Can Fracturing Calcium Deposits Clear a Path, Delay TAVR?

Patrice Wendling

May 29, 2019

PARIS — A percutaneous device that scores calcium deposits in aortic valve leaflets had a substantial effect on aortic valve area in patients scheduled for transcatheter aortic valve replacement (TAVR) in a small feasibility study.

Use of the Leaflex Performer catheter (Pi-Cardia) in 16 patients increased aortic valve area (from 0.7 to 1.2 cm2) and lowered both the mean pressure gradient (from 34 to 18 mm Hg) and peak-to-peak pressure gradient (51 to 21 mm Hg; P = .001 for all).

The transfemoral device scores the leaflets to create multiple fractures at specific areas of valve calcification. These gaps between the calcium deposits potentially increase leaflet flexibility while preserving the ventricular tissue of the native valve, according to investigators.

Andreas Baumbach

"The first series was planned in the context of TAVR and general anesthesia to provide a stable environment for hemodynamic testing and allow for necessary device iterations," explained lead investigator Andreas Baumbach, MD, Queen Mary University of London and Barts Heart Center, London. "Where is this going? I think the Leaflex as a stand-alone procedure has the potential to fill a gap and expand treatment options for patients with aortic stenosis."

He noted that they were selective in this early group, screening all patients with CT and excluding those with "prohibitively large calcium blobs" on the leaflets. The 16 patients (mean age, 83.5 years; 69% male) had degenerative calcified aortic stenosis, a mean baseline pressure gradient of 40 cm2, and left ventricular ejection fraction of 57.8%. Embolic protection (Sentinel) was used in all cases.

The Leaflet Performer was successfully introduced using a 16F sheath without pacing in all patients. Scoring was performed in 11, with a device iteration after four cases fixing an expansion issue.

"The device is very reminiscent of the first-generation self-expanding valves in the way it goes through the arch," Baumbach told attendees at the Congress of the European Association of Percutaneous Cardiovascular Intervention 2019. "There was no problem bringing it into position. The procedure itself, overall, probably takes 20 minutes; the scoring itself 3 seconds."

He noted that the current iteration comes in one size, allowing for annulus diameters between 23 and 26 mm, but the next generation will come in three sizes and be able to cut through larger "chunks" of calcium.

"The current device design is strictly for tricuspid [valves]. But there's no reason — and there's actually a plan — why a different design shouldn't be specific for bicuspid and should actually open up the bicuspid environment, either as an alternative procedure or to improve the final implantation of a TAVI prosthesis," Baumbach said.

As to its safety, there was one noncardiac death not related to the procedure at 16 days and two nonembolic strokes: one the result of a prolonged procedure and the other related to emergency surgery after perforation of the left ventricle. No large particles were captured in the Sentinel devices, he said.

Session comoderator Simon Redwood, MD, St. Thomas' Hospital, London, said the lack of embolic strokes in the series was "impressive" given that pieces of calcium might spin off during scoring.

Panelist Olaf Wendler, MD, professor of cardiac surgery, King's College London, said the technology differs from decalcification using balloon aortic valvuloplasty (BAV), but cautioned that scoring may create more inflammation and scarring.

"We will see what happens, but the other question I have is, where do you see this device going?" Wendler said. "Do you think that will replace TAVRs in the future?"

"Your comment and question go hand in hand," Baumbach replied. "We don't know what happens in the long run. Is this a procedure that will create a large aortic valve area indefinitely? Probably not. But can it push out the next procedure for 2, 3, 4, 5 years? Maybe yes. And in this case, this procedure will have a role, of course, in environments where TAVI is still prohibitively expensive and in patients in whom we don't want to implant a valve at that point in time."

Commenting further to | Medscape Cardiology, Wendler said: "With the current age of patients around 75 to 80 years, I don't think that a delay of treatment is in any way positive."

"It all depends on how high the risk of complications, such as cerebral embolizations, will be," he added. "We stopped doing pre-TAVI balloon aortoplasties because they created a risk of cerebral embolization. This risk was removed when we introduced non-BAV TAVI procedures."

Baumbach reports institutional research support from Abbott Vascular and consulting/speaker fees from AstraZeneca, Sinomed, Microport, Abbott Vascular, Cardinal Health, and KSH.

Congress of the European Association of Percutaneous Cardiovascular Intervention (EuroPCR) 2019. Presented May 22, 2019.

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