Bioprosthetic Surgical Aortic Valve Replacement in Patients under the Age of 60 Years

Background: Bioprosthetic surgical aortic valve replacement (sAVR) is increasingly adopted in younger patients to avoid lifelong anticoagulation. For informed decisions, knowledge of the real-world outcome of such a choice is critical.

Method: INDURE is a prospective, open-label, multicenter, CoreLab-supported registry in patients younger than 60 years undergoing bioprosthetic sAVR and with a follow-up of 5 years. We aim to determine VARC-2 defined time-related valve safety and freedom from stage 3 structural valve degeneration (SVD).

Results: As of July 2021, a total of 441 patients were documented across 21 sites in Europe and Canada. Patients had a mean age of 53.5 ± 6.9 years, 23% were female, 74% bicuspid valves, 26% with NYHA III or IV, and with a EuroSCORE II of 1.6 ± 1.9%. Stenosis (71.4%) was the predominant AV pathology. Regurgitation (34.0 vs. 21.3%; p = 0.008), bicuspid valves (83.5 vs. 70.7%; p = 0.010), were all less common in the youngest patients (<50 years [n = 104] vs. those 50–60 years [n = 337]). Diabetes (6.7 vs. 15.3%; p = 0.025) and hypertension (30.8 vs. 55.7%; p < 0.001) were less common.

72% of the patients underwent full sternotomy, 53% isolated AVR, and 23 mm (30.0%) and 25 mm (29.1%) were the most commonly used valves. After the procedure, the mean pressure gradient was 11.6 ± 4.4 mm Hg (20.7 ± 7.8 peak), and the EOA 2.1 ± 0.6 cm² (indexed 1.1 ± 0.3). Values only slightly changed by the 1-year follow-up.

All-cause mortality was 0.5% at discharge (5.2% at 1 year; 75% not valve-related), stroke was 0.7% (2.0% at 1 year), life-threatening bleeding was 3.2% (7.5% at 1 year), and pacemaker requirement was 3.9% (12.3% at 1 year). The procedure was repeated in one patient at 1 year. Endocarditis, valve thrombosis, and SVD Salaun stage >3 were all not observed at discharge, while 3 patients had valve thrombosis (2.1%) at 1 year. One patient had endocarditis at 1 year (0.7%) and was classified as SVD Salaun stage >3 (0.7%) because of severe transprosthetic valve regurgitation. There were no differences in the event rates between patients younger than 50 years and those between 50 and 60 years.

Conclusion: Results of INDURE indicate excellent procedural outcomes, comparable across subgroups defined by age with respect to gradients and orifice areas. Preliminary safety outcomes at 1 year were 5.2% all-cause mortality, 0.7% endocarditis, and 0.7% stage 3 SVD. Ongoing follow-up continues to evaluate the safety and durability of bioprosthetic sAVR in patients younger than 60 years.

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Publikationsverlauf

Artikel online veröffentlicht:
03. Februar 2022