Feasibility, Technical Safety, and Early Clinical Experience with an Automated Annular Suturing Device in Minimally Invasive Valve Replacement

Background: Minimally invasive cardiac valve surgery (MIVS) provides distinct clinical advantages, yet annular suturing remains a technically demanding step. Automated annular suturing devices (RAM®) have been developed to standardize suture placement during valve replacement. This study evaluates the initial clinical feasibility, technical safety, and operational integration of automated suturing during its institutional adoption phase. Methods: We retrospectively evaluated 43 consecutive patients undergoing MIVS supported by the RAM® system (2021–2025), stratified into mitral valve replacements (RAM-MVR, n = 26) and aortic valve replacements (RAM-AVR, n = 17). Technical parameters, procedural safety metrics, and perioperative outcomes were descriptively analyzed and contextualized against our broader institutional MIVS platform using percutaneous femoral cannulation (n = 182). Results: Automated annular suturing achieved a 100% technical feasibility rate (43/43, 95% CI: 91.8–100.0%) with zero mechanical device failures or intraoperative suture-line disruptions (0%, 95% CI: 0.0–8.2%). In the RAM-MVR cohort, median cross-clamp and cardiopulmonary bypass (CPB) times were 73.0 min (IQR 64.0–91.0) and 114.5 min (IQR 94.8–129.5), respectively. In RAM-AVR, median cross-clamp time was 75.0 min (IQR 71.0–83.0). Thirty-day mortality was 4.7% (2/43, 95% CI: 0.6–15.8%), secondary to non-device-related medical complications in high-risk baseline patients. Postoperative echocardiography demonstrated no paravalvular regurgitation (0%, 95% CI: 0.0–8.2%). Conclusions: Initial institutional experience demonstrates that automated annular suturing is technically feasible and safe in minimally invasive mitral and aortic valve replacement. The system enables consistent procedural execution across valve positions. These observational data support automated suturing as a feasible alternative to manual suturing in MIVS workflows.