TY - JOUR
T1 - Mitroflow aortic bioprosthesis 5-year follow-up
T2 - North American prospective multicenter study
AU - Asch, Federico M.
AU - Heimansohn, David
AU - Doyle, Daniel
AU - Dembitsky, Walter
AU - Ferdinand, Francis D.
AU - Swanson, Jeffrey
AU - Dearani, Joseph A.
AU - Weissman, Neil J.
PY - 2012/10
Y1 - 2012/10
N2 - Background: The Mitroflow valve (Sorin Group, Milan, Italy) has been in use since 1982 and has shown long-term durability in large studies from European centers but has not been studied for long-term hemodynamics in large standardized multicenter trials. This study sought to assess the hemodynamics of the Mitroflow valve by extending the duration of follow-up in an ongoing prospective multicenter trial conducted in North America. Methods: Six sites participated in this midterm study requiring annual follow-up and echocardiographic evaluation using a standardized transthoracic echocardiography acquisition protocol. Results: There were 276 patients enrolled (age 74 ± 8 years) and 54% were in New York Heart Association (NYHA) functional class III-IV. Follow-up from the time of valve implantation had a mean of 4.0 ± 1.7 years with a cumulative follow-up of 1,102 patient-years. At 5 years of follow-up, 99% of patients were free of moderate or severe aortic regurgitation and 94% were in NYHA functional class I or II. Between baseline and 5 years, mean gradients increased an average of 0.4 to 4.3 mm Hg. The change in effective orifice area was appreciably small (-0.1 to -0.3 cm2) after 5 years. There were 57 deaths (4 early and 53 late) and 9 valve explants. Conclusions: The Mitroflow valve implanted in the aortic position has shown to be hemodynamically stable over a 5-year follow-up in an elderly population with a high prevalence of comorbid conditions.
AB - Background: The Mitroflow valve (Sorin Group, Milan, Italy) has been in use since 1982 and has shown long-term durability in large studies from European centers but has not been studied for long-term hemodynamics in large standardized multicenter trials. This study sought to assess the hemodynamics of the Mitroflow valve by extending the duration of follow-up in an ongoing prospective multicenter trial conducted in North America. Methods: Six sites participated in this midterm study requiring annual follow-up and echocardiographic evaluation using a standardized transthoracic echocardiography acquisition protocol. Results: There were 276 patients enrolled (age 74 ± 8 years) and 54% were in New York Heart Association (NYHA) functional class III-IV. Follow-up from the time of valve implantation had a mean of 4.0 ± 1.7 years with a cumulative follow-up of 1,102 patient-years. At 5 years of follow-up, 99% of patients were free of moderate or severe aortic regurgitation and 94% were in NYHA functional class I or II. Between baseline and 5 years, mean gradients increased an average of 0.4 to 4.3 mm Hg. The change in effective orifice area was appreciably small (-0.1 to -0.3 cm2) after 5 years. There were 57 deaths (4 early and 53 late) and 9 valve explants. Conclusions: The Mitroflow valve implanted in the aortic position has shown to be hemodynamically stable over a 5-year follow-up in an elderly population with a high prevalence of comorbid conditions.
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U2 - 10.1016/j.athoracsur.2012.04.090
DO - 10.1016/j.athoracsur.2012.04.090
M3 - Article
C2 - 22818964
AN - SCOPUS:84866646482
SN - 0003-4975
VL - 94
SP - 1198
EP - 1203
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 4
ER -