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

Abstract

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 m2) 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 (p = 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, p = 0.039), there were no significant differences in the effective orifice area in all patients (1.57 ± 0.41 cm2 vs. 1.53 ± 0.34 cm2, p = 0.568), and each valve size. The effective orifice area index was also similar between the two groups in overall (p = 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)

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves

“…18,[20][21][22] A previous study, which reported preliminary analyses of the present trial, demonstrated that early hemodynamic and clinical outcomes were comparable between the AVA-LUS and CEPME groups. 5 One significant finding in the preliminary analyses was that the AVMPG of the 19-mm prostheses was lower in the AVALUS group than in the CEPME group (17.0 AE 6.3 vs. 22.8 AE 6.6 mm Hg, p ¼ 0.039). However, the authors deferred this finding from the conclusions because it has been recommended to evaluate the hemodynamic performance of AV prostheses at 6 months to 1 year after surgery, because several unstable factors, including BSA, anemia, inflammation, and other medical conditions, could affect early hemodynamic performance of prosthetic AV.…”

“…To perform a comparative analysis of the efficacy and safety of this newly introduced bioprosthesis, a prospective randomized controlled trial (RCT) comparing the Avalus TM with the worldwide used Carpentier-Edwards PERIMOUNT Magna Ease (CEPME; Edwards Lifesciences, Irvine, CA, USA) was designed, and preliminary results of this trial were recently published by the authors. 5 The present study was conducted to compare 1-year hemodynamic performances after AVR using the Avalus TM valve with those using CEPME, which is the primary endpoint of this RCT (ClinicalTrials.gov identifier: NCT03796442).…”

“…The operative strategies have been previously described. 5 Surgeries were performed using median sternotomy or upper partial sternotomy under cardiopulmonary bypass with cold cardioplegic arrest. After the diseased AV was excised, the annulus was prepared for landing the prosthesis, and the proper valve sizes for both types of prostheses were decided before randomization.…”