Real-World Registry Evaluates Perceval Bioprosthesis Via Mini-Thoracotomy Versus Mini-Sternotomy in Aortic Valve Replacement Patients
This prospective international real-world registry study evaluated surgical approaches for aortic valve replacement across 55 institutions. The population consisted of patients undergoing isolated aortic valve replacement by minimally invasive cardiac surgery approaches. A total of 1,652 patients were enrolled in the registry. Following propensity score matching, the analysis included 261 patients per approach to compare the two surgical techniques.
The intervention involved implanting the Perceval sutureless bioprosthesis via mini-thoracotomy, while the comparator utilized the same bioprosthesis via mini-sternotomy. Results indicated that intensive care unit stay and hospital stay were shorter in the mini-thoracotomy group compared to the mini-sternotomy group. However, the specific p-values for these differences were truncated in the source data, preventing precise statistical assessment. Perioperative complication rates were reported as low for both groups.
Long-term clinical and echocardiographic outcomes demonstrated no significant differences between the mini-thoracotomy and mini-sternotomy approaches. Safety data regarding adverse events, serious adverse events, discontinuations, and tolerability were not reported in the registry. The study design is observational, which limits the ability to establish causality between the surgical approach and outcomes. Follow-up duration was not reported, and key limitations were not detailed in the source material. Clinicians should interpret these findings cautiously given the registry nature and missing safety details.