The Carpentier-Edwards Classic™ and Physio™ Mitral Annuloplasty Rings: A Randomized Trial
Objective: To evaluate clinical and echocardiographic outcomes for the semi-flexible Carpentier-Edwards Physio and the rigid Classic mitral annuloplasty ring.
Methods: Ninety-six patients were randomized for either a Classic (n = 53) or a Physio (n = 43) ring from October 1995 through July 1997. Mean follow-up was 5.1 years (range .1-6.6). We included standard patient characteristics at baseline and during follow-up. Analyses were adjusted for age and gender, and for factors that differed across groups at baseline. In 2002, echocardiography was performed in 74% of the survivors.
Results: We found a 16% difference in mortality: 14% in the Physio group (n = 6) and 30% in the Classic group (n = 16) (adjusted P = .41). Life table analysis shows that the absolute risk of death after 30 months is lower in the Physio group. Intra-operative repair failure occurred in 3 patients (6%) of the Classic group, and in 4 (9%) of the Physio group, resulting in mitral valve replacement. Late failure occurred in 1 patient (2%) in the Classic group, and in 4 (9%) in the Physio group. At follow-up, left ventricular function did not differ across groups (ejection fraction 45% and 48% (adjusted P = .65)). The combined NYHA class III-IV had improved for the Classic group in 42% and for the Physio group in 34%.
Conclusion: Although the 16% difference in mortality did not reach statistical significance, it is considered clinically important. No differences in morbidity, valve function, and left ventricular function were found. Further research to explain the difference in mortality is required.
Helmcke F, Nanda NC, Hsiung MC, et al. 1987. Color doppler assessment of mitral regurgitation with orthogonal planes. Circulation 75:175-83.nBorghetti V, Campana M, Scotti C, et al. 2000. Biologic versus prosthetic ring in mitral-valve repair: enhancement of mitral annulus dynamics and left-ventricular function with pericardial annuloplasty at long term. Eur J Cardio-thorac Surg 17:431-9.nCarpentier A. 1969. La valvuloplastie reconstitutive. Une nouvelle technique de valvuloplastie mitrale. Presse Med 77:251-3.nCarpentier A. 1983. Cardiac valve surgery - the "French" correction. J Thorac Cardiovasc Surg 86:323-37.nCarpentier AF, Lessana A, Relland JYM, et al. 1995. The "Physio-Ring": an advanced concept in mitral valve annuloplasty. Ann Thorac Surg 60:1177-86.nCosgrove DM, Arcidi JM, Rodriguez L, Stewart WJ, Powell K, Thomas JD. 1995. Initial experience with the Cosgrove-Edwards annuloplasty system. Ann Thorac Surg 60:499-504.nDavid TE, Komeda M, Pollick C, Burns RJ. 1989. Mitral valve annuloplasty: the effect of the type on left ventricular function. Ann Thorac Surg 47:524-8.nDavid TE, Armstrong S, Sun Z. 1995. Left ventricular function after mitral valve surgery. J Heart Valve Dis 4(Suppl 2):175-80.nDeloche A, Jebara VA, Relland JY, et al. 1990. Valve repair with Carpentier techniques. The second decade. J Thorac Cardiovasc Surg 99:990-1002.nGillinov AM, Cosgrove DM. 2002. Mitral valve repair for degenerative disease. J Heart Valve Dis 11(Suppl 1):15-20.nYamaura Y, Yoshikawa J, Yoshida K, Hozumi T, Akasaka T, Okada Y. 1995. Three-dimensional analysis of configuration and dynamics in patients with an annuloplasty ring by multiplane transesophageal echocardiography: comparison between flexible and rigid annuloplasty rings. J Heart Valve Dis 4:619-22.nEnriquez-Sarano M, Miller FA Jr, Hayes SN, Bailey KR, Tajik AJ, Seward JB. 1995. Effective mitral regurgitant orifice area: clinical use and itfalls of the proximal isovelocity surface area method. J Am Coll Cardiol 25:703-9.nGreen GR, Dagum P, Glasson JR, et al. 1998. Semirigid or flexible mitral annuloplasty rings do not affect global or basal regional left ventricular systolic function. Circulation 98(Suppl 19):II 128-35.nKreindel MS, Schiavone WA, Lever HM, Cosgrove D. 1986. Systolic anterior motion of the mitral valve after carpentier ring valvuloplasty for mitral valve prolapse. Am J Cardiol 57:408-12.nDagum P, Green GR, Glasson JR, et al. 1999. Potential mechanism of left ventricular outflow tract obstruction after mitral ring annuloplasty. J Thorac Cardiovasc Surg 117:472-80.nDall'Agata A, Taams MA, Fioretti PM., Roelandt JRTC, van Herwerden LA. 1998. Cosgrove-Edwards mitral ring dynamics measured with transesophageal three-dimensional echocardiography. Ann Thorac Surg 65:485-90.nOtto CM. 2000. Valvular stenosis: diagnosis, quantitation and clinical approach. In: Otto CM, ed. Textbook of Clinical Echocardiography, 2nd ed. Philadelphia: Saunders, pp. 229-64.nVan Rijk-Zwikker GL, Schipperheyn JJ, Huysmans HA, Bruschke AV. 1989. Influence of mitral valve prosthesis or rigid mitral ring on left ventricular pump function. A study on exposed and isolated blood-perfused porcine hearts. Circulation 80(3 Pt 1):I-1-I-7.nVan Rijk-Zwikker GL, Mast F, Schipperheyn JJ, Huysmans HA, Bruschke AVG. 1990. Comparison of rigid and flexible rings for annuloplasty of the porcine mitral valve. Circulation 82(Suppl IV):58-64.nVan Rijk-Zwikker GL, Delemarre BJ, Huysmans HA. 1994. Mitral valve anatomy and morphology: relevance to mitral valve replacement and valve reconstruction. J Card Surg 9(Suppl):255-61.n
How to Cite
Author Disclosure & Copyright Transfer Agreement
In order to publish the original work of another person(s), The Heart Surgery Forum® must receive an acknowledgment of the Author Agreement and Copyright Transfer Statement transferring to Forum Multimedia Publishing, L.L.C., a subsidiary of Carden Jennings Publishing Co., Ltd. the exclusive rights to print and distribute the author(s) work in all media forms. Failure to check Copyright Transfer agreement box below will delay publication of the manuscript.
