valve platform in patients with aortic stenosis was associated with beneficial outcomes including:

Statistically significantly hemodynamic performance improvement of the bioprosthetic valve, as indicated by a low aortic valve (AV) pressure gradient (mean 8.7 mmHg overall); and

Improved heart function, as demonstrated by a statistically significant reduction in left ventricular size over time (16 percent reduction in mean LV mass index).

So we’re left with the proposal that the balloon-expansion method, conceived to facilitate less invasive implantation of these valves, might just offer significant side benefits compared with conventional equivalents.

Physician comments 

“There is evidence from our experience that the expansion of the frame during valve implantation can potentially widen and reshape a narrowed left ventricular outflow tract, which directs blood flow into the aortic valve. This patient benefit was demonstrated in our study through clinically significant reductions in aortic valve mean pressure gradient and left ventricular size,” said Dr. Wahlers. “This design element also helped clinicians better select a valve size most appropriate for the patient, which can be a challenge with conventional valves, and enabled more efficient blood flow through the valve.”

Company comments

“We are pleased that these data demonstrated important advantages that were meaningful for patients, which is significant given that the EDWARDS INTUITY valve platform is built on the proven Carpentier-Edwards PERIMOUNT heart valve design and represents a new procedural approach to aortic valve surgery. We are continuing our launch of the EDWARDS INTUITY Elite valve in Europe, to provide a new treatment option for surgeons that is built on a surgical valve platform they trust,” said Donald E. Bobo, Jr., Edwards’ corporate vice president, heart valve therapy.

Source: Edwards Lifesciences Corporation, Market Wired

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