SAN FRANCISCO, CA — Data from a review presented today at TCT 2013 should serve as a reminder to operators of what they can do to avoid what has emerged as a key predictor of poor outcomes following transcatheter aortic-valve replacement (TAVR): paravalvular aortic regurgitation.

Aortic regurgitation is a frequent complication following TAVR, and multiple studies have shown it is associated with an increased risk of mortality, as reported by heartwire . In the present analysis, researchers stressed that the use of an undersized aortic valve remains a key factor significantly associated with an increased risk of paravalvular regurgitation and recommended 3D imaging for accurately sizing the device.

"There are so many studies that show that undersizing the valve is the problem," said Dr Samir Kapadia (Cleveland Clinic, OH) said during the weeklong meeting that kicked off here on Sunday. "So you have to have a 3D assessment of the valve, of the annular size. And when you say the annular size, it is the aortic valve at rest. It's also not necessarily just the annulus, but the [left ventricular outflow tract] LVOT and the sinuses. You need to understand the whole apparatus to determine exactly where you're going to put the valve. That will [also] determine the risk of annular rupture and the risk of [needing a] pacemaker."

In addition, the presence of aortic-valve calcification, specifically calcification in the aortic annulus, is also associated with aortic regurgitation following TAVR. The depth of the valve implantation is another factor significantly associated with an increased risk, according to Kapadia.

Presenting data today during a session on aortic-valve therapies, Kapadia highlighted a previous review of 12 926 patients treated with TAVR. Of these, 40% received the Medtronic CoreValve and 56.3% received the Edwards Sapien or Sapien XT valve. More than one in 10 patients who received a device developed moderate or severe aortic regurgitation, and almost 50% of patients developed trivial or mild regurgitation. In the subgroup analysis, moderate or severe aortic regurgitation was reported in 16.0% of patients treated with CoreValve and 9.1% of those with the Edwards device.

In that analysis, moderate or severe aortic regurgitation was associated with a threefold higher risk of death at 30 days and a more than twofold higher risk of death at one year.

During the TCT meeting, Kapadia told the audience that operators have options if aortic regurgitation occurs following TAVR. One such option is to postdilate the valve, although there are some data to suggest that postdilation is associated with an increased risk of the patient later needing a pacemaker and a risk of neurological events.  The placement of a second valve inside the first—the so-called valve-in-valve procedure—can help eliminate paravalvular aortic regurgitation.

"The downside is that even after good judgment, we still see aortic regurgitation," said Kapadia. The best way to avoid it, he added, is to accurately measure the aortic annulus.

Following the session, Dr Jonathon Leipsic (University of British Columbia, Vancouver) highlighted the role of computed tomography for such accurate measurements. He agreed with Kapadia, telling the audience that "paravalvular regurgitation is common, and paravalvular regurgitation is also bad." Leipsic said there are difficulties in sizing the annulus with 2D echocardiography, the traditional means of measurement.

Earlier this year, in a story reported by heartwire , the Society of Cardiovascular Computed Tomography (SCCT) issued a consensus statement on the use of CT imaging before TAVR except in patients where such imaging is contraindicated.


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