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J. Thorac. Cardiovasc. Surg. · Jul 2015
The Freedom Solo pericardial stentless valve: Single-center experience, outcomes, and long-term durability.
- Olaf Stanger, Irina Bleuel, Fabian Gisler, Volkhard Göber, Sylvia Reineke, Brigitta Gahl, Thierry Aymard, Lars Englberger, Thierry Carrel, and Hendrik Tevaearai.
- Clinic for Cardiovascular Surgery, Inselspital University Hospital Bern, Bern, Switzerland. Electronic address: oh.stanger@gmail.com.
- J. Thorac. Cardiovasc. Surg. 2015 Jul 1; 150 (1): 70-7.
ObjectivesTo report our institutional experience and long-term results with the Freedom Solo bovine pericardial stentless bioprosthesis (Sorin Group, Saluggia, Italy).MethodsBetween January 2005 and November 2009, 149 patients (mean age, 73.6 ± 8.7 years; 68 [45.6%] female) underwent isolated (n = 75) or combined (n = 74) aortic valve replacement (AVR) using the Solo in our institution. Follow-up was 100% complete with an average follow-up time of 5.9 ± 2.6 years (maximum, 9.6 years) and a total of 885.3 patient years.ResultsOperative (30-day) mortality was 2.7% (1.3% for isolated AVR [n = 1] and 4.0% for combined procedures [n = 3]). All causes of death were not valve-related. Preoperative peak (mean) gradients of 74.2 ± 23.0 mm Hg (48.6 ± 16.3 mm Hg) decreased to 15.6 ± 5.4 mm Hg (8.8 ± 3.0 mm Hg) after AVR, and remained low for up to 9 years. The postoperative effective orifice area was 1.6 ± 0.57 cm(2), 1.90 ± 0.45 cm(2), 2.12 ± 0.48 cm(2), and 2.20 ± 0.66 cm(2) for the valve sizes 21, 23, 25, and 27, respectively, with absence of severe prosthesis-patient mismatch and 0.7% (n = 1) experienced moderate prosthesis-patient mismatch. During follow-up, 26 patients experienced structural valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation, and SVD at 9 years averaged 0.57 (range, 0.47-0.66), 0.82 (range, 0.69-0.90), and 0.70 (range, 0.57-0.79), respectively.ConclusionsThe Freedom Solo stentless aortic valve is safe to implant and shows excellent early and midterm hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5-6 years and the need for explantation increased markedly, suggesting low durability.Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
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