A current form follows:
The author(s) hereby transfer(s), assign(s), or otherwise convey(s) all copyright ownership of the manuscript submitted to Forum Multimedia Publishing, LLC (Publisher). The copyright transfer covers the exclusive rights to reproduce and distribute the article and the material contained therein throughout the world in all languages and in all media of expression now known or later developed, including but not limited to reprints, photographic reproduction, microfilm, electronic data processing (including programming, storage, and transmission to other electronic data record(s), or any other reproductions of similar nature), and translations.
However, Publisher grants back to the author(s) the following:
- The right to make and distribute copies of all or part of this work for use of the author(s) in teaching;
- The right to use, after publication in The Heart Surgery Forum, all or part of the material from this work in a book by the author(s), or in a collection of work by the author(s);
- The royalty-free right to make copies of this work for internal distribution within the institution/company that employs the author(s) subject to the provisions below for a work-made-for-hire;
- The right to use figures and tables from this work, and up to 250 words of text, for any purpose;
- The right to make oral presentations of material from this work.
Publisher reserves the right to grant or refuse permission to third parties to republish all or part of the article or translations thereof. To republish, such third parties must obtain written permission from the Publisher. (This is in accordance with the Copyright Statute, United States Code, Title 17. Exception: If all authors were bona fide officers or employees of the U.S. Government at the time the paper was prepared, the work is a “work of the US Government” (prepared by an officer or employee of the US Government as part of official duties), and therefore is not subject to US copyright; such exception should be indicated on signature lines. If this work was prepared under US Government contract or grant, the US Government may reproduce, royalty-free, all or portions of this work and may authorize others to do so, for official US Government purposes only, if the US Government contract or grant so requires.
I have participated in the conception and design of this work and in the writing of the manuscript and take public responsibility for it. Neither this manuscript nor one with substantially similar content under my authorship has been published, has been submitted for publication elsewhere, or will be submitted for publication elsewhere while under consideration by The Heart Surgery Forum, except as described in an attachment. I have reviewed this manuscript (original version) and approve its submission. If I am listed above as corresponding author, I will provide all authors with information regarding this manuscript and will obtain their approval before submitting any revision. I attest to the validity, accuracy, and legitimacy of the content of the manuscript and understand that Publisher assumes no responsibility for the validity, accuracy, and legitimacy of its content. I warrant that this manuscript is original with me and that I have full power to make this Agreement. I warrant that it contains no matter that is libelous or otherwise unlawful or that invades individual privacy or infringes any copyright or other proprietary right. I agree to indemnify and hold Publisher harmless of and from any claim made against Publisher that relates to or arises out of the publication of the manuscript and agree that this indemnification shall include payment of all costs and expenses relating to the defense of any such claim, including all reasonable attorney’s fees.
I warrant that I have no financial interest in the drugs, devices, or procedures described in the manuscript (except as disclosed in the attached statement).
I state that the institutional Human Subjects Committee and/or the Ethics Committee approved the clinical protocol reported in this manuscript for the use of experimental techniques, drugs, or devices in human subjects and appropriate informed consent documents were utilized.
Furthermore, I state that any and all animals used for experimental purposes received humane care in USDA registered facilities in compliance with the “Principles of Laboratory Animal Care” formulated by the National Society for Medical Research and the “Guide for the Care and Use of Laboratory Animals” prepared by the Institute of Laboratory Animal Resources and published by the National Institutes of Health (NIH Publication No. 85-23, revised 1985).