Next-generation TAVR valve linked to less paravalvular leak vs. predecessors
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Key takeaways:
- A new generation of a balloon-expandable transcatheter aortic valve replacement system reduced paravalvular leak compared with older devices.
- Clinical outcomes were mostly similar.
The fifth generation of a balloon-expandable transcatheter aortic valve replacement system was associated with lower rates of paravalvular leak and lower mean gradients compared with predecessor systems, researchers reported.
The researchers evaluated patients included in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry who underwent TAVR with the fifth-generation valve (Sapien 3 Ultra Resilia, Edwards Lifesciences) or predecessor balloon-expandable valves (Sapien 3 and Sapien 3 Ultra, Edwards Lifesciences) from 2021 to June 2023. The findings were presented at Cardiovascular Research Technologies and simultaneously published in JACC: Cardiovascular Interventions.
‘Several key improvements’
“The Sapien 3 Ultra Resilia valve incorporates several key improvements over its predecessors,” Curtiss T. Stinis, MD, FACC, FSCAI, clinical professor of medicine, director of peripheral interventions and program director of the interventional cardiology fellowship at Scripps Clinic, told Healio. “Firstly, it contains bovine tissue treated with a special process that caps free aldehydes and reduces the ability of calcium in the body to bind to the leaflet tissue. This is intended to reduce structural valve deterioration due to leaflet calcification, which will hopefully translate into improved long-term valve durability for patients. Secondly, the two smaller valve sizes (20 mm and 23 mm) incorporate a modified leaflet hinge attachment geometry intended to improve hemodynamic performance. And lastly, the Ultra Resilia valve includes a 29 mm valve size. This is relevant because prior to the availability of the Ultra Resilia valve, patients requiring treatment with a 29 mm valve could only be treated with the Sapien 3 valve, which has a less advanced sealing skirt since the immediate predecessor valve (Sapien 3 Ultra) did not include a 29 mm size. The improved sealing skirt of the Ultra series was known to reduce paravalvular leak as compared to the Sapien 3 valve, but was not available in a 29 mm size until Sapien 3 Ultra Resilia.”
Using propensity matching, the researchers compared 10,312 patients who had TAVR with the fifth-generation valve with 10,312 patients who had TAVR with a predecessor valve. In both groups, the mean age was 77 years and 61% were men.
There were no differences between the groups in the following clinical outcomes in the hospital or at 30 days: all-cause death, cardiac death, stroke, new pacemaker implantation, new-onset atrial fibrillation, aortic valve readmission, life-threatening bleeding or major vascular complications.
However, the fifth-generation device was associated with a higher rate of 30-day readmission compared with the predecessor devices (8.5% vs. 7.7%; P = .04), according to the researchers.
At discharge, the fifth-generation device group had lower mean gradients (9.2 mm Hg vs. 12 mm Hg; P < .0001) and larger aortic valve area (2.1 cm2 vs. 1.9 cm2; P < .0001), the researchers found.
Reduced paravalvular leak
The fifth-generation device group was more likely than the predecessor device group to have no paravalvular leak at discharge (P < .0001) and at 30 days (P = .006), and among patients who received a 29 mm valve, those who received the Sapien 3 Ultra Resilia had lower mild paravalvular leak rates than those who received the Sapien 3 (5.3% vs. 9.4%; P < .0001), according to the researchers.
“The main implications for this study are that TAVR with Sapien 3 Ultra Resilia is associated with excellent procedural and early clinical outcomes as well as hemodynamic improvements and reduced paravalvular leak,” Stinis told Healio. “In addition, it is hoped that the Resilia tissue will be associated with longer durability than previous TAVR designs — an important consideration for younger and lower-risk patients undergoing TAVR since longer durability will extend the time between valve interventions and potentially reduce the overall number of needed valve interventions for these patients. Longer-term studies will be needed to further assess the ability of Resilia tissue to reduce TAVR structural valve deterioration and improve durability; however, the ongoing COMMENCE trial, which is evaluating Resilia tissue in a surgical patient population, thus far looks promising at 7 years with no evidence of significant structural valve deterioration.”
Reference:
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Stinis CT, et al. Best abstracts | Valve & structural heart | Aortic valve session two. Presented at: Cardiovascular Research Technologies; March 9-12, 2024; Washington, D.C.
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