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Ann Thorac Surg 2006;81:2277-2278
© 2006 The Society of Thoracic Surgeons
Division of Cardiothoracic Surgery, Jackson Memorial Hospital, University of Miami, 1611 NW 12th Ave, East Tower 3072 (R-114), Miami, FL 33136
(Email: rstevens2{at}um-jmh.org; tsalerno{at}med.miami.edu).
Filsoufi and colleagues [1] report a retrospective analysis of a novel device (ring) to correct functional tricuspid regurgitation (TR) during repair of another heart valve. The Edwards MC3 annuloplasty ring (Edwards LifeSciences, Irvine, CA) has a three-dimensional, saddle-shape configuration that the authors claim prevents failure after repair of TR.
The hallmark of any hypothesis-driven study is elimination of all variables except one. This study comes short of this goal so that one has to evaluate the results carefully. The authors respectfully acknowledge a bias in their study in that they utilize a new ring and at the same time they downsize the tricuspid annulus.
The hypothesis of the study is that a three-dimensional ring is superior to other rings. This hypothesis is limited by the fact that no comparison between groups is made and retrospective data is presented. The manufacturers who supply the product provide computer-based modeling on their website to defend the superiority of the design of this ring. Implantation of three-dimensional rings caused 100% of the patients to have no-to-mild TR, thereby supporting this argument. However, the confounding variable that the authors introduced is downsizing of the measured annulus.
Is downsizing of the annulus sufficient enough to account for improved outcome? Alternatively, does the three-dimensional shape of the ring account for improved results? This is a dilemma that is not answered by this study. To progress to the next level of scientific debate, let the reader decide! Certainly the authors are noted experts in valvular surgery and they confidently report the data. For the sake of this commentary, we will argue that size matters and that Filsoufi and colleagues' [1] intentional downsizing of the annulus is the reason for improvement in results.
In the "French Correction," Carpentier [2] uses an indication for correction for TR in women when annular size is greater than a 33 obturator or a 35 obturator in men. He does not mention altering the size of the annulus. Even in McCarthy and colleagues' article [3], which was as recent as 2004, sizing of the tricuspid repair was "at discretion of the surgeon." There is mention of downsizing of the annulus when their group transitioned from the rigid Carpentier ring to the flexible Cosgrove ring. The current authors note that McCarthy and colleagues [3] utilized larger ring sizes compared with the current authors (Table 1). Even with transition toward a smaller annulus, McCarthy and colleagues [3] could not eliminate failure after tricuspid repair. The current authors overall utilized a smaller ring more frequently than McCarthy's group [3] (even after the transition to a flexible ring). As long as patients are not shrinking, smaller ring sizes may significantly reduce the rate of residual TR after tricuspid repair.
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The authors will do well to report long-term data, which we suspect will show no progression of the disease.
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