Safety and Efficacy of Contemporary Rapid Deployment Valves—A Comparative Analysis

Background: Presently two differently designed rapid deployment valves (RDV) are commercially available—the Edwards INTUITY and the Corcym Perceval Plus. This study compares valve performances in a large consecutive cohort.

Methods: All consecutive isolated aortic valve replacements (AVR) or AVR in combination with CABG were included between 2016 and 2022 using either the INTUITY (n = 309) or the Perceval Plus (n = 338). Multiple valve procedures or non-IFU-conform implantations were ruled out. The final study group consisted of 647 patients. Preoperative aortic annular diameter (CT scan and 3D echocardiography), intraoperative adverse events (AE), predischarge hemodynamic parameters as well as permanent pacemaker implantation (PPI) rates were analyzed. Predischarge transthoracic echocardiography was performed by a single examiner between postoperative day 5 and 6.

Results: Mean preoperative annular diameter differed not significantly between both groups (INTUITY 24.7 ± 2.4 mm versus Perceval Plus 24.2 ± 2.2 mm; p = 0.06). Intraoperative AE were likewise counterbalanced by means of valve malpositioning (INTUITY 3.6% versus Perceval Plus 2.4%; p = 0.49), repeated x-clamp (INTUITY 2.9% versus Perceval Plus 2.4%; p = 0.49), and use of a different prosthesis (INTUIYT 4.2% versus Perceval Plus 1.8%; p = 0.10). Postoperative mean effective orifice area generally differed not significantly (INTUITY 1.73 ± 0.25 cm² versus Perceval Plus 1.70 ± 0.23 cm²; p = 0.15), but was significantly larger with the Perceval Plus in patients with an aortic annulus ≤23 mm (n = 114; Perceval Plus 1.59 ± 0.22 cm² versus INTUITY 1.44 ± 0.18 cm²; p = 0.04). Postoperative PVL (>trace) was less frequent in Perceval Plus (2.4% versus 5.5%; p = 0.04) and PPI rate was comparable (INTUITY 6.2% versus Perceval Plus 5.9%; p = 1.00). No case of valve thrombosis was documented.

Conclusion: Both RDVs are safe and highly effective with mainly comparable hemodynamic outcomes at a high safety profile with low rates of permanent pacemaker implantations. The INTUITY had higher rates of PVL, whereas the Perceval Plus provided larger EOAs in smaller aortic annulus.

Publikationsverlauf

Artikel online veröffentlicht:
11. Februar 2025