麻豆传媒

The Sapien 3 Ultra delivered on its promise to reduce paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR), according to registry data.

The discharge echocardiogram showed patients leaving the hospital with the same mean gradient of 11.9 mm Hg whether they had received the Sapien 3 or the Ultra, reported Tamim Nazif, MD, of New York-Presbyterian/Columbia University Medical Center in New York City.

With the Ultra, aortic valve areas were larger (1.90 vs 1.79 cm², P<0.01), and more patients were left with no paravalvular regurgitation (90.0% vs 85.7%, P<0.01), Nazif reported in a presentation at the Transcatheter Valve Therapy (TVT) virtual meeting.

"The current study is the largest available analysis of TAVR outcomes with the balloon-expandable Sapien 3 Ultra valve and demonstrated excellent clinical outcomes at 30 days," he stated.

Sapien 3 Ultra was designed with a 40% taller outer skirt on the Sapien 3 frame to reduce PVR. The newer device was FDA approved in late 2018 (with relatively few data) and got an expanded indication to treat low-risk patients in 2019.

From the , Nazif's group had identified 40,740 patients who underwent elective TAVR with these devices in 2019-2020. They excluded alternative access and valve-in-valve cases.

Propensity matching yielded 1,324 matched pairs for comparison between Sapien 3 Ultra and Sapien 3 recipients. Baseline characteristics were similar between groups (average age almost 80; 44% men; 4.4% STS risk score).

Operators opted for similarly sized Sapien 3 and Ultra valves. Patients in the Ultra group had shorter procedures (75.3 vs 81.7 minutes, P<0.01) and required less fluoroscopy time (13.2 vs 14.7 minutes, P<0.01), according to Nazif.

The reduction in procedural time is striking, said David Cohen, MD, based in Kansas City, Missouri, during the discussion.

Nazif speculated that the difference could be attributed to a reduction in post-dilation with the newer valve.

Ultra and Sapien 3 groups shared similar 30-day clinical outcomes such as all-cause mortality (0.9% vs 1.3%), stroke (1.2% vs 1.7%), and new pacemakers including those in people with implants at baseline (6.0% vs 5.7%).

Although the rate of coronary obstruction was low at 0.1% in this experience, it is nevertheless a potential drawback of the Ultra's taller skirt, commented J. Dawn Abbott, MD, of Warren Alpert Medical School of Brown University in Providence, Rhode Island, during the discussion.

Nazif's response was that the taller skirt still doesn't come up to the level where the coronary arteries typically are, and wouldn't be expected to cover the outflow.

The higher skirt may pose other issues in valve-in-valve TAVR, Abbott said.

"That's an area where the benefit of the Ultra may be attenuated," Nazif agreed.

He acknowledged the possibility of residual confounding in the observational study. When both Sapien 3 and Ultra valves were commercially available, operators did their cases with the newer device, he said.

Moreover, TVT registry data were site-reported, and there was no independent adjudication of PVR.

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