Automated Versus Conventional Annular Suturing in Totally Endoscopic Aortic Valve and Ascending Aorta Replacement: A Prospective Randomized Trial
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Background
Totally endoscopic aortic valve replacement (AVR) combined with ascending aorta replacement (AAR) remains technically demanding, with prolonged CPB and ischemic times. Annular suturing is a principal technical limitation; automated devices aim to simplify this step and improve efficiency. This study compared early clinical outcomes between automated and conventional annular suturing in totally endoscopic AVR with concomitant AAR.
Methods
Between August 2023 and February 2026, 86 patients undergoing totally endoscopic AVR with concomitant AAR via right anterior minithoracotomy (RAMT) were randomized 1:1 to automated annular (RAM group; n=43) or conventional suturing (conventional group; n=43) in this single-center trial. Primary endpoints were technical success and procedural times; secondary endpoints included complications and 30-day mortality.
Results
Baseline characteristics were comparable, bicuspid aortic valve morphology was more frequent in the RAM group (74.4% vs. 53.5%; P = 0.043). Automated suturing was associated with shorter median procedure (120.8 vs. 144.0 minutes; P = 0.004), CPB (90.0 vs. 105.0 minutes; P = 0.005), and aortic cross-clamp times (62.0 vs. 74.0 minutes; P = 0.003), respectively. No stroke, conversion to sternotomy, paravalvular leakage, or 30-day mortality occurred in either group. Hospital stay was shorter with automated suturing (6.0 vs. 7.0 days; P = 0.037), while total treatment cost, accounting for incremental device cost, did not differ significantly (P = 0.421).
Conclusions
Automated annular suturing appears to be a safe, efficient alternative to conventional suturing in totally endoscopic AVR with AAR, associated with reduced operative and ischemic times and shorter hospital stay without compromising early outcomes.
CLINICAL PERSPECTIVE
What Is New?
In this randomized trial of totally endoscopic aortic valve replacement with ascending aorta replacement (n=86), automated annular suturing with the RAM device was associated with shorter procedure, cardiopulmonary bypass, and aortic cross-clamp times and a shorter hospital stay (6 vs 7 days) than conventional suturing. Earlier evidence for automated annular suturing came mainly from observational series in isolated valve replacement, and this trial extends the observation to combined aortic valve and ascending aorta surgery. No stroke, conversion to sternotomy, paravalvular leakage, or 30-day mortality occurred in either group, and total treatment cost did not differ significantly because the incremental device cost offset the savings from the shorter hospital stay.
What Are the Clinical Implications?
Automated annular suturing may be a safe and efficient option to reduce ischemic and bypass times in technically demanding totally endoscopic aortic procedures at experienced centers. Centers considering adoption should expect cost neutrality rather than cost savings during the index hospitalization. Larger multicenter trials with longer follow-up, including centers earlier in their learning curve, are needed to confirm generalizability and valve durability.
