Preliminary Report from a Randomized Controlled Trial Comparing Two Bovine Pericardial Valves.

Background: A randomized controlled trial was designed to compare 1-year hemodynamic profiles and clinical outcomes after bioprosthetic aortic valve replacement (AVR) using a recently introduced (study group) and world-widely used (control group) bovine pericardial bioprostheses. This study evaluated early postoperative outcomes as a preliminary analysis.

Methods: The primary end point of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. Patients were screened to enroll 70 patients in each group based on a noninferiority design. Early postoperative hemodynamic and clinical outcomes were compared between the two groups.

Results: There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m) between the two groups. The AVMPG on early postoperative echocardiography was 15.2 ± 4.6 mm Hg and 16.5 ± 6.2 mm Hg in the study and control groups, respectively ( = 0.177). Although AVMPG of the 19 mm prostheses was lower in the study group than in the control group (17.0 ± 6.3 mm Hg vs. 22.8 ± 6.6 mm Hg,  = 0.039), there were no significant differences in the effective orifice area in all patients (1.57 ± 0.41 cm vs. 1.53 ± 0.34 cm,  = 0.568), and each valve size. The effective orifice area index was also similar between the two groups in overall ( = 0.352), and in each valve size. There were no significant differences in clinical outcomes including operative mortality and postoperative complications between the two groups.

Conclusion: Early postoperative hemodynamic and clinical results after AVR using a recently introduced bovine pericardial valve were comparable with those using the control valve (NCT03796442).