Long-term results after 1000 aortic valve replacements with rapid-deployment valves: a single center analysis

I. Coti¹, P. Werner¹, J. El-Nashar², A. Kocher¹, G. Laufer¹, M. Andreas^1
1Department of Cardiac surgery, Medical University of Vienna, Vienna, Wien ²Medical University of Vienna, Vienna, Wien

Purpose: Rapid-deployment (RD) prostheses facilitate minimally invasive surgical aortic valve replacement (SAVR) by reducing procedural times and showed improved valve hemodynamics due to the incorporated stent frame (1). This study aimed to analyze long-term durability, survival and valve related adverse events after 1000 RD-SAVRs in a single-center study cohort.

Methods: Between May 2010 and May 2023, 1000 consecutive patients with severe aortic stenosis or combined aortic valve disease implanted with a rapid-deployment valve at our institution were included in a prospective and ongoing database with longitudinal end-point assessment. Median follow-up was 53 months [IQR: 26-80] and the total accumulated follow-up was 4533 patient years. Preoperative characteristics, operative parameters, survival, valve related adverse events and valve hemodynamics were assessed. Adverse events were classified after the EACTS/ STS/ AATS guidelines for reporting morbidity and mortality after valve interventions (2).

Results: Mean age was 73±7 years, 45% female. Median EuroScore II and STS Score were 2.7% [IQR: 1.4-5.5] and 1.9% [IQR: 1.3-3.1]. Concomitant procedures were performed in 500 (50%) patients. In case of isolated SAVR, a minimally invasive surgical approach was conducted in 415 patients (83%), of which 44.2% (n=221) through a right anterior thoracotomy. Mean gradients at discharge, one year, three and five years were 12±5, 11±4, 11±5 and 13±8 mmHg. New early pacemaker implantation was required in 9.1%. Perioperative Stroke ( < 72h) was observed in 1.6% (n=16) and overall thrombembolic and major bleeding events were observed in 6.4% (n=64). Freedom from severe structural valve degeneration at 5-years follow-up was 99%±0.5%. Re-intervention or re-operation with valve explantation for structural degeneration, non-structural dysfunction or endocarditis occurred in 38 cases (3.8%). Moderate or severe paravalvular leak was observed in 2.9% (n=29) and re-operation with valve explantation due to non-structural valve dysfunction (NSVD) was observed in 1.7% (n=17). Overall 30-Day Mortality was 0.6% (n=3) and 0.2% (n=1) in isolated RD-SAVR and survival at 1, 3 and 5-years FU-up was 95%, 88% and 81%, respectively.

Conclusion: Rapid-deployment valves showed excellent long-term hemodynamics with stable transvalvular gradients and consequently one of the lowest 5-year structural valve degeneration rates for stented bioprostheses reported in the literature. Modern SAVR with RD prostheses can be performed with excellent results and near zero perioperative mortality in a real-world collective.

Identify the source of the funding for this research project: The patients from multicenter clinical trials (TRITON, FOUNDATION) funded by Edwards Lifesciences (Irvine, CA, USA) were included in this analysis. Our institution receives financial support from the same company to conduct a long-term follow up after Intuity valve implantation and maintain a long-term follow-up registry.