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- W2092730997 abstract "HomeCirculationVol. 130, No. 23Early Structural Valve Deterioration of the Mitroflow Aortic Bioprosthesis Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBEarly Structural Valve Deterioration of the Mitroflow Aortic Bioprosthesis Tsuyoshi Kaneko, MD, Igor Gosev, MD, Marzia Leacche, MD and John G. Byrne, MD Tsuyoshi KanekoTsuyoshi Kaneko From the Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, MA. Search for more papers by this author , Igor GosevIgor Gosev From the Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, MA. Search for more papers by this author , Marzia LeaccheMarzia Leacche From the Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, MA. Search for more papers by this author and John G. ByrneJohn G. Byrne From the Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, MA. Search for more papers by this author Originally published29 Oct 2014https://doi.org/10.1161/CIRCULATIONAHA.114.013368Circulation. 2014;130:1997–1998Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: December 2, 2014: Previous Version 1 There has been a trend toward more frequent use of bioprosthetic valves, especially in the young generations, over the last decade.1,2 According to the Society of Thoracic Surgeons database, use of bioprosthetic valve increased from 44% in 1996 to 78% in 2006 in North America.1 Freedom from warfarin use and restrictions on diet and activities make bioprosthetic valves more attractive and popular, and multiple reports have shown that choosing a bioprosthetic valve does not decrease survival despite the increased rate of reoperation.3,4Article see p 2012The Mitroflow aortic prosthesis (Sorin Group Inc) is one of the most frequently used bioprostheses, with >100 000 implanted worldwide.5 The bovine pericardium is mounted externally around the stent, which maximizes the flow relative to the stent size. The valve is placed in the supra-annular position compared with the intra-annular position in some of the other bioprostheses. These characteristics allow superior valve hemodynamics in the Mitroflow aortic valve, especially in those with a small aortic annulus (19 and 21 mm)6; therefore, the Mitroflow aortic valve is considered an ideal valve for patients with a small aortic root.The Achilles heel of the bioprosthetic valve is structural valve deterioration (SVD). Cusp tears and thickening, calcification, pannus formation, and thrombus lead to deterioration of the valve,7 which is the leading reason for reoperation in bioprosthetic valves. The rate of SVD differs among ages; valves implanted in younger patients degenerate faster. For patients >65 years of age, the 10-year freedom from SVD in new pericardial valves is typically >90%.8In this issue of Circulation, Sénage et al9 strike a note of warning against the use of the Mitroflow aortic valve. Some of the previous reports have shown 99% 5-year freedom from SVD in Mitroflow valve,6,10 but in this report, the 5-year freedom from SVD was 91.6% and, when a 19-mm Mitroflow was used, 79.8%. The follow-up time was short (3.8±2.0 years), but the first SVD was observed only 14 months after implantation. The cumulative probability of SVD increased significantly from 0.8% at 2 years to 8.4% at 5 years. Most of this early SVD (92%) was caused by calcified prosthetic stenosis rather than a tear of the leaflet or regurgitation. A small-diameter prosthesis (19 and 21 mm) was used in 64.2% of the patients and was a significant risk factor for SVD in both univariate and multivariate analyses. This is a big concern because Mitroflow has been considered the ideal valve in patients with a small root, as mentioned earlier.This is not the first report that questioned the durability of the Mitroflow aortic valve. Alvarez et al11 reported their series of 491 patients >70 years of age who received a Mitroflow aortic bioprosthesis. Freedom from SVD was 95% at 5 years but dropped sharply to 55.8% in 10 years. The median time from operation to SVD was 48 months. Joshi et al12 reported a 3.6% incidence of early SVD within 6 years, requiring reoperation in patients <60 years of age who had a Mitroflow aortic valve