Long Term Outcomes of Freestyle Stentless Aortic Bioprosthesis: A Single Center Experience
Keywords:Aortic Aneurysm. Aortic Surgery. Freestyle Stentless Bioprosthesis
Background: The study is presenting our long-term clinical results after freestyle stentless aortic root bioprosthesis replacement in patients with severe aortic insufficiency with ascending aortic aneurysm.
Methods: Seventy-seven patients with ascending aortic aneurysms and aortic valve insufficiency underwent a total root replacement procedure using a stentless “Freestyle” valve (Medtronic Inc., Minneapolis, Minnesota). There were 50 (64.9%) men and 27 (35.1%) women. Mean age was 68.7 ± 11.1 years. The surgical procedure used a complete root replacement. Concomitant procedures included coronary artery bypass grafting in 15 (19.5%) patients.
Results: The mean cardiopulmonary bypass time was 130.3 ± 26.4 minutes and total aortic cross clamp time was 99.5 ± 23.6 minutes. Hospital mortality was 2.6%. The median follow-up time was 11.2 years. The 5- and 10-years freedom from aortic valve reoperation were 97.4 ± 1.2% and 93.4 ± 4.9%, respectively. During 10 years follow up, there were 14 late deaths; 4 deaths were cardiac, and 10 deaths were noncardiac. Valve-related deaths were attributable to thromboembolism in 1 patient, endocarditis in 2 patients, and congestive heart failure in 1 patient.
Conclusion: The freestyle stentless aortic root bioprosthesis offered good clinical outcomes, in terms of survival and structural valve deterioration. The Freestyle valve is a viable option for use in patients undergoing bioprosthetic aortic valve replacement and expected desire for long-term durability.
Bach DS, Kon ND, Dumesnil JG, Sintek CF, Doty DB. 2005. Ten-year outcome after aortic valve replacement with the Freestyle Stentless Bioprosthesis. Ann Thorac Surg 80:480–7.
Bentall H, De Bono A. 1968. A technique for complete replacement of the ascending aorta. Thorax 23:338 –9.
Cartier CP, Dumensil GJ, Metras J, Desaulniers D, Doyle DP, Lemieux MD, et al. 1999. Clinical and hemodynamic performance of the Freestyle aortic root bioprosthesis. Ann Thorac Surg 67:345-51.
David TE, Ivanov J, Armstrong S, Feindel CM, Webb GD. 2002. Aortic valve-sparing operations in patients with aneurysms of the aortic root or ascending aorta. Ann Thorac Surg 74:1758–61.
Doty DB, Cafferty A, Kon ND, Huysmans HA, Krause AH Jr, Westaby S. 1998. Medtronic Freestyle aortic root bioprosthesis: implant techniques. J Card Surg 13:369 –75.
Ennker JAC, Albert AA, Rosendahl UP, Ennker IC, Dalladaku F, Florath I. 2008. Ten-year experience with stentless aortic valves: full-root versus subcoronary implantation. Ann Thorac Surg 85:445–53.
Ennker JAC, Ennker IC, Albert AA, Resendahl UP, Bauer S, Florath I. 2009. The Freestyle stentless bioprosthesis in more than 1000 patients: a single-center experience over 10 years. J Card Surg 24:41–8.
Gelsomino S, Morocutti G, Frassani R, Masullo G, Da Col P, Spedicato L, et al. 2003. Long-term results of Bentall composite aortic root replacement for ascending aortic aneurysms and dissections. Chest 124:984–8.
Gulbins H, Reichenspurner H. 2009. Which Patients Benefit From Stentless Aortic Valve Replacement? Ann Thorac Surg. 88(6):2061-8.
Hagl C, Strauch JT, Spielvogel D, Galla JD, Lansman SL, Squitieri R, et al. 2003. Is the Bentall procedure for ascending aorta or aortic valve replacement the best approach for long-term event-free survival Ann Thorac Surg 76:698–703.
Karangelis D, Tzertzemelis D, Demis AA1, Economidou S, Panagiotou M. 2018. Eighteen years of clinical experience with a modification of the Bentall button technique for total root replacement. J Thorac Dis. 10 (12):6733-6741.
Kouchoukos NT, Wareing TH, Murphy SF, Perrillo JB. 1991. Sixteen- year experience with aortic root replacement. Results of 172 operations. Ann Surg 214:308 –20.
Mastrobuoni S, de Kerchove L, Solari S, Astarci P, Poncelet A, Noirhomme P, Rubay J, El Khoury G. 2016. The Ross procedure in young adults: over 20 years of experience in our Institution. Eur J Cardiothorac Surg. 49(2):507-12; discussion 512-3.
Schachner T, Vertacnik K, Nagiller J, Laufer G. 2005. Factors associated with mortality and long time survival in patients undergoing modified Bentall operations. J Cardiovasc Surg 46:449–55.
Shapira OM, Aldea GS, Cutter SM, Fitzgerald CA, Lazar AN, Shemin RJ. 1999. Improved clinical outcomes after operation of the proximal aorta: a 10-year experience. Ann Thorac Surg 4:1030–7.
Silberman S, Shaheen J, Merin O, Fink D, Shapira N, Liviatan-Strauss N, Bitran D. 2001. Exercise hemodynamics of aortic prostheses: comparison between stentless bioprostheses and mechanical valves. Ann Thorac Surg. 72(4):1217-21.
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management.
Westaby S, Katsumata T, Houel R, Shinfeld A. 1998. Stentless xenograft repair of the dissected aortic root. Ann Thorac Surg 65:1448-50.
Woldendorp K, Starra E, Seco M, Hendel PN, Jeremy RW, Wilson MK, et al. 2014. Replacement of the aortic root with a composite valve-graft conduit: risk factor analysis in 246 consecutive patients. Heart Lung Circ 23:1187–93.
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