• J. Am. Coll. Cardiol. · Jul 2013

    Randomized Controlled Trial

    Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve).

    • Raj R Makkar, Hasan Jilaihawi, Tarun Chakravarty, Gregory P Fontana, Samir Kapadia, Vasilis Babaliaros, Wen Cheng, Vinod H Thourani, Joseph Bavaria, Lars Svensson, Susheel Kodali, Takahiro Shiota, Robert Siegel, E Murat Tuzcu, Ke Xu, Rebecca T Hahn, Howard C Herrmann, Mark Reisman, Brian Whisenant, Scott Lim, Nirat Beohar, Michael Mack, Paul Teirstein, Charanjit Rihal, Pamela S Douglas, Eugene Blackstone, Augusto Pichard, John G Webb, and Martin B Leon.
    • Heart Institute, Cedars-Sinai Heart Institute, Los Angeles, California 90048, USA. Raj.Makkar@cshs.org
    • J. Am. Coll. Cardiol. 2013 Jul 30;62(5):418-30.

    ObjectivesThis study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR).BackgroundTAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date.MethodsPatients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively.ResultsFrom a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60).ConclusionsAcute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning.Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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