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. 2021 Jan 29;59(2):434-441.
doi: 10.1093/ejcts/ezaa311.

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Krzysztof Bartus  1   2 , Radoslaw Litwinowicz  1   2 , Agata Bilewska  3 , Maciej Stapor  1 , Maciej Bochenek  1   2   4 , Jacek Rozanski  3 , Jerzy Sadowski  1   2 , Grzegorz Filip  1   2 , Mariusz Kusmierczyk  3 , Boguslaw Kapelak  1   2
Affiliations

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Krzysztof Bartus et al. Eur J Cardiothorac Surg. .

Abstract

Objectives: Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.

Methods: This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory.

Results: Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years.

Conclusions: The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue.

Clinical trial registration number: NCT01651052.

Keywords: Aortic valve replacement; Bioprosthesis; RESILIA.

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Figures

Figure 1:
Figure 1:
Surgical approach undertaken for the study cohort.
Figure 2:
Figure 2:
Intraoperative outcomes for the study cohort. The error bars represent ± standard deviation. AVR: aortic valve replacement.
Figure 3:
Figure 3:
Kaplan–Meier curve showing freedom from all-cause mortality and structural valve deterioration. SE: standard error; SVD: structural valve degeneration.
Figure 4:
Figure 4:
(A) Mean gradients in the patient cohort by valve size over the 5 year observational period. (B) Mean effective orifice areas in the patient cohort by valve size and over the 5 year observational period.
Figure 5:
Figure 5:
Central/transvalvular (A), paravalvular (B) and total regurgitation (C) in the study cohort over the 5 year observational study period.
None
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References

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