PMID- 22818964
OWN - NLM
STAT- MEDLINE
DCOM- 20121204
LR  - 20161125
IS  - 1552-6259 (Electronic)
IS  - 0003-4975 (Linking)
VI  - 94
IP  - 4
DP  - 2012 Oct
TI  - Mitroflow aortic bioprosthesis 5-year follow-up: north american prospective 
      multicenter study.
PG  - 1198-203
LID - S0003-4975(12)00962-9 [pii]
LID - 10.1016/j.athoracsur.2012.04.090 [doi]
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.
CI  - Copyright (c) 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All 
      rights reserved.
FAU - Asch, Federico M
AU  - Asch FM
AD  - Medstar Health Research Institute at Medstar Washington Hospital Center, 
      Georgetown University School of Medicine, Washington, DC 20010, USA. 
      federico.asch@medstar.net
FAU - Heimansohn, David
AU  - Heimansohn D
FAU - Doyle, Daniel
AU  - Doyle D
FAU - Dembitsky, Walter
AU  - Dembitsky W
FAU - Ferdinand, Francis D
AU  - Ferdinand FD
FAU - Swanson, Jeffrey
AU  - Swanson J
FAU - Dearani, Joseph A
AU  - Dearani JA
FAU - Weissman, Neil J
AU  - Weissman NJ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120720
PL  - Netherlands
TA  - Ann Thorac Surg
JT  - The Annals of thoracic surgery
JID - 15030100R
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/diagnostic imaging/*surgery
MH  - *Bioprosthesis
MH  - Echocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis
MH  - Hemodynamics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mitral Valve Insufficiency/diagnostic imaging/physiopathology/*surgery
MH  - North America
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/07/24 06:00
MHDA- 2012/12/10 06:00
CRDT- 2012/07/24 06:00
PHST- 2012/02/28 00:00 [received]
PHST- 2012/04/23 00:00 [revised]
PHST- 2012/04/26 00:00 [accepted]
PHST- 2012/07/24 06:00 [entrez]
PHST- 2012/07/24 06:00 [pubmed]
PHST- 2012/12/10 06:00 [medline]
AID - S0003-4975(12)00962-9 [pii]
AID - 10.1016/j.athoracsur.2012.04.090 [doi]
PST - ppublish
SO  - Ann Thorac Surg. 2012 Oct;94(4):1198-203. doi: 10.1016/j.athoracsur.2012.04.090. 
      Epub 2012 Jul 20.