Original articleAdult cardiacA European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis
Section snippets
Study Design
This prospective, multicenter, nonrandomized trial included 18 centers from 8 European countries, and was registered with the US National Institutes of Health (NCT00876525, www.clinicaltrials.org). Patients were enrolled as part of a US Food and Drug Administration study.
Inclusion and Exclusion Criteria
Patients were referred for native or prosthetic aortic valve replacement and had to be at least 18 years old and capable of providing written informed consent. Patients with previously implanted mitral or tricuspid prostheses,
Operative Data
Table 2 provides the operative results. Approximately 50% of this cohort received a 23-mm valve or smaller. One or more concomitant procedures were required in 43.2% of patients, with coronary artery bypass grafting being the most common (91.4%). Mean aortic cross-clamp time was 64 minutes for isolated aortic valve replacement and greater than 71 minutes when additional procedures were required.
Mortality
There were 9 deaths during the first 30 days after surgery (30-day mortality, 1.5%). All of them were
Comment
Historically, tissue heart valves were anticipated to last for 10 to 15 years before calcific degeneration required their replacement. Subsequent improvements in valve design and biologic materials have further reduced the rate of valve calcification and reoperation, with particular relevance in the elderly population, in which prolonged durability of bioprosthetic valves has been broadly reported 15, 19.
Stentless valves were introduced into clinical practice in the early 1990s with the goal of
References (32)
- et al.
The Sorin Freedom SOLO stentless aortic valve: technique of implantation and operative results in 109 patients
J Thorac Cardiovasc Surg
(2010) - et al.
Single-suture line placement of a pericardial stentless valve
J Thorac Cardiovasc Surg
(2005) - et al.
Single-center experience using the Freedom SOLO aortic bioprosthesis
J Thorac Cardiovasc Surg
(2013) - et al.
Guidelines for reporting mortality and morbidity after cardiac valve interventions
Ann Thorac Surg
(2008) - et al.
Severe thrombocytopenia and its clinical impact after implant of the stentless Freedom Solo bioprosthesis
Ann Thorac Surg
(2013) - et al.
The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority?
J Thorac Cardiovasc Surg
(2014) - et al.
Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 20 years
J Thorac Cardiovasc Surg
(2005) - et al.
Thrombocytopenia after aortic valve replacement with Freedom Solo bioprosthesis: a propensity study
Ann Thorac Surg
(2010) - et al.
Design and performance characteristics of the Pericarbon Stentless valve
J Heart Valve Dis
(1995) - et al.
Operative technique and early hemodynamic results with the Freedom Solo valve
J Heart Valve Dis
(2006)
Technique for implant of the stentless aortic valve Freedom solo
Multimed Man Cardiothorac Surg
The Sorin Freedom SOLO stentless aortic valve: easier implantation technique with potentially less risk of complications
Eur J Cardiothorac Surg
The Sorin Freedom SOLO stentless tissue valve: early outcomes after aortic valve replacement
Tex Heart Inst J
The Freedom SOLO valve: superior hemodynamic results with a new stentless pericardial valve for aortic valve replacement
J Heart Valve Dis
The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial
J Heart Valve Dis
Short-term hemodynamic performance of the Sorin Freedom SOLO stentless valve
J Heart Valve Dis
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Hemodynamic and clinical performance of Solo stentless bioprosthetic aortic valves
2018, Revista Portuguesa de CardiologiaCitation Excerpt :Despite this transient thrombocytopenia, only four patients underwent early resternotomy for bleeding and no episodes of hemorrhagic stroke were observed. The FS/SS supra-annular implantation technique is believed to reduce the incidence of postoperative permanent pacemaker implantation due to AV conduction disturbances, with previously published numbers between 1.3% and 2.7%, lower than those reported for stented prostheses (7% for isolated AVR).9–12 In our series, nine individuals (2.7%) underwent definitive pacemaker implantation; of these, six underwent combined procedures and one had active endocarditis.
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