implanted. These numbers are high compared with the historical numbers for other pericardial valves. One study showed a higher incidence of SVD in the Mitroflow group compared with the group receiving a Carpentier-Edwards Perimount valve (Edwards Life Science, Irvine, CA) at 10 years (44% vs 13%).13 Interestingly, age, which typically is one of the most important factors for SVD, did not have any significance in this report. The high incidence of early SVD of Mitroflow was seen in both young and elderly patients.In the report by Sénage et al, one third of patients who experienced SVD presented with what the authors describe as “accelerated SVD.” This was defined by an increase in mean valvular gradient >25 mm Hg/y. Recently, Saleeb et al14 have reported this accelerated degeneration of the Mitroflow valve in a young patient population (<30 years of age). Freedom from valve failure was 53% at 2 years and 18% at 3 years in this series. Life-threatening SVD was detected at a median of 6 months after a normal or mild gradient on a previous echocardiogram. Pathological examination showed that intrinsic calcification causing valve fixation was the main reason for this accelerated degeneration. The Sénage et al report gives us more insight into this phenomenon; accelerated SVD was seen more often in patients with a small aortic prosthesis (76.9%) and in patients with a prosthesis gradient >30 mm Hg. This subgroup had 46.2% valve-related death rate after the occurrence of accelerated SVD. SVD had the strongest correlation of mortality, with an increased risk of death of 7.7. This highlights the importance of frequent monitoring with echocardiograms in patients who have a small prosthesis and gradient >30 mm Hg across the bioprosthesis. Given these data, echocardiogram surveillance should be performed at ≤6 months for early detection.Another important finding in this article was the underreported incidence of SVD. In many articles, SVD is reported as the rate of reoperation and explantation of the old prosthesis. This underestimates the incidence of SVD because many patients may develop SVD but few may receive surgical treatment. In this series, an echocardiogram was used to follow up these patients, and an increased gradient and valve insufficiency were used as the criteria for SVD. Only 10.3% of patients with SVD underwent reoperative aortic valve replacement; 11.4% died suddenly and another 11.4% died while on the wait list. There is a question of why 51.4% were not referred to surgery, but this shows the underreported incidence of SVD if reoperation alone is used as the criterion.The externally mounted pericardial valve poses problems for valve-in-valve transcatheter solutions. Because the internal diameter of Mitroflow valve is only 15.4 mm for the 19-mm valve and 17.3 mm for the 21-mm valve, no transcatheter valve currently is recommended because of the likelihood of a postprocedural gradient.15 There is also a concern about coronary obstruction when valve-in-valve replacement is performed because of the externally placed valve leaflet pushing into the ostium.16 For these reasons, reoperation for small Mitroflow SVD likely has to be done through a traditional surgical approach. This report does not provide the presence of symptoms at the time of diagnosis of SVD; however, given the poor outcome of these patients, reoperative aortic valve surgery or a transcatheter procedure for high-risk non–small-annulus patients should be offered when the diagnosis of SVD is made, even if the patient is asymptomatic.This early SVD could be attributed to the absence of antimineralization treatment in older-generation Mitroflow aortic valves. Flameng at al17 compared the incidence of SVD in valves with and without antimineralization therapy. There was an increased incidence of SVD (70.1% versus 90.9% 10-year freedom from SVD) in valves without antimineralization therapy.The Mitroflow A12 was introduced in 1992. This model was modified from the original Mitroflow A11 by reversing the external cloth so that the ribbed side was external. This valve was used widely in Europe and Canada and was subsequently approved in the United States in 2007. The Mitroflow LX is