Aortic valve replacement (AVR) remains the standard treatment for advanced aortic valve disease, supplemented by transcatheter aortic valve implantation. In the 1970s, bovine pericardial prostheses were introduced to enhance hemodynamic outcomes and mitigate the risk of structural valve degeneration compared to their porcine predecessors. Over time, successive generations of these prostheses have improved durability. 

The Carpentier Edwards Magna Ease® bioprosthesis, introduced in 2008, evolved from previous Carpentier Edwards PERIMOUNT® models. While short- and mid-term results for this device have shown promise, long-term outcomes in clinical practice have yet to be thoroughly explored. This study aims to assess long-term clinical outcomes, hemodynamic performance, and durability of this bioprosthesis. 

From January 2010 to December 2012, 871 patients underwent AVR with the Carpentier Edwards Magna Ease® bioprosthesis. Isolated and combined procedures (e.g., coronary artery bypass grafting, mitral valve surgery, or ascending aorta procedures) were included. Patients under 18, cases involving concomitant aortic annular enlargement, and bioprosthesis placement in other positions (mitral/pulmonary) were excluded. Retrospective preoperative, intraoperative, and postoperative data were collected from the remaining 689 cases in an anonymized database. 

The primary endpoint was the likelihood of structural valve degeneration (SVD). Additional variables included clinical and echocardiographic outcomes and major events, such as mortality, endocarditis, non-structural prosthetic degeneration, and the need for repeat AVR. 

The mean follow-up period was 7.9 ± 2.5 years. The average age was 70.8 years, with a predominance of male patients (64.4%). Severe aortic stenosis was the main indication for surgery (82.6%). More than half of the patients underwent isolated AVR (55.3%), with coronary artery bypass grafting being the most common concurrent procedure. The mean ICU stay was 2.6 days, and the mean hospital stay was 8.9 days. Postoperative complications included atrial fibrillation in 28.4% of patients, with 2% requiring pacemaker implantation, and only two patients required reoperation due to paravalvular leak. 

At ten years, the cumulative incidence of cardiovascular mortality was 6.7%, with a 1.9% rate of repeat aortic valve surgery. Endocarditis accounted for 52.3% of reoperation cases. The cumulative incidence of moderate SVD was 3.6%. Prosthetic mean gradient exhibited a slight increase over time, rising from 11.3 ± 5.2 mmHg in the first year to 12.6 ± 7.4 mmHg at ten years (p < 0.01). 

Subgroup analysis indicated a higher incidence of events among younger patients: structural valve degeneration (9.7% for <65 years vs. 2.7% for >75 years, p = 0.013) and prosthesis reoperation (7.8% for <65 years vs. 0.4% for >75 years, p = 0.02). No significant differences were found based on prosthetic size. Infectious endocarditis incidence was similar across age and prosthetic size categories (p > 0.05). 

The authors conclude that the long-term outcomes of the Carpentier Edwards Magna Ease® bioprosthesis, in terms of freedom from structural valve degeneration or prosthetic endocarditis, hemodynamic values, and clinical outcomes, are superior to those of other aortic bioprostheses and previous generations. These findings extend the positive results observed at mid-term follow-up (3–5 years). 

COMMENTARY: 

This study is one of the few that evaluates long-term outcomes for the Carpentier Edwards Magna Ease® bioprosthesis. The third-generation bioprosthesis is widely used in our region, and the data collected, including serial testing and prosthesis-related events, optimally represent its ten-year performance. 

This study provides a new perspective on AVR, offering an optimal prosthesis choice for patients over 60–65 years of age. Following this publication, we might aim to optimize outcomes in younger patients, where a higher complication rate is observed, considering their longer life expectancy. Extended follow-up beyond ten years would be valuable to assess how the prosthesis performs in younger patients over time. 

Thanks to this study, we have reliable data on this bioprosthesis, ensuring a low risk of reoperation and long-term complications post-AVR. This information addresses patient concerns regarding surgery, offering statistically significant and reasonable prognostic data. 

REFERENCE: 

Francica A, Benvegnù L, San Biagio L, Tropea I, Luciani GB, Faggian G, Onorati F. Ten-year clinical and echocardiographic follow-up of third-generation biological prostheses in the aortic position. J Thorac Cardiovasc Surg. 2024 May;167(5):1705-1713.e8. doi: 10.1016/j.jtcvs.2022.10.023.