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Horst, M; Easo, J; Hölzl, PP; Eichstaedt, HC; Kronberg, K; Nordmeyer, P; Dapunt, OE.
The Freedom SOLO valve: mid-term clinical results with a stentless pericardial valve for aortic valve replacement.
J HEART VALVE DIS. 2011; 20(6): 704-710.
Web of Science PubMed

Co-authors Med Uni Graz: Dapunt Otto Eugen
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Abstract:: The study aim was to evaluate the Freedom SOLO pericardial stentless valve prosthesis implanted in a subcoronary or supra-annular position, using a single running suture, over a follow up period of up to five years. The clinical data obtained after aortic valve replacement (AVR) were analyzed retrospectively for validation. Between April 2004 and September 2009, a total of 143 patients (81 males, 62 females; mean age 71 +/- 7 years; range: 41-87 years) underwent primary AVR using the Freedom SOLO valve, implanted with a supra-annular subcoronary technique. Isolated AVR was performed on 120 patients, while 23 patients required additional surgery that included coronary artery bypass grafting (n = 5), ascending aorta replacement (n = 1), atrial fibrillation surgery (n = 9), and mitral valve repair (n = 1). Clinical investigations were performed before, during and after surgery; the follow up was 100% complete. A subgroup of patients (70%) was investigated echocardiographically during the follow up period to analyze the hemodynamic performance of the prosthesis. For all procedures the mean ischemia time was 66 +/- 15 min, and the mean cardiopulmonary bypass (CPB) time 88 +/- 20 min. For isolated AVR, the mean cross-clamp time was 65 +/- 14 min, and the mean CPB time 85 +/- 17 min. The predominant implanted valve size was 25 mm (42%). Operative mortality was 4.9% (7/143), with an overall mortality of 10.5% (15/143) at 4.7 years of follow up. The mean follow up was 1.8 +/- 1.4 years, and the total follow up 257 patient-years. At postoperative follow up the mean valve gradient was 10.6 mmHg, while the effective orifice area was 1.9 +/- 0.6 cm2 at one month and 1.9 +/- 0.6 cm2 at 12 months. The Freedom SOLO valve was implanted in a cohort of patients, using a simplified, supra-annular subcoronary technique, with no technical problems. Subsequently, the valve demonstrated an excellent clinical performance for up to five years. Further long-term follow up will be required to confirm the performance of the prosthesis with regards to structural and nonstructural valve stability.
Find related publications in this database (using NLM MeSH Indexing): Adult -; Aged -; Aged, 80 and over -; Aortic Valve -; Clinical Trials as Topic -; Female -; Heart Valve Prosthesis -; Heart Valve Prosthesis Implantation -; Hemodynamics -; Humans -; Male -; Middle Aged -; Retrospective Studies -