Outcomes after Implantation of a Latest Generation Biological Valve with a New Anticalcification Treatment

Background: This latest generation aortic valve is a pericardial bio-prosthesis with a new anticalcification treatment that shows promising in vitro results in terms of reduced calcification. Only limited follow up data is available due to the novelty of this valve.

Methods: A total of 110 patients underwent AVR using a novel bioprosthetic valve December 2018 and January 2022. Procedural, early (<30 days) and late (>30 days) outcomes were collected. Echocardiographic evaluation of hemodynamic performance was performed after 1 year and 3 years. The median follow up time was 3.8 years.

Results: The mean age was 68.3 ± 7.9 years, and the mean logistic Euroscore II 2.1 ± 1.3%. Early all-cause mortality was 1.8% (n = 2) A stroke rate of 0.9% (n = 1) occurred. Major paravalvular leaks did not occur. New pacemaker implantation rate was 4.5% (n = 5). Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 92.1%, 100%, and 97.6%, respectively. One case of endocarditis was in seen in the follow up period. At 3 years, the mean effective orifice area was 1.7 ± 0.3 cm² with a mean gradient of 10.4 ± 3.8 mmHg. 98.1% of patients had none/trivial paravalvular leakage and 97.7% had non/trivial transvalvular regurgitation, respectively.

Conclusion: This latest generation bioprosthesis offers excellent safety and hemodynamic performance with minimal regurgitation and no evidence of structural valve deterioration.

Publication History

Article published online:
13 February 2024