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.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
03 February 2022