a variation of the A12 and had minor revisions such as the use of an automatic sewing machine, reduction of sewing ring seams to 1 seam, and prefixation by glutaraldehyde rather than postfixation.18 Both Mitroflow A11/12 and Mitroflow LX do not undergo antimineralization treatment. The most recent modification, Mitroflow with phospholipid reduction therapy, added this step. This chemical process uses long-chain alcohol solution to remove phospholipids from the tissue. This new valve was approved for CE marking in 2011 in Europe, and it was approved by the US Food Drug and Administration in April 2014.19Although antimineralization treatment is still a hypothetical explanation for the accelerated degeneration seen in the Mitroflow valve, this reports warns about a potential epidemic of SVD in patients who had Mitroflow A12 and LX implanted. It is unclear whether the Mitroflow with phospholipid reduction therapy will be able to prevent this type of SVD, but this is a separate issue. Monitoring patients who received older-generation Mitroflow with frequent echocardiography is mandatory to prevent undesired complications, especially in high-risk patients. Aggressive treatment is needed even in asymptomatic patients once the gradient becomes severe.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to John G. Byrne, MD, Division of Cardiac Surgery, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115. E-mail [email protected]References1. Brown JM, O’Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database.J Thorac Cardiovasc Surg. 2009; 137:82–90.CrossrefMedlineGoogle Scholar2. Kaneko T, Cohn LH, Aranki SF. Tissue valve is the preferred option for patients aged 60 and older.Circulation. 2013; 128:1365–1371.LinkGoogle Scholar3. Chiang YP, Chikwe J, Moskowitz AJ, Itagaki S, Adams DH, Egorova NN. Survival and long-term outcomes following bioprosthetic vs mechanical aortic valve replacement in patients aged 50 to 69 years.JAMA. 2014; 312:1323–1329.CrossrefMedlineGoogle Scholar4. McClure RS, McGurk S, Cevasco M, Maloney A, Gosev I, Wiegerinck EM, Salvio G, Tokmaji G, Borstlap W, Nauta F, Cohn LH. Late outcomes comparison of nonelderly patients with stented bioprosthetic and mechanical valves in the aortic position: a propensity-matched analysis [published online ahead of print January 15, 2014].J Thorac Cardiovasc Surg. doi: 10.1016/j.jtcvs.2013.12.042. http://www.jtcvsonline.org/article/S0022-5223%2814%2900018-X/abstract. Accessed November 12, 2014.Google Scholar5. Gerosa G, Tarzia V, Rizzoli G, Bottio T. Small aortic annulus: the hydrodynamic performances of 5 commercially available tissue valves.J Thorac Cardiovasc Surg. 2006; 131:1058–1064.CrossrefMedlineGoogle Scholar6. Jamieson WR, Forgie WR, Hayden RI, Langlois Y, Ling H, Stanford EA, Roberts KA, Dolman WB. Hemodynamic performance of Mitroflow aortic pericardial bioprosthesis: optimizing management for the small aortic annulus.Thorac Cardiovasc Surg. 2010; 58:69–75.CrossrefMedlineGoogle Scholar7. Butany J, Feng T, Luk A, Law K, Suri R, Nair V. Modes of failure in explanted Mitroflow pericardial valves.Ann Thorac Surg. 2011; 92:1621–1627.CrossrefMedlineGoogle Scholar8. Rahimtoola SH. Choice of prosthetic heart valve in adults: an update.J Am Coll Cardiol. 2010; 55:2413–2426.CrossrefMedlineGoogle Scholar9. Sénage T, Le Tourneau T, Foucher Y, Pattier S, Cueff C, Michel M, Serfaty JM, Mugniot A, Périgaud C, Carton HF, Al Habash O, Baron O, Roussel JC. Early structural valve deterioration of Mitroflow aortic bioprosthesis: mode, incidence, and impact on outcome in a large cohort of patients.Circulation. 