PMID- 20609765
OWN - NLM
STAT- MEDLINE
DCOM- 20100803
LR  - 20100708
IS  - 1552-6259 (Electronic)
IS  - 0003-4975 (Linking)
VI  - 90
IP  - 1
DP  - 2010 Jul
TI  - A North American, prospective, multicenter assessment of the Mitroflow aortic 
      pericardial prosthesis.
PG  - 144-152.e1-3
LID - 10.1016/j.athoracsur.2010.02.108 [doi]
AB  - BACKGROUND: The aim of the Mitroflow aortic pericardial valve study was to 
      prospectively assess performance of the Mitroflow prosthesis among North American 
      patients. METHODS: The study was conducted between November 2003 and December 
      2007 on patients requiring aortic valve replacement. The study cohort consisted 
      of 689 patients (391 male, 298 female), with a mean age of 74.3 +/- 8.4 years, 
      and 46.6% of whom were New York Heart Association (NYHA) class I/II 
      preoperatively. Patients were followed at 3 to 6 months and yearly until study 
      closure. Mean follow-up was 25.7 +/- 12 months, and total follow-up was 1,474.4 
      patient-years, with a maximum of 48.7 months. RESULTS: Postoperatively, more than 
      97% of evaluated patients were NYHA class I/II. At 3 years, 131 patients had 
      died, for an actuarial survival of 79.1%; and the 3-year actuarial freedom from 
      valve-related death, valve explant, all valve reoperation, and structural valve 
      dysfunction was 97.0%, 98.1%, 97.9%, and 99.2%, respectively. Other valve-related 
      complications included prosthetic valve endocarditis (1.4% per patient-year), 
      thromboembolic episodes (1.3% per patient-year), major embolism (0.5% per 
      patient-year), perivalvular leak (0.6% per patient-year), and major 
      anticoagulation-related bleeding (0.6% per patient-year). Echocardiograms at 1 
      year showed mean pressure gradients averaged from 7.3 +/- 1.8 mm Hg to 13.4 +/- 
      5.1 mm Hg, and peak gradients averaged from 14.3 +/- 4.7 mm Hg to 26.0 +/- 9.2 mm 
      Hg for valve sizes 27 to 19. Aortic regurgitation in patients was absent/trace 
      (90.2%) or mild (8.7%); none was severe. CONCLUSIONS: The early results of this 
      study show a low incidence of valve-related adverse events and excellent 
      hemodynamic performance. Continued follow-up is needed to determine if long-term 
      durability in North American patients is comparable to that in previous reports 
      on the durability of the Mitroflow valve.
CI  - Copyright 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All 
      rights reserved.
FAU - Conte, John
AU  - Conte J
AD  - Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland 21205, 
      USA. jconte@csurg.jhmi.jhu.edu
FAU - Weissman, Neil
AU  - Weissman N
FAU - Dearani, Joseph A
AU  - Dearani JA
FAU - Bavaria, Joseph
AU  - Bavaria J
FAU - Heimansohn, David
AU  - Heimansohn D
FAU - Dembitsky, Walter
AU  - Dembitsky W
FAU - Doyle, Daniel
AU  - Doyle D
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
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/*surgery
MH  - Bioprosthesis
MH  - Female
MH  - Heart Valve Diseases/*surgery
MH  - *Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - North America
MH  - Prospective Studies
EDAT- 2010/07/09 06:00
MHDA- 2010/08/04 06:00
CRDT- 2010/07/09 06:00
PHST- 2009/09/23 00:00 [received]
PHST- 2010/02/23 00:00 [revised]
PHST- 2010/02/26 00:00 [accepted]
PHST- 2010/07/09 06:00 [entrez]
PHST- 2010/07/09 06:00 [pubmed]
PHST- 2010/08/04 06:00 [medline]
AID - S0003-4975(10)00657-0 [pii]
AID - 10.1016/j.athoracsur.2010.02.108 [doi]
PST - ppublish
SO  - Ann Thorac Surg. 2010 Jul;90(1):144-152.e1-3. doi: 
      10.1016/j.athoracsur.2010.02.108.