PMID- 21342776
OWN - NLM
STAT- MEDLINE
DCOM- 20120207
LR  - 20220409
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Linking)
VI  - 40
IP  - 3
DP  - 2011 Sep
TI  - Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis.
PG  - 749-55
LID - 10.1016/j.ejcts.2010.12.068 [doi]
AB  - OBJECTIVE: The ATS 3f Enable(R) Bioprosthesis is a self-expanding valve with a 
      tubular design that allows for decreased leaflet stress and preservation of 
      aortic sinuses. We report the midterm results of a prospective, multicenter 
      clinical study evaluating the safety and efficacy of this stented bioprosthesis 
      in patients undergoing isolated aortic valve replacement with or without 
      concomitant procedures. METHODS: A total of 140 patients (mean age: 76 +/- 6 years; 
      63% of patients in New York Heart Association (NYHA) stage III-IV) received the 
      ATS 3f Enable((R)) Bioprosthesis in 10 European centers between March 2007 and 
      December 2009. The total accumulated follow-up is 121.8 patient-years. RESULTS: 
      Valve implantation resulted in significant improvement of patients' symptoms. 
      Mean systolic gradient was 9.04 +/- 3.56 and 8.62 +/- 3.16 mm Hg with mean effective 
      orifice area of 1.69 +/- 0.52 and 1.67 +/- 0.44 at 6 months and 1 year, respectively. 
      No significant transvalvular aortic regurgitation was observed. Early 
      complications included three major paravalvular leaks (PVL; 2.1%) resulting in 
      valve explantation and one thrombo-embolic (0.7%) event. All, but one, of the 
      early PVLs were evident intra-operatively with the medical decision made not to 
      reposition or resolve immediately. Late adverse events included three 
      explantations (2.5% per patient-year): one due to PVL and two due to 
      endocarditis. There was an additional case of late endocarditis (0.8% per 
      patient-year) that resolved by medical management. No structural deterioration, 
      valve-related thrombosis or hemolysis was documented. CONCLUSIONS: The sutureless 
      valve implantation technique is feasible and safe with the ATS 3f Enable 
      Bioprosthesis. Valve implantation resulted in excellent hemodynamics and 
      significant clinical improvement. Overall, these data confirm the safety and 
      clinical utility of the Enable(R) Bioprosthesis for aortic valve replacement.
CI  - Copyright (c) 2011 European Association for Cardio-Thoracic Surgery. Published by 
      Elsevier B.V. All rights reserved.
FAU - Martens, Sven
AU  - Martens S
AD  - Department for Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe 
      University, Frankfurt, Germany. martens.herz@gmx.de
FAU - Sadowski, Jerzy
AU  - Sadowski J
FAU - Eckstein, Friedrich S
AU  - Eckstein FS
FAU - Bartus, Krzysztof
AU  - Bartus K
FAU - Kapelak, Boguslaw
AU  - Kapelak B
FAU - Sievers, Hans-Hinrich
AU  - Sievers HH
FAU - Schlensak, Christian
AU  - Schlensak C
FAU - Carrel, Thierry
AU  - Carrel T
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110220
PL  - Germany
TA  - Eur J Cardiothorac Surg
JT  - European journal of cardio-thoracic surgery : official journal of the European 
      Association for Cardio-thoracic Surgery
JID - 8804069
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/*surgery
MH  - Aortic Valve Insufficiency/physiopathology/surgery
MH  - Aortic Valve Stenosis/physiopathology/surgery
MH  - *Bioprosthesis
MH  - Epidemiologic Methods
MH  - Female
MH  - *Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation/adverse effects/*methods
MH  - Hemodynamics/physiology
MH  - Humans
MH  - Male
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Rheumatic Heart Disease/physiopathology/surgery
MH  - Stents
MH  - Sutures
MH  - Treatment Outcome
EDAT- 2011/02/24 06:00
MHDA- 2012/02/09 06:00
CRDT- 2011/02/24 06:00
PHST- 2010/08/31 00:00 [received]
PHST- 2010/12/13 00:00 [revised]
PHST- 2010/12/16 00:00 [accepted]
PHST- 2011/02/24 06:00 [entrez]
PHST- 2011/02/24 06:00 [pubmed]
PHST- 2012/02/09 06:00 [medline]
AID - S1010-7940(11)00029-7 [pii]
AID - 10.1016/j.ejcts.2010.12.068 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. 
      Epub 2011 Feb 20.