The Sapien 3 Ultra delivered on its promise to attenuate paravalvular regurgitation (PVR) after transcatheter aortic valve change (TAVR), in step with registry data.
The discharge echocardiogram showed patients leaving the successfully being facility with the identical point out gradient of 11.9 mm Hg whether or not they had purchased the Sapien 3 or the Ultra, reported Tamim Nazif, MD, of Novel York-Presbyterian/Columbia College Clinical Center in Novel York City.
With the Ultra, aortic valve areas enjoy been elevated (1.90 vs 1.79 cm2, P<0.01), and extra patients enjoy been left with out a paravalvular regurgitation (90.0% vs 85.7%, P<0.01), Nazif reported in a presentation at the Transcatheter Valve Therapy (TVT) virtual assembly.
“Basically the most popular glance is largely the most appealing on hand evaluation of TAVR outcomes with the balloon-expandable Sapien 3 Ultra valve and demonstrated preferrred medical outcomes at 30 days,” he said.
Sapien 3 Ultra used to be designed with a 40% taller outer skirt on the Sapien 3 body to attenuate PVR. The more recent instrument used to be FDA licensed in dreary 2018 (with somewhat few data) and purchased an expanded indication to address low-likelihood patients in 2019.
From the STS/ACC TVT Registry, Nazif’s neighborhood had identified 40,740 patients who underwent elective TAVR with these devices in 2019-2020. They excluded change to find entry to and valve-in-valve circumstances.
Propensity matching yielded 1,324 matched pairs for comparison between Sapien 3 Ultra and Sapien 3 recipients. Baseline characteristics enjoy been identical between groups (moderate age practically 80; 44% males; 4.4% STS likelihood get).
Operators opted for in a similar method sized Sapien 3 and Ultra valves. Patients within the Ultra neighborhood had shorter procedures (75.3 vs 81.7 minutes, P<0.01) and required much less fluoroscopy time (13.2 vs 14.7 minutes, P<0.01), in step with Nazif.
The low cost in procedural time is putting, acknowledged David Cohen, MD, of Saint Luke’s Mid The US Coronary heart Institute in Kansas City, Missouri, right by the discussion.
Nazif speculated that the adaptation will seemingly be attributed to a low cost in submit-dilation with the more recent valve.
Ultra and Sapien 3 groups shared identical 30-day medical outcomes much like all-cause mortality (0.9% vs 1.3%), stroke (1.2% vs 1.7%), and original pacemakers including those in of us with implants at baseline (6.0% vs 5.7%).
Though the payment of coronary obstruction used to be low at 0.1% in this skills, it is on the change hand a doable drawback of the Ultra’s taller skirt, commented J. Dawn Abbott, MD, of Warren Alpert Clinical College of Brown College in Providence, Rhode Island, right by the discussion.
Nazif’s response used to be that the taller skirt mild would not advance as much as the stage the put aside the coronary arteries on the total are, and would not be anticipated to veil the outflow.
The bigger skirt could maybe additionally just pose diversified factors in valve-in-valve TAVR, Abbott acknowledged.
“That’s an home the put aside the mighty thing about the Ultra will seemingly be attenuated,” Nazif agreed.
He acknowledged the change of residual confounding within the observational glance. When both Sapien 3 and Ultra valves enjoy been commercially on hand, operators did their circumstances with the more recent instrument, he acknowledged.
Furthermore, TVT registry data enjoy been put-reported, and there used to be no self sufficient adjudication of PVR.
Disclosures
Statistical evaluation for the glance used to be conducted by Edwards Lifesciences.
Nazif disclosed relevant relationships with Edwards Lifesciences, Medtronic, Boston Scientific, Baylis Clinical, Biotrace Clinical, and Keystone Coronary heart/Venus Medtech.
