OBJECTIVES: The purpose of this study was to determine the prevalence and severity of paravalvular regurgitation (PVR) in the Artificial Valve Endocarditis Reduction Trial (AVERT) cohort. BACKGROUND: The initial AVERT cohort consisted of 807 patients randomized to receive either a Silzone-coated prosthetic valve or a conventional prosthetic valve; early clinical reports showed higher rates of valve explant caused by PVR for Silzone-coated prosthetic valve. METHODS: Of the 678 eligible patients, 575 (85%) underwent postoperative transthoracic echocardiograms. The presence and severity of PVR were identified by color flow Doppler. Reviewers were blinded to the type of prosthetic valve and the demographic and clinical variables. RESULTS: Among those who underwent echocardiography (Silzone-coated prosthetic valve, n = 285 and conventional prosthetic valve, n = 290), 59% had prosthetic aortic valves, 32% prosthetic mitral valves, and 9% had both; demographic and clinical findings (i.e., prosthetic valve endocarditis, thromboembolism, bleeding, and all-cause death) were similar for the two groups. Echocardiographically determined PVR was present in 50 valves: Silzone-coated prosthetic valve, 29 of 285 (10%) and conventional prosthetic valve, 21 of 290 (7%, p = NS); the severity of PVR was similar in both groups. Kaplan-Meier analysis showed no significant differences in PVR at 24 months from valve implantation between the two groups (24-month event-free rate: 93% Silzone-coated prosthetic valve vs. 94% conventional prosthetic valve, p = NS). CONCLUSIONS: Excluding those patients who had initial prosthetic valve explant, the two-year echocardiographic follow-up of the AVERT cohort shows no statistically significant differences in the prevalence or severity of PVR in the Silzone-coated prosthetic valve compared with the conventional prosthetic valve. Further monitoring is warranted to determine whether these clinical outcomes remain similar on long-term follow-up.
RCT Entities:
OBJECTIVES: The purpose of this study was to determine the prevalence and severity of paravalvular regurgitation (PVR) in the Artificial Valve Endocarditis Reduction Trial (AVERT) cohort. BACKGROUND: The initial AVERT cohort consisted of 807 patients randomized to receive either a Silzone-coated prosthetic valve or a conventional prosthetic valve; early clinical reports showed higher rates of valve explant caused by PVR for Silzone-coated prosthetic valve. METHODS: Of the 678 eligible patients, 575 (85%) underwent postoperative transthoracic echocardiograms. The presence and severity of PVR were identified by color flow Doppler. Reviewers were blinded to the type of prosthetic valve and the demographic and clinical variables. RESULTS: Among those who underwent echocardiography (Silzone-coated prosthetic valve, n = 285 and conventional prosthetic valve, n = 290), 59% had prosthetic aortic valves, 32% prosthetic mitral valves, and 9% had both; demographic and clinical findings (i.e., prosthetic valve endocarditis, thromboembolism, bleeding, and all-cause death) were similar for the two groups. Echocardiographically determined PVR was present in 50 valves: Silzone-coated prosthetic valve, 29 of 285 (10%) and conventional prosthetic valve, 21 of 290 (7%, p = NS); the severity of PVR was similar in both groups. Kaplan-Meier analysis showed no significant differences in PVR at 24 months from valve implantation between the two groups (24-month event-free rate: 93% Silzone-coated prosthetic valve vs. 94% conventional prosthetic valve, p = NS). CONCLUSIONS: Excluding those patients who had initial prosthetic valve explant, the two-year echocardiographic follow-up of the AVERT cohort shows no statistically significant differences in the prevalence or severity of PVR in the Silzone-coated prosthetic valve compared with the conventional prosthetic valve. Further monitoring is warranted to determine whether these clinical outcomes remain similar on long-term follow-up.
Authors: Rebecca T Hahn; Philippe Pibarot; William J Stewart; Neil J Weissman; Deepika Gopalakrishnan; Martin G Keane; Saif Anwaruddin; Zuyue Wang; Martin Bilsker; Brian R Lindman; Howard C Herrmann; Susheel K Kodali; Raj Makkar; Vinod H Thourani; Lars G Svensson; Jodi J Akin; William N Anderson; Martin B Leon; Pamela S Douglas Journal: J Am Coll Cardiol Date: 2013-04-23 Impact factor: 24.094
Authors: Andreas Kolk; Christoph Pautke; Donald Hall; Stefan Wagenpfeil; Klaus-Dietrich Wolff; Herbert Deppe Journal: Wien Med Wochenschr Date: 2009-12
Authors: Amani D Politano; Kristin T Campbell; Laura H Rosenberger; Robert G Sawyer Journal: Surg Infect (Larchmt) Date: 2013-02-28 Impact factor: 2.150