Literature DB >> 20329497

The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial.

Sven Beholz1, Alberto Repossini, Ugolino Livi, Marc Schepens, Mohamed El Gabry, Klaus Matschke, Uday Trivedi, Lothar Eckel, Otto Dapunt, José Luis Zamorano.   

Abstract

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate the early results, hemodynamics and left ventricular remodeling after aortic valve replacement (AVR) with the Freedom SOLO valve, a bovine pericardial valve bioprosthesis, using a single running suture line in a supra-annular position.
METHODS: Between July 2004 and September 2006, a total of 256 patients (116 males; 140 females; mean age 74.5 +/- 6.4 years; range: 41-89 years) who underwent AVR with the Freedom SOLO valve in nine European institutions were enrolled in the study. The indications for AVR were stenosis in 182 patients, regurgitation in 15, and combined in 57. Preoperatively, 37%, 59% and 4% of the patients were in NYHA classes I-II, III, and IV, respectively. Concomitant procedures were performed in 91 patients (36%). A patient subgroup underwent echocardiography preoperatively (n=192), and at one (n=194) and 12 (n=165) months postoperatively.
RESULTS: The early mortality was 2.3% (n=6). There were 18 late deaths (6.2%/pt-yr). After 12 months, 82% of the patients were in NYHA class I-II. Linearized rates were 0.69%/pt-yr for bleeding, 0.34%/pt-yr for thromboembolism, 0.0%/pt-yr for structural degeneration and thrombosis, 1.37%/pt-yr for paravalvular leak, and 2.06%/pt-yr for endocarditis. Five patients required reoperation. Twelve-month transprosthetic regurgitation was graded as absent in 92% of cases. The mean gradient was 42.3 +/- 20.2 mmHg preoperatively, 6.5 +/- 3.8 mmHg at one month, and 6.7 +/- 4.1 mmHg at 12 months. The effective orifice area was improved from 0.78 +/- 0.35 cm2 preoperatively to 1.90 +/- 0.56 cm2 at one month and 1.89 +/- 0.56 cm2 at 12 months. The left ventricular mass was decreased by 23%, from 217.8 +/- 77.2 g/m2 preoperatively to 167.4 +/- 68.2 g/m2 at one year. The mean left ventricular ejection fraction was 65.5 +/- 14.2% preoperatively, and 64.5 +/- 12.5% and 66.0 +/- 10.6% at one month and at 12 months, respectively.
CONCLUSION: The data obtained suggest that the Freedom SOLO stentless bioprosthesis shows excellent early clinical and hemodynamic results, resulting in a significant regression of left ventricular hypertrophy and improvement in left ventricular systolic function.

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Mesh:

Year:  2010        PMID: 20329497

Source DB:  PubMed          Journal:  J Heart Valve Dis        ISSN: 0966-8519


  8 in total

1.  Platelet reduction after stentless pericardial aortic valve replacement.

Authors:  Alberto Repossini; Daniel Bloch; Claudio Muneretto; Paolo Piccoli; Gianluigi Bisleri; Sven Beholz
Journal:  Interact Cardiovasc Thorac Surg       Date:  2012-01-24

2.  A 76-year old man with a torn Freedom SOLO bioprosthesis.

Authors:  Laurens W Wollersheim; Wilson W Li; Jan van der Meulen; Bas A de Mol
Journal:  Interact Cardiovasc Thorac Surg       Date:  2013-10-20

3.  Evaluation of platelet count after isolated biological aortic valve replacement with Freedom Solo bioprosthesis.

Authors:  Antonio Miceli; Daniyar Gilmanov; Michele Murzi; Maria S Parri; Alfredo G Cerillo; Stefano Bevilacqua; Pier A Farneti; Mattia Glauber
Journal:  Eur J Cardiothorac Surg       Date:  2012-01       Impact factor: 4.191

4.  Hemodynamics of Pericardial Aortic Valves: Contemporary Stented versus Stentless Valves in a Matched Comparison.

Authors:  Torsten Christ; Sebastian Holinski; Konstantin Zhigalov; Christina Barbara Zielinski; Herko Grubitzsch
Journal:  Ann Thorac Cardiovasc Surg       Date:  2017-09-08       Impact factor: 1.520

5.  The Sorin Freedom SOLO stentless tissue valve: early outcomes after aortic valve replacement.

Authors:  Garip Altintas; Adem Ilkay Diken; Onur Hanedan; Okan Yurdakok; Sertan Ozyalcin; Seref Alp Kucuker; Mehmet Ali Ozatik
Journal:  Tex Heart Inst J       Date:  2013

6.  Late outcome analysis of the Braile Biomédica® pericardial valve in the aortic position.

Authors:  Lisandro Gonçalves Azeredo; Elinthon Tavares Veronese; José Augusto Duncan Santiago; Carlos Manuel de Almeida Brandão; Pablo Maria Alberto Pomerantzeff; Fabio Biscegli Jatene
Journal:  Rev Bras Cir Cardiovasc       Date:  2014 Jul-Sep

7.  Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies.

Authors:  Farid Foroutan; Gordon H Guyatt; Kathleen O'Brien; Eva Bain; Madeleine Stein; Sai Bhagra; Daegan Sit; Rakhshan Kamran; Yaping Chang; Tahira Devji; Hassan Mir; Veena Manja; Toni Schofield; Reed A Siemieniuk; Thomas Agoritsas; Rodrigo Bagur; Catherine M Otto; Per O Vandvik
Journal:  BMJ       Date:  2016-09-28

8.  In Vitro Study of a Stentless Aortic Bioprosthesis Made of Bacterial Cellulose.

Authors:  Kinga Dawidowska; Piotr Siondalski; Magdalena Kołaczkowska
Journal:  Cardiovasc Eng Technol       Date:  2020-11-17       Impact factor: 2.495

  8 in total

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