The Edwards Intuity® prosthesis belongs to a recent generation of devices designed for aortic stenosis treatment. It is a rapid-deployment prosthesis, similar to other devices like the Livanova Perceval S® and the now-defunct Medtronic 3F®, which are collectively known as sutureless or rapid-deployment prostheses. These devices have found their therapeutic niche, especially in promoting minimally invasive approaches and reducing surgical times in complex combined procedures.

While any of these devices may appear suitable for similar indications, specific design characteristics render the Edwards Intuity® prosthesis better suited for combined procedures involving coronary artery revascularization or ascending aorta replacement, as it does not interfere with the proximal anastomoses of grafts or vascular conduits due to its supra-annular profile. In combined aortic and mitral valve surgeries, particularly with mitral valve replacement, other sutureless prostheses, such as the Livanova Perceval S®, are preferred due to their subannular profile, which minimizes interference during the procedure.

Bottio et al.’s study assesses the mid-term performance of the Edwards Intuity® bioprosthesis compared to the Carpentier Edwards Magna Ease® prosthesis, which is considered the gold standard for design and pericardium treatment. The Edwards Intuity® has been in use for around ten years. With the longest series reporting outcomes up to seven years, incorporating the initial learning curve, which included a paravalvular leak rate between 5–12% and an atrioventricular block incidence of approximately 10%. In contrast, the Carpentier Edwards Magna Ease® has the longest follow-up, with series extending over 20 years and reintervention rates below 15% in patients over 65 years.

A total of 285 patients were recruited from two European centers (Padua, Italy, and Lugano, Switzerland) and divided into two groups based on the aortic bioprosthesis used: 50.5% received the Edwards Intuity® and 49.5% the Carpentier Edwards Magna Ease®. A propensity score adjustment and Cox regression analysis were applied. No significant differences were observed in 30-day mortality (2.8% vs 5%) or at the five-year follow-up (7% vs 9%). Significantly shorter aortic cross-clamping and cardiopulmonary bypass times were achieved with the Edwards Intuity® (94 vs 120 min, p<0.001; 128 vs 160 min, p<0.001), and its hemodynamic performance was superior, mainly due to a greater left ventricular outflow tract clearance by eliminating suture material and native ring interference.

COMMENTARY:

Although this study does not follow a non-inferiority design, it demonstrates comparable outcomes for the new-generation Edwards Intuity® prosthesis compared to its reference. With potential advantages in simplifying the surgical technique and achieving better hemodynamic outcomes for the implanted prosthesis. As seen in other studies, the immediate impact derived from this technical simplification does not translate into “hard” clinical outcomes. Survival, likely due to procedural equivalency or the need for larger samples are necessary to find statistically significant differences. Additionally, longer follow-ups are needed in such studies to assess long-term degeneration rates compared to the Carpentier Magna Ease® prosthesis and to evaluate the potential impact of lower gradients, with consequent myocardial mass regression and potential survival benefit. Finally, given that rapid-deployment prostheses allow for a larger post-implant valve area, their role as a platform for valve-in-valve procedures compared to conventional sutured prostheses remains to be determined, particularly in patients with small aortic annuli, where experience remains limited.

REFERENCE:

Bottio T, Piperata A, Guariento A, Lorenzoni G, Cavicchiolo AG, Gemelli M et al. Standard versus rapid-deployment aortic valve replacement and concomitant myocardial revascularization: 5-year bi-centre clinical outcomes. Eur J Cardiothorac Surg. 2022 Oct 4;62(5). doi: 10.1093/ejcts/ezac476.