2014; 130:2012–2020.LinkGoogle Scholar10. Asch FM, Heimansohn D, Doyle D, Dembitsky W, Ferdinand FD, Swanson J, Dearani JA, Weissman NJ. Mitroflow aortic bioprosthesis 5-year follow-up: North American Prospective Multicenter Study.Ann Thorac Surg. 2012; 94:1198–1203.CrossrefMedlineGoogle Scholar11. Alvarez JR, Sierra J, Vega M, Adrio B, Martinez-Comendador J, Gude F, Martinez-Cereijo J, Garcia J. Early calcification of the aortic Mitroflow pericardial bioprosthesis in the elderly.Interact Cardiovasc Thorac Surg. 2009; 9:842–846.CrossrefMedlineGoogle Scholar12. Joshi V, Prosser K, Richens D. Early prosthetic valve degeneration with Mitroflow aortic valves: determination of incidence and risk factors.Interact Cardiovasc Thorac Surg. 2014; 19:36–40.CrossrefMedlineGoogle Scholar13. Houel R, Le Besnerais P, Soustelle C, Kirsch M, Hillion ML, Loisance D. Lack of durability of the Mitroflow valve does not affect survival.J Heart Valve Dis. 1999; 8:368–374.MedlineGoogle Scholar14. Saleeb SF, Newburger JW, Geva T, Baird CW, Gauvreau K, Padera RF, Del Nido PJ, Borisuk MJ, Sanders SP, Mayer JE. Accelerated degeneration of a bovine pericardial bioprosthetic aortic valve in children and young adults.Circulation. 2014; 130:51–60.LinkGoogle Scholar15. Bapat VN, Attia R, Thomas M. Effect of valve design on the stent internal diameter of a bioprosthetic valve: a concept of true internal diameter and its implications for the valve-in-valve procedure.JACC Cardiovasc Interv. 2014; 7:115–127.CrossrefMedlineGoogle Scholar16. Gurvitch R, Cheung A, Bedogni F, Webb JG. Coronary obstruction following transcatheter aortic valve-in-valve implantation for failed surgical bioprostheses.Catheter Cardiovasc Interv. 2011; 77:439–444.CrossrefMedlineGoogle Scholar17. Flameng W, Rega F, Vercalsteren M, Herijgers P, Meuris B. Antimineralization treatment and patient-prosthesis mismatch are major determinants of the onset and incidence of structural valve degeneration in bioprosthetic heart valves.J Thorac Cardiovasc Surg. 2014; 147:1219–1224.CrossrefMedlineGoogle Scholar18. Jamieson WRE, Yankah CA, Lorusso R, Benhameid O, Hayden RI, Forgie R, Ling H. Clinical and Hemodynamic Performance of the Sorin Mitroflow Pericardial Bioprosthesis, Aortic Valve, Prof.Chen Ying-Fu (Ed.). 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Theologou T, Harky A, Shaw M, Harrington D, Kuduvalli M, Oo A and Field M (2019) Mitroflow and Perimount Magna 10 years outcomes a direct propensity match analysis to assess reintervention rates and long follow‐up mortality, Journal of Cardiac Surgery, 10.1111/jocs.14250, 34:11, (1279-1287), Online publication date: 1-Nov-2019. Tavakoli R, Danial P, Oudjana A, Jamshidi P, Gassmann M, Leprince P and Lebreton G (2018) Biological aortic valve replacement: advantages and optimal indications of stentless compared to stented valve substitutes. A review, General Thoracic and Cardiovascular Surgery, 10.1007/s11748-018-0884-3, 66:5, (247-256), Online publication date: 1-May-2018. Bassano C, Gislao V, Bovio E, Melino S, Tropea I, Saitto G, Pugliese M, Colella D, Scafuri A and Ruvolo G (2018) An Unexpected Risk Factor for Early Structural Deterioration of Biological Aortic Valve Prostheses, The Annals of Thoracic Surgery, 10.1016/j.athoracsur.2017.07.014, 105:2, (521-527), Online publication date: 1-Feb-2018. Mao J, Wang Y, Philippe E, Cianciulli T, Vesely I, How D, Bourget J, Germain L, Zhang Z and Guidoin R (2017) Microstructural alterations owing to handling of bovine pericardium to manufacture bioprosthetic heart valves: A potential risk for cusp dehiscence, Morphologie, 10.1016/j.morpho.2017.03.003, 101:333, (77-87), Online publication date: 1-Jun-2017. Ius F, Koigeldiyev N, Roumieh M, Ismail I, Tudorache I, Shrestha M, Fleissner F, Haverich A and Cebotari S (2015) Impact of sinuses of Valsalva on prosthesis durability in patients undergoing ascending aorta and aortic valve replacement with Carpentier-Edwards bioprosthesis: a propensity score-based study, European Journal of Cardio-Thoracic Surgery, 10.1093/ejcts/ezv425, 49:6, (1676-1684), Online publication date: 1-Jun-2016. Wollersheim L, Li W, Kaya A, Bouma B, Driessen A, van Boven W, van der Meulen J and de Mol B (2016) Stentless vs Stented Aortic Valve Bioprostheses in the Small Aortic Root, Seminars in Thoracic and Cardiovascular Surgery, 10.1053/j.semtcvs.2016.02.012, 28:2, (390-397), Online publication date: 1-Oct-2017. December 2, 2014Vol 130, Issue 23 Advertisement Article InformationMetrics © 2014 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.114.013368PMID: 25355913 Originally publishedOctober 29, 2014 KeywordsEditorialsbioprosthesisheart valvesaortic valvePDF download Advertisement SubjectsCardiovascular Surgery" @default.
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