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. 2022 Aug 3;62(3):ezac374.
doi: 10.1093/ejcts/ezac374.

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes

Robert J M Klautz  1 , François Dagenais  2 , Michael J Reardon  3 , Rüdiger Lange  4 , Michael G Moront  5 , Louis Labrousse  6 , Neil J Weissman  7 , Vivek Rao  8 , Himanshu J Patel  9 , Fang Liu  10 , Joseph F Sabik  11
Affiliations

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes

Robert J M Klautz et al. Eur J Cardiothorac Surg. .

Abstract

Objectives: This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement.

Methods: Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated.

Results: A total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery.

Conclusions: The findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis.

Keywords: Aortic valve disease; Bovine pericardial aortic bioprosthesis; Cardiac surgery; Surgical aortic valve replacement.

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Figures

Figure 1:
Figure 1:
Survival over a 5-year period.
Figure 2:
Figure 2:
Comparison of valve-related safety end points with the objective performance criteria. OPC: objective performance criteria.
Figure 3:
Figure 3:
Estimated instantaneous hazard rate of all-cause reintervention over a 5- year period.
Figure 4:
Figure 4:
(Top) Mean aortic gradient by visit and valve size over a 5-year period. Values show gradients at 5 years. (Bottom) Temporal trend of mean aortic gradient analysed longitudinally.
Figure 5:
Figure 5:
New York Heart Association (NYHA) functional class over a 5-year period.
None
See this image and copyright information in PMC

Comment in

References

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