Commentary: Trifecta valve: Does a word of caution prevail?

Central MessageAlthough Trifecta valves provided excellent hemodynamics, unpredictable structural valve deterioration associated with abrupt leaflet tear remains a major concern.See Article page 106 in the December 2020 issue. Although Trifecta valves provided excellent hemodynamics, unpredictable structural valve deterioration associated with abrupt leaflet tear remains a major concern. See Article page 106 in the December 2020 issue. The use of bioprosthetic valves for surgical aortic valve replacement has increased during the last few decades due to continuous improvements in durability and hemodynamic performance.1Goldstone A.B. Chiu P. Baiocchi M. Lingala B. Patrick W.L. Fischbein M.P. et al.Mechanical or biologic prostheses for aortic-valve and mitral-valve replacement.N Engl J Med. 2017; 377: 1847-1857Crossref PubMed Scopus (228) Google Scholar,2Brown J.M. O'CarBrien S.M. Wu C. Sikora J.A. Griffith B.P. Gammie J.S. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: change in risks, valve types, and outcomes in the Society of Thoracic Surgeons national database.J Thorac Cardiovasc Surg. 2009; 137: 82-90Abstract Full Text Full Text PDF PubMed Scopus (684) Google Scholar Many commercially available aortic bioprosthetic valves have been modified to increase their effective orifice area, minimize transvalvular pressure gradient, and avoid patient–prosthetic mismatch (PPM) after surgery.3Bavaria J.E. Desai N.D. Cheung A. Petracek M.R. Groh M.A. Borger M.A. et al.The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical trial.J Thorac Cardiovasc Surg. 2014; 147: 590-597Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar The Trifecta bioprosthetic aortic valve (Abbott, St Paul, Minn) is a trileaflet, stented pericardial valve designed for supra-annular placement during surgical aortic valve replacement. The valve leaflets are made from a single bovine pericardial tissue that is externally mounted on a titanium stent to maximize hemodynamic performance.3Bavaria J.E. Desai N.D. Cheung A. Petracek M.R. Groh M.A. Borger M.A. et al.The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical trial.J Thorac Cardiovasc Surg. 2014; 147: 590-597Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar,4Kilic A. Sultan I. Navid F. Aranda-Michel A. Chu D. Thoma F. et al.Trifecta aortic bioprosthesis: midterm results in 1,953 patients form a single center.Ann Thorac Surg. 2019; 107: 1356-1363Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar The Trifecta valve has shown excellent hemodynamic performance with a low transvalvular gradient, acceptable effective orifice area, and low rates of PPM.5Phan K. Ha H. Phan S. Misfeld M. Di Eusanio M. Yan T.D. Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: a systematic review and meta-analysis.J Thorac Cardiovasc Surg. 2015; 149: 1567-1575Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar However, a number of early Trifecta valve failures have been reported, and the most common cause of dysfunction was aortic regurgitation due to leaflet tear involving the noncoronary cusp and pannus formation in the inflow portion.6Sexena P. Greason K.L. Schaff H.V. Early structural valve deterioration of the Trifecta aortic valve biologic prosthesis: a word of caution.J Thorac Cardiovasc Surg. 2014; 147: e10-e11Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar, 7Campisi S. Camilleri L. Innorta A. Azarnoush K. Early failures of Trifecta aortic bioprosthesis.J Thorac Cardiovasc Surg. 2014; 148: e133-e134Abstract Full Text Full Text PDF PubMed Google Scholar, 8Haussig S. Schuler G. Linke A. Treatment of a failing St Jude Medical Trifecta aortic bioprosthesis.J Thorac Cardiovasc Surg. 2014; 148: e133-e134Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar, 9Kaira A. Rehman H. Ramchandani M. Barker C.M. Lawrie G.M. Reul R.M. et al.Early Trifecta valve failure: report of a cluster of cases from a tertiary care referral center.J Thorac Cardiovasc Surg. 2017; 154: 1235-1240Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar, 10Eichinger S. Badreldin A.M.A. Eichinger W.B. Early degeneration caused by cusp tear of first-generation Trifecta bioprosthesis.Ann Thorac Surg. 2018; 106: e297-e298Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar Although the mechanism of these early failures is unclear, it has been suggested that technical failures, such as incautious knot tying, oversized valve selection, and accidental bending of the sewing ring or the titanium stent posts, may cause a change in valve geometry, eventually leading to leaflet damage and tearing.11Jamieson W.R.E. St Jude Medical Trifecta aortic prosthesis: considerations for implantation.J Thorac Cardiovasc Surg. 2015; 149: 1576-1577Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar To avoid these technical pitfalls, the next-generation Trifecta valve with Glide Technology (Trifecta GT; Abbott) was introduced in 2016. This new valve allows easier suturing and better placement in the native annulus, with a modified holder to facilitate parachuting and seating to minimize distortion to the stent and leaflets.12Anselmi A. Ruggieri V.G. Lelong B. Flecher E. Corbineau H. Langanay T. et al.Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement.J Thorac Cardiovasc Surg. 2017; 153: 21-28Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar Thocuta and colleagues13Thocuta L. Liesman D. Kim K. Fukuhara S. Early failure of the Trifecta GT bioprostheses.J Thorac Cardiovasc Surg Tech. 2020; 4: 106-108Google Scholar reported an unexpected early failure of the refined Trifecta GT that presented as newly diagnosed severe aortic insufficiency associated with a detached cusp at the stent post between the noncoronary and the right coronary cusps.13Thocuta L. Liesman D. Kim K. Fukuhara S. Early failure of the Trifecta GT bioprostheses.J Thorac Cardiovasc Surg Tech. 2020; 4: 106-108Google Scholar Noncalcified leaflet tears at the stent post or at the bottom of the leaflet without significant leaflet calcification are rather typical for Trifecta valves, whereas slow progress of calcification has been the primary cause of structural valve deterioration (SVD) in other types of bioprosthetic valves.12Anselmi A. Ruggieri V.G. Lelong B. Flecher E. Corbineau H. Langanay T. et al.Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement.J Thorac Cardiovasc Surg. 2017; 153: 21-28Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar Given the characteristics and timing of the SVD in the newer Trifecta GT, hemodynamic or mechanical stress on the externally mounted leaflet of the valve may contribute to the incidence of SVD, as has been seen among other externally mounted leaflet valves, including the Ionescu–Shiley valves in the 1980s,14Walley V.M. Keon C.A. Khalili M. Moher D. Campagna M.C. Keon W.J. Ionescu–Shiley valve failure I: experience with 125 standard-profile explants.Ann Thorac Surg. 1992; 54: 111-116Abstract Full Text PDF PubMed Scopus (22) Google Scholar,15Walley V.M. Keon C.A. Khalili M. Moher D. Campagna M.C. Keon W.J. Ionescu–Shiley valve failure II: experience with 25 low-profile explants.Ann Thorac Surg. 1992; 54: 117-123Abstract Full Text PDF PubMed Scopus (15) Google Scholar and the recent-generation Mitroflow valves in the 2000s.16Sénage T. Le Tourneau T. Foucher Y. Pattier S. Cueff C. Michel M. et al.Early structural valve deterioration of Mitroflow aortic bioprosthesis: mode, incidence and impact on outcome in a large cohort of patients.Circulation. 2014; 130: 2012-2020Crossref PubMed Scopus (134) Google Scholar Trifecta valves provided excellent early- to mid-term hemodynamic performance and a very low rate of PPM up to 6 or 7 years after surgery.3Bavaria J.E. Desai N.D. Cheung A. Petracek M.R. Groh M.A. Borger M.A. et al.The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical trial.J Thorac Cardiovasc Surg. 2014; 147: 590-597Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar,12Anselmi A. Ruggieri V.G. Lelong B. Flecher E. Corbineau H. Langanay T. et al.Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement.J Thorac Cardiovasc Surg. 2017; 153: 21-28Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar,17Lehmann S. Jawad K. Dieterlen M.T. Hoyer A. Garbade J. Davierwala P. et al.Durability and clinical experience using a bovine pericardial prosthetic aortic valve.J Thorac Cardiovasc Surg. November 27, 2019; ([Epub ahead of print])Abstract Full Text Full Text PDF Scopus (9) Google Scholar The absolute number of observed SVD cases remains limited.12Anselmi A. Ruggieri V.G. Lelong B. Flecher E. Corbineau H. Langanay T. et al.Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement.J Thorac Cardiovasc Surg. 2017; 153: 21-28Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar,17Lehmann S. Jawad K. Dieterlen M.T. Hoyer A. Garbade J. Davierwala P. et al.Durability and clinical experience using a bovine pericardial prosthetic aortic valve.J Thorac Cardiovasc Surg. November 27, 2019; ([Epub ahead of print])Abstract Full Text Full Text PDF Scopus (9) Google Scholar However, clinical presentation of SVD caused by abrupt valve tears often involves sudden-onset severe dyspnea and heart failure and may require emergent redo surgery or a valve-in-valve procedure.12Anselmi A. Ruggieri V.G. Lelong B. Flecher E. Corbineau H. Langanay T. et al.Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement.J Thorac Cardiovasc Surg. 2017; 153: 21-28Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar,13Thocuta L. Liesman D. Kim K. Fukuhara S. Early failure of the Trifecta GT bioprostheses.J Thorac Cardiovasc Surg Tech. 2020; 4: 106-108Google Scholar,18Biancari F. Valtola A. Juvonen T. Husso A. Dahlbacka S. Laakso T. et al.Trifecta versus Perimount Magna Ease aortic valve prostheses.Ann Thorac Surg. 2020; 110: 879-888Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar Physicians involved in the follow-up of these patients should always keep in mind the possibility of rapid SVD in the Trifecta valve. Thus, I recommend a “word of caution” regarding this valve. Early failure of the Trifecta GT bioprosthesesJTCVS TechniquesVol. 4PreviewTrifecta bioprosthetic valves with Glide Technology, also known as Trifecta GT (Abbott Vascular, Santa Clara, Calif), were approved by the US Food and Drug Administration in 2016. These are stented valves with a bovine pericardial sheet externally mounted on a titanium stent. There were several reports of early failure involving the first-generation Trifecta that were related to structural valve degeneration secondary to leaflet calcification, pannus formation, and cusps tear presenting less than 7 years after implantation. 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