麻豆传媒

PARIS -- A device that slices calcium bridges on valves affected by calcified aortic stenosis helped leaflet mobility in patients slated for transcatheter aortic valve replacement (TAVR), researchers reported from a case series.

Among 16 patients who had calcifications scored by the Leaflex Performer, followed by TAVR, improvements were observed over baseline:

• Aortic valve area increased from 0.7 to 1.2 cm² (P=0.001)
• Mean pressure gradient reduced from 34 to 18 mmHg (P=0.001)
• Peak to peak pressure gradient went down from 51 to 21 mmHg (P=0.001)

There was one non-cardiac death within 30 days and two non-embolic strokes -- one the result of a prolonged procedure and the other stemming from emergency surgery following left ventricular (LV) perforation, according to the presentation by Andreas Baumbach, MD, of England's Bristol Heart Institute, at the here.

Other complications of calcium scoring included one worsening aortic regurgitation and two conduction disturbances.

Baumbach told the audience that the procedure is "entirely different" from balloon valvuloplasty, where the stretching can produce immediate recoil, and for which the results usually don't last. With the Leaflex, he said, there's "no reason to think there's any recoil because nothing is stretched."

Session co-moderator Simon Redwood, MD, of St. Thomas Hospital in London, called the lack of embolic strokes in this series "impressive" as one might expect pieces to fly off during calcium scoring. (In fact, the embolic protection device used in all cases netted no large particles, Baumbach said in response.)

Yet Olaf Wendler, MD, of King's Health Partners in London, also warned of the risk of scarring that would lead to additional calcification in the years or months to come.

"We don't know what happens in the long run," Baumbach admitted. "Is this a procedure that will create a large aortic valve indefinitely? Probably not. But can it push out the next procedure for the next 2 to 5 years? Maybe yes. Maybe it will have a role in environments where a) TAVR is still prohibitively expensive, and b) in patients we don't want to implant a valve at that time."

He and fellow operators (at several centers in Europe and Israel) had opted for TAVR and general anesthesia "to provide a stable environment for hemodynamic testing and allow for necessary device iterations."

Performance and safety of the Leaflex were assessed by transthoracic and transesophageal echocardiography.

In 11 out of 16 cases, scoring was successfully performed and followed by TAVR. Two patients were left with greater-than-mild paravalvular leaks.

Patients averaged age 83.5 years and 69% were men. The cohort was roughly split between those in the New York Heart Association Class II (44%) and Class III (56%).

Operators only took people with tricuspid anatomy. They also excluded those with prohibitively large blocks of calcium, severe aortic regurgitation, and severely reduced left ventricular ejection fraction.

Baumbach also told attendees that the Leaflex has promise "as a standalone procedure [with] the potential to fill a gap and expand treatment options for patients with aortic stenosis. Clinical studies are planned for the evaluation of acute and long-term results following treatment with the Leaflex Performer."

"I think the technology is provocative but [a] very early stage to draw any hard and fast conclusions of what its role would be in the armamentarium of tools to treat aortic stenosis," commented Chandan Devireddy, MD, of Emory University School of Medicine in Atlanta. "Given that this was performed with a TAVR in the same setting and not as a standalone procedure also limits our ability to predict what its safety profile would be like in a broader setting."

No matter how attractive the concept, it will take a randomized trial against balloon valvuloplasty as a standalone therapy for Leaflex to demonstrate that it has safety and value, Devireddy told 麻豆传媒.

Comment