Balloon-vs. Self-Expanding Transcatheter Valve for Failed Small Surgical Aortic Bioprostheses:1-Year Results of the LYTEN Trial.

Document Type

Article

Publication Date

12-25-2023

Publication Title

JACC. Cardiovascular interventions

Abstract

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.

OBJECTIVE: To compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR.

METHODS: Patients with a failed small (≤ 23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler-echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria.

RESULTS: A total of 98 patients underwent ViV-TAVR (46-BEV, 52-SEV). Patients receiving a SEV had a lower peak and mean trans-aortic gradients (peak: 42±15 mmHg-BEV vs. 27±14 mmHg-SEV, p˂0.001; mean: 22±8 mmHg-BEV vs. 14±7 mmHg-SEV, p < 0.001), and a higher rate on intended valve hemodynamic performance (BEV:30%, SEV:76%, p < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA class > II, BEV: 7.3%, SEV:4.1%, p=0.505) or quality of life (KCCQ, BEV:77.9±21.2, SEV:81.8±14.8, p=0.334). No differences in all-cause mortality (BEV:6.5%, SEV:3.9%, p=0.495), heart failure hospitalization (BEV:6.5%, SEV:1.9%, p=0.214), stroke (BEV:0%, SEV:1.9%; p=0.369), myocardial infarction (BEV:0%, SEV:1.9%, p=0.347), or pacemaker implantation (BEV:2.2%, SEV:1.9%, p=0.898) were found.

CONCLUSIONS: In patients who underwent ViV-TAVR for small failed aortic bioprostheses, a better hemodynamic profile was found after one year in patients receiving a SEV. Differences were not found between SEV and BEV in regard to functional status, quality of life, or clinical outcomes.

Volume

16

Issue

24

First Page

2999

Last Page

3012

DOI

10.1016/j.jcin.2023.10.028

ISSN

1876-7605

PubMed ID

37